Previcox
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-04-2020
Karatteristiċi tal-prodott
(SPC)
28-04-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
13-11-2012
Ingredjent attiv:
firocoxib
Disponibbli minn:
Boehringer Ingelheim Vetmedica GmbH
Kodiċi ATC:
QM01AH90
INN (Isem Internazzjonali):
firocoxib
Grupp terapewtiku:
Dogs
Żona terapewtika:
Anti-inflammatory and anti-rheumatic products, non-steroids
Indikazzjonijiet terapewtiċi:
TabletsFor the relief of pain and inflammation associated with osteoarthritis in dogs.For the relief of postoperative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.Oral pasteAlleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Sommarju tal-prodott:
Revision: 23
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2004-09-13
Fuljett ta 'informazzjoni
18
3B
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET
PREVICOX 57 MG CHEWABLE TABLETS FOR DOGS
PREVICOX 227 MG CHEWABLE 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim
Animal Health France SCS,
4 Chemin du Calquet, 31000 Toulouse, France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Previcox 57 mg chewable tablets for dogs
Previcox 227 mg chewable tablets for dogs
firocoxib
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
ACTIVE SUBSTANCE:
firocoxib
57 mg
or
firocoxib
227 mg
EXCIPIENTS:
Iron oxides (E172)
Caramel (E150d)
Tan-brown, round, convex, tablets with a cross-shaped break line on
one side. The tablets can be
divided into 2 or 4 equal parts.
4.
INDICATION(S)
For the relief of pain and inflammation associated with osteoarthritis
in dogs.
For the relief of post-operative pain and inflammation associated with
soft-tissue, orthopaedic and
dental surgery in dogs.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches.
Do not use in animals less than 10 weeks of age or less than 3 kg
bodyweight.
Do not use in animals suffering from gastrointestinal bleeding, blood
dyscrasia or haemorrhagic
disorders.
20
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs).
6.
ADVERSE REACTIONS
Emesis and diarrhoea have occasionally been reported. These reactions
are generally of a transitory
nature and are reversible when the treatment is stopped. Renal and/or
hepatic disorders have been
reported in very rare cases in dogs administered the recommended
treatment dose
_. _
Rarely, nervous
system disorders have been reported in treated dogs.
_ _
If adverse reactions like vomiting, repeated diarrhoea, faecal occult
blood, sudden weight loss,
anorexia, lethargy, degra
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Karatteristiċi tal-prodott
1
ANNEX I
0B
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Previcox 57 mg chewable tablets for dogs
Previcox 227 mg chewable tablets for dogs
firocoxib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
firocoxib
57 mg
or
firocoxib
227 mg
EXCIPIENTS:
Iron oxides (E172)
Caramel (E150d)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Tan-brown, round, convex, tablets with a cross-shaped break line on
one side. The tablets can be
divided into 2 or 4 equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the relief of pain and inflammation associated with osteoarthritis
in dogs.
For the relief of post-operative pain and inflammation associated with
soft-tissue, orthopaedic and
dental surgery in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches.
Do not use in animals less than 10 weeks of age or less than 3 kg body
weight.
Do not use in animals suffering from gastrointestinal bleeding, blood
dyscrasia or haemorrhagic
disorders.
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs).
4.4
SPECIAL WARNINGS
None.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The recommended dose, see section 4.9, should not be exceeded.
Use in very young animals, or animals with suspected or confirmed
impairment of renal, cardiac or
hepatic function may involve additional risk. If such use cannot be
avoided, those dogs require careful
veterinary monitoring.
Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there
is a potential risk of
increased renal toxicity. Concurrent administration of potentially
nephrotoxic drugs should be
avoided.
Use this product under strict veterinary monitoring where there is a
risk of gastrointestinal bleeding, or
if the animal previously displayed intolerance to NSAIDs. Renal and/or
hepatic disorders have been
reported
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