Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
APREPITANT
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
A04AD12
CAPSULES
APREPITANT 80 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
APREPITANT
APREPITANT
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 including high-dose cisplatin. - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
2021-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only EMEND ® 80 mg Capsules EMEND ® 125 mg Capsules Each capsule contains: Aprepitant 80 mg Each capsule contains: Aprepitant 125 mg For a list of inactive ingredients see section 6 "FURTHER INFOMATION". See also section 2.9 “Important information about some of the ingredients of EMEND”. Read the entire leaflet carefully before you start taking this medicine. • This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or the pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • This medicine is not intended for children and adolescents under 18 years of age. 1. WHAT EMEND IS INTENDED FOR? EMEND capsules are intended for use in adult patients, in combination with other anti-emetic medicines: - To prevent acute and delayed nausea and vomiting caused by chemotherapy (cancer treatment) of highly emetogenic potential (strong trigger of nausea and vomiting). - To prevent chemotherapy induced nausea and vomiting (CINV) that are caused by chemotherapy (cancer treatment) of moderate emetogenic potential (moderate trigger of nausea and vomiting). Therapeutic group: EMEND is a neurokinin 1 (NK 1 ) receptor antagonist. 2. BEFORE YOU TAKE EMEND 2.1 Do not take EMEND: − if you are hypersensitive (allergic) to aprepitant or any of the other ingredients of EMEND (for a list of inactive ingredients, see 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 your treatment must be modified before you start taking EMEND. Taking EMEND with these medications could result in serious or life-threatening p Διαβάστε το πλήρες έγγραφο
1 1. NAME OF THE MEDICINAL PRODUCT EMEND ® 125 mg capsules EMEND ® 80 mg 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 known effect: Each capsule contains 80 mg of sucrose (in the 80 mg capsule). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. The 125 mg gelatin capsule (no. 1) is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. The 80 mg gelatin capsules (no. 2) 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 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, including high-dose cisplatin (see section 4.2). • Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (see section 4.2) 4.2 Posology and method of administration Posology EMEND is given for 3 days as part of a regimen that includes 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. The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy: 2 _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 Dexam Διαβάστε το πλήρες έγγραφο