Tryplase Capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Pancreatin

Saatavilla:

MSD Animal Health UK Limited

ATC-koodi:

QA09AA02

INN (Kansainvälinen yleisnimi):

Pancreatin

Lääkemuoto:

Capsule, hard

Prescription tyyppi:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Terapeuttinen ryhmä:

Cats, Dogs

Terapeuttinen alue:

Gastrointestinal

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

1994-09-02

Valmisteyhteenveto

Revised: December 2012
AN: 00881/2012
Page 1 of 5
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
Revised: December 2012
AN: 00881/2012
Page 2 of 5
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