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Dosage form: & nbspsolution for intramuscular injection
Composition:

Active substance: immunoglobulin for protein - 10%

Excipient: stabilizer - glycine (aminoacetic acid) 2%, water for injection.

Description:

Transparent or slightly opalescent liquid, colorless or light yellow in color. The appearance of a slight precipitate, which disappears when shaken, is allowed.

Pharmacotherapeutic group:Immunoglobulin
ATX: & nbsp
  • Immunoglobulin human antiresus Rho (D)
  • Pharmacodynamics:

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

    The active component of the drug is immunoglobulin G, containing incomplete anti-Rho (D) -antibodies. The drug prevents rhesus sensitization (the formation of anti-Rho (D)-antibodies) during pregnancy in Rh-negative women who gave birth Rho (D)-positive children or undergoing an artificial termination of pregnancy Rho (D)-positive blood of the husband.

    Pharmacokinetics:

    The maximum concentration of antibodies in the blood after intramuscular injection of human immunoglobulinantiresus Rho (D) is reached after 24 hours, the half-life of antibodies from the body is 4-5 weeks.

    Indications:

    The drug is used only as directed by a doctor.

    Human immunoglobulin antiresus Rho(D) are used to prevent Rhesus-conflict in Rh-negative women who are not sensitized to the antigen Rho(D) (ie, those who did not develop Rh antibodies) provided: pregnancy and birth of a Rh-positive child, with artificial and spontaneous abortion, with the interruption of ectopic pregnancy, with the threat of abortion at any time, after an amniocentesis and other procedures associated with a risk of fetal blood flow into the mother's bloodstream, as well as in obtaining an abdominal injury cavity.

    Contraindications:

    Introduction of human immunoglobulin antiresus Rho(D) is contraindicated to Rh-positive puerperas; Rh-negative puerperas sensitized to the antigen Rho(D) (in the blood serum of which rhesus antibodies were detected).

    Dosing and Administration:

    Human immunoglobulin antiresus Rho(D) are used only intramuscularly.

    Before the injection, the ampoule with the drug is kept for 2 hours at room temperature (20 ± 2) ° C.To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. The drug in the opened ampoule is not subject to storage.

    One dose (300 μg) corresponds to 1 ml at a titer of antibodies of 1: 2000 or 2 ml at an antibody titer of 1: 1000.

    During pregnancy in Rh-negative women without sensitization phenomena non-specific desensitizing therapy is performed at a period of 10-12, 24-25, 32-33 weeks of gestation. Immunoglobulin human antiresus Rho (D) is administered at a single dose (300 μg) intramuscularly.

    When Rh (+) (positive Rh factor) of her husband's blood, the introduction of an immunoglobulin antiresus Rho (D) 300 μg intramuscularly with a period of 28-30 weeks.

    Repeated administration of immunoglobulin no later than 48-72 hours after delivery at the birth of a Rh-positive child.

    With the artificial termination of pregnancy At a gestation period of more than 13 weeks, a single dose of the drug (300 μg) is recommended. If the pregnancy is interrupted if the period is less than 13 weeks, it is recommended to enter 50 μg of the drug.

    When a trauma of the abdominal cavity during the second or third trimester of pregnancy it is recommended to enter one dose of the drug (300 μg).

    If a trauma to the abdominal cavity requires the administration of the drug at a period of 13-18 weeks of gestation, another dose (300 μg) should be administered with a gestation period of 26-28 weeks.

    Side effects:

    In rare cases, reactions may occur in the form of skin hyperemia at the site of administration and rise in temperature to 37.5 ° C during the first 24 hours after the administration, as well as dyspepsia.

    Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock, so those receiving the drug should be monitored for 30 minutes.

    In the room where the drug is administered, there should be antishock therapy.

    Interaction:

    Therapy with immunoglobulin can be combined with other drugs, in particular antibiotics.

    Special instructions:

    Immunization of women with live vaccines should be carried out no earlier than 3 months after the introduction of human immunoglobulin antiresus Rho(D).

    Do not administer intravenously.

    Form release / dosage:Solution for intramuscular injection, 300 μg / dose.
    Packaging:

    For 1.0 ml (300 μg) of the drug with an antibody titer of at least 1: 2000 or 2.0 ml (300 μg) at an antibody titer of 1: 1000 in ampoules.

    For 1 or 10 ampoules, together with the instructions for use and the ampoule knife are packed in a pack of cardboard box.

    Storage conditions:

    The drug is stored in a dry, dark place at a temperature of 2 to 10 ° C.

    Unsuitable for use drugs in ampoules with broken integrity or labeling, with a change in physical properties (discoloration, cloudiness of solution, the presence of non-flocculating flakes), expired, with improper storage.

    Keep out of the reach of children.

    Transportation is carried out by any kind of covered transport at a temperature of 2 to 10 ° C.

    Shelf life:

    3 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N003599 / 01
    Date of registration:28.10.2009 / 11.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:IVANOV REGIONAL STATION OF BLOOD TRANSFUSION IVANOV REGIONAL STATION OF BLOOD TRANSFUSION Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.11.2017
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