The recovery of Factor VII should be carried out immediately before use. When used as an infusion, use only the supplied infusion system.
Restoration of lyophilizate
1. Preheat the unopened vial containing the solvent to room temperature (max 37 ° C).
2. Remove the protective discs from the vials with lyophilizate and with the solvent (Fig. A) and clean the stoppers of both vials.
3. Remove, rotating and removing, the protective coating from one end of the attached transfer needle (Figure B). Introduce the open needle through a rubber stopper into a vial of solvent (Figure B).
4. Remove the protective coating from the other end of the needle for transfer, avoiding touching the open end.
5. Turn the solvent bottle vertically above the flask with concentrate and insert the free end of the needle for transfer through the rubber stopper of the vial with the concentrate (Fig. D).Under the action of vacuum, the solvent will flow into the vial with the concentrate.
6. Disconnect the two vials by removing the needle from the vial of the vial with the concentrate (Figure D). Shake and rotate the vial with concentrate to accelerate dissolution.
7. After the restoration of the concentrate is complete, insert the attached aeration needle (Figure E) and allow the foam to settle completely. Remove the aeration needle.
Method of administration
1. Remove, rotating and removing, the protective coating from one end of the attached filter needle, and put it on a sterile disposable syringe. Draw the solution into the syringe (Figure F).
2. Disconnect the filter needle from the syringe and perform a slow intravenous injection of the solution (maximum injection rate: 2 mL / min) using a transfusion system (or attached disposable needle).
3. For home treatment, make sure that the used needles and syringes are folded back into the recovery kit box and return this box to your hemophilia center.
Doses and duration of substitution therapy depend on the severity of Factor VII deficiency, the localization and extent of bleeding episodes, and the clinical condition of the patient.The relationship between the residual level of Factor VII and the propensity to bleed is less unambiguous in individual patients than in classical hemophilia.
The number of Factor VII units introduced is expressed in International Units (ME), corresponding to the existing WHO standard for factor VII preparations. The activity of Factor VII in plasma is expressed either as a percentage (relative to normal plasma) or in International Units (relative to the International Standard for Factor VII in Plasma).
One International Unit (ME) of Factor VII activity is equivalent to the activity of Factor VII in one ml of normal human plasma. The calculation of the required dose is based on empirical observation, according to which, 1 International Unit (ME) of factor VII per kg of body weight increases the activity of Factor VII in plasma by about 1.9% (1.9 IU / dl) from normal activity.
Required dose is determined using the following formula:
The required dose (ME) = body weight (kg) x desired increase in Factor VII activity (IU / ml) x 0.5 (inverse of empirically observed recovery (ml / kg))
If individual recovery is known, the inverse of this value should be used for calculation, instead of 0.5.
In each individual case, the amount that must be entered and the frequency of application should always be correlated with clinical efficacy. This is especially important in the treatment of Factor VII deficiency, since the individual tendency to bleeding does not depend strictly on the measurement with
laboratory samples of Factor VII activity in plasma. The intervals between doses should take into account the short half-life of Factor VII from the circulatory bed, which is about 3 to 5 hours. When Factor VII is used as intermittent injections / infusions, 6-8 hour intervals between doses are adequate. Usually, in the treatment of Factor VII deficiency, lower doses of the missing factor are required, depending on the activity in normal plasma, compared with classical haemophilia (hemophilia A and B). The following table provides sample recommendations for the use of intermittent injections / infusions, based on limited clinical experience. Medical data based on clinical efficacy studies are not available.
| Degree of bleeding / Type of surgical intervention | Required level factor VII IU / ml * | Frequency of administration (hours) / Duration of therapy (days) |
| Light bleeding | 0,10-0,20 | Single dose |
| Severe bleeding | 0,25-0,40 (lower - higher levels) | Within 8-10 days or until complete healing ** |
| Small surgical interventions | 0,20-0,30 | A single dose before a surgical operation or, if the estimated risk of bleeding is more obvious, until the wound is healed * |
| Large surgical interventions | Before operation> 0.50 Then 0.25-0.45 (lower - higher levels) | Within 8-10 days or until the wound is fully healed * |
* 1 IU / ml = 100 IU / dl = 100% of normal plasma. The activity of factor VII in plasma is expressed either as a percentage (relative to normal plasma) or in International Units (relative to the international standard for factor VII in plasma)
** Based on the clinical evaluation in a separate case, closer to the end of treatment, lower doses could be sufficient provided that adequate hemostasis is achieved. The intervals between doses should take into account the short half-life of Factor VII from the circulatory bed, which is about 3 to 5 hours. If necessary, maintain high levels of Factor VII for extended periods of time, doses should be administered at an interval of 8-12 hours.
Any unused preparation and waste material must be destroyed in accordance with local requirements.
The color of the solution can vary from colorless to pale yellow or light brown. Do not use solutions that are cloudy or containing sediments. The reconstituted preparations must be visually inspected for mechanical inclusions and discoloration before use.
The drug should be used immediately after recovery.