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Dosage form: & nbspLiophilizate for the preparation of solution for infusion.
Composition:

The preparation includes 1 bottle with lyophilizate for the preparation of a solution for infusions, 1 vial with a solvent and sterile apyrogenic equipment for preparation and administration of the drug.

Composition

1 bottle

Active substance:

Human factors of blood coagulation IX, II AND X *

200 M.E.

500 M.E.

Auxiliary components:

Sodium chloride

81,0mg

162,0mg

Three-base sodium citrate

25,8 mg

51,6 mg

Glycine

46,3 mg

92,6 mg

Heparin

20 M.E.

50 M.E.

Antithrombin III M.E. / ml

<0,125

<0,125

1 bottle with a solvent contains 10 ml or 20 ml of water for injection.

* activity is indicated for the blood coagulation factor IX, which is determined according to WHO requirements, the number of clotting factors II and X corresponds to an average content of 200 ml or 500 ml of fresh plasma.

Description:

Lyophilizate white or pale yellow.

After dissolution, a clear or slightly opalescent colorless or light yellow solution.

Pharmacotherapeutic group:hemostatic agent
Pharmacodynamics:

Uman Complex compensates for the deficiency of coagulation factor IX and eliminates hypocoagulation in patients with deficiency. The drug in the human body is converted to the activated factor IXa and in combination with factor VIII activates the blood clotting factor X (Xa), which causes the transition of prothrombin in thrombin and promotes the formation of a fibrin clot. The drug raises the level of vitamin K-dependent coagulation factors in blood plasma (II, VII, IX, X).

With a decrease in the level of coagulation factor IX below 5%, the risk of spontaneous bleeding increases sharply, the level of coagulation factor IX above 20% ensures satisfactory hemostasis.

Immediately after intravenous administration of the drug in the blood serum, about 30-40% of the coagulation factor IX is determined, then the haemostatic activity gradually decreases.

Indications:

Treatment and prevention of bleeding in patients with single or multiple coagulation factor IX deficiency (hemophilia B, Christmass disease), blood coagulation factor II (prothrombin deficiency), or X (Stewart-Prouard's deficiency).

Treatment and prevention of bleeding in patients with a single or multiple acquired prothrombin complex deficiency.

Contraindications:

Hypersensitivity to the components of the drug.

High risk of thrombosis or disseminated intravascular coagulation.

Carefully: Carefully appoint patients with coronary artery disease or myocardial infarction in anamnesis, liver disease, postoperative period, newborn.
Pregnancy and lactation:

In clinical studies on the use of the drug during pregnancy complications are not established. Experimental animal studies are not sufficient to assess the effect on reproductive function, the development of an embryo or fetus, the course of pregnancy, peri- and postnatal development of a child. In this regard, the drug can be used only if the expected benefit for a woman exceeds the possible risk to the fetus and the baby.

Dosing and Administration:

Doses and duration of substitution therapy depend on the severity of the hemostatic function, on the localization and volume of bleeding, and on the clinical condition of the patient.

The calculation of the required dose is based on empirical data:

1 ME coagulation factor IX per kg of body weight increases the activity of coagulation factor IX in plasma by 0.8% and 1 ME Coagulation factor II increases the activity of factor II or X by 1.5%, respectively.

The required dose is determined by the following formula:

Initial dose = body weight (kg) x required increase in factor IX (%) x 1.2

Important: in each individual case, when determining the necessary amount and frequency of the drug, always take into account clinical effectiveness. In the event of bleeding, the activity of the coagulation factor IX in the relevant period should not be lower than the level of activity of the corresponding factor in blood plasma (% of the norm) indicated in the table:

Severity of bleeding

Required level of coagulation factor IX in blood plasma

Duration of administration

Hemorrhages in the joint

30%

At least one day, depending on the severity of the bleeding.

Bleeding in the muscles

30-50%

3-4 days or until the bleeding stops.

Minor head trauma

Extraction of the tooth

Intervention of moderate severity

Hemorrhages from the oral cavity

Acquired deficit of phof the prothrombin complex

The dose and duration of substitution therapy depend on the severity of the disorder of the hemostatic function, the localization and severity of bleeding, and the clinical condition.

