DBL™ Ephedrine Sulfate

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Ephedrine sulfate 30 mg/mL

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

Ephedrine sulfate 30 mg/mL

Dosis:

30 mg/mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Ephedrine sulfate 30 mg/mL Excipient: Sodium chloride Water for injection

Unidades en paquete:

Ampoule, glass, 5 x 1mL, 5 dose units

clase:

Class B2 Controlled Drug

tipo de receta:

Class B2 Controlled Drug

Fabricat per:

Siegfried PharmaChemikalien Minden GmbH

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 1mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Data d'autorització:

1984-03-08

Fitxa tècnica

Hosp 7.0
Page 1 of 8
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL
™
Ephedrine Sulfate Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
™
Ephedrine Sulfate Injection is a sterile solution of Ephedrine Sulfate
in Water for
Injections. Each mL contains 30 mg of Ephedrine Sulfate and 3 mg of
Sodium Chloride in
Water for Injections.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL
™
Ephedrine Sulfate Injection is a sterile solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
™
Ephedrine Sulfate Injection is indicated in the treatment of shock
unresponsive to
fluid replacement. It is also indicated in the treatment of
hypotension secondary to spinal
anaesthesia. DBL
™
Ephedrine Sulfate Injection has also been used in the treatment of
bronchial
asthma
and
reversible
bronchospasm
although
more
selective
agents
(beta-
adrenergic agonists) are now available.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL
™
Ephedrine Sulfate Injection is administered by the intramuscular,
subcutaneous or
intravenous route. Patients in shock may require intravenous
administration to ensure
absorption of the drug. When administered intravenously, the injection
should be given
slowly. Care should be taken to avoid extravasation, since this may
result in tissue necrosis
and sloughing. Ephedrine sulfate should be administered in the lowest
effective dose. The
parenteral adult dose should not exceed 150 mg in 24 hours.
As a pressor:
_Adult dose:_ The usual adult dose is 25-50 mg (range 10-50 mg)
administered intramuscularly
or subcutaneously. Additional doses should be based on patient
response. The intravenous
route may be used if an immediate response is required. The dosage for
the intravenous route
is 10-25 mg which may be repeated every 5-10 minute until the desired
response is obtained.
_Paediatric dose:_ The recommended paediatric dose is 3 mg/kg/day or
100 mg/m
2
/day via the
intravenous or subcutaneous route, given in 4-6 divided doses.
Hosp 7.0
Page 2 of 8
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