Cimalgex
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
14-01-2016
Svojstava lijeka
(SPC)
14-01-2016
Izvješće o ocjeni javnog
(PAR)
26-07-2011
Aktivni sastojci:
cimicoxib
Dostupno od:
Vétoquinol SA
ATC koda:
QM01AH93
INN (International ime):
cimicoxib
Terapijska grupa:
Dogs
Područje terapije:
Musculo-skeletal system
Terapijske indikacije:
Relief of pain and inflammation associated with osteoarthritis.Management of peri-operative pain due to orthopaedic or soft-tissue surgeries.
Proizvod sažetak:
Revision: 1
Status autorizacije:
Authorised
Datum autorizacije:
2011-02-18
Uputa o lijeku
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET
CIMALGEX 8 MG CHEWABLE TABLETS FOR DOGS
CIMALGEX 30 MG CHEWABLE TABLETS FOR DOGS
CIMALGEX 80 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
Vétoquinol SA
Magny Vernois
70200 Lure
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cimalgex 8 mg chewable tablets for dogs
Cimalgex 30 mg chewable tablets for dogs
Cimalgex 80 mg chewable tablets for dogs
Cimicoxib
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each tablet contains:
Cimicoxib 8 mg
Cimicoxib 30 mg
Cimicoxib 80 mg
Cimalgex 8 mg tablets are oblong, white to pale brown, with a
break-line on both sides and can be
divided into equal halves.
Cimalgex 30 mg, tablets: oblong, white to pale brown, chewable tablets
with 2 break-lines on both
sides. The tablets can be divided into equal thirds.
Cimalgex 80 mg, tablets: oblong, white to pale brown, chewable tablets
with 3 break-lines on both
sides. The tablets can be divided into equal quarters.
4.
INDICATIONS
For the treatment of pain and inflammation associated with
osteoarthritis, and the management of peri-
operative pain due to orthopaedic or soft tissue surgery, in dogs.
5.
CONTRAINDICATIONS
Do not use in dogs less than 10 weeks of age.
Do not use in dogs suffering from stomach or digestive system
disorders or in dogs with bleeding
problems.
Do not use at the same time as corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs).
Do not use if the dog is hypersensitive to cimicoxib or any of the
other ingredients in the product.
Do not use in breeding, pregnant or lactating animals (see Section 12
“Special precautions for dogs”).
18
6.
ADVERSE REACTIONS
Mild gastro-intestinal disorders (vomiting and/or diarrhoea) were very
commonly reported but these
only lasted for a short time.
On rare occasions, serious gastrointestinal problems such as bleeding
and ulcer formation have
occurred. Other adverse reactions incl
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Svojstava lijeka
1
ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cimalgex 8 mg chewable tablets for dogs
Cimalgex 30 mg chewable tablets for dogs
Cimalgex 80 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Cimalgex 8 mg
cimicoxib 8 mg
Cimalgex 30 mg
cimicoxib 30 mg
Cimalgex 80 mg
cimicoxib 80 mg
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Cimalgex 8 mg, tablets: oblong, white to pale brown, chewable tablets
with 1 break-line on both
sides.The tablets can be divided into equal halves.
Cimalgex 30 mg, tablets: oblong, white to pale brown, chewable tablets
with 2 break-lines on both
sides. The tablets can be divided into equal thirds.
Cimalgex 80 mg, tablets: oblong, white to pale brown, chewable tablets
with 3 break-lines on both
sides. The tablets can be divided into equal quarters.
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, and the management of peri-
operative pain due to orthopaedic or soft tissue surgery, in dogs.
4.3
CONTRAINDICATIONS
Do no use in dogs less than 10 weeks of age.
Do not use in dogs suffering from gastrointestinal disorders or
haemorrhagic disorders.
Do not use concomitantly with corticosteroids or other non-steroidal
anti-inflammatory drugs
(NSAIDs). Refer also to section 4.8
Do not use in case of hypersensitivity to cimicoxib or to any of the
excipients.
Do not use in breeding, pregnant and lactating animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
3
Since the safety of the medicinal product has not been adequately
demonstrated in young animals,
careful monitoring is advised during the treatment of young dogs aged
less than 6 months.
Use in animals suffering from impaired cardiac, renal or hepatic
function, may involve additional risk.
If such u
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