PRIMPERAN INJECTABLE SOLUTION

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

METOCLOPRAMIDE HYDROCHLORIDE

Tilgjengelig fra:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

METOCLOPRAMIDE HYDROCHLORIDE

Enheter i pakken:

6Units Units

Produsert av:

DELPHARM DIJON

Preparatomtale

NAME OF THE MEDICINAL PRODUCT
Primperan ® 10mg/2ml solution for injection in ampoules .
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide hydroch loride……………………………………………………………… …10.50mg
(equivalent to 10.00mg of anhydrous metoclopramide hydrochlorid e)
for one 2ml ampoule.
Excipient: sodium
For a complete list of excipients, see List of excipients
PHARMACEUTICAL FORM
Solution for injection.
CLINICAL PARTICULARS
Therapeutic indications
Adult population
Primperan 10 mg/2 ml solution for injection in ampoules is indicated for use in adults for:
 prevention of post -operative nausea and vomiting,
 symptomatic treatment of nausea and vomiting, including nausea and vomiting induced
 by migraine attacks,
 prevention of radiotherapy -induced nausea and vomiti ng.
Pediatric population
Primperan 10 mg/2 ml solution for injection in ampoules is indicated in children aged 1 to 18
years for:
 prevention of delayed chemotherapy -induced nausea and vomiting as a second -line
option,
 prevention of post -operative nausea and vomiting as a second -line option.
Posology and method of administration
The solution can be administered by the i ntramuscular or intravenous route .
The intravenous doses must be administered as a slow bolus (for at least 3 minutes).
All indications (adults)
A single 10 mg dose is recommended for the prevention of post -operative nausea and
vomiting.
The recommended dose for the symptomatic treatment of nausea and vomiting, including
nausea and vomiting induced by migraine attacks and for the preventi on of radiotherapy induced
nausea and vomiting is 10 mg per dose, 1 to 3 times daily. The maximum
recommended daily dose is 30 mg or 0.5 mg/kg.
Treatment duration when administering by injection should be as short as possible and a
switch to administration via oral or rectal route should be instituted as quickly as possible.
Children from 1 to 18 years of age :
The recommended dosage is 0.1 to 0.15 mg/kg, 1 to 3 times daily, by intrave