Universal reference book for medicines
Product name: AGEMFIL B (AGEMFIL B)

Active substance: human coagulation factor IX

Type: A drug of factors (VIII and Willebrand) coagulation

Producer: FGBU Hematology Research Center Roszdrav (Russia)
Composition, form of production and packaging
Lyophilized powder for solution for infusion
1 fl.

coagulation factor IX human 250 IU

Bottles for blood substitutes (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Aghemfil B contains purified concentrate of factor IX of blood coagulation, which is obtained from a pool of freshly frozen blood plasma from donors.
Control for the absence of a surface antigen of hepatitis B virus (HBsAg), antibodies to hepatitis C virus (anti-HCV) and human immunodeficiency virus-HIV-1 / HIV-2 is carried out by means of an enzyme immunoassay. The coagulation factor IX has a hemostatic effect; increases the content of factor IX in plasma, restores hemostasis in patients with deficiency. The active form of factor IX - factor IXa - in combination with factor VIII activates factor X, which promotes the transition of prothrombin to thrombin and formation of fibrin clot.Increases plasma levels of vitamin K-dependent coagulation factors (II, VII, IX, and X). With a decrease in the plasma level of factor IX below 5% of the norm, the risk of spontaneous hemorrhage increases sharply, and a content above 20% of the norm ensures satisfactory hemostasis.
PHARMACOKINETICS

About 40% of factor IX is detected in the blood immediately after IV infusions, then the haemostatic activity gradually decreases T 1/2 - 20 hours.

INDICATIONS

- treatment and prevention of hemorrhage in patients with hemophilia B, including during an emergency or planned surgical intervention.

DOSING MODE

The drug is used only intravenously after complete dissolution in 20 ml of water for injection.
The recommended rate of administration is 100 IU / min.
Preparation of the solution: Aghemil B must be diluted only in sterile water for injection.
Prior to dilution, the vial with the preparation and sterile water for injection should be brought to a temperature of 20-30 ° C. Sterile disposable needle and syringe to collect the required volume of sterile water for injection (20 ml) and insert it into the vial with the drug. For complete dissolution, gently shake the vial without shaking. After 3-5 minutes, a clear or slightly opalescent solution should be obtained. Diluted preparation should be used within 1 hour after preparation. When forming a gel or clot in a vial, the resulting solution can not be used. The dose of Aghemil B is individually selected to restore haemostasis, depending on the degree of bleeding and the required level of factor IX. The introduction of one unit of activity (ME) of factor IX per kg of body weight increases the level of factor IX in blood plasma by an average of 1% and the following formula can be recommended to calculate the dose:
Required dose = necessary increase in activity.
IX (%) x body weight (kg) / 1 (% / IU / kg)
To achieve a satisfactory clinical result, it is necessary to correlate the therapeutic effect with the data of measurements of the level of factor IX in the patient's blood plasma.The required dose of the drug for a single administration and the duration of treatment depends on the severity of factor IX deficiency, as well as the location and volume of bleeding and the clinical condition of the patient.

Easy bleeding.
For treatment of superficial or beginning bleeding within 2-3 days, a dose of Aghemfil B is introduced, which allows maintaining the concentration of factor IX in the blood plasma at 30%.
Moderate bleeding.
For the treatment of moderate bleeding, the level of factor IX should be raised to 30-50% by administration of Aghemil B within 3-4 days at intervals of 12-14 hours.
Severe bleeding.
In patients with life-threatening bleeding or bleeding to vital organs (central nervous system, zygopharyngeal or retroperitoneal space, ilio-lumbar muscle), the level of factor IX in blood plasma should be increased to 80-100% by administration of Aghemil B within 10-14 days with intervals of 12-14 hours.
Surgery.
The intensity of the replacement therapy with Agymphil B depends on the type of surgical operation and the subsequent postoperative regimen. With extensive surgical interventions, the level of factor IX should be maintained at a level of at least 50%. For this purpose, transfusions of Agymphil B can be repeated every 6-12 hours for 10-14 days.
Prevention.
The scheme of preventive treatment should be adjusted in accordance with the individual needs of the patient. As a rule, for maintenance therapy in patients with severe hemophilia, the dose of 20-30 IU / kg of Aghemil B administered 3 times a week is effective to maintain 3-5% of the level of factor IX in blood plasma


SIDE EFFECT

Too fast administration of the drug can sometimes cause a brief increase in body temperature, chills, headache.
In some cases, nausea, tachycardia, a tingling sensation in the body, back pain, postoperative thrombosis, allergic reactions (hives, anaphylactic reaction), a decrease in resistance to infectious diseases may appear.
CONTRAINDICATIONS

- DIC-syndrome;

- Acute thrombosis;

acute myocardial infarction;

- deficiency of factor VII;

acute liver failure;

- individual hypersensitivity to the drug,

PREGNANCY AND LACTATION

Studies of the influence of Agemphil B on the reproductive capacity of animals have not been conducted.
It is not known whether Aghemil B can cause fetal damage or affect reproductive capacity when administered to a pregnant woman. Aghemfil B should be given to women only if the expected benefit exceeds the possible risk for both the woman and the fetus / child.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in acute liver failure.

SPECIAL INSTRUCTIONS

Impact on the ability to drive vehicles and manage mechanisms

Indications that Agamphil B can reduce the ability to drive a car or work with machines, no.

OVERDOSE

Symptoms of an overdose of Agemphilus B are unknown.

DRUG INTERACTION

Unknown.
Agyfil B should not be injected into any syringe with any other medications.
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a dark place inaccessible to children (2-6 ° C).
List B. Shelf life - 1 year.

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