Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
eptacog alfa (activated)
Novo Nordisk A/S
B02BD08
eptacog alfa (activated)
Antihemorrhagics
Hemophilia B; Thrombasthenia; Factor VII Deficiency; Hemophilia A
NovoSeven is indicated 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 inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU);in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration;in patients with acquired haemophilia;in patients with congenital factor-VII deficiency;in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions.in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
Revision: 38
Authorised
1996-02-23
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOSEVEN 1 MG (50 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOSEVEN 2 MG (100 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOSEVEN 5 MG (250 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION NOVOSEVEN 8 MG (400 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION eptacog alfa (activated) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS INJECTION 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. • 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 NovoSeven is and what it is used for 2. What you need to know before you use NovoSeven 3. How to use NovoSeven 4. Possible side effects 5. How to store NovoSeven 6. Contents of the pack and other information Overleaf: Instructions on how to use NovoSeven 1. WHAT NOVOSEVEN IS AND WHAT IT IS USED FOR NovoSeven is a blood coagulation factor. It works by making the blood clot at the site of bleeding, when the body's own clotting factors are not working. NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments. Early treatment with NovoSeven reduces how much you bleed and for how long. It works in all types of bleeds, including joint bleeds. This reduces the need for hospitalisation and days absent from work and school. It is used in certain groups of people: • If you were _born with haemophilia_ and do not respond normally to factors VIII or IX treatment • If you have _acquired haemophilia_ • If you have _Factor VII deficiency_ • If you have _Glanzmann’s thrombasthenia_ (a bleeding disorder) and your condition cannot be treated effectively Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoSeven 1 m g (50 KIU) NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial). NovoSeven 2 m g (100 KIU) NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial). NovoSeven 5 m g (250 KIU) NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial). NovoSeven 8 mg (400 KIU) NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial). 1 KIU equals 1,000 IU (International Units). eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology. After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White lyophilised powder. Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoSeven is indicated 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 inhibitors to coagulation factors VIII or IX Przeczytaj cały dokument