The dosage regimen also depends on the half-life in vivo necessary factor and body weight of the patient.To ensure complete control of therapy, as far as possible, it is necessary to monitor blood coagulability by means of coagulation tests.

In the case of massive bleeding and before operations that are accompanied by a high risk of bleeding, it is necessary to administer the prothrombin complex preparation to normal prothrombin time.

Cooking method

Uman Complex must be dissolved immediately before administration. Do not use the solution in the presence of flaky and other mechanical inclusions in it.

The drug is administered intravenously for 3-5 minutes under the control of the patient's pulse.

Add the solvent to the lyophilizate through a double needle and rotate the vial with the concentrate until completely dissolved. The lyophilizate can dissolve faster when the solvent is heated in a water bath to a temperature of no higher than 37 ° C. With incomplete dissolution of the drug, it will be difficult to filter the drug through the filter needle. To avoid foaming, the solvent must be slowly poured onto the wall of the vial with lyophilizate. After the preparation of the solution, it must be dialed into the syringe,using the supplied filter needle and injected intravenously with the supplied kit.

Side effects:

In rare cases, anaphylactic and allergic reactions to the drug were observed.

Increased body temperature.

Formation of antibodies to one or more factors of blood coagulation, included in the preparation.

Overdose:

The use of high doses of human prothrombin complex concentrate can lead to myocardial infarction, DIC syndrome, venous thrombosis and pulmonary embolism. The risk group consists of patients with a predisposition to the listed diseases.

Interaction:

Uman Complex should not be mixed with other drugs.

For the administration of the drug, only approved equipment should be used, since the use of other equipment may lead to a decrease in the effectiveness of therapy due to the deposition of the drug on the internal surfaces of certain medical devices for intravenous administration.

Special instructions:

Patients who need a course of treatment with the drug Uman Complex D.I. longer than 3-5 days, should be carefully monitored in order to timely detect symptoms of DIC syndrome.

The experience of treating hereditary deficiency of coagulation factors II and X is limited.

Under certain conditions, more calculated quantities may be required, especially at the initial dose. In particular, in the case of extensive surgical interventions, it is necessary to monitor the substitution therapy using coagulation tests. With long-term prophylaxis of bleeding in patients with severe hemophilia B, initial doses may amount to 10-20 IU of coagulation factor IX per kg of body weight.

Uman Complex is made from human plasma. When using plasma or products made from human plasma, the transmission of infectious agents, including those that are as yet unknown, can not be completely ruled out. To reduce the risk of transmission, careful selection of donors and harvested plasma is carried out by special testing (monitoring each portion of plasma used to produce the drug for lack of HIV type 1 and 2, HbsAg, antibodies to the hepatitis C virus and ALT activity, in addition, each pool of plasma is tested by a polymerase chain reaction to detect the genome of the hepatitis C virus).In addition to testing in the production process, measures for double inactivation of viruses (solvent-detergent method and heat treatment at 100 ° C for 30 minutes) are included.

If necessary, in the absence of a coagulation factor concentrate IX, patients with hemophilia B can be introduced into the Uman Complex.

If anaphylactic reactions occur, stop the injection immediately.

It is necessary to carefully monitor the patient's condition for the detection of symptoms of disseminated intravascular coagulation.

Form release / dosage:LIofilizate for the preparation of a solution for infusions, 500 IU.
Packaging:

Uman Complex (500 ME) - a vial of clear glass with a lyophilizate containing 500 ME prothrombin complex of a human, a bottle with a solvent of 20 ml, sterile apyrogenic equipment (syringe 20 ml, needle-butterfly with catheter, needle-adapter, filter needle, aseptic adhesive) for intravenous infusion of the drug.

Storage conditions:

At a temperature of 2-8 ° C, in a place protected from light. Do not freeze.

Can not be used after the expiration date.

After preparation, the solution must be used immediately.

Keep out of the reach of children.

Shelf life:

2 years under all conditions of storage with undamaged packaging.

Terms of leave from pharmacies:On prescription
Registration number:P N015135 / 01-2003
Date of registration:23.01.2009
Expiration Date:Unlimited
The owner of the registration certificate:Kedrion SpAKedrion SpA Italy
Manufacturer: & nbsp
Representation: & nbspCEDRION SpA CEDRION SpA Italy
Information update date: & nbsp05.01.2017
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