Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Emicizumab
Roche Registration Limited
B02BX06
emicizumab
Antihemorrhagics
Hemophilia A
Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency):with factor VIII inhibitorswithout factor VIII inhibitors who have:severe disease (FVIII < 1%)moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype.Hemlibra can be used in all age groups.
Revision: 15
Authorised
2018-02-23
58 B. PACKAGE LEAFLET 59 PACKAGE LEAFLET: INFORMATION FOR THE USER HEMLIBRA 30 MG/ML SOLUTION FOR INJECTION emicizumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ● Keep this leaflet. You may need to read it again. ● If you have any further questions, ask your doctor, pharmacist or nurse. ● This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ● If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In addition to this leaflet, your doctor will give you a patient card, which contains important safety information that you need to be aware of. Keep this patient card with you. WHAT IS IN THIS LEAFLET 1. What Hemlibra is and what it is used for 2. What you need to know before you use Hemlibra 3. How to use Hemlibra 4. Possible side effects 5. How to store Hemlibra 6. Contents of the pack and other information 7. Instructions for use 1. WHAT HEMLIBRA IS AND WHAT IT IS USED FOR WHAT HEMLIBRA IS Hemlibra contains the active substance “emicizumab”. This belongs to a group of medicines called “monoclonal antibodies”. Monoclonal antibodies are a type of protein that recognise and bind to a target in the body. WHAT HEMLIBRA IS USED FOR Hemlibra is a medicine used for treating patients of all ages with haemophilia A (congenital factor VIII deficiency): ● who have developed factor VIII inhibitors ● who have not developed factor VIII inhibitors with: - severe disease (the factor VIII blood level is less than 1%) - moderate disease (the factor VIII blood level is from 1% to 5%) with severe bleeding phenotype. 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 Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 0.4 mL contains 12 mg of emicizumab at a concentration of 30 mg/mL. 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. Each vial of 2 mL contains 300 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 in 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 ● without factor VIII inhibitors who have: - severe disease (FVIII < 1%) - moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups. 3 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 bleeding disorders. Posology Treatment (including routine prophylaxis) with bypassing agents (e.g. activated prothrombin complex concentrate [aPCC] and activated recombinant human FVII [rFVIIa]) should be discontinued the day before starting Hemlibra therapy (see section 4.4). Factor VIII Lestu allt skjalið