Hyper DRO C D solution for intramuscular injection syringes 1 ml
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Description
The release of the immunobiological medicinal product is carried out according to the doctor's prescription and if the thermocontainer from the customer buys in which the medicinal product is placed, the delivery of this medicinal product to the medical organization under the condition of storage in a special thermal container shall not exceed 48 hours after its purchase.
Active ingredients
Human immunoglobulin antihoresus Rho (D)
Release form
Solution
Composition
Active ingredient: immunoglobulin G 1500 IU (300 mcg). Excipients: glycine, water for injection.
Pharmacological effect
Immunological drug. It is an immunologically active protein fraction isolated from human plasma or donor serum tested for the absence of antibodies to human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen. The active component of the drug is immunoglobulin G, containing incomplete anti-Rh0 (D) antibodies. Prevents isoimmunization in the Rh-negative body of a woman exposed to Rh-positive blood as a result of fetal blood entering the mother’s bloodstream at the birth of a Rh-positive baby, abortion (both spontaneous and artificial), in the event of an amniocentesis or in the event of injury abdominal during pregnancy. With the introduction of human immunoglobulin, Rh0 (D) antirhesus for 72 hours after giving birth to a fully mature Rh0 (D) -positive baby Rh0 (D) -negative mother, the frequency of Rh isoimmunization is reduced.
Pharmacokinetics
Absorption: Cmax antibodies in the blood is achieved after 24 hours. Deduction: T1 / 2 antibodies from the body is 4-5 weeks.
Indications
The drug is indicated for use in Rh-negative women who are not sensitized to the Rh0 (D) antigen (i.e., in the absence of Rh antibodies), provided that: pregnancy and the birth of the Rh-positive child, with artificial and spontaneous abortion, with interruption of ectopic pregnancy , with the threat of termination of pregnancy at any time, after carrying out amniocentesis and other procedures associated with the risk of fetal blood entering the mother’s bloodstream, as well as in the event of an abdominal injury.
Contraindications
Rh-positive puerperas, Rh-negative puerperas sensitized to the Rh0 (D) antigen (in whose blood serum Rh-antibodies are detected), hypersensitivity to the drug. It is forbidden to administer the drug to the newborn.
Precautionary measures
The drug can not be administered intravenously!
Dosage and administration
The drug is administered intramuscularly in 1 dose (1500 IU) or 2 doses (3000 IU) once: for the puerperal - within 72 hours after delivery, while abortion - immediately after the end of the operation. The following criteria must be met: the mother must be Rh-negative and should not be already sensitized to the Rh0 (D) factor, her child must be Rh-positive. If the drug is administered before delivery, it is important that the mother receives another 1 dose of the drug after the birth of the Rh-positive baby within 72 hours after delivery. If it is determined that the father is Rh-negative, there is no need to administer the drug. Before the introduction of the syringes with the drug is incubated for 2 hours at room temperature (20 ± 2 ° C). In order to avoid the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. For prophylaxis in the postpartum period, 1 dose (1500 IU) of HyperROU S / D should be administered during the first 72 hours after delivery. The need for a certain dose in the case of the passage of the full term of pregnancy varies depending on the blood volume of the fetus that has entered the mother’s bloodstream. In 1 dose (1500 IU) there is a sufficient amount of antibodies to prevent sensitization to the Rh factor, if the volume of fetal red blood cells that have entered the bloodstream does not exceed 15 ml. When a larger volume of red blood cells of the fetus is expected to enter the mother’s bloodstream (more than 30 ml of whole blood or more than 15 ml of red blood cells), fetus red blood cells should be counted using an approved laboratory method (for example, a modified Kleihauer and Betka acid leaching-staining method ) to set the required dose of the drug. The calculated volume of red blood cells of the fetus that fell into the bloodstream of the mother is divided into 15 ml and receive the number of doses of the drug HyperRO S / D, which must be entered. If more than 15 ml of erythrocytes of a fetus are expected or a fraction is obtained as a result of dose calculation, the number of doses should be rounded up to the next whole number upwards, for example, when obtaining a result of 1.4, 2 doses (3000 IU) of the drug should be injected. You should enter a dose of the drug (1500 IU) at about the 28th week of pregnancy.For this, it is necessary to introduce another 1 dose (1500 IU), preferably within 72 hours after birth, if the baby is born to be Rh-positive. In case of continuation of pregnancy after the threat of abortion arises at any stage of pregnancy, 1 dose (1500 IU) of the drug should be administered. If more than 15 ml of erythrocytes of the fetus are suspected in the mother’s bloodstream, the dose should be changed (as indicated above). After a spontaneous abortion, induced abortion, or termination of ectopic pregnancy with a gestational age of more than 13 weeks, it is recommended to administer 1 dose (1500 IU) of the drug. If more than 15 ml of erythrocytes of the fetus are suspected in the mother’s bloodstream, the dose should be changed (as indicated above). If the pregnancy is interrupted for a period of less than 13 weeks, a single dose of the HyperROW S / D mini-dose is possible (approximately 250 IU). After the amniocentesis is carried out on the 15-18th week of pregnancy, or during the third trimester of pregnancy, or when an injury occurs to the abdominal organs during the second and / or third trimester of pregnancy, a dose (1500 IU) of the drug should be administered. If more than 15 ml of erythrocytes are suspected of entering the mother’s bloodstream, the dose should be changed as described above. If an injury to the abdominal organs, amniocentesis, or other unfavorable circumstance requires the administration of the drug at a period of 13–18 weeks of pregnancy, another 1 dose (1500 IU) should be given at a period of 26–28 weeks. To maintain protection throughout pregnancy, the concentration of passively obtained antibodies to Rh0 (D) cannot be lowered below the level necessary to prevent an immune response to Rh-positive red blood cells. T1 / 2 of the human immunoglobulin antirhesus Rh0 (D) is 23-26 days. In any case, the dose of the drug should be administered within 72 hours after delivery, if the baby is Rh-positive. If childbirth occurs within 3 weeks after receiving the last dose, the postpartum dose can be canceled (with the exception of cases when more than 15 ml of fetus erythrocytes entered the mother’s bloodstream).
Side effects
Possible: hyperemia, increase in body temperature up to 37.5 ° C (during the first days after administration), dyspeptic phenomena. In some cases: in patients with altered reactivity (including deficiency in immunoglobulin A), allergic reactions of various types may develop (including anaphylactic shock).
special instructions
In children born to women who received human immunoglobulin Rh0 (D) antirhesus before delivery, at birth, poorly positive results of direct tests for the presence of antiglobulin can be obtained. In the serum of the mother it is possible to detect antibodies to Rh0 (D), obtained passively, if screening tests for antibodies are made after prenatal or postpartum administration of human immunoglobulin to Rh0 (D). Immunization of women with live vaccines should be carried out no earlier than 3 months after drug administration. In connection with the possibility of the development of allergic reactions, patients within 30 minutes after the administration of the drug should be monitored. In the room where the drug is injected, should be anti-shock therapy. With the development of anaphylactic reactions used antihistamines, corticosteroids and alpha-adrenomimetiki. Therapy with HyperROU S / D can be combined with other drugs, in particular with antibiotics.