Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Catridecacog, Quantity: 5.25 mg/mL
Novo Nordisk Pharmaceuticals Pty Ltd
Catridecacog
Drug delivery system
Excipient Ingredients:
Intravenous
1 vial of powder for injection and one vial of diluent for resuspension with one vial adaptor
Not Scheduled after consideration by Committee
NovoThirteen is indicated for routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.
Visual Identification: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2013-11-07
page 1 of 5 NovoThirteen-cmiv2.doc NOVOTHIRTEEN ® 2500 IU catridecacog (rys) Recombinant coagulation factor XIII CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT NOVOTHIRTEEN ® IS USED FOR 1 BEFORE YOU USE NOVOTHIRTEEN ® . 1 USING NOVOTHIRTEEN ® ................ 2 WHILE YOU ARE USING NOVOTHIRTEEN ® .................................................... 2 SIDE EFFECTS ................................. 3 STORAGE ....................................... 3 PRODUCT DESCRIPTION .................. 3 NOVOTHIRTEEN ® USER INSTRUCTIONS 4 This leaflet answers some common questions about NovoThirteen ® . It does not contain all the available information. It does not take the place of talking to your doctor or healthcare professional. All medicines have risks and benefits. Your doctor has weighed the risks of you using NovoThirteen ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NOVOTHIRTEEN ® IS USED FOR NovoThirteen ® contains the active substance catridecacog, which is identical to human coagulation factor XIII, and is produced by recombinant technology. FXIII is an enzyme necessary for blood clotting. NovoThirteen ® is used to prevent bleeding in patients who are missing the factor XIII (A-subunit) protein. NovoThirteen ® replaces the missing Factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot. ASK YOUR DOCTOR OR HEALTHCARE PROFESSIONAL IF YOU HAVE ANY QUESTIONS ABOUT WHY NOVOTHIRTEEN ® HAS BEEN GIVEN TO YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE NOVOTHIRTEEN ® _WHEN _ _NOVOTHIRTEEN_ _®_ _ _ _SHOULD NOT BE USED _ You should not use or be treated with NovoThirteen ® if you have an allergy to: • catridecacog or any of the ingredients listed at the end of this leaflet (refer to the section “Side effects” to look for signs of an allergic reaction). IF Lugege kogu dokumenti
Product Information NovoThirteen piv3.docx Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION NOVOTHIRTEEN ® CATRIDECACOG (RYS) 1. NAME OF THE MEDICINE Recombinant human factor XIII (rFXIII) 2500 IU (15 mg) powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoThirteen contains catridecacog, a recombinant coagulation factor XIII A-subunit with a molecular mass of approximately 83.2 kDa. Catridecacog is produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology, without the use of animal derived materials. One vial of NovoThirteen contains 2500 IU catridecacog per 3 mL, after reconstitution, corresponding to a concentration of 833 IU/mL. The specific activity of rFXIII is approximately 165 IU/mg protein. The potency of this medicinal product is expressed in international units (IU). These units are not interchangeable with the units used to express the potency for other FXIII-containing products. 3. PHARMACEUTICAL FORM NovoThirteen is supplied as a white lyophilised powder to be reconstituted with solvent for injection. The solvent is clear and colourless. The reconstituted solution has a pH of approximately 8.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoThirteen is indicated for routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be initiated and continued for a period of time 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. For detailed instructions for reconstitution and administration of NovoThirteen, refer to the Instructions for Use leaflet. Product Information NovoThirteen piv3.docx Page 2 of 19 Dosage _DOSE AND DOSE INTERVAL _ The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection. The dose volume in millilitre Lugege kogu dokumenti