Partobulin SDP (Partobulin SDF)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceImmunoglobulin human antiresus Rho (D)Immunoglobulin human antiresus Rho (D)
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    • Dosage form: & nbspSolution for intramuscular injection 1250 IU / ml.
    Composition:1 ready-to-use syringe with 1 ml Partobulin SDP contains:
    Human immunoglobulin antiresus Rho (D) 1250 IU (250 μg)
    in the form of total protein from 100 to 170 mg
    Glycine 22.5 mg
    Sodium chloride 3.0 mg
    Macrogol (polyethylene glycol) 8.0 mg
    Water for injection up to 1.0 ml
    Description:Transparent or slightly opalescent, colorless or pale yellow solution.
    Pharmacotherapeutic group:MIBP is a globulin.
    ATX: & nbsp

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

    Pharmacodynamics:Partobulin SDP is a human immunoglobulin antiresus Rh0(D), which prevents rhesus sensitization in the Rh (D) -negative body when Rh (D) -positive blood acts on it.

    Pharmacokinetics:Antibodies are detected in the plasma no later than 24 hours after intramuscular injection. The maximum concentration of antibodies in the plasma is established 2 days after the administration (average antibody titer of 1:32), which persists for up to 7 days.
    The period of ionulovleniya partobulin from the blood flow in patients with normal levels of IgG is an average of 23.4 days. IgG and IgG-containing immune complexes undergo decomposition in the cells of the reticuloendothelial system.
    Indications:1. Prevention of Rhesus Immunization in Rh-negative Women
    - Pregnancy / childbirth with Rh-positive fetus.
    - Abortion / threatening abortion, ectopic pregnancy, bladder skidding.
    - Placental bleeding that occurs with amniocentesis, chorion biopsy, obstetric manipulation (eg, external obstetric turn), as well as prenatal bleeding.
    2. Treatment with Rh-negative Rh-positive blood transfusion or erythrocyte mass.
    Contraindications:Hypersensitivity to any component of the drug.
    Partobulin SDP is not prescribed to Rh-positive pregnant women, as well as Rh-negative pregnant women, sensitized to the Rh antigen0(D), in the serum of which Rhesus antibodies were detected.
    It is not allowed to administer the drug to a newborn.
    Pregnancy and lactation:The drug is used in pregnancy.
    Dosing and Administration:Prenatal prophylaxis:
    Enter 1,250 IU at 28 weeks of gestation. In some cases, the earlier initiation of prevention is justified.
    Postnatal prevention
    If it is determined that the newborn is Rh-positive, 1250 ME should be administered no later than 72 hours after the birth.
    The recommended standard dose is 1250 ME, which should be administered as soon as possible after delivery, no later than 72 hours.
    If there is a suspicion of extensive placental bleeding, its volume should be determined by available methods and an additional dose of immunoglobulin antiresus is introduced.
    Ectopic pregnancy, bladder skidding, abortion:
    Pregnancy up to 12 weeks:
    It is recommended to enter 1250 ME within 72 hours after the termination of pregnancy.
    Pregnancy over 12 weeks:
    It is recommended to enter 1250 MB within 72 hours after the termination of pregnancy.
    Amniocentesis, chorionic biopsy:
    It is recommended to administer 1250 ME within 72 hours after the diagnostic procedure.
    Macrotransfusion (more than 4 ml of fetal blood)
    1250 ME per 1 ml of the mother of Rh rhesus-lodged fetal blood.
    Transfusion of Rh-incompatible blood or erythrocyte mass:
    In the case of whole blood transfusions, the volume of incoming erythrocytes is calculated by multiplying the volume of transfused Rh-positive blood into the donor's hematocrit.For every 10 ml of Rhesus-positive red blood cells transfused during transfusion, the patient should receive a single dose of 1,250 IU (250 μg) no later than 72 hours after transfusion.
    These measures should be taken (without the prior exchange transfusion) only if the red blood cells transfused to the patient of Rh-positive blood make up less than 20% of all circulating red blood cells in his blood.
    Mode of application
    Partobulin SDP should be administered slowly by deep intramuscular injection.
    When hemorrhagic disorders, when intramuscular injections are contraindicated, partopulin SDP can be injected subcutaneously. Place the injection should be gently massaged and put a compress.
    If a large dose is prescribed (> 5 mL), it is advisable to insert it in portions into different parts. This should be done no later than 72 hours after the event associated with the use of this drug.
    Rules for handling the drug:
    The drug should be heated to room temperature or body temperature before use.
    Usually the solution is transparent or slightly opalescent. The drug can not be administered if the solution is cloudy or there are inclusions in it.
