Human antistaphylococcal immunoglobulin
Instructions for use:
HUMAN IMMUNOGLOBULIN ANTISTAPHYLOCOCCAL,
solution for intramuscular administration 100 ME
Registration number:
R N000942/01 dated 07/08/2008.
The drug is a concentrated solution of a purified fraction of immunoglobulins, isolated by fractionation with ethyl alcohol at temperatures below 0 °C from the blood plasma of healthy donors, containing antibodies to staphylococcal exotoxin and tested individually from each donor for the absence of hepatitis B virus surface antigen (HBsAg), antibodies to hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2.
Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, slight sediment may appear, which disappears after gentle shaking at a temperature of (20 ± 2) °C.
One dose (1 ampoule) contains at least 100 IU of antialphastaphylolysin. Stabilizer - glycine at a concentration of (2.25±0.75)%. The protein concentration in immunoglobulin is from 9.5 to 10.5%. The drug does not contain preservatives or antibiotics.
Immunological properties.
The active principle of the drug is immunoglobulins, which have the activity of antibodies that neutralize staphylococcal exotoxin (alphastaphylolysin).
Purpose.
Treatment of diseases of staphylococcal etiology in children and adults.
Directions for use and dosage.
Liquid antistaphylococcal immunoglobulin is injected intramuscularly into the upper outer quadrant of the gluteal muscle or into the outer surface of the thigh. Before injection, ampoules with the drug are kept for 2 hours at room temperature from 18 to 22 °C.
The opening of the ampoules and the administration procedure are carried out in strict compliance with the rules of asepsis and antiseptics. To avoid foam formation, the drug is drawn into a syringe with a wide bore needle. The drug cannot be stored in an opened ampoule.
The dose of the drug and the frequency of its administration depend on the indications for use:
- with generalized staphylococcal
infections, the minimum single dose is 5 IU of antialphastaphylolysine per 1 kg of body weight (for children less than 5 years old, the single dose of the drug should be at least 100 IU);
- for localized diseases
the minimum single dose is at least 100 IU.
The course of treatment consists of 3 to 5 injections given daily or every other day, depending on the severity of the disease and the therapeutic effect.
Side effects.
As a rule, there are no reactions to the administration of immunoglobulin. In rare cases, local reactions may develop in the form of hyperemia and an increase in temperature to 37.5 ° C during the first day after administration of the drug. Individual people with altered reactivity may develop allergic reactions of various types, and in extremely rare cases, anaphylactic shock; therefore, people who have been administered the drug should be under medical supervision for 30 minutes after its administration.
Vaccination sites must be provided with anti-shock therapy.
The administration of immunoglobulin is registered in established accounting forms indicating the manufacturer, batch number, date of manufacture, expiration date, date of administration, dose and nature of the reaction to the administration.
Contraindications.
The use of antistaphylococcal human immunoglobulin is contraindicated in persons with a history of severe allergic reactions to the administration of human blood products.
In cases of severe sepsis, the only contraindication for the use of the drug is a history of anaphylactic shock when administering human blood products.
For persons suffering from allergic diseases or with a history of clinically significant allergic reactions, antihistamines are recommended on the day of immunoglobulin administration and for the next 8 days.
For persons suffering from immunopathological systemic diseases (diseases of the blood, connective tissue, nephritis, etc.), the drug should be administered against the background of appropriate therapy.
The drug is not suitable for use if the integrity of the ampoules or their labeling is damaged, the physical properties are changed (turbidity, color change, the presence of unbreakable flakes), if the expiration date has expired and the storage conditions are not met.
Interactions with other drugs.
Not installed.
Release form.
1 dose (at least 100 IU) in a volume of 3 to 5 ml in ampoules. A) 10 ampoules in a cardboard pack with instructions for use. B) 5 or 10 ampoules in blister packs. 1 or 2 blister packs in a pack with instructions for use, an ampoule knife or an ampoule scarifier.
Vacation conditions.
Dispensed with a doctor's prescription.
Best before date. Storage and transportation conditions.
Best before date. 2 years. A drug that has expired cannot be used. Store and transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 °C out of the reach of children. Freezing is not allowed.
, Russia.
see also
HUMAN IMMUNOGLOBULIN ANTISTAPHYLOCOCCAL
Registration certificate:
R N001823/01 dated 02/06/2009
Trade name of the drug
: Human antistaphylococcal immunoglobulin.
