Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
METOCLOPRAMIDE 2HCl EQV METOCLOPRAMIDE 2HCl (ANHYDROUS)
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Pending
10 mg/2 ml
INJECTION
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
SANOFI WINTHROP INDUSTRIE
1990-05-21
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 Đọc toàn bộ tài liệu