Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
fosaprepitant
Merck Sharp & Dohme B.V.
A04AD12
fosaprepitant
Antiemetics and antinauseants,
Vomiting; Cancer
Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.Ivemend 150 mg is given as part of a combination therapy.
Revision: 24
Authorised
2008-01-11
28 B. PACKAGE LEAFLET 29 PACKAGE L EAFLET: INFORMATION FOR THE USER IVEMEND 150 MG POWDER FOR SOLUTION FOR INFUSION fosaprepitant READ A LL OF THIS LEAFLET CAREFULLY BEFORE YOU STA RT USING THIS MEDICINE BECAUSE IT CONTAINS IMP ORTANT INFORMA TION FOR YOU . - Kee p this leaflet. You may need to read it again. - If you have any f urther questions, ask your doctor, pharmacist, or nurse. - If you ge t any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in th is leaflet. See section 4. WHAT IS I N THIS LEAFLET 1. What IVEMEND i s and what it is used for 2. What you need to know before you use IVEMEND 3. How to use IVEMEND 4. Possible side effects 5. Ho w to store IVEMEND 6. Contents of the pack a nd other information 1. W HAT IVEMEND IS AND WHA T IT IS USED FOR IVEMEND contains th e active substance fosaprepitant which is converted to aprepitant in your body. It belongs to a group of medici nes called "neu rokinin 1 (NK 1 ) receptor antago nists". The b rain has a specific area that controls nausea and vomiting. IVEMEND works by blocking signals to that area, thereby reducing nausea and vomiting. IVEMEND is used in adults , adolescents, and childre n aged 6 months or older IN COMBINATION WITH O THER MEDICINE S to prevent nau sea and vomiting caused by chemot herapy (cancer treatment) that is a strong or moderate trigger of nausea and vomiting . 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IVEMEND DO NOT USE IVEMEND • if yo u are allergic to f osaprepitan t , aprepitant, or to polysorbat e 8 0 or any of the other ingredients of this medicine (listed in sec tion 6). • with medicines containing pimozide (used to treat psychiatric illnesses), te rfenadine and astemizole (u sed for hay fever and othe r all ergic conditions), cisapride (u sed for treat ing digestive problems). Tell your doctor if you are taking these me dicines since the treatment must be modified before you start using IVEMEND. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist, or nurs e be Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IVEMEND 150 mg powder for solu tion for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains fosaprepitant dimeglumine equivalent t o 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosa prepitant (1 mg/ml) (see section 6.6). For t he full list of excipients, see section 6.1. 3. PHARMACEUTICAL FOR M Po wder for solution for infusion. White to off - white amorphous powd er. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of nausea and vomiting associated with highly a nd moderately emetogenic cancer chemother apy in adults and paediatri c patients aged 6 months and older . IVEMEND 150 mg is given as part o f a com bination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The recommend ed dose is 150 mg administered as an infusi on OVER 20-30 MINUTES on Day 1, initiated approximately 30 minutes prior to chemotherapy (see sec tion 6. 6). IVEMEND should be administered in conjunction with a corticosteroid and a 5 -HT 3 antagonist as specified i n the tables below. 3 The following regimens are recommended for the p reven tion of nausea and vomiting associated with emetogenic cancer che motherapy. TABLE 1: RECOMMENDED DOSING FOR T HE PREVENTIO N OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CH EMOTHERAPY REGIMEN IN ADULTS DAY 1 DAY 2 DAY 3 DAY 4 IVEMEND 150 mg intravenously none none none Dexamethasone 12 mg orally 8 mg orally 8 MG ORALLY TWICE DAILY 8 MG ORALLY TWICE DAILY 5-HT 3 antagonists Standard dose of 5-HT 3 antagonists. See the product information for the selected 5-HT 3 antagonist for appropriate dos ing information none none none DEXAMETHASONE should be administered 3 0 minut es prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. Dexamethasone should also be a dm inistered in the evenings on Days 3 and 4 . The dose of dexamethasone acco unts f Lees het volledige document