GALLIPRANT 60 mg Tablets for Dogs

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Grapiprant

Beschikbaar vanaf:

Elanco GmbH

ATC-code:

QM01AX92

INN (Algemene Internationale Benaming):

Grapiprant

farmaceutische vorm:

Tablet

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Dogs

Therapeutisch gebied:

Anti Inflammatory NSAID

Autorisatie-status:

Authorized

Autorisatie datum:

2018-01-09

Productkenmerken

Revised: August 2023
AN: 01352/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Galliprant 60 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Grapiprant
60 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Galliprant 60 mg tablets: A brown speckled, biconvex oval tablet with
a score on one
face separating the debossed number ‘60’ on one half and the
letters ‘MG’ on the
other half; the letter ‘G’ is debossed on the other face. The
tablet can be divided into
equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of pain associated with mild to moderate
osteoarthritis in dogs.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or any
of the
excipients.
Do not use in pregnant, lactating or breeding animals. See section
4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The majority of clinical cases assessed in the clinical field studies
suffered from mild
to moderate osteoarthritis based on the veterinary assessment. To
achieve a
substantiated response to treatment, use the veterinary medicinal
product only in
mild and moderate cases of osteoarthritis.
Revised: August 2023
AN: 01352/2023
Page 2 of 7
From the two clinical field studies, the overall success rates based
on CBPI (Canine
Brief Pain Inventory, as completed by the owner) at 28 days after the
start of the
treatment, were 51.3% (120/235) for Galliprant and 35.5% (82/231) for
the placebo
group. This difference in favour of Galliprant was statistically
significant
(p-value= 0.0008).
A clinical response to treatment is usually seen within 7 days. If no
clinical
improvement is apparent after 14 days, treatment with Galliprant
should be
discontinued and different treatment options should be explored in
consultation with
the veterinarian.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in a