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• association label "hydrocortisone tablets are indicated in the following conditions primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia non suppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in during an exacerbation or as maintenance therapy in selected cases of pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia for palliative management of to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "ketorolac tromethamine ophthalmic solution 5 is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis ketorolac tromethamine ophthalmic solution 5 ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction ketorolac tromethamine ophthalmic solution 5 is a nonsteroidal anti inflammatory indicated for the treatment of inflammation following cataract surgery 1 the temporary relief of ocular itching due to seasonal allergic conjunctivitis 1" assertion.
• association label "cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below recommended dosages durations of therapy and applicable patient populations vary among these infections please see dosage and administration acute otitis media streptococcus pneumoniae streptococcus pyogenes haemophilus influenzae moraxella branhamella catarrhalis pharyngitis and or tonsillitis streptococcus pyogenes note community acquired pneumonia s pneumoniae h influenzae acute bacterial exacerbation of chronic bronchitis s pneumoniae h influenzae m catarrhalis h influenzae acute uncomplicated urethral and cervical gonorrhea neisseria gonorrhoeae acute uncomplicated ano rectal infections in women neisseria gonorrhoeae note n gonorrhoeae n gonorrhoeae uncomplicated skin and skin structure infections staphylococcus aureus streptococcus pyogenes note dosage and administration acute maxillary sinusitis haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis uncomplicated urinary tract infections cystitis escherichia coli klebsiella pneumoniae proteus mirabilis staphylococcus saprophyticus note clinical studies appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime therapy may be instituted while awaiting the results of these studies once these results become available antimicrobial therapy should be adjusted accordingly to reduce the development of drug resistant bacteria and maintain the effectiveness of cefpodoxime proxetil for oral suspension usp and other antibacterial drugs cefpodoxime proxetil for oral suspension usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "seroquel xr is an atypical antipsychotic indicated for the treatment of schizophrenia 1 1 adults efficacy was established with seroquel xr in one 6 week and one maintenance trial in patients with schizophrenia as well as in three 6 week trials with seroquel in patients with schizophrenia 14 1 acute treatment of manic or mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or divalproex 1 2 adults efficacy was established with seroquel xr in one 3 week trial in patients with manic or mixed episodes associated with bipolar i disorder as well as two 12 week monotherapy trials and one 3 week adjunctive trial with seroquel in patients with manic episodes associated with bipolar i disorder 14 2 acute treatment of depressive episodes associated with bipolar disorder 1 2 adults efficacy was established with seroquel xr in one 8 week trial in patients with bipolar i or ii disorder as well as two 8 week trials with seroquel in patients with bipolar i or ii disorder 14 2 maintenance treatment of bipolar i disorder as an adjunct to lithium or divalproex 1 2 adults efficacy was established with seroquel in two maintenance trials in patients with bipolar i disorder 14 2 adjunctive treatment of major depressive disorder mdd 1 3 adults efficacy as an adjunct to antidepressants was established in two 6 week trials in patients with mdd who had an inadequate response to an antidepressant alone 14 3 seroquel xr is indicated for the treatment of schizophrenia the efficacy of seroquel xr in schizophrenia was established in one 6 week and one maintenance trial in adults with schizophrenia as well by extrapolation from three 6 week trials in adults with schizophrenia treated with seroquel see clinical studies seroquel xr is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or divalproex the efficacy of seroquel xr in manic or mixed episodes of bipolar i disorder was established in one 3 week trial in adults with manic or mixed episodes associated with bipolar i disorder as well by extrapolation from two 12 week monotherapy and one 3 week adjunctive trial in adults with manic episodes associated with bipolar i disorder treated with seroquel see clinical studies seroquel xr is indicated for the acute treatment of depressive episodes associated with bipolar disorder the efficacy of seroquel xr was established in one 8 week trial in adults with bipolar i or ii disorder as well as extrapolation from two 8 week trials in adults with bipolar i or ii disorder treated with seroquel see clinical studies seroquel xr is indicated for the maintenance treatment of bipolar i disorder as an adjunct to lithium or divalproex efficacy was extrapolated from two maintenance trials in adults with bipolar i disorder treated with seroquel the effectiveness of monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials see clinical studies seroquel xr is indicated for use as adjunctive therapy to antidepressants for the treatment of mdd the efficacy of seroquel xr as adjunctive therapy to antidepressants in mdd was established in two 6 week trials in adults with mdd who had an inadequate response to antidepressant treatment see clinical studies" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of achromycin v tetracycline hcl capsules usp and other antibacterial drugs achromycin