Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROMOSOZUMAB
Amgen Biopharmaceuticals Malaysia Sdn Bhd
ROMOSOZUMAB
2 Pre-Filled Syringes
Amgen Manufacturing Limited
EVENITY ® SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105MG/1.17ML Romosozumab (105 mg/1.17 ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET? 1. What EVENITY is Used for 2. How EVENITY Works 3. Before You Use EVENITY 4. How to Use EVENITY 5. While You are Using EVENITY 6. Side Effects 7. Storage and Disposal of EVENITY 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT EVENITY? EVENITY CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: • increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Before you receive EVENITY, tell your doctor if you have had a heart attack or stroke, especially if it has happened in the past year. See “ WHILE YOU ARE USING EVENITY ” WHAT EVENITY IS USED FOR EVENITY is used to treat: • severe osteoporosis in women after menopause, at high risk of fracture Osteoporosis is a disease that makes your bones thin and fragile. Osteoporosis is most common in women following menopause. Many patients with osteoporosis have no symptoms, but they are still at risk of breaking a bone because osteoporosis has made their bones weak. HOW EVENITY WORKS EVENITY contains romosozumab, a medicine that helps build bone, which makes bone stronger and less likely to break. EVENITY inhibits a protein called sclerostin. By binding and preventing the activity of sclerostin, EVENITY rapidly promotes bone building and also decreases break down of bone. EVENITY’s dual effect of both building new bone and also decreasing break down of existing bone will strengthen your bones, improve your bone mass and structure, and lower your chance of breaking bones. BEFORE YOU USE EVENITY Tell your doctor if you had a heart attack or stroke, especially if it happened in the past year. - _When you must not use it_ DO NOT use if you have low calcium levels in your blood. Your doctor can tell you if your levels are too low. DO NOT use if you ar Διαβάστε το πλήρες έγγραφο
1 Amgen Proprietary - Confidential WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH • EVENITY MAY INCREASE THE RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH _[SEE WARNINGS AND PRECAUTION (4.4)]. _EVENITY SHOULD NOT BE INITIATED IN PATIENTS WHO HAVE HAD A MYOCARDIAL INFARCTION OR STROKE WITHIN THE PRECEDING YEAR. CONSIDER WHETHER THE BENEFITS OUTWEIGH THE RISKS IN PATIENTS WITH A HISTORY OF MI OR STROKE AND OTHER CARDIOVASCULAR RISK FACTORS. IF A PATIENT EXPERIENCES A MYOCARDIAL INFARCTION OR STROKE DURING THERAPY, EVENITY SHOULD BE DISCONTINUED. 1. NAME OF THE MEDICINAL PRODUCT EVENITY ® solution for injection in pre-filled syringe 105 mg/1.17 mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EVENITY solution for injection in pre-filled syringe 105 mg Each pre-filled syringe contains 105 mg romosozumab in 1.17 mL (90 mg/mL) solution. EVENITY (romosozumab) is a humanised monoclonal antibody (IgG2) with high affinity and specificity for sclerostin. Romosozumab has an approximate molecular weight of 145 kDa and is produced in a mammalian cell line (Chinese hamster ovary) by recombinant DNA technology. For the full list of excipients, see List of Excipients (6.1). 3. PHARMACEUTICAL FORM Solution for subcutaneous injection. EVENITY is a sterile, preservative-free, clear to opalescent, colourless to light yellow solution, pH 5.2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Postmenopausal Osteoporosis EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1). 4.2 DOSAGE AND ADMINISTRATION Dosage The recommended dose of EVENITY is 210 mg administered subcutaneously. Administer EVENITY once every month for 12 doses. Patients should be adequately supplemented with calcium and vitamin D [see Contraindications (4.3), Special Warnings and Precautions for Use (4.4), and Pharmacodynamic properties, clinical data (5.1)] If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, Διαβάστε το πλήρες έγγραφο