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 |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- fluid and electrolyte therapy in children
- stoichiometry lab weebly
- you can safely dispose of many solid chemicals in the
- summary of product characteristics smpc
- food additive usda
- nsn 6840 00 242 4770 home interact
- conejo valley unified school district homepage
- maryland fire and rescue institute maryland fire and
Related searches
- summary of history of philosophy
- summary of product characteristics
- summary of books of the bible pdf
- characteristics of product design
- product characteristics in marketing
- product characteristics and requirements
- example of summary of an article
- characteristics of product quality
- product characteristics examples
- summary of each chapter of huckleberry finn
- summary of life of jesus
- summary of the declaration of independence