אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 25 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: colloidal anhydrous silica; hydrogenated castor oil; microcrystalline cellulose; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium; povidone - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; povidone; microcrystalline cellulose; magnesium stearate; hydrogenated castor oil; maize starch; lactose monohydrate - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 300 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; povidone; hydrogenated castor oil; maize starch; magnesium stearate; lactose monohydrate; croscarmellose sodium - stada irbesartan hct is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

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

rare disease therapeutics, inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine 6 g - cystadane® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.  included within the category of homocystinuria are:   - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. pregnancy category c: animal reproduction studies have not been conducted with cystadane.  it is also not known whether cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  cystadane should be given to a pregnant woman only if clearly needed. it is not known whether cystadane is excreted in human milk.  use only if clearly needed. the majority of case studies of homocystinuria patients treated with cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see clinical studies (14)].   children younger than 3 years of age may benefit

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

ropack inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine 1 g in 1 g - cystadane ® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. included within the category of homocystinuria are: - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. pregnancy category c: animal reproduction studies have not been conducted with cystadane. it is also not known whether cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  cystadane should be given to a pregnant woman only if clearly needed. it is not known whether cystadane is excreted in human milk. use only if clearly needed. the majority of case studies of homocystinuria patients treated with cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see clinical studies ( 14)]. children younger than 3 years of age may benefit from dose titration [see dosag

מלטה - אנגלית - Medicines Authority

stada arzneimittel ag stadastraße 2-18, 61118 bad vilbel, germany - dutasteride - capsule - dutasteride 0.5 mg - urologicals

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

recordati rare diseases - betaine anhydrous - homocystinuria - other alimentary tract and metabolism products, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl).cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

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

recordati rare diseases - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine 1 g in 1 g - cystadane ® is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. included within the category of homocystinuria are: - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. risk summary available data from a limited number of published case reports and postmarketing experience with cystadane use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with betaine. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnanc

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

stada arzneimittel ag - olmesartan medoxomil; hydrochlorothiazide - film-coated tablet - 20 mg/12.5 milligram(s) - angiotensin ii antagonists and diuretics; olmesartan medoxomil and diuretics

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

stada arzneimittel ag - olmesartan medoxomil; hydrochlorothiazide - film-coated tablet - 20 mg/25 milligram(s) - angiotensin ii antagonists and diuretics; olmesartan medoxomil and diuretics