Uman COMPLEX D.I.
Active material: human blood coagulation factors II, IX, X
When ATH: B02BD
CCF: The drug plasma factors (II, IX, X) clotting
ICD-10 codes (testimony): D67, D68.2, D68.4
When CSF: 20.01.06
Manufacturer: KEDRION S.p.A. (Italy)
Pharmaceutical form, composition and packaging
Valium for solution for infusion white or bledno-jeltogo color; the resulting clear or slightly opalescent solution, colorless or light yellow.
| 1 fl. | |
| human blood coagulation factors II, IX, X | 500 ME * |
Excipients: sodium chloride, tribasic sodium citrate, glycine, Heparin, antithrombin III ME.
Solvent: water d / and – 20 ml.
Glass Bottles (1) together with the solvent (fl. 1 PC.) sterile and non-pyrogenic equipment for the introduction of (syringe 20 ml, needle “butterfly” catheter, needle adapter, Needle filter, adhesive plaster) – packs cardboard.
* Activity is indicated for blood clotting factor IX, which is determined in accordance with WHO requirements, the amount of coagulation factors II and X corresponds to the average content in 200 ml or 500 ml of fresh plasma.
Pharmacological action
The drug plasma factors (II, IX, X) clotting. Compensates for the deficiency of coagulation factor IX and eliminates hypocoagulation patients with its deficiency. The drug in the human body is converted into activated factor IXa in combination with a factor VIII activates blood coagulation factor X (ha), which causes the transition of prothrombin into thrombin and promotes the formation of a fibrin clot. The drug increases the plasma level of vitamin K-dependent clotting factors (II, VII, IX, X).
By reducing the levels of blood coagulation Factor IX below 5% sharply increases the risk of spontaneous bleeding, blood coagulation factor IX above 20% It provides satisfactory hemostasis.
Pharmacokinetics
Immediately after the on / in the serum drug is determined about 30-40% coagulation factor IX, then gradually reduced hemostatic activity.
Testimony
- treatment and prevention of bleeding in patients with single or multiple deficiency of coagulation factor IX (Hemophilia B, Christmas disease), coagulation factor II (prothrombin deficiency) or blood coagulation factor X (failure Stewart-Prouerta);
- treatment and prevention of bleeding in patients with single or multiple acquired deficiency of the prothrombin complex.
Dosage regimen
Dose and duration of substitution therapy depend on the severity of the disorder of the haemostatic function, on the location and amount of bleeding, and the clinical condition of the patient.
The calculation of the required dose is based on empirical data: 1 ME coagulation factor IX per kg body weight increases the activity of coagulation factor IX in plasma by 0.8% and 1 ME coagulation factor II Factor II activity increases or X respectively 1.5%.
The desired dose is determined before the following formula:
Initial dose = body weight (kg) x desired increment of factor IX (%) x 1.2
Attention must be paid to the fact, that in each case, in determining the amount and frequency of administration should always take into account the clinical efficacy. When bleeding occurs, the activity of blood coagulation factor IX into an appropriate period should not be below the level of the table corresponding factor activity in blood plasma (% from the norm):
| The severity of bleeding | The required level of coagulation factor IX in the blood plasma | duration of administration |
| Hemarthrosis | 30% | At least, 1 day depending on the severity of the bleeding |
| Bleeding into muscles | 30-50% | 3-4 days or until the bleeding stops |
| head minor injury | 30-50% | 3-4 days or until the bleeding stops |
| extraction of teeth | 30-50% | 3-4 days or until the bleeding stops |
| Surgeries of medium gravity | 30-50% | 3-4 days or until the bleeding stops |
| Bleeding from the oral cavity | 30-50% | 3-4 days or until the bleeding stops |
When acquired deficiency of factors of the prothrombin complex dose and duration of substitution therapy depend on the severity of disorders hemostatic function, localization and severity of bleeding and clinical status. The dosage regimen also depends on the T1/2 in vivo and necessary factor in patient weight. To ensure complete control therapy, as far as it's possible, You need to control blood clotting by means of coagulation tests. In the case of major bleeding and before operations, which are accompanied by a high risk of bleeding, the drug must be administered prothrombin complex values to obtain normal prothrombin time.
