THROMBATE III SUMMARY
Antithrombin III (Human), THROMBATE III® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III.
THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.
Subjects with AT-III deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease.
The diagnosis of hereditary antithrombin III (AT-III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-III levels, and the exclusion of acquired deficiency.
AT-III in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary AT-III deficiencies.16
The AT-III level in neonates of parents with hereditary AT-III deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.)17
Plasma levels of AT-III are lower in neonates than adults, averaging approximately 60% in normal term infants.18,19 AT-III levels in premature infants may be much lower.18,19 Low plasma AT-III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with Antithrombin III (Human), THROMBATE III® of neonates be discussed with an expert on coagulation.11