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Lactobalance® (Tablets, Capsules) Instructions for Use

Therapeutic Category

Dietary supplement – source of bifidobacteria and lactobacilli

Properties

Dietary supplement to food.

Probiotic microorganisms are non-pathogenic, non-toxigenic microorganisms that enter the human intestine with food, have a beneficial effect on the human body and normalize the composition and biological activity of the digestive tract microflora: mainly microorganisms of the genera Bifidobacterium, Lactobacillus, Propionibacterium, Lactococcus.

Bifidobacteria preserve and improve the physiological balance of the intestinal microflora and restore the deficiency of bifidobacteria; exhibit antagonistic activity against a wide range of pathogenic and opportunistic microorganisms; neutralize toxic metabolic products; promote the absorption of minerals (including iron), proteins, carbohydrates; possess vitamin-forming activity, in particular of group B; prevent the formation of protracted forms of intestinal infections; increase the non-specific resistance of the body.

Lactobacilli are an important component of the normal microflora of the digestive and genital tract of mammals. They possess diverse biological properties and actively participate in metabolic and regulatory processes. They exhibit pronounced antagonistic activity against a wide range of aerobic and facultative anaerobic gram-negative and gram-positive bacteria, as well as some obligate anaerobic microorganisms. This activity is most pronounced in representatives of the species Lactobacillus acidophilus, L. plantarum, L. casei, L. fermentii, L. buchneri.

Bacteria of the probiotic strain Lactobacillus reuteri exhibit specific anti-Helicobacter activity. The peculiarity of these lactobacilli is that they recognize the surface receptors of the Helicobacter pylori cell wall and bind to it. So-called co-aggregates are formed, which are naturally excreted from the body through the gastrointestinal tract. As a result, the content of H. pylori in the body decreases, which helps to reduce the risk of stomach and duodenal diseases.

Lactobacilli and bifidobacteria are used in dietary supplements both separately and in combination.

Lactobacilli and bifidobacteria, interacting synergistically, maintain and regulate the physiological balance of the intestinal microflora, increasing the resistance of the intestinal mucosa to pathogenic microorganisms; inhibit the translocation of pathogenic bacteria in the colon, possess antagonistic activity against many pathogenic and opportunistic microorganisms, and normalize immunity indicators when it is suppressed.

A combination of lactobacilli and bifidobacteria can be used in dietary supplements also containing vitamins A, E, C.

Scope of Application

As an auxiliary agent for dysbiosis of various etiologies, acute intestinal infections; chronic colitis of various etiologies (including nonspecific ulcerative colitis), inflammatory diseases of the stomach and duodenum (including those associated with the presence of Helicobacter pylori); prevention of acute and chronic gastrointestinal diseases; debilitating diseases and prolonged stress; predisposition to allergic conditions; surgical interventions on the gastrointestinal tract (pre- and postoperative period); for infants (especially when switching to artificial feeding early).

ICD codes

ICD-10 code Indication
A04.9 Unspecified bacterial intestinal infection
A09.0 Other and unspecified gastroenteritis and colitis of infectious origin (infectious diarrhea NOS)
B98.0 Helicobacter pylori as the cause of diseases classified elsewhere
K25 Gastric ulcer
K26 Duodenal ulcer
K29 Gastritis and duodenitis
K51 Ulcerative colitis
K52 Other noninfectious gastroenteritis and colitis
K63.8 Other specified diseases of intestine
K92.9 Unspecified disease of digestive system
P92 Feeding problems of newborn
T78.4 Allergy, unspecified
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
Z73.3 Stress, not elsewhere classified (physical and mental strain)
Z98.8 Other specified postprocedural states
ICD-11 code Indication
1A0Z Bacterial intestinal infections, unspecified
1A40.Z Infectious gastroenteritis or colitis, unspecified
4A8Z Allergic conditions or hypersensitivity conditions of unspecified type
DA42.81 Radiation gastritis
DA42.8Z Gastritis due to external causes, unspecified
DA42.Z Gastritis, unspecified
DA51.53 Radiation duodenitis
DA51.5Z Duodenitis due to external causes, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB33.2Z Allergic or alimentary colitis, unspecified
DB33.4Y Other specified colitis or proctitis caused by external agents
DB33.4Z Colitis or proctitis caused by external agents, unspecified
DB36.Z Certain infections of the colon, unspecified
DD71.Z Ulcerative colitis, unspecified
DE2Z Diseases of the digestive system, unspecified
KD32.Z Feeding problems of newborn, unspecified
ME24 Clinical manifestations referable to the digestive system
QB6Z Surgical or postprocedural conditions, unspecified
QB9A Preparatory procedures for subsequent treatment
QE01 Stress, not elsewhere classified
XN3DY Helicobacter pylori (H. pylori)

