Country: Israel
Language: English
Source: Ministry of Health
EPHEDRINE HYDROCHLORIDE
CTS LTD
R03CA02
SOLUTION FOR INJECTION
EPHEDRINE HYDROCHLORIDE 50 MG/ML
S.C, I.V, I.M
Required
SINTETICA SA , SWITZERLAND
EPHEDRINE
Ephedrine Hydrochloride is used in the prevention and treatment of hypotension from spinal or epidural anaesthesia and during general anaesthesia, with or without a reduction in the heart rate, administered for a surgical or obstetric procedure.
2021-10-31
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ephedrin Sintetica 50 mg/ml Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 50 mg ephedrine hydrochloride. 1 ampoule with 1 ml solution contains 50 mg ephedrine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, administered subcutaneously, intravenously, intramuscularly. Clear, colourless liquid. The pH of the solution is comprised between 5.0-6.5. The osmolality of the solution is comprised between 440-480 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention and treatment of hypotension from spinal or epidural anaesthesia and during general anaesthesia, with or without a reduction in the heart rate, administered for a surgical or obstetric procedure. 4.2 Posology and method of administration Posology Adults and adolescents Ephedrine must be administered at the lowest effective dose over the shortest possible period of time. Adjust the dosage of Ephedrin Sintetica on case-by-case basis depending on the cardiovascular and hemodynamic parameters. The following dosage is provided for guidance purposes only. Adults: 5-25 mg i.v., administered slowly. It is recommended that Ephedrin Sintetica be administered in divided doses of 5-10 mg until the blood pressure normalizes. Maximum daily dose (150 mg/24h). Ephedrin Sintetica can also be administered s.c or i.m. The dose is 25-50 mg (range 10- 50 mg). If necessary, a second of 50 mg dose may be administered i.m, or 10-25 mg administered i.v. Children: The recommended pediatric dose is 3 mg/kg per day (750 micrograms/kg per dose) or 100 mg/m² per day (25 mg/m 2 per dose) in 4-6 doses per day, administered s.c. or i.v. The bolus i.v. dose for hypotension is 0.1-0.3 mg/kg. When administered intravenously, the injection should be given slowly. Elderly patients As for adults, starting from 5 mg boluses. Method of administration Ephedrine must be used solely by or unde Read the complete document