Terms of preparation and administration of the solution for infusion
A solution of Complex DI preparation Umán. It should be prepared immediately before administration. Do not use if solution therein flake and other mechanical admixtures.
The drug is administered in / for 3-5 min controlled by the patient's pulse.
To obtain a solution to be added with a solvent into the vial through the double needle lyophilisate and rotated until complete dissolution vial. The lyophilisate can be dissolved more quickly by heating the solvent in a water bath to a temperature not higher than 37 ° C. difficulty in filtering will occur Incomplete dissolution of the drug preparation through a filter needle. To avoid foaming, the solvent must be poured slowly on the vial wall with the lyophilisate. After preparing the solution you need to dial it in a syringe, using the enclosed filter needle and enter the I / O with the supplied kit.
Side effect
Rarely: anaphylactic and allergic reactions, fever; antibodies to one or more coagulation factors, part of the drug.
Contraindications
- a high risk of thrombosis or disseminated intravascular coagulation;
- Hypersensitivity to the drug.
FROM caution should be prescribed to patients with coronary artery disease or myocardial infarction, liver disease, We are in period posleperatsionnom, and newborn.
Pregnancy and lactation
In clinical studies on the use of the drug during pregnancy complication not found. Experimental studies animals are insufficient to assess the effects on reproduction, development of an embryo or fetus, during pregnancy, peri- and postnatal development of the child.
In this regard the drug may be used during pregnancy and lactation only, if the expected benefit to the woman than the potential risk to the fetus or child.
Cautions
Patients, that use of the drug Uman Complex DI. show more 3-5 days, should be kept under close supervision for the purpose of early detection of DIC symptoms.
Previous treatment hereditary deficiency of blood coagulation factors II and X is limited.
Under certain conditions may require administering the drug in doses, more than calculated, especially at the beginning of treatment. In particular, in the case of major surgery is necessary to establish monitoring of substitution therapy by means of coagulation tests. With long-term prevention of bleeding in patients with severe hemophilia in the initial dose may amount to 10-20 ME coagulation factor IX per kg body weight.
The drug Uman Complex DI. produced from human plasma. When using a plasma or products, prepared from human plasma, it is impossible to completely eliminate the transmission of infectious agents, incl. yet unknown. To reduce the risk of transmission of a thorough selection of donors and plasma harvested by special testing (control of each portion of the plasma, used to produce the drug in the absence of HIV type 1 and 2, HbsAg , antibodies to hepatitis C virus and ALT, Besides, conducted testing of each plasma pool polymerase chain reaction to detect the genome of the hepatitis C virus). In addition to testing in the production process includes measures to double viral inactivation (Solvent-detergent method, and heat treatment at 100 ° C for 30 m).
If necessary, in the absence of a concentrate of coagulation factor IX patients with hemophilia B can enter Umán Complex DI.
If an anaphylactic reaction occurs, immediately discontinue administration of the drug.
It is necessary to carefully monitor the patient's condition for signs of disseminated intravascular coagulation.
Overdose
The use of high doses of human prothrombin complex concentrate can lead to myocardial infarction, DIC, vein thrombosis and pulmonary embolism. risk group consists of patients with a predisposition to these diseases.
Drug Interactions
The drug Uman Complex DI. should not be mixed with other drugs.
Only approved equipment should be used for administration, since the use of other equipment can reduce the effectiveness of therapy due to settling of the drug in the inner surfaces of certain medical devices to / in the introductions.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored in the dark, out of reach of children at a temperature of from 2 ° to 8 ° C.; Do not freeze. Shelf life – 2 year (if all the conditions of storage in the sealed containers). Can not be used after the expiry date.
