PRIMPERAN INJECTION 10 mg/2 ml

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

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환자 정보 전단 환자 정보 전단 (PIL)
10-07-2014

유효 성분:

METOCLOPRAMIDE 2HCl EQV METOCLOPRAMIDE 2HCl (ANHYDROUS)

제공처:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC 코드:

Pending

복용량:

10 mg/2 ml

약제 형태:

INJECTION

관리 경로:

INTRAVENOUS, INTRAMUSCULAR

처방전 유형:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

승인 날짜:

1990-05-21

환자 정보 전단

                                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 
                                
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