Normobact^® L (Powder) Instructions for Use

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

Manufactured By

Master Pharm, S.A. (Poland)

For

Pharmaceutical Works “POLPHARMA”, SA (Poland)

Contact Information

AKRIKHIN JSC (Russia)

Dosage Form

Normobact® L

Powder 4×109 CFU+800 mg/1 sachet: sachet 3 g 10 pcs.

Dosage Form, Packaging, and Product Composition

Powder from white to cream-colored.

Composition per 1 sachet (3 g) maltodextrin, lyophilized lactic acid bacteria Lactobacillus rhamnosus GG – 4×10⁹ CFU, fructooligosaccharides, mono- and diglycerides of fatty acids (E471) – a substance preventing caking.

3 g – sachets (10) – cardboard packs.

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

Normobact^® L is a dietary supplement combining probiotics (live lactic acid bacteria Lactobacillus rhamnosus GG) and prebiotics (fructooligosaccharides).

This combination prolongs the lifespan of “beneficial” bacteria and significantly increases their quantity in the intestine; it restores the body’s immune resilience.

Fructooligosaccharides (prebiotics) are dietary fibers belonging to the class of low-calorie non-digestible carbohydrates.

They are necessary for the normal functioning of the intestine and are a source of nutrition for the intestinal microflora.

Maltodextrin is a product of incomplete starch hydrolysis, it is non-toxic.

It is an auxiliary component of the Normobact^® L dietary supplement, neutral for infant digestion.

Mono- and diglycerides of fatty acids (E471) are a food additive of natural origin, belonging to the class of harmless substances.

It is widely used as a stabilizer and emulsifier in the production of baby food, confectionery, and bakery products.

LGG^® – Lactobacillus rhamnosus, isolated by Professors Gorbach and Goldin.

1. Safety of LGG^®

• LGG^® belongs to the representatives of the normal gastrointestinal microbiota and is a natural part of the intestinal barrier;
• LGG^® is the most studied strain of probiotic microorganisms;
• LGG^® has been used since 1990;
• LGG^® is described in more than 1000 scientific publications;
• More than 300 clinical studies have been conducted with LGG^® in all age groups (from newborns to adults, including pregnant women) on all continents (Asia, Australia, Africa, Europe, North and South America);
• LGG^® has been granted GRAS status “Generally Recognized As Safe” by the FDA (U.S. Food and Drug Administration (2007));
• LGG^® has been granted QPS status “Qualified Presumption of Safety” by the European Food Safety Authority (EFSA).

2. Properties of LGG^®

• Resistance to the effects of gastric juice hydrochloric acid and bile, therefore LGG^® remain viable when passing through the gastrointestinal tract;
• Maximum adhesive capacity – LGG^® effectively attach to the epithelium of the intestinal mucosa, colonize it and displace pathogenic flora.

3. LGG^® contribute to

• Synthesis of compounds that inhibit the growth of pathogenic microorganisms;
• Synthesis of lactic acid, favorably influencing the development of bifidobacteria;
• Reduction of the risk of microflora imbalance development;
• Increase in the body’s non-specific resistance;
• Increase in phagocyte activity;
• Increase in the levels of immunoglobulins (IgA), anti-inflammatory cytokines, IL-6, IL-10 (interleukins 6 and 10).

4. Studied effects of LGG^® on the human body

Scope of Application

Of the Normobact^® L product

As a dietary supplement – a source of probiotic microorganisms and fructooligosaccharides, contributing to

• Improvement of intestinal function;
• Restoration of intestinal microflora balance;
• Strengthening of immunity and acceleration of the body’s adaptation processes.

Possible cases of application

• Antibiotic intake;
• Intestinal infections and poisonings;
• Stool disorders (diarrhea, constipation);
• Food allergy, atopic dermatitis;
• Change in diet and eating regimen (travel);
• Decrease in the body’s defenses;
• Imbalance of microflora.

ICD codes

Dosage Regimen

Take orally during meals, immediately after dissolving in liquid.

Infants from 1 month and children under 3 years are prescribed 1 sachet/day.

For children under 3 years, the contents of the sachet should be dissolved in a sufficient amount of liquid before use; for breastfed infants, the contents of the sachet should be dissolved in expressed breast milk before use.

Children over 3 years and adults are prescribed 1-2 sachets/day.

The contents of the sachet should be dissolved in water, yogurt, or milk before use.

Do not exceed the recommended daily dose.

The duration of use averages 10-14 days.

During and after a course of antibiotic treatment, the duration of Normobact^® L use can be 2-3 weeks.

Contraindications

• Individual intolerance to the components of the dietary supplement.

Special Instructions

Dietary supplement, not a medicinal product.

Consult a doctor before use.

Normobact^® L is not intended for parenteral use.

Normobact^® L has not been treated with ionizing radiation.

In the Normobact^® L dietary supplement, the Lactobacillus rhamnosus GG (LGG^®) strain is of natural origin and has not undergone any genetic modifications.

Normobact^® L does not contain cow’s milk proteins, lactose, gluten, or sucrose, therefore it can be used by individuals intolerant to these substances.

Normobact^® L should not be used as the main source of nutrition.

Storage Conditions

The product should be stored in the original packaging in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

Over-the-Counter

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.