Anbinex Powder For Injection 500 I.U.

GRIFOLS ASIA PACIFIC PTE. LTD.

GRIFOLS ASIA PACIFIC PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**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. Posology In congenital deficiency, dosage should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment. The number of units of antithrombin administered is expressed in International Units (I.U.), which are related to the current WHO standard for antithrombin. Antithrombin activity plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for antithrombin in plasma). One International Unit (I.U.) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma. The calculation of the required dosage of antithrombin is based on the empirical finding that 1 International Unit (I.U.) antithrombin per kg body weight raises the plasma antithrombin activity by approximately 1.1% to 1.6%. The initial dose is determined using the following formula: **Required units = bodyweight (kg) x (100 - basal antithrombin activity \[%\]) x 0.8** The initial target of antithrombin activity depends on the clinical situation. When the indication for antithrombin substitution is established, the dosage should be sufficient to reach the target antithrombin activity, and to maintain an effective level. The dosage should be determined and monitored on the basis of laboratory measurements of the antithrombin activity, which should be performed at least twice a day until the patient is stabilised, thereafter once a day, preferably immediately before next infusion. Correction of the dosage should take into account both signs of increased antithrombin turnover according to laboratory controls and clinical course. The antithrombin activity should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level. The usual starting dose in congenital deficiency would be 30 – 50 international units/kg. Thereafter, dosage and frequency, as well as duration of treatment should be adjusted to the biological data and clinical situation. Paediatric patients Anbinex® is not recommended for use in children below 6 due to insufficient data on safety and efficacy. Method of administration Dissolve the preparation as described in section "Special precautions for disposal and handling" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The product should be administered via the intravenous route. Administration rate should not exceed 0.08 ml/kg/min.