Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
GRANISETRON HYDROCHLORIDE
Atnahs Pharma UK Limited
A04AA02
GRANISETRON HYDROCHLORIDE
3 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
granisetron
Marketed
1991-12-16
IE 735-1976 APIL 28051813 START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this See section 4. 1. What Kytril is and what it is used for 2. What you need to know before you are given Kytril 3. How Kytril will be given 4. Possible side effects 5. How to store Kytril 6. Contents of the pack and information 1. WHAT KYTRIL IS AND WHAT IT IS USED FOR Kytril contains the active substance granisetron. This belongs to a group of medicines called ‘5-HT 3 receptor antagonists’ or ‘anti-emetics’. Kytril 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KYTRIL DO NOT USE KYTRIL ● if you are allergic (hypersensitive) to granisetron or any of the other ingredients of Kytril (listed in Section 6: Further information). If you are not sure, talk to your doctor, nurse or pharmacist before having the injection. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before using Kytril, especially if you: ● are having problems with your bowel movements because of a blockage of your gut (intestines) ● have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities) ● are taking other ‘5-HT 3 receptor antagonist’ medicines. These include dolasetron, ondansetron used like Kytril in the treatment and preven Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kytril 3 mg/3 ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is granisetron. Each ml solution for injection contains 1 mg of granisetron (as the hydrochloride). Excipient with known effect: sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. The solution for injection is a clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kytril solution for injection is indicated in adults for the prevention and treatment of - acute nausea and vomiting associated with chemotherapy and radiotherapy. - post-operative nausea and vomiting. Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy. Kytril 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 (10-40 µg/kg) of Kytril 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 (10-40 µg/kg) of Kytril 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 of Kytril solution for injection may be administered at least 10 minutes apart. The maximum dose to be administered over 24 hours should not exceed 9 mg. _Combination with adrenocortical steroid_ The efficacy of parenteral granisetron may be enhanced by an additional intravenous dose of an adrenocortical stero Perskaitykite visą dokumentą