AIMAFIKS

Active material: clotting factor IX human
When ATH: B02BD04
CCF: The preparation of blood coagulation factor IX
ICD-10 codes (testimony): D67, D68.4
Manufacturer: KEDRION S.p.A. (Italy)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Valium for solution for infusion white or bledno-jeltogo color; prepared solution is clear or slightly opalescent, colorless or light yellow.

Excipients: sodium chloride, sodium citrate, glycine, Heparin, Antithrombin III.

Solvent: water d / and – 5 ml.

Glass Bottles (1) together with the solvent (fl. 1 PC.) and a sterile pyrogen-free system (syringe 10 ml, needle – “butterfly” catheter, needle adapter, Needle filter, band-aid aseptic) – cardboard boxes.

Valium for solution for infusion white or bledno-jeltogo color; prepared solution is clear or slightly opalescent, colorless or light yellow.

Excipients: sodium chloride, sodium citrate, glycine, Heparin, Antithrombin III.

Solvent: water d / and – 10 ml.

Glass Bottles (1) together with the solvent (fl. 1 PC.) and a sterile pyrogen-free system (syringe 10 ml, needle “butterfly” catheter, needle adapter, Needle filter, band-aid aseptic) – cardboard boxes.

Valium for solution for infusion white or bledno-jeltogo color; prepared solution is clear or slightly opalescent, colorless or light yellow.

Excipients: sodium chloride, sodium citrate, glycine, Heparin, Antithrombin III.

Solvent: water d / and – 10 ml.

Glass Bottles (1) together with the solvent (fl. 1 PC.) and a sterile pyrogen-free system (syringe 10 ml, needle “butterfly” catheter, needle adapter, Needle filter, band-aid aseptic) – cardboard boxes.

* – activity is defined in accordance with who standards 84/681; the specific activity of not less 80 IU/mg protein in the final product.

Pharmacological action

Blood coagulation factor IX, derived from human blood plasma. Represents a single chain glycoprotein with a molecular weight of about 68 000 Yes.

Factor IX – It is a vitamin k-dependent clotting factor, that is synthesized in the liver. Factor IX factor is activated by IHa internal mechanism and coagulation factor VII complex + tissue factor through some external mechanism of coagulation. Activated factor IX in combination with activated factor VIII activate factor X. The result is the conversion of protrombina in trombin. Thrombin then converts Fibrinogen into fibrin, and, thus, a clot is formed. The activity of factor IX is significantly reduced in patients with hemophilia, and so a substitution therapy.

Introduction of factor IX concentrate, derived from human blood plasma, patients with hemophilia in restoration 30-60% activity of factor IX in the blood.

Coagulation factor IX, derived from human blood plasma, is a normal part of human plasma and acts as an endogenous factor IX.

Pharmacokinetics

T_1/2 factor IX lasts 16 to 30 no, average – 24 no.

Testimony

is the treatment and prevention of bleeding in succession (Hemophilia B) and acquired deficiency factor IX.

Dosage regimen

Dose and duration of therapy depends on the severity of the violation of Hemostatic function, localization and severity of bleeding and clinical manifestations of disease.

The activity of one unit of factor IX is the quantity of factor IX in one ml normal human blood plasma.

Calculation of the dose of factor IX is based on data, derived empirically: 1 ME factor IX per kg body weight increases the activity of factor IX plasma patient 0.8% from the norm.

Initial dose is determined by the following formula:

The required number of units = body weight (kg) x the desired increase in factor IX (%) x 1.2

It is important to take into account, that the number of drug-based and frequency of application should always be focused on clinical efficacy in each case.

In the following cases, bleeding the concentration factor IX should not fall below a specified level of activity in plasma (in % from the norm) in the corresponding period:

Under certain circumstances, especially when determining the initial dose, may require the introduction of a more substantial dosage, and something, which is calculated above. In particular, in cases of severe surgical interventions must be exact video monitor replacement therapy through coagulation analysis (Factor IX activity in plasma of the patient).

