PRIMPERAN TABLET 10 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

METOCLOPRAMIDE HCl EQV ANHYDROUS METOCLOPRAMIDE HCl

Tilgængelig fra:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-kode:

Pending

Dosering:

10 mg

Lægemiddelform:

TABLET

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

SANOFI WINTHROP INDUSTRIE

Autorisation dato:

1989-05-05

Indlægsseddel

PRIMPERAN
®
 10MG 
TABLET 
[SANOFI LOGO] 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Anhydrous metoclopramide hydrochloride 10 mg 
Excipients to 1 scored tablet 

PHARMACEUTICAL FORM 
Scored tablet 

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

POSOLOGY AND METHOD OF ADMINISTRATION 
Usual dosage: 
Adults: 
The recommended single dose is 10 mg, repeated up to three times
daily. 
The maximum recommended daily dose is 30 mg or 0.5 mg/kg body
weight. 
The maximum recommended treatment duration is 5 days. 

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 years); 
The recommended dose is 0.10 to 0.15 mg/kg body weight, repeated up
to three times daily. The 
maximum dose in 24 hours is 0.5 mg/kg body weight. 

Dosing table 
Age Body 
Weight 
Dose Frequency 
9-18 years 
30-60 kg 
5 mg 
Up to 3 times daily 
15-18 years 
Over 60 kg 
10 mg 
Up to 3 times daily 
The maximum treatment duration is 5 days for prevention of delayed
chemotherapy induced nausea and 
vomiting (CINV). 

Tablets are not suitable for use in children weighing less than
30 kg. Other pharmaceutical forms may be 
more appropriate for admini