Human immunoglobulin antiresus 300mcg dose ampoule 1ml N1
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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 normal
Release form
Ampoules
Composition
Human immunoglobulin Rh0 (D) antirhesus 300 mcg.
Pharmacological effect
The Cmax of antibodies in the blood is reached after 24 hours. The half-life of a human immunoglobulin Rh0 (D) antirhesus is 23-26 days. T1 / 2 antibodies from the body - 4-5 weeks.
Pharmacokinetics
Immunologically active protein fraction isolated from human plasma or serum donors tested for the absence of antibodies to HIV (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen. Prevents isoimmunization of Rho (D) -negative mother subjected to Rh0 (D) -positive blood of the fetus at birth, Rh0 (D) -positive baby, abortion (both spontaneous and artificial), in the case of amniocentesis or in the case of abdominal trauma during pregnancy. Reduces h sion frequency rezusizoimmunizatsii mother drug when administered for 48-72 hours after birth fully nurtured Rh0 (D) -positive child Rh0 (D) -negative mother
Indications
- prevention of Rh-conflict in Rh-negative women who are not sensitized to the Rh0 (D) antigen (i.e. not developed Rh-antibodies) under the condition of first pregnancy and the birth of Rh-positive baby whose blood is compatible with the blood of the mother in blood groups AVO systems; - in case of artificial interruption of pregnancy in Rh-negative women, who are also not sensitized to the Rh0 (D) antigen, in the case of Rh-positive affiliation of the husband’s blood.
Contraindications
- hypersensitivity; - Rh-negative puerperas sensitized to the Rh0 (D) antigen, in whose serum rh-antibodies are detected; - newborns.
Use during pregnancy and lactation
It is applied according to indications during pregnancy.
Dosage and administration
Prior to the introduction of the ampoule with the drug is incubated for 2 h at room temperature (18-22 ° C).In order to avoid foam formation, the drug is drawn into the syringe with a needle with a wide lumen. The drug in the opened vial cannot be stored. It is not allowed to be administered intravenously. V / m, 1 dose, once: the puerperal - during the first 48-72 hours after delivery, with artificial interruption of pregnancy - immediately after the end of the operation. One dose - 300 mcg with a titer of 1: 2000 or 600 mcg with a titer of 1: 1000. The need for a specific dose in the case of the passage of the full term of pregnancy may be different depending on the blood volume of the fetus that entered the mother’s bloodstream. 1 dose (300 mcg) contains enough antibodies to prevent sensitization to the Rh factor if the volume of red blood cells that have entered the bloodstream does not exceed 15 ml. In cases where a larger volume of fetus red blood cells is expected to enter the bloodstream (over 30 ml whole blood or more than 15 ml of red blood cells), fetal red blood cells should be counted using an approved laboratory procedure (for example, a modified Kleihauer and Betke acid washout-staining method) to establish the necessary dose immunoglobulin. The calculated volume of red blood cells of the fetus that fell into the bloodstream of the mother, divided into 15 ml and get the number of doses of the drug that must be entered. If 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 (600 mcg) of the drug should be administered). To carry out prophylaxis, in the prenatal period, enter 1 dose of the drug (300 mkg) approximately on the 28th week of pregnancy. Then it is necessary to introduce another 1 dose (300 mcg), preferably within 48-72 hours after delivery, if the baby is Rh-positive. If pregnancy continues after the threat of abortion arises at any stage of pregnancy, another 1 dose should be administered (300 mcg a) drug. If more than 15 ml of erythrocytes of the fetus are suspected in the mother’s bloodstream, the dose should be changed as described 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 inject 1 dose (300 μg) of the drug (or more if more than 15 ml of fetus erythrocytes are suspected of entering the mother’s bloodstream).If the pregnancy is interrupted for a period of less than 13 weeks of gestation, a mini-dose can be used once (approximately 50 mcg). After an amniocentesis, either at 15–18 weeks of gestation, or during the third trimester of pregnancy, or when receiving injuries of the abdominal cavity during the second or third trimester, it is recommended to administer 1 dose (300 μg) of the drug (or more if suspected maternal blood flow of more than 15 ml of fetus erythrocytes). 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 gestation, another 1 dose (300 μg) should be given for a period of 26–28 weeks. To maintain protection throughout pregnancy, the concentration of passively obtained antibodies to Rh0 (D) should not be lower than the value needed to prevent an immune response to Rh-positive red blood cells of the fetus. In any case, the dose of the drug should be administered within 48-72 hours after delivery - If the child 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
Hyperemia and hyperthermia up to 37.5 ° C (during the first days after administration), dyspepsia; rarely (with hypersensitivity, including with IgA deficiency) - allergic reactions (up to anaphylactic shock).
Interaction with other drugs
May be used in combination with other drugs (including antibiotics).
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 performed after prenatal or postnatal administration of human immunoglobulin to Rh0 (D). Immunization of women with live vaccines should be carried out no earlier than after 3 months after administration of immunoglobulin antiresus. Preparations in vials and syringes with compromised integrity or labeling are not suitable for use, when physical properties change (discoloration, clouding of the solution, presence of unbreakable flakes), with expired, if stored improperly. If it is determined that the father of Rh0 (D) is negative, there is no need to administer the drug. After the administration of the drug, patients should be monitored for 30 minutes.Medical offices should have anti-shock therapy. With the development of anaphylactoid reactions, antihistamines, corticosteroids and alpha adrenomimetics are used. The drug is not administered to Rh-positive puerperas.