Immunorho Kedrion 300 micrograms (1500ME) vial with p-lem (g water/injection) 1 pc.

Immunoro Kedrion – immunoglobulin. The active component of the preparation are antibodies specific against Rh0 (D) -antigen human erythrocytes. The drug prevents isoimmunization in Rh-negative woman’s body, as a result of fetal blood to the mother’s bloodstream at birth Rh-positive baby, at spontaneous and induced abortions in the case of amniocentesis, or upon receipt of the abdominal cavity trauma during pregnancy.

Anti-D immunoglobulins are polyclonal immunoglobulins action mechanism of which consists in neutralization Rh0 (D) -antigenov present in Rhesus positive blood embryo. Effective period of the drug is on average from 48 to 144 hours, with the highest concentration of human immunoglobulin antirezus Rh0 (D) is achieved at a mean of 56 hours after drug administration.

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

pharmacokinetics

Determined value of the concentration of antibodies in the blood is reached after about 20 minutes after the / im injection of the drug. Cmax antibodies in plasma is normally achieved within 2-3 days after injection.

T1 / 2 of the human immunoglobulin antirezus Rh0 (D) is different, 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 substance:
Immune globulin human antirhesus Rho[D]

Manufacturer

Kedrion SpA, Italy

Composition

Composition 1 ml final solution:

active ingredient:

human plasma proteins containing at least 90% of immunoglobulins – 25-180 mg [including human immunoglobulin antirezus Rh0 (D) – 0,15 mg];

auxiliaries :

glycine – 22.5 mg;

Sodium chloride – 9 mg;

solvent:

Water for injection – up to 1 ml
.

Indications

Prevention of anti-D (Rh0) immunization in Rh-negative women (Rh0 (D)), are not sensitized to Rh0 (D) -antigenu, and in women with slightly positive blood Rh (Du), during pregnancy and the birth of Rh positive baby.

The drug is used in the artificial and spontaneous termination of pregnancy in rhesus-negative women who are not sensitized to Rh0 (D) -antigenu, in the case of Rh-positive blood father toiletries, as well as by amniocentesis, external cephalic version, the trauma of the abdomen, prenatal bleeding , ectopic pregnancy and chorionic villus sampling; prophylaxis of anti-D (Rh0) immunization in Rh-negative patients following transfusion of Rhesus incompatible-positive blood or erythrocyte concentrates.

Contraindications

• hypersensitivity to the drug;
• sensitized to Rh0 (D) -antigenu Rh-positive and Rh-negative women, the serum which is found Rh antibodies;
• newborn.

Side effects

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

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

How to accept, acceptance rate and dosage

A solution formulation is administered intramuscularly.

Postpartum prophylaxis. 1000-1500 IU (200-300 g) are recommended as an optimal standard dose without testing for infiltration into the bloodstream maternal fetal hemoglobin (HbF) by the method Klyayhauera-Bethke. The drug is administered to the mother as soon as possible after delivery, but not later than 72 hours.

Prenatal and post-exposure prophylaxis. The first dose of 1000-1500 IU (200-300 mcg) in the 28th week of pregnancy. Next dose 1000-1500 IU (200 – 300 g) are administered within 72 hours after birth, if a child born Rhesus positive.

After the abortion, ectopic pregnancy or hydatidiform mole. During the first 72 h after intervention drug is administered in a dose of 600-750 IU (120-150 g) up to 12 weeks of gestation; 1250-1500 IU (250-300 g) after 12 weeks of pregnancy; 1250-1500 IU (250-300 g) after amniocentesis or chorionic villus sampling.

After incompatible transfusions of Rh-positive blood. 500 IU-1250 IU (100-250 g) per 10 ml of transfused blood for several days.

In case of pathology of coagulation when the / m administering drugs is contraindicated human immunoglobulin antirezus Rh0 (D) may be introduced into n / k. Following injection at the injection site carefully applied compress.

If required a large total dose (5 ml), it is recommended to divide it into smaller doses and do injections in different places.

Storage conditions

In the dark place at a temperature not higher than 25 ° C (not frozen).

Active substance

Immune globulin human antirhesus Rho[D]

Interaction

Human immunoglobulin antirezus Rh0 (D) can not be mixed with other drugs.

Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chicken pox in the period up to 3 months.

Pregnancy and lactation

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

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