Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Aprepitant
Merck Sharp & Dohme B.V.
A04AD12
aprepitant
Antiemetics and antinauseants,
Vomiting; Postoperative Nausea and Vomiting; Cancer
Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.
Revision: 30
Authorised
2003-11-11
58 B. PACKAGE LEAFLET 59 PACKAGE LEAFLET: INFORMATION FOR TH E USER EMEND 125 MG HARD CAPSULES EMEND 80 MG HARD CAPSULES aprepitant READ ALL OF THIS LEAF L ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. IF YOU ARE THE PARENT OF A CHILD TAKING EMEND, PLEASE READ THIS INFORMATION CAREFULLY . - Keep this leaflet. You may need to read it again. - If you have a ny further questions, ask the doctor, pharmacist, or nurse. - This medicine has been prescribed for you or the child only. Do not pass it on to others. It may ha rm them, even if their signs of illness are the same. - If you or the child gets any side effe c ts, 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. Wh at EMEND is and what it is used for 2. What you need to know before you take or give EMEND 3. H ow to take EMEND 4. Possible side effects 5. How to store EMEND 6. Contents of the pack and other information 1. WHAT EMEND IS AND WHAT IT IS USED FOR EMEND c ontains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK 1 ) receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing na usea and vomiting. EMEND capsules are used in adults and adolescents from the age of 12 years I N COMBINATION WITH OTHER MEDICINES to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and v omiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin) . 2. WHAT YOU NEED T O KNOW BEFORE YOU TAKE OR GIVE EMEND DO NOT TAKE EMEND - if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6). - with medicines containing pimozide (used to treat psychiatric illnesses), terfenad ine and astemizole (used for hay fever and other allergic conditions), cisapride (used fo Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EMEND 125 mg hard capsules EMEND 80 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 125 mg capsule contains 125 mg of aprepitant . Each 80 mg capsule contains 80 mg of aprepitant. Excipient with known effect Each capsule contains 125 mg of sucrose (in the 125 mg capsule) . Excipient with kn own effect Each capsule contains 80 mg of sucrose (in the 80 mg capsule). For the full list o f excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. The 125 mg capsule is opaque with a white body a n d pink cap with “462” and “125 mg” printed radially in black ink on the b ody. The 80 m g capsules are opaque with a white body and cap with “461” and “80 mg” printed radially in black ink on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention nausea and vomiting associated with highly and moderately emet ogenic cancer chemotherapy in adults and adolescents from th e age of 12. EMEND 125 mg/80 mg is given as part of combination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF AD MINISTRATION Posology Adults EMEND is given for 3 days as part of a regim en that inclu des a corticosteroid and a 5 -HT 3 antagonist. The recommended dose is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning . 3 The following regimens are recommended in adults for t he prevention of nausea and vomiting associated w ith emetogenic cancer chemotherapy: Highly Emetogenic Chemotherapy Regimen Day 1 Day 2 Day 3 Day 4 EMEND 125 mg orally 80 mg orally 80 mg orally none Dexamethasone 12 mg orally 8 mg orally 8 mg orally 8 mg orally 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 chemothe rapy treatmen t on Day 1 and in the morning on Days 2 to 4. The dose of Przeczytaj cały dokument