Prevention of Rh (D) immunization in Rh (D) negative women - pregnancy / childbirth Rh (D) -positive. For postpartum administration, during pregnancy and after removal of the fetus beyond 12 weeks of gestation, in threatening unborn or premature delivery, after diagnostic amniocentesis above 12 weeks of pregnancy.
Composition:
1 ampoule contains a concentrate of human anti-D 50 μg or 150 μg of anti-D globulin.
Action:
The preparation is a human immunoglobulin concentrate with a high content of anti-D IgG. Passive immunization with anti-D immunoglobulin prevents Rh (D) immunization in more than 99% of cases, provided a sufficient dose of anti-D immunoglobulin is given early after exposure to Rh (D) -positive red fetal cells. The 50 μg dose protects against the immunizing action about 2.5 ml of Rh positive blood cells, and the 150 μg dose protects against the immunizing action of about 7 ml of Rh positive blood cells. The preparation given to a woman intramuscularly up to 72 hours after delivery or after miscarriage, prevents the production of anti-D antibodies, and thus prevents the occurrence of haemolytic disease in newborns in the Next pregnancy. The mechanism of inhibiting the immunization of Rh (D) -positive erythrocytes may be associated with the release of red blood cells from the circulation before they reach an immunocompetent location or it may be more related to the mechanism of formation of immune complexes by recognizing foreign antigen and its presentation by appropriate cells in the right place in the presence of or the absence of an antibody. After intramuscular administration, detectable antibody titers are observed after approximately 4 hours. The maximum titer usually occurs after 5 days. T0,5 in the recipient's circulation with normal IgG level is 2 weeks.
Contraindications:
Hypersensitivity to any of the ingredients. Do not administer intravenously. Do not give to newborns. Do not give Rh (D) positive.
Precautions:
Patients should be observed at least 20 minutes after administration. If signs of anaphylactic reaction appear, the drug should be immediately discontinued and appropriate medical treatment should be instituted. When medicines prepared from human blood or plasma are administered, the risk of transmission of infectious agents, including pathogens and unknown viruses, can not be totally excluded. This risk is reduced by: selection of donors based on clinical history, testing of a single donor plasma unit and pool of plasma for the presence of HBs antigen, anti-HIV and HCV; plasma pool testing for the presence of HCV genetic material; the method used to inactivate / remove viruses in the production process, validated with the use of model viruses. Measures that are considered effective relate to enveloped viruses such as HIV, HBV and HCV, but may be of limited importance for non-enveloped viruses such as HAV and / or parvovirus B19. There is clinical experience that the hepatitis A virus and parvovirus B19 are not transmitted when immunoglobulins are used. It is also suspected that the presence of antibodies plays an important role in the virological safety of the preparation.
Pregnancy and lactation:
The preparation is used during pregnancy and can be used during breast-feeding.
Side effects:
You may experience: pain and tenderness at the injection site. Rarely: fever, malaise, headache, skin reactions, chills. In isolated cases: nausea, vomiting, hypotension, tachycardia, allergic and anaphylactic reactions characterized by dyspnoea and symptoms of shock, even when the patient did not show hypersensitivity reactions after the previous administration of the preparation.
Dosage:
Intramuscularly. Gamma anti-D 50: 1 dose is given up to 12 weeks of pregnancy in the period of 48 h, at the latest up to 72 h - after spontaneous abortion, termination of pregnancy, removal of ectopic pregnancy. Gamma anti-D 150: the preparation is given in 48 h and 72 h in the following states - 1 dose is given after a physiological delivery, after removal of the fetus beyond 12 weeks of pregnancy, in threatened unborn or premature delivery, after diagnostic amniocentesis above 12 weeks.pregnancy; 2 doses are given after a pathological delivery, e.g. caesarean section, manual extraction of the placenta, after the birth of a dead fetus; many doses are given after multiple births; 2-3 doses are given after the fetus has been bled into the mother's bloodstream (it is advisable to determine the amount of transplacental leakage and appropriate dose selection); moreover, 2 doses are given once in the 28th week of pregnancy to Rh-negative women, in whom anti-D antibodies are not detected by the papain and anti-globulin test. In the case of coagulation disorders, when intramuscular administration is contraindicated, the preparation can be administered subcutaneously. If a high-dose intramuscular preparation (above 5 ml) is required, it is possible to administer it in divided doses to various sites.
(C)
