Immunoglobuline complex KIP (Lyophilisate) Instructions for Use

ATC Code

J06BA (Immunoglobulins, normal human)

Active Substance

Human normal immunoglobulin [IgG+IgA+IgM]

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immunoglobulins; normal human immunoglobulins

Pharmacological Action

Immunostimulating drug. It increases specific immunity, increases the content of immunoglobulins and antibodies to enterobacteria (Shigella, Salmonella, Escherichia, etc.) and enteroviruses. The immunobiological properties of the drug are due to the content of IgG, IgA, IgM included in its composition.

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

Indications

• Complex treatment of acute intestinal infections caused by enterobacteria in children aged from 1 month to 14 years.

ICD codes

Dosage Regimen

Lyophilisate

After opening, add 5 ml (1/2 tablespoon) of boiled water at room temperature to the vial. The drug is dissolved with gentle shaking.

It is administered orally, 1-2 doses (vials) 2-3 times a day, depending on the patient’s age and the severity of the disease, 30 minutes before meals for 5 days. If necessary, the course of treatment is repeated.

The drug should not be used if the vial lacks a label or has incomplete information on it, or if there are cracks on the vials.

Adverse Reactions

Reaction to administration is usually absent. Sometimes, in individuals with increased allergic sensitivity, local reactions in the form of local polymorphic skin rashes may occur. In case of skin rash, antihistamines are prescribed.

Contraindications

• Allergic reactions (skin rash, angioedema (Quincke’s edema), anaphylactic shock) to immunoglobulin or other human blood preparations (including in the anamnesis).

Use in Pregnancy and Lactation

The drug is not intended for use in adults.

Pediatric Use

It is used in children aged from 1 month to 14 years according to indications.

Special Precautions

Precautions for use

The drug should not be used if the integrity of the vial is compromised or if the labeling is missing, if there are coarse foreign inclusions, if the physical properties of the drug have changed, or if the temperature storage regime has been violated.

The administration of the drug is recorded in the established accounting forms, indicating the batch number, expiration date, manufacturer, date of administration, dose, and the nature of the reaction to the administration of the drug (if it occurs).

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles, as well as activities requiring increased concentration of attention and speed of psychomotor reactions.

Overdose

Cases of overdose have not been described.

Drug Interactions

No undesirable interactions with other medicinal products have been noted.

It can be used in combination with antibiotics, chemotherapeutic agents, and bacteriophages.

Storage Conditions

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.