EPHEDRINE HCL STEROP 50 MG1 ML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

EPHEDRINE HYDROCHLORIDE

Verfügbar ab:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC-Code:

R03CA02

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

EPHEDRINE HYDROCHLORIDE 50 MG / 1 ML

Verabreichungsweg:

S.C, I.M, I.V

Verschreibungstyp:

Required

Hergestellt von:

LABORATOIRES STEROP, BELGIUM

Therapiebereich:

EPHEDRINE

Anwendungsgebiete:

Ephedrine Hydrochloride is used in the prevention and treatment of hypotension from spinal or epidural anesthesia and during general anesthesia, with or without a reduction in the heart rate, administered for a surgical or obstetric procedure.

Berechtigungsdatum:

2019-12-30

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
EPHEDRINE HCL STEROP 50MG/1ML
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 1 ml solution contains 50mg ephedrine hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection, administered subcutaneously, intravenously,
intramuscularly.
Aqueous, clear, uncolored solution, free of visible particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of hypotension from spinal or epidural
anesthesia and during general
anesthesia, 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 Ephedrine HCl Sterop 50mg/1ml on case-by-case
basis depending on the
cardiovascular and hemodynamic parameters. The following dosage is
provided for guidance
purposes only.
ADULTS:
5-25mg I.V., administered slowly.
It is recommended that Ephedrine HCl Sterop 50mg/1ml be administered
in divided doses of 5-
10mg until the blood pressure normalizes.
Maximum daily dose - 150 mg/24h.
Ephedrine HCl Sterop 50mg/1ml can also be administered S.C. or I.M.
The dose is 25-50mg
(range 10-50mg). If necessary, a second dose of 50mg may be
administered I.M., or 10-25mg
administered I.V.
CHILDREN:
The recommended pediatric dose is 3mg/kg per day (750 micrograms/kg
per dose) or 100mg/m²
per day (25mg/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 5mg boluses.
METHOD OF ADMINISTRATION
Ephedrine must be used solely by or under the supervision of the
anesthetist.
4.3 CONTRAINDICATIONS
Ephedrine should not be used in case of:
* Hypersensitivity to the active substance or to any of