Instruction for use: Feiba

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

Active substance: Anti-inhibitor Coagulant Complex

ATX

B02BD03 Coagulation Factor VIII Fracture inhibitors

Pharmacological group

Coagulants (including coagulation factors), hemostatics

The nosological classification (ICD-10)

D66 Hereditary factor VIII deficiency: Congenital insufficiency of factor VIII; Hemophilia; Hemophilia A; Hemophilia classical; Deficiency of antihemophilic factor of blood VIII; Deficiency of the coagulation factor VIII; Inhibitory form of hemophilia A; Bleeding at hemophilia A; Hereditary hemophilia; Hereditary anomalies of antihemophilic factor VIII; Failure factor VIII; Insufficiency of coagulation factor VIII; Acquired hemophilia; Coagulopathies are hereditary

D67 Hereditary factor IX deficiency: Congenital factor IX deficiency; Congenital deficiency of the coagulation factor IX; Hemorrhagic syndrome with factor IX deficiency; Hemophilia B; Hemophilia B with a factor IX inhibitor; Hemophilia B in children; Deficiency of the coagulation factor IX; Inhibitory form of hemophilia; Inhibitory form of hemophilia B; Coagulopathies are hereditary; Bleeding and haemorrhage in hemophilia B; Bleeding with acquired or congenital deficiency of factor IX; Hereditary hemophilia

D68.2 Hereditary deficiency of other coagulation factors: Coagulation factor II deficiency; Deficiency of the clotting factor VII; Deficiency of the coagulation factor X; Deficiency of the coagulation factor XII; Dysfibrinogenemia; Hereditary anomalies of the Stewart-Prower factor (factor X); Hereditary anomalies of factor Hageman (factor XII); Insufficiency of plasma clotting factors; Stuart-Prower factor deficiency; Hereditary deficiency of AT-III

R58 Bleeding, not elsewhere classified: Abdominal apoplexy; Hemorrhagia; Haemorrhage of the esophagus; Hemorrhage; Generalized bleeding; Diffuse bleeding; Diffuse bleeding; Prolonged bleeding; Blood loss; Blood loss during surgical interventions; Bleeding during surgery and in the postoperative period; Bleeding during labor; Bleeding and haemorrhage in hemophilia B; Bleeding from the gums; Bleeding intraoperative abdominal; Bleeding against a background of coumarin anticoagulants; Hepatic hepatitis; Bleeding in hemophilia A; Bleeding at hemophilia A; Bleeding with inhibitory forms of hemophilia A and B; Bleeding due to leukemia; Bleeding in patients with leukemia; Bleeding; Bleeding due to portal hypertension; Bleeding due to hyperfibrinolysis; Drug bleeding; Local bleeding; Local bleeding due to activation of fibrinolysis; Massive blood loss; Acute blood loss; Parenchymal hemorrhage; Hepatic bleeding; Postoperative hemorrhage; Kidney bleeding; Vascular-platelet hemostasis; Traumatic bleeding; Threatening bleeding; Chronic blood loss

Composition and release form

1 bottle with lyophilized powder for the preparation of the injectable solution contains clotting factors II, VII, IX and X (in combination) 500 or 1000 IU; Complete with water for injection (bottles of 20 and 40 ml) and a set of accessories for dissolution and injection (syringes and needles), in the box 1 set.

Characteristic

Anti-inhibitory coagulant complex with standard activity FEIBA (Factor Eight Inhibitor Bypass Activity). 1 mg protein contains 0.7 to 2.5 IU of FEBA, factors II, IX and X (mostly in the non-activated form), activated factor VII, VIII (at concentrations up to 0.1 IU per IU FEBA). The plasma used to produce the drug undergoes mandatory testing for ALT, as well as the absence of HBsAg, anti-HCV, HIV-1 and HIV-2 antibodies.

Pharmachologic effect

Mode of action - Hemostatic.

Temporarily eliminates the defect of the clotting system bypassing the inhibitors to factors VIII, IX and XII.

Indications for the preparation of Feiba

Bleeding with inhibitory forms of hemophilia A and B; Severe or life-threatening bleeding in patients on the background of the acquired deficiency of factors VIII, IX and XII.

Contraindications

DIC-syndrome, myocardial infarction, acute thrombosis and / or embolism (at low titers of inhibitors of coagulation factors).

Side effects

Nausea, vomiting, allergic reactions (fever, urticaria).

Interaction

Compatible with a concentrate of factor VIII (possibly combined assignment for inducing immunotolerance in patients with an inhibitory form of hemophilia).

Dosing and Administration

IV (solution is prepared before use), slowly, 50-100 IU / kg; The maximum single dose is 100 IU / kg, the daily dose is 200 IU / kg.

Precautionary measures

It is not recommended to combine with antifibrinolytic agents (epsilon-aminocaproic acid).

Storage conditions of the drug Feiba

At a temperature of 2-8 ° C. Within the specified period, it can be stored at room temperature (up to 25 ° C) for 6 months.

Keep out of the reach of children.

The shelf life of the drug Feiba

2 years.

Do not use beyond the expiration date printed on the package.