Združene države Amerike - angleščina - NLM (National Library of Medicine)

blendpack, inc. - sodium salicylate (unii: wiq1h85syp) (salicylic acid - unii:o414pz4lpz) - for use in the drinking water of poultry and swine as an aid in reducing pain, fever and inflammation calf label claim indications for use, calves:  supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g., anti-infective) therapy if necessary. contraindications, calves:  do not use sodium salicylate in neonates or calves less than 2 weeks of age dosage, calves:  40 mg sodium salicylate per kg body weight once daily, for 1-3 days. administer orally in drinking water or milk (replacer). recommended withdrawal period for all food animals following use at “usual dosages”: meat 24 hours.

Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

dopharma (research) n.v. - sodium salicylate 800 mg/g - eq. salicylic acid 690 mg/g - powder for oral solution - 800 mg/g - sodium salicylate 800 mg/g - sodium salicylate - cattle; pig

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - potassium chloride, quantity: 0.3 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium chloride, quantity: 6.02 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - potassium chloride, quantity: 0.3 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium chloride, quantity: 6.02 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes

Združene države Amerike - angleščina - 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.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

trigen laboratories, 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

Združene države Amerike - angleščina - 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

Irska - angleščina - HPRA (Health Products Regulatory Authority)

dopharma research b.v. - sodium salicylate ph. eur. (equivalent to salicylic acid as sodium salt) - powder for oral solution - 800 mg/ml - sodium salicylate - bovine, porcine - n.s.a.i.d

Izrael - angleščina - 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.

Izrael - angleščina - 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.