Rezonativ (anti-d human immunoglobulin) solution for injections 625 IU/ml. 1 ml. ampoule №1

Description

Rezonativ (anti-d human immunoglobulin) solution for injections 625 IU/ml. 1 ml. ampoule №1

Composition 

international non-proprietary name: Human anti-D immunoglobulin;

active substance: 1 ml of solution contains 625 IU (125 μg) of human anti-D immunoglobulin. (human protein content 165 mg, with a human immunoglobulin G content of at least 95%);

excipients: glycine, sodium chloride, sodium acetate, polysorbate 80, water for injections.

The content of immunoglobulin A (IgA) does not exceed 0.05% of the total protein content.

• One 1 ml ampoule contains 625 IU (125 μg) of human anti-Rhesus (anti-D) immunoglobulin.
• One 2 ml ampoule contains 1250 IU (250 μg) of human anti-Rhesus (anti-D) immunoglobulin.

Activity is determined by quantitative analysis of Hebrew. Pharm. Equivalence in International Units of the international reference drug is indicated by the World Health Organization.

Distribution of IgG-type subclasses (approximate values): IgG1 – 70.5%, IgG2 – 26.0%, IgG3 – 2.8%, IgG4 – 0.8%. Maximum IgA content: 82.5 μg/ml. It is made from human blood plasma.

Medicinal form

Solution for injection.

Main physicochemical properties: transparent or slightly opalescent solution from colorless to weak yellow or light brown color. Slight turbidity or a small amount of mechanical inclusions may form during storage.

Pharmacotherapeutic group

Immune serums and immunoglobulins. Anti-D (Rh) immunoglobulin.
ATX code J06B B01.

Pharmacological properties

Anti-D immunoglobulin contains specific antibodies (IgG) to the D rhesus (Rh) antigen of human erythrocytes.

During pregnancy and especially childbirth, fetal erythrocytes can enter the mother’s blood. If the woman is Rh(D)-negative and the fetus is Rh(D)-positive, the woman can become immunized with the Rh(D) antigen and produce anti-Rh(D) antibodies that pass transplacentally and can cause hemolytic disease of the newborn. Passive immunization with anti-D immunoglobulin prevents Rh(D) immunization in more than 99% of cases, provided that an adequate dose of anti-D immunoglobulin is administered shortly after exposure to Rh(D)-positive fetal erythrocytes.

The mechanism of suppression of immunization of Rh(D)-positive erythrocytes by anti-D immunoglobulin is unknown. Such suppression may be due to clearance of red blood cells from the circulation before they reach immunocompetent sites, or perhaps due to more complex mechanisms involved in foreign antigen recognition and antigen presentation by appropriate cells at appropriate sites in the presence or absence of antibody.

Indications

Rezonativ solution is prescribed:

• for the prevention of complications (Rh-conflict) in Rh-negative patients not sensitized to the Rh0 (D) antigen in the prenatal period;
• for the prevention of Rh-conflict in Rh-negative, non-sensitized patients (subject to the first pregnancy, the birth of a Rh-positive baby, whose blood is compatible with the mother’s blood according to the ABO system), in the postpartum period;
• to prevent sensitization of an Rh-negative woman during abortion (artificial abortion) in case of a positive rhesus of the husband’s blood;
• to prevent sensitization of an Rh-negative woman in case of artificial / spontaneous abortion, amniocentesis, trauma to the abdominal organs of a pregnant woman.

Contraindications

Rezonativ solution is not used:

• with intolerance to the components;
• in the presence of antibodies to Ig A;
• with selective Ig A deficiency;
• in case of severe allergic reactions after the introduction of protein preparations of blood, a history of donor immunoglobulins;
• with a positive Rh factor of a woman in labor / pregnant woman;
• with severe thrombocytopenia, other hemostatic disorders.

Application during pregnancy and lactation

Only on indications.

Method of administration and dosage

Rezonativ solution is used parenterally.
The following criteria must be evaluated before use:

• the mother is Rh-negative and not sensitized to the Rh0 (D) antigen;
• A child of an Rh negative mother has a negative Rh factor and a Coombs test (direct antiglobulin test).

If the drug is administered before delivery, the mother needs to receive another dose within three days of delivery after the birth of the Rh-positive baby.
If it is determined that the father of the fetus is Rh negative, there is no need to prescribe the drug.
The dose is determined in accordance with the rate of Rh-positive fetal red blood cells detected in the mother’s bloodstream. Dose calculation: to neutralize 0.5 ml of Rh-positive erythrocytes or 1.0 ml of Rh-positive blood, 50 IU (10 μg) of anti-D immunoglobulin is required.

The Rezonativ solution is administered intramuscularly:

• for prophylaxis in the prenatal period, a single dose of 1250 IU (250 μg) is administered at 28-30 weeks; or twice injected at 1250 ME – at 28 and 34 weeks of pregnancy;
• for postpartum prophylaxis, 1250 IU is administered once for 72 hours after childbirth;
• in case of artificial interruption (including ectopic) pregnancy – immediately after the operation, 1250 ME is injected once;
• in case of spontaneous abortion or the threat of miscarriage – 1250 IU (250 μg) is injected once;
• in case of amniocentesis, injuries of the abdominal organs in the II and / or III trimesters of pregnancy – 1250 ME is injected once immediately after the end of the operation.

Overdose

Not described.

Side effects:

• Musculoskeletal disorders: arthralgia.
• Dermatological disorders: skin rash, erythema, itching.
• Digestive disorders: nausea, vomiting.
• Cardiovascular disorders: arterial hypotension, tachycardia.
• Neurological disorders: headache.
• Immune disorders: anaphylactic reactions, angioedema, allergic dermatitis, urticaria.
• Reactions at the injection site: itching, soreness, edema, erythema, redness, induration, rash.
• General: malaise, fever, chills.