CEPROTIN Powder and solvent for solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
CEPROTIN 500 IU powder and solvent for solution for injection.
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 ...
Pharmaceutical form
Powder and solvent for solution for injection. 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 ...
Therapeutic indications
CEPROTIN is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency. Furthermore CEPROTIN is indicated for short-term prophylaxis in patients ...
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. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Special warnings and precautions for use
As the risk of an allergic type hypersensitivity reaction cannot be excluded, patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness ...
Interaction with other medicinal products and other forms of interaction
No interactions with other medicinal products are currently known. In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e.g. warfarin), a transient hypercoagulable ...
Fertility, pregnancy and lactation
Although CEPROTIN has been used safely in the treatment of pregnant protein C-deficient women, its safety for use in human pregnancy has not been established in controlled clinical trials. Furthermore ...
Effects on ability to drive and use machines
CEPROTIN has no influence on the ability to drive and use machines.
Undesirable effects
As with any intravenous product allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning ...
Overdose
No symptoms of overdose with CEPROTIN have been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: group antithrombotic; ATC Code: B01AD12 Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver. It is converted by thrombin/thrombomodulin-complex ...
Pharmacokinetic properties
21 asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data. The protein C plasma activity was measured by chromogenic assay. The individual ...
Preclinical safety data
Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C. Therefore experimental studies on tumorigenic or mutagenic effects particularly in heterologous ...
List of excipients
Powder: Human albumin Sodium chloride Sodium citrate, 2H<sub>2</sub>0 Solvent: Sterilised Water for Injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. The reconstituted solution should be used immediately.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3. ...
Nature and contents of container
500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU). The solvent comes in vials of neutral glass of hydrolytic type ...
Special precautions for disposal and other handling
Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle. Gently rotate the vial until all powder ...
Marketing authorization holder
Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221 Vienna, Austria
Marketing authorization number(s)
EU/1/01/190/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 July 2001 Date of last renewal: 16 July 2006
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