Daxocox

국가: 유럽 연합

언어: 영어

출처: EMA (European Medicines Agency)

유효 성분:

enflicoxib

제공처:

Ecuphar NV

ATC 코드:

QM01AH95

INN (국제 이름):

enflicoxib

치료 그룹:

Dogs

치료 영역:

Antiinflammatory and antirheumatic products

치료 징후:

For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.

승인 상태:

Authorised

승인 날짜:

2021-04-20

환자 정보 전단

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
DAXOCOX 15 MG TABLETS FOR DOGS
DAXOCOX 30 MG TABLETS FOR DOGS
DAXOCOX 45 MG TABLETS FOR DOGS
DAXOCOX 70 MG TABLETS FOR DOGS
DAXOCOX 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:
Ecuphar NV
Legeweg 157-i
B-8020 Oostkamp, Belgium
Manufacturer responsible for batch release:
Lelypharma B.V.
Zuiveringweg 42
8243 PZ
Lelystad
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Daxocox 15 mg tablets for dogs
Daxocox 30 mg tablets for dogs
Daxocox 45 mg tablets for dogs
Daxocox 70 mg tablets for dogs
Daxocox 100 mg tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains:
ACTIVE SUBSTANCE:
Enflicoxib
15 mg
Enflicoxib
30 mg
Enflicoxib
45 mg
Enflicoxib
70 mg
Enflicoxib
100 mg
EXCIPIENTS:
Iron oxide black (E172) 0.26%
Iron oxide yellow (E172) 0.45%
Iron oxide red (E172) 0.50%
Brown round and convex tablets.
4.
INDICATION(S)
For the treatment of pain and inflammation associated with
osteoarthritis (or degenerative joint
disease) in dogs.
18
5.
CONTRAINDICATIONS
Do not use in animals suffering from gastrointestinal disorders,
protein or blood losing enteropathy or
haemorrhagic disorders.
Do not use in cases of impaired renal or hepatic function.
Do not use in cases of cardiac insufficiency.
Do not use in pregnant or lactating dogs.
Do not use in animals intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of known hypersensitivity to sulphonamides.
Do not use in any dehydrated, hypovolemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
6.
ADVERSE REACTIONS
Vomiting, soft faeces and/or diarrhoea have been commonly reported in
clinical trials, but most cases
recovered without treatment.
Apathy, loss of appetite or haemorrhagic diarrhoea have been reported
i

제품 특성 요약

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Daxocox 15 mg tablets for dogs
Daxocox 30 mg tablets for dogs
Daxocox 45 mg tablets for dogs
Daxocox 70 mg tablets for dogs
Daxocox 100 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Enflicoxib
15 mg
Enflicoxib
30 mg
Enflicoxib
45 mg
Enflicoxib
70 mg
Enflicoxib
100 mg
EXCIPIENTS:
Iron oxide black (E172) 0.26%
Iron oxide yellow (E172) 0.45%
Iron oxide red (E172) 0.50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
Brown, round and convex tablets.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of pain and inflammation associated with
osteoarthritis (or degenerative joint disease)
in dogs.
4.3
CONTRAINDICATIONS
Do not use in animals suffering from gastrointestinal disorders,
protein or blood losing enteropathy or
haemorrhagic disorders.
Do not use in cases of impaired renal or hepatic function.
Do not use in cases of cardiac insufficiency.
Do not use in pregnant or lactating dogs.
Do not use in animals intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of known hypersensitivity to sulphonamides.
3
Do not use in any dehydrated, hypovolemic or hypotensive animal, as
there is a potential risk of
increased renal toxicity.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do
not
administer
other
Non-Steroidal
Anti-Inflammatory
Drugs
(NSAIDs)
or
glucocorticoids
concurrently or within 2 weeks of the last administration of this
veterinary medicinal product.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Since the safety of the medicinal product has not been fully
demonstrated in very young animals, careful
monitoring is advised during the treatment of young dogs aged less
than 6 months.
The active metabolite of enflicoxib exhibits an extended plasma
half-life du