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) ].

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

United States - English - 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

United States - English - 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

Canada - English - Health Canada

gahler enterprises ltd. - betaine hydrochloride - tablet - 500mg - betaine hydrochloride 500mg - digestants

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)

periosciences llc - sodium monofluorophosphate (unii: c810jcz56q) (fluoride ion - unii:q80vpu408o) - fluoride ion 1.3 mg in 1 ml - anticavity aids in prevention of dental cavities

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

jazz pharmaceuticals, inc. - betaine, anhydrous (unii: 3scv180c9w) (betaine, anhydrous - unii:3scv180c9w) - powder, for solution - 180 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 deficiencies or defects in: - cystathionine beta-synthase (cbs), - 5,10-methylenetetrahydrofolate reductase (mthfr), - cobalamin cofactor metabolism (cbl ). patient response to cystadane can be monitored by homocysteine plasma levels (see dosage and administration). response usually occurs within a week and steady state within a month. cystadane has been administered concomitantly with vitamin b6 (pyridoxine), vitamin b12 (cobalamin), and folate.

Canada - English - Health Canada

rheingold food international ltd. - betaine hydrochloride; pepsin - tablet - 324mg; 135mg - betaine hydrochloride 324mg; pepsin 135mg - digestants

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

gowoonsesang cosmetics co., ltd. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine 0.5 g in 100 ml