Composition, form of production and packaging
Lyophilizate for the preparation of a solution for infusions in the form of powder or amorphous mass of white or light yellow color.
1 f. 1 ml of finished r-ra
human coagulation factor IX 250 IU 50 IU
Excipients: heparin, sodium chloride, sodium citrate dihydrate, lysine hydrochloride, arginine hydrochloride.
Solvent: water d / u - 5 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (fl.) and a dissolution kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in a separate cardboard bundle.
Lyophilizate for the preparation of a solution for infusions in the form of powder or amorphous mass of white or light yellow color.
1 f. 1 ml of finished r-ra
human coagulation factor IX 500 IU 100 IU
Excipients: heparin, sodium chloride, sodium citrate dihydrate, lysine hydrochloride, arginine hydrochloride.
Solvent: water d / u - 5 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (fl.) and a dissolution kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in a separate cardboard bundle.
Lyophilizate for the preparation of a solution for infusions in the form of powder or amorphous mass of white or light yellow color.
1 f. 1 ml of finished r-ra
human coagulation factor IX 1000 IU 100 IU
Excipients: heparin, sodium chloride, sodium citrate dihydrate, lysine hydrochloride, arginine hydrochloride.
Solvent: water d / u - 10 ml.
Glass bottles (1) - cardboard packs; complete with a solvent (fl.) and a dissolution kit (disposable syringe, double-ended needle, filter needle, butterfly needle, 2 disinfectant wipes) in 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. Octanine F В® (filtered) is a concentrate of coagulation factor IX, which is a single-chain glycoprotein with a molecular weight of 68,000 daltons. The drug is included in the processes of blood clotting, promotes the transition of prothrombin to thrombin and the formation of a fibrin clot in patients with hemophilia.Injections of the drug Octanine F В® (filtered) increase the activity of the coagulation factor IX to 30-60%.
PHARMACOKINETICS
About 30-50% of the blood coagulation factor IX is determined in the blood immediately after infusion, T 1/2 - up to 29.1 hours.
The specific activity of the drug Octanine F В® (filtered) is approximately 100 IU / mg protein.
INDICATIONS
- treatment and prevention of bleeding in patients with hemophilia B (congenital or acquired deficiency of coagulation factor IX).
DOSING MODE
Octanine F В® (filtered) should be administered IV after dissolution in water for injection, which is included in the package of the preparation. Treatment should be started under the supervision of a specialist in antihemophilic therapy. The dose and duration of therapy depend on the degree of deficiency of the coagulation factor IX, the localization and intensity of bleeding and the clinical condition of the patient.
Calculation of the administered dose: the number of coagulation factor units entered in IX is expressed in international units (ME) in accordance with accepted WHO standards for coagulation factor preparations IX. The activity of the factor itself in plasma is expressed in the same ME or in% with respect to its content in normal plasma. Calculation of the required dose is based on the assumption that the administration of 1 ME of blood coagulation factor IX per 1 kg of patient's heat increases the activity of this factor in the body by 1.3%.
The calculation is based on the formula:
required dose (ME) = body weight (kg) x desired level of coagulation factor IX ME / dl x 0.8.
It must be taken into account that the number and frequency of application always depends on the individual clinical effect. Drugs of coagulation factor IX usually do not apply more often 1 time / day.
Approximate doses of the drug are presented in the table.
Severity of bleeding / type of surgical intervention Necessary level of coagulation factor IX (%) Frequency of administration and duration of therapy
Bleeding
Early hemarthrosis, bleeding in case of traumatic injury of the vessels of the limb 20-40 1 time / day until the end of bleeding (relief of pain)
Intensive: hemarthrosis, bleeding with traumatic injury of the vessels of the limb, hematoma 30-60 1 time / day 3-4 days or longer until the disappearance of pain or immobility
Dangerous for life bleeding: intraperitoneal, in the neck, cranial-brain 60-100 Every 8-24 hours before the end of the threat of life
Surgical procedures
Small operations, including tooth extraction 30-60 Every 24 hours until recovery
Serious (cavitary) surgeries (before and after surgery) 80-100 Every 8-24 hours before wound healing, then within 7 days to maintain factor level within 30-60%
In some cases, especially with the introduction of the initial dose, the administration of the drug at higher doses is required.
The clinical response to the introduction of coagulation factor IX is individual, therefore it is recommended to determine the level of this factor in the blood on the background of the treatment, especially in cases of serious surgical interventions.
For the purpose of long-term prophylaxis of bleeding in severe hemophilia B, the drug is administered in a dose of 20-30 IU / kg 2 times / week. Sometimes, especially at a young age, the drug should be injected more often or in large doses.
It is necessary to control the possible formation in the patient of 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 the inhibitor level does not exceed 10 Bethesda units per 1 ml in the determination (Bethesda test), the administration of additional doses of factor IX usually leads to its neutralization and the desired clinical effect. At an antibody level of more than 10 BE, consideration should also be given to the use of activated PBS (concentrate prothrombin complex factors) or activated factor VII. Such treatment should be carried out only by specialists in the field of antihemophilic therapy.
Rules for the preparation and administration of a solution
The solvent (water for injection) and the concentrate in closed bottles should be brought to room temperature. If a water bath is used to warm the solvent, care must be taken to ensure that water does not come into contact with rubber stoppers or vial caps. The temperature of the water bath should not exceed 37 В° C.
Remove the protective caps from the vial of concentrate and c of the water bottle and disinfect the rubber stoppers of both vials with one of the disinfecting napkins.The short end of the double-ended needle is released from the plastic package, pierce the water bottle and press down until it stops. Flip the water bottle together with the needle, release the long end of the double-ended needle, pierce the flask with concentrate and press down until it stops. Vacuum in a vial of concentrate draws in water. A bottle of water, together with a needle, is separated from the vial with concentrate. The drug will dissolve quickly, for this, the bottle should only be slightly shaken. To use, only a colorless, clear solution without sediment is allowed.
