REPLENIN-VF
Active material: highly purified concentrate of the human coagulation factor IX
When ATH: B02BD04
CCF: The preparation of blood coagulation factor IX
ICD-10 codes (testimony): D67, D68.4
When CSF: 20.01.06
Manufacturer: BIO PRODUCTS Laboratory (Great Britain)
Pharmaceutical form, composition and packaging
Valium for solution for infusion in the form of a powder or porous mass of white or almost white; prepared solution is clear or slightly opalescent, colorless to pale yellow.
| 1 ml ready-r-ra | 1 fl. | |
| highly purified concentrate of the human coagulation factor IX | 50 ME | 500 ME |
Excipients: L-lysine monohydrate, glycine, trinatriya citrate, lemon acid, sodium dihydrogen phosphate dihydrate, sodium chloride.
Bottles of colorless glass (1) complete with a sterile needle filter – packs cardboard.
Pharmacological action
Hemostatic drug. It is a highly purified concentrate of the human coagulation factor IX, isolated from the blood of carefully selected donors, tested for the absence of HIV, hepatitis viruses B and C, also specially treated to remove the above and other possible viruses. It represents a chain glycoprotein with a molecular weight of about 68 000 Yes.
Compensates for lack of clotting factor IX and, thus, eliminates hypocoagulation patients with its deficiency. Introduced in the blood increases in plasma drug levels K-dependent coagulation factors (II, VII, IX, X).
The blood clotting process is converted into activated factor IX (Factor IXa), which in combination with factor VIII needs factor X to the active form Ha. Under the influence of the last transition occurs prothrombin to thrombin, preobrazuyushtego fibrinogen into fibrin, thereby forming a fibrin clot.
Pharmacokinetics
T1/2 after i / v injection in patients with hemophilia B is about 1 d.
Testimony
- Treatment and prevention of bleeding in patients with hemophilia B, acquired deficiency of clotting factor IX.
Dosage regimen
Treatment should be done under medical supervision, having the necessary experience treating patients with hemophilia B. The dose and duration of treatment depends on many factors and are evaluated by the attending physician.
Preparations factor IX rarely require treatment often 1 times / day.
The amount of Factor IX is expressed in International Units (ME), which correspond to the generally accepted standard of WHO for drugs, containing factor IX.
The activity of factor IX in plasma or expressed in percentage (It corresponds to the normal human plasma) or in International Units (Compliance with international standards for factor IX in plasma).
One IU of Factor IX activity is equivalent to the same amount of factor IX 1 ml of normal human plasma.
The calculation of the required dosage of factor IX is based on the results of empirical studies, showing, that the introduction of 1 IU preparation Replenin-WF kg body weight, It increases the level of factor IX in blood plasma 1.3% from normal activity.
Dose is calculated by the following formula:
the required number of units of the drug = body weight (kg) × desired level of increased activity of factor IX (%) × 0.8
The following table gives a rough estimate of the required dose for different situations.
| The severity of bleeding / Type of surgical procedure | Therapeutically required level of factor IX in plasma (%) | Multiplicity of / duration of treatment |
| Bleeding: | ||
| Early hemarthrosis, bleeding into the muscles or mouth | 20-40 | Repeat administration every 24 no, least, 1 times / day to the relief of bleeding, for pain or until recovery. |
| More extensive hemarthrosis, bleeding into the muscles or hematoma | 30-60 | Repeat administration every 24 h for 3-6 days prior to the termination of pain and discomfort. |
| Bleeding, life-threatening (incl. Intracranial, intraperitoneal, gastrointestinal) | 60-100 | Repeat administration every 8-24 h to eliminate the threat to the life of the patient. |
| Surgery: | ||
| Slight (incl. extraction of teeth) | 30-60 | Repeat administration every 24 no, least, 1 time / day before recovery. |
| Extensive surgery (before- and postoperative period) | 80-100 | Repeat administration every 8-24 hours until the desired level of healing wounds, then therapy for, at least, follow 7 days to maintain factor IX activity level 30-60% |
Under certain circumstances, especially, when determining the initial dose may need to introduce more substantial dose, and something, which is calculated above. In particular, With extensive surgical interventions should be to monitor the substitution therapy by analyzing blood clotting (Factor IX activity in plasma of the patient).
During the first few days after surgery should be monitored plasma concentrations of factor IX and, if necessary, repeat introduction every Replenina-WF 12-24 no. After a few days the dose and frequency of administration may be reduced. Treatment is usually continued for 10 days or more.
If the concentration of factor IX has not reached the desired level or falls faster, than expected (during 12 no), must suspect the presence of inhibitors of factor IX, and conduct the necessary studies to determine these inhibitors.
In children dose, equal 1 IU / kg, perhaps, result in a smaller rise in Factor IX activity. Currently, there is insufficient data on the use of the drug in the WF-Replenin children under the age of 6 years.
The mixed solution of the drug should be administered in / in slowly (at approximately 3 ml / min).
