Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
human protein C
Takeda Manufacturing Austria AG
B01AD12
human protein C
Antithrombotic agents
Purpura Fulminans; Protein C Deficiency
CEPROTIN is indicated for prophylaxis and treatment of purpura fulminans coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency.
Revision: 19
Authorised
2001-07-16
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER CEPROTIN 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION human protein C 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What CEPROTIN is and what it is used for 2. What you need to know before you use CEPROTIN 3. How to use CEPROTIN 4. Possible side effects 5. How to store CEPROTIN 6. Contents of the pack and other information 1. WHAT CEPROTIN IS AND WHAT IT IS USED FOR CEPROTIN belongs to a class of medicines called antithrombotics. This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood. Protein C plays a major role in prevention of excessive clot formation thus, prevent and/or treat intravascular thrombosis. CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency. CEPROTIN may also be used in the treatment and prevention of a rare complication of a blood thinner medicine (anticoagulant medicine named coumarin) which may result in severe skin lesion (necrosis). Additionally, CEPROTIN may be used in the treatment of blood clot (venous thrombotic) events. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CEPROTIN DO NOT USE CEPROTIN - if you are allergic to human protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin. However, in the case of life-threatening thrombotic complications your doctor may still decide Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CEPROTIN 500 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Protein C from human plasma purified by mouse monoclonal antibodies. CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container. The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C. The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard. *One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma. Excipients with known effect: This medicinal product contains 22.5 mg sodium per vial. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Human protein C, powder and solvent for solution for injection. Lyophilised white or cream coloured powder or friable solid. After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CEPROTIN is indicated for prophylaxis and treatment of purpura fulminans coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in substitution therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible. Posology The dose should be adjusted on the basis of laboratory assessment for each individual case. Treatment of acute episodes and short-term prophylaxis (including invasive procedures) A protein C activity of 100 % (1 IU/ml) should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment. An initial dose of 60 to 80 IU/kg for determination of recovery and Baca dokumen lengkapnya