SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Lectade Plus Powder for Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients %w/w g/sachet

Sachet A(Electrolyte mix)

Sodium chloride 5.933 4.59

Glycine 3.891 3.01

Potassium dihydrogen phosphate 1.758 1.36

Sodium acid citrate 2.327 1.80

Potassium citrate 4.188 3.24

Sodium citrate 0.853 0.66

Sachet B

Glucose monohydrate 81.037 62.69

Other ingredients

Erythrosine E127 (Sachet A) 0.007 0.005

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

3. PHARMACEUTICAL FORM

Powder for oral solution.

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

4. CLINICAL PARTICULARS

4.1 Target species

Calves

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

None.

None.

4.5 Special precautions for use

None.

4.6 Adverse reactions (frequency and seriousness)

None known.

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

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

4.9 Amounts to be administered and administration route

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.

Scouring calves

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.

Duration of treatment

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.

General recommendations

Keep feeding utensils clean.

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

No adverse effects are to be expected from an accidental overdose.

Meat: Zero days.

5. PHARMACOLOGICAL PROPERTIES

A glucose-glycine-electrolyte formulation which is effective in oral rehydration therapy. The underlying principles of this are:

linked to the movement of sodium and water.

offsets fluid loss, so reversing the process of dehydration and diarrhoea;

3. When diarrhoea is caused by bacterial enteroxtoxins, 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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

The full composition of the product is listed under section 2 of this SPC.

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after dilution or reconstitution according to direction: 24 hours.

6.4. Special precautions for storage

Store in a dry place.

Do not store above 25^°C.

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

Lectade Plus 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.

Available in cartons of 12 or 48 paired sachets.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Elanco Animal Health

Eli Lilly & Company Limited

Lilly House

Priestly Road

Basingstoke

Hampshire

RG24 9NL

8. MARKETING AUTHORISATION NUMBER

Vm00006/4133

9. DATE OF THE FIRST AUTHORISATION

Date: 20 December 1993

10. DATE OF REVISION OF THE TEXT

Date: April 2015

Approved: 08 April 2015