Human antistaphylococcus immunoglobuline (Solution) Instructions for Use

ATC Code

J06BB08 (Human staphylococcal immunoglobulin)

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

The drug is an immunologically active protein fraction isolated from the serum or plasma of healthy donors (tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus, and hepatitis B surface antigen), purified and concentrated by fractionation with ethyl alcohol.

The active component of the drug is immunoglobulins possessing antibody activity against staphylococcal exotoxin.

Pharmacological action – immunostimulating. Binds staphylococcal exotoxin.

The drug also increases the body’s nonspecific resistance.

Pharmacokinetics

C_max of antibodies in the blood is reached after 24 hours, T_1/2 of antibodies from the body is 4-5 weeks.

Indications

• Staphylococcal etiology infections in children and adults.

ICD codes

Dosage Regimen

Solution

Antistaphylococcal immunoglobulin is administered intramuscularly into the upper outer quadrant of the gluteal muscle or the outer surface of the thigh.

It is prohibited to administer the drug intravenously.

Before the injection, the ampoules with the drug are kept for 2 hours at room temperature (20±2) °C. Opening of the ampoules and the administration procedure are carried out in compliance with the rules of asepsis and antisepsis. To avoid foam formation, the drug is drawn into the syringe with a needle with a wide lumen. The drug in an opened ampoule must not be stored. Drugs in ampoules with damaged integrity or labeling, with changed physical properties (color change, solution turbidity, presence of non-dispersible flakes), or stored incorrectly are not suitable for use.

The dose of the drug and the frequency of its administration depend on the indications for use.

In generalized staphylococcal infection, the minimum single dose of the drug is 5 IU of anti-alpha-staphylolysin per 1 kg of body weight for an adult (for children under 5 years of age, the minimum single dose of the drug should be at least 100 IU).

In milder local forms – focal infections – the minimum single dose of the drug for an adult is at least 100 IU.

The course of treatment consists of 3-5 injections, administered daily or every other day, depending on the severity of the disease, the patient’s condition, and the therapeutic effect.

Adverse Reactions

In rare cases, local reactions may develop in the form of skin hyperemia at the site of intramuscular injection and an increase in temperature (hyperthermia) up to 37.5°C (99.5°F) during the first 24 hours after administration, as well as dyspeptic phenomena.

In some individuals with altered reactivity, allergic reactions of various types may develop, and in exceptional cases – anaphylactic shock; therefore, persons who have received the drug should be under observation for 30 minutes.

Vaccination sites must be equipped with anti-shock therapy means. In case of anaphylactic reactions, antihistamines, glucocorticosteroids, and adrenomimetics are used.

Contraindications

• Administration of immunoglobulin is contraindicated in persons with a history of severe allergic reactions to human blood products;
• In cases of severe sepsis, the only contraindication for immunoglobulin administration is a history of anaphylactic shock to human blood products;
• For persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, administration of antihistamines is recommended on the day of immunoglobulin administration and for the next 8 days. During an exacerbation of the allergic process, the drug is administered based on the conclusion of an allergist;
• For persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis, etc.), the drug should be administered against the background of appropriate therapy.

Use in Pregnancy and Lactation

During pregnancy and lactation, it is administered only for strict indications, when the intended benefit for the mother outweighs the potential risk for the infant.

Pediatric Use

Prescribed for children

Special Precautions

Administration of immunoglobulin and prophylactic vaccinations treatment with immunoglobulin preparations reduces the effectiveness of vaccination, therefore vaccinations should be carried out no earlier than 2-3 months after immunoglobulin administration.

After immunoglobulin administration, a passive increase in the content of antibodies in the patient’s blood may be observed (for example, to erythrocyte antigens A, B, or D), which may lead to erroneous false-positive interpretation of serological testing results (Coombs test).

Drug Interactions

Immunoglobulin therapy can be combined with other medications, in particular, antibiotics.

Storage Conditions

The drug should be stored in a dry, light-protected place at a temperature of 2 to 10°C (50°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.