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

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.

United States - English - 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.

United States - English - 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.

United States - English - 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

Israel - English - Ministry of Health

rekah pharmaceutical industry ltd, israel - sodium bicarbonate - tablets - sodium bicarbonate 500 mg - sodium bicarbonate - sodium bicarbonate - antacid.

Israel - English - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 450 mg / 100 ml - sodium chloride - sodium chloride - supply of water and electrolytes.

Israel - English - Ministry of Health

lapidot medical import and marketing ltd - sodium chloride - solution for injection - sodium chloride 9 mg/ml - sodium chloride - sodium chloride - short - term intravascular volume substitution. hypotonic dehydration or isotonic dehydration.vehicle solution for supplementary medication.fluid and electrolyte replacement, hypochloremic alkalosis and chloride losses.externally for wound irrigation and moistening of wound tamponade dressings.

Israel - English - Ministry of Health

lapidot medical import and marketing ltd - sodium chloride - solution for injection - sodium chloride 0.9 g / 100 ml - sodium chloride - sodium chloride - short - term intravascular volume substitution. hypotonic dehydration or isotonic dehydration.vehicle solution for supplementary medication.fluid and electrolyte replacement, hypochloremic alkalosis and chloride losses.externally for wound irrigation and moistening of wound tamponade dressings.

Israel - English - Ministry of Health

lapidot medical import and marketing ltd - sodium chloride - solution for injection - sodium chloride 0.9 g / 100 ml - sodium chloride - sodium chloride - short - term intravascular volume substitution. hypotonic dehydration or isotonic dehydration.vehicle solution for supplementary medication.fluid and electrolyte replacement, hypochloremic alkalosis and chloride losses.externally for wound irrigation and moistening of wound tamponade dressings.