Instruction for use: Immunine

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

Composition and release form

1 bottle with a capacity of 5 or 10 ml with lyophilized powder for the preparation of the injection solution contains a factor of blood coagulation IX 200, 600 or 1200 IU, complete with water for injection in 5 or 10 ml vials and a set of accessories for dissolution and administration (syringes and needles ); In the box 1 set.

Pharmachologic effect

Mode of action - hemostatic.

Increases the level of factor IX in blood plasma and temporarily eliminates the defect of the clotting system in patients with its deficiency.

Indications of preparation Immunine

Bleeding in acquired or congenital factor IX deficiency: hemophilia B, hemophilia B with a factor IX inhibitor, acquired factor IX deficiency caused by the appearance of an appropriate inhibitor (treatment and prevention).

Contraindications

Hypersensitivity.

Application of pregnancy and breastfeeding

Allowed only in cases of acute necessity.

Side effects

In rare cases, thromboembolic complications (especially in patients with a high risk of thrombosis and / or high doses.) Allergic reactions (fever, urticaria, nausea, vomiting, shortness of breath, blood pressure, shock).

Dosing and Administration

• IV by drop or stream indusion (injection rate not more than 2 ml / min), dissolve 200-600 IU in 5 ml and 1200 IU in 10 ml of water for injection, immediately before injection. To assess the effectiveness of therapy and calculate the required maintenance dose, determine the content of factor IX in the blood plasma and use the formula - dose (ME) = body weight (kg) x desired factor IX increase (%) x 1.2. Imunin is administered every 24 hours; For maintenance treatment of severe hemophilia B - 20-30 IU / kg 2 times a week; For the prevention of bleeding during surgery - 1 hour before surgery; After a major intervention - every 12 hours (during the first postoperative day).

Precautionary measures

When allergic reactions occur, the injection (infusion) must be discontinued and an antihistamine or anti-shock therapy initiated. Before surgery, patients with hemophilia B along with Immunin recommended low doses of heparin (prevention of thrombosis). If there is a risk of thrombus formation (for example, in patients with liver disease, thrombophlebitis, angina or myocardial infarction in the anamnesis), the level of factor IX above 60% of the norm should not be increased in the blood, continuous monitoring of blood clotting parameters is necessary, since there is a risk of developing the DIC syndrome Even with a suspicion of it, therapy should be immediately interrupted).

Special instructions

• For the infusion use a disposable system with an adequate filter. The solution should be quickly consumed quickly and not reused.

Storage conditions of the drug Immunine

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of Immunine

2 years. Within the specified period, it can be stored at room temperature (up to 25 ° C) for 3 months.

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