البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fosaprepitant dimeglumine
Merck Sharp & Dohme Ltd
Fosaprepitant dimeglumine
150mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5013945002584
PACKAGE LEAFLET: INFORMATION FOR THE USER IVEMEND ® 150 MG POWDER FOR SOLUTION FOR INFUSION fosaprepitant READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist, or nurse. - If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IVEMEND is 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. How to store IVEMEND 6. Contents of the pack and other information 1. WHAT IVEMEND IS AND WHAT IT IS USED FOR IVEMEND contains the active substance fosaprepitant which is converted to aprepitant in your body. It belongs to a group of medicines called "neurokinin 1 (NK 1 ) receptor antagonists". The brain 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 children aged 6 months or older IN COMBINATION WITH OTHER MEDICINES to prevent nausea and vomiting caused by chemotherapy (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 you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or any of the other ingredients (listed in section 6). with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since the treatment must be modified before you start using IVEMEND. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist, or nurse before using IVEMEND. Before treatment with this medicine, tell your doctor if you اقرأ الوثيقة كاملة
OBJECT 1 IVEMEND 150 MG POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 15-May-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product IVEMEND ® 150 mg powder for solution for infusion. 2. Qualitative and quantitative composition Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion. White to off-white amorphous powder. 4. Clinical particulars 4.1 Therapeutic indications 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 (see section 4.2). 4.2 Posology and method of administration Posology _Adults _ The recommended dose is 150 mg administered as an infusion OVER 20-30 MINUTES on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6). IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below. The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy. _Highly Emetogenic Chemotherapy Regimen_ 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 dosing information none none none DEXAMETHASONE should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. Dexamethasone should also be administered in the evenings on Days 3 and 4. The dose of dexamethasone accounts for active substance interactio اقرأ الوثيقة كاملة