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

arrotex pharmaceuticals pty ltd - sodium valproate, quantity: 200 mg - tablet, enteric coated - excipient ingredients: purified talc; triethyl citrate; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; povidone; magnesium stearate; citric acid; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; indigo carmine; sunset yellow fcf; allura red ac; polyvinyl alcohol; macrogol 3350; xanthan gum; lecithin - epilepsy. primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy.. mania. for the treatment of mania where other therapy has proved inadequate or is inappropriate.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - sodium valproate; valproic acid - tablet, film coated - 133.2 mg - sodium valproate 133.2 mg; valproic acid 58 mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - sodium valproate; valproic acid - tablet, film coated - 199.8 mg - sodium valproate 199.8 mg; valproic acid 87 mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - sodium valproate; valproic acid - tablet, film coated - 333 mg - sodium valproate 333 mg; valproic acid 145 mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - sodium valproate - enteric coated tablet - 200.00 mg - sodium valproate 200.00 mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - sodium valproate - syrup - 200 mg/5 ml - sodium valproate 200mg/5ml

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

desitin pharma ltd - sodium valproate - modified-release granules - 1gram

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

sanofi-aventis australia pty ltd - sodium valproate, quantity: 40 mg/ml - oral liquid - excipient ingredients: sorbitol; sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; saccharin sodium; brilliant scarlet 4r; purified water; sucrose; flavour - epilepsy: primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy. mania: for the treatment of mania where other therapy has proved inadequate or is inappropriate

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

onpharma, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 84 mg in 1 ml - sodium bicarbonate inj., 8.4% usp neutralizing additive solution is indicated to hasten onset of analgesia and reduce injection pain, by adjusting commercial preparations of lidocaine w/ epinephrine anesthetic solution to a more physiologic ph. not for use as a systemic alkalizer. barash pg, cullen bf, stoelting rk, clinical anesthesia (4th ed. 2001 lippincott williams and wilken). bhatt h, powell kj, jean da, first aid for the anesthesiology boards, an insider's guide (2011, mcgraw-hill medical). cepeda ms, tzortzopoulou a, thackrey m, hudcova j, arora gandhi p, schumann r., adjusting the ph of lidocaine for reducing pain on injection. cochrane database of systematic reviews 2010, issue 12. art. no.: cd006581. chu lf, clinical anesthesiology board review(2005, mcgraw-hill medical). malamed sf,handbook of local anesthesiology(5th ed. 2004, elsevier mosby). miller rd, miller's anesthesia (6th ed. 2004). stoelting rk, miller rd,basics of anesthesia(5th ed. 2007, churchill livingstone el

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

mylan institutional 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 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. available data with sodium phenylacetate and sodium benzoate injection 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 phenylacetate and sodium benzoate injection. 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. there are no data on the presence of sodium phenylacetate, sodium benzoate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium phenylacetate and sodium benzoate injection and any potential adverse effects on the breastfed infant from sodium phenylacetate and sodium benzoate injection or from the underlying maternal condition. sodium phenylacetate and sodium benzoate injection has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period [see dosage and administration (2) ]. clinical studies of sodium phenylacetate and sodium benzoate injection did not include any patients aged 65 and over to determine whether they respond differently from younger patients. urea cycle disorders are presently diseases of the pediatric and younger adult populations. no pharmacokinetic studies of sodium phenylacetate and sodium benzoate injection have been performed in geriatric patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population. pharmacokinetic parameters of sodium phenylacetate and sodium benzoate injection were compared in healthy males and females. bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. however, conclusions cannot be drawn due to the limited number of subjects in this study. limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. however, metabolic conjugation of sodium phenylacetate and sodium benzoate is known to take place in the liver and kidney. therefore, caution should be used in administering sodium phenylacetate and sodium benzoate injection to patients with hepatic insufficiency. the drug metabolites of sodium phenylacetate and sodium benzoate injection (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. therefore, use caution and closely monitor patients with impaired renal function who receive sodium phenylacetate and sodium benzoate injection.