Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Fosaprepitant dimeglumine 197.5mg ((free acid) (120.8 mg))
Merck Sharp & Dohme (New Zealand) Limited
Fosaprepitant dimeglumine 197.5 mg ((free acid) (120.8 mg))
115 mg
Powder for injection
Active: Fosaprepitant dimeglumine 197.5mg ((free acid) (120.8 mg)) Excipient: Disodium edetate Hydrochloric acid Lactose Polysorbate 80 Sodium hydroxide Water for injection
Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper, 1 dose unit
Prescription
Prescription
Laboratoires Merck Sharp & Dohme - Chibret
Package - Contents - Shelf Life: Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at or below 25°C - Vial, glass, Borosilicate Type I with 13 mm latex free rubber stoper - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at or below 25°C
2006-05-26
EMEND IV™ _fosaprepitant dimeglumine _ Intravenous WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EMEND IV. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given EMEND IV against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor. Keep this leaflet with the medicine. You may need to read it again. WHAT EMEND IV IS USED FOR Your doctor has prescribed EMEND IV for the prevention of nausea and vomiting associated with your cancer chemotherapy treatment. HOW EMEND IV WORKS EMEND IV is a member of a class of medicines called neurokinin 1 (NK 1 ) receptor antagonists that is used ALONG WITH OTHER MEDICINES to prevent and control nausea (sick feeling in the back of throat and stomach) and vomiting (throwing up) caused by your cancer chemotherapy treatment. BEFORE YOU ARE GIVEN EMEND IV WHEN YOU MUST NOT BE GIVEN IT Do not have EMEND IV if: • you have an allergy to EMEND IV or any of the ingredients listed at the end of this leaflet • the packaging is torn or shows signs of tampering • the expiry date on the pack has passed. If you receive this medicine after the expiry date has passed, it may not work. If you are not sure whether you should start EMEND IV, talk to your doctor. EMEND IV has not been adequately studied in children. Therefore, EMEND IV should not be given to children. EMEND IV works equally well in and is equally well-tolerated by older and younger adult patients. No dosage adjustment is necessary for older patients. BEFORE EMEND IV IS STARTED Tell your doctor if: • you are pregnant or intend to become pregnant • you are breast-feeding or plan to breast-feed • you have any past or present medical problems • you have any alle Διαβάστε το πλήρες έγγραφο
NAME OF MEDICINE EMEND IV™ _fosaprepitant dimeglumine _ Intravenous PRESENTATION EMEND IV 115 mg is for intravenous use and comes in a 10 mL vial with a grey butyl stopper and aluminium seal with a light blue plastic flip off lid. EMEND IV 150 mg is for intravenous use and comes in a 10 mL vial with a grey butyl stopper and aluminium seal with a dark grey plastic flip off lid. Each 10 mL vial contains either 115 mg or 150 mg of fosaprepitant free acid as a white to off white lyophilised solid. The reconstitution liquid is clear. THERAPEUTIC CLASS EMEND IV (fosaprepitant dimeglumine, MSD), is a prodrug of aprepitant, a substance P/neurokinin (NK 1 ) receptor antagonist. INDICATIONS EMEND IV, 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 Dosage and Administration) • moderately emetogenic cancer chemotherapy (see Dosage and Administration). DOSAGE AND ADMINISTRATION EMEND IV for intravenous administration is a lyophilised prodrug of aprepitant (EMEND ® ) containing polysorbate 80 (PS80). EMEND IV is available as a 150 mg and 115 mg IV for infusion. EMEND IV 150 MG EMEND IV 150 mg is administered on Day 1 only as an infusion OVER 20 – 30 MINUTES initiated approximately 30 minutes prior to chemotherapy. No capsules of EMEND are administered on Days 2 and 3. EMEND IV should be administered in conjunction with a corticosteroid and a 5-HT 3 antagonist as specified in the tables below. The recommended dosage of dexamethasone with EMEND IV 150 mg differs from the recommended dosage of dexamethasone with EMEND IV 115 mg on Days 3 and 4. Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: Day 1 Day 2 Day 3 Day 4 EMEND IV 150 mg IV none none none Dexameth Διαβάστε το πλήρες έγγραφο