Human Anti-D Immunoglobulin

Characteristic

The drug is an immunologically active protein fraction of the serum or blood plasma of immunized (or immunized) donors, tested for the absence of antibodies to HIV-1, HIV-2, hepatitis C virus and surface hepatitis B virus antigen, purified and concentrated by the ethanol fractionation method, which passed the stage viral inactivation by solvent-detergent method, with a high content of anti-rho antibodies (d). the protein content in 1.0 ml of the drug is from 0.09 to 0.11 g. transparent or with slight opalescence, colorless or yellowish liquid. during storage, a slight precipitate may appear, disappearing with shaking. the drug does not contain preservatives and antibiotics.

The active drug base is immunoglobulin specific for Rh antigen_o (D) The drug prevents Rh sensitization of Rh-negative women, possible as a result of Rh_o (D) -fetal positive blood into the mother’s bloodstream at birth Rh_o (D) -positive children, during termination of pregnancy (both spontaneous and artificial), in the case of an amniocentesis, while receiving injuries of the abdominal cavity during pregnancy.

Specific Anti-Rh Antibodies_o(D) - 1,500 IU (300 μg immunoglobulin).

Indications

• For prophylaxis in the prenatal period in Rh-negative women not sensitized to the rho (d) antigen; for prophylaxis in the postpartum period in Rh-negative women who are not sensitized to the rho (d) antigen, that is, who did not develop Rh antibodies (on condition of the first pregnancy and the birth of a Rh-positive baby whose blood is compatible with maternal blood by blood groups systems av0); with artificial termination of pregnancy in Rh-negative women, also not sensitized to rho (d) antigen, in the case of Rh-positive blood of the husband; with miscarriage and the threat of miscarriage at any stage of pregnancy; during amniocentesis; with injuries of the abdominal cavity during pregnancy.

Application

The drug should be administered in / m!

When applying, the following criteria must be considered:

• mother should be Rh negative and should not be already sensitized to Rh antigen_o (D);
• her baby should be Rh-positive and have a negative direct antiglobulin test result. If the drug is administered before childbirth, it is very important that the mother receives another dose of the drug after the birth of a Rh-positive baby within 72 hours after delivery. If it is established that the father is Rh-negative, then there is no need to administer the drug.

Immunoglobulin is administered at 1500 IU (300 μg) IM once:

• for prophylaxis in the prenatal period at about 28 weeks of gestation. After this, one more dose of 1500 IU (300 mcg) should be administered, preferably within 72 hours after delivery, if the baby is Rh-positive;
• for prophylaxis in the postpartum period within 72 hours after childbirth;
• with artificial abortion, termination of an ectopic pregnancy - immediately after the operation. During pregnancy for more than 13 weeks, the introduction of a single dose is recommended, if the pregnancy is interrupted before 13 weeks, a single dose of a mini-dose of immunoglobulin of approximately 250 IU (50 μg) is possible;
• with miscarriage and the threat of miscarriage - at any stage of pregnancy;
• when conducting amniocentesis or with an injury to the abdominal organs during the II and / or III trimester of pregnancy - immediately after the operation is completed, it is recommended to introduce one dose of the drug. If during an amniocentesis or an abdominal injury it is necessary to administer the drug during the period of 13–18 weeks of pregnancy, then another dose of 1,500 IU (300 μg) (1 ampoule) should be administered during the period of 26–28 weeks of pregnancy.

Contraindications

The drug is contraindicated: with selective iga deficiency, provided that antibodies to iga are present; in the presence of severe allergic reactions to the introduction of protein preparations of human blood in the anamnesis, as well as hypersensitivity reactions to human donor immunoglobulins. administration of the drug is contraindicated for Rh-positive women in labor, as well as Rh-negative women in labor sensitized to the rho (d) antigen, in the blood plasma of which Rh antibodies are detected. the drug should not be administered in cases of severe thrombocytopenia and other hemostatic disorders.

Side effects

As a rule, there are no reactions to the introduction of immunoglobulin.

Possible:

reactions at the injection site - edema, pain, erythema, thickening, redness, rash, itching;

general disorders and reactions - fever, weakness, chills;

on the part of the immune system - hypersensitivity reactions, and in extremely rare cases, anaphylactic shock;

from the nervous system - headache;

from the cardiovascular system - tachycardia, hypotension;

from the gastrointestinal tract - nausea, vomiting;

on the part of the skin and subcutaneous tissues - erythema, itching;

from the musculoskeletal and connective tissue - arthralgia.

special instructions

It is forbidden to administer the drug in / in!

Patients who receive the drug should be monitored by a healthcare provider for 30 minutes.

Antihistamines are recommended for patients with a history of allergic diseases or those with an anamnesis on the day of the introduction of immunoglobulin and the next 3 days. In the event of anaphylactic shock, standard anti-shock therapy is performed.

Apply under medical supervision. Prior to administration, the ampoules with the preparation are kept for 2 hours at room temperature (20 ± 2) ° C. In an open ampoule, the drug is not subject to storage. After the expiration date, the use of the drug is unacceptable.

Incompatibility. When introduced, it is unacceptable to mix the drug in the same syringe with other drugs.

Use during pregnancy and lactation. The drug should be used during pregnancy and lactation if indicated. See INDICATIONS, APPLICATION sections.

Children. The safety and effectiveness of the drug in children have not been studied.

It is forbidden to administer the drug to newborns!

In children born to women who received the drug before birth, at birth, it is possible to obtain weakly positive results of direct tests for the presence of antiglobulin. In the mothers blood serum, the detection of antibodies to Rh is possible_o (D) obtained passively if antibody screening tests are performed after prenatal or postnatal administration of an immunoglobulin Rh antiresus_o (D) human.

Impact on the ability to drive vehicles. Not investigated.

Interactions

A combination with other specific drugs is possible. immunization of women with live vaccines should be carried out no earlier than 3 months after the administration of the immunoglobulin anti-rhesus rho (d) preparation.

Overdose

Not studied.

Storage conditions

In a dry, dark place at a temperature of 2–8 ° c.