Treatment should be started under the supervision of a doctor who has experience in treating patients with antithrombin deficiency.
Doses
In case of congenital insufficiency, the dose should be selected for each patient individually, taking into account the family history of thromboembolic conditions, existing clinical risk factors, laboratory results and the content of antithrombin III in plasma.
In cases of acquired failure, the dose and duration of substitution therapy depend on the activity of antithrombin in the plasma, the presence of signs of increased metabolism of antithrombin, as well as from the underlying disease and the severity of the clinical condition.
The dose and frequency of administration should always be based on clinical efficacy and laboratory results in each case.
The number of units of antithrombin administered is expressed in international units (ME), which are calculated in relation to the current WHO standard for antithrombin. The activity of antithrombin in plasma is expressed either as a percentage (relative to normal human plasma) or in international units (in relation to the international standard of antithrombin in plasma).
1 international unit (ME) antithrombin activity is equivalent to antithrombin activity in one milliliter of normal human plasma. Calculation of the required dose of antithrombin is based on empirical evidence that 1 international unit (ME) antithrombin per kilogram of body weight increases the activity of antithrombin in the plasma by about 2%.
The initial dose is calculated using the following formula:
Required dose (ME) = body weight (kg) x (target level - baseline activity level [%]) x 0.5
The initial target antithrombin activity depends on the clinical situation. If the indication of substitution therapy is established, the dose should be sufficient to achieve the target antithrombin activity, and also to maintain its effective concentration. The dose should be determined and monitored on the basis of laboratory measurements of antithrombin activity, which should be determined at least twice a day, preferably immediately before the next administration. Dose adjustment is performed taking into account laboratory manifestations of increased metabolism of antithrombin and clinical course of the disease.The activity of antithrombin should be maintained at a level above 80% throughout the course of treatment, unless clinical features indicate the need to maintain another effective level.
Usually the initial dose for congenital insufficiency is 30-50 IU / kg. Subsequently, the dose, the interval between administrations and the duration of treatment should be adjusted taking into account the results of biochemical studies and the clinical situation.
The use of antithrombin III in children less than 6 years old has not been adequately studied.
Mode of application
The drug is administered intravenously. The maximum rate of administration is 5 ml / min. Dissolve the contents of the vial with the drug Antithrombin III human immediately before administration. For this purpose it is necessary to use only the supplied kit for dissolution and administration. The resulting solution should be used immediately after dissolution, since the preparation does not contain preservatives.
Before administration, the solution must be visually examined for the presence of strangers inclusions or discoloration. Mud solutions or solutions with sediment should not be used.Unused solution is to be disposed of in accordance with established rules.
Preparation of the solution
- Preheat the closed vial with the solvent to room temperature (not above 37 ° C).
- Remove protective caps from vials with lyophilizate and solvent (Fig. A) and disinfect the rubber stoppers on both vials.
- Turn and then remove the protective cap from one end of the supplied adapter needle (Figure B). Pierce the stopper of the vial with the solvent with the free end of the needle (Figure B).
- Remove the protective cap from the other end of the adapter needle without touching the needle itself.
- Turn over the vial with the solvent and pierce the stopper of the vial with the lyophilisate with the free end of the needle (Fig. D). The solvent will flow into the vial with the lyophilizate under the action of a vacuum.
- Disconnect the vials by removing the needle from the vial with the drug (Figure D). Easy wiggle or rotation of the vial will accelerate the dissolution of the powder.
- After completely dissolving the drug to deposit foam, puncture the stopper of the vial with the preparation (Figure E). Then remove the airway needle.
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The introduction of the resulting solution
- Turn and then remove the protective cap from the supplied filter needle and put the needle on a sterile disposable syringe. Draw the solution into the syringe (Figure F).
- Disconnect the needle filter from the syringe and slowly (maximum injection rate 5 ml / min), inject the solution intravenously, using the supplied disposable needle (butterfly needle).