v tetracycline hcl capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy achromycin v tetracycline hcl capsules usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below upper respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae hemophilus influenzae lower respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae mycoplasma pneumoniae klebsiella sp skin and soft tissue infections caused by streptococcus pyogenes staphylococcus aureaus infections caused by rickettsia including rocky mountain spotted fever typhus group infections q fever rickettsialpox psittacosis of ornithosis caused by chlamydia psittaci infections caused by chlamydia trachomatis granuloma inquinale caused by calymmatobacterium granulomatis relapsing fever caused by borrelia sp bartonellosis caused by bartonella bacilliformis chancroid caused by hemophilus ducreyi tularemia caused by francisella tularensis plaque caused by yersinia pestis cholera caused by vibrio cholerae brucellosis caused by brucella species infections due to campylobacter fetus as adjunctive therapy in intestinal amebiasis caused by entamoeba histolytica urinary tract infections caused by susceptible strains of escherichia coli klebsiella other infections caused by susceptible gram negative organisms such as e coli enterobacter aerogenes shigella sp acinetobacter sp klebsiella sp bacteroides sp in severe acne adjunctive therapy with achromycin v tetracycline hcl capsules usp may be useful when penicillin is contraindicated tetracyclines are alternative drugs in the treatment of the following infections syphilis and yaws caused by treponema pallidum pertenue vincent s infection caused by fusobacterium fusiforme infections caused by neisseria gonorrhoeae anthrax caused by bacillus anthracis infections due to listeria monocytogenes actinomycosis caused by actinomyces infections due to clostridium" assertion.
• association label "torsemide tablets are a loop diuretic indicated for the treatment of edema associated with heart failure renal disease or hepatic disease 1 1 the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 2 torsemide tablets are indicated for the treatment of edema associated with heart failure renal disease or hepatic disease torsemide tablets are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs there are no controlled trials demonstrating risk reduction with torsemide control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal the antihypertensive effects of torsemide tablets are on the average greater in black patients than in nonblack patients see clinical pharmacology 12 2 torsemide tablets can be used alone or in combination with other antihypertensive agents" assertion.
• association label "osteoarthritis rheumatoid arthritis and acute painful shoulder choline magnesium trisalicylate liquid is effective and generally well tolerated and is logical choice whenever salicylate treatment is indicated it is particularly suitable when a once a day or b i d dosage regimen is important to patient compliance when gastrointestinal intolerance to aspirin is encountered when gastrointestinal microbleeding or hematologic effects of aspirin are considered a patient hazard and when interference or the risk of interference with normal platelet function by aspirin or by propionic acid derivatives is considered to be clinically undesirable use of choline magnesium trisalicylate liquid is appropriate when a liquid dosage form is preferred as in the elderly patient the efficacy of choline magnesium trisalicylate liquid has not been studied in those patients who are designated by the american rheumatism association as belonging in analgesic and antipyretic action in children" assertion.
• association label "seizure disorders clonazepam tablets usp are useful alone or as an adjunct in the treatment of the lennox gastaut syndrome petit mal variant akinetic and myoclonic seizures in patients with absence seizures petit mal who have failed to respond to succinimides clonazepam tablets usp may be useful in some studies up to 3 of patients have shown a loss of anticonvulsant activity often within 3 months of administration in some cases dosage adjustment may reestablish efficacy panic disorder clonazepam tablts usp are indicated for the treatment of panic disorder with or without agoraphobia as defined in dsm iv panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks worry about the implications or consequences of the attacks and or a significant change in behavior related to the attacks the efficacy of clonazepam tablets usp was established in two 6 to 9 week trials in panic disorder patients whose diagnoses corresponded to the dsm iiir category of panic disorder see clinical pharmacology clinical trials panic disorder dsm iv is characterized by recurrent unexpected panic attacks i e a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes the effectiveness of clonazepam tablets usp in long term use that is for more than 9 weeks has not been systematically studied in controlled clinical trials the physician who elects to use clonazepam tablets usp for extended periods should periodically reevaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
• association label "colchicine tablets usp are an alkaloid indicated for prophylaxis and treatment of gout flares in adults 1 1 familial mediterranean fever fmf in adults and children 4 years or older 1 2 colchicine tablets usp are not an analgesic medication and should not be used to treat pain from other causes colchicine tablets usp are indicated for prophylaxis and the treatment of acute gout flares prophylaxis of gout flares treatment of gout flares colchicine tablets usp are indicated in adults and children four years or older for treatment of familial mediterranean fever fmf" assertion.
