Neohepatect (Neohepatect)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceHuman immunoglobulin against hepatitis BHuman immunoglobulin against hepatitis B
Similar drugsTo uncover
  • Antigope®
    solution w / m 
    MICROGEN FGUP Scientific and Production Association     Russia
  • Neohepatect
    solution d / infusion 
    Biotest Pharma GmbH     Germany
    • Dosage form: & nbspRAster for infusion.
    Composition:

    In 1 ml of solution contains:

    Active substance: proteins of human plasma 50 mg of them: immunoglobulin G * not less than 96%, immunoglobulin A (IgA) not more than 2 mg (4%).

    Antibody content against hepatitis B virus: 50 ME.

    Excipients:

    Glycine 300 μmol

    Water for injection up to 1 ml

    * Distribution of immunoglobulin subclasses G (IgG):

    IgG1 - 59%, IgG2 - 35%, IgG-3%, IgG4 - 3%.

    Description:

    Colorless or light yellow, transparent or slightly opalescent liquid.

    Pharmacotherapeutic group:immunoglobulin
    ATX: & nbsp

    J.06.B.B.04   Human immunoglobulin against hepatitis B

    Pharmacodynamics:

    Neohepatect is a preparation of immunoglobulin, which is made from a plasma of donors with a high titer of antibodies against hepatitis B.

    Distribution of immunoglobulin subclasses G corresponds to the distribution in the plasma of healthy donors.

    Pharmacokinetics:

    Bioavailability of Neohepatect at infusion is 100%. The distribution between plasma and extravascular fluid occurs rather quickly, the half-life of Neohepatect is on average 22 days. Immunoglobulin G and complexes IgG are utilized by the cells of the reticuloendothelial system.

    Additional information

    Standard measures for the prevention of infections due to the use of medicinal products prepared from human blood or blood plasma, including donor blood, include monitoring the blood of individual donors and plasma pools for specific markers and the inclusion in the production process of appropriate stages for inactivation / removal of viruses. Despite this, when using medicinal products prepared from human blood or plasma, it is impossible to completely exclude the possibility of transfer of infectious agents. This also applies to unknown or newly discovered viruses and other pathogens.

    The measures taken are considered effective against enveloped viruses, for example, human immunodeficiency virus, hepatitis B virus and hepatitis C virus, and have partial effectiveness against such non-enveloped viruses as hepatitis A virus and parvovirus B19. There is a positive clinical experience indicating that there is no transfer of hepatitis A virus or parvovirus B19 to immunoglobulins, and it is also assumed that the content of antibodies plays an important role in providing antiviral safety.

    It is strongly recommended that each time the patient is injected with the Neohepatect drug, record the name and number of the series of the drug so that the relationship between the patient and the drug series can be traced.

    Indications:

    1) Immunoprophylaxis of hepatitis B in newborns born from mothers who carry the surface antigen of the hepatitis B virus.

    2) Immunoprophylaxis of hepatitis B in:

    - Patients who are not vaccinated against hepatitis B or who do not have documented evidence of vaccinations and who are at risk of contracting hepatitis B virus because of contact with material suspected of being infected (for example, if the integrity of the skin is broken by injecting needle or direct contact with the mucosa).

    In such cases, the introduction of Neohepatect is recommended to be carried out simultaneously with vaccination against hepatitis B (simultaneous active and passive immunization). Vaccination thus initiated should be continued in accordance with the instructions for use of the vaccine.

    Introduction Neohepatect is not shown,if the patient who has been exposed to the hepatitis B virus has been vaccinated in the full scheme and he has developed a sufficient number of antibodies (minimum 10 IU / L of serum). If the amount of antibodies to HBs-antigen can not be determined within 24 hours after contact with the contaminated material, then in any case, combined prevention (vaccine and immunoglobulin) is necessary.

    The use of Neohepatect is indicated for persons with a tendency to bleeding, who require immediate prevention of hepatitis B, since the introduction of intramuscular drugs can lead to local hemorrhages.

    3) Patients with an increased risk of contracting hepatitis B virus before or at the same time as hepatitis B vaccination (before surgery, repeated blood transfusion, hemodialysis, etc.).

