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Pharmaceutical particulars
A glucose-glycine-electrolyte formulation which is effective in oral rehydration therapy. The underlying principles of this are:
1. Intestinal absorption of glucose and amino acids is an active process linked to the movement of sodium and water.
2. The linked absorption increases net fluid and electrolyte uptake and offsets fluid loss, so reversing the process of dehydration and diarrhoea;
3. When diarrhoea is caused by bacterial enterotoxins, the active transport of glucose and glycine is not impaired;
Diarrhoea may result in dehydration, hyponatraemia, hyperkalaemia and acidosis. Effective oral rehydration therapy will reverse the net secretion of fluid and electrolytes into the gut and promote net absorption of water, electrolytes and nutrients. The active ingredients of the product act in this way. Glucose and glycine are actively absorbed by a sodium-dependent mechanism, bringing about a net uptake of water. In addition, these ingredients also act as a source of energy (glucose) and amino acids (glycine). This increased content of energy and amino acid is particularly important for the calf when milk is withheld during the treatment regime.
Sodium and chloride ions from the salt form an essential part of the sodium-dependent glucose and glycine transport mechanism, which promotes the absorption of water. Potassium dihydrogen phosphate provides potassium, phosphate and hydrogen ions, helping to restore electrolyte balance. Citrate ions further enhance water uptake from the gut and indirectly provide bicarbonate to correct the acidosis of dehydration and diarrhoea. The product has extra citrate ions which aid this process.
When made up with water as directed, the product forms an isotonic solution. This is beneficial, as a hypertonic solution would promote further water secretion into the gut, so exacerbating the diarrhoea.
List of excipients
The full composition of the product is listed under the Qualitative and Quantative Composition section of this SPC.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after reconstitution according to directions: 24 hours.
Special precautions for storage
Store in a dry place.
Do not store above 25°C.
Nature and composition of immediate packaging
The veterinary medicinal product is presented in twinned laminated sachets of two sizes. The laminate consists of paper (outside), polyethylene, aluminium foil, polyethylene (inside).
Sachet A contains 14.66g of the electrolyte mix
Sachet B contains 62.69g of the glucose.
The veterinary medicinal product is available in cartons of 12 or 48 paired sachets.
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.