Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Aprepitant 165mg
Merck Sharp & Dohme (New Zealand) Limited
Aprepitant 165 mg
165 mg
Capsule
Active: Aprepitant 165mg Excipient: Gelatin Hyprolose Indigo carmine Microcrystalline cellulose as beads Sodium laurilsulfate Sucrose Titanium dioxide
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, Cold form Al/polyamide blisters with either laquered Al foil or laminated Al/polyester/paper lidding - 1 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, Cold form Al/polyamide blisters with either laquered Al foil or laminated Al/polyester/paper lidding - 6 capsules - 48 months from date of manufacture stored at or below 30°C
2012-11-28
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 _CHEMOTHERAPY INDUCED _ _NAUSEA AND VOMITING _ EMEND, in combination with other medicines, is used to prevent nausea (feeling sick) and vomiting associated with cancer chemotherapy. _POST-OPERATIVE NAUSEA AND _ _VOMITING _ EMEND is used to prevent nausea (feeling sick) and vomiting which can occur after surgery. 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 cause serious or life- threatening reactions. DO NOT TAKE EMEND IF YOU HAVE A RARE HEREDITARY PROBLEM OF FRUCTOSE IN Прочетете целия документ
Page 1 of 19 NEW ZEALAND DATA SHEET 1 PRODUCT NAME EMEND ® 40 mg, 80 mg, 125 mg, and 165 mg capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 40 mg capsule contains 40 mg of aprepitant Each 80 mg capsule contains 80 mg of aprepitant Each 125 mg capsule contains 125 mg of aprepitant Each 165 mg capsule contains 165 mg of aprepitant _Excipients with known effect _ Each 40 mg capsule contains 40 mg of sucrose. Each 80 mg capsule contains 80 mg of sucrose. Each 125 mg capsule contains 125 mg sucrose. Each 165 mg capsule contains 165 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 40 mg: A size #4 opaque, hard gelatin capsule with white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink. Dimensions are overall length 14.3 mm. 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. 165 mg: A size #0 opaque. Hard gelatin capsule with a white body and light blue cap with “466” and “165 mg” printed radially in black ink. Dimensions are overall length 21.7 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). EMEND is indicated for the prevention of postoperative nausea and vomiting. Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV) EMEND (aprepitant) is available as capsules for oral administration. EMEND is given for 1 day or for 3 days as part of a regimen that includes a corticosteroi Прочетете целия документ