Instruction for use: Emoclot D.I.

Dosage form: Lyophilizate for the preparation of a solution for infusions

Active substance: Coagulation factor VIII

ATX

B02BD02 Coagulation factor VIII

Pharmacological group:

Hemostatic agent [Coagulants (including factors of blood coagulation), hemostatics]

Composition and release form

Lyophilizate for the preparation of a solution for infusions (highly purified double viral inactivation) 1 fl.

Active substance: The activity of the human coagulation factor VIII in combination with von Willebrand factor 250 IU 500 IU 1000 IU

Specific activity (in the final product): Not less than 80 IU / mg protein

Excipients:

Sodium citrate 14.7 mg 29.4 mg 29.4 mg

Sodium chloride 33 mg 66 mg 66 mg

Glycine 45 mg 90 mg 90 mg

Calcium chloride 0.73 mg 1.47 mg 1.47 mg

Solvent: Water for Injection 5 ml 10 ml 10 ml

In bottles of 5 and 10 ml (complete with a solvent in bottles of 5 and 10 ml and sterile pyrogen-free equipment for intravenous infusion); In the box 1 set.

Pharmachologic effect

Mode action - Replenishing deficiency of coagulation factor VIII.

Dosing and Administration

Treatment and prevention of bleeding episodes caused by hereditary and acute factor VIII deficiency (hemophilia A, haemophilia A with factor VIII inhibitors, acute factor VIII deficiency due to spontaneous appearance of factor VIII inhibitors), von Willebrand disease. Treatment should begin under the strict supervision of a doctor who has experience in the therapy of hemophilia. Doses and duration of substitution therapy depend on the severity of factor VIII deficiency, the localization and volume of bleeding, and the severity of the clinical condition of the patient. The calculation of the required dose of factor VIII is based on empirical data:

1 IU of factor VIII / kg of body weight increases the activity of factor VIII in plasma by 1.5-2%. Calculation of the required dose of the drug is made by the formula:

The necessary dose (ME factor VIII) = body weight (kg) x required increase in factor VIII activity (%) x 0.5.

The total dose and frequency of drug administration should always be correlated with clinical efficacy in each case. The level of factor VIII necessary to stop or prevent bleeding during surgical interventions, as well as the duration of maintenance of the necessary activity of factor VIII, are shown in the table:

In some cases, large quantities of the drug may be necessary, especially at the beginning of therapy. During the course of treatment it is recommended to determine the activity of factor VIII for correcting the dose of the drug and the frequency of its administration. With extensive surgical interventions, accurate monitoring of substitution therapy is required, which implies the determination of factor VIII in blood plasma.

IV, for 3-5 minutes, under the control of the pulse. The solution is prepared immediately before administration. Do not use the solution in the presence of flocculent and mechanical inclusions in it. Add the solvent, heated in a water bath to 37 ° C, slowly along the wall of the vial with lyophilizate, rotate the vial with the concentrate until completely dissolved. Change the filter needle and, using injection equipment, introduce the drug.

With long-term prevention of severe hemophilia A - 10-50 IU of factor VIII / kg of body weight every 2-3 days. In some cases, especially in young patients, large doses or shorter intervals of administration may be required. If the expected increase in plasma factor activity is not observed or the bleeding is not controlled by the appropriate dose, a study should be conducted for the presence of inhibitors of factor VIII activity. If it is present in an amount of less than 10 Be / ml, the administration of an additional amount of factor VIII can neutralize it. If the level of inhibitor is more than 10 BY or a high response in history, the use of activated concentrate of the prothrombin complex is recommended.

Manufacturer

Kedrion S.p.A., Italy.

A comment

Representation in Russia: Pharma Riace Ltd.

Storage conditions of the drug Emoclot D.I.

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Emoclot D.I.

2 years.

Do not use after the expiry date printed on the package.