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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

Bottle OTC Icon 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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