PRIMPERAN TABLET 10 mg
देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
सूचना पत्रक
(PIL)
10-07-2014
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
METOCLOPRAMIDE HCl EQV ANHYDROUS METOCLOPRAMIDE HCl
थमां उपलब्ध:
SANOFI-AVENTIS SINGAPORE PTE. LTD.
ए.टी.सी कोड:
Pending
डोज़:
10 mg
फार्मास्यूटिकल फॉर्म:
TABLET
प्रशासन का मार्ग:
ORAL
प्रिस्क्रिप्शन प्रकार:
Prescription Only
द्वारा बनाया गया:
SANOFI WINTHROP INDUSTRIE
प्राधिकरण की तारीख:
1989-05-05
सूचना पत्रक
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
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