SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Tryplase Capsules

2. Qualitative and Quantitative Composition

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

Excipients: Capsule shell

Indigo Carmine E 132 0.238% w/v

Tartrazine E102 0.114% w/v

Titanium Dioxide E171 1.0 % w/v

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule hard

Shiny opaque dark green capsules

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

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.

4.3 Contra-indications

Not applicable

4.4 Special warning for each target species

The correct dosage should be adjusted to suit the individual case (see 4.9).

4.5 Special precautions for use

i. Special precautions for use in animals

Sprinkle on the feed with care as the powder can be irritant to skin and mucous membranes.

ii. Special precautions to be taken by the person administering the medicinal product to animals.

Wash hands after administration of capsules.

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

Not contra- indicated for use during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

Do not administer whole capsules.

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.

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.

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 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No specific treatment or antidote recommended

4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Vet Code:QA09AA02

The product is a replacement therapy. The capsules contain a concentrated extract of pig pancreas, standardised to provide the following activity:

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

In exocrine pancreatic insufficiency the addition of these extracts to the feed aids in proper digestion of fat, protein and starch.

5.2 Pharmacokinetic particulars

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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule shells:

Indigo Carmine E132

TartrazineE102

Titanium Dioxide E 171

Gelatin,

Calcium carbobate

Magnesium stearate

Talc purified

Lactose monohydrate

6.2 Incompatibilities

None known but product should not be mixed with other products.

6.3 Shelf Life

Shelf life of the veterinary medicinal product as packaged for sale: 12 months

6.4 Special precautions for storage

Do not store above 25^oC. Store in tightly closed original container.

Store in a dry place. Protect from light.

6.5 Nature and composition of immediate packaging

Opaque, white polypropylene securitainers with a polyethylene lid containing 100 or 250 capsules.

6.6 Special precautions for disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

None.

7. MARKETING AUTHORISATION HOLDER

INTERVET UK Ltd.

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4319

9. DATE OF FIRST AUTHORISATION

Date: 02 September 1994

10. DATE OF REVISION OF TEXT

Date:December 2012

Approved:

13/12/12