Synbiotic Maxilac® Baby (Granules) Instructions for Use
Marketing Authorization Holder
FP Obolenskoe, JSC (Russia)
Manufactured By
Labomar, S.P.A. (Italy)
Contact Information
BINNOPHARM GROUP LLC (Russia)
Dosage Form
 |
Synbiotic Maxilac® Baby | Granules for oral use: 1.5 g sachets 10 pcs. |
Dosage Form, Packaging, and Product Composition
| Granules for oral use | 1 sachet | Average/Recommended Daily Intake (RDI)* |
| Probiotic microorganisms | ≥1×109 CFU** | |
| Including Lactobacilli | 6.6×108 CFU | 5×107 CFU |
| Lactobacillus acidophilus LA-14 | 1.11×108CFU | |
| Lactobacillus rhamnosus GG | 1.11×108CFU | |
| Lactobacillus casei LC-11 | 1.11×108CFU | |
| Lactobacillus paracasei Lpc-37 | 1.11×108CFU | |
| Lactobacillus plantarum Lp-115 | 1.11×108CFU | |
| Lactobacillus salivarius Ls-33 | 1.11×108CFU | |
| Including Bifidobacteria | 3.3×108 CFU | 5×108 CFU |
| Bifidobacterium longum Bl-05 | 1.11×108CFU | |
| Bifidobacterium lactis Bl-04 | 1.11×108 CFU | |
| Bifidobacterium bifidum Bb-02/lactis | 1.11×108CFU | |
| Prebiotic component fructooligosaccharides | 0.538 g | 5 g |
* Appendix No. 5 to the Decision of the Customs Union Commission dated May 28, 2010 No. 299 (as amended on January 22, 2019) “On the application of sanitary measures in the customs union”.
** CFU – colony-forming unit of bacteria (an indicator of the number of viable microorganisms).
Excipients: maltodextrin (filler) – 0.85 g, silicon dioxide (disintegrant) – 0.1 g.
1.5 g – sachets (10) – cardboard boxes.
Therapeutic Category
Dietary supplement – synbiotic (probiotic + prebiotic)
Properties
Synbiotic Maxilac® Baby is the first synbiotic that contains 9 cultures of beneficial bacteria in the concentration necessary for a child’s intestine – 1 billion CFU.
The Lactobacilli contained in the composition of Synbiotic Maxilac® Baby suppress the growth of pathogenic microflora, provide a protective function for the body and naturally strengthen immunity.
Bifidobacteria, which are also part of Synbiotic Maxilac® Baby, participate in the synthesis of amino acids, proteins and vitamins, enhance the absorption of calcium ions, iron, and vitamin D.
Fructooligosaccharides (prebiotic in the composition of Synbiotic Maxilac® Baby) stimulate the rapid reproduction of beneficial microorganisms, which inhibits the development of pathogenic bacteria, reduce intestinal contamination with toxins and improve its function, stimulate peristalsis, cleanse from toxins, serve for the prevention of constipation and diarrhea, and contribute to the normalization of gastrointestinal functions.
Synbiotic Maxilac® Baby is specially created for children and is produced using an innovative manufacturing technology. This technology protects the microgranules from the effects of internal and external environmental factors, due to which a large part of the probiotic bacteria in the composition of Synbiotic Maxilac® Baby reaches the intestine, rather than dissolving in the stomach, which positively affects the restoration of the gastrointestinal microflora, as the concentration of microorganism colonies increases from the stomach to the large intestine.
Synbiotic Maxilac® Baby does not contain casein or preservatives, therefore it is safe for children with allergies to products of this group.
Synbiotic Maxilac® Baby can be used in children with lactose intolerance.
Scope of Application
Of the product Synbiotic Maxilac® Baby
As a dietary supplement – a source of probiotic microorganisms (a complex of lacto- and bifidobacteria) and fructooligosaccharides
- For normalization of intestinal microflora during and/or after taking medications that may cause changes in the qualitative and/or quantitative composition of the gastrointestinal microbiocenosis;
- As an auxiliary agent for functional intestinal disorders (diarrhea, dyspepsia, constipation, flatulence, nausea, belching, vomiting, abdominal pain and discomfort;
- To maintain immunity during seasonal surges of infectious diseases;
- For the prevention of intestinal disorders when changing climate or place of stay.
ICD codes
| ICD-10 code | Indication |
| E63.8 | Other specified types of nutritional deficiency |
| K30 | Functional dyspepsia (digestive disorder) |
| K59.0 | Constipation |
| K59.1 | Functional diarrhea |
| K59.8 | Other specified functional intestinal disorders |
| K63.8 | Other specified diseases of intestine |
| P78.3 | Noninfective neonatal diarrhea |
| P78.9 | Disorder of the digestive system in the perinatal period, unspecified |
| R10.4 | Other and unspecified abdominal pain (colic) |
| R11 | Nausea and vomiting |
| R14 | Flatulence and related conditions (including abdominal bloating, belching) |
| Y40.9 | Systemic antibiotics, unspecified |
| Y53.9 | Agents primarily affecting the gastrointestinal tract, unspecified |
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. |
Synbiotic Maxilac® Baby is taken orally with meals. The contents of the sachet are recommended to be dissolved in 50 ml of warm water or milk.
Children from the first days of life up to 2 years are prescribed 1 sachet/day. Children from 2 years and adults – 2 sachets/day (in 1 or 2 doses).
The duration of administration is at least 10 days. If necessary, the intake of Synbiotic Maxilac® Baby can be extended up to 1 month.
Contraindications
- Individual intolerance to the components.
Special Instructions
Dietary supplement. Is not a medicinal product.
Before using Synbiotic Maxilac® Baby, it is recommended to consult a doctor. Before use by children, it is recommended to consult a pediatrician.
For normalization of intestinal microflora in adults and children from 3 years, it is recommended to use Maxilac® (capsules).
Dispensing Status
Through pharmacy networks and specialized stores, departments of the retail chain.
Storage Conditions
The product should be stored out of the reach of children at a temperature not exceeding 25°C (77°F); does not require refrigeration.
Shelf Life
Shelf life – 2 years.
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![Synbiotic Maxilac® Baby [Granules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Synbiotic Maxilac® Baby [Granules] 2")