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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

ATENATIV Pwd. Sol. (2007)

Αναφορές

Βιβλιογραφική αναφορά

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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