Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Metoclopramide hydrochloride
Mercury Pharmaceuticals (Ireland) Ltd
A03FA; A03FA01
Metoclopramide hydrochloride
5 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Propulsives; metoclopramide
Marketed
1984-10-11
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METOCLOPRAMIDE 5MG/ML SOLUTION FOR INJECTION metoclopramide hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Metoclopramide Injection is and what it is used for 2. What you need to know before you are given Metoclopramide Injection 3. How you will be given Metoclopramide Injection 4. Possible side effects 5. How to store Metoclopramide Injection 6. Contents of the pack and other information 1. WHAT METOCLOPRAMIDE INJECTION IS AND WHAT IT IS USED FOR Metoclopramide is an antiemetic. It contains a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting) Adult population Metoclopramide Injection is used in adults: - to prevent nausea and vomiting that may occur after surgery - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine - to prevent nausea and vomiting caused by radiotherapy Paediatric population Metoclopramide Injection is used in children (aged 1-18 years) only if other treatment does not work or cannot be used: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to treat nausea and vomiting that has occurred after surgery 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METOCLOPRAMIDE INJECTION YOU MUST NOT BE GIVEN METOCLOPRAMIDE INJECTION: - if you are allergic to metoclopramide hydrochloride or any of the other ingredients of this medicine (listed in section 6). - if you have bleeding, ob Read the complete document
Health Products Regulatory Authority 16 September 2022 CRN00CZYP Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoclopramide 5mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml contains metoclopramide hydrochloride equivalent to 10mg of anhydrous metoclopramide hydrochloride. Excipient(s) with known effect Sodium Metabisulphite (E223) - 2 mg/2 ml ( i.e. 1mg/ml) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection Clear colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metoclopramide is indicated in adults for: - Prevention of post operative nausea and vomiting (PONV) - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting - Prevention of radiotherapy induced nausea and vomiting (RINV). PAEDIATRIC POPULATION: Metoclopramide is indicated in children (aged 1-18 years) for: - 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 Metoclopramide should not be used in children younger than 1 year as there are insufficient data regarding efficacy and safety of the product in this population. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: ROUTE OF ADMINISTRATION: The solution can be administered intravenously or intramuscularly. Intravenous doses should be administered as a slow bolus (at least over 3 minutes). ADULT POPULATION For prevention of PONV a single dose of 10mg is recommended. For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight. The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment sh Read the complete document