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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules: 7, 14, 28, 30, 60, or 90 pcs.
Marketing Authorization Holder
UNIPHARM, LLC (Russia)
Manufactured By
Wakunaga Of America, Co. Ltd. (USA)
Dosage Form
| 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.
Tablets: 7, 14, 28, 30, 60, or 90 pcs.
Marketing Authorization Holder
UNIPHARM, LLC (Russia)
Manufactured By
Wakunaga Of America, Co. Ltd. (USA)
Dosage Form
| 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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