Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration in the form of a powder or an amorphous mass of white or light yellow color.
1 f.
human coagulation factor VIII 250 IU,
which corresponds to a protein content of 5.5 mg
Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.
Solvent: water d / u - 5 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (1 pc.) and an insertion kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in a polyethylene bag and a separate cardboard bundle.
Lyophilizate for the preparation of a solution for intravenous administration in the form of a powder or an amorphous mass of white or light yellow color.
1 f.
human coagulation factor VIII 500 IU,
which corresponds to a protein content of 11 mg
Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.
Solvent: water d / u - 10 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (1 pc.) and an insertion kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in a polyethylene bag and a separate cardboard bundle.
Lyophilizate for the preparation of a solution for intravenous administration in the form of a powder or an amorphous mass of white or light yellow color.
1 f.
human coagulation factor VIII 1000 IU,
which corresponds to a protein content of 22 mg
Excipients: glycine, sodium chloride, sodium citrate, calcium chloride.
Solvent: water d / u - 10 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (1 pc.) and an insertion kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in a polyethylene bag and a separate cardboard bundle.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Hemostatic drug. Promotes the transition of prothrombin to thrombin and the formation of a fibrin clot.
PHARMACOKINETICS
In patients with hemophilia, A T 1/2 is 12 hours. The activity of the coagulation factor VIII is reduced by 15% for 12 hours. The coagulation factor VIII is thermolabile and rapidly degrades with increasing temperature, which leads to a decrease in T 1/2 .
INDICATIONS
- treatment and prevention of bleeding in patients (including children under the age of 6 years) with congenital hemophilia A or acquired deficiency of the coagulation factor VIII, incl. inhibitory forms (using the method of induction of immune tolerance).
DOSING MODE
Octanate В® is administered IV after dilution with water for injection, which is packaged in the package. The dose of Octanate and the duration of replacement therapy depend on the degree of deficiency of the coagulation factor VIII, the localization and duration of bleeding, and the clinical state of the patient.
The dose of the drug is expressed in International Units (ME) in accordance with accepted WHO standards for the coagulation factor VIII. The activity of the blood coagulation factor VIII in plasma is expressed either as a percentage (relative to the normal content of the factor in human plasma) or in IU (relative to the International Standard for Coagulation Factor VIII).
1 IU of coagulation factor VIII is equivalent to its content in 1 ml of normal human plasma. Calculation of the required dose is based on empirically obtained results, according to which 1 IU / kg of blood coagulation factor VIII raises the level of plasma factor by 1.5-2% of normal content. To calculate the dose necessary for the patient, the initial level of activity of the coagulation factor VIII is determined and the extent to which this activity needs to be increased is estimated.
Required dose = body weight (kg)? the desired increase in the level of coagulation factor VIII (%) (ME / dl)? 0.5.
The number and frequency of the drug should always correspond to clinical effectiveness in each individual case.
In the event of subsequent bleeding, the level of activity of the coagulation factor VIII should not decrease below the initial plasma level (% of normal content) at the appropriate time period. The following table can be used as a guideline for choosing a dose of coagulation factor VIII for various bleeding and surgical interventions.
Severity of bleeding / type of surgical intervention Necessary level of coagulation factor VIII (%) Frequency of administration and duration of therapy
Bleeding
Early hemarthrosis, intramuscular hemorrhage, bleeding in the oral cavity 20-40 Repeated every 12-24 hours, at least 1 day, until relief of pain or healing of the source of bleeding
More extensive hemarthroses, intramuscular bleeding or bruising 30-60 Repeated administration every 12-24 hours for 3-4 days, before pain and disability recover
Life-threatening hemorrhages 60-100 Repeated injections every 8-24 hours, until the threat of life disappears completely
Surgical interventions
Small, including tooth extraction 30-60 Every 24 hours, at least 1 day, until healing is achieved
Large 80-100 (pre- and postoperative) Repeated administration every 8-24 hours, until adequate wound healing, then at least 7 days to maintain the activity of coagulation factor VIII at a level of 30-60%
Patients respond to the administration of the drug individually, with a different level of in vivo recovery, T 1/2 of the coagulation factor VIII is variable. Therefore, in the course of treatment, the level of administration of the dose and the frequency of administration should be monitored. The activity of the coagulation factor VIII should be monitored with substitution therapy, especially during major surgical interventions.
The doses indicated in the table are indicative. The doctor sets the necessary dose and frequency of the drug individually.
With the purpose of long-term prophylaxis of bleeding in severe form of hemophilia A, the drug is prescribed in a dose of 20-40 IU / kg of body weight every 2-3 days. In some cases, especially in young patients, it may be necessary to reduce the interval between administrations or increase the dose.
