Immunoglobulin complex preparation (Immunoglobuline complex)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceThe human immunoglobulin is normal [IgG + IgA + IgM]The human immunoglobulin is normal [IgG + IgA + IgM]
Dosage form: & nbsplyophilizate for oral solution preparation
Composition:

1 bottle of the drug contains 300 mg of protein.

Preservatives and antibiotics does not.

Stabilizer - glycine in a concentration of 3.0%,

Description:It looks like an amorphous mass of white color, a bluish tint is permissible.
Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

J.06.B.A.02   Immunoglobulin normal human for intravenous administration

Pharmacodynamics:

Immunoglobulin complex preparation, lyophilizate for solution for oral administration, is a lyophilized protein solution containing immunoglobulins IgG, IgM, IgA, isolated from the blood plasma of healthy donors, tested for the absence of the surface antigen of the hepatitis B virus (MBs Ag), antibodies to the hepatitis C virus and human immunodeficiency viruses HIV-1, HIV-2.

The active ingredient of the preparation is immunologically active fractions of human serum proteins.

Indications:

Treatment of acute intestinal infections caused by enterobacteria in children from 1 month to 14 years of age.

Contraindications:

Contraindicated the use of an immunoglobulin complex drug for children who had a history of an allergic reaction when a human immunoglobulin is administered a normal or Immunoglobulin complex drug (Quincke's edema, allergic rash, anaphylactic shock).

Dosing and Administration:

Immediately before use, the vial is opened, 5 ml of cooled boiled water is added. The drug is dissolved with gentle shaking. The dissolution time should not exceed 5 minutes. The contents of one bottle are drunk 1-2 times a day for 5 days, on an empty stomach 30 minutes before meals.

Dissolved drug is a colorless transparent liquid, slight opalescence is allowed.

The drug can not be used:

- if there is no label on the vial or incomplete information on it;

- if there are cracks on the bottle;

- in the presence of extraneous inclusions;

- at expired shelf life;

- if stored incorrectly.

Side effects:

The reaction to the administration of the drug is usually absent.

In rare cases, especially in persons with increased allergization, local polymorphic skin rashes may occur. In these cases, further administration of the drug can be continued in combination with antihistamines.

Interaction:

It is possible to use the Immunoglobulin complex preparation in combination with antibiotics, chemotherapeutic drugs, bacteriophages.

Special instructions:The introduction of the drug is registered in the established registration form indicating the batch number, expiry date, the manufacturer, the date of implementation, the number of mg of protein and the nature of infusion reactions (in its development).
Form release / dosage:Lyophilizate for solution for oral administration, 300 mg.
Packaging:

In a vial containing 300 mg of protein.

5 bottles in a pack with instructions for use.

Storage conditions:Storage and transportation of the preparation in accordance with SP 3.3.2.1248-03 in a dry place protected from light and out of reach of children at a temperature of 2 to 8 ° C.
Shelf life:3 years. The drug with expired shelf life is not subject to application.
Terms of leave from pharmacies:On prescription
Registration number:LSR-002313/10
Date of registration:22.03.2010
Expiration Date:Unlimited
The owner of the registration certificate:Zelenogradsk IMMUNOBIOLOGICAL ENTERPRISE, CJSC Zelenogradsk IMMUNOBIOLOGICAL ENTERPRISE, CJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp24.10.2017
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