USA - engelsk - 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 - engelsk - Ministry of Health

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

Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

demo s.a. (0000003568) 21st km national road athens-lamia, krioneri, attiki, 14568 - sodium chloride - solution for intravenous infusion - 0.9% w/v - sodium chloride (0007647145) 9g - sodium chloride

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

australian nuclear science and technology organisation t/a ansto - sodium iodide(131i), quantity: 50 mbq - oral liquid, solution - excipient ingredients: sodium thiosulfate pentahydrate; water for injections; sodium bicarbonate - sodium iodide (131i) solution bp (for therapy) is indicated in the treatment of hyperthyroidism's and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma

USA - engelsk - NLM (National Library of Medicine)

hope pharmaceuticals - sodium nitrite (unii: m0kg633d4f) (nitrite ion - unii:j39976l608) - sodium nitrite 30 mg in 1 ml - sodium nitrite injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. when the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with sodium nitrite injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. none risk summary life-sustaining therapy should not be withheld. cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see clinical considerations). therefore, if a pregnant woman has known or suspected cyanide poisoning, sodium nitrite injection for sequential use with sodium thiosulfate injection is recommended [see indications and usage (1)]. there are no available data on sodium nitrite injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal

USA - engelsk - NLM (National Library of Medicine)

hope pharmaceuticals - sodium thiosulfate (unii: hx1032v43m) (thiosulfate ion - unii:llt6xv39py) - sodium thiosulfate 250 mg in 1 ml - sodium thiosulfate injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. when the diagnosis of cyanide poisoning is uncertain, the potential risks associated with sodium thiosulfate injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. none risk summary there are no available data on sodium thiosulfate injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see clinical considerations). therefore, if a pregnant woman has known or suspected cyanide poisoning, sodium thiosulfate injection for sequential use with sodium nitrite is recommended [see indications and usage (1)] . in published animal studies, no evidence of embryotoxicity or malformations was reported when sodium thiosulfate was administered during organogenesis to pregnant mice, rats, hamsters, or rats at 0.2 to 0.9 times the human daily dose of 12.5 g for cyanide poisoning. the studies did not test doses that were comparable to the human dose for cyanide poisoning (see data). 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 us 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. clinical considerations disease-associated maternal and/or embryo/fetal risk cyanide readily crosses the placenta. cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated. life-sustaining therapy should not be withheld due to pregnancy. data animal data: no malformations or evidence of embryo-fetal toxicity were noted when pregnant mice, rats, hamsters, or rabbits were administered oral doses of sodium thiosulfate of up to 550, 400, 400, or 580 mg/kg, respectively during organogenesis (0.2, 0.3, 0.26, and 0.9 times the human dose of 12.5 g/60 kg person for cyanide poisoning based on body surface area). published studies suggest that treatment with sodium thiosulfate ameliorates the teratogenic effects of maternal cyanide poisoning in hamsters. risk summary there are no data on the presence of sodium thiosulfate in human or animal milk, the effects on the breastfed infant, or the effects on milk production. cyanide and thiocyanate (which is formed when sodium thiosulfate combines with cyanide) are present in human milk. because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with sodium thiosulfate injection. there are no data to determine when breastfeeding may be safely restarted following the administration of sodium thiosulfate injection. there are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium thiosulfate in the pediatric population. as for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports. sodium thiosulfate is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. sodium thiosulfate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

USA - engelsk - NLM (National Library of Medicine)

american regent, inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 9 mg in 1 ml - intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. none known.

USA - engelsk - NLM (National Library of Medicine)

laboratorios grifols sa - sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698, sodium cation - unii:lyr4m0nh37) - sodium chloride 9 g in 1000 ml - sodium chloride injection, usp is indicated as a source of water and electrolytes. 0.9% sodium chloride injection, usp is also indicated for use as a priming solution in hemodialysis procedures. none known.

USA - engelsk - NLM (National Library of Medicine)

liebel-flarsheim company llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37) - sodium chloride .9 mg in 1 ml - - 125 ml syringe:  sodium chloride injection usp 0.9% is indicated for use in flushing compatible contrast agents through liebel-flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following liebel-flarsheim power injectors: angiomat® , illumena® , illumena® néo, ct9000® , ct9000® adv, optistat® , optivantage® and optistar elite. none risk summary administration of sodium chloride injection usp 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with sodium chloride injection usp 0.9.% 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 2-4% and 15-20%, respectively. risk summary appropriate administration of sodium chloride injection usp 0.9% is not known to cause ha

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

link medical products pty ltd t/a link pharmaceuticals - thiopental sodium, quantity: 0.5 g - injection, powder for - excipient ingredients: - indications as at 08 dec 1993 : pentothal may be used : 1. as the sole anaesthetic agent for brief surgical procedures; 2. for the induction of anaesthesia prior to the administration of other anaesthetic agents; 3. for the short-term control of condvulsive states; 4. to supplement regional anaesthesia or low potency agents such as nitrous oxide.