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

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.

How to take, the dosage

The drug solution is administered intramuscularly.

Postpartum prophylaxis. 1000-1500 IU (200-300 mcg) is recommended as the optimal standard dose without prior testing for maternal fetal hemoglobin (HbF) infiltration into the bloodstream by the Kleihauer-Betke method. The drug is administered to the mother as soon as possible after delivery, but no later than 72 h.

Prenatal and postpartum prophylaxis. The first dose of 1000-1500 IU (200-300 mcg) at the 28th week of pregnancy. The next dose of 1000-1500 IU (200-300 mcg) is administered within 72 h after delivery if the baby is born Rh-positive.

After an abortion, ectopic pregnancy, or bubbleworm. During the first 72 h after the intervention, the drug is administered at a dose of 600-750 IU (120-150 mcg) before the 12th week of pregnancy; 1250-1500 IU (250-300 mcg) after the 12th week of pregnancy; 1250-1500 IU (250-300 mcg) after amniocentesis or chorionic biopsy.

After incompatible rhesus-positive blood transfusion. 500 IU-1250 IU (100-250 mcg) for every 10 ml of transfused blood for several days.

In cases of pathology of the clotting system, when the injection is contraindicated, human anti-rhesus Rh0(D) immunoglobulin may be administered by injection. After injection, the injection site is gently covered with a compress.

If a large total dose (more than 5 ml) is required, it is recommended that it be divided into smaller doses and injected into different sites.

Interaction

Human anti-Rh0(D) immunoglobulin must not be mixed with other preparations.

It reduces the activity of attenuated live vaccines against measles, rubella, mumps, varicella for up to 3 months.

Contraindications

Side effects

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

Systemic reactions: infrequent – fever, skin reactions, chills; rarely – dyspeptic phenomena (nausea and vomiting), decreased BP, tachycardia, allergic or anaphylactic reactions.

Pregnancy use

This medicine is used during pregnancy and for 72 hours after delivery.

No adverse effects on pregnancy, fetus or newborn have been noted.