Composition, form of production and packaging
Lyophilizate for the preparation of a solution for infusions of white or pale yellow color; the resulting solution is clear or slightly opalescent, colorless or light yellow in color.
human coagulation factors II, IX, X 500 IU *
Excipients: sodium chloride, sodium citrate tribasic, glycine, heparin, antithrombin III ME
Solvent: water d / and - 20 ml.
Glass vials (1) complete with a solvent (1 pc.) And sterile pyrogen-free equipment for administration (20 ml syringe, "butterfly" needle with catheter, needle-adapter, needle-filter, adhesive plaster) - cardboard packs.
* 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.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Hemostatic drug. Replenishes the lack of coagulation factor IX and eliminates hypocoagulation in patients with its deficiency. The drug in the human body is converted to the activated factor IXa and in combination with the coagulation factor VIII activates the blood clotting factor X (Xa), which causes the prothrombin to enter 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.
- treatment and prevention of bleeding in patients with single or multiple coagulation factor deficiency IX (hemophilia B, Christmass disease), blood coagulation factor II (prothrombin deficiency) or coagulation factor X (Stewart-Prouardt deficiency);
- Treatment and prevention of bleeding in patients with single or multiple acquired prothrombin complex deficiency.
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 IU of the blood coagulation factor IX per kg of body weight increases the activity of the coagulation factor IX in plasma by 0.8% and 1 IU of the coagulation factor II increases the activity of factor II or X by 1.5%, respectively.
The required dose is determined to the following formula:
Initial dose = body weight (kg)? necessary increase in factor IX (%)? 1.2
It is necessary to pay special attention to the fact that in each individual case, when determining the necessary quantity and frequency of drug administration, clinical effectiveness should always be considered. 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 plasma Duration of administration
Hemorrhages in the joint 30% At least 1 day, depending on the severity of the bleeding
Bleeding in the muscles 30-50% 3-4 days or until the hemorrhage stops
Minor head trauma 30-50% 3-4 days or until bleeding stops
Extraction of the tooth 30-50% 3-4 days or until the bleeding stops
Interventions of medium severity 30-50% 3-4 days or until bleeding stops
Bleeding from the oral cavity 30-50% 3-4 days or until the bleeding stops
With the acquired deficiency of prothrombin complex factors, the dose and duration of substitution therapy depend on the severity of hemostatic function, the localization and severity of bleeding, and the clinical condition. The dosage regimen also depends on T 1/2 in vivo of the required 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.
Preparation and administration of a solution for infusions
Solution of the drug Uman Complex D.I. should be prepared immediately prior to 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.
To obtain a solution, add the solvent to the vial with lyophilisate through a double needle and rotate the vial until it dissolves completely. The lyophilizate can dissolve faster when the solvent is heated in a water bath to a temperature of no higher than 37 В° 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 inserted into / with the supplied kit.
Rarely: anaphylactic and allergic reactions, fever; the formation of antibodies to one or more of the clotting factors that make up the drug.
- high risk of thrombosis or disseminated intravascular coagulation;
- Hypersensitivity to the components of the drug.
Caution should be given to patients with coronary artery disease or a history of myocardial infarction, liver disease in the postoperative period, and newborns.
PREGNANCY AND LACTATION
In clinical studies on the use of the drug in pregnancy complications are not established. Experimental animal studies are insufficient to assess the effect on reproductive function, the development of an embryo or fetus, the course of pregnancy, the peri- and postnatal development of a child.
In this regard, the drug can be used during pregnancy and lactation only if the expected benefit for a woman exceeds the possible risk to the fetus or child.
Patients who use the drug Uman Complex D.I. shown more 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, it may be necessary to administer the drug in doses that are more calculated, especially at the beginning of the treatment. 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 hemorrhage in patients with severe hemophilia B, initial doses may amount to 10-20 IU of coagulation factor IX per kg of body weight.
The drug Uman Complex D.I. is produced from human plasma. When using plasma or products made from human plasma, it is not possible to completely exclude the transmission of infectious agents, incl. still unknown. To reduce the risk of transmission, careful selection of donors and harvested plasma is carried out by special testing (monitoring of each portion of the plasma used to produce the drug for the absence of HIV types 1 and 2, HBsAg, antibodies to the hepatitis C virus and ALT activity, in addition, each pool is tested plasma 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 В° C for 30 min) are included.
If necessary, in the absence of a coagulation factor concentrate IX, patients with haemophilia B can be introduced with Uman Complex D.I.
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.
The use of high doses of human prothrombin complex concentrate can lead to myocardial infarction, DVS-syndrome, thrombosis of veins and pulmonary embolism.The risk group consists of patients with a predisposition to the listed diseases.
The drug Uman Complex D.I. should not be mixed with other drugs.
For the introduction of the drug should be used only approved equipment, as 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 IV injections.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a protected from light, out of reach of children at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years (subject to all storage conditions with undamaged packaging). Do not use after expiry date.