• association label "a intravenous or intramuscular administration when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition those products labeled for intravenous or intramuscular use are indicated as follows 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance acute adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice mineralocorticoid supplementation may be necessary particularly when synthetic analogs are used preoperatively and in the event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in post traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus severe erythema multiforme stevens johnson syndrome exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema epinephrine is the drug of first choice 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus iritis iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy regional enteritis systemic therapy 8 respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti tuberculosis chemotherapy loeffler s syndrome not manageable by other means aspiration pneumonitis 9 hematologic disorders acquired autoimmune hemolytic anemia idiopathic thrombocytopenic purpura in adults i v only i m administration is contraindicated secondary thrombocytopenia in adults erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 1 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemic of childhood 11 edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management b intra articular or soft tissue administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intra articular or soft tissue administration are indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post traumatic osteoarthritis c intralesional administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intralesional administration are indicated for keloids localized hypertrophic infiltrated inflammatory lesions of lichen planus psoriatic plaques granuloma annulare and lichen simplex chronicus neurodermatitis discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon ganglia" assertion.
• association label "docetaxel injection usp injection concentrate is a microtubule inhibitor indicated for breast cancer bc 1 1 non small cell lung cancer nsclc 1 2 hormone refractory prostate cancer hrpc 1 3 gastric adenocarcinoma gc 1 4 squamous cell carcinoma of the head and neck cancer scchn 1 5 docetaxel injection usp injection concentrate is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy docetaxel injection usp injection concentrate in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node positive breast cancer docetaxel injection usp injection concentrate as a single agent is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior platinum based chemotherapy docetaxel injection usp injection concentrate in combination with cisplatin is indicated for the treatment of patients with unresectable locally advanced or metastatic non small cell lung cancer who have not previously received chemotherapy for this condition docetaxel injection usp injection concentrate in combination with prednisone is indicated for the treatment of patients with androgen independent hormone refractory metastatic prostate cancer docetaxel injection usp injection concentrate in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction who have not received prior chemotherapy for advanced disease docetaxel injection usp injection concentrate in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck scchn" assertion.
• association label "penicillin g sodium for injection usp is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin g therapy with penicillin g sodium for injection usp may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below however once these results become available appropriate therapy should be continued clinical indication infecting organism septicemia empyema pneumonia pericarditis endocarditis meningitis streptococcus pyogenes group a b hemolytic streptococcus other b hemolytic streptococci including groups c h g l and m streptococcus pneumoniae staphylococcus penicillinase producing strains anthrax bacillus anthracis actinomycosis cervico facial disease and thoracic and abdominal disease actinomyces israelil botulism adjunctive therapy to antitoxin gas gangrene and tetanus adjunctive therapy to human tetanus immune globulin clostridium species diphtheria adjunctive therapy to antitoxin and prevention of the carrier state corynebacterium diphtheriae erysipelothrix endocarditis erysipelothrix rhusiopthiae fusospirochetosis severe infections of the oropharynx vincent s lower respiratory tract and genital area fusobacterium species and spirochetes listeria infections including meningitis and endocarditis listeria monocytogenes pasteurella infections including bacteremia and meningitis pasteurella multocida haverhill fever streptobacillus moniliformis rat bite fever spirillum minus or streptobacillus moniliformis disseminated gonococcal infections neisseria gonorrhoeae penicillin susceptible syphilis congenital and neurosyphilis treponema pallidum meningococcal meningitis and or septicemia neisseria meningitidis gram negative bacillary infections bacteremias escherichia coli enterobacter aerogenes alcaligenes faecalis salmonella shigella proteus mirabilis is not the drug of choice in the treatment of gram negative bacillary infections to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g sodium and other antibacterial drugs penicillin g sodium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "verapamil hydrochloride tablets usp are indicated for the treatment of the following angina 1 angina at rest including vasospastic prinzmetal s variant angina unstable crescendo pre infarction angina 2 chronic stable angina classic effort associated angina arrhythmias 1 in association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and or atrial fibrillation see warnings accessory bypass tract 2 prophylaxis of repetitive paroxysmal supraventricular tachycardia essential hypertension verapamil hydrochloride tablets are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy" assertion.
• association label "when oral therapy is not feasible the intramuscular use control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus the intra articular or soft tissue administration the intralesional administration betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "gatifloxacin ophthalmic solution 5 is a topical fluoroquinolone anti infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms haemophilus influenzae staphylococcus aureus staphylococcus epidermidis streptococcus mitis streptococcus oralis streptococcus pneumoniae efficacy for this organism was studied in fewer than 1 infections 1 gatifloxacin ophthalmic solution 5 is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms aerobic gram positive bacteria staphylococcus aureus staphylococcus epidermidis streptococcus mitis streptococcus oralis streptococcus pneumoniae aerobic gram negative bacteria haemophilus influenzae" assertion.
