Immunoro Cedrion, lyophilizate 300 µg

Immunoro Kedrion is an immunoglobulin. The active component of the drug is specific antibodies against the Rh0(D)-antigen of human erythrocytes. The drug prevents isoimmunization in a Rh-negative woman, as a result of fetal blood entering the mother’s bloodstream at the birth of a Rh-positive child, at spontaneous and induced abortions, in the case of amniocentesis or at abdominal trauma during pregnancy.

The anti-D immunoglobulins are polyclonal immunoglobulins whose mechanism of action is to neutralize the Rh0(D)-antigens present in the rhesus-positive blood of the embryo. The period of effective action of the drug is on average from 48 to 144 h, while the highest concentration of human anti-Rh0(D) immunoglobulin is achieved on average in 56 h after the drug administration.

The drug is an immunologically active protein fraction isolated from virucinactivated human plasma tested for the absence of antibodies to human immunodeficiency viruses (HIV-1, HIV-2), hepatitis C virus and hepatitis B virus surface antigen.

Pharmacokinetics

The determined value of antibody concentration is reached in blood approximately 20 minutes after intravenous injection of the drug. Cmax of antibodies in blood plasma is usually reached 2-3 days after injection.

The T1/2 of human anti-Rhesus Rh0(D) immunoglobulin is individual, equal to that of normal human immunoglobulin and is 3-4 weeks. Immunoglobulin and its complexes are degraded in cells of the reticuloendothelial system.

Indications

Prevention of anti-D (Rh0) immunization in rhesus-negative women (Rh0(D)) who are not sensitized to the Rh0(D)-antigen and in women who are slightly rhesus-positive (Du) during pregnancy and birth of a rhesus-positive baby.

The drug is used for artificial and spontaneous termination of pregnancy in Rh-negative women who are not sensitized to the Rh0(D)-antigen, in case of Rh-pos-positive blood of the father, as well as during amniocentesis, external turn to the head, abdominal trauma, prenatal bleeding, ectopic pregnancy and chorionic villus test; prevention of anti-D (Rh0) immunization in rhesus-negative patients after incompatible transfusions of rhesus-positive blood or red blood cell concentrates.

Active ingredient

Human anti-Rho immunoglobulin Rho (D)

Composition

Composition of 1 ml of prepared solution:

the active ingredient:

Human plasma proteins containing at least 90% immunoglobulins – 25-180 mg [including human anti-Rhesus immunoglobulin Rh0(D) – 0.15 mg];

auxiliary components:

Glycine – 22.5 mg;

Sodium chloride – 9 mg;

Solvent:

water for injection – up to 1 ml.

.