Immunoglobulin complex preparation for enteral administration (IMMUNOGLOBULINE COMPLEX (KIP))

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:

In 1 dose of the drug contains (300 ± 25) mg of protein; stabilizer - glycine (aminoacetic acid) - (150 ± 25) mg.

Description:The amorphous mass of white color is allowed a bluish tinge.
Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

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

Pharmacodynamics:

The drug is a lyophilized complex of immunoglobulins of classes IgG, IgM, IgA, isolated from the blood plasma of healthy donors. All plasma used in production is tested for the absence of a surface antigen of the hepatitis B virus (HBsAg), antibodies to hepatitis C virus, human immunodeficiency viruses HIV-1 and HIV-2, PCR for the absence of RNA to hepatitis C virus, RNA to HIV and DNA to the hepatitis B virus.At least 97% of the total protein is immunoglobulins of classes IgG, IgA, IgM. The drug does not contain preservatives and antibiotics.

Immunostimulating agent. Raises the specific immunity, increases the content of immunoglobulins and antibodies to enterobacteria (shigella, salmonella, escherichia, etc.) and enteroviruses. Immunobiological properties of the drug are due to the content of its constituent IgG, IgA, IgM.

Indications:Complex treatment of acute intestinal infections caused by enterobacteria in children aged 1 month to 14 years.
Contraindications:

Allergic reactions (skin rash, angioedema (Quincke's edema), anaphylactic shock) to immunoglobulin or other blood products of a person (including in the anamnesis).

Pregnancy and lactation:

The drug is not intended for use in adults.

Dosing and Administration:

Through the mouth, 1 dose, equal to the contents of one bottle, 1-2 times a day for 5 days. Before use, the drug is dissolved in 5 ml (1/2 tbsp) boiled water at room temperature by lightly shaking for no more than 5 minutes.

The dissolved preparation is a colorless transparent liquid, allowed slight opalescence.The drug is used on an empty stomach 30 minutes before eating.

The drug in the opened vial is not subject to storage.

Side effects:

The reaction to the administration is usually absent.

Sometimes in individuals with increased allergenic reactions local reactions may occur in the form of local polymorphous skin rashes. In case of skin rash, antihistamines are prescribed.

Overdose:Cases of overdose are not described.
Interaction:

Undesirable interactions with other drugs have not been noted.

It is possible to use in combination with antibiotics, chemotherapeutic agents and bacteriophages.

Special instructions:

The drug can not be used: if integrity is violated or there is no marking vial, in the presence of rough foreign inclusions, with a change in the physical properties of the drug, in the event of a violation of the temperature regime of storage.

The preparation of the drug is registered in the prescribed registration forms with the indication of the serial number, expiry date, manufacturer, date of administration, dose and the nature of the reaction to the drug administration (with its development).

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

The drug does not affect the management of vehicles, as well as activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Lyophilizate for solution for oral administration, 300 mg.

Packaging:

1 dose per vial.

5 bottles in a pack with instructions for use.

Storage conditions:

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:LS-001547
Date of registration:01.02.2012 / 02.07.2013
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
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