PRIMPERAN INJECTION 10 mg/2 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

METOCLOPRAMIDE 2HCl EQV METOCLOPRAMIDE 2HCl (ANHYDROUS)

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

Pending

Dosage:

10 mg/2 ml

Pharmaceutical form:

INJECTION

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Authorization date:

1990-05-21

Patient Information leaflet

PRIMPERAN
®

INJECTION 
[SANOFI LOGO] 
SOLUTION FOR INJECTION IN AMPOULES METOCLOPRAMIDE HYDROCHLORIDE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Metoclopramide hydrochloride 10.50 mg (quantity equivalent to
anhydrous metoclopramide hydrochloride 
10.00 mg) 
Excipients: sodium chloride, water for injection q.s.f. one
ampoule of 2 ml. 

PHARMACEUTICAL FORM 
Solution for injection 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Adults: 
-  Prevention of post operative nausea and vomiting (PONV) 
-  Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting 
-  Prevention of delayed radiotherapy induced nausea and vomiting
(RINV) 
Children (aged 1-18 years): 
-  Prevention of delayed chemotherapy induced nausea and
vomiting (CINV) as a second line option 
-  Treatment of established post operative nausea and vomiting
(PONV) as a second line option 

POSOLOGY AND METHOD OF ADMINISTRATION 
Adults: 
Prevention of PONV: a single dose of 10 mg is recommended. 
Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting 
and prevention of radiotherapy induced nausea and vomiting (RINV):
recommended single dose of 10 
mg, repeated up to three times daily. 

The maximum recommended daily dose is 30 mg or 0.5 mg/kg body
weight. 
The injectable treatment duration should be as short as possible
and transfer to oral or rectal treatment 
should be made as soon as possible. 

In elderly patients a dose reduction should be considered, based
on renal and hepatic function and 
overall frailty. 
In patients with severe hepatic impairment, the dose should
be reduced by 50%. 
In patients with severe renal impairment
(creatinine clearance ≤ 15 mL/min), the daily dose should be 
reduced by 75%. 
In patients with moderate to severe renal impairment
(creatinine clearance 15-60 mL/min), the dose 
should be reduced by 50%. 

Children (aged 1-18