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 Rh-negative women (Rh0(D)), not sensitized to the Rh0(D) antigen, and in women with weakly positive Rh blood (Du), during pregnancy and the birth of a Rh-positive child.

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 the case of Rh-positive blood of the father, as well as for amniocentesis, external rotation to the head, trauma to the abdominal organs, prenatal hemorrhage, ectopic pregnancy and chorionic villus sampling; prophylaxis of anti-D (Rh0) immunization in Rh-negative patients after incompatible transfusion of Rh-positive blood or red blood cell concentrates.

Pharmacological effect

Immunoro Kedrion – 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’s body, as a result of the entry of fetal blood into the mother’s bloodstream at the birth of a Rh-positive child, during spontaneous and induced abortions, in the case of amniocentesis, or in the event of injury to the abdominal organs during pregnancy.

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

The drug is an immunologically active protein fraction isolated from virus-inactivated 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 detectable antibody concentration is achieved in the blood approximately 20 minutes after the intramuscular injection of the drug. Cmax of antibodies in blood plasma is usually achieved 2-3 days after injection.

T1/2 of human anti-rhesus immunoglobulin Rh0(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.

Active ingredient

Human anti-rhesus immunoglobulin Rho (D)

Composition

Composition of 1 ml of the finished solution:

active substance:

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

auxiliary components:

glycine – 22.5 mg;

sodium chloride – 9 mg;

solvent:

water for injection – up to 1 ml.

Pregnancy

This drug is used during pregnancy and for 72 hours after birth.

No harmful effects on the course of pregnancy, the fetus or the newborn were noted.

Contraindications

hypersensitivity to the components of the drug;
Rh-positive and Rh-negative women sensitized to the Rh0(D) antigen, in whose blood serum Rh antibodies are detected;
newborns.

Side Effects

Local reactions: pain at the injection site. This can be avoided by injecting a large volume of solution in several doses of less than 5 ml in several different places.

Systemic reactions: infrequently – fever, skin reactions, chills; rarely – dyspeptic symptoms (nausea and vomiting), decreased blood pressure, tachycardia, allergic or anaphylactic reactions.

Interaction

Human anti-rhesus immunoglobulin Rh0(D) cannot be mixed with other drugs.

Reduces the activity of attenuated live vaccines against measles, rubella, mumps, and chickenpox for a period of up to 3 months.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C (do not freeze).

Shelf life

3 years

Manufacturer

Kedrion S.p.A., Italy