SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)



SUMMARY OF PRODUCTS CHARACTERISTICS

| |

|1. |NAME OF THE VETERINARY MEDICINAL PRODUCT |

| |Diaproof-K powder for oral solution |

|2. |QUALITATIVE AND QUANTITATIVE COMPOSITION |

| |Qualitative composition |Quantitative 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 | |

| |sodium 88 mmol/L | |

| |potassium 15 mmol/L | |

| |chloride 48 mmol/L | |

| |bicarbonate 52 mmol/L (includes bicarbonate derived from| |

| |acetate) | |

| |glucose 80 mmol/L | |

| | |% w/w |g/65.25g sachet |

| | |4.28 |2.79 |

| | |4.39 |2.86 |

| | |7.02 |4.58 |

| | |2.48 |1.62 |

| | |0.76 |0.50 |

| | |36.15 |23.59 |

| | |3.92 |2.56 |

| | |40.86 |26.66 |

| | | | |

| | | | |

| | |0.14 |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) |

| |Vm 05928/4000 |

|9. |DATE OF FIRST AUTHORISATION |

| | |

| |Date: 2 February 1988 |

|10. |DATE OF REVISION OF THE TEXT |

| | |

| |Date: February 2010 |

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