Universal reference book for medicines
Name of the preparation: HUMAN IMMUNOGLOBULIN ANTIRESEUS Rho (D) (IMMUNE GLOBULIN HUMAN ANTIRHESUS Rho (D))

Active substance: human anti-D immunoglobulin

Type: Immunological preparation.
Immunoglobulin
Manufacturer: IVANOVSKAYA REGIONAL STATION TRANSFUSION OF BLOOD GUZ (Russia)
A typical clinical and pharmacological article
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Immunologically active protein fraction isolated from human plasma or donor sera tested for the absence of antibodies to HIV (HIV-1, HIV-2), hepatitis C virus and Hepatitis B surface antigen.

Prevents the isoimmunization of Rho (D) -negative mother exposed to Rh 0 (D) -positive fetal blood at the birth of the Rh 0 (D) -positive child, with abortion (both spontaneous and artificial), in case of amniocentesis or when receiving injuries of the abdominal cavity during pregnancy.

Reduces the frequency of maternal rhizisimunization with the introduction of the drug within 48-72 hours after the birth of a fully-born Rh 0 (D) -positive child Rh 0(D) -negative mother.

PHARMACOKINETICS
C max antibodies in the blood are reached after 24 hours. The half-life of human immunoglobulin antiresus Rh 0 (D) is 23-26 days.
T 1/2 antibody from the body - 4-5 weeks.
INDICATIONS
- Rhesus-conflict prevention in Rh-negative women not sensitized to the Rh 0 (D) antigen (ie, those who did not develop Rh antibodies) under the condition of the first pregnancy and the birth of a Rh-positive child whose blood is compatible with the mother's blood in groups blood system ABO;

- with the artificial termination of pregnancy in Rh-negative women, also not sensitized to Rh 0 (D) -antigen, in the case of Rh-positive blood belonging to the husband.

DOSING MODE
Before the beginning of the introduction, the ampoule with the drug is kept for 2 hours at room temperature (18-22 ° C).
To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. The drug in the opened vial is not subject to storage.
You can not enter I / O.

In / m, 1 dose, once: the puerperium - during the first 48-72 h after delivery, with the artificial termination of pregnancy - immediately after the end of the operation.One dose is 300 μg at a titer of 1: 2000 or 600 μg at a titer of 1: 1000.

The need for a certain dose in the case of the passage of the full term of pregnancy can be different depending on the volume of fetal blood that has entered the mother's bloodstream.
One dose (300 μg) contains a sufficient number of antibodies to prevent sensitization to the Rh factor, if the volume of erythrocytes in the bloodstream does not exceed 15 ml.
In cases where a large amount of erythrocytes of the fetus is expected to enter the bloodstream of the mother (more than 30 ml of whole blood or more than 15 ml of erythrocytes), the fetal erythrocytes should be counted using an approved laboratory procedure (for example, the modified acid washing-staining method according to Kleihauer and Bethke ) to establish the required dose of immunoglobulin.
The calculated volume of red blood cells in the mother's bloodstream is divided into 15 ml and the number of doses of the drug is obtained, which must be entered. If, as a result of calculating the dose, a fraction is obtained, the number of doses should be rounded up to the next whole number in the direction of increase (for example, when receiving the result 1.4, 2 doses (600 μg) of the drug should be given).
For prevention in the prenatal period, 1 dose of the drug (300 μg) should be administered approximately at the 28th week of pregnancy.
Then it is necessary to introduce another 1 dose (300 μg), preferably within 48-72 hours after childbirth, if the born child is Rh-positive.
In case of continuation of pregnancy after occurrence of threat of an abortion at any term of pregnancy it is necessary to enter 1 more dose (300 mkg) of a preparation.
If a mother is expected to enter the bloodstream of more than 15 ml of fetal erythrocytes, the dose should be changed as described in the above.
After a spontaneous abortion, artificial abortion or interruption of an ectopic pregnancy at a gestation period of more than 13 weeks, it is recommended to inject 1 dose (300 μg) of the drug (or more if a mother gets more than 15 ml of fetal erythrocytes into the bloodstream).

If the pregnancy is interrupted for less than 13 weeks of pregnancy, a single dose of a mini-dose (approximately 50 μg) is possible.

After an amniocentesis, either at 15-18 weeks of gestation, or during the third trimester of pregnancy, or if you are injured in 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 of entering blood flow of the mother over 15 ml of fetal erythrocytes).
If a trauma of the abdominal organs, amniocentesis or other unfavorable circumstance requires the administration of the drug at the term of 13-18 weeks of pregnancy, one more dose (300 micrograms) should be administered at a period of 26-28 weeks. To maintain protection throughout the pregnancy, the concentration of passively received antibodies to Rh 0 (D) should not fall below the value necessary to prevent an immune response to the 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 (except in cases where more than 15 ml of fetal erythrocytes have entered the bloodstream of the mother).
SIDE EFFECT
Hyperemia and hyperthermia to 37.5 ° C (within the first 24 hours after the administration), dyspepsia;
rarely (with hypersensitivity, including with IgA deficiency) - allergic reactions (up to anaphylactic shock).
CONTRAINDICATIONS
hypersensitivity;

- Rh-negative puerperas sensitized to Rh 0 (D) antigen, in the serum of which Rh-antibodies were detected;

- newborns.

PREGNANCY AND LACTATION
It is used according to the indications during pregnancy.

APPLICATION FOR CHILDREN
Contraindicated in newborns.

SPECIAL INSTRUCTIONS
In children born from women who received immunoglobulin human antiresus Rh 0 (D) before birth, at birth it is possible to obtain poorly positive results of direct tests for the presence of antiglobulin.
In the mother's blood serum, antibodies to Rh 0 (D) obtained passively can be detected if antibody screening tests are performed after prenatal or postnatal administration of the human immunoglobulin to Rh 0 (D).
Immunization of women with live vaccines should be carried out no earlier than 3 months after the introduction of immunoglobulin antiresus.

Not suitable for use in vials and syringes with broken integrity or marking, with a change in physical properties (discoloration, cloudiness of solution, the presence of non-flocculating flakes), with expired shelf life, with improper storage.

If it is determined that the father Rh 0 (D) is negative, it is not necessary to administer the drug.

After administration of the drug, patients should be monitored for 30 minutes.
Medical offices should have the means of anti-shock therapy. With the development of anaphylactoid reactions, antihistamines, GCS and alpha-adrenomimetics are used.
The drug is not injected Rh-positive puerperas.

DRUG INTERACTION
Possible use in combination with other medicines (including antibiotics).

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