Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 150 mg - quetiapine extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine [see clinical studies (14.1) ]. quetiapine  extended-release tablets are 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 quetiapine  extended-release tablets 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. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar i disorder as well as

Armenija - angleščina - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

macleods pharmaceuticals ltd. - ethambutol (ethambutol hydrochloride) - tablets film-coated - 400mg

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. ibandronate sodium tablets increases bone mineral density (bmd) and reduce the incidence of vertebral fractures. the optimal duration of use has not been determined. the safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium tablets are contraindicated in patients with the following conditions:   o abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1] )   o inability to stand or sit upright for at le

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)]. limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets  is not recommended to be initiated, unless the  benefit outweighs the risk, in: • adult females with cd4+ cell counts greater than 250 cells/mm3 or • adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine  is contraindicated: • in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)]. • for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)]. pregnancy exposure registry

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)].  emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 1 mg - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - candesartan cilexetil 16 mg - candesartan cilexitil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces 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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with candesartan cilexitil and hydrochlorothiazide tablets. 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 j

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - entacapone (unii: 4975g9nm6t) (entacapone - unii:4975g9nm6t) - entacapone 200 mg - entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with parkinson’s disease (see clinical pharmacology, clinical studies).   entacapone tablets effectiveness has not been systematically evaluated in patients with parkinson’s disease who do not experience end-of-dose “wearing-off”. entacapone tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. entacapone tablets are not a controlled substance. animal studies to evaluate the drug abuse and potential dependence have not been conducted. although clinical studies have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: • severe renal impairment (egfr below 30 ml/min/1.73 m2 ) (see warnings and precautions ).  • known hypersensitivity to metformin hydrochloride. • acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin.

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate; emtricitabine; efavirenz -