Active Ingredients

When reconstituted as recommended, it contains;

Glycine 20 mmol/L

Sodium 50 mmol/L

Potassium 20 mmol/L

Chloride 39 mmol/L

Citrate 10 mmol/L

Phosphate 5 mmol/L

Glucose 160 mmol/L

Powder for oral solution.

Presented in a paired sachet, containing a pink crystalline powder in one, and a white crystalline powder in the other.

Target species
Calves

Indications for use, specifying the target species
The veterinary medicinal product is indicated as an oral rehydration therapy for the treatment of diarrhoea in calves by reversing the process of dehydration, acidosis and loss of electrolytes associated with diarrhoea, whether caused by bacteria, viruses, cryptosporidia or inappropriate nutrition.

Contraindications
None.

Special warnings for each target species

In severe cases of dehydration some animals may require additional intravenous re-hydration therapy. In such cases consult a veterinary surgeon.

Not applicable.

Not applicable.

Not applicable.

None.

Adverse reactions (frequency and seriousness)
Target species: Calves

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

Use during pregnancy, lactation or lay
Not applicable.

None known.

The veterinary medicinal product has been shown to be compatible with oral antibiotics such as amoxicillin, ampicillin and oxytetracycline.

For oral administration only.

The contents of sachets A and B should be added to 2 litres (approximately 3.5 pints) of fresh water, at a temperature of about 35°C.

Immediately scour symptoms show, withdraw milk or milk replacer and offer 2 litres of solution twice daily for two days (four feeds). For the next four feeds offer 1 litre of product solution added to 1 litre of milk or milk replacer. Thereafter feed as normal.

If the scouring is established or severe, thus causing serious dehydration, the

solution should be fed three or four times daily. The product may be used on its own for a maximum of four days.

Ensure that adequate colostrums is fed to all calves.

Keep feeding utensils clean.

Any medicated water which is not consumed within 24 hours should be discarded.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects are to be expected from an accidental overdose.

Withdrawal period(s)
Meat: Zero days.

Pharmacotherapeutic group: Oral electrolytes and carbohydrates.

ATCvet code: QA07CQ02

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.

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.

Store in a dry place.
Do not store above 25°C.

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.

N/A

Vm 00879/4177

20 December 1993

February 2024

Veterinary medicinal product not subject to prescription.