País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Metoclopramide hydrochloride monohydrate 5 mg/mL;
AstraZeneca Limited
Metoclopramide hydrochloride monohydrate 5 mg/mL
5 mg/mL
Solution for injection
Active: Metoclopramide hydrochloride monohydrate 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection
Polyamp, 5mg/mL in 2mL x 50, 100 mL
Prescription
Prescription
Dipharma Francis Srl
Package - Contents - Shelf Life: Polyamp, 5mg/mL in 2mL x 50 - 100 mL - 18 months from date of manufacture stored at or below 25°C
1993-12-08
Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ Metoclopramide Injection Ampoule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metoclopramide Injection contains metoclopramide hydrochloride monohydrate 10.54 mg/2 mL, e quivalent to m etoclopramide hydrochloride 10 mg/2 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection. Metoclopramide Injection is a clear, colourless, sterile, preservative-free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS (20 YEARS AND OVER) • Relief of nausea and vomiting associated with migraine, cancer therapy (chemotherapy or radiation), malignant disease, labour, infectious disease and uraemia • Control of post-operative vomiting • Assist in small bowel intubation Metoclopramide is of little benefit for the prevention or treatment of motion sickness. YOUNG ADULTS AND CHILDREN (OVER 1 YEAR OF AGE) Metoclopramide should be restricted to the following conditions and only used as second line therapy, when used to treat children and young adults under 20 years of age because of the risk of adverse effects: • Severe intractable vomiting of known cause • Vomiting associated with radiation therapy or intolerance to cytotoxic drugs • Assist in small bowel intubation 4.2 DOSE AND METHOD OF ADMINISTRATION The dosage recommendations should be strictly adhered to in order to minimise the possibility of dystonic side effects. Metoclopramide should only be used after careful examination has excluded any underlying disorder (such as cerebral irritation) that may have induced nausea and vomiting. Total daily doses of metoclopramide should not normally exceed 0.5 mg/kg bodyweight with a maximum of 30 mg daily. This should be less (if possible) in children and young adults, when given by injection. Maximum recommended treatment duration is 5 days in all age groups. Page 2 of 11 Usual dosage is as follows and should be administered intramuscularly or by slow intravenous injection over 1 to 2 minutes. _ADULTS _ _20 years a Leia o documento completo