Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
catridecacog
Novo Nordisk A/S
B02BD11
catridecacog
Antihemorrhagics
Blood Coagulation Disorders, Inherited
Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.
Revision: 7
Authorised
2012-09-03
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER NOVOTHIRTEEN 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION catridecacog (recombinant coagulation factor XIII) 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. – 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 NovoThirteen is and what it is used for 2. What you need to know before you use NovoThirteen 3. How to use NovoThirteen 4. Possible side effects 5. How to store NovoThirteen 6. Contents of the pack and other information. 1. WHAT NOVOTHIRTEEN IS AND WHAT IT IS USED FOR WHAT NOVOTHIRTEEN IS NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting. NovoThirteen replaces the missing factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot. WHAT NOVOTHIRTEEN IS USED FOR NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOTHIRTEEN It is important that you use NovoThirteen for injection immediately after preparation. DO NOT USE NOVOTHIRTEEN • If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6). If you are not sure, ask your doctor before using this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor before using NovoThirteen: • If you have or have ever had a higher risk of blood clots forming (thrombosis), as NovoThirteen may increase the severity of a pre-existing blood clot. Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA): 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml. The specific activity of NovoThirteen is approximately 165 IU/mg protein. The active substance is produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white and the solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Long term prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency. Treatment of breakthrough bleeding episodes during regular prophylaxis. NovoThirteen can be used for all age groups. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a doctor experienced in the treatment of rare bleeding disorders. The congenital factor XIII A-subunit deficiency should be confirmed by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping. Posology The potency of this medicinal product is expressed in international units (IU). Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4). _Prophylaxis _ The recommended dose for prophylactic treatment is 35 IU/kg body weight once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection. _Treatment of bleeds _ If a breakthrough bleed occurs during regular prophylaxis, it is recommended to treat with a single dose of 35 IU/kg body weight administered as an intravenous bolus injection. If bleeds occur in a patient who is not on regular prophylaxis, a single dose of 35 Pročitajte cijeli dokument