United States - English - 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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - sodium thiosulfate+sodium nitrite - antidote

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

hope pharmaceuticals pty ltd - sodium thiosulfate pentahydrate, quantity: 12.5 g - solution - excipient ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide - hope pharmaceuticals sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite.,sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

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

pfizer australia pty ltd - sodium thiosulfate pentahydrate, quantity: 2.5 g - injection, solution - excipient ingredients: sulfuric acid; sodium metabisulfite; dibasic sodium phosphate dodecahydrate; water for injections; sodium hydroxide - dbl sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite. sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

Philippines - English - FDA (Food And Drug Administration)

ceva animal health (philippines), inc. - sodium chloride , sodium thiosulfate , sodium bicarbonate (vet.) - powder for oral solution - formulation: each 10 g contains: sodium chloride .............................4.768 g sodium thiosulfate ................................1.52 g sodium bicarbonate ........................... 950 mg carrier .......................................... qs.ad.

Israel - English - Ministry of Health

hope pharmaceuticals ltd, israel - sodium thiosulfate - solution for injection - sodium thiosulfate 250 mg / 1 ml - thiosulfate - sodium thiosulfate is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening. when the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with sodium thiosulfate should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

Ireland - English - HPRA (Health Products Regulatory Authority)

hope pharmaceuticals ltd - sodium thiosulfate - solution for injection - 250 milligram(s)/millilitre - antidotes; thiosulfate

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - sodium thiosulfate pentahydrate 250 mg/ml - solution for injection - 25% w/v - active: sodium thiosulfate pentahydrate 250 mg/ml excipient: dibasic sodium phosphate dodecahydrate sodium metabisulfite water for injection - dbl™ sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite. sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning

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

pfizer australia pty ltd - sodium nitroprusside, quantity: 50 mg - injection, solution - excipient ingredients: water for injections - dbl? sodium nitroprusside injection is indicated for:,1. immediate reduction of blood pressure in patients with hypertensive crises. concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.,2. producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.,3. short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

United States - English - 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