ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - felbamate (unii: x72rbb02n8) (felbamate - unii:x72rbb02n8) - felbamate 400 mg - felbamate tablets, usp are not indicated as a first line antiepileptic treatment (see warnings ). felbamate tablets, usp are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. if these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with lennox-gastaut syndrome in children. felbamate is contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. it should not be used in patients with a history of any blood dyscrasia or hepa

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th), losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - hydrochlorothiazide 12.5 mg - losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide. 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, f

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - losartan potassium 25 mg - losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. 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

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - exemestane (unii: ny22hmq4bx) (exemestane - unii:ny22hmq4bx) - exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see clinical studies (14.1)]. exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see clinical studies (14.2) ]. exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. risk summary based on findings in animal studies and its mechanism of action, exemetane can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited human data from case reports are insufficient to inform a drug-associated risk. in animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride capsules, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly  interfere with  social  or  occupational  functioning,  in  order  to  meet  the dsm-iii-r (circa 1,989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego  dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on t

ארצות הברית - אנגלית - NLM (National Library of Medicine)

able c&c co., ltd. - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - sunscreen - helps prevent sunburn - if used as directed with other sun protection measures(see directions ), decreases the risk of skin cancer and early skin aging caused by the sun on damaged or broken skin

ארצות הברית - אנגלית - NLM (National Library of Medicine)

zydus lifesciences limited - nadolol (unii: fen504330v) (nadolol - unii:fen504330v) - nadolol 40 mg - nadolol tablets are indicated for the long-term management of patients with angina pectoris. nadolol 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 nadolol. 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 pro

ישראל - אנגלית - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - film coated tablets - ivacaftor 150 mg - ivacaftor - kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older and weighing 25 kg or more who have one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. limitations of use : kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

ישראל - אנגלית - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 50 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

ישראל - אנגלית - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 75 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.