देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Aprepitant 40mg
Merck Sharp & Dohme (New Zealand) Limited
Aprepitant 40 mg
40 mg
Capsule
Active: Aprepitant 40mg Excipient: Hyprolose Micronised sodium lauryl sulphate Opaque white and mustard yellow hard gelatin capsule (contains titanium dioxide, yellow iron) Microcrystalline cellulose Purified water Sodium laurilsulfate Sucrose
Blister pack, 1 capsule
Prescription
Prescription
Siegfried Evionnaz SA
Emend, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: · moderately emetogenic cancer chemotherapy. · highly emetogenic cancer chemotherapy.
Package - Contents - Shelf Life: Blister pack, - 1 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, - 5 capsules - 48 months from date of manufacture stored at or below 30°C
2005-10-20
EMEND ® 1 EMEND ® Aprepitant CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EMEND. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking EMEND against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EMEND IS USED FOR EMEND, in combination with other medicines, is used to prevent nausea (feeling sick) and vomiting associated with cancer chemotherapy. EMEND belongs to a group of medicines called neurokinin 1 (NK1) receptor antagonists. It works by blocking the actions of substances in your brain, called substance P neurokinins, that cause nausea and vomiting. Your doctor may have prescribed EMEND for another reason. Ask your doctor if you have any questions about why EMEND has been prescribed for you. The safety and effectiveness of EMEND in children and teenagers under the age of 18 years have not been established. EMEND is not addictive. BEFORE YOU TAKE EMEND WHEN YOU MUST NOT TAKE IT DO NOT TAKE EMEND IF YOU HAVE AN ALLERGY TO EMEND OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE EMEND IF YOU ARE TAKING: Cisapride*, used to treat stomach reflux pimozide*, used to treat psychotic conditions terfenadine (Teldane*) and astemizole (Hismanal*), antihistamines used for allergic conditions, including hayfever * not available in New Zealand St Johns Wort - a herb used to treat depression Taking EMEND with these medicines may cau se serious or life- threatening reactions. DO NOT TAKE EMEND IF YOU HAVE A RARE HEREDITARY PROBLEM OF FRUCTOSE INTOLERANCE, GLUCOSE - GALACTOSE MALABSORPTION, OR SUCROSE- ISOMALTASE INSUFFICIENCY. DO NOT TAKE EMEND IF YOU ARE BREAST- FEEDING OR PLAN TO BREAST - FEED. It is not known if EMEND pass पूरा दस्तावेज़ पढ़ें
Page 1 of 16 NEW ZEALAND DATA SHEET 1 PRODUCT NAME EMEND ® 80 mg and 125 mg and capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 80 mg capsule contains 80 mg of aprepitant Each 125 mg capsule contains 125 mg of aprepitant Excipients with known effect Each 80 mg capsule contains 80 mg of sucrose. Each 125 mg capsule contains 125 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 80 mg: A size #2 opaque, hard gelatin capsule with white body and white cap with “461” and “80 mg” printed radially in black ink. Dimensions are overall length 18.0 mm. 125 mg: A size #1 opaque, hard gelatin capsule with white body and pink cap with “462” and “125 mg” printed radially in black ink. Dimensions are overall length 19.4 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EMEND, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: highly emetogenic cancer chemotherapy (see Section 4.2 ) moderately emetogenic cancer chemotherapy (see Section 4.2). 4.2 DOSE AND METHOD OF ADMINISTRATION EMEND (aprepitant) is available as capsules for oral administration. EMEND is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The data sheet for the co - administered 5 - HT3 antagonist (e.g., ondansetron) must be consulted prior to initiation of treatment with EMEND. The recommended dose of EMEND for the 3 - day oral regimen is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. Page 2 of 16 Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: 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 antagonist (e.g., ondansetron) See the data sheet for the selected 5-HT 3 antagonist for appropriate dosing info पूरा दस्तावेज़ पढ़ें