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

ailex pharmaceuticals, llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p

Israel - English - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 0.9 %w/v - sodium chloride - sodium chloride - treatment of isotonic extracellular dehydration. treatment of sodium depletion. vehicle or diluent of compatible drugs for parenteral administration.

Israel - English - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 0.9 %w/v - sodium chloride - sodium chloride - treatment of isotonic extracellular dehydration. treatment of sodium depletion. vehicle or diluent of compatible drugs for parenteral administration.

Israel - English - Ministry of Health

truemed ltd, israel - sodium phenylbutyrate - granules - sodium phenylbutyrate 483 mg/g - sodium phenylbutyrate - pheburane is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase. it is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.

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

wockhardt bio pty ltd - sodium valproate, quantity: 1000 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

wockhardt bio pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

amylyx pharmaceuticals inc - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e), taurursodiol dihydrate (unii: u7xrv7rz1i) (taurursodiol - unii:60eux8mn5x) - relyvrio is indicated for the treatment of amyotrophic lateral sclerosis (als) in adults. none. risk summary there are no available data on relyvrio use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, administration of sodium phenylbutyrate and taurursodiol to rats throughout pregnancy and lactation resulted in increased offspring mortality at all doses tested, which were less than or similar to the clinical doses. 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. data animal data oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day, containing sodium phenylbutyrate and taurursodiol in a 3:1 ratio) to pregnant mice during the period of organogenesis was not associated with any adverse effects. at the highest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were similar to the maximum recommended dose (6 g sodium phenylbutyrate and 2 g taurursodiol) in humans (mrhds), based on body surface area (mg/m2 ). oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day) to pregnant rats during the period of organogenesis was not associated with any adverse effects. at the highest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were approximately 2-fold the mrhds, based on mg/m2 . oral administration of the combination of sodium phenylbutyrate and taurursodiol (0, 375, 750, or 1500 mg/kg/day) to rats throughout pregnancy and lactation resulted in increases in stillbirth at all doses and pup deaths at the highest dose tested. a no effect dose for adverse developmental effects in rats was not identified. at the lowest dose of the combination of sodium phenylbutyrate and taurursodiol tested, the doses of sodium phenylbutyrate and taurursodiol were less than the mrhds, based on mg/m2 . risk summary there are no data on the presence of sodium phenylbutyrate or taurursodiol in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for relyvrio and any potential adverse effects on the breastfed child from relyvrio or from the underlying maternal condition. safety and effectiveness of relyvrio in pediatric patients have not been established. of the 89 patients with als who received relyvrio in study 1, 25 patients (28%) were 65 years of age or older, while 4 patients (4.5%) were 75 years of age and older with the oldest patient being 79 years old. no overall differences in safety or effectiveness were observed between those patients 65 years of age and older and those <65 years of age.  although differences in responses between the elderly and younger patients were not identified, greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is needed for patients with mild renal impairment. avoid use in patients with moderate or severe renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is needed for patients with mild hepatic impairment. avoid use in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3)] .

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

acer therapeutics inc. - sodium phenylbutyrate (unii: nt6k61736t) (phenylbutyric acid - unii:7wy7ybi87e) - olpruva is indicated as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area (bsa) of 1.2 m2 or greater, with urea cycle disorders (ucds) involving deficiencies of carbamylphosphate synthetase (cps), ornithine transcarbamylase (otc), or argininosuccinic acid synthetase (as). limitations of use episodes of acute hyperammonemia may occur in patients while on olpruva. olpruva is not indicated for the treatment of acute hyperammonemia, which can be a life-threatening medical emergency that requires rapid acting interventions to reduce plasma ammonia levels. none. risk summary available data with sodium phenylbutyrate use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with sodium phenylbutyrate. based on published animal data, pheny

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - sodium phenylbutyrate - oral suspension - 250mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - sodium phenylbutyrate - oral suspension - 200mg/1ml