Revised: February 2010

(ATCVet code amended)

SUMMARY OF PRODUCTS CHARACTERISTICS
1. / NAME OF THE VETERINARY MEDICINAL PRODUCT
Diaproof-K powder for oral solution
2. / QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Active ingredients
Sodium chloride
Sodium acetate
Sodium bicarbonate
Potassium chloride
Magnesium hydroxide
Glucose monohydrate
Wheat bran
Ispaghula husk
Excipients
Ferric Oxide Red
When reconstituted as recommended, it contains
sodium88 mmol/L
potassium15 mmol/L
chloride48 mmol/L
bicarbonate52 mmol/L (includes bicarbonate derived from acetate)
glucose80 mmol/L / Quantitative composition
% w/w / g/65.25g sachet
4.28
4.39
7.02
2.48
0.76
36.15
3.92
40.86
0.14 / 2.79
2.86
4.58
1.62
0.50
23.59
2.56
26.66
0.09
For a full list of excipients please see section 6.1.
3. / PHARMACEUTICAL FORM
Powder for oral solution.
The appearance of the product is pinkish brown flakes.
4. / CLINICAL PARTICULARS
4.1 / Target species
Cattle (calves)
4.2 / Indications for use, specifying the target species
For the treatment of diarrhoea in young calves.
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
Any medicated water which is not consumed immediately should be discarded.
ii. / Special precautions for the person administering the veterinary medicinal product to animals
None
iii. / Other precautions
None
4.6 / Adverse reactions (frequency and seriousness)
None known
4.7 / Use during pregnancy, lactation or lay
Not applicable
4.8 / Interaction with other medicinal products and other forms of interaction
None known
4.9 / Amount(s) to be administered and administration route
Diaproof-K is for oral use
(i) For using sachets
The product should be dissolved in warm water (40°C/104°F) immediately before administration.
Give three doses, each consisting of the contents of one sachet in 1.5 litres of warm water, at intervals of 12 hours. If necessary, after a further 12 hours give a fourth dose. To prepare this fourth dose dissolve the contents of one sachet in 1.5 litres of water and mix 3/4 litre of this solution with 3/4 litre of milk.
In severe cases of diarrhoea, one dose consisting of the contents of one sachet in 1.5 litres of warm water should be given on 6 occasions at intervals of 8 hours, followed by a seventh dose after a further 8 hours. To prepare this seventh dose dissolve the contents of one sachet in 1.5 litres of water and mix 3/4 litre of this solution with 3/4 litre of milk.
(ii) For using bulk packs
The product should be dissolved in warm water (40°C/104°F) immediately before administration.
Give three doses, each consisting of 1.5 measures in 1.5 litres of warm water, at intervals of 12 hours. If necessary, after a further 12 hours give a fourth dose. To prepare this fourth dose, dissolve 1.5 measures in 1.5 litres of water and mix 3/4 litre of this solution with 3/4 litre of milk.
In severe cases of diarrhoea, one dose consisting of 1.5 measures in 1.5 litres of warm water should be given on 6 occasions at intervals of 8 hours, followed by a seventh dose after a further 8 hours. To prepare this seventh dose, dissolve 1.5 measures in 1.5 litres of water and mix 3/4 litre of this solution with 3/4 litre of milk.
4.10 / Overdose (symptoms, emergency procedures, antidotes), if necessary
There are no known adverse effects if an overdose of the medicinal product is administered.
4.11 / Withdrawal period(s)
Cattle:meat – zero days
milk – zero hours
5. / PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Antidiarrheals, intestinal anti-inflammatory/antiinfective agents, Electroytes with carbohydrates, Oral rehydration formulations for veterinary use
ATC Vet Code:QA07CQ02
5.1 / Pharmacodynamic properties
The product provides a combination of nutrients and electrolytes. Diarrhoea can result in dehydration and acidosis. Oral rehydration therapy reverses secretion of fluid and electrolytes into the gut caused by diarrhoea and promotes absorption of water, electrolytes and nutrients.
Glucose is actively absorbed resulting in uptake of water as well as
providing a source of energy. Sodium and chloride ions also promote the absorption of water. Acetate acts as a source of bicarbonate to correct acidosis as well as stimulating water and sodium absorption thereby contributing to the rehydration process.
The fibre-component absorbs water and thus retains water in the GI tract while forming a mucilaginous mass and increases faecal mass.
5.2 / Pharmacokinetic properties
Not applicable.
5.3 / Environmental properties
6. / PHARMACEUTICAL PARTICULARS
6.1 / List of excipients
Ferric Oxide Red (E172)
6.2 / Incompatibilities
None known
6.3 / Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
6.4 / Special precautions for storage
Do not store above 25°C. Store in tightly closed original container.
Any medicated water which is not consumed immediately should be discarded.
6.5 / Nature and composition of immediate packaging
400 g of product in a white high density polyethylene container with a white low density polyethylene re-sealable plastic push fit air-locked lid.
1 kg of product in a white polypropylene container with a white low density polyethylene re-sealable plastic push fit air-locked lid.
2.5 kg of product in a white polypropylene container with a white polypropylene re-sealable plastic push fit air-locked lid.
Each container is supplied with a graduated measuring cup capable of providing one measure (43.5g), 3/4 measure (32.6g) and 1/2 measure (21.8g).
Carton containing 12 heat-sealed laminate sachets made of 44gsm paper, 12gsm polyethylene, 9µm aluminium and 35gsm low density polyethylene. Each sachet contains 65.25 g of product.
Not all pack sizes may be marketed.
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
Forum Products Limited
41-51 Brighton Road
Redhill
Surrey
RH1 6YS
8. / MARKETING AUTHORISATION NUMBER(S)
Vm05928/4000
9. / DATE OF FIRST AUTHORISATION
Date: 2 February 1988
10. / DATE OF REVISION OF THE TEXT
Date:February 2010