Galliprant
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
17-08-2021
Vara einkenni
(SPC)
17-08-2021
Opinber matsskýrsla
(PAR)
06-02-2018
Virkt innihaldsefni:
grapiprant
Fáanlegur frá:
Elanco GmbH
ATC númer:
QM01AX92
INN (Alþjóðlegt nafn):
grapiprant
Meðferðarhópur:
Dogs
Lækningarsvæði:
Other antiinflammatory and antirheumatic agents, non-steroids
Ábendingar:
For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
Vörulýsing:
Revision: 5
Leyfisstaða:
Authorised
Leyfisdagur:
2018-01-09
Upplýsingar fylgiseðill
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
GALLIPRANT 20 MG TABLETS FOR DOGS
GALLIPRANT 60 MG TABLETS FOR DOGS
GALLIPRANT 100 MG TABLETS FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for batch release:
Elanco France S.A.S.
26 Rue de la Chapelle
68330 Huningue
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Galliprant 20 mg tablets for dogs
Galliprant 60 mg tablets for dogs
Galliprant 100 mg tablets for dogs
grapiprant
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One tablet contains:
ACTIVE SUBSTANCE:
Grapiprant
20 mg
Grapiprant
60 mg
Grapiprant
100 mg
20 mg tablet: A brown speckled, biconvex oval tablet with a score on
one face separating the debossed
number ‘20’ 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.
60 mg tablet: 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.
100 mg tablet: A brown speckled, biconvex oval tablet with the
debossed number ‘100’ on one half
and the letters ‘MG’ on the other half; the letter ‘G’ is
debossed on the other face.
4.
INDICATION(S)
18
For the treatment of pain associated with mild to moderate
osteoarthritis in dogs.
5.
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.
6.
ADVERSE REACTIONS
Vomiting was observed very commonly in clinical studies. Soft-formed
faeces, diarrhoea and
inappetence were commonly observed in clinical studies. These signs
were generally transient.
Elevated liver enzymes, elevated BUN, el
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1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Galliprant 20 mg tablets for dogs
Galliprant 60 mg tablets for dogs
Galliprant 100 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Grapiprant
20 mg
Grapiprant
60 mg
Grapiprant
100 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
20 mg tablet: A brown speckled, biconvex oval tablet with a score on
one face separating the debossed
number ‘20’ 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.
60 mg tablet: 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.
100 mg tablet: A brown speckled, biconvex oval tablet with the
debossed number ‘100’ on one half
and the letters ‘MG’ on the other half; the letter ‘G’ is
debossed on the other face.
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.
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%
3
(120/235) for G
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