GALLIPRANT 100 mg Tablets for Dogs

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 animals
Grapiprant is a methylbenzenesulfonamide. It is not known whether dogs with a
history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant.
If signs of sulphonamide hypersensitivity occur, treatment should be discontinued.
Use with caution in dogs suffering from pre-existing liver, cardiovascular or renal
dysfunctions or from gastrointestinal disease.
The concurrent use of grapiprant with other anti-inflammatory agents has not been
studied and should be avoided.
The safety of the veterinary medicinal product has not been established in dogs
under 9 months of age and in dogs weighing less than 3.6 kg.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Wash hands after handling of the veterinary medicinal product.
In case of accidental ingestion by children, mild and reversible gastrointestinal signs
and nausea may be observed. In case of accidental ingestion, seek medical advice
immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable

Revised: August 2023
AN: 01352/2023
4.6 Adverse reactions (frequency and seriousness)
Target species: Dogs
Very common
(>1 animal / 10 animals treated):
VomitingCommon
(1 to 10 animals / 100 animals treated):
Loose stool, Diarrhoea
Inappetance
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Haematemesis, Haemorrhagic
diarrhoea
Pancreatitis
Elevated blood urea nitrogen (BUN),
Elevated creatinine, Elevated liver
enzymes, Hypoalbuminaemia
,
Hypoproteinaemia
1
These signs were not associated with any clinically significant observations or
events.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See section ‘Contact details’ of the package leaflet.
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant, lactating or breeding animals as the safety of grapiprant has
not been established during pregnancy and lactation or in dogs used for breeding.
4.8 Interaction with other medicinal products and other forms of interaction
Prior treatment with other anti-inflammatory substances may result in additional or
increased severity of adverse effects and accordingly a treatment-free period with
such veterinary medicinal products should be observed before the commencement of
treatment with this veterinary medicinal product. The treatment-free period should
take into account the pharmacokinetic properties of the products used previously.
The concomitant use of protein-bound veterinary medicinal products with grapiprant
has not been studied. Commonly used protein-bound veterinary medicinal products
include cardiac, anticonvulsant and behavioural medicinal products.
Veterinary medicinal product compatibility should be monitored in animals requiring
adjunctive therapy.
4.9 Amount(s) to be administered and administration route
For oral use.
Administer this veterinary medicinal product on an empty stomach (e.g. in the
morning) and at least one hour before the next meal, once daily at a target dose of
2 mg per kg body weight (bw).

Revised: August 2023
AN: 01352/2023
Duration of treatment will depend on the response observed to treatment. As field
studies were limited to 28 days, longer-term treatment should be considered carefully
and regular monitoring undertaken by the veterinarian.
Since clinical signs of canine osteoarthritis wax-and-wane, intermittent treatment may
be beneficial in some dogs.
The following number of tablets should be given once daily:
Body weight
(kg)
20 mg
tablet
60 mg
tablet
100 mg
tablet
Dose
range
(mg/kg bw)
3.6-