Doses
Single dose and frequency of administration are set individually, taking into account the initial parameters of the coagulation system, localization and severity of bleeding, the clinical state of the patient.
When appointing patients with acquired deficiency factors of the prothrombin complex, in particular, for the treatment and prevention of bleeding in case of an overdose of indirect anticoagulants, vitamin K antagonists, should be guided by the value of either Quim's prothrombin or an international normalized ratio (INR), depending on which indicator determines the laboratory.
If you are guided by the value of prothrombin by Kviku, you should proceed from the assumption that 1 ME of the drug per 1 kg of body weight increases the value of prothrombin by about 1%.
If the initial value of INR is taken into account, the calculation of the dose is carried out as follows (see table).
| Initial value MHO | Single dose of the drug at a rate of 1 kg of body weight |
| 2,0-3,9 | 25 IU / kg |
| 4,0-5,9 | 35 IU / kg |
| ≥6,0 | 50 IU / kg |
The goal of treatment is to achieve an INR of 1.0-1.2; sometimes up to 1.5, depending on the clinical situation. The question of introducing a repeated dose of the drug should be addressed individually, taking into account the dynamics of the patient's clinical condition, concomitant therapy and the achieved value of INR.
When appointing patients with congenital insufficiency one of the factors of the prothrombin complex, a single dose is calculated for each patient individually (see formulas for calculating the required dose), and the intervals between administrations are set depending on the value of the half-life of the deficit factor. Treatment should begin under the supervision of a physician with experience in the treatment of blood clotting disorders.
Formulas for calculating the required dose
factor II: dose (ME) = body weight (kg) x desired factor increase (%) x 0.5;
factor VII: dose (ME) = body weight (kg) x desired factor increase (%) x 0.6;
factor IX: dose (ME) = body weight (kg) x desired factor increase (%) х 1,2;
factor X: dose (ME) = body weight (kg) x desired factor increase (%) x 0.6.
In the case of massive surgery, careful monitoring of the level of deficient clotting factor and / or prothrombin ratio according to Kviku and correction of therapy with Prothromplex 600, depending on the dynamics of these parameters, are necessary.
Note. The input dose of a specific factor is expressed in International units (ME), which are determined in accordance with the current WHO standard for each factor.The activity of the clotting factor in plasma is expressed either as a percentage (relative to normal plasma) or in International units (in accordance with the international standard for a particular coagulation factor).
One International unit (ME) of clotting factor activity is equivalent to the amount in one ml of normal human plasma.
Preparation of a solution and its introduction
The contents of the vial with lyophilisate are dissolved immediately before administration. For this purpose it is necessary to use only the supplied kit for dissolution and administration. The reconstituted solution should be clear or slightly opalescent. Do not use the solution if it is cloudy or there are inclusions in it. Unused solution is to be disposed of in accordance with established rules.
Preparation of the reconstituted solution:
1. Unopened vial with solvent (water for injection) bring to room temperature (not above 37 ° C).
2. Remove protective caps from vials with lyophilizate and with a solvent (Fig. A) and disinfect with rubber alcohol rubber stoppers on both vials.
3. Rotate and then remove the protective packaging from one end of the transfer needle (Figure B) supplied. Puncture the rubber stopper of the vial with the solvent with this end of the needle (Figure B).
4. Carefully remove the protective package from the other end of the transfer needle, without touching the needle itself.
5. Turn the vial with solvent and pierce the free end of the needle to transfer the rubber stopper of the vial with the lyophilizate (Fig. D). Due to the vacuum water for injections will enter the vial with lyophilizate.
6. Disconnect the vials by removing the needle for transfer from the vial with lyophilizate (Fig. D). For a faster dissolution of the drug, the vial can be gently rotated and shaken.
7. To deposit the foam after completely dissolving the lyophilisate, insert the airway needle in the kit (figure E) into the vial. Remove airway needle after foam settling (see Figure 1).
Intravenous administration
You must follow the rules of asepsis!
1. Turn and then remove the protective packaging from the filter needle and secure it to a sterile disposable syringe. Draw the solution into the syringe (Figure F).
2. Disconnect the needle filter from the syringe, fix the needle-"butterfly" or disposable needle for injections on the syringe and inject the solution intravenously slowly (at a rate of no more than 2 ml / min).
To prepare the solution of Prothromplex 600 and for its administration, use only the supplied kit for dissolution and administration.