Instruction for use: Bebulin TIM 4

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

Active substance: Antihemophilic factor IX

ATX

B02BD04 Antihemophilic factor IX

Pharmacological group:

Coagulants (including factors of blood coagulation), hemostatics

The nosological classification (ICD-10)

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

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 contains lyophilized powder for the preparation of an injection solution (human coagulation factor IX, a factor of Kristmas, at a concentration of at least 50 times its fresh plasma content) of 200, 600 or 1200 IU, complete with water for injection (vials 10, 10 and 20 ml) and a set of accessories for dissolution and administration. 1 mg of protein contains 1 to 3 IU of factor IX. 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.

Elimination of the deficiency of the coagulation factor IX.

Indications of preparation Bebulin TIM 4

Disorders of hemostasis against the background of congenital or acquired factor IX deficiency.

Contraindications

Coagulopathy of consumption.

Side effects

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

Dosing and Administration

• IV (solution is prepared before use), with a speed of no more than 5 ml / min. The dose depends on the degree of deficiency of factor IX (the administration of 1 IU / kg raises the level of the factor in the plasma by 0.8%).

Storage conditions of the drug Bebulin TIM 4

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of Bebulin TIM 4

2 years (6 months at a temperature of no higher than 25 ° C).

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