Thrombate

Dosage Forms And Strengths

THROMBATE III is a sterile lyophilized powder for reconstitution in single use vials. Each vial of THROMBATE III contains the labeled amount of antithrombin in units per vial, typically 500 units.

When reconstituted with 10 mL of Sterile Water for Injection, USP, the final concentration is approximately 50 units per mL.

The potency is determined with a standard calibrated in International Units against a World Health Organization (WHO) antithrombin reference preparation.

Storage And Handling

THROMBATE III is supplied in a kit containing one single use vial of THROMBATE III lyophilized powder for reconstitution, one vial of Sterile Water for Injection, USP, one sterile double-ended transfer needle, and one sterile filter needle. The total activity of AT in International Units is stated on the label of the THROMBATE III vial.

Components used in the packaging of THROMBATE III are made with natural rubber latex.

• Store THROMBATE III at temperatures not to exceed 25°C (77°F).
• Avoid freezing as breakage of the diluent vial might occur.

REFERENCES

1. Schwartz RS, Bauer KA, Rosenberg RD, et al. Clinical experience with antithrombin III concentrate in treatment of congenital and acquired deficiency of antithrombin. Am J Med. 1989;87 (Suppl 3B):53S-60S.

2. Mannucci PM, Boyer C, Wolf M, et al. Treatment of congenital antithrombin III deficiency with concentrates. Br J Haematol. 1982;50(3):531-5.

3. Collen D, Schetz J, de Cock F, et al. Metabolism of antithrombin III (heparin cofactor) in man: effects of venous thrombosis and of heparin administration. Eur J Clin Invest. 1977;7(1):27-35.

4. Marciniak E, Gockerman JP. Heparin-induced decrease in circulating antithrombin-III. Lancet. 1977;2(8038):581-4.

5. O’Brien JR, Etherington MD. Effect of heparin and warfarin on antithrombin III. Lancet. 1977;2(8050):1232.

6. Kakkar VV, Bentley PG, Scully MF, et al. Antithrombin III and heparin. Lancet. 1980;1(8159):103-4. Mean ± SEM

Manufactured by: Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA. Revised: July 2017