Immunoglobulin human antistaphylococcal - instructions for use, dose, side effects, contraindications

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

The active component of the drug is immunoglobulins, which have antibodies to staphylococcal exotoxin (in titer not below 20 IU / 1 ml). 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:

Treatment of various diseases of 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.

Pregnancy and lactation:

The use of the drug during pregnancy and lactation is possible only for life indications.

Dosing and Administration:

The drug 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. 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 easier localized forms of infection the minimum single dose of the drug is at least 100 ME.

The course of treatment consists of three to five 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. Therefore, the person who received the drug should be monitored for 30 minutes.

Interaction:

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

Special instructions:

The preparation should be visually transparent, should not contain a suspension and a sediment. It is considered suitable for use under the condition of the preservation of tightness and sealing, the absence of cracks in the ampoules, the safety of the label. The results of visual inspection and data labels (the name of the drug, the manufacturer, batch number) are recorded in the history of the disease.

Before the injection, the ampoule with the drug is kept for two 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.

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

- Individuals 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. 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 and others) should be given the drug on the background of appropriate therapy.

In the room where the drug is administered, there should be antishock therapy. With the development of anaphylactic reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

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

Packaging:

For 3-5 ml (100 IU / 1 dose) - in ampoules with a capacity of 5 ml.

10 ampoules are packed in a pack of cardboard box.

In the pack, put the instructions for use and the ampoule knife. In the event that the ampoules have a colored ring of fracture, an incision, an identification color point on the vial of an ampoule, an ampoule knife is not put into a pack of cardboard.

Storage conditions:

In dry, protected from light and out of reach of children at a temperature of 2 ° C to 8 ° C. Freezing is not allowed.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N001823 / 01

Date of registration:06.02.2009 / 29.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:SVERDLOVSK REGIONAL STATION OF BLOOD TRANSFUSION OF GBUZ SOSVERDLOVSK REGIONAL STATION OF BLOOD TRANSFUSION OF GBUZ SO Russia

Manufacturer: & nbsp

SVERDLOVSK REGIONAL STATION OF BLOOD TRANSFUSION OF GBUZ SO Russia

Information update date: & nbsp07.11.2017

Illustrated instructions

Instructions

Immunoglobulin human antistaphylococcal (Immunoglobulinum humanum antistaphylococcum)