Cow lactoglobulin against coli-proteus (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Rostov Research Institute Of Microbiology And Parasitology Of Rospotrebnadzor, FSUE (Russia)

ATC Code

J06BB (Specific immunoglobulins)

Dosage Form

Cow lactoglobulin against coli-proteus

Lyophilizate for preparation of solution for oral administration 0.5 g/dose: 0.5 g or 1 g vial 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for oral administration of a yellowish-white color, easily soluble in water, odorless.

0.5 g (1 dose) – vials (10) – carton packs.
1 g (2 doses) – vials (10) – carton packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP

Pharmacological Action

Anti-coli-proteus lactoglobulin is a purified fraction of globulins from immune cow colostrum, obtained by alcohol precipitation and lyophilized.

The specific reagent is immune globulins containing antibodies to pathogenic Escherichia coli serogroups 026, 055, 0111, 0119, Proteus vulgaris serogroup 043 and Proteus mirabilis serogroup 035.

The therapeutic effect of the drug is due to the content of specific antibodies to Escherichia coli, Proteus vulgaris and Proteus mirabilis, which have antimicrobial and toxin-neutralizing effects.

Indications

• Treatment of coli infection and dysbacteriosis accompanied by massive excretion of proteus in young children.

ICD codes

Dosage Regimen

Lactoglobulin is administered orally 20-30 minutes before meals.

The metal cap and rubber stopper are removed from the vial, and boiled water at room temperature is added at the rate of 10 ml (2 teaspoons) per one dose; mix.

Do not shake the drug when diluting.

Within 5 minutes after adding water, a transparent, slightly opalescent liquid with a yellowish tint should form.

If the vial contains 2 doses, the diluted drug, closed with a stopper, is allowed to be stored at a temperature of 2 to 10°C (50°F) for no more than 1 day.

The drug is unsuitable for use if the packaging integrity is compromised, if it is unlabeled, if there are changes in physical properties, if there are foreign inclusions, if stored improperly, or if the expiration date has passed.

The drug is prescribed from the first days of the illness: for children under 6 months – 1 dose 2 times a day; for children over 6 months – 2 doses 2 times a day.

In mild and moderate forms of the disease, the course of treatment is from 7 to 14 days. In severe cases, the frequency of drug administration can be increased to three times, and the course of treatment can be extended to 21 days.

Treatment of children with coli infection with lactoglobulin is carried out against the background of generally accepted antibacterial and symptomatic therapy.

When treating children with dysbacteriosis, the drug is used for selective decontamination of proteus, hemolytic lactose-negative Escherichia coli in combination with preparations containing bifidobacteria and lactobacilli (bifidumbacterin, lactobacterin, acylact, etc.).

Adverse Reactions

No reactions to the administration of the drug have been registered.

Contraindications

• Individual intolerance to cow’s milk.

Pediatric Use

Used in children according to indications.

Drug Interactions

Lactoglobulin is compatible with antibiotics, normoflora preparations (bifidumbacterin, bificol, bifiliz, lactobacterin, acylact, acipol).

Storage Conditions

The drug is transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 10°C (50°F). Store in a dry, dark place out of the reach of children at a temperature of 2 to 10°C (50°F).

Shelf Life

Shelf life – 4 years. The drug with an expired shelf life must not be used.

Dispensing Status

Available without a 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.