International nonproprietary name or generic name
: Human antistaphylococcal immunoglobulin
Dosage form:
solution for intramuscular administration.
Composition:
1 dose of the drug (3-5 ml) contains as an active substance - human antistaphylococcal immunoglobulin 100 IU.
Excipients:
glycine 20 mg, sodium chloride 9 mg, water for injection.
Description.
Transparent or slightly opalescent liquid, colorless or slightly yellow in color, without foreign inclusions.
Pharmacotherapeutic group:
MIBP - globulin.
ATX code
[J06BB08].
Pharmachologic effect.
The drug is an immunologically active protein fraction containing a wide range of antibodies, isolated from human plasma or serum of donors tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and hepatitis B virus surface antigen. Active a component of the drug are immunoglobulins that have the activity of antibodies to staphylococcal exotoxin (in a titer of at least 20 IU/1 ml). The drug also increases the body's nonspecific resistance.
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 for use.
Treatment of various diseases of staphylococcal etiology in children and adults.
Contraindications.
The administration of immunoglobulin is contraindicated in persons with a history of allergic reactions or severe systemic reactions to human blood products.
In cases of severe sepsis, the only contraindication for immunoglobulin administration is a history of anaphylactic shock to human blood products.
Directions for use and doses
The drug is administered intramuscularly into the upper outer quadrant of the gluteal muscle or the outer surface of the thigh. The drug should not be administered intravenously. The dose of the drug and the frequency of its administration depend on the indications for use.
For generalized staphylococcal infection
The minimum single dose of the drug is 5 IU of antialphastaphylolysine per 1 kg of body weight.
For children under 5 years of age, a single dose of the drug should be at least 100 IU.
For milder localized forms of infection
the minimum single dose of the drug is at least 100 IU. The course of treatment consists of three to five injections given daily or every other day, depending on the severity of the disease, the patient’s condition and the therapeutic effect.
Side effect.
In rare cases, reactions may develop in the form of hyperemia and an increase in temperature to 37.5 ° C during the first day after administration, as well as dyspeptic symptoms. Individuals with altered reactivity may develop allergic reactions of various types, and in exceptional cases, anaphylactic shock. Therefore, persons receiving the drug should be observed for 30 minutes.
Interaction with other drugs.
Immunoglobulin therapy can be combined with other drugs, in particular antibiotics.
Special instructions.
The drug should be visually transparent and should not contain suspension or sediment. It is considered suitable for use provided that the sealing and sealing are maintained, there are no cracks in the ampoules, and the label is intact. The results of the visual examination and label data (name of the drug, manufacturer, batch number) are recorded in the medical history. Before the injection, ampoules with the drug are kept for two hours at room temperature (20±2) °C. To avoid foam formation, the drug is drawn into a syringe with a wide-bore needle. The drug cannot be stored in an opened ampoule.
• Treatment with immunoglobulin preparations reduces the effectiveness of vaccination, so vaccinations are carried out no earlier than 2-3 months after the administration of immunoglobulin.
For persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, antihistamines are recommended on the day of immunoglobulin administration and for the next 8 days. During the period of exacerbation of the allergic process, the drug is administered according to the conclusion of an allergist.
For persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis and others), the drug should be administered against the background of appropriate therapy.
Antishock therapy must be available in the room where the drug is administered. When anaphylactic reactions develop, antihistamines, glucocorticosteroids and adrenergic agonists are used.
Pregnancy and lactation
The use of the drug during pregnancy and breastfeeding is possible only for health reasons.
Release form.
Solution for intramuscular administration, 3-5 ml (100 IU/1 dose) - in ampoules with a capacity of 5 ml. 10 ampoules are packed in a cardboard box. The pack contains instructions for use and an ampoule knife. If the ampoules have a colored break ring, a notch, or an identification colored dot on the ampoule clamp, the ampoule knife is not inserted into the cardboard pack.
Storage conditions.
In a dry place, protected from light and out of reach of children, at a temperature of 2 ° C to 8 ° C. Freezing is not allowed.
Best before date.
2 years. Do not use after expiration date.
Conditions for dispensing from pharmacies
. By doctor's prescription.
Manufacturer.
State healthcare institution "Sverdlovsk Regional Blood Transfusion Station"