• association label "caspofungin acetate is an echinocandin antifungal indicated in adults and pediatric patients 3 months of age and older for empirical therapy for presumed fungal infections in febrile neutropenic patients 1 treatment of candidemia and the following candida 1 treatment of esophageal candidiasis 1 treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies 1 caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile neutropenic adult and pediatric patients 3 months of age and older see clinical studies 14 1 14 5 caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections intra abdominal abscesses peritonitis and pleural space infections in adult and pediatric patients 3 months of age and older see clinical studies 14 2 14 5 limitations of use candida caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients 3 months of age and older see clinical studies 14 3 14 5 limitations of use see clinical studies 14 3 caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients 3 months of age and older who are refractory to or intolerant of other therapies see clinical studies 14 4 14 5 limitations of use" assertion.
• association label "acetylcysteine solution usp is indicated as adjuvant therapy for patients with abnormal viscid or inspissated mucous secretions in such conditions as chronic bronchopulmonary disease chronic emphysema emphysema with bronchitis chronic asthmatic bronchitis tuberculosis bronchiectasis and primary amyloidosis of the lung acute bronchopulmonary disease pneumonia bronchitis tracheobronchitis pulmonary complications of cystic fibrosis tracheostomy care pulmonary complications associated with surgery use during anesthesia post traumatic chest conditions atelectasis due to mucous obstruction diagnostic bronchial studies bronchograms bronchospirometry and bronchial wedge catheterization acetylcysteine solution usp administered orally is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen it is essential to initiate treatment as soon as possible after the overdose and in any case within 24 hours of ingestion" assertion.
• association label "hypertension atenolol tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure lowers the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol usp control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy atenolol tablets usp may be administered with other antihypertensive agents angina pectoris due to coronary atherosclerosis atenolol tablets usp are indicated for the long term management of patients with angina pectoris acute myocardial infarction atenolol tablets usp are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality treatment can be initiated as soon as the patient s clinical condition allows see dosage and administration contraindications and warnings in general there is no basis for treating patients like those who were excluded from the isis 1 trial blood pressure less than 1 mm hg systolic heart rate less than 5 bpm or have other reasons to avoid beta blockade as noted above some subgroups e g elderly patients with systolic blood pressure below 12 mm hg seemed less likely to benefit" assertion.
• association label "rabeprazole sodium delayed release tablets is a proton pump inhibitor ppi indicated in adults for healing of erosive or ulcerative gastroesophageal reflux disease gerd 1 1 maintenance of healing of erosive or ulcerative gerd 1 2 treatment of symptomatic gerd 1 3 healing of duodenal ulcers 1 4 helicobacter pylori 1 5 treatment of pathological hypersecretory conditions including zollinger ellison syndrome 1 6 in adolescent patients 12 years of age and older for short term treatment of symptomatic gerd 1 7 rabeprazole sodium delayed release tablets is indicated for short term 4 to 8 weeks treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease gerd for those patients who have not healed after 8 weeks of treatment an additional 8 week course of rabeprazole sodium delayed release tablets may be considered rabeprazole sodium delayed release tablets is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease gerd maintenance controlled studies do not extend beyond 12 months rabeprazole sodium delayed release tablets is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks rabeprazole sodium delayed release tablets is indicated for short term up to four weeks treatment in the healing and symptomatic relief of duodenal ulcers most patients heal within four weeks rabeprazole sodium delayed release tablets in combination with amoxicillin and clarithromycin as a three drug regimen is indicated for the treatment of patients with h pylori h pylori h pylori see clinical studies 14 5 dosage and administration 2 5 in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 2 clinical pharmacology 12 2 rabeprazole sodium delayed release tablets is indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome rabeprazole sodium delayed release tablets is indicated for the treatment of symptomatic gerd in adolescents 12 years of age and above for up to 8 weeks" assertion.
• association label "dalfampridine extended release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis ms this was demonstrated by an increase in walking speed see clinical studies 14 dalfampridine extended release tablets are a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis ms this was demonstrated by an increase in walking speed 1 14" assertion.
