Australia - English - Department of Health (Therapeutic Goods Administration)

nature's wealth products - betaine hydrochloride, quantity: 25 mg; taraxacum officinale, quantity: 12.5 mg; fucus vesiculosus, quantity: 25 mg; pyridoxine hydrochloride, quantity: 30 mg; cyanocobalamin, quantity: 25 microgram; folic acid, quantity: 100 microgram; choline bitartrate, quantity: 340 mg; inositol, quantity: 335 mg; dl-methionine, quantity: 335 mg; carnitine, quantity: 50 mg; chelidonium majus, quantity: 25 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; soy polysaccharide; hypromellose; magnesium stearate; povidone; colloidal anhydrous silica; dextrin; iron oxide red; macrogol 400; powdered cellulose - super fat burners assists in fat metabolism/burning and can only be effective if taken in conjunction with a kilojoule/calorie controlled diet. vitamins can only be of assistance if the dietary vitamin intake is inadequate.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

21st century products sdn. bhd. - betaine hcl; folic acid; kelp; vitamin b6; choline bitartrate; inositol; dl methionine; vitamin b12 -

United States - English - NLM (National Library of Medicine)

novitium pharma llc - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution 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 post marketing experience with betaine anhydrous for oral solution 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 majo

United States - English - NLM (National Library of Medicine)

oakrum pharma, llc - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution 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 post marketing experience with betaine anhydrous for oral solution 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

United States - English - NLM (National Library of Medicine)

lukare medical, llc - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution 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: none. risk summary available data from a limited number of published case reports and postmarketing experience with betaine anhydrous for oral solution 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 pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary there are no data on the presence of betaine in hum

United States - English - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution 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 post marketing experience with betaine anhydrous for oral solution 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

United States - English - NLM (National Library of Medicine)

eton pharmaceuticals, inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine anhydrous for oral solution 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. 8.1 pregnancy risk summary available data from a limited number of published case reports and post-marketing experience with betaine anhydrous for oral solution 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 pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 lactation risk summary there are no data on the presence of betaine in human or animal milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for betaine anhydrous for oral solution and any potential adverse effects on the breastfed child from betaine anhydrous for oral solution or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of betaine anhydrous for oral solution have been established in pediatric patients. the majority of case studies of homocystinuria patients treated with betaine anhydrous for oral solution 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 dosage and administration (2.1) ].

Canada - English - Health Canada

canat laboratories inc. - choline bitartrate; inositol; dl-methionine; vitamin b6; betaine hydrochloride - tablet - 1g; 500mg; 200mg; 50mg; 200mg - choline bitartrate 1g; inositol 500mg; dl-methionine 200mg; vitamin b6 50mg; betaine hydrochloride 200mg - vitamin b complex

Australia - English - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - betaine, quantity: 1 g/g - powder, oral - excipient ingredients: - as an adjunct in the treatment of homocystinuria.

United States - English - 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