<p> Revised: December 2012 AN: 00881/2012</p><p>SUMMARY OF PRODUCT CHARACTERISTICS</p><p>1. NAME OF THE VETERINARY MEDICINAL PRODUCT </p><p>Tryplase Capsules</p><p>2. Qualitative and Quantitative Composition</p><p>Active substances: Pancreatin Not less than 12,600 Ph.Eur. Units lipase Not less than 9,000 Ph.Eur. Units amylase Not less than 450 Ph.Eur. Units protease</p><p>Excipients: Capsule shell Indigo Carmine E 132 0.238% w/v Tartrazine E102 0.114% w/v Titanium Dioxide E171 1.0 % w/v</p><p>For full list of excipients, see section 6.1.</p><p>3 PHARMACEUTICAL FORM</p><p>Capsule hard Shiny opaque dark green capsules</p><p>4. CLINICAL PARTICULARS</p><p>4.1 Target species</p><p>Dogs and cats</p><p>4.2 Indications for use, specifying the target species</p><p>The product contains the three major pancreatic enzymes responsible for the digestion of fat, protein and starch in the small intestine. The formulation is particularly suitable for replacement therapy or supplementation in the dog and cat. The product is indicated for the treatment of impaired digestion and diarrhoea caused by deficiencies in pancreatic exocrine secretion. Administration may also be indicated in cases of non-specific diarrhoea where persistent hypermotility of the intestine prevents adequate utilisation of pancreatic enzymes.</p><p>4.3 Contra-indications</p><p>Not applicable</p><p>Page 1 of 5 Revised: December 2012 AN: 00881/2012</p><p>4.4 Special warning for each target species</p><p>The correct dosage should be adjusted to suit the individual case (see 4.9).</p><p>4.5 Special precautions for use</p><p> i. Special precautions for use in animals</p><p>Sprinkle on the feed with care as the powder can be irritant to skin and mucous membranes.</p><p> ii. Special precautions to be taken by the person administering the medicinal product to animals.</p><p>Wash hands after administration of capsules.</p><p>4.6 Adverse reactions (frequency and seriousness)</p><p>None</p><p>4.7 Use during pregnancy, lactation or lay</p><p>Not contra- indicated for use during pregnancy.</p><p>4.8 Interaction with other medicinal products and other forms of interaction</p><p>None known</p><p>4.9 Amounts to be administered and administration route</p><p>Do not administer whole capsules.</p><p>Dogs: The contents of 2-5 capsules per day, sprinkled on food or milk. 5 capsules are sufficient to digest the declared fat, protein and carbohydrate content of a 1lb (approx. 500 g) tin of dog food.</p><p>Cats: The contents of 1-2 capsules per day, sprinkled on food or milk. 2 capsules are sufficient to digest the declared fat, protein and carbohydrate content of a ½ lb (approx. 250 g) tin of cat food.</p><p>When an animal receives more than one meal daily, the dose should be divided appropriately between the feeds. The dose should be adjusted to obtain faeces of normal consistency and will thus be variable. After a course of treatment and when signs are controlled, it is advisable to reduce the dose gradually over a seven day period in order to ascertain either the degree of recovery, or necessity for a permanent maintenance dose. Where permanent therapy is required, dose levels should be reduced periodically to see whether pancreatic recovery has taken place. However, more often the deficiency is progressive and patients should be re-examined at</p><p>Page 2 of 5 Revised: December 2012 AN: 00881/2012</p><p> intervals to ensure stability. Proper dietary control is also essential for the successful management of cases suffering from pancreatic insufficiency. Consult a veterinary surgeon for advice.</p><p>4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary</p><p>No specific treatment or antidote recommended</p><p>4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero</p><p>Not applicable.</p><p>5. PHARMACOLOGICAL PROPERTIES</p><p>5.1 Pharmacodynamic properties</p><p>ATC Vet Code: QA09AA02</p><p>The product is a replacement therapy. The capsules contain a concentrated extract of pig pancreas, standardised to provide the following activity:</p><p>Lipase - sufficient to digest 17 g of dietary fat Trypsin - sufficient to digest 34 g of dietary protein Amylase - sufficient to digest 40 g of dietary starch</p><p>In exocrine pancreatic insufficiency the addition of these extracts to the feed aids in proper digestion of fat, protein and starch.</p><p>5.2 Pharmacokinetic particulars</p><p>The product is administered orally and acts locally in the digestive tract, therefore pharmacokinetic data is not applicable. The dose administered depends on the amount of pancreatic function which remains in each case and the daily food consumption/size of the animal.</p><p>6 PHARMACEUTICAL PARTICULARS</p><p>6.1 List of excipients Capsule shells: Indigo Carmine E132 TartrazineE102 Titanium Dioxide E 171 Gelatin,</p><p>Calcium carbobate Magnesium stearate Talc purified Lactose monohydrate</p><p>Page 3 of 5 Revised: December 2012 AN: 00881/2012</p><p>6.2 Incompatibilities</p><p>None known but product should not be mixed with other products.</p><p>6.3 Shelf Life</p><p>Shelf life of the veterinary medicinal product as packaged for sale: 12 months</p><p>6.4 Special precautions for storage</p><p>Do not store above 25oC. Store in tightly closed original container. Store in a dry place. Protect from light.</p><p>6.5 Nature and composition of immediate packaging</p><p>Opaque, white polypropylene securitainers with a polyethylene lid containing 100 or 250 capsules.</p><p>6.6 Special precautions for disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate</p><p>None.</p><p>7. MARKETING AUTHORISATION HOLDER</p><p>INTERVET UK Ltd. Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ</p><p>8. MARKETING AUTHORISATION NUMBER</p><p>Vm 01708/4319</p><p>9. DATE OF FIRST AUTHORISATION</p><p>Date: 02 September 1994</p><p>10. DATE OF REVISION OF TEXT</p><p>Date: December 2012</p><p>Approved: 13/12/12</p><p>Page 4 of 5 Revised: December 2012 AN: 00881/2012</p><p>Page 5 of 5</p>