Immunoglobulin human antistaphylococcal (Immunoglobulinum humanum antistaphylococcum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceImmunoglobulin human anti-staphylococcalImmunoglobulin human anti-staphylococcal
Dosage form: & nbspsolution for intramuscular injection
Composition:

1 dose (ampoule) contains:

active substance: antialfastafilolizin - not less than 100 ME;

adjuvant: stabilizer - glycine (aminoacetic acid) - (2,25 ± 0,75)%.

The drug does not contain preservatives and antibiotics.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, a slight deposit may appear, disappearing after a slight shaking.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.B.08   Staphylococcal human immunoglobulin

Pharmacodynamics:

The preparation is a concentrated solution of the purified fraction of immunoglobulins isolated by the method of fractionation with ethyl alcohol from the blood plasma of healthy dopors containing antibodies to staphylococcal exotoxin and individually tested for the absence of a surface antigen of the hepatitis B virusHBsAg), antibodies to the hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2.

The active component of the drug is immunoglobulins, which have antibodies to staphylococcal exotoxin (alfastafilolizin). The drug also has nonspecific activity, manifested in increasing the resistance of the body.

Pharmacokinetics:

The maximum concentration of antibodies in the blood is reached 24-48 hours after administration, the half-life of antibodies from the body is 3-4 weeks.

Indications:

Staphylococcal etiology in children and adults (as part of combination therapy).

Contraindications:

- Pincreased sensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of class A immunoglobulin (IgA) and the presence of antibodies against IgA;

- hypersensitivity to the components of the drug;

- presence in the anamnesis of allergic reactions to blood products of the person.

In cases of severe sepsis, the only contraindication for administration is an anaphylactic shock to a person's blood products in an 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. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

Persons suffering from diseases in the genesis of which are leading immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis),the drug is prescribed after consultation of the appropriate specialist.

Use with caution in the following risk groups:

- in patients older than 65 years;

- in patients with severe heart failure;

- in patients with renal insufficiency.

Pregnancy and lactation:

The safety of the drug during pregnancy and during breastfeeding during controlled clinical trials has not been studied. The use of the drug during pregnancy and during breastfeeding is possible only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby. Immunoglobulins penetrate into breast milk and protective antibodies during breastfeeding can be transmitted from mother to child.

Dosing and Administration:

The drug is injected intramuscularly into the upper outer quadrant of the gluteus muscle or to 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. Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules.To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. The drug with the ampoule is not subject to storage.

The preparation is not suitable for use in ampoules with broken integrity, marking, and also when physical properties change (color change, cloudiness of solution, presence of unbreakable flakes), expired shelf life and non-observance of storage conditions.

The dose of immunoglobulin 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 under 5 years a single dose of the drug should be at least 100 ME.

With localized forms of staphylococcal 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:

The incidence of side effects is determined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases).

The following side effects are possible:

General disorders and disorders at the site of administration:

Often: soreness in the injection site.

Rarely: chills, hyperthermia, weakness, hyperemia at the injection site.

Immune system disorders:

Very rarely: allergic reactions (hives, itching, rash), anaphylactic shock.

Impaired nervous system:

Very rarely: headache, dizziness.

Disorders from the digestive system:

Very rarely: nausea, vomiting.

Disorders from the musculoskeletal system:

Very rarely: pain in the back, joint pain.

Disorders from the cardiovascular system:

Rarely: lowering blood pressure.

Overdose:No cases of drug overdose have been reported.
Interaction:

The drug can be used in complex therapy of the disease in combination with other drugs, in particular antibiotics. It is not allowed to mix the drug with other drugs in the same syringe.

In infants, do not apply simultaneously with calcium gluconate.

The introduction of immunoglobulin can reduce the effectiveness of active immunization, so live vaccines (against measles, mumps, rubella, chicken pox) should be administered no earlier than 3 months after the administration of the immunoglobulin.After vaccination against these infections, the immunoglobulin should be administered no earlier than 2 weeks; if immunoglobulin is required before this time, vaccination against measles, mumps, rubella, chicken pox should be repeated. Vaccinations against other infections can be carried out at any time before or after the administration of the immunoglobulin.

In the case of measles vaccination, a decrease in the effectiveness of the vaccine is possible within 1 year after the administration of the immunoglobulin. In this regard, in patients vaccinated with the measles vaccine, it is recommended to monitor the level of antibodies.

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

During the administration of the drug, the patient's condition should be carefully monitored.

Persons receiving the drug should be under medical supervision for 30 minutes after the administration. Premises where the drug is administered should be provided with anti-shock therapy.

The introduction of an immunoglobulin can lead to a transient increase in various passively transmitted antibodies in the patient's blood and to false positive results from serological tests (eg, Coombs test).

The drug should be registered in the prescribed registration forms with the name of the drug, serial number, date of issue, expiration date, manufacturer, date of administration, dose and adverse reactions to the drug. Special precautions when destroying an unused preparation are not available.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles, mechanisms, as well as the ability to perform actions that require increased concentration and speed of psychomotor reactions.

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

For 1 dose (not less than 100 ME) in a volume of 3 to 5 ml in an ampoule.

A) For 10 ampoules with instructions for use, with a knife ampoule or scarifier ampullum in a pack of cardboard.

B) 5 ampoules in a cassette contour pack. 2 cassette contour packs with instructions for use in a pack of cardboard.

When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

Storage conditions:

Store in accordance with SP 3.3.2.1248-03 at a temperature of from 2 to 8 ° C in a place inaccessible to children.Freezing is not allowed.

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 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 N000942 / 01
Date of registration:08.07.2008 / 03.06.2013
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp24.10.2017
Illustrated instructions
    Instructions
    Up