Estados Unidos - inglês - NLM (National Library of Medicine)

xiromed, llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data ]. the estimated

Estados Unidos - inglês - NLM (National Library of Medicine)

sagent pharmaceuticals - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryo-fetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimate

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

martindale pharmaceuticals ltd - ephedrine hydrochloride - solution for injection - 30 milligram(s)/millilitre - ephedrine

Bélgica - inglês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - ephedrine hydrochloride 10 mg/ml - solution for injection - 10 mg/1 ml - ephedrine hydrochloride 10 mg/ml - adrenergic and dopaminergic agents; r03ca02 ephedrine

Bélgica - inglês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - ephedrine hydrochloride 50 mg/ml - solution for injection - 50 mg/1 ml - ephedrine hydrochloride 50 mg/ml - adrenergic and dopaminergic agents; r03ca02 ephedrine

Canadá - inglês - Health Canada

auro pharma inc - ephedrine sulfate - solution - 50mg - ephedrine sulfate 50mg

Canadá - inglês - Health Canada

eugia pharma inc. - ephedrine sulfate - solution - 50mg - ephedrine sulfate 50mg

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

max health limited - ephedrine hydrochloride 30 mg/ml - solution for injection - 30 mg/ml - active: ephedrine hydrochloride 30 mg/ml excipient: water for injection - indicated in the treatment of hypotension secondary to spinal anaesthesia in adults.

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

johnson & johnson (ireland) limited - pseudoephedrine hydrochloride ; dextromethorphan hydrobromide ; triprolidine hydrochloride - syrup - 30/10/1.25 milligram - pseudoephedrine, combinations

Estados Unidos - inglês - NLM (National Library of Medicine)

par pharmaceutical, inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - corphedra is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none r isk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations] . animal reproduction studies have not been conducted with ephedrine sulfate. 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. c linical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports descri