• association label "minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum caused by chlamydia trachomatis psittacosis ornithosis due to chlamydia psittaci trachoma caused by chlamydia trachomatis although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis endocervical or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella species in conjunction with streptomycin bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis minocycline is indicated for the treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species minocycline hydrochloride capsules usp are indicated for the treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory tract infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus note minocycline is not the drug of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated minocycline is an alternative drug in the treatment of the following infections uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium species in acute intestinal amebiasis minocycline may be a useful adjunct to amebicides in severe acne minocycline may be useful adjunctive therapy oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers diagnostic laboratory procedures including serotyping and susceptibility testing should be performed to establish the carrier state and the correct treatment it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high oral minocycline is not indicated for the treatment of meningococcal infection although no controlled clinical efficacy studies have been conducted limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum to reduce the development of drug resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules usp and other antibacterial drugs minocycline hydrochloride capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy close" assertion.
• association label "1 1 healing of erosive or ulcerative gerd in adults rabeprazole sodium delayed release tablets are indicated for short term 4 to 8 weeks treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease gerd for those patients who have not healed after 8 weeks of treatment an additional 8 week course of rabeprazole sodium delayed release tablets may be considered 1 2 maintenance of healing of erosive or ulcerative gerd in adults rabeprazole sodium delayed release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease gerd maintenance controlled studies do not extend beyond 12 months 1 3 treatment of symptomatic gerd in adults rabeprazole sodium delayed release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks 1 4 healing of duodenal ulcers in adults rabeprazole sodium delayed release tablets are indicated for short term up to four weeks treatment in the healing and symptomatic relief of duodenal ulcers most patients heal within four weeks 1 5 helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in adults rabeprazole sodium delayed release tablets in combination with amoxicillin and clarithromycin as a three drug regimen are indicated for the treatment of patients with h pylori infection and duodenal ulcer disease active or history within the past 5 years to eradicate h pylori eradication of h pylori has been shown to reduce the risk of duodenal ulcer recurrence see clinical studies 14 5 and dosage and administration 2 5 in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 2 and the clarithromycin package insert clinical pharmacology 12 2 1 6 treatment of pathological hypersecretory conditions including zollinger ellison syndrome in adults rabeprazole sodium delayed release tablets are indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome 1 7 short term treatment of symptomatic gerd in adolescent patients 12 years of age and older rabeprazole sodium delayed release tablets are indicated for the treatment of symptomatic gerd in adolescents 12 years of age and above for up to 8 weeks" assertion.
• association label "minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum caused by chlamydia trachomatis psittacosis ornithosis due to chlamydia psittaci trachoma caused by chlamydia trachomatis although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis endocervical or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella species in conjunction with streptomycin bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis minocycline is indicated for the treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species minocycline hydrochloride capsules usp are indicated for the treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory tract infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus note minocycline is not the drug of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated minocycline is an alternative drug in the treatment of the following infections uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium species in acute intestinal amebiasis minocycline may be a useful adjunct to amebicides in severe acne minocycline may be useful adjunctive therapy oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers diagnostic laboratory procedures including serotyping and susceptibility testing should be performed to establish the carrier state and the correct treatment it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high oral minocycline is not indicated for the treatment of meningococcal infection although no controlled clinical efficacy studies have been conducted limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum to reduce the development of drug resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules usp and other antibacterial drugs minocycline hydrochloride capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy close" assertion.
• association label "cimetidine tablets are indicated in most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks see concomitant antacids should be given as needed for relief of pain however simultaneous administration of cimetidine tablets and antacids is not recommended since antacids have been reported to interfere with the absorption of cimetidine 1 short term treatment of active duodenal ulcer dosage and administration duodenal ulcer patients have been maintained on continued treatment with cimetidine tablets 4 mg at bedtime for periods of up to 5 years 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer there is no information concerning usefulness of treatment periods of longer than 8 weeks 3 short term treatment of active benign gastric ulcer erosive esophagitis diagnosed by endoscopy treatment is indicated for 12 weeks for healing of lesions and control of symptoms the use of cimetidine tablets beyond 12 weeks has not been established see 4 erosive gastroesophageal reflux gerd dosage and administration gerd i e zollinger ellison syndrome systemic mastocytosis multiple endocrine adenomas 5 the treatment of pathological hypersecretory conditions" assertion.