In some patients after treatment, the formation of inhibitory antibodies to the coagulation factor VIII is possible, which may affect the effectiveness of further treatment. If, against the background of the therapy, there is no expected increase in the activity of factor VIII or the required hemostatic effect is absent, consultation in a specialized treatment center using the Bethesda test is recommended. To eliminate the inhibitor to the coagulation factor VIII, induction therapy of immune tolerance can be used. Its basis is the daily administration of coagulation factor VIII at a concentration exceeding the blocking capacity of the inhibitor (100-200 IU / kg / day, depending on the inhibitor titer). The coagulation factor VIII, performing the antigen function, provokes the growth of the inhibitor titer before the development of tolerance, i.e. before 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. It is recommended that the solvent (water for injection) and lyophilizate in closed bottles be brought to room temperature. If a water bath is used before the solvent is heated, care should be taken to ensure that water does not come into contact with rubber stoppers or bottle caps. The temperature of the water bath should not exceed 37 В° 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. Release the short end of the double-ended needle from the plastic packaging, 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. Remove the water bottle with the needle from the vial with lyophilizate. The drug will dissolve quickly; for this, the bottle must be slightly shaken. To use, only a colorless, transparent or slightly opalescent solution without sediment is allowed.
Rules for the preparation and administration of a solution
As a precautionary measure, it is necessary to monitor 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.
After dissolving the concentrate according to the instructions, remove the protective coating from the filter needle and insert it into the vial with the concentrate.Remove the cap from the filter needle and attach the syringe. Turn the vial with the syringe upside down and draw the solution into the syringe. Injections should be carried out in accordance with the rules of asepsis and antiseptics. Disconnect the filter needle from the syringe and attach a butterfly needle instead.
The solution should be injected iv slowly at a rate of 2-3 ml / min.
If you use more than one vial of Octane, you can 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 should be disposed of in accordance with existing regulations.
SIDE EFFECT
Allergic reactions: rarely - angioneurotic edema, burning sensation in the area of ​​administration, chills, hot flashes, urticaria (including generalized), headache, decreased blood pressure, apathy, nausea, vomiting, anxiety, tachycardia, chest tightness, dyspnea , fever, sensation of trembling. Very rarely (<1/10 000), these symptoms can progress to the development of a severe anaphylactic reaction, including shock.
Patients with hemophilia A may develop antibodies (inhibitors) to the coagulation factor VIII (<1/1000). The presence of inhibitors leads to an unsatisfactory clinical response to the administration of the drug. In such cases it is recommended to contact specialized hematological / hemophilic centers. It is necessary to examine the patient for the presence of antibodies using appropriate methods (Bethesda test).
CONTRAINDICATIONS
- Hypersensitivity to the factor of blood coagulation VIII or components of the drug.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is possible in cases when the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant.
APPLICATION FOR CHILDREN
The application is possible according to the dosing regimen.
SPECIAL INSTRUCTIONS
When using the drug, hypersensitivity reactions may develop, as with other injectable preparations of protein origin.
In addition to the coagulation factor VIII, the preparation also contains trace amounts of other blood proteins. Early signs of hypersensitivity reactions are urticaria, chest tightness, dyspnea, lowering of blood pressure and anaphylaxis (severe allergic reaction). If these symptoms occur, stop the injection immediately. In case of shock development, modern methods of anti-shock therapy should be used.
In the case of using medicines derived from human blood or plasma, the possibility of transmitting infectious agents can not be completely ruled out. This also applies to pathogens of unknown diseases. However, the risk of transmission of infectious agents is reduced due to the following measures:
- selection of donors by medical examination and examination, as well as screening of plasma pools for the presence of hepatitis B virus (HBV) antigens, antibodies to HIV and to hepatitis C virus (HCV);
- analysis of plasma pools for the presence of genetic material of HCV;
- Inactivation / removal procedures included in the production process, which were confirmed on the virus model. These procedures are effective for HIV, hepatitis A virus (HAV), HBV and HCV. Inactivation / deletion procedures may have limited efficacy against non-enveloped viruses, one of which is paravovirus B19. Parvovirus B19 can cause serious reactions in seronegative pregnant women (intrauterine infection), as well as in individuals with immunodeficiency or increased erythrocyte production (eg, hemolytic anemia).
When a concentrate of coagulation factor VIII derived from plasma is administered, vaccination against hepatitis A and hepatitis B is recommended.
In case of allergic reactions, it is necessary to examine the patient for the presence of an inhibitor. In patients who have inhibitors of the coagulation factor VIII, there may be an increased risk of anaphylactic reactions during subsequent treatment with octanate. Therefore, the first use of this drug according to the prescribing of the attending physician should be carried out under medical supervision in conditions that ensure the provision of qualified medical care in the event of allergic reactions.
Do not use other drugs during the administration of Octanate.
For the introduction of Octane, use only the injection devices that come with the package. On the internal surface of some injection devices adsorption of the coagulation factor VIII is possible, which leads to a decrease in the effectiveness of treatment.
OVERDOSE
Despite the fact that no symptoms of an overdose of the coagulation factor VIII were observed, it is recommended not to exceed the prescribed dose.
DRUG INTERACTION
There are no data on the interaction of octanate with other drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of 2 В° to 25 В° C; Do not freeze. Shelf life - 3 years.
