Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Grapiprant
Elanco GmbH
QM01AX92
Grapiprant
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Anti Inflammatory NSAID
Authorized
2018-01-09
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 Read the complete document