Immunoglobulin human antistaphylococcal (Immunoglobulinum humanum antistaphylococcum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceImmunoglobulin human anti-staphylococcalImmunoglobulin human anti-staphylococcal
Dosage form: & nbspsolution for intramuscular injection
Composition:

Immunoglobulin - 100 g, aminoacetic acid - 2 g, sodium chloride - 9 g, water for injection up to 1 l.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. The appearance of a slight precipitate, which disappears when shaken, is allowed.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.B.08   Staphylococcal human immunoglobulin

Pharmacodynamics:

The preparation is an immunologically active protein fraction isolated from human plasma or donor sera tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and the hepatitis B surface antigen.

The active component of the drug is immunoglobulins, which have antibodies to staphylococcal exotoxin. The drug also increases the nonspecific resistance of the body.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached after 24 hours, the half-life of antibodies from the body is 4-5 weeks.

Indications:

Staphylococcal etiology in children and adults (as part of combination therapy).

Contraindications:

Allergic reactions or severe systemic reactions to human blood products in the anamnesis.

In cases of severe sepsis, the only contraindication for the administration of immunoglobulin is an anaphylactic shock to human blood products in the anamnesis.

Carefully:Pregnancy, lactation.
Dosing and Administration:

The anti-staphylococcal human immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteus muscle or the external surface of the thigh. Do not administer the drug intravenously.

Before the injection, the ampoule with the drug is kept for 2 hours at room temperature (20 ± 2) ° C. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. The drug in the opened ampoule is not subject to storage.

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

With generalized staphylococcal infection the minimum single dose of the drug is 5 ME antialfastafilolizina per 1 kg of body weight.

For children less than 5 years old a single dose of the drug should be at least 100 ME.

With lighter local forms of infection the minimum single dose of the drug is at least 100 ME.

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

Side effects:

Hyperemia and an increase in temperature to 37.5 ° C during the first day after the administration, dyspepsia.

Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock (persons receiving the drug should be monitored for 30 minutes); In the room where the drug is injected, anti-shock therapy should be available.

Treatment with immunoglobulin can be combined with other drugs, in particular, antibiotics.

Special instructions:

Persons with 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. In the period of aggravation of the allergic process, the drug is administered by the conclusion of an allergist.

Persons suffering from autoimmune diseases (blood diseases, connective tissue, nephritis, etc.), the drug should be administered against the background of appropriate therapy.
Form release / dosage:Solution for intramuscular injection, 100 IU.
Packaging:In ampoules of 3 ml (at least 100 ME antialfastafilolizina).
10 ampoules are packed in a pack of cardboard for consumer packaging along with instructions for use.
Storage conditions:

In dry, protected from light, out of reach of children, at a temperature of 2 to +10 ° C.

Not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (discoloration, cloudiness of solution, the presence of non-flocculating flakes), expired, with improper storage.

Transporting is carried out by any kind of covered transport at a temperature of 2 to +10 ° C.
Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription
Registration number:LSR-007021/08
Date of registration:02.09.2008
Expiration Date:Unlimited
The owner of the registration certificate:Belgorod regional blood transfusion station OGUZ Belgorod regional blood transfusion station OGUZ Russia
Manufacturer: & nbsp
Information update date: & nbsp07.11.2017
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