ProbioLog Transit^® (Powder) Instructions for Use

Marketing Authorization Holder

Maoli Spindler, LLC (Russia)

Manufactured By

Mayoly CHC (France)

Contact Information

MAYOLI FARMA LLC (Russia)

Dosage Form

ProbioLog Transit®

Powder for oral administration: sachet 6.5 g 14 pcs.

Dosage Form, Packaging, and Product Composition

The content of active components in 1 sachet does not exceed the upper limit of the permissible daily intake*.
* In accordance with the requirements of Appendix 5, Chapter II, Section 1 of the “Unified Sanitary, Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Surveillance (Control)” of the Customs Union (EAEU).

Excipients: maltodextrin (filler), silicon dioxide (anti-caking agent, E551).

Does not contain sugar. Does not contain GMOs.

6.5 g (1 dose) – sachets (14) – cardboard boxes.

Therapeutic Category

Dietary supplement – synbiotic (probiotic + prebiotic)

Properties

The dietary supplement ProbioLog Transit^® is a specialized synbiotic – an enhanced combination of the prebiotic inulin and the probiotic strain of bifidobacteria Bifidobacterium lactis HN019 ATCC: SD5674 to improve intestinal motility in constipation and symptoms of intestinal discomfort associated with stool retention, by normalizing the intestinal microflora.

Bifidobacterium lactis (B. lactis) HN019 is a probiotic, a strain of normal intestinal microflora with proven efficacy, studied in experimental and clinical trials, including those involving humans suffering from gastrointestinal disorders with predominant symptoms such as constipation, irregular bowel movements and flatulence. In constipation, defecation occurs less than 3 times a week.

The probiotic strain B. lactis HN019 helps maintain normal bowel function due to the following effects:

• Significant reduction in intestinal transit time required for complete digestion of food;
• Significant reduction in the frequency of gastrointestinal symptoms such as constipation, irregular bowel movements and flatulence;
• Positive effect on the composition of the intestinal microflora: increase in the total number of beneficial lacto- and bifidobacteria and suppression of a number of pathogenic microorganisms.

The strain B. lactis HN019 has high resistance to the acidic environment of the stomach and bile salts, and has the ability to firmly bind to intestinal cells, which ensures its survival when passing through the gastrointestinal tract and a beneficial effect on the composition of the microflora in adults and the elderly.

According to research, the probiotic strain B. lactis HN019 has a high safety profile and does not have any undesirable effects on the body.

These effects are specific only to the B. lactis HN019 strain.

Inulin is a prebiotic, plant dietary fiber that has a positive effect on the intestinal microflora, the processes of digestion and absorption of food, as well as the evacuation of undigested residues.

Inulin is one of the first recognized, well-studied prebiotics with a high profile of safety and efficacy. It has GRAS status (Generally Recognized As Safe).

In accordance with the efficacy criteria for prebiotics, inulin has the following properties:

• It is not digested in the upper gastrointestinal tract, which allows it to reach the large intestine, where most of it is consumed by the beneficial intestinal microflora;
• It has a bifidogenic effect – it selectively stimulates the bifidobacteria of the intestinal microflora (when taken at a dose of 5 g/day or more). Therefore, it promotes the growth and activity of this type of probiotic bacteria and reduces the number of putrefactive microorganisms such as Clostridia, helping to form a healthier composition of the colon microflora.

According to research data, inulin has the following effects for normalizing digestion:

• It helps improve the frequency and composition of stool by increasing fecal biomass and water, stimulating bowel activity in constipation;
• It helps improve the composition of the intestinal microflora. The prebiotic index of inulin (increase in the absolute number of bifidobacteria per 1 g of feces) is (4.000±0.082)×10⁸.

An important condition for achieving the bifidogenic effect of inulin is the presence of a sufficient number of bifidobacteria in the intestine. ProbioLog Transit^® helps to ensure this condition, as it contains both inulin and the probiotic strain of bifidobacteria Bifidobacterium lactis HN019.

ProbioLog Transit^®, when taken as a course from 14 days, contributes to:

• Normalization of bowel movements by reducing intestinal transit time and increasing stool frequency;
• Reduction in the frequency of symptoms of intestinal discomfort associated with constipation, irregular bowel movements and flatulence;
• Normalization of the composition of the intestinal microflora involved in the digestive processes.

Scope of Application

Of the product ProbioLog Transit^®

• As a dietary supplement – a source of natural plant fibers (inulin) and probiotic bifidobacteria (Bifidobacterium lactis HN019) to ensure regular bowel movements by improving the composition of the intestinal microbiota, which can stimulate colon peristalsis in case of intestinal dysfunctions associated with slowed intestinal transit and stool retention.

ICD codes

Dosage Regimen

Take orally, with meals. Dissolve the contents of 1 sachet (6.5 g) in 150-200 ml of water at room temperature; it can be added to food (yogurt, cottage cheese, etc.).

Adults and children over 14 years old take 1 time per day with meals. The duration of intake is 14-30 days. If necessary, the intake can be repeated.

Side effects

During the use of the ProbioLog Transit^® complex in clinical studies, no cases of habituation or adverse events were observed.

Contraindications

• Individual intolerance to the components of the product;
• Pregnancy;
• Breastfeeding period.

Use during pregnancy and lactation

Contraindicated for use during pregnancy and breastfeeding.

Special instructions

Dietary supplement. Is not a medicinal product.

It is recommended to consult a doctor before use.

Before giving the dietary supplement to children, it is necessary to consult a pediatrician.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

The product should be stored in a dry place, protected from light, away from heat sources at a temperature from 8°C (46.4°F) to 25°C (77°F).

Shelf Life

Shelf life – 24 months. Do not use after the expiration date.

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.