Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
palonosetron hydrochloride
Helsinn Birex Pharmaceuticals Ltd.
A04AA05
palonosetron
Antiemetics and antinauseants, , Serotonin (5HT3) antagonists
Vomiting; Cancer
Aloxi is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.Aloxi is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Revision: 22
Authorised
2005-03-22
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER ALOXI 250 MICROGRAMS SOLUTION FOR INJECTION Palonosetron 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. • 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 Aloxi is and what it is used for 2. What you need to know before you are given Aloxi 3. How you are given Aloxi 4. Possible side effects 5. How to store Aloxi 6. Contents of the pack and other information 1. WHAT ALOXI IS AND WHAT IT IS USED FOR Aloxi contains the active substance palonosetron. This belongs to a group of medicines called ‘serotonin (5HT 3 ) antagonists’. Aloxi is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy. It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALOXI DO NOT TAKE ALOXI IF: • you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). You will not be given Aloxi if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Aloxi if: • you have a blocked bowel or have had repeated constipation in the past • you have had heart problems or heart problems run in your family, such as changes in your heart beat (‘QT prolongation’) • you have an imbalance of certain minerals in your blood which has not been treated - such as potassium and magnesium. If any of t Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aloxi 250 micrograms solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms palonosetron (as hydrochloride). Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aloxi is indicated in adults for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Aloxi is indicated in paediatric patients 1 month of age and older for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Aloxi should be used only before chemotherapy administration. This medicinal product should be administered by a healthcare professional under appropriate medical supervision. Posology _Adults _ 250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. Aloxi should be injected over 30 seconds. The efficacy of Aloxi in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy. _Elderly people _ No dose adjustment is necessary for the elderly. _ _ 3 _ _ _Paediatric population _ _ _ _Children and Adolescents (aged 1 month to 17 years): _ 20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy. The safety and efficacy of Aloxi in children aged le Pročitajte cijeli dokument