Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

An effervescent, rapidly dissolving, white tablet individually packed in an aluminium container.

Each tablet contains:
	Sodium chloride	2.34 g
	Potassium chloride	1.12 g
	Sodium bicarbonate	6.72 g
	Citric acid (anhydrous)	3.84 g
	Lactose monohydrate	32.44 g
	Glycine	2.25 g

The addition of one Effydral tablet to 1 litre of water produces an isotonic, oral rehydration solution with the following composition:

Sodium	120mmol
Potassium	15mmol
Chloride	55mmol
Bicarbonate + citrate	80mmol*
Lactose	90mmol†
Glycine	30mmol
*Total alkali expressed as bicarbonate equivalents
†90mmol lactose is equivalent to 180 mmol glucose

Uses

Effydral is specially formulated to provide rapid correction of dehydration, electrolyte loss and metabolic acidosis particularly when these disturbances arise as a consequence of diarrhoea.

Calves: Effydral is recommended to reverse the process of dehydration and loss of electrolytes following diarrhoea resulting from bacteria such as E.coli or viruses such as rotavirus.

It is also indicated to reduce the incidence of diarrhoea in bought-in calves.

Pigs: Effydral is recommended 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 setback after periods of stress eg weaning, transporting, etc.

Dosage and administration

Effydral is intended for oral administration only.

Effydral solution is prepared by adding 1 effervescent tablet to 1 litre of luke-warm (about 37°C) water. The solution should be freshly made up just prior to feeding, using clean water and utensils.

If solution has been stored in a refrigerator (2-8°C), gently warm to 37°C before administration.

Dosage

Calves

(i) Calves with diarrhoea: Treatment should commence immediately diarrhoea is noticed. Withdraw milk or milk replacer and feed 2 or 3 litres of Effydral solution, depending on calf size or severity of diarrhoea, twice daily for 2 days. During the next 2 days, feed 1 or 1.5 litres of Effydral solution mixed with an equal quantity of milk or milk replacer. Normal feeding can then usually be resumed.

In cases of severe dehydration Effydral solution should be administered in 3 or 4 feeds per day. If necessary the solution may be administered by stomach tube. Normally, calves can be fed Effydral solution exclusively for up to 4 days without harmful effects.

(ii) Bought-in calves: Instead of milk or milk replacer the first feed on arrival should consist of 2 litres of Effydral solution. The second feed should contain 1 litre of Effydral solution mixed with 1 litre of milk or milk replacer. Thereafter feed as normal.

Pigs

(i) Birth to weaning: When scour occurs make Effydral available ad libitum in a clean utensil. The amount consumed per pig depends on age.

(ii) Weaned pig: Allow ad libitum consumption up to a maximum of 1 litre per pig per day. Provide untreated water at all times.

Contra-indications and warnings, etc

For Animal Treatment Only

If the gastrointestinal tract is completely obstructed, care should be taken when administering oral solutions.

Whenever possible adequate colostrum should be fed to calves and pigs.

Avoid over-feeding of milk or milk replacer.

Solutions should be prepared using clean water and feeding utensils should be kept clean. Replace with fresh solution every 24 hours.

If Effydral is administered in too concentrated a solution to a calf or pig, free access to drinking water should be provided.

In very severe cases of dehydration accompanied by shock, additional intravenous fluid therapy may be required with an appropriate parenteral solution.

If signs of disease persist or appear, consult a veterinary surgeon.

Keep out of reach and sight of children.

Meat withdrawal period–zero days.

User warning: Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C. Once dissolved in water store in a refrigerator (2-8°C). Any medicated water not consumed within 24 hours should be discarded. Keep container in outer carton.

When the product is dissolved, using the in-use shelf-life which is specified on this package leaflet, the date on which any product remaining in the carton should be discarded should be worked out. This discard date should be written in the space provided.

Disposal

Dispose of unused solution in slurry or dirty water. Dispose of unused tablets and empty packaging in the farm refuse.

Legal category

AVM-GSL

Packaging Quantities

Cardboard carton containing 48 tablets, each tablet individually packed in an aluminium container closed with aluminium foil.

Further information

The vital attributes of an effective oral rehydration solution are that it should contain appropriate amounts of sodium and small organic molecules like glucose and galactose to ensure its complete absorption. It should also contain sufficient sodium bicarbonate or bicarbonate precursor, to enable restoration of the extracellular fluid volume (and therefore, circulatory volume) and correction of the metabolic acidosis. Effydral effectively combats dehydration, electrolyte losses (especially hypona-traemia) and metabolic acidosis which are the most serious consequences of diarrhoea.

Marketing authorisation number

Vm 01596/4141.