Immunoglobulin human antistaphylococcal (Immunoglobulinum antistaphylococcum humanum)

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:

1 dose in 3 ml (100 ME) of the preparation contains:

active substance: immunoglobulin (protein) 0.3 g ((10 ± 0.5)%);

Excipients: glycine (aminoacetic acid) 0.06 g (2%), atode for injection up to 3 ml.

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 serum or plasma from healthy donors (tested for the absence of antibodies to 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, which have antibodies to staphylococcal exotoxin.

Pharmacological action - immunostimulating. It binds staphylococcal exotoxin.

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. The drug also increases the nonspecific resistance of the body.

Indications:Infections of staphylococcal etiology in children and adults.
Contraindications:

Contraindicated the introduction of immunoglobulin to people who have a history of severe allergic reactions to blood products of man.

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:

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.

Pregnancy and lactation:

During pregnancy and lactation, they are administered only on strict indications, when the intended benefit for the mother exceeds the potential risk for the baby.

Dosing and Administration:

Immunoglobulin antistaphylococcal 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. Opening of ampoules and the procedure of administration are carried out under the rules of aseptic and antiseptic. 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. Do not use drugs in ampoules with broken integrity or labeling, with a change in physical properties (discoloration, and cloudiness of the solution, the presence of non-breakable flakes), with improper 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 IU of antiallfastafilolizina per 1 kg of adult body weight (for children under 5 years, the minimum single dose of the drug should be at least 100 ME).

With lighter local forms - focal infections - the minimum single dose of the drug for an adult 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:

In rare cases, local reactions may occur in the form of skin hyperemia in the area of ​​intramuscular injection and rise in temperature (hyperthermia) to 37.5 ° C during the first day after administration, as well as dyspepsia.

Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock, in this connection, those who receive the drug should be monitored for 30 minutes. Vaccination sites should be provided with anti-shock therapy. When developing Anaphylactic reactions use antihistamines, glucocorticosteroids and adrenomimetics.

Interaction:

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

Special instructions:The drug is used only as directed by a doctor.

Introduction of immunoglobulin and preventive vaccinations: immunoglobulin preparations treatment reduces the efficiency of vaccination, however grafting is carried out not earlier than after 2-3 months after the administration of immunoglobulin.

After introduction of the immunoglobulin may be a passive increase in antibody content in blood of the patient (e.g., erythrocyte antigens A, B or D), which can lead to erroneous interpretations of false positive serological test results (Coombs test).

Form release / dosage:Solution for intramuscular injection, 100 IU.
Packaging:

In ampoules of 3.0 ml 1 dose (100 IU).

10 ampoules in a pile of cardboard boxed.

In each pack put the instructions for use and the ampoule opener.

Storage conditions:

The drug is stored in a dry, dark place at a temperature of 2 to 10 ° C.

Keep out of the reach of children.

Shipping performed by any kind of covered transport at a temperature of from 2 to 10 ° C.

Shelf life:

2 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LS-000388
Date of registration:18.08.2011 / 11.12.2012
Expiration Date:Unlimited
The owner of the registration certificate:IVANOV REGIONAL STATION OF BLOOD TRANSFUSION IVANOV REGIONAL STATION OF BLOOD TRANSFUSION Russia
Manufacturer: & nbsp
Information update date: & nbsp07.11.2017
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