Ready-to-use drug should be administered immediately after dissolution. As a preventive measure, it is necessary to control the pulse rate before and during the administration of the drug. With a marked increase in the pulse rate, it is necessary to take a break or decrease the rate of administration.
With a filter needle, pierce the rubber plug of the vial with the concentrate. Connect the other end of the needle to a disposable syringe. Turn the vial and collect the solution into the syringe. Disinfect the skin at the injection site. Release the syringe with the solution and attach the butterfly needle, do an IV injection. Enter the solution into the vein at a rate of 2-3 ml / min.
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 injection is to be destroyed.
SIDE EFFECT
Allergic reactions: rarely - allergic reactions, fever; in isolated cases - anaphylactic reactions (sometimes coinciding with the formation of an inhibitor to the coagulation factor IX.) The necessary therapy depends on the type and severity of the reaction.
On the part of the blood clotting system: thromboembolic complications are possible (high-purity preparation is rarely associated with similar reactions, but in the past, with myocardial infarction, there was myocardial infarction, venous thrombosis, pulmonary embolism and DIC syndrome). Given the presence of heparin in the preparation, in exceptional cases, a sudden decrease in the number of platelets by 50% in comparison with the baseline (thrombocytopenia, type II) immediately after the administration of the drug or, in the presence of hypersensitivity to heparin in the anamnesis, 6-14 days after treatment. Severe thrombocytopenia can be accompanied by thrombosis, consumption coagulopathy, petechiae, black stool. In these cases, the use of the drug Octanein F В® (filtered) should be discontinued and the heparin-containing drugs should not be prescribed to the patient.
CONTRAINDICATIONS
- Acute thrombosis;
acute myocardial infarction;
- DIC-syndrome;
acute renal failure;
- Hypersensitivity to the components of the drug.
With caution should prescribe the drug to children under the age of 6, in which preparations of the coagulation factor IX were used rarely, and patients previously untreated.
PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the safety of the drug during pregnancy and lactation were not conducted. The decision to prescribe a drug of this category of patients is taken individually.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug in acute kidney failure.
In the case of an allergy in the history and formation of inhibitory antibodies, when trying to use immunotolerant therapy, cases of development of a nephrotic syndrome are noted.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Patients with liver disease should carefully weigh the risk of using the drug and the benefits of therapy.
APPLICATION FOR CHILDREN
With caution should prescribe the drug to children under the age of 6, in whom preparations of the coagulation factor IX were used rarely.
SPECIAL INSTRUCTIONS
The formation of inhibitory antibodies is a known complication encountered in the treatment of hemophilia. These antibodies consist of immunoglobulins G and act against coagulation factor IX. Therefore, careful clinical and laboratory monitoring of patients using coagulation factor preparations IX is necessary. All patients with allergies should be screened for an inhibitor that increases the risk of anaphylaxis. Primary administration of the coagulation factor IX drug should be carried out under medical supervision in institutions where adequate treatment of any allergic reactions is possible.
The appearance of inhibitory antibodies to the coagulation factor IX is usually accompanied by an insufficient clinical effect of the drug. In this case, consultation is recommended in a specialized antihemophilic center. If the patient receives the preparation of the coagulation factor IX for the first time in his life, it is advisable to use the Bethesda test in dynamics.
In the case of an allergy in the history and formation of inhibitory antibodies, when trying to use immunotolerant therapy, cases of development of a nephrotic syndrome are noted.
As with any protein preparation for intravenous administration, the patient may have allergic reactions by type of hypersensitivity. Early signs include red spots or generalized skin rash, chest tightness, dizziness, falling blood pressure and anaphylaxis. If these symptoms appear, discontinue the drug immediately and seek medical advice. In the case of shock, the treatment is carried out according to the general rules of anti-shock therapy.
With the use of blood products, the possibility of transferring infectious agents, including unknowns to date, and the development of appropriate infectious diseases can not be completely ruled out. The risk of transmission of such infections is significantly reduced by screening donors and screening plasma portions for hepatitis B and C viruses and HIV; testing of plasma pools for the presence of genetic material of hepatitis C and antibodies to hepatitis B and C; included in the production process procedures for the removal and inactivation of viruses that are considered effective against hepatitis A, B and C viruses and HIV. As the inactivation stages, C / D treatment and nanofiltration are used. All existing procedures have a limited effect against parvovirus B19, which, however, have a pronounced pathogenic effect only on patients with severe immunodeficiency and on pregnant women.
Preventive vaccination against hepatitis A and B is recommended, as usual, when using any blood products by patients.
The use of drugs of coagulation factor IX is associated with the development of thromboembolic complications (especially when using drugs of low purity), therefore their use in patients with signs of fibrinolysis or DIC syndrome is potentially dangerous.
In patients with liver disease, thrombembolia risk, DIC syndrome, in the early postoperative period, the risk of using the drug and the benefits of therapy should be carefully weighed. If it is necessary to use the drug, clinical monitoring of possible early signs of thrombus formation or coagulopathy should be carried out.
Influence on the ability to manage motor vehicles and work with mechanisms
Data showing a negative effect of the drug Octanein F В® (filtered) on the ability to drive vehicles or work with mechanisms, are absent.
OVERDOSE
There are no reports of symptoms of an overdose of Octanein F В® (filtered).
DRUG INTERACTION
Octanine F В® (filtered) is incompatible with other drugs, because additional activation or inactivation of the coagulation factor IX is possible.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