• association label "when oral therapy is not feasible the intramuscular use control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus the intra articular or soft tissue administration the intralesional administration betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "seroquel xr is an atypical antipsychotic indicated for the treatment of schizophrenia 1 1 adults efficacy was established with seroquel xr in one 6 week and one maintenance trial in patients with schizophrenia as well as in three 6 week trials with seroquel in patients with schizophrenia 14 1 acute treatment of manic or mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or divalproex 1 2 adults efficacy was established with seroquel xr in one 3 week trial in patients with manic or mixed episodes associated with bipolar i disorder as well as two 12 week monotherapy trials and one 3 week adjunctive trial with seroquel in patients with manic episodes associated with bipolar i disorder 14 2 acute treatment of depressive episodes associated with bipolar disorder 1 2 adults efficacy was established with seroquel xr in one 8 week trial in patients with bipolar i or ii disorder as well as two 8 week trials with seroquel in patients with bipolar i or ii disorder 14 2 maintenance treatment of bipolar i disorder as an adjunct to lithium or divalproex 1 2 adults efficacy was established with seroquel in two maintenance trials in patients with bipolar i disorder 14 2 adjunctive treatment of major depressive disorder mdd 1 3 adults efficacy as an adjunct to antidepressants was established in two 6 week trials in patients with mdd who had an inadequate response to an antidepressant alone 14 3 seroquel xr is indicated for the treatment of schizophrenia the efficacy of seroquel xr in schizophrenia was established in one 6 week and one maintenance trial in adults with schizophrenia as well by extrapolation from three 6 week trials in adults with schizophrenia treated with seroquel see clinical studies seroquel xr is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or divalproex the efficacy of seroquel xr in manic or mixed episodes of bipolar i disorder was established in one 3 week trial in adults with manic or mixed episodes associated with bipolar i disorder as well by extrapolation from two 12 week monotherapy and one 3 week adjunctive trial in adults with manic episodes associated with bipolar i disorder treated with seroquel see clinical studies seroquel xr is indicated for the acute treatment of depressive episodes associated with bipolar disorder the efficacy of seroquel xr was established in one 8 week trial in adults with bipolar i or ii disorder as well as extrapolation from two 8 week trials in adults with bipolar i or ii disorder treated with seroquel see clinical studies seroquel xr is indicated for the maintenance treatment of bipolar i disorder as an adjunct to lithium or divalproex efficacy was extrapolated from two maintenance trials in adults with bipolar i disorder treated with seroquel the effectiveness of monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials see clinical studies seroquel xr is indicated for use as adjunctive therapy to antidepressants for the treatment of mdd the efficacy of seroquel xr as adjunctive therapy to antidepressants in mdd was established in two 6 week trials in adults with mdd who had an inadequate response to antidepressant treatment see clinical studies" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
• association label "a intravenous or intramuscular administration when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition those products labeled for intravenous or intramuscular use are indicated as follows 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance acute adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice mineralocorticoid supplementation may be necessary particularly when synthetic analogs are used preoperatively and in the event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in post traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus severe erythema multiforme stevens johnson syndrome exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema epinephrine is the drug of first choice 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus iritis iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy regional enteritis systemic therapy 8 respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti tuberculosis chemotherapy loeffler s syndrome not manageable by other means aspiration pneumonitis 9 hematologic disorders acquired autoimmune hemolytic anemia idiopathic thrombocytopenic purpura in adults i v only i m administration is contraindicated secondary thrombocytopenia in adults erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 1 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemic of childhood 11 edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management b intra articular or soft tissue administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intra articular or soft tissue administration are indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post traumatic osteoarthritis c intralesional administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intralesional administration are indicated for keloids localized hypertrophic infiltrated inflammatory lesions of lichen planus psoriatic plaques granuloma annulare and lichen simplex chronicus neurodermatitis discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon ganglia" assertion.
• association label "risperidone is an atypical antipsychotic agent indicated for treatment of schizophrenia in adults 1 1 alone or in combination with lithium or valproate for the short term treatment of acute manic or mixed episodes associated with bipolar i disorder in adults 1 2 due to janssen pharmaceuticals corporation s marketing exclusivity rights this drug product is not labeled for use in pediatric patients with schizophrenia bipolar mania or autistic disorder 1 1 1 2 1 3 adults risperidone is indicated for the acute and maintenance treatment of schizophrenia see clinical studies 14 1 adolescents due to janssen pharmaceuticals corporation s marketing exclusivity rights this drug product is not labeled for use in pediatric patients with schizophrenia pediatric use information for the treatment of pediatric patients with schizophrenia 13 to 17 years of age is approved for janssen pharmaceuticals corporation s risperidone drug products monotherapy adults and pediatrics risperidone is indicated for the short term treatment of acute manic or mixed episodes associated with bipolar i disorder in adults see clinical studies 14 2 due to janssen pharmaceuticals corporation s marketing exclusivity rights this drug product is not labeled for use in pediatric patients with bipolar mania pediatric use information for the treatment of pediatric patients with bipolar mania 1 to 17 years of age is approved for janssen pharmaceuticals corporation s risperidone drug products combination therapy adults the combination of risperidone with lithium or valproate is indicated for the short term treatment of acute manic or mixed episodes associated with bipolar i disorder see clinical studies 14 3 pediatrics due to janssen pharmaceuticals corporation s marketing exclusivity rights this drug product is not labeled for use in pediatric patients with irritability associated with autistic disorder information regarding the treatment of pediatric patients with irritability associated with autistic disorder 5 to 16 years of age is approved for janssen pharmaceuticals corporation s risperidone drug products" assertion.
