Active substanceImmunoglobulin human anti-staphylococcalImmunoglobulin human anti-staphylococcal
Dosage form: & nbspsolution for intramuscular injection
Composition:Immunoglobulin, aminoacetic acid (glycine), sodium chloride.

One The dose of the drug (3 ml) contains not less than 100 ME antialfastafilolizina.

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.

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:

Staphylococcal etiology in children and adults.

Contraindications:

Contraindicated in the introduction of immunoglobulin to people who have a history of allergic reactions or severe systemic reactions to human blood products

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 on the day of immunoglobulin administration and for the next 8 days are recommended to prescribe antihistamines. 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.) should be given the drug on the background of appropriate therapy.

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. In order to avoid the formation of the yen, the drug is injected into the syringe with a needle with a wide opening. 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:

In rare cases, reactions may occur in the form of hyperemia and rise in temperature to 37.5 ° C during the first 24 hours after the administration, as well as dyspepsia.

Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock, and therefore those receiving the drug should be monitored for 30 minutes. In the room where the drug is administered, there should be antishock therapy. With the development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

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. Treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations are conducted no earlier than 2-3 months after the administration of immunoglobulin.

Form release / dosage:Solution for intramuscular injection, 10% (100 IU / dose).
Packaging:In ampoules of 3 ml (100 IU / 1 dose).

10 ampoules are packed in a pack of cardboard for consumer packaging along with instructions for use.

Storage conditions:

The drug is stored in a dry, dark place at a temperature of 2 to +8 ° C.

Shelf life:

2 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:P N003866 / 01
Date of registration:03.12.2009
Expiration Date:Unlimited
The owner of the registration certificate:LIPETSK REGIONAL STATION OF BLOOD TRANSFUSION LIPETSK REGIONAL STATION OF BLOOD TRANSFUSION Russia
Manufacturer: & nbsp
Information update date: & nbsp07.11.2017
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