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Capsules

Used in accordance with the recommendations for the specific product used.

Side Effects

Possible: allergic reactions.

Contraindications

Hypersensitivity to the active substances contained in the product used.

Use During Pregnancy and Breastfeeding

During pregnancy and breastfeeding, only products intended for pregnant women and nursing mothers should be used.

Special Instructions

Not a medicinal product.

Consult a doctor before using the product.

Do not exceed the recommended dose of the product used.

In children, only dietary supplements intended for the corresponding age group should be used.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

UNIPHARM, LLC (Russia)

Manufactured By

Wakunaga Of America, Co. Ltd. (USA)

Dosage Form

Bottle OTC Icon Lactobalance® Capsules: 7, 14, 28, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 378 mg.

1 caps.
Probiotic microorganisms ≥3 × 109 CFU*, incl.
   3 strains of live lactobacilli (L. Gasseri KS-13, L. Gasseri LAC-343, L. Rhamnosus LCS-742) ≥1 × 109 CFU
   6 strains of live bifidobacteria (B. Bifidum G9-1, B. Longum MM-2, B. Longum BB536 Strain M, B. Infantis M-63, B. Breve M16V Type T, B. Lactis B1-04) ≥2 × 109 CFU

* CFU – colony-forming unit (an indicator of the number of viable microorganisms).

Excipients : potato starch, gelatin, silicon dioxide.

7 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (1) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
30 pcs. – dark brown glass bottle (1) – cardboard packs.
60 pcs. – dark brown glass bottle (1) – cardboard packs.
90 pcs. – dark brown glass bottle (1) – cardboard packs.

Marketing Authorization Holder

UNIPHARM, LLC (Russia)

Manufactured By

Wakunaga Of America, Co. Ltd. (USA)

Dosage Form

Bottle OTC Icon Lactobalance® Kids Tablets: 7, 14, 28, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Product Composition

Tablets weighing 444 mg.

1 tab.
Probiotic microorganisms* 1.0 × 109 CFU**, incl.
   Live lactobacilli (L. Gasseri KS-13) ≥7.5 × 108 CFU
   Live bifidobacteria (B. Bifidum G9-1, B. Longum MM-2) ≥2.5 × 108 CFU

* probiotic mixture ((3ST40FR30) (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2).
** CFU – colony-forming unit (an indicator of the number of viable microorganisms).

Excipients : fructose, dextrin (stabilizer), corn starch (stabilizer), calcium carbonate (acidity regulator), magnesium salt of stearic acid (stabilizer), natural vanilla flavor.

7 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – plastic bottles (1) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.
30 pcs. – plastic bottles (1) – cardboard packs.
60 pcs. – plastic bottles (1) – cardboard packs.
90 pcs. – plastic bottles (1) – cardboard packs.
10 pcs. – glass bottles (1) – cardboard packs.
20 pcs. – glass bottles (1) – cardboard packs.
30 pcs. – glass bottles (1) – cardboard packs.
60 pcs. – glass bottles (1) – cardboard packs.
90 pcs. – glass bottles (1) – cardboard packs.

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