EPHEDRIN SINTETICA 50 MGML

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

EPHEDRINE HYDROCHLORIDE

Tersedia dari:

CTS LTD

Kode ATC:

R03CA02

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

EPHEDRINE HYDROCHLORIDE 50 MG/ML

Rute administrasi :

S.C, I.V, I.M

Jenis Resep:

Required

Diproduksi oleh:

SINTETICA SA , SWITZERLAND

Area terapi:

EPHEDRINE

Indikasi Terapi:

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.

Tanggal Otorisasi:

2021-10-31

Karakteristik produk

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