Preparation of injection solution
To prepare a solution for injection, water for injection should be used. The preparation and a bottle with water for injections are warmed to a temperature of 20-30 ° C.Remove flips from the flasks and wipe the plugs with a swab dipped in alcohol.
Further for the preparation of solution for injection, one of the following methods is used:
A) Using a sterile needle and syringe (which is destroyed after use), draw into the syringe water for injection and transfer it to the vial with the drug. After puncturing the vial of the vial with the drug water itself flows into a vial, because vacuum vacuum is created in it.
Attention: The supplied needle with filter can not be used for transfer of water for injection.
Or:
B) Remove the protective tip from one end of the two-pointed needle and insert it through the stopper into the water injection bottle. Remove the tip from the other end of the needle, place a vial of water over the vial of the drug and insert the free end of the needle through the stopper into the vial of the drug. After puncturing the vial of the vial with the drug water itself flows into a vial. In the bottle with water for injection will remain a small amount of water.
Attention: If water does not flow into the vial with the drug, it means that the tightness of the package is broken. In this case, you can not use the drug.
Then proceed as follows:
A) Remove the syringe from the needle, then remove the needle from the bottle with the drug Or:
B) Disconnect the two vials by removing the needle first from the vial of water, and then from the vial with the drug.
Carefully rotate the vial of the drug between the palms of the hands to dissolve the drug. For no more than 5 minutes, a clear or slightly opalescent liquid forms. If, in order to obtain the required dose, the amount of the drug required is greater than that containing one vial, the contents of the required number of vials must be fused together. After preparation of the solution of the preparation, wipe the stopper of the bottle with a tampon moistened with alcohol. The dissolved preparation should be transferred from the vial to the plastic "portable filter" through the supplied needle with a sterile filter to release the solution from the tiny undissolved particles that may be present in it.
Attention: The solution should be applied within no more than one hour after preparation. If the diluted formulation forms a gel or clots when the solution is or flakes precipitate, it can not be used.About such facts, as well as the fact that there is no vacuum in the vial with the drug (see above) should be reported to the manufacturer.
Administration of the drug
The prepared solution is administered intravenously slowly (at a rate of approximately 3 ml / min).
To administer the drug, attach a suitable needle (for example, a "butterfly" needle) to the syringe. Despite the low probability of side effects, the dose of the drug (especially the first one) should be administered slowly (approximately 3 ml / min). If you need to enter the contents of more than one vial of the drug, you should collect the contents of the required number of vials in a single syringe of a suitable size, transferring the solution from each vial with the drug through a separate sterile filter needle.
Dosage applied
Treatment should be carried out under the supervision of an experienced physician who has the necessary experience of treating patients with hemophilia.
The dose and duration of treatment depends on many factors and is evaluated by the attending physician. Drugs of factor IX rarely require administration more than once a day.
The amount of introduced factor IX is expressed in the International Units (ME), which correspond to the generally accepted WHO standard for preparations containing factor IX. Factor IX activity. in blood plasma is expressed either as a percentage (corresponds to normal human blood plasma) or in International Units (corresponds to the International Standard for factor IX in blood plasma).
One International Unit (ME) of factor IX activity is equivalent to the same amount of factor IX in 1 ml of normal human plasma.
The calculation of the required dose of factor IX is based on the results of empirical studies showing that administration of 1 ME preparation Replenin - VF per kg of body weight, increases the level of factor IX in blood plasma by 1.3% of normal activity.
The dose of the drug is calculated by the following formula:
| The required number of units of the drug = body weight (kg) x required level of increase in the activity of factor IX (%) x 0.8 |
The table below gives an approximate estimate of the required dose for different situations.
| Severity of bleeding Type of surgical procedures | The therapeutically necessary level of factor IX in blood plasma (%) | Multiplicity of administration / duration of treatment |
| Bleeding: |
| Early hemarthrosis, cerebral hemorrhage or into the oral cavity | 20-40 | Repeat injections every 24 hours, at least 1 time per day until relief of bleeding, pain or before recovery. |
| More extensive hemarthrosis, muscle hemorrhage or hematoma | 30-60 | Repeat injections every 24 hours for 3-6 days until pain and discomfort ceases. |
| Hemorrhages threatening life: - Intracranial, intra-abdominal hemorrhages, - - Gastrointestinal bleeding | 60-100 | Repeat introductions every 8-24 hours to eliminate the threat to the life of the patient |
| Surgical operations: |
| - minor incl. extraction of teeth | 30-60 | Repeat injections every 24 hours, at least 1 time per day until recovery. |
| Extensive surgical interventions (pre- and postoperative period) | 80-100 | Repeat introductions every 8-24 hour to achieve the necessary level of wound healing, then therapy for at least the next 7 days to maintain the activity of the factor IX at the level of 30-60% |
In certain circumstances, especially when determining the initial dose, a more significant dose of the drug may be required than the one calculated above.In particular, in cases of extensive surgical interventions, it is necessary to monitor substitution therapy through a blood coagulation assay (factor IX activity in the patient's blood plasma).
During the first few days after the operation, the concentration of the plasma Coagulation Factor IX should be monitored and, if necessary, repeated administration of Replenin-VF every 12-24 hours. After a few days, the dose and multiplicity of administration can be reduced. Treatment is usually continued for 10 days or more.
If the concentration of the Coagulation Factor IX does not reach the desired level or decreases more rapidly than expected (within 12 hours), the presence of inhibitors of the Coagulation Factor IX should be suspected and necessary studies should be conducted to determine these inhibitors.
Use in children
A dose of 1 IU / kg may result in a smaller increase in the activity of the coagulation factor IX.
Currently, the manufacturer does not have sufficient data on the use of the drug Replenin-VF in children younger than 6 years.
Precautionary measures
Do not apply the solution of the drug if it contains mechanical particles, flocculent sediment, if the diluted preparation forms a gel or clots.Do not use the drug if the integrity of the package or storage conditions is violated.