    4) Prevention of re-infection with hepatitis B virus in patients after liver transplantation in connection with hepatic insufficiency, induced by the hepatitis B virus.

    5) Patients who do not have an immune response (there is not enough AT for hepatitis B) after vaccination, and for whom ongoing prevention is needed because of the continuing risk of infection with the hepatitis B virus.

    Contraindications:

    Hypersensitivity to human immunoglobulin and other blood products, especially in rare cases of a deficiency in the blood of an immunoglobulin class A (IgA) and the presence of antibodies against IgA.

    Hypersensitivity to other components of the drug.

    Pregnancy and lactation:

    Safety of medicinal product during application during of pregnancy in controlled clinical trials is not established, so pregnant women should be used with caution. Clinical experience of the use of immunoglobulins indicates the absence of harmful effects of drugs on the course of pregnancy or on the fetus and newborns.

    Immunoglobulins are secreted with breast milk and can help protect newborns from pathogenic microorganisms.

    Clinical experience of the use of immunoglobulins indicates the absence of harmful effects of drugs on fertility.

    Dosing and Administration:

    Method of administration

    Before the introduction of Neohepatekta it is necessary to visually check the contents of the vial. The solution should be clear or slightly opalescent.An opaque or precipitating solution should not be used.

    Before use, the drug should be allowed to stand for several minutes at room temperature.

    Neohepatect is intended for intravenous infusion.

    The preparation is not subject to preliminary dilution.

    The initial infusion rate should be 0.1 ml / kg body weight / hour. If the drug is well tolerated after 10 minutes after the start of the injection, the rate can be gradually increased to 1 ml / kg body weight / hour.

    Clinical experience of Neohepatect in newborns born from mothers-carriers HBs-antigen, showed that the drug in a dose of 2 ml, administered for 5-15 minutes, is well tolerated.

    Do not mix Neohepatect with other medicines. Do not add any other drugs to the Neohepatext solution.

    The vial should be used immediately. Due to the risk of bacterial contamination, the unused residue of the drug is not subject to storage.

    Recommended dosages of the drug:

    If nothing else is assigned, the following is recommended:

    For the prevention of hepatitis B in newborns whose mothers are infected with the hepatitis B virus:

    Immediately after the birth of a child, 30-100 ME (0.6-2 ml) of Neohepatect per kg of body weight. Urgent vaccination against hepatitis B is recommended. The first injection of the vaccine can be carried out on the same day as the injection of Neohepatect, only in different parts of the body.

    For the prevention of hepatitis B in nonimmunized patients after exposure to a material suspected of containing hepatitis B virus:

    depending on the nature of the contact, at least 500 ME (10 ml) as soon as possible after contact, preferably for 24-72 hours.

    For prevention at a high risk of hepatitis B infection (for example, in hemodialysis units):

    administered once 8-12 ME (0.16-0.24 ml) / kg, maximum 500 ME (10 ml) every 2 months prior to the formation of seroconversion after vaccination.

    Patients who do not have an immune response (there is no measurable amount of antibodies to hepatitis B) after vaccination and who need constant prevention:

    a dose of 500 ME (10 ml) in the case of adults and 8 ME (0.16 ml) / kg in the case of children, every 2 months; The minimal prophylactic antibody titer is 10 mIU / ml.

    Prevention of reinfection with hepatitis B virus after liver transplantation caused by hepatitis B:

    Adults:

    10 000 ME per day perioperatively, then 2000-10000 ME (40-200 ml) / day for 7 days, and if necessary to maintain the level of antibodies above 100-150 IU / L in HBV-DNA-negative patients and above 500 IU / L in HBV-DNA-positive patients.

    Children:

    Dosage should be adjusted depending on the body surface area based on 10 000 IU / 1.73 m2.

