Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue.
1 f.
coagulation factor VIII 1240-1700 IU
Excipients: albumin, polyethylene glycol, histidine, glycine, mouse protein (not more than 0.1 ng / 1 IU of factor VIII), organic solvent (tri-n-butyl phosphate), detergent (octoxylol 9).
Solvent: water d / u - 10 ml
bottles (1) complete with a solvent (fl.), a double-sided needle, a needle with a filter - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white illy white with a yellowish hue.
1 f.
coagulation factor VIII 220-450 IU
Excipients: albumin, polyethylene glycol, histidine, glycine, mouse protein (no more than 0.1 ng / 1 MU of factor VIII), organic solvent (tri-n-butyl phosphate), detergent (octoxylol 9).
Solvent: water d / u - 10 ml.
bottles (1) complete with a solvent (fl.) and needles d / dissolution and injection (two-sided needle, needle with a filter) - packs cardboard.
30 ml - bottles (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue.
1 f.
coagulation factor VIII 451-849 IU
Excipients: albumin, polyethylene glycol, histidine, glycine, mouse protein (not more than 0.1 ng / 1 IU of factor VIII), organic solvent (tri-n-butyl phosphate), detergent (octoxylol 9) ..
Solvent: water d / u - 10 ml
bottles (1) complete with a solvent (fl.), a double-sided needle, a needle with a filter - packs of cardboard.
Solvent: water d / u - 10 ml
30 ml - bottles (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue.
1 f.
coagulation factor VIII 850-1240 IU
Excipients: albumin, polyethylene glycol, histidine, glycine of mouse protein (not more than 0.1 ng / 1 IU of factor VIII), organic solvent (tri-n-butyl phosphate), detergent (octoxylol 9) ..
Solvent: water d / u - 10 ml
bottles (1) complete with a solvent (fl.), a double-sided needle, a needle with a filter - packs of cardboard.
Solvent: water d / u - 10 ml
30 ml - bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Factor VIII is a normal plasma protein necessary for blood clotting. Its IV administration increases the level of factor VIII in plasma and provides a temporary correction of the defect of the hemostasis system in patients with haemophilia A. Introduction Hemofil M also corrects the disorders caused by the inhibitors to factor VIII, in cases when the inhibitor titer does not exceed 10 Bethesda Units ) for 1 ml.
PHARMACOKINETICS
T 1/2 hemophilus M, administered to patients with factor VIII deficiency, is 14.8 В± 3 hours.
INDICATIONS
- treatment and prevention of haemorrhagic episodes in hemophilia A;
- Acquired coagulopathies with inhibitors to factor VIII with a titer of inhibitors of no more than 10 BYU per 1ml.
DOSING MODE
On the vial with the preparation Hemofil M the specific activity of factor VIII, expressed in International Units per vial, is indicated. Activity is measured in accordance with the International Standard of WHO.
The expected level of elevation of factor VIII in vivo, expressed in IU / 100 ml of plasma or in percentage (%), can be calculated by multiplying the single dose of the drug (in IU / kg body weight) by 2. The calculation is based on empirically obtained data that when the drug is administered from the calculation of 1 IU of factor VIII per kg of body weight, the level of factor VIII in plasma rises by 2 IU / 100 ml, or 2%.
Example:
1) The dose in 1750 ME, administered to a patient with a body weight of 70 kg, i.e. 25 IU / kg (1750/70), should cause an increase in the level of factor VIII to 25 x 2 = 50 IU / 100 ml, or up to 50%.
2) In a child with a body weight of 40 kg, the level of activity of factor VIII, equal to 70%, can be achieved by administering a dose of 70/2 x 40 = 1400 IU.
The drug after the preparation of the solution is injected iv slowly at a rate of up to 10 ml / min.
Table of recommended doses of the drug.
The doses of the drug should be monitored by a doctor. The table can serve as an auxiliary guide.
Severity of hemorrhagic syndrome Factor VIII activity in plasma necessary to achieve hemostasis (in% or IU / 100 ml of plasma) Frequency of administration
Beginning hemarthrosis, bleeding in soft tissue or bleeding from the oral mucosa 20-40 Every 12-24 hours for 1-3 days before resorption of hemorrhage or stop bleeding
Severe hemarthrosis, bleeding, or soft tissue hematoma 30-60 Every 12-24 hours for 3 days or more until the pain disappears and the movements recover
Life threatening bleeding: intracranial, internal cavity, bleeding from the larynx and others 60-100 Every 8-24 hours before the bleeding stops
Small surgical interventions, incl. tooth extraction 60-80 Approximately in 70% of cases, a single administration of the drug is sufficient in combination with oral administration of antifibrinolytic agents
Large surgical interventions 80-100 (pre- and postoperatively) Repeated administration every 8-24 h until wound healing
Other dosage regimens are also proposed, for example, continuous maintenance therapy.
Although the dose can be determined based on the above calculations, it is strongly recommended, where possible, to conduct regular laboratory studies of the patient's plasma at regular intervals to monitor the level of factor VIII in the patient. Thus, it is monitored whether the desired level of factor VIII is achieved and whether it is maintained at a predetermined level.
Especially important is the careful monitoring of the ongoing replacement therapy in cases of large surgical interventions or life-threatening bleeding.
Preparation of the drug solution
1. Heat the flasks with dry Hemofil M concentrate and the solvent (sterile water for injection) to room temperature.
2. Remove the protective caps from the vials with concentrate and solvent and expose the rubber stoppers.
3. Treat the plugs with a bactericidal solution.
4. Remove the protective cap from one end of the double-sided needle and pierce the stopper of the solvent vial with this end of the needle.
