Octane is administered intravenously, after dilution with water for injection.
The dose of Octanate and the duration of replacement therapy depend on the degree of deficiency of the VIII factor of blood coagulation, the localization and duration of bleeding, and the objective condition of the patient.
Calculation of dose
The number of units of the VIII coagulation factor used is expressed in International Units (ME), established by the current WHO standards for the VIII coagulation factor. The activity of the VIII factor in plasma is expressed either as a percentage (relative to the normal content of the factor in human plasma) or in the International Units (relative to the International Standard for the VIII coagulation factor).
One International Unit of VIII coagulation factor is equivalent to the content of this factor in one ml of normal human plasma. Calculation of the required dose is based on empirically obtained results, according to which 1 IU / kg VIII of the clotting factor increases the level of the plasma factor by 1.5-2% of normal content. To calculate the dose necessary for the patient, determine its initial level of activity of the VIII factor of blood coagulation and how much this activity needs to be increased.
Required dose = body weight (kg) x desired increase in the level of FVIII (%) (IU / dl) x 0.5
The number and frequency of use of the VIII factor of blood coagulation should always correspond to clinical efficacy in each individual case.
In the event of subsequent bleeding, the level of activity of the VIII factor of blood coagulation should not decrease below the initial plasma level (% of normal content) at the appropriate time period.The following table can be used as a guide for choosing doses of the VIII factor of blood coagulation for various bleeding and surgical interventions.
| Severity of bleeding / A type surgical
interventions | Necessary level Φ VIII (%) | Frequency of administration (hours) / Duration of treatment (days) |
| Bleeding |
| Early hemarthrosis, intramuscular hemorrhage, oral bleeding | 20-40 | Repeat every 12-24 hours, at least 1 day, until pain subsides or healing of the source of bleeding. |
| More intense bleeding, intramuscular bleeding or bruising | 30-60 | Repeated administration every 12-24 hours for 3-4 days, until pain subsides and recovery. |
| Life threatening bleeding. | 60-100 | Repeated administration every 8-24. hour, until the threat completely disappears. |
| Surgical interventions |
| Small, including tooth extraction | 30-60 | Every 24 hours, at least 1 day, until healing is achieved. |
| Large | 80-100 (pre- and post-operative) | Repeated administration every 8-24 hours, until adequate wound healing, then at least 7 days to support the activity of F VIII at the level of 30-60% |
Patients respond to the VIII coagulation factor individually, demonstrating a different level of recovery in vivo and a different half-life of the factor.Therefore, the level of this factor should be determined in the course of treatment to regulate the applied dose and frequency of administrations. The activity of the VIII coagulation factor should be monitored during replacement therapy, especially during major surgical interventions.
The doses indicated in the table serve for general guidance. To determine the required dose and frequency of use of the drug, the recommendation of the attending physician is necessary.
Prevention of bleeding: For prolonged prevention of bleeding in patients with severe hemophilia A, VIII, a blood coagulation factor of 20-40 IU / kg body weight should be administered every 2-3 days. In some cases, especially in young patients, it may be necessary to reduce the gap between the administrations or increase the dose.
Inhibitory antibodies: in some patients after treatment, the formation of inhibitory antibodies to the VIII factor of blood coagulation is possible, which may affect the effectiveness of further treatment. If, against the background of the treatment, there is no expected increase in the activity of factor VIII or the required hemostatic effect is absent, consultation is recommended in a specialized treatment center using Bethesda test.To eliminate the inhibitor to the VIII factor of blood coagulation, induction therapy of immune tolerance can be used. Its basis is the daily administration of the VIII factor of blood coagulation, in a concentration exceeding the blocking ability of the inhibitor (100-200 IU / kg per day, depending on the inhibitor titer). Coagulation factor VIII, fulfilling the function of the antigen, provokes the growth of the inhibitor titer before the development of tolerance, that is, the decrease and subsequent disappearance of the inhibitor. Therapy is continuous and continues on average from 10 to 18 months. Such treatment should be carried out only by specialists in the field of antihemophilic therapy.
Dissolution of lyophilizate
1. Thinner (water for injections) and lyophilizate in closed vials to bring to room temperature. If a water bath is used to warm the solvent, care should be taken to ensure that water Do not come into contact with rubber Cork or lid vials. The temperature of the water bath should not exceed 37 ° C.
2. Remove the protective caps from the vials with lyophilizate and water, disinfect the rubber stoppers of both vials with one of the disinfecting napkins.
3. The short end of the double-ended needle is released from the plastic package, pierce the stopper of the vial with water and press down until it stops.
4. Turn the water bottle together with the needle, release the long end of the double-ended needle, pierce the stopper of the vial with the lyophilizate and press down until it stops. Vacuum in the vial with lyophilizate draws in water.
5. A bottle of water, together with a needle, is separated from the vial with a lyophilizate. The drug will dissolve quickly, for this, the bottle should be slightly shaken. To use, only a colorless, transparent or slightly opalescent solution without sediment is allowed.
Instructions for intravenous administration
As a precautionary measure, it is necessary to control the heart rate before and during the administration of Octanate. In the case of pronounced acceleration of the pulse, slow or stop the drug administration.
1. After dissolving the lyophilisate according to the instructions above, remove the protective one. cover with a needle with a filter and stick it into the vial with a dissolved lyophilizate.
2. Remove the cap from the needle with the filter and attach the syringe.
3. Turn the bottle with the syringe upside down and draw the solution into the syringe.
4. Disinfect the intended site of injection with an alcoholic napkin.
5. Disconnect the needle with the filter from the syringe and attach the butterfly needle instead.
6. Enter the solution intravenously slowly, at a rate of 2-3 ml per minute.
If more than one vial of Octanate is used, it is possible to use the syringe and the butterfly needle repeatedly.
The filter needle is for single use only. Always use a needle with a filter to take the prepared solution into the syringe.
Any unused solution of the drug must be disposed of according to existing rules.