The drug after the preparation of the solution is injected slowly or dripwise intravenously. After preparation, the solution should be introduced within three hours. Do not freeze the prepared solution!
Therapy should begin under the supervision of a doctor with experience in the treatment of hemophilia. Doses and duration of substitution therapy depend on the degree of FVIII deficiency, localization, bleeding intensity and severity of the clinical condition of the patient.
The amount of FVIII administered is expressed in International Units (ME), which correspond to the generally accepted WHO standard for preparations containing FVIII. Plasma FVIII activity is expressed either as a percentage (corresponds to normal human plasma), or in International Units (corresponds to the International Standard for FVIII in plasma).
One International Unit (ME) of activity vvIII is equivalent to the same amount of vVIII in 1 ml of normal human plasma.
Calculation of dose
The calculation of the required dose of FVIII is based on the empirically established fact that when 1 ME FVIII per kg of body weight, the activity of fVIII in plasma increases by 1.5-2% of normal activity.
The dose of the drug is calculated by the following formula:
| The required dose of Coate-DWI (ME FVIII) = body weight (kg) x desired increase in FVIII (in%) / 2% / IU / kg. |
Example, a child weighing 15 kg:
The required dose (ME FVIII) = 15 kg x 100% / 2% / IU / kg = 750 ME
In each specific case, the amount of drug administered and the frequency of administration should be correlated with clinical efficacy.
If the expected level of fVIII concentration can not be achieved with the calculated dose, or if bleeding can not be controlled after the administration of the calculated dose, it should be suspected that the patient has inhibitors whose presence and level should be confirmed by laboratory tests. In the presence of an inhibitor, the required dose of FVIII significantly varies and the dose can be determined only by a clinical response. Some patients with a low inhibitor titer (up to 10 Bethesda units) can continue treatment with FVIII without significantly elevating the inhibitor titer.Patients with a higher inhibitor titer may need to use other drugs. Treatment of immunological tolerance using repeated doses of the fVIII concentrate administered according to a pre-prescribed schedule may lead to the disappearance of the inhibitor. The most successful regimes were the use of high doses of FVIII, administered at least once a day. However, the most effective mode of administration of any given dose was not developed.
Light bleeding: Mild superficial or early bleeding may stop when a dose of 10 IU / kg body weight is administered, which leads to an increase in the vVIII level by about 20% in vivo. Until the appearance of signs of further bleeding, repeated administration is not required.
Moderate bleeding: For more serious bleeding (eg, single hemarthrosis, certain trauma), the level of FVIII should be raised by 30-50% by administering approximately 15-25 IU / kg body weight. If it is necessary to continue therapy, repeated doses may be 10-15 IU / kg body weight and administered every 8-12 hours until the bleeding stops completely.
Severe bleeding: To achieve hemostasis in patients with life-threatening bleeding or bleeding to vital organs (for example, central nervous system, zygomatic or retroperitoneal space, vagina of ilio-lumbar muscle), the level of FVIII should be increased by 80-100% of normal. This can be achieved in most patients with Coate-DVI at a rate of 40-50 IU / kg body weight, maintaining a dose of 20-25 IU / kg body weight, administered every 8-12 hours until the bleeding stops completely.
Surgical interventions: For large surgical interventions, the level of FVIII should be raised to about 100% by administering a pre-operative dose of 50 IU / kg body weight. The level of FVIII should be monitored before and during the entire operation period to confirm the adequacy of substitution therapy. To maintain the haemostatic level, repeated injections may need to be repeated every 6-12 hours for 10-14 days after the operation. The intensity of the necessary replacement therapy for FVIII depends on the type of surgical intervention and the subsequent postoperative regimen.
Hemostasis for small surgical interventions can be provided with less intensive treatment regimens.
&hide_Cookie=yes)
Prolonged prevention: For long-term prophylaxis in severe forms of hemophilia A, doses of 20-40 ME FVIII per kg of body weight every 2-3 days. In some cases, especially in young patients, it may be necessary to reduce the intervals between administrations or increase doses of the drug to prevent hemorrhages.
Preparation of the drug solution
The Coate-DWI solution is prepared immediately before the introduction. The prepared solution retains chemical and physical stability for 3 hours at a temperature of 20 ° -25 ° C, but it should be used immediately after preparation. The user is responsible for the conditions and duration of storage of the prepared solution. Do not use a turbid solution or solution with inclusions. Unused solution is to be disposed of properly.
Observe the rules of asepsis!
1. Heat the vial with the solvent (sterile water for injection) to room temperature (no higher than 37 ° C).
2. Remove the protective caps from the vials with concentrate and solvent (Figure A) and disinfect the rubber stoppers of both bottles.
3. Remove the protective coating in the form of an insulating film from the plastic cartridge of the transfer needle and puncture the plugvial with a solvent (Figure B).
4 Remove the protective cap from the other end of the transfer system. Do not touch the bare end of the system.
5 Turn the solvent vial over a vial of dry concentrate and pierce the center of the vial with the free end of the needle (Fig. C). Due to the vacuum, the solvent will flow into the vial with the drug. Keep the solvent bottle at an angle to the concentrate vial in order to direct the solvent jet to the wall of the vial with the concentrate. Avoid excessive foaming. Wait for about 1 minute.
6. Separate the vials by pulling the needle of the system for transfer from the vial of the vial to the preparation (Fig. D). Vigorously rotate the bottle until completely dissolved, without causing excessive foaming (Fig. E).
7. After completely dissolving the concentrate, draw the solution into the syringe through the supplied needle with the filter (Fig. F). Replace the needle with the filter on the injection needle and inject the solution intravenously.
8. If the patient is required to enter more than one vial, the contents of the two vials can be dialed into one syringe through a different unused needle with a filter before attaching the injection needle.
Introduction
Observe the rules of asepsis!
The duration of administration should be determined in accordance with the individual response of the patient, but the entire dose for 5-10 minutes in general is well tolerated.