    The unused remnant of the drug, the syringe and the residual waste after the injection must be discarded.
    Side effects:There is a local soreness in the injection site. Sometimes there is fever, malaise, headache, skin reactions, chills. In rare cases: nausea, vomiting, hypotension, tachycardia; there are reports of the possibility of developing allergic or anaphylactic reactions, including breathing and shock, even in cases where hypersensitivity reactions were not noted in response to previous administration of the drug.
    Overdose:Cases of overdose are not described. In case of an overdose of anti-Rh0 (D) immunoglobulin, as well as during transfusion of Rhesus-incompatible blood, it is necessary to provide constant medical monitoring of the clinical condition of patients and laboratory parameters due to the possibility of developing a hemolytic reaction.
    Interaction:Active immunization with live viral vaccines should be postponed to 3 months after the last use of anti-Rh0 (D) immunoglobulin, since it is possible to reduce the effectiveness of vaccination.
    After the introduction of immunoglobulin, a temporary increase in the level of various antibodies is possible.This can lead to false positive results when using serological diagnostic methods.
    The results of blood group tests, as well as antibody tests (including Coombs' reaction, or an antiglobulin test) change markedly against the background of the use of anti-Rh0 (D) immunoglobulin.
    Partobulin should not be mixed with other drugs. It should be administered as a separate injection.
    Special instructions:Do not administer intravenously due to a shock hazard.
    When using the drug for postpartum prophylaxis, it should be administered only to the mother. It is not allowed to administer the drug to a newborn.
    When Partobulin SDP is administered, the patient should be observed for at least 20 minutes.
    If a hypersensitivity reaction appears during the administration of Partobulin SDP, the injection should be stopped immediately.
    True hypersensitivity reactions are rare, but the patient should be warned about possible allergic reactions, including such as hives, generalized urticaria rash, chest tightness, dyspnea, hypotension and anaphylactic reaction. The intensity of therapy of the phenomenon depends on the nature of the side effect and its severity.Minor allergic manifestations can be treated with antihistamines. In the case of shock, you should act in accordance with the currently established rules for treating shock.
    Partobulin SDP contains a small amount of IgA. Although anti-Rh0 (D) Immunoglobulin has been successfully used in individuals with IgA deficiency, the physician should assess the relationship between the risk of developing hypersensitivity reactions and the benefits of therapy.
    Special Precautions
    With the introduction of drugs prepared from human blood or plasma, the possibility of transmitting infectious agents can not be completely ruled out. This also applies to pathogens of unknown nature. However, the risk of transmission of infectious agents is reduced due to the following measures:
    - Selection of donors based on the medical examination and screening of blood or plasma donated by each donor to HbsAg and antibodies to viruses (HIV +) of the 1st and 2nd type and hepatitis C.
    - Testing of plasma pools for the presence of genomic material of hepatitis B and C viruses, viruses (HIV +) of the 1 st and 2 nd type and parvovirus B19.
    - In the production process, the methods of inactivation and removal of HIV viruses of the 1st and 2nd type, hepatitis A, B, C and parovirus B19 viruses are used.
    It is recommended, whenever possible, every time you use partobulin SDP to register the series and number of individual package of the drug in the patient's medical history.
    Effect on the ability to drive transp. cf. and fur:There is no impact on the ability to drive and move vehicles.
    Form release / dosage:Solution for intramuscular injection 1250 IU / ml.
    Packaging:In a transparent glass syringe with a needle protected by a rubber cap that is packed in a PET blister sealed with paper, laminated with a polymer. 1 syringe, ready for use, together with instructions for use, placed in a cardboard box.
    Storage conditions:In the dark place at a temperature of 2 ° C to 8 ° C.
    freeze.
    Keep out of the reach of children.
    Shelf life:2 years.
    The drug should not be used if the expiration date indicated on the package has expired.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009449/08
    Date of registration:26.11.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Baxter AGBaxter AG Austria
    Manufacturer: & nbsp
    Representation: & nbspBaxter Baxter USA
    Information update date: & nbsp2016-12-15
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