Immunoro Kedrion (Immunorho Kedrion)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceImmunoglobulin human antiresus Rho (D)Immunoglobulin human antiresus Rho (D)
Similar drugsTo uncover
  • HyperROU® S / D
    solution w / m 
    Grifols Therapyutics Inc.     USA
  • Immunoro Kedrion
    lyophilizate w / m 
    Kedrion SpA     Italy
  • KAMROU
    solution w / m 
    Kamada Co., Ltd.     Israel
  • Partobulin SDP
    solution w / m 
    Baxter AG     Austria
  • Rezogam® H
    solution w / m in / in 
    CESEL Behring AG     Switzerland
  • Resonative
    solution w / m 
    Octapharma AB     Sweden
    • Dosage form: & nbsplyophilizate for the preparation of a solution for intramuscular injection
    Composition:

    Component name

    Content in 1 ml reconstituted drug solution

    Active substance:

    Proteins of human plasma, containing not less than 90% of immunoglobulins, including

    human immunoglobulin antiresus Rho(D)


    25-180 mg


    150 μg (750 IU)

    Excipients:

    Glycine

    Sodium chloride

    Water for injections

    22.5 mg

    9.0 mg

    up to 1 ml

    Description:

    Lyophilisate of white or light yellow color. After reconstitution, an opalescent colorless or light yellow solution.

    Solvent (water for injections) is a clear, colorless liquid.

    Pharmacotherapeutic group:Immunoglobulins
    ATX: & nbsp

    J.06.B.B.01   Immunoglobulin human antiresus Rho (D)

    Pharmacodynamics:

    The active component of the drug is specific antibodies against the Rho (D) -antigen of human erythrocytes.The drug prevents isoimmunization in the Rh-negative organism of a woman, as a result of the fetal blood flow into the mother's bloodstream at the birth of a Rh-positive child, with spontaneous and artificial abortion, in the case of an amniocentesis or in injuries to the abdominal organs during pregnancy.

    Anti-D immunoglobulins are polyclonal immunoglobulins, the mechanism of action of which is to neutralize the Rho (D) antigens present in the Rh-positive embryo blood. The effective period of the drug is an average of 48 to 144 hours, with the highest concentration of human immunoglobulin Rhres (D) antiresus achieved on average 56 hours after drug administration.

    The preparation is an immunologically active protein fraction isolated from the virus-inactivated human plasma, tested for the absence of antibodies to human immunodeficiency viruses (HIV-1, HIV-2), hepatitis C virus and the surface antigen of the hepatitis B virus.

    Pharmacokinetics:The detectable antibody concentration is reached in the blood approximately 20 minutes after intramuscular injection of the drug.The maximum concentration of antibodies in the blood plasma is usually achieved 2-3 days after the injection. The half-life of human immunoglobulin Rhres (D) antiresus is individual, equal to that of human immunoglobulin normal and is 3-4 weeks. Immunoglobulin and its complexes are destroyed in the cells of the reticuloendothelial system.
    Indications:

    Prevention of anti-D (Rho) immunization in Rh-negative women (Rho (D)), not sensitized to Rho (D) -antigen, and in women with low-positive rhesus blood (Du), during pregnancy and the birth of a Rh-positive child . The drug is used for artificial and spontaneous termination of pregnancy in Rh-negative women who are not sensitized to Rho (D) -antigen, in the case of Rh-positive blood of the father, as well as in amniocentesis, external turn on the head, trauma of the abdominal cavity, prenatal bleeding , ectopic pregnancy and a sample of the villous chorion.

    Prevention of anti-D (Rho) immunization in Rh-negative patients after incompatible transfusion of Rh-positive blood or erythrocyte concentrates.

    Contraindications:

    Hypersensitivity to the components of the drug.

    The administration of the drug is contraindicated to Rh-positive women, as well as Rh-negative women, sensitized to Rho (D) -antigen, in the serum of which Rh-antibodies are found. The drug is not allowed to be administered to newborns.

    Pregnancy and lactation:This drug is used during pregnancy and within 72 hours after childbirth. There were no harmful effects on the course of pregnancy, fetus or newborn.
    Dosing and Administration:

    The drug solution is administered intramuscularly.

    Postpartum prevention. 1000 - 1500 IU (200-300 μg) is recommended as the optimal standard dose without preliminary testing for infiltration into the bloodstream of the mother of fetal hemoglobin (HbF) by the method of Kleihauer-Betke. The drug is administered to the mother as soon as possible after delivery, but no later than 72 hours.

    Prenatal and postnatal prophylaxis. The first dose of 1000 - 1500 IU (200 - 300 mkg) at the 28th week of pregnancy. The next dose of 1000 - 1500 IU (200 -300 μg) is administered within 72 hours after childbirth if the child was born resusively.

