Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Metoclopramide hydrochloride
Amdipharm Limited
A03FA; A03FA01
Metoclopramide hydrochloride
5 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Propulsives; metoclopramide
Not marketed
1994-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MAXOLON ® 5 MG/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. The product is known by name above but will be referred to as Maxolon Injection throughout the rest of this leaflet. WHAT IS IN THIS LEAFLET 1. What Maxolon injection is and what it is used for 2. What you need to know before you are given Maxolon Injection. 3. How you will be given Maxolon Injection 4. Possible side effects 5. How to store Maxolon Injection 6. Contents of the pack and other information 1. WHAT MAXOLON INJECTION IS AND WHAT IT IS USED FOR Maxolon Injection 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 Maxolon 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 Maxolon 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 MAXOLON INJECTION YOU MUST NOT BE GIVEN MAXOLON INJECTION: - if you are allergic to metoclopramide hydrochloride or any of the other ingredients of this medicine ( Les hele dokumentet
Health Products Regulatory Authority 14 September 2022 CRN00CZYN Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxolon 5 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml ampoule contains metoclopramide hydrochloride monohydrate equivalent to 10 mg of the anhydrous substance. Excipient(s) with known effect: Sodium Metabisulphite (E223)- 2.96 mg Sodium- 6.22 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT POPULATION Maxolon 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 Maxolon 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). Health Products Regulatory Authority 14 September 2022 CRN00CZYN Page 2 of 9 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 andvomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): therecommended 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 shoul Les hele dokumentet