Download Revised: December 2012 AN: 00881/2012 SUMMARY OF

Revised: December 2012
AN: 00881/2012
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
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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
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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.
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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
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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 25oC. 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
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