In cases of prolonged prophylaxis of bleeding in patients with severe hemophilia b drug dose 10-25 Me/kg of body weight should be applied at intervals 3-4 day.

In patients with the presence of antibodies to factor IX (inhibitors) requires special therapy. Immune tolerance can be achieved by treating the concentrate factor IX.

The drug is recommended in a dose of not more 100 Me/kg body weight/day. Dissolved drug give/in slowly.

Rules for solution for the on/in the introduction

In vial with liofilizatom solvent should be added through a two-pronged needle and rotate vial until complete dissolution liofilizata.

Valium can be dissolved faster solvent when heated in a water bath (When temperature is not above 37° c).

If the extract is not completely dissolve, be difficult filtering through the filtering needle.

The formation of foam can be avoided, slowly pouring paint thinner on the walls of the vial with lyophilized powder.

Once the solution is ready, dial it in syringe, then replace the filter needle to another and impose a solution in/in slowly, using sterile injection equipment supplied.

The cooking time of the solution should not exceed 3 m. After cooking it must be immediately use. The contents of the vial must be used fully in one introduction. Solution, the remaining unused, to be destroyed in the prescribed manner.

Side effect

Rarely: allergic or anaphylactic reactions, fever, the appearance of antibodies to factor IX.

Contraindications

is a high risk of thrombosis, thromboembolism;

is a high risk of disseminated intravascular coagulation syndrome;

is a high risk of myocardial infarction;

- Hypersensitivity to the drug.

Pregnancy and lactation

When you apply the concentrate factor IX pregnant women during control clinical research of complications is not installed.

Experimental studies on animals is insufficient to assess the security impact of the drug on the reproductive function, development of an embryo or fetus, during pregnancy and peri- and postnatal development of the child.

Product Aimafiks can be used during pregnancy and breastfeeding in cases of urgent need, When the expected benefits exceed the potential risk to the woman and the child.

Cautions

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

Based on the experience of application of preparations with low purity factor IX (prothrombin complex concentrate), There is a potential risk of thrombosis or disseminated intravascular coagulation in the treatment of drug factor IX from human blood plasma. Because of the possible risk of complications should be applied trombogennyh precautions for use of the preparation of factor IX in patients with cardiovascular disease, with liver disease, patients in the postoperative period, in newborns or in patients with risk of thromboembolism, or disseminated intravascular coagulation syndrome. In all these situations the potential advantage of treatment with factor IX must be weighed in the light of possible these complications. After repeated application of factor IX inhibitor level must be defined in the plasma. Use of factor IX in high doses may be associated with risk of myocardial infarction, DIC, venous thrombosis and pulmonary embolism.

When medications are used, manufactured from human blood or plasma, You cannot completely exclude the probability of infectious diseases as a result of transmission of known and not yet known infectious pathogens. In order to reduce the risk of transmission of infectious pathogens is carried out by a careful selection of donors and harvested plasma by a special type of absence of HIV testing 1 and type 2, HbsAg , antibodies to HCV and ALT. In addition each pool tested plasma polymerase chain reaction for detection of hepatitis c virus genome.

In the manufacturing process of the drug Aimafiks is carried out double virusinaktivacija (solvent detergentnyj method and thermal treatment at 100° c for 30 m).

The drug can be used within the time limits, indicated on the package. Usually the solution transparent or slightly Opalescent. You cannot use the muddy solution or if it has flaky residue or other mechanical particles.

Effects on ability to drive vehicles and management mechanisms

Not installed, that use of the drug Aimafiks may adversely affect the ability to manage the transport.

Overdose

In case of overdose appears in patients risk of thromboembolic complications or disseminated intravascular coagulation syndrome.

Drug Interactions

No known interaction of factor IX with other drugs.

Do not mix a solution of Aimafiks drug with other drugs. For injection can only use proven injection kits from the enclosed kit.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark and out of reach of children at a temperature from 2° to 8° c. Shelf life – 2 year (while maintaining the integrity of the package and the full observance of conditions of storage).

Cooked solution should be used immediately.