2010/09/17

Aimafix

Composition, structure and packing

Lyophilisates for solution for infusion of white or pale yellow; prepared solution is clear or slightly opalescent, colorless or pale yellow.

1 vial. coagulation factor IX 200 IU human.

Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.

Solvent: water w / and - 5 ml.

Glass Bottles (1) together with the solvent (flacons 1 pc.) Apyrogenic and sterile system (10 ml syringe, needle - a butterfly with a catheter, needle-adapter, needle-pass, band-aid aseptic) - cartons.

Lyophilisates for solution for infusion of white or pale yellow; prepared solution is clear or slightly opalescent, colorless or pale yellow.

1 vial. coagulation factor IX human 500 IU.

Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.

Solvent: water w / and - 10 ml.

Glass Bottles (1) together with the solvent (flacons 1 pc.) Apyrogenic and sterile system (10 ml syringe, needle butterfly with a catheter, needle-adapter, needle-pass, band-aid aseptic) - cartons.

Lyophilisates for solution for infusion of white or pale yellow; prepared solution is clear or slightly opalescent, colorless or pale yellow.

1 vial. coagulation factor IX human 1000 IU.

Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.

Solvent: water w / and - 10 ml.

Clinico-pharmacological group: preparation of factor IX blood clotting.

Pharmacological action

Clotting factor IX, derived from human blood plasma. It is a single chain glycoprotein with a molecular weight of about 68 000 Yes.

Factor IX - a vitamin K-dependent clotting factor, which is synthesized in the liver. Factor IX activated factor IHa through the internal mechanism of coagulation factor VII + complex of tissue factor by an external mechanism of coagulation. Activated factor IX in combination with activated factor VIII is activated factor X. The result is the transformation of prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and, thus, forming a clot. The activity of factor IX significantly reduced in patients with hemophilia B, and therefore require replacement therapy.

Introduction to concentrate factor IX, derived from human blood plasma, patients with haemophilia B leads to the restoration of 30-60% activity of factor IX in the blood. Clotting factor IX, derived from human blood plasma, is a common component of human plasma and acts as an endogenous factor IX.

Pharmacokinetics

T1 / 2 of factor IX lasts from 16 to 30 hours on average - 24 hours

Statement
treatment and prevention of bleeding in hereditary (hemophilia B) and acquired deficiency of factor IX.

Dosage regimen

The dose and duration of substitution therapy depend on the severity of the violation of hemostatic function, localization and intensity of bleeding and clinical manifestations of disease. The activity of one unit of factor IX corresponds to the number of factor IX in one ml of normal human blood plasma.

Under certain circumstances, especially when determining the initial dose may need to introduce more substantial dose, than that calculated above. In particular, in cases of severe surgical interventions necessary to accurately monitor system for the substitution therapy by means of coagulation analysis (activity of factor IX in the blood plasma of patients).

In cases of long-term prevention of bleeding in patients with severe hemophilia in the drug at a dose of 10-25 ME / kg of body weight should be applied at intervals of 3-4 days.

Patients with the presence of antibodies to factor IX (inhibitors) require special treatment. Immune tolerance could be achieved by treating the concentrate factor IX.

The drug is recommended to introduce a dose of 100 ME / kg of body weight / day. The dissolved drug is introduced into / in slowly.

Rules for the preparation of the solution in / introduction

Into a vial containing lyophilisates should be added to the solvent through a double needle and rotate the vial until completely dissolved lyophilizate.

Lyophilisates can be dissolved more quickly by heating the solvent in a water bath (at temperature not above 37 ° C).

If not completely dissolved lyophilisates be difficult filtering through the filter needle. Foam formation can be avoided by slowly pouring the solvent on the walls of the vial with lyophilisates. Once the solution is ready, you should type it in a syringe, then replace the filter needle to the other and impose a solution in / in slowly, using sterile injecting equipment from a kit.

Preparation time the solution should not exceed 3 minutes. After cooking, it should be immediately used. The contents of the vial should be used entirely in a single introduction. The solution, the remaining unused, shall be destroyed in due course.

Side effect

Rare: allergic or anaphylactic reactions, increased body temperature, the appearance of antibodies to factor IX.

Contraindications
high risk of thrombosis, thromboembolism;
high risk of DIC-syndrome;
high risk of myocardial infarction;
Hypersensitivity to the drug's components.

Pregnancy and lactation

In the application of factor IX concentrate pregnant women during controlled clinical studies of complications has not been established.

Experimental studies on animals is insufficient to assess the safety impact of the drug on the reproductive function, development of the embryo or fetus during pregnancy and the peri-and postnatal development of the child. Therefore, drug Aimafiks can be used during pregnancy and during breast-feeding in cases of urgent necessity, when the expected benefit exceeds the potential risk to women and children.

Cautions

In cases of allergic or anaphylactic reactions of the drug should be immediately stopped and started when necessary antishock therapy.

Based on the experience of drugs with low purity factor IX (prothrombin complex concentrate), there is a potential risk of thrombosis or disseminated intravascular coagulation during treatment with factor IX from human plasma. Because of the possible risk of thrombosis complications must implement precautionary measures when using the product of factor IX in patients with cardiovascular diseases, diseases of the liver, patients in the postoperative period, in newborns or in patients with risk of thromboembolism or DIC-syndrome. In all these situations, the potential benefit of treatment with factor IX should be weighed in the light of these possible complications. After repeated application of factor IX must be determined level of the inhibitor in plasma. Use of factor IX in high doses may be associated with risk of myocardial infarction, DIC-syndrome, venous thrombosis and pulmonary embolism.

When used medicines made from human blood or plasma, can not completely exclude the risk of infectious diseases as a result of transmission of known and yet unknown infectious agents. In order to reduce the risk of transmission of infectious agents carried out a careful selection of donors and plasma harvested by a special test for the absence of HIV type 1 and type 2, HbsAg, antibodies to HCV and ALT levels. Besides the testing of each pool of plasma polymerase chain reaction to detect the genome of hepatitis C.

During production of the drug Aimafiks and double virusinaktivatsiya (solvent detergent and heat treatment method at 100 ° C for 30 min).

The drug can be used within the time frame specified on the package. Usually the solution is transparent or slightly opalescent. Do not use turbid solution or the presence of a flocculent residue or other mechanical particles.

Effects on ability to driving and controlling mechanism is not established that the use of the drug Aimafiks may adversely affect the ability to manage transportation.

Overdose

In case of overdose there is a risk of thromboembolic complications in patients or DIC-syndrome.

Drug Interactions

Do not know the interaction of factor IX with other drugs.

You should not mix the solution of the drug Aimafiks with other drugs. For the introduction of the drug can be used only proven sets for injection from the supplied kit.

Terms and Conditions of storage

The drug should be stored protected from light and away from children at a temperature of 2 ° to 8 ° C.

Shelf life - 2 years (subject to maintaining the integrity of packaging and full compliance with the conditions of storage). The prepared solution should be used immediately.