Rehydron® Bio (Powder) Instructions for Use
Marketing Authorization Holder
Valenta Pharm, JSC (Russia)
Manufactured By
S.I.I.T., s.r.l. (Italy)
Contact Information
VALENTA PHARM JSC (Russia)
Dosage Form
| Rehydron® Bio | Powder for oral solution preparation: sachet (A+B) 6.4 g 5 pcs. |
Dosage Form, Packaging, and Product Composition
Powder for preparation of oral solution
| 1 sachet A | |
| Corn maltodextrin (carrier) | 1900 mg |
| Lactobacillus rhamnosus GG | 100 mg |
The content of lyophilized Lactobacillus rhamnosus GG bacteria is 1×109 CFU.
| 1 sachet B | |
| Glucose | 3020 mg |
| Sodium citrate | 580 mg |
| Sodium chloride | 360 mg |
| Potassium chloride | 300 mg |
| Strawberry flavor | 120 mg |
| Silicon dioxide (E551, anticaking agent) | 10 mg |
| Sucralose (E955, sweetener) | 10 mg |
Composition and osmolarity of substances in the finished Rehydron® Bio solution:
Glucose – 85 mmol/l;
Sodium (Na+) – 60 mmol/l;
Chloride (Cl–) – 50 mmol/l;
Potassium (K+) – 20 mmol/l;
Citrate – 10 mmol/l;
Total osmolarity of the Rehydron® Bio solution – 225 mmol/l.
Nutritional value per 100 ml of the finished solution: carbohydrates – 2.46 g, proteins – 0 g, fats – 0 g.
Energy value per 100 ml of the finished solution: 10 kcal/42 kJ.
Packaging: 5 paired sachets (A+B) of 6.4 g powder each, in a cardboard box.
Therapeutic Category
Dietary supplement – source of electrolytes, lactobacilli and prebiotics
Properties
Biologically active food supplement. Not a medicinal product.
Sodium citrate, sodium chloride and potassium chloride help restore the water-electrolyte balance. Usually, a deficiency of electrolytes in the body is observed in conditions associated with fluid loss, such as diarrhea, dehydration, high fever, etc.
Glucose is a source of energy that provides the basic needs of the body.
Lyophilized Lactobacillus rhamnosus GG bacteria help restore and maintain normal intestinal microflora.
Maltodextrin is a prebiotic component and stimulates the growth of normal intestinal microflora.
Scope of Application
Of the product Rehydron® Bio
- For oral rehydration in case of significant fluid loss, as well as to improve the functional state of the gastrointestinal tract.
ICD codes
| ICD-10 code | Indication |
| E86 | Volume depletion (including dehydration, hypovolemia) |
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. |
The contents of two sachets (A and B) are dissolved in 200 ml of water at room temperature and taken orally. If there is no certainty that the water is suitable for drinking, it should be boiled and cooled before preparing the solution.
The concentration of salts and glucose in the finished solution promotes optimal absorption of the active substances.
For adults and children over 3 years of age, Rehydron® Bio should be used according to the data given in the table.
| Weight (kg) | Volume of finished Rehydron® Bio solution (ml/day) | Additional fluid volume (ml/day) | Total fluid requirement (l/day) |
| 12 | 550 | 750 | 1.3 |
| 14 | 600 | 800 | 1.4 |
| 16 | 620 | 880 | 1.5 |
| 18 | 650 | 950 | 1.6 |
| 20 | 700 | 1000 | 1.7 |
| 25 | 750 | 1050 | 1.8 |
| 30 | 800 | 1100 | 1.9 |
| 40 | 900 | 1200 | 2.1 |
| 50 | 1000 | 1300 | 2.3 |
| 70 | 1200 | 1500 | 2.7 |
The finished solution should be used within 24 hours.
Contraindications
- Individual intolerance to the components of Rehydron® Bio;
- Children under 3 years of age.
Special Instructions
Biologically active food supplement. Not a medicinal product.
Dispensing Status
For sale to the public through pharmacy chains and specialized stores, departments of the trading network.
Storage Conditions
Store in a dry place at room temperature.
Shelf Life
Shelf life – 2 years. Do not use after the expiration date printed on the packaging.
After preparation, the solution should be stored in the refrigerator at a temperature from 2°C (35.6°F) to 8°C (46.4°F) for 24 hours.
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
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