• association label "diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of aeds who require intermittent use of diazepam to control bouts of increased seizure activity evidence to support the use of diazepam rectal gel was adduced in two controlled trials see clinical pharmacology clinical studies subsection that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity sometimes heralded by nonconvulsive symptoms that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely although these clusters or bouts of seizures differed among patients for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient the conclusion that a patient experienced such unique episodes of seizure activity was based on historical information" assertion.
• association label "lansoprazole delayed release orally disintegrating tablets are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of h pylori 1 2 maintenance of healed duodenal ulcers in adults 1 3 treatment of active benign gastric ulcer in adults 1 4 healing of non steroidal anti inflammatory drugs nsaid associated gastric ulcer in adults 1 5 risk reduction of nsaid associated gastric ulcer in adults 1 6 treatment of symptomatic gastroesophageal reflux disease gerd in adults and pediatric patients 1 year of age and older 1 7 treatment of erosive esophagitis ee in adults and pediatric patients 1 year of age and older 1 8 maintenance of healing of ee in adults 1 9 pathological hypersecretory conditions including zollinger ellison syndrome zes in adults 1 1 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment for four weeks for healing and symptom relief of active duodenal ulcer see clinical studies 14 1 triple therapy lansoprazole delayed release orally disintegrating tablets amoxicillin clarithromycin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h pylori h pylori h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin and clarithromycin dual therapy lansoprazole delayed release orally disintegrating tablets amoxicillin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected microbiology h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers controlled studies do not extend beyond 12 months see clinical studies 14 3 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment up to eight weeks for healing and symptom relief of active benign gastric ulcer see clinical studies 14 4 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the treatment of nsaid associated gastric ulcer in patients who continue nsaid use controlled studies did not extend beyond eight weeks see clinical studies 14 5 lansoprazole delayed release orally disintegrating tablets are indicated in adults for reducing the risk of nsaid associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an nsaid controlled studies did not extend beyond 12 weeks see clinical studies 14 6 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for the treatment of heartburn and other symptoms associated with gerd see clinical studies 14 7 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for healing and symptom relief of all grades of ee for adults who do not heal with lansoprazole delayed release orally disintegrating tablets for eight weeks 5 to 1 it may be helpful to give an additional eight weeks of treatment if there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed release orally disintegrating tablets may be considered see clinical studies 14 8 lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of ee controlled studies did not extend beyond 12 months see clinical studies 14 9 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome see clinical studies 14 1" assertion.
• association label "indications and usage neoplastic disease methotrexate is indicated in the treatment of gestational choriocarcinoma chorioadenoma destuens and hydatidiform mole methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer epidermoid cancers of the head and neck advanced mycosis fungoides cutaneous t cell lymphoma and lung cancer particularly squamous cell and small cell types methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non hodgkin s lymphomas psoriasis methotrexate is indicated in the symptomatic control of severe recalcitrant disabling psoriasis that is not adequately responsive to other forms of therapy but only when the diagnosis has been established as by biopsy and or after dermatologic consultation it is important that a psoriasis flare is not due to an undiagnosed concomitant disease affecting immune responses rheumatoid arthritis including polyarticular course juvenile rheumatoid arthritis methotrexate is indicated in the management of selected adults with severs active rheumatoid arthritis acr criteria or children with active polyarticular course juvenile rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non steroidal antiinflammatory agents nsaids aspirin nsaids and or low dose steroids may be continued although the possibility of increased toxicity with concomitant use of nsaids including salicylates has not been fully explored see precautions drug interactions steroids may be reduced gradually in patients who respond to methotrexate combined use of methotrexate with gold penicilamine hydroxychloroquine sulfasalazine or cytotoxic agents has not been studied any may increase the incidence of adverse effects rest and physiotherapy as indicated should be continued" assertion.
