Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Granisetron hydrochloride
Martindale Pharmaceuticals Ltd
A04AA; A04AA02
Granisetron hydrochloride
3mg/3ml
Concentrate for solution for injection
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; granisetron
Not marketed
2008-09-05
MODULE 1 1.3 PRODUCT INFORMATION APPLICANT: MARTINDALE PHARMACEUTICALS LTD PRODUCT: GRANISETRON MARTINDALE PHARMA ® 3MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION LEAFLET MODULE 1 1.3 PRODUCT INFORMATION APPLICANT: MARTINDALE PHARMACEUTICALS LTD PRODUCT: GRANISETRON MARTINDALE PHARMA ® 3MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION PACKAGE LEAFLET INFORMATION FOR THE PATIENT GRANISETRON MARTINDALE PHARMA 3MG/3ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION Granisetron 3mg/3ml (Concentrate for Solution for Injection/Infusion) WHAT IS IN THIS LEAFLET 1. What Granisetron Martindale Pharma is and what it is used for 2. What you need to know before you are given Granisetron Martindale Pharma 3. How you will be given Granisetron Martindale Pharma 4. Possible side effects 5. How to store Granisetron Martindale Pharma 6. Contents of the pack and other information 1. WHAT GRANISETRON MARTINDALE PHARMA IS AND WHAT IT IS USED FOR Granisetron Martindale Pharma contains a medicine called granisetron. This belongs to a group of medicines called ‘5-HT 3 receptor antagonists’ or ‘anti-emetics’. Granisetron Martindale Pharma is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer, and by surgery. The solution for injection is for use in adults and children from 2 years old. Granisetron Martindale Pharma will be given to you by a doctor or nurse in a hospital environment. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GRANISETRON MARTINDALE PHARMA DO NOT TAKE GRANISETRON MARTINDALE PHARMA • If you are allergic to granisetron or any other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, nurse or pharmacist before having the injection. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before taking Granisetron Martindale Pharma if you: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR Y Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Granisetron Martindale Pharma 3mg/3ml Concentrate for Solution for Injection/Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is granisetron. Each 3 ml of concentrate contains 3mg granisetron (as hydrochloride) (1 mg/ml) Each 1 ml of concentrate contains 27 mg sodium chloride, equivalent to 10.62 mg of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for injection/infusion The solution for injection/infusion is a sterile, clear and colourless liquid, with a pH of 4.0 – 6.0. The osmolarity of the product is approximately 310 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron Martindale Pharma is indicated in adults for the prevention and treatment of - acute nausea and vomiting associated with chemotherapy and radiotherapy. - post-operative nausea and vomiting. Granisetron Martindale Pharma solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy. Granisetron Martindale Pharma solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) PREVENTION (ACUTE AND DELAYED NAUSEA) A dose of 1-3 mg (10-40µg/kg) of Granisetron Martindale Pharma solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy. The solution should be diluted to 5ml per mg. TREATMENT (ACUTE NAUSEA) A dose of 1-3 mg (10-40µg/kg) of Granisetron Martindale Pharma solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion and administered over 5 minutes. The solution should be diluted to 5ml per mg. Further maintenance doses Preberite celoten dokument