5. Remove the protective cap from the other end of the double-sided needle. Turn the vial with the solvent over and quickly pierce the center of the vial with Hemofil M. with the free end of the needle. By vacuum, the solvent will flow into the vial with the drug.
6. Disconnect the vials by removing the needle from the vial plug with the solvent, and then remove the needle from the vial with the drug. Gently shake the bottle until the drug dissolves completely. Make sure that the entire preparation is completely dissolved, otherwise it will remain on the filter when injected.
Prepared solution does not cool.
Administration of the drug
I / in at room temperature not later than 3 hours after the preparation of the solution.
IV injection with syringe
Before introduction, inspect for any discoloration or foreign matter in the solution.
It is recommended to use plastic syringes, because When using this type of medication, the inner surface of glass syringes usually becomes sticky.
1. Attach the filter needle to the disposable syringe and pull the plunger toward yourself to draw air into the syringe.
2. Insert the needle into the bottle with the prepared solution of Hemophilus M.
3. Insert air into the vial, and then draw the solution into the syringe.
4. Remove the needle filter from the syringe, put a suitable needle on it and enter the IV preparation, as recommended further.
5. If the patient needs to enter more than 1 bottle of Hemophilus M, the contents of the vials can be typed in 1 syringe. As a result, the loss of the drug is reduced. In this case, the contents of each vial should be typed through a separate unused needle filter.
1 needle-filter is designed to set the contents of only 1 bottle
The rate of administration
Haemophil M can be administered at a rate of up to 10 ml / min without significant adverse reactions.
Before and after the administration of the drug should determine the pulse rate. If the pulse rate is significantly increased, a decrease in speed or suspension of the drug administration usually allows you to quickly eliminate these symptoms.
SIDE EFFECT
When using Hemophil, allergic reactions can be noted. Patients should be informed of early symptoms of hypersensitivity, such as urticaria, rash, chest tightness, stridor breathing, lowering blood pressure and anaphylaxis, when it is recommended that the drug be discontinued.
Despite the presence of traces of mouse protein in Hemophilus M (less than 0.1 ng per 1 MEA VIII), no antibodies to the murine protein have been detected.
There are reports of single episodes of the appearance in patients of chest tightness, nausea and taste disturbance at the time of drug administration.
The protein contained in the preparation in the highest concentration is albumin. Reactions to the administration of albumin are very rare, although nausea, fever, chills, or skin rashes may occur.
CONTRAINDICATIONS
- lactation period;
- pregnancy
- Hypersensitivity to mouse protein.
PREGNANCY AND LACTATION
Studies of the influence of Hemofil M on reproductive function in animals have not been conducted. It is not known whether the drug can cause fetal damage when administered to a pregnant woman or disrupt reproductive function. Prescribe during pregnancy on strict indications. Contraindicated during lactation.
SPECIAL INSTRUCTIONS
Hemophilus M should be given only with a confirmed diagnosis of factor VIII deficiency. Do not expect a positive effect from the appointment of the drug in the presence of a deficit of other factors.
The production technology of Hemofil M significantly reduces the content of group-specific antibodies in the final preparation.
Hemophilus M is produced from human plasma.
All drugs prepared from human plasma can contain infectious agents, for example, viruses, which can lead to the development of the disease. The risk of transmission of infectious agents with such drugs is maximally reduced as a result of screening donors for previously transferred ones and testing for the presence of current viral infections, as well as technological processes for the removal and / or inactivation of viruses, but it can not be completely ruled out.
Studies have shown that the solvent-detergent treatment of Hemofil M in the production process leads to the inactivation of lipid-containing viruses such as hepatitis B virus and human immunodeficiency virus, and has virtually no effect on anti-hemophilic activity. The effectiveness of Method M in viral inactivation was demonstrated in vitro both for shell and non-enveloped viruses.
Clinical studies on the use of Hemophil M in patients who had not previously received antihemophilic drugs (PUPs) showed that patients had no evidence of hepatitis A or B in the follow-up period up to 9 months.
Some viruses, such as parvovirus B19 or hepatitis A, are extremely difficult to remove or inactivate. Parvovirus B19 can cause serious complications in pregnant women and in persons with impaired immunity.
Because this drug is produced from human blood, there is a risk of transmission of infectious agents, for example, theoretically, the causative agent of Creutzfeldt-Jakob disease.
All diseases detected by the doctor and, possibly, caused by this drug to inform the manufacturer.
The patient should be informed of the possible risk and benefits of therapy with this medication.
Although the dose can be determined based on the above calculations, it is strongly recommended, where possible, to conduct regular laboratory studies of the patient's plasma at regular intervals to monitor the level of factor VIII in the patient. Thus, it is monitored whether the desired level of factor VIII is achieved and whether it is maintained at a predetermined level. If the activity of factor VIII in the patient's plasma does not reach the desired level, or the bleeding is not controlled, despite the sufficient dose of the drug, the presence of inhibitors should be suspected.
Special laboratory methods can detect the presence of inhibitors and quantify them.
If the inhibitor titer is low (<10 Unit Design / ml), then after the introduction of factor VIII in an amount sufficient to neutralize the inhibitors, an additional amount of factor VIII will have a predictable effect.
DRUG INTERACTION
It is not known.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store at a temperature of 2 В° C to 30 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 30 months. Do not use after expiration date
