Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Emicizumab
ROCHE (MALAYSIA) SDN. BHD.
Emicizumab
3 ml
F.HOFFMANN-LA ROCHE LTD
_Consumer Medication Information Leaflet (RiMUP) _ HEMLIBRA ® _Emicizumab 30mg/ml, 150mg/ml _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Hemlibra is used for 2. How Hemlibra works 3. Before you use Hemlibra 4. How to use Hemlibra 5. While you are using Hemlibra 6. Side effects 7. Storage and disposal of Hemlibra 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT HEMLIBRA IS USED FOR Hemlibra is a medicine used for treating patients of all ages with ● either haemophilia A who have developed factor VIII inhibitors ● or with severe haemophilia A without factor VIII inhibitors (the FVIII blood level is less than 1%). Haemophilia A is an inherited condition caused by a lack of factor VIII, an essential substance required for blood to clot and stop any bleeding. The medicine prevents bleeding or reduces bleeding episodes in people with this condition. Some patients with haemophilia A can develop factor VIII inhibitors (antibodies against factor VIII) which stop the replacement factor VIII from working. HOW HEMLIBRA WORKS Hemlibra restores the function of missing activated factor VIII that is needed for effective clotting. Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors. BEFORE YOU USE HEMLIBRA - _WHEN YOU MUST NOT USE IT_ DO NOT TAKE HEMLIBRA IF: 1. if you are allergic to emicizumab or any of the other ingredients of this medicine 2. the package is torn or shows signs of tampering 3. the expiry date (EXP) printed on the pack has passed If you are not sure if you should be taking Hemlibra, talk to your doctor or pharmacist. - _BEFORE YOU START TO USE IT _ WARNINGS AND PRECAUTIONS IT IS VERY IMPORTANT YOU TALK TO YOUR DOCTOR ABOUT WHEN AND HOW TO USE “BYPASSING AGENTS” (medicines that help blood clot but which work in a different way from factor VIII). THIS IS BECAUSE TREATMENT WITH BYPASSING AGENTS MAY NEED TO BE CHANGED WHILE RECEIVING HEMLIBRA. Examples of bypassing agents include activated pro Կարդացեք ամբողջական փաստաթուղթը
HEMLIBRA ® Emicizumab 1. NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hemlibra 30 mg/mL solution for injection Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL. Hemlibra 150 mg/mL solution for injection Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL. Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL. Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL. * Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology i n mammalian Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with ● haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors ● severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors. Hemlibra can be used in all age groups. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleedin g disorders. Posology Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4). Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment. The recommended dose is 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks, all doses administered as a subcu Կարդացեք ամբողջական փաստաթուղթը