Equioxx
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-01-2022
Charakterystyka produktu
(SPC)
26-01-2022
Sprawozdanie z oceny publicznego
(PAR)
06-03-2017
Składnik aktywny:
firocoxib
Dostępny od:
Audevard
Kod ATC:
QM01AH90
INN (International Nazwa):
firocoxib
Grupa terapeutyczna:
Horses
Dziedzina terapeutyczna:
Anti-inflammatory and anti-rheumatic products, non-steroids
Wskazania:
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2008-06-25
Ulotka dla pacjenta
33
B.
PACKAGE LEAFLET
34
PACKAGE LEAFLET
EQUIOXX 8.2 MG/G ORAL PASTE FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Marketing authorisation holder:
Audevard
37-39 rue de Neuilly
92110, Clichy
France
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France
4 chemin du Calquet
31000 Toulouse
France
Ceva Santé Animale
10, av. de La Ballastière
33500 Libourne
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
EQUIOXX 8.2 mg/g oral paste for horses.
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Firocoxib 8.2 mg/g
4.
INDICATION(S)
Alleviation of pain and inflammation associated with osteoarthritis
and reduction of associated
lameness in horses
_. _
_ _
_ _
5.
CONTRAINDICATIONS
Do not use in animals suffering from gastrointestinal disorders and
haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals.
Do not use concomitantly with corticosteroids or other NSAIDs.
35
6.
ADVERSE REACTIONS
Lesions (erosion/ulceration) of the oral mucosa and of the skin around
the mouth were very commonly
observed in treated animals during tolerance studies. These lesions
were mild and resolved without
treatment. Salivation and labial and tongue oedema have been
uncommonly associated with the oral
lesions in a field study.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals, including isolated
reports treated)
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform yo
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
EQUIOXX 8.2 mg/g oral paste for horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe contains 7.32 g of paste and delivers:
Firocoxib 8.2 mg/g
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
White to off-white paste.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of pain and inflammation associated with osteoarthritis
and reduction of associated
lameness in horses
_. _
_ _
4.3
CONTRAINDICATIONS
Do not use in animals suffering from gastrointestinal disorders and
haemorrhage, impaired hepatic,
cardiac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals (see section
4.7).
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs) (see section 4.8).
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use in animals less than 10 weeks. If side effects occur,
treatment should be discontinued and
the advice of a veterinarian should be sought. Avoid use in any
dehydrated, hypovolaemic or
hypotensive animal, as there may be potential risk of increased renal
toxicity. Concurrent
administration of potentially nephrotoxic veterinary medicinal
products should be avoided.
The recommended treatment dose and duration should not be exceeded.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the
label to the physician.
Avoid contact with eyes and skin. If it occurs, rinse affected area
immediately with water.
Wash hands after use of the veterinary medicinal product.
Like other medicinal products that inhibit COX-2, pregnan
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