देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
Eptacog beta (activated)
Laboratoire Francais du Fractionnement et des Biotechnologies
B02BD08
Eptacog beta (activated)
Antihemorrhagics
Hemophilia A; Hemophilia B
CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU)); in patients with congenital haemophilia with low titre inhibitors (BU
Authorised
2022-07-15
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER CEVENFACTA 1 MG (45 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION CEVENFACTA 2 MG (90 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION CEVENFACTA 5 MG (225 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION eptacog beta (activated) This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CEVENFACTA is and what it is used for 2. What you need to know before you use CEVENFACTA 3. How to use CEVENFACTA 4. Possible side effects 5. How to store CEVENFACTA 6. Contents of the pack and other information 7. CEVENFACTA Instructions For Use 1. WHAT CEVENFACTA IS AND WHAT IT IS USED FOR CEVENFACTA contains the active substance eptacog beta (activated), a recombinant human coagulation Factor VIIa (rhFVIIa). CEVENFACTA is used in adults and adolescents (12 years of age or older) who were born with haemophilia A or B and who have developed inhibitors (antibodies). It is used for: - the treatment of bleeding episodes, - the management of bleeding during surgery. HOW CEVENFACTA WORKS This medicine works by making the blood clot at the site of bleeding, when the body’s own clotting factors are not working. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CEVENFACTA _ _ DO NOT USE CEVENFACTA - if you are allergic to eptacog beta (activated), पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection Each vial contains nominally 1 mg eptacog beta (activated) (45 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 1.1 mL of water for injections. CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection Each vial contains nominally 2 mg eptacog beta (activated) (90 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 2.2 mL of water for injections. CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection Each vial contains nominally 5 mg eptacog beta (activated)(225 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 5.2 mL of water for injections. The potency (IU) is determined using a clotting assay. 1 KIU equals 1 000 IU (International Units). Eptacog beta (activated) is a recombinant coagulation Factor VIIa (rFVIIa) with a molecular mass of approximately 50 000 Daltons produced from rabbit milk by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White to off-white lyophilised powder. Solvent: clear and colourless solution. The solution has a pH of approximately 6. The osmolality is approximately 290 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3 CEVENFACTA is indi पूरा दस्तावेज़ पढ़ें