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Neobiotic Lactobalance® (Capsules, Powder) Instructions for Use

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

This dietary supplement is a balanced combination of probiotic microorganisms (bifidobacteria and lactobacilli), lactic acid bacteria, and prebiotics for the restoration of normal gut microbiota, enhancement of the protective function of the immune system and the body’s overall resistance, absorption of beneficial substances, and synthesis of important vitamins and amino acids.

The components of the product contribute to: the prevention and treatment of intestinal dysbiosis of various etiologies, including in gastric and duodenal ulcers, pancreatitis, cholecystitis, hepatitis, and other diseases of the digestive system; prevention of the development of intestinal infection (inhibit the growth of pathogenic bacteria); reduction in the frequency of chronic constipation/diarrhea during long-term antibiotic therapy; relief of constipation (normalizes bowel function); supplementation to standard Helicobacter pylori eradication therapy; enhancement of anti-inflammatory properties in patients with ulcerative colitis and other inflammatory bowel diseases (inhibit the secretion or destroy toxins released by some pathogenic bacteria in the human body); prevention of hospital-acquired infections and dysbiosis in patients frequently suffering from acute respiratory viral infections (ARVI); helps reduce the level of fatigue and tiredness; boosting immunity (helps maintain a sufficient number of circulating antibodies in the blood); reduction of cholesterol levels; positive effect on the function of the liver and kidneys in patients with hypercholesterolemia; weight loss; providing conditions for the action of digestive enzymes, production and absorption of vitamins, minerals, and amino acids; as well as maintaining healthy skin and nervous system; prevention of allergic reactions (reduces the frequency of alimentary allergic reactions), prevention of atopic dermatitis development; reduction of intoxication manifestations of hepatic encephalopathy in individuals with liver cirrhosis; restoration and maintenance of normal vaginal microflora in dysbiosis, restoration of the natural acidic environment in the vagina (pH 3.8-4.5) and increasing the resistance of the mucous membrane to the effects of pathogenic microorganisms; maintaining normal intestinal function during climate change; reduction in the formation of toxins and harmful carcinogenic substances in the intestine, such as ammonia, indole, and hydrogen sulfide.

Scope of Application

As a dietary supplement – a source of probiotic microorganisms (bifidobacteria and lactobacilli), lactic acid microorganisms, fructooligosaccharides, and an additional source of vitamin C for the prevention of dysbiosis, natural restoration of normal gut microbiota in chronic gastrointestinal conditions, antibiotic therapy, maintaining normal intestinal function during climate change, supporting immunity, reducing the risk of allergy manifestations, in lactase deficiency.

ICD codes

ICD-10 code Indication
E54 Deficiency of ascorbic acid
E63.8 Other specified types of nutritional deficiency
E73.1 Secondary lactase deficiency
K63.8 Other specified diseases of intestine
T78.4 Allergy, unspecified
Y40 Systemically acting antibiotics
ICD-11 code Indication
4A8Z Allergic conditions or hypersensitivity conditions of unspecified type
5B56.Z Vitamin C deficiency, unspecified
5B7Z Malnutrition, unspecified
5C61.62 Secondary lactase deficiency
8D40.0 Encephalopathy due to nutritional deficiency
DA92.1 Pneumatosis intestinalis of the small intestine
DA98.Z Polyps of small intestine, unspecified
DB31.1 Pneumatosis of the colon
DB36.Z Certain infections of the colon, unspecified
DE2Z Diseases of the digestive system, unspecified
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

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.

Capsules, Powder

Used in adults and children in the form of products intended for the respective age group.

The dosing regimen depends on the product used.

Contraindications

Individual intolerance to the components of the dietary supplement.

Special Instructions

This is a dietary supplement, not a medicinal product.

Consultation with a doctor is recommended before use.

In children, use in the form of products intended for this category of patients, taking into account age restrictions.

Consultation with a pediatrician is necessary before use in children.

In children under 5 years of age, should be used in agreement with and under the supervision of a pediatrician.

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

Cell Biotech, Co. Ltd. (Republic of Korea)

For

UNIPHARM, Inc. (USA)

Dosage Form

Bottle OTC Icon Neobiotic Lactobalance® Capsules: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 350 mg.

1 capsule
Probiotic complex ≥5×109 CFU
   Live bifidobacteria (Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3, Bifidobacterium bifidum CBT BF3) ≥24.4×108 CFU/g
   Live lactobacilli (Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5) ≥16.8×108 CFU/g
   Live lactic acid microorganisms Streptococcus thermophilus CBT ST3 ≥8.8×108 CFU/g
Prebiotic complex: fructooligosaccharides 175 mg
Ascorbic acid (vitamin C) 12 mg (20%)*

* % of the recommended daily intake level (TR CU 022/2011).
Does not exceed the upper permissible daily intake level.

Nutrients Nutritional value per 1 capsule % of RDI per 1 capsule Nutritional value per 100 ml
Protein 0 g 0% 0 g
Carbohydrates 0.33 g 0.13% 95 g
Fats 0 g 0% 0 g
Energy value 5.68 kJ/1.36 kcal 1623.4 kJ/388 kcal

Excipients: maltodextrin – 46.55 mg, corn starch – 80.38 mg, magnesium stearate (anti-caking agent) – 3.5 mg.

Capsule shell composition: hypromellose (carrier) – 75 mg.

10 pcs. – plastic bottles (1) – cardboard packs.
20 pcs. – plastic bottles (1) – cardboard packs.
30 pcs. – plastic bottles (1) – cardboard packs.

Marketing Authorization Holder

UNIPHARM, LLC (Russia)

Manufactured By

Cell Biotech, Co. Ltd. (Republic of Korea)

For

UNIPHARM, Inc. (USA)

Dosage Form

Bottle OTC Icon Neobiotic Lactobalance® Baby Powder for oral administration: sachet 1 g 10 pcs.

Dosage Form, Packaging, and Product Composition

Powder for oral administration.

1 sachet
Probiotic complex 1×109 CFU,
   Including live Lactobacilli ≥4×108 CFU
      Lactobacillus rhamnosus CBT LR5 2×108 CFU
      Lactobacillus plantarum CBT LP3 2×108 CFU
   Including live Bifidobacteria ≥6×108 CFU
      Bifidobacterium infantis CBT BT1 1.5×108 CFU
      Bifidobacterium longum CBT BG7 1.5×108 CFU
      Bifidobacterium bifidum CBT BF3 1.5×108 CFU
      Bifidobacterium breve CBT BR3 1.5×108 CFU
Prebiotic complex: fructooligosaccharides 265.28 mg

Nutritional value per 1 g: carbohydrates – 1 g.
Energy value: 17 kJ (4 kcal).

Excipients: maltose, fructooligosaccharides, dextrose (glucose), maltodextrin.

1 g – sachets (10) – cardboard packs.

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