Composition, form of production and packaging
Lyophilizate for the preparation of solution for the / m introduction of white or light yellow color; solvent - clear, colorless liquid; the prepared solution is opalescent colorless or light yellow in color.
1 ml of finished r-ra
proteins of human plasma (containing not less than 90% of immunoglobulins) 25-180 mg,
in t.ch. immunoglobulin human antiresus Rh 0 (D) 150 Ојg (750 IU)
Excipients: glycine, sodium chloride.
Solvent: water d / u (up to 1 ml).
Glass vials (1) complete with a solvent (amp 2 ml 1 pc.) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Immunoglobulin. The active component of the drug is specific antibodies against human Rh 0 (D) -antigen. The drug prevents isoimmunization in the Rh-negative organism of a woman, as a result of the fetal blood flow into the bloodstream of the mother at the birth of a Rh-positive child, with spontaneous and artificial abortion, in the case of an amniocentesis or in injuring the abdominal organs during pregnancy.
Anti-D immunoglobulins are polyclonal immunoglobulins, the mechanism of action of which is to neutralize the Rh 0 (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, Rh 0 (D) antiresus is 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 hepatitis B surface antigen.
The determined value of the concentration of antibodies is reached in the blood approximately 20 minutes after the intravenous injection of the drug. C max antibodies in blood plasma are usually achieved 2-3 days after the injection.
T 1/2 of human immunoglobulin, the antiresus Rh 0 (D) is individual, equal to that of normal human immunoglobulin and is 3-4 weeks. Immunoglobulin and its complexes are destroyed in the cells of the reticuloendothelial system.
- the prevention of anti-D (Rh 0 ) immunization in Rh-negative women (Rh 0 (D)), not sensitized to Rh 0 (D) -antigen, and in women with R-positive blood (Du) in pregnancy and the birth of a Rh-positive child. The drug is used for artificial and spontaneous termination of pregnancy in Rh-negative women not sensitized to Rh 0(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 (Rh 0 ) immunization in Rh-negative patients after incompatible transfusion of Rh-positive blood or erythrocyte concentrates.
The solution of the drug is given in / m.
Postpartum prevention . 1000-1500 IU (200-300 Ојg) is recommended as the optimal standard dose without preliminary testing for infiltration into the bloodstream of the mother of fetal hemoglobin (HbF) by the Kleihauer-Betke method. The drug is administered to the mother as soon as possible after delivery, but not later than 72 hours.
Prenatal and postnatal prophylaxis . The first dose is 1000-1500 IU (200-300 Ојg) at the 28th week of pregnancy. The next dose of 1000-1500 IU (200-300 Ојg) is administered within 72 hours after childbirth if the child was born Rh-positive.
After abortion, ectopic pregnancy or bladder drift . During the first 72 hours after the intervention, the drug is administered at a dose of 600-750 IU (120-150 Ојg) until the 12th week of pregnancy; 1250-1500 IU (250-300 mcg) after 12 weeks of pregnancy; 1250-1500 IU (250-300 Ојg) after amniocentesis or chorionic biopsy.
After an incompatible transfusion of Rh-positive blood . 500 IU-1250 IU (100-250 Ојg) for every 10 ml of transfused blood for several days.
In the case of the pathology of the coagulation system, when IM is not contraindicated, human immunoglobulin Rh 0 (D) can be injected. 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
It is necessary to 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 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. Remains of the drug must be destroyed.
Local reactions: soreness at the injection site. This can be avoided if a large volume solution is administered in several doses of less than 5 ml in several different places.
Systemic reactions: infrequently - fever, skin reactions, chills; rarely - dyspeptic phenomena (nausea and vomiting), lowering blood pressure, tachycardia, allergic or anaphylactic reactions.
hypersensitivity to the components of the drug;
- Rhesus-positive and Rh-negative women sensitized to Rh 0 (D) -antigen, whose serum contains Rh antibodies;
PREGNANCY AND LACTATION
This drug is used during pregnancy and for 72 hours after childbirth. There were no harmful effects on the course of pregnancy, fetus or newborn.
You can not inject the drug in / in connection with the possibility of development of shock. The introduction should be in / m. 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 / m injected human immunoglobulin antiresus Rh 0 (D) are rare. With the appearance of the first symptoms of the development of anaphylactoid reactions, anti-shock therapy is performed with the use of antihistamines, alpha-adrenomimetics and GCS.
Intolerance to immunoglobulins develops in very rare cases of immunoglobulin A deficiency (IgA) when the patient has antibodies against IgA.
Patient follow-up is continued for 30-60 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 Rhres 0 (D) significantly influences the results of studies such as the detection 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, when using drugs manufactured from human blood or plasma, the probability of transmission of infection, including unknown or new viruses and other infectious agents, can not be completely ruled out.
No cases of overdose have been reported.
Immunoglobulin human antiresus Rh 0 (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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children and protected from light at a temperature of no higher than 25 В° C. Do not freeze. Shelf life - 3 years.