For the administration, attach a suitable needle (eg, needle type “butterfly”) to the syringe. Despite the low probability of side effects, dose (especially the first) should be administered slowly (at approximately 3 ml / min). If you must enter the contents of a 1 vial of the drug, should collect the contents of the required number of vials 1 syringe an appropriate volume, transferring solution from each vial through a single needle with a sterile filter.
Preparation of injection solution
To prepare the solution for injection use Water for injection. Formulation and vial of water for injection was warmed to a temperature of from 20 ° to 30 ° C.. Remove a vial and wipe the plug flips swab, dipped in alcohol.
Further, for solution for injection using one of the following:
1. Using a sterile needle and syringe (are destroyed after use), should dial into the syringe with water for injection and transfer it in the vial. After piercing the stopper vial water itself flows into the bottle, because it created a vacuum suction. Attention must be paid to the fact, that comes bundled with the filter needle can not be used to transfer the water for injections.
2. Remove protective tip at one end and double-ended needle inserted through the stopper into the vial of water for injection. Remove the tip at the other end of the needle, place a bottle of water over the vial and put the free end of the needle through the cork into the bottle with the drug. After piercing the stopper vial water itself flows into the bottle. Vial of water for injection remain a small amount of water. Attention must be paid to the fact, if no water flows into the vial, was a leakproof packaging and the drug can not be used.
Then, should do the following: remove the syringe with the needle, remove the needle from the vial. Either disconnect 2 bottle, Remove the needle from the vial first with water, then from the vial.
It gently rotate the vial between your hands to dissolve the drug. Within no more 5 mines should form a clear or slightly opalescent liquid. If to obtain the required dose requires a greater amount of drug, than contains 1 bottle, the contents of the required number of vials should be drained together.
After preparing a solution of the drug should be wiped with cork bottle swab dipped in alcohol. The dissolved drug should be transferred from the vial into a plastic “Portable Filter” via the supplied drug needle with a sterile filter for the release of the solution able to be present in it the smallest undissolved particles.
The solution should be applied for no more than 1 hours after preparation. If dilution of the drug forms a gel or clot, If the solution has flakes or precipitate, you can not use the drug. On these facts, as well as the fact that no vacuum in the vial should be reported to the manufacturer.
Side effect
From the digestive system: rarely – nausea, jaundice, anorexia, abdominal distention.
CNS: rarely – headache, confusion.
Cardio-vascular system: rarely – tachycardia, postoperative thrombosis.
Allergic reactions: rarely – fever, chills, fever, hives, anaphylactic reactions.
Other: rarely – weight loss, tingling sensations in the body, backache, malaise, fever, decrease resistance to infectious diseases, the appearance of antibodies to factor IX.
Contraindications
- Severe liver;
- DIC;
- Hypersensitivity to factor IX or to other components of the drug.
Not recommended use the drug in patients, with inhibitors of blood coagulation factor VIII, as well as for correcting violations of coagulation factors in patients with liver diseases, the abolition of oral antikoagulyatntov.
FROM caution should use the drug in children.
Pregnancy and lactation
When using Replenina-WF during pregnancy and lactation complications were noted. Nonetheless, application of the drug during pregnancy is possible only in the case, when the intended benefits to the mother outweighs the potential risk to the fetus and newborn.
Cautions
For dilution of the drug should be used sterile water for injection.
When administered to patients drugs, prepared from human plasma, can not completely exclude the risk of infection is not yet known, or known viruses. To reduce the risk of infection is carried out under strict control of the selection of blood donors.
Besides, during production Replenin WF-pass 2 special step to remove viruses:
1. Solvent / detergent treatment, HIV destroys, HBV, HCV.
2. Special viral filtration to remove such viruses, as VGA and parvovirusy.
Nonetheless, human blood products can not be fully guaranteed by the presence of these viruses, so the manufacturer recommends before treatment to make the patient vaccinated against hepatitis A and hepatitis B.
When using low factor IX preparations purification (prothrombin complex concentrate) there have been cases of thromboembolism. At present, clinical experience shows, that when applying preparations of high purity factor IX, which is the Replenin-WF, this risk is greatly reduced. But, This potential risk should be considered when assigning Replenina-VF patients with heart disease, liver, after a recent surgery, if history were cases of thrombosis or embolism, or have reason to fear blood clots or extensive bruising.
In the case of allergic reactions or anaphylactic reactions, should immediately stop administering the drug and, if necessary, to carry out anti shock therapy.
Some patients with a congenital deficiency of Factor IX after treatment may form antibodies thereto. This can lead to inefficiency of the drug. If you suspect the presence of antibodies to factor IX should be analyzed for their identification, especially before the proposed operation.
You should check the level of factor IX in the blood before and after treatment, especially during the first year.
Do not use a solution of the drug in the presence of its mechanical parts, floc, If dilution of the drug forms a gel or clot.
Do not use the drug in violation of the integrity of the packaging or storage conditions.
Use in Pediatrics
It is with the utmost care to prescribe a drug for children.
Effects on ability to drive vehicles and management mechanisms
It is not known about the influence of the drug's ability to operate a vehicle or any other mechanisms.
Overdose
Reported cases of overdose were reported.
Drug Interactions
Until now there has not been any drug interactions with other drugs.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 3 year.