    Side effects:

    Frequency of adverse events by WHO graduation:

    Very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1,000, <1/100), rarely (≥1 / 10,000, <1/1 000) , very rarely (<1/10 000), is unknown (it is impossible to estimate from available data)

    Classification of undesirable reactions in accordance with the damage to organs and organ systems (MedDRA)

    Undesirable reactions

    Frequency

    Immune system disorders

    Hypersensitivity

    Rarely

    Anaphylactic shock

    Rarely

    Disturbances from the nervous system

    Headache

    Rarely

    Heart Disease

    Tachycardia

    Rarely

    Vascular disorders

    Arterial hypotension

    Rarely

    Infringements from gastrointestinal tract

    Nausea, vomiting

    Rarely

    Disturbances from the skin and subcutaneous tissues

    Skin reactions, erythema, pruritus, pruritis

    Rarely

    Musculo-skeletal and connective tissue disorders

    Arthralgia

    Rarely

    General disorders and condition of injection site

    Increased fever, malaise, chills

    Rarely

    During the prevention of organ transplant infection, very rare cases of intolerance reactions are possible, which may be associated with an increase in the interval between injections. When applying Neogepatekt been cases of reversible aseptic meningitis, reversible haemolytic anemia / haemolysis, increase in serum creatinine and / or acute renal failure.

    Reported the occurrence of thromboembolic reactions in elderly patients, patients with cerebral or cardiac ischemia, and in patients with excessive weight or hypovolemic patients.

    Overdose:

    Clinical manifestations of an overdose are not known.

    Interaction:

    Do not add any other drugs to the solution of Neohepatect, since changing the electrolyte concentration or the pH value can lead to protein precipitation or denaturation.

    Live attenuated (attenuated) vaccines:

    At least for 6 weeks and 3 months after administration of immunoglobulins can reduce the effectiveness of live attenuated vaccines for viral diseases such as measles, rubella, mumps and varicella.Vaccination against these diseases should be carried out no earlier than after the occurrence of 3 months after the introduction of Neohepatect. The interval between the introduction of immunoglobulin and measles vaccine can be increased to 1 year. In this regard, patients who need to be vaccinated against measles should first be examined for the presence of specific antibodies.

    Special instructions:

    When using the drug Neoheppetect thromboembolic complications are possible. Therefore, caution is recommended, especially in patients with risk factors for thrombotic complications.

    Patients should be under regular supervision for the level of antibodies to HBs antigen of hepatitis B virus in the serum.

    Some undesirable reactions may occur more often if the infusion rate is too high and in patients with hypo or agammaglobulinemia deficient IgA or without it. Follow the recommendations in the section "Method of administration and dose".

    Specific allergic reactions occur rarely.

    Neohepatect contains IgA. In persons with a deficit IgA probably the formation of antibodies to IgA, and they can have anaphylactoid reactions.Before the introduction of Neohepathect, it is necessary to evaluate the relationship between the benefits of using the drug and the potential risk of hypersensitivity reactions.

    In rare cases, Neohepatect can cause a drop in blood pressure with an anaphylactoid reaction even in patients who previously tolerated treatment with Neohepatect.

    If suspected of an allergic or anaphylactic reaction, stop the injection immediately. In the event of shock, standard anti-shock therapy should be used.

    Effect on serological tests

    After injection of Neohepatekt, a temporary increase in various passively-tolerated antibodies in the patient's blood can lead to false-positive serological test results.

    Passive transfer of antibodies to erythrocyte antigens, for example, A, B, D, can distort the results of some serological tests for antibodies to red blood cells, for example, a direct antiglobulin test (DAT, a direct test of Coombs).

    Effect on the ability to drive transp. cf. and fur:

    There is no indication that the Neohepatect can affect the ability to drive or service machinery.

    Form release / dosage:RAster for infusion, 50 IU / ml.
    Packaging:

    For 2, 10, 40 ml of the drug in bottles of colorless glass, sealed with a stopper with an aluminum cap.

    One bottle in a cardboard box with instructions for use. The cardboard box is sealed from above with an intact self-adhesive film (first opening control).

    Storage conditions:

    The preparation is transported at a temperature of 2 to 8 ° C. Do not freeze.

    The drug is stored at a temperature of 2 to 8 ° C, in a dry, dark place.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015018 / 01
    Date of registration:25.11.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Biotest Pharma GmbHBiotest Pharma GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBIOTEST PHARMA GmbHBIOTEST PHARMA GmbHRussia
    Information update date: & nbsp03.12.2016
    Illustrated instructions
      Instructions
      Up