• association label "iressa is indicated for the first line treatment of patients with metastatic non small cell lung cancer nsclc whose tumors have epidermal growth factor receptor egfr exon 19 deletions or exon 21 l858r substitution mutations as detected by an fda approved test see clinical studies 14 limitation of use safety and efficacy of iressa have not been established in patients with metastatic nsclc whose tumors have egfr mutations other than exon 19 deletions or exon 21 l858r substitution mutations see clinical studies 14 iressa is a tyrosine kinase inhibitor indicated for the first line treatment of patients with metastatic non small cell lung cancer nsclc whose tumors have epidermal growth factor receptor egfr exon 19 deletions or exon 21 l858r substitution mutations as detected by an fda approved test 1 limitation of use safety and efficacy of iressa have not been established in patients whose tumors have egfr mutations other than exon 19 deletions or exon 21 l858r substitution mutations 1" assertion.
• association label "omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are indicated for short term treatment of active duodenal ulcer in adults most patients heal within four weeks some patients may require an additional four weeks of therapy eradication of h pylori has been shown to reduce the risk of duodenal ulcer recurrence triple therapy omeprazole delayed release capsules in combination with clarithromycin and amoxicillin is indicated for treatment of patients with h pylori infection and duodenal ulcer disease active or up to 1 year history to eradicate h pylori in adults dual therapy omeprazole delayed release capsules in combination with clarithromycin are indicated for treatment of patients with h pylori infection and duodenal ulcer disease to eradicate h pylori in adults among patients who fail therapy omeprazole delayed release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 4 and the clarithromycin prescribing information microbiology sectio n omeprazole delayed release capsules are indicated for short term treatment 4 to 8 weeks of active benign gastric ulcer in adults omeprazole delayed release capsules are indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks in patients 2 years of age and older pediatric patients 2 years of age to adults omeprazole delayed release capsules are indicated for the short term treatment 4 to 8 weeks of ee due to acid mediated gerd that has been diagnosed by endoscopy in patients 2 years of age and older the efficacy of omeprazole delayed release capsules used for longer than 8 weeks in patients with ee has not been established if a patient does not respond to 8 weeks of treatment an additional 4 weeks of treatment may be given if there is recurrence of ee or gerd symptoms e g heartburn additional 4 to 8 week courses of omeprazole delayed release capsules may be considered omeprazole delayed release capsules are indicated for the maintenance healing of ee due to acid mediated gerd in patients 2 years of age and older controlled studies do not extend beyond 12 months omeprazole delayed release capsules are indicated for the long term treatment of pathological hypersecretory conditions e g zollinger ellison syndrome multiple endocrine adenomas and systemic mastocytosis in adults" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin v potassium tablets penicillin v potassium for oral solution and other antibacterial drugs penicillin v potassium tablets and penicillin v potassium for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antimicrobial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin v potassium tablets usp and penicillin v potassium for oral solution usp are indicated in the treatment of mild to moderately severe infections due to penicillin g sensitive microorganisms therapy should be guided by bacteriological studies including sensitivity tests and by clinical response note severe pneumonia empyema bacteremia pericarditis meningitis and arthritis should not be treated with penicillin v during the acute stage indicated surgical procedures should be performed the following infections will usually respond to adequate dosage of penicillin v streptococcal infections without bacteremia mild to moderate infections of the upper respiratory tract scarlet fever and mild erysipelas note streptococci in groups a c g h l and m are very sensitive to penicillin other groups including group d enterococcus are resistant pneumococcal infections mild to moderately severe infections of the respiratory tract staphylococcal infections penicillin g sensitive mild infections of the skin and soft tissues note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections fusospirochetosis vincent s gingivitis and pharyngitis mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin note necessary dental care should be accomplished in infections involving the gum tissue medical conditions in which oral penicillin therapy is indicated as prophylaxis for the prevention of recurrence following rheumatic fever and or chorea prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions although no controlled clinical efficacy studies have been conducted penicillin v has been suggested by the american heart association and the american dental association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1 oral penicillin should not be used in those patients at particularly high risk for endocarditis e g those with prosthetic heart valves or surgically constructed systemic pulmonary shunts penicillin v should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery lower intestinal tract surgery sigmoidoscopy and childbirth since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen note when selecting antibiotics for the prevention of bacterial endocarditis the physician or dentist should read the full joint statement of the american heart association and the american dental association the manufacturer s complete drug information can be viewed on the fda site here" assertion.
• association label "prednisone tablets are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
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