Composition, form of production and packaging
Solution for the / m introduction 3 ml
immunoglobulin human antistaphylococcal 100 IU
Excipients: glycine, sodium chloride.
3 ml - ampoules (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
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 virus
C and the surface antigen of the hepatitis B virus), purified and concentrated by the ethanol fractionation method.
The active component of the drug is immunoglobulins, which have antibodies to staphylococcal exotoxin.
Pharmacological action - immunostimulating. It binds staphylococcal exotoxin.
The drug also increases the nonspecific resistance of the body.
C max antibodies in the blood are reached after 24 h, T 1/2 antibody from the body is 4-5 weeks.
- infections of staphylococcal etiology in children and adults.
Immunoglobulin antistaphylococcal is injected intramuscularly into the upper outer square 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 allowed to stand for 2 hours at room temperature (20 В± 2) В° 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. Not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (discoloration, turbidity of the solution, the presence of non-developing flakes), with improper storage.
The dose of the drug and the frequency of its administration depend on the indications for use.
In case of generalized staphylococcal infection, the minimum single dose of the drug is 5 IU of antiallfastophylolysin per 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.
In rare cases, local reactions may occur in the form of skin hyperemia in the area of вЂ‹вЂ‹intramuscular injection and temperature hanging (hyperthermia) to 37.5 В° 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, in this regard, persons receiving the drug should be monitored for 30 minutes.
Vaccination sites should be provided with anti-shock therapy. With the development of anaphylactic reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.
- the administration of immunoglobulin is contraindicated to persons who have a history of severe allergic 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 history;
- People 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. During the acute 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.
APPLICATION FOR CHILDREN
Assign to children
Introduction of immunoglobulin and preventive vaccinations: treatment with immunoglobulin drugs reduces the effectiveness of vaccination, so vaccinations are carried out not earlier than 2-3 months after the introduction of immunoglobulin.
After the administration of the immunoglobulin, a passive increase in the amount of antibodies in the patient's blood (for example, to erythrocyte antigens A, B or D) can occur, which can lead to erroneous false positive interpretation of the results of serological testing (Coombs test).
Therapy with immunoglobulin can be combined with other drugs, in particular, antibiotics.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
The drug is stored in a dry, dark place at a temperature of 2 to 10 В° C. Keep out of the reach of children. Shelf life - 2 years.