Riik: Malta
keel: inglise
Allikas: Medicines Authority
FACTOR II, PROTHROMBIN, FACTOR IX, HUMAN, FACTOR X, FACTOR VII
Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria
B02BD01
FACTOR II (PROTHROMBIN) 24-45 IU/mg FACTOR IX, HUMAN 30 IU/mg FACTOR X, HUMAN 30 IU/mg FACTOR VII, HUMAN 25 IU/mg
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR II (PROTHROMBIN) 24-45 IU/mg FACTOR IX, HUMAN 30 IU/mg FACTOR X, HUMAN 30 IU/mg FACTOR VII, HUMAN 25 IU/mg
POM
ANTIHEMORRHAGICS
Authorised
2014-07-17
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PROTHROMPLEX TOTAL 600 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Active substance: Human Prothrombin Complex READ ALL OF THIS LEAFLET CAREFULLY BEFORE ADMINISTRATION OF 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. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Prothromplex TOTAL is and what it is used for 2. What you need to know before you use Prothromplex TOTAL 3. How to use Prothromplex TOTAL 4. Possible side effects 5. How to store Prothromplex TOTAL 6. Contents of the pack and other information 1. WHAT PROTHROMPLEX TOTAL IS AND WHAT IT IS USED FOR Prothromplex TOTAL is a preparation made from human plasma (the liquid part of blood). It contains the blood clotting factors II, VII, IX and X (prothrombin complex coagulation factors). As well as protein C. These clotting factors are vitamin K dependent and, like vitamin K, they play an important role in blood clotting. In the event of a deficiency of one of these factors, blood does not clot as rapidly as usual, which leads to an increased bleeding tendency. Prothromplex TOTAL is used for: • the treatment of bleeding • the prevention of bleeding immediately before or after surgery • the conditions acquired deficiency and congenital deficiency of coagulation factors _Acquired deficiency: _ You may develop a deficiency of the vitamin K-dependent coagulation factors (acquired deficiency), for example, from treatment with or an overdose of medicinal products that reduce the effect of vitamin K (so-called vitamin K antagonists). _Congenital deficiency:_ If you were born with a deficiency (congenital deficiency), this medicine may be given to you immediately before or after surgery if the appropriate individual factor concentrate is not available. Lugege kogu dokumenti
1. NAME OF THE MEDICINAL PRODUCT Prothromplex TOTAL 600 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: human prothrombin complex Prothromplex TOTAL 600 IU is a powder for solution for intravenous application. Each vial nominally contains the following IU of human coagulation factors. PER VIAL IU AFTER RECONSTITUTION IN 20 ML STERILIZED WATER FOR INJECTIONS IU/ML Human coagulation factor II 450 - 850 22.5 - 42.5 Human coagulation factor VII 500 25 Human coagulation factor IX 600 30 Human coagulation factor X 600 30 The total protein content per vial is 300 - 750 mg. The specific activity of the product is at least 0.6 IU/mg, in relation to the factor IX activity. One vial contains at least 400 IU Protein C co-purified with the blood coagulation factors. The activity (IU) of factor IX was determined by the one-step coagulation test described in the European Pharmacopoeia, which is calibrated against the International Standard for Factor IX Concentrates of the World Health Organisation (WHO). The activity (IU) of factor II, factor VII and factor X was determined by the chromogenic assay described in the European Pharmacopoeia, which is calibrated against the International Standards for Factor II, Factor VII and Factor X Concentrates of the World Health Organisation (WHO). The activity (IU) of protein C was determined by the chromogenic assay described in the European Pharmacopoeia, which is calibrated against the International Standard for Protein C Concentrates of the World Health Organisation (WHO). Excipients with known effect Prothromplex TOTAL 600 IU contains 81.7 mg sodium per vial. Furthermore, each vial contains heparin sodium (max. 0.5 IU/IU factor IX). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: White to light yellow, freeze dried powdery or compact dry substance. Solvent: Sterilized water for injections. After reconstitution, the pH value of the solution is 6. Lugege kogu dokumenti