ATENATIV Powder and solvent for solution for infusion (2007)
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Name of the medicinal product
Atenativ 50 IU/mL, powder and solvent for solution for infusion.
Qualitative and quantitative composition
Atenativ is presented as a powder and solvent for solution for infusion containing 500 IU, 1000 IU or 1500 IU lyophilised human plasma-derived antithrombin per vial. The product contains 50 IU/mL human ...
Pharmaceutical form
Powder and solvent for solution for infusion. Atenativ is supplied in freeze-dried form. The concentrate is administered intravenously after reconstitution in the accompanying solution.
Therapeutic indications
Patients with congenital deficiency. a) Prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations (especially during surgery or during peri-partum period), in association with ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with deficiency of antithrombin. Physiology Dosage should be individualised for each patient ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use
Antithrombin should be administered restrictively in connection with acquired antithrombin deficiency and in consultation with a coagulation specialist (also see section 5.1). As with any intravenous protein ...
Interaction with other medicinal products and other forms of interaction
Heparin: antithrombin replacement during administration of heparin in therapeutic dosage increases the risk of bleeding. The effect of antithrombin is greatly enhanced by heparin. The half-life of antithrombin ...
Pregnancy and lactation
Experience as to the safety of human antithrombin products for use in human pregnancy is limited. Atenativ should be administered to pregnant and lactating antithrombin deficient women only if clearly ...
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
Undesirable effects
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, ...
Overdose
No symptoms of overdose with antithrombin have been reported.
Pharmacodynamic properties
Pharmacotherapeutic Group: Antithrombotic agents, heparin group ATC Code: B01AB02 Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serin protease inhibitor) superfamily. It is ...
Pharmacokinetic properties
Pharmacokinetic studies with Atenativ have shown a mean biological half life of about 3 days. The half life may be reduced to approximately 1.5 days in the case of concurrent heparin treatment.
Preclinical safety data
Atenativ contains trace amounts of the chemicals tributyl phosphate and octoxynol, which are used during manufacturing for viral inactivation. In non-clinical studies, effects of these impurities were ...
List of excipients
Sodium chloride Human albumin Acetyltryptophan Sodium caprylate Solvent/Diluent: water for injection.
Incompatibilities
Atenativ should not be mixed with other medicinal products.
Shelf life
Shelf life: 36 months (infusion vial). The reconstituted solution should be used within 12 hours.
Special precautions for storage
To be stored at 2°C to 8°C. Within its shelf-life the product may be stored at 25°C for up to one month, without being refrigerated again during this period, and must be withdrawn if not used after this. ...
Nature and contents of container
Injection vial of type II glass (Ph.Eur.), 50 or 100 mL with a bromobutyl rubber stopper sealed with an aluminium pull-off cap.
Special precautions for disposal and other handling
The freeze-dried powder is reconstituted in sterile water for injection. After reconstitution Atenativ may be mixed with isotonic sodium chloride solution (9 mg/mL) and/or isotonic glucose solution (55 ...
Date of revision of the text
02/2007