summary of product characteristics

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Revised: April 2011

AN: 02053/2010 – 02056/2010

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Elanco Scour Formula Powder for oral solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sachet A

Glycine

Citric acid anhydrous

Potassium citrate monohydrate

Potassium dihydrogen phosphate

% w/w

9.649

0.749

0.187

6.370

Sodium chloride 13.396

30.351

Sachet B

Glucose monohydrate 69.649

Total 100.00

When reconstituted as recommended, it contains:

Glycine

Sodium

Potassium

Chloride

Citrate

Phosphate

Glucose mmol/Litre

41

73

16

73

1

15

114

3. PHARMACEUTICAL FORM

Powder for oral solution.

Presented as a white crystalline powder.

4. CLINICAL PARTICULARS

4.1 Target species

Horses, calves, lambs and pigs.

4.2 Indications for use, specifying the target species

Calves

To reverse the process of dehydration and loss of electrolytes following diarrhoea resulting from bacteria such as E. coli or viruses such as rotavirus.

To reduce scouring in bought-in calves.

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AN: 02053/2010 – 02056/2010

Pigs

To reverse the process of dehydration and loss of electrolytes following pre and post-weaning diarrhoea resulting from bacteria such as E. coli or viruses such as rotavirus.

To encourage fluid intake and prevent dehydration and set back after periods of stress, e.g. weaning, transporting, etc.

As a short-term measure to prevent dehydration in piglets when the sow is suffering from agalactia.

Lambs

To reverse the process of dehydration and electrolyte loss following diarrhoea.

To encourage fluid intake and to prevent dehydration in cases of starvation at lambing.

Horses

To reverse the process of dehydration and loss of electrolytes following diarrhoea.

To replace electrolytes lost through sweating especially after prolonged exercise, e.g. endurance rides.

To treat subclinical dehydration (reflected by raised serum protein and packed cell volume) in performance horses.

4.3 Contraindications

None.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use i. Special precautions for use in animals ii.

Mix well after reconstitution in water.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

None.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

May be used during pregnancy and lactation.

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4.8 Interaction with other medicinal products and other forms of interaction

Electrolyte solutions are not compatible with sulphonamides.

4.9 Amounts to be administered and administration route

The product is intended for oral administration only.

The contents of Sachet A and B are to be added to 2 litres (3 ½ pints) of water.

Calves

Bought-in calves: Feed 2 litres of solution made up as directed instead of milk as the first feed on arrival. For the second feed, use 1 litre of prepared solution mixed with 1 litre of milk or milk replacer. Thereafter feed as normal.

Scouring calves: Immediately scour symptoms show, withdraw milk or milk replacer and feed 2 litres of solution made up as directed twice daily for 2 days (four feeds).

For the next four feeds use 1 litre of prepared solution mixed with 1 litre of milk or milk replacer. Thereafter feed as normal.

Duration of treatment: If the scouring is established or severe 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.

Pigs

Suckling pigs: Immediately scour symptoms show, fresh solution made up as directed should be made available, in a cube drinker or similar clean vessel, to the whole litter. The amount of solution consumed will depend on the age of the piglets, the number in the litter and the severity of the scouring. For example, a litter of 1week-old piglets will consume approximately 2-3 litres per day. The amount consumed will increase with the age of the piglets and where individual piglets are obviously too weak to suck or drink they may be dosed individually by hand, via a feeding bottle and teat. The amount given may be 20-30 ml on each occasion, three or four times a day.

Weaned pigs: Weaned pigs showing signs of scour should have fresh solution made available in a suitable clean vessel - cube drinker, trough or drum with nipple drinker (depending on the size of the group). Solid feed intake should be restricted for 1-2 days, but the normal fresh water supply should be continued. (Occasionally it may be necessary to stop the water supply for a few hours to encourage the pigs to start drinking the solution). The amount of solution consumed will depend on the number of pigs in the group and the severity of the scour, but as a general guide each weaner should be offered about 1 litre per day.

Weaned piglets sometimes overdrink the solution if given ad lib . Amounts should therefore be limited to 1 litre per day or the concentration reduced to 50 % of normal when this is encountered.

Duration of treatment: Prepared solution should be made available for 4 days. If there has been some improvement after 4 days, but the scour has not cleared completely, treatment may be continued for up to 8 days in total.

Agalactia: Where piglets are receiving reduced milk or none at all, access to the solution for a maximum of 2 days will prevent dehydration and will also partly offset the nutritive loss. Where agalactia persists for longer periods, a sow milk replacer should be used.

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Revised: April 2011

AN: 02053/2010 – 02056/2010

Periods of stress: The product may be used at half the usual concentration, i.e. one sachet in 4 litres for 2-3 days following any period of stress (i.e. weaning, transporting, etc.). Access to the solution will help to increase fluid and electrolyte consumption and absorption, thus minimising any possible setback.

Notes: Care must be taken to ensure that piglets are not left without solution, drinking water or sow’s milk. Check the supply of solution every 12 hours and replenish as necessary. Replace with fresh solution every 24 hours.

Lambs

Scouring lambs: Feed 150 - 200 ml of solution made up as directed 2 - 4 times daily as required. The solution should be at blood heat and given via a feeding bottle and teat. The lamb should be allowed to suck the ewe. Any unused solution may be kept in a clean vessel in a cool place, but should be discarded after 24 hours.

Horses

Diarrhoea: Foals may be offered the prepared solution at a dose of one sachet dissolved in 2 litres of drinking water (or in the normal water intake if this is sufficient). Alternatively, foals may be dosed by stomach tube. In this case, one sachet is dissolved in 2 litres of water and dosed at approximately 20 - 30 ml/kg bodyweight. Administration should be repeated daily as required. Ordinary drinking water should be made available after administration of the solution. Older horses should be offered Elanco Scour Formula added to drinking water (1 – 2 sachets daily).

Electrolyte replacement after exercise: 1 - 2 sachets per day added to drinking water or dissolved at a rate of 1 sachet per 2 - 4 litres of water and offered at drinking breaks during endurance rides.

Treatment of subclinical dehydration: 1 sachet to be given twice daily dissolved in drinking water. Dosage to be continued for 3 days.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse effects are expected from an accidental overdose.

4.11 Withdrawal period(s)

Meat – Zero days.

5. PHARMACOLOGICAL PROPERTIES

For use in horses, calves, lambs and pigs as an oral rehydration therapy which promotes intestinal absorption of water and electrolytes.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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

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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

Do not store above 25°C.

Store in a dry place.

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

6.5 Nature and composition of immediate packaging

Elanco Scour Formula is presented in twinned laminated sachets. The laminate consists of paper (outside), polyethylene, aluminium foil and polyethylene (inside).

Sachet A: contains 19.44g of the electrolyte mix.

6.6

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

Sachet B: contains 44.60g of the glucose.

Available in boxes of 12 and 36 paired sachets. Not all pack sizes may be marketed.

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

Priestley Road

Basingstoke

Hampshire

RG24 9NL.

8. MARKETING AUTHORISATION NUMBER

Vm 00006/4135

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9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

Date: 28 th April 1993

– Date First Authorisation

10. DATE OF REVISION OF THE TEXT

Date: April 2011

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