    After abortion, ectopic pregnancy, or bladder drift. During the first 72 hours after the intervention, the drug is administered at a dose of 600 to 750 IU (120 to 150 μg) until the 12th week of pregnancy; 1250 - 1500 IU (250-300 mcg) after 12 weeks of pregnancy; 1250 - 1500 IU (250-300 mcg) after amniocentesis or chorionic biopsy.

    After an incompatible transfusion of Rh-positive blood. 500 IU - 1250 IU (100 - 250 μg) for every 10 ml of transfused blood for several days.

    In the case of pathology of the coagulation system, when intramuscular administration of drugs is contraindicated, human immunoglobulin antiresus Rho(D) can be administered subcutaneously. After injection, place a compress on the injection site carefully. If a larger total dose (more than 5 ml) is required, it is recommended to divide it into smaller doses and inject into different places.

    Preparation and administration of the drug solution.

    Warm the vial with the lyophilisate of the preparation and the ampoule with the solvent to room temperature or body temperature. Collect the contents of the ampoule with the solvent in the injection syringe, remove the protective cap from the rubber bottle stopper with lyophilizate and slowly introduce the solvent into the vial; gently shake the vial with solution or wait until the lyophilizate is completely dissolved; draw the solution into the syringe; replace the needle and inject.

    Incomplete dissolution of the lyophilizate leads to a loss of activity of the preparation. Do not use if the solution is cloudy or contains sediment. Lyophilizate from the opened vial should be restored and used immediately. Residue the drug to destroy.

    Side effects:At the injection site, soreness may occur. This can be avoided if a large volume solution is administered in several doses of less than 5 ml in several different places. Fever, skin reactions and chills are not observed often. Rarely, dyspeptic phenomena such as nausea and vomiting, as well as lowering blood pressure, tachycardia, allergic or anaphylactic reactions occur. When the first symptoms of anaphylactoid reactions develop, anti-shock therapy is performed with antihistamines, alpha-adrenomimetics and glucocorticosteroids.
    Overdose:No cases of overdose have been reported.
    Interaction:

    Immunoglobulin human antiresus Rho (D) can not be mixed with other drugs.

    Reduces the activity of weakened live vaccines against measles, rubella, mumps, chicken pox for a period of up to 3 months.

    Special instructions:

    Do not use intravenously because of the potential for shock. The introduction should be intramuscular. In order to avoid getting the drug into the blood vessels, it is necessary to pull the syringe plunger toward yourself before starting the injection and check if there is blood in the syringe. The true allergic reactions to the intramuscularly introduced human immunoglobulin Rhres (D) antiresus are rare.

    Immunoglobulin intolerance develops in very rare cases of immunoglobulin A deficiency (IgA) when the patient has antibodies against IgA.

    Patient follow-up is continued for 30 to 60 minutes after the injection. The drug is immediately discontinued if you suspect an allergic or anaphylactic reaction. In case of shock development, anti-shock therapy is used.

    After the introduction of immunoglobulin, a passive increase in the antibody content in the patient's blood can occur, which can lead to erroneous false positive interpretation of the results of serological testing. The introduction of human immunoglobulin Rhre (D) antiresus significantly influences the assays such as the determination of antibodies and blood groups, including the Coombs test and an antiglobulin test.

    Viral safety. When manufacturing medicines from human blood or plasma, a set of measures is used to prevent possible transmission of infection to patients. These measures include careful selection of healthy donors, ensuring the elimination of the risk of infectious infection of donors, as well as monitoring the blood of each donor and the total pool of plasma for the absence of viruses and infections. Each plasma unit used to manufacture the drug is tested for the absence of a surface antigen of the hepatitis B virus and antibodies to human immunodeficiency viruses (HIV-1, 2), to hepatitis C virus. Each pool of plasma is also monitored for the absence of HCV RNA by polymerase chain reaction. To produce the drug, only that plasma is used that gives negative results for all of the above tests. The production of human blood products also includes stages in the production of blood or human plasma to allow inactivation or removal of viruses. Despite this, with the use of medicines made from human blood or plasma, the probability of transmission of infection can not be completely excluded,including, unknown or new viruses and other infectious agents.

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

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intramuscular injection of 300 μg (1500 IU).

    Solvent (water for injection) 2 ml each.

    Packaging:

    Lyophilizate for the preparation of a solution for intramuscular injection of 300 μg (1500 IU) in a bottle of transparent neutral glass of hydrolytic class 1, sealed with a halobutyl stopper and wound with an aluminum cap with a protective plastic cover with a control of the first opening.

    Solvent (water for injection) 2 ml each in an ampoule of transparent neutral glass of hydrolytic class 1.

    1 vial with lyophilizate, 1 ampoule with a solvent and instruction on the use of the drug in a cardboard bundle.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep the drug out of the reach of children.

    Shelf life:

    3 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007741/10
    Date of registration:06.08.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Kedrion SpAKedrion SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspCEDRION SpA CEDRION SpA Italy
    Information update date: & nbsp07.11.2017
    Illustrated instructions
      Instructions
      Up