Probielle^® Baby (Suspension) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Master Pharm, S.A. (Poland)

On Behalf Of

WALMARK, a.s. (Czech Republic)

Trademark Owner

Stada Arzneimittel, AG (Germany)

Contact Information

NIZHPHARM group of companies (Russia)

Dosage Form

Probielle® Baby

Oral suspension: 10 ml bottle with a dosing pipette

Dosage Form, Packaging, and Product Composition

Suspension for oral administration.

Children 0-11 months

Children 1-3 years

Excipients : medium-chain triglycerides.

10 ml (up to 40 doses) – bottles (1) with a dosing pipette – cardboard packs.

Therapeutic Category

Dietary supplement for correcting the composition of the intestinal microflora and strengthening natural immunity

Properties

The dietary supplement Probielle^® Baby is a special combination of 2.5 billion beneficial lacto- and bifidobacteria and vitamin D₃, specially designed to support the development of natural microflora and the immune system of children from the first days of life.

Probielle^® Baby can help normalize the intestinal microflora and the baby’s stool, thereby reducing the risk of such unpleasant sensations as colic and bloating. Probielle^® Baby helps the child adapt faster to changes in the external environment, during travel, including when changing water and food, as well as during socialization in kindergarten. Probielle^® Baby helps to adapt more easily to the introduction of complementary foods and the baby’s complete transition to infant formulas.

The importance of intestinal microflora in children

The first years of a child’s life are crucial for their future health. Properly formed intestinal microflora in children is the key to a strong immune system and normal bowel function, as well as providing the body with all the necessary vitamins and trace elements.

During the first 2 years of a child’s life, their microflora is formed, which remains unchanged in the following years. During the process of colonizing the intestinal microflora with bacteria, the child may experience stool disorders, colic, bloating, flatulence, abdominal cramps, constipation, diarrhea.

What can negatively affect the intestinal microflora:

• Changes in diet (for example, switching from breast milk to formulas);
• Use of antibiotics;
• Acute respiratory viral infections or intestinal infections;
• Allergy and/or food intolerance, for example lactose intolerance;
• Helminthic infestations;
• Living in industrially developed cities;
• Stress;
• Deficiency of vitamins and minerals;
• Birth by cesarean section or prematurely;
• Unfavorable course of the neonatal period;
• Late initiation of breastfeeding;
• Prolonged stay in the maternity hospital or hospital;
• Early artificial feeding;
• Predisposition to the development of dermatological diseases.

Bifidobacterium lactis – one of the most studied species of bifidobacteria in our body. Bifidobacteria are found in mother’s breast milk and colonize the intestines in the first hours of a child’s life, having a major impact on the formation of microflora and bowel function. Additional use of B. animalis lactis bifidobacteria may lead to a reduction in intestinal colic in young children (while also helping to reduce irritability and crying time), constipation, bloating, and acute diarrhea.

Lactobacillus rhamnosus GG (LGG) – one of the most studied strains of probiotic bacteria in the world and belongs to the group of lactobacilli. This type of bacteria positively affects the child’s microflora and ensures the proper formation of immunity. It has been clinically proven that additional use of LGG helps reduce the risk of infectious diseases, the possibility of atopic dermatitis and food allergy manifestations, enhances the response to vaccination, and also reduces the symptoms of acute diarrhea and antibiotic-associated diarrhea.

Vitamin D₃– is responsible for the formation of immunity and musculoskeletal tissue. Breast milk itself does not provide infants with a sufficient amount of vitamin D₃, although this vitamin is responsible for the formation and support of the child’s immune and nervous systems and is essential for the development and maintenance of healthy bone tissue throughout a person’s life. It has been proven that additional intake of vitamin D₃ helps reduce the incidence of infectious respiratory diseases. Due to the geographical location in Russia, there is a lack of sunny days, which is why the consumption of vitamin D₃ is recommended throughout the year.

Scope of Application

Of the Probielle^® Baby product

As a dietary supplement – a source of probiotic microorganisms (Lactobacillus rhamnosus, Bifidobacterium lactis), an additional source of vitamin D₃, a means to support the formation of the baby’s natural intestinal microflora, improve gastrointestinal function and strengthen the immune system

• To normalize regular stool and reduce the intensity of colic in young children and associated symptoms of irritability and crying in children;
• To support the immune system during its formation and functioning;
• When taking antibiotics and after completing a course of antibiotic treatment;
• For constipation, bloating, diarrhea and other digestive disorders;
• To reduce the risk of diarrhea caused by viral or bacterial gastrointestinal infections (including rotavirus infection);
• To reduce the risk of intestinal disorders when changing climate, places of stay;
• For manifestations associated with food allergies and dermatitis, including for the prevention of atopic dermatitis in children;
• During the formation of microflora in formula-fed babies and during the introduction of complementary foods;
• During the formation of microflora in babies born prematurely and/or by cesarean section.

ICD codes

Dosage Regimen

Children from birth to 1 year – 1/2 pipette (0.25 ml) once a day with meals.

Children from 1 year to 3 years – 1 pipette (0.5 ml) once a day with meals.

Before use, the bottle must be shaken to mix the suspension evenly.

The suspension can be added to milk, milk formulas, liquid food, water at room temperature and used during feeding.

The duration of administration is from 10 days to 2 months; if necessary, the course can be repeated.

Probielle^® Baby can be used for lactase deficiency, celiac disease and allergy to cow’s milk protein.

After each use, remove the pipette from the bottle, wash under running water, and store separately. The bottle after opening should be tightly closed with the cap.

Contraindications

• Individual intolerance to the product components.

Special Instructions

Not a medicine.

For children, use in agreement with and under the supervision of 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 out of reach of children, in a dry place, protected from direct sunlight, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 18 months. After opening, store for 2 months.

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.