Octaneine F (filtered) should be administered intravenously after dissolution in the attached water for injection. Treatment should begin under the supervision of a specialist in anti-hemophilic therapy. The dose and duration of treatment depend on the degree of deficiency of coagulation factor IX, localization and intensity of bleeding and the patient's clinical condition.
Calculation of the administered dose: the number of injected units of the blood coagulation factor IX is expressed in international units (ME), in accordance with the World Health Organization standard for coagulation factor preparations IX. The activity of the factor itself in plasma is expressed in these ME or as a percentage of its content in normal plasma. The required dose calculation is based on the assumption that the administration of 1 ME factor IX per 1 kg of patient weight increase factor activity in the body by 1.3%.
The calculation is based on the formula:
| Required count ME = body weight (kg) x desired level of factor IX ME / dl x 0.8 |
It should be borne in mind that the number and frequency of use depends on the individual clinical effect of the treatment. Drugs of coagulation factor IX usually do not apply more often than once a day.
Approximate dosages can be determined from the following table:
| Severity of bleeding or type of surgical procedure | The level of blood coagulation factor IX required in% | Frequency of administration and duration of therapy |
| Bleeding |
| Early hemarthrosis, bleeding with traumatic injury of the vessels of the limb. | 20-40 | Repeat once a day until bleeding ceases (pain relieves pain) |
| Intensive: hemarthrosis, bleeding with traumatic injury of the vessels of the limb, hematoma. | 30-60 | Once a day 3-4 days or longer until the disappearance of pain or immobility |
| Dangerous for life bleeding: intraperitoneal, in the neck, craniocerebral. | 60-100 | Repeat the administration every 8-24 hours until the end of life threat. |
| Surgical procedures |
| Small operations, including tooth extraction | 30-60 | Every 24 hours until recovery |
| Large (cavitary) operations (before and after surgery) | 80-100 | Repeatedly every 8-24 hours before wound healing, then within 7 days to maintain the level of favors within 30-60% |
In some cases, especially when the initial dose is administered, higher doses of the drug are required.
Response to the introduction of coagulation factor IX is individual, so it is also desirable to determine the level of the factor in the blood on the background of the treatment, especially in cases of serious surgical procedures.
Preventive treatment: long-term prophylaxis of bleeding with severe Hemophilia B is achieved by the administration of factor IX at a dose of 20-30 IU / kg twice a week.Sometimes, especially at a young age, you should inject the drug, either more often or in large doses.
Inhibitory antibodies: it is necessary to monitor the possibility of formation in the patient of inhibitory antibodies to the coagulation factor IX. The determination of antibodies should be performed in the absence of the effect of an adequate dose or if it is not possible to achieve the desired level of the factor in the plasma with adequate administration. If during the Bethesda test the level of inhibitory antibodies does not exceed 10 Bethesda units (BE) per 1 ml, the administration of additional doses of the coagulation factor IX usually leads to neutralization of the antibodies and the desired clinical effect. At a level of inhibitory antibodies more than 10 BE should also consider the use of (activated) PPS (concentrate prothrombin complex factors) or activated factor VII. Such treatment should be carried out only by specialists in the field of antihemophilic therapy.
Dissolution of coagulation factor lyophilizate IX
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 did not come into contact with rubber stoppers or lids of vials.The temperature of the water bath should not exceed 37 ° C.
2. Remove the protective caps of vials with lyophilizate and water, disinfect the rubber stoppers of both vials with one of the disinfectant 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, clear solution without sediment is allowed.
Introduction
Ready-to-use drug should be administered immediately after dissolution. As a prophylaxis, determine the pulse rate before and during administration. If there is a marked increase in the pulse rate, take a break or simply reduce the rate of injection.
1. With a filter needle, puncture the rubber stopper of the vial with lyophilizate.
2. Connect the other end of the needle to a disposable syringe.
3. Turn the vial and collect the solution into the syringe.
4. Disinfect the skin at the injection site.
5. Release the syringe with the solution and attach the butterfly needle.
6. Enter the solution into the vein at a rate of 2-3 ml per minute.
If the patient receives more than one vial of the drug, the same disposable cannula (butterfly needle) can be used. A syringe can also be used for several vials of the drug. However, for a set of ready-to-use solutions, a new filter needle must be used each time.
The solution remaining after the injection is immediately destroyed.