Cimalgex

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
14-01-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
14-01-2016
Public Assessment Report Public Assessment Report (PAR)
26-07-2011

Active ingredient:

cimicoxib

Available from:

Vétoquinol SA

ATC code:

QM01AH93

INN (International Name):

cimicoxib

Therapeutic group:

Klieb

Therapeutic area:

Sistema musculo-skeletali

Therapeutic indications:

Eżenzjoni ta 'uġigħ u infjammazzjoni assoċjati ma' osteoartrite. Ġestjoni ta 'uġigħ perijoperattiv minħabba kirurġiji ortopediċi jew tat-tessut artab.

Product summary:

Revision: 1

Authorization status:

Awtorizzat

Authorization date:

2011-02-18

Patient Information leaflet

                                16
B. FULJETT TA’ TAGĦRIF FIL-PAKKETT
17
FULJETT TA’ TAGĦRIF
CIMALGEX 8 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
CIMALGEX 30 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
CIMALGEX 80 MG PILLOLI LI JINTMAGĦDU GĦALL-KLIEB
1.
L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ U
L-ISEM U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-MANIFATTURA
RESPONSABBLI LI JĦALLI L-KONSENJA TMUR FIS-SUQ, JEKK DIFFERENTI
Vétoquinol SA
Magny Vernois
70200 Lure
Franza
2.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Cimalgex 8 mg pilloli li jintmagħdu għall-klieb
Cimalgex 30 mg pilloli li jintmagħdu għall-klieb
Cimalgex 80 mg pilloli li jintmagħdu għall-klieb
Cimicoxib
3.
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) U INGREDJENT(I) OĦRA
Kull pillola fiha:
Cimicoxib 8 mg
Cimicoxib 30 mg
Cimicoxib 80 mg
Cimalgex 8 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod għal
kannella ċari, li jistgħu jintmagħdu
b’ferq fuq iż-żewġ naħat.
Il-pilloli jistgħu jinqasmu f’żewġ partijiet ugwali.
Cimalgex 30 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod
għal kannella ċari, li jintmagħdu b’2
ifruq fuq iż-żewġ naħat. Il-pilloli jistg
ħu jinqasmu f’tlett partijiet ugwali.
Cimalgex 80 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod
għal kannella ċari, li jintmagħdu bi 3
ifruq fuq iż-żewġ naħat. Il-pilloli jistgħu jinqasmu
f’partijiet ugwali.
4.
INDIKAZZJONIJIET
Għall-kura mill-uġigħ u l-infjammazzjoni marbuta ma’
osteoartrite, u l-kontroll ta’ uġigħ waqt
interventi kirurġiċi minħabba kirurġija ortopedika jew kirurġija
dovuta għal tessut artab, fil-klieb.
5.
KONTRAINDIKAZZJONIJIET
Tużax fuq klieb li għadhom m’għalqux l-10 ġimgħat.
Tużax fuq klieb li jbatu minn disturbi fl-istonku jew is-sistema
diġestiva jew fi klieb bi problemi ta’
emorraġija.
Tużax fl-istess waqt ma’ kortikoseterojdi jew mediċini
anti-infjammatorji mhux sterojdi (NSAIDs)
oħra.
Tużax jekk il-kelb għandu sensittività eċċessiva għal cimicoxib
jew xi wieħed mis-sustanzi l-oħra
fil-prodott.
1
                                
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Summary of Product characteristics

                                1
ANNESS I
KARATTERISTIĊI TAL-PRODOTT FIL-QOSOR
2
1.
ISEM TAL-PRODOTT MEDIĊINALI VETERINARJU
Cimalgex 8 mg pilloli li jintmagħdu għal klieb
Cimalgex 30 mg pilloli li jintmagħdu għal klieb
Cimalgex 80 mg pilloli li jintmagħdu għal klieb
2.
KOMPOŻIZZJONI KWALITTATIVA U KWANTITATTIVA
Kull pillola fiha:
SUSTANZA ATTIVA:
Cimalgex 8 mg
cimicoxib 8 mg
Cimalgex 30 mg
cimicoxib 30 mg
Cimalgex 80 mg
cimicoxib 80 mg
Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pilloli li jintmagħdu
Cimalgex 8 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod għal
kannella ċari, li jistgħu jintmagħdu
b’ferq fuq iż-żewġ naħat.
Il-pilloli jistgħu jinqasmu f’żewġ partijiet ugwali.
Cimalgex 30 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod
għal kannella ċari, li jintmagħdu b’2
ifruq fuq iż-żewġ naħat. Il-pilloli jistgħu jinqasmu f’tlett
partijiet ugwali.
Cimalgex 80 mg, pilloli: pilloli oblongi ta’ lewn bajdani bojod
għal kannella ċari, li jintmagħdu bi 3
ifruq fuq iż-
żewġ naħat. Il-pilloli jistgħu jinqasmu f’partijiet ugwali.
4.
TAGĦRIF KLINIKU
4.1
SPEĊI LI FUQHOM SER JINTUŻA L-PRODOTT
Klieb
4.2
INDIKAZZJONIJIET GĦAL UŻU TAL-PRODOTT LI JISPEĊIFIKAW L-ISPEĊI LI
FUQHOM SER JINTUŻA L-PRODOTT
Għall-kura mill-uġigħ u l-infjammazzjoni marbuta ma’
osteoartrite, u l-kontroll ta’ uġigħ waqt
interventi kirurġiċi minħabba kirurġija ortopedika jew kirurġija
dovuta għal tessut artab, fil-klieb.
4.3
KONTRAINDIKAZZJONIJIET
Tużax fuq klieb li għadhom m’għalqux l-10 ġimgħat.
Tużax fuq klieb li jbatu minn disturbi gastrointestinali jew
emorraġiċi.
Tużax fl-istess waqt ma’ kortikoseterojdi jew mediċini oħra mhux
sterojdi li jaġixxu kontra
l-infjammazzjoni (NSAIDs). Ara wkoll sezzjoni 4.8
Tużax f’każijiet ta’ sensittività għal cimicoxib jew f’każ
ta’ ingredjenti mhux attivi.
Tużax fuq annimali waqt it-tgħ
ammir, it-tqala u l-irdigħ.
4.4
TWISSIJIET SPEĊJALI GĦAL KULL SPEĊI LI GĦALIHA HU INDIKAT
IL
                                
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Active ingredient cimicoxib

cimicoxib

ATC code QM01AH93

QM01AH93

Marketed by Vétoquinol SA

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INN (International Name) cimicoxib

cimicoxib

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Patient Information leaflet Patient Information leaflet Bulgarian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Bulgarian 14-01-2016
Public Assessment Report Public Assessment Report Bulgarian 26-07-2011
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Summary of Product characteristics Summary of Product characteristics Spanish 14-01-2016
Public Assessment Report Public Assessment Report Spanish 26-07-2011
Patient Information leaflet Patient Information leaflet Czech 14-01-2016
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Public Assessment Report Public Assessment Report Czech 26-07-2011
Patient Information leaflet Patient Information leaflet Danish 14-01-2016
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Public Assessment Report Public Assessment Report Danish 26-07-2011
Patient Information leaflet Patient Information leaflet German 14-01-2016
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Public Assessment Report Public Assessment Report German 26-07-2011
Patient Information leaflet Patient Information leaflet Estonian 14-01-2016
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Public Assessment Report Public Assessment Report Estonian 26-07-2011
Patient Information leaflet Patient Information leaflet Greek 14-01-2016
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Public Assessment Report Public Assessment Report Greek 26-07-2011
Patient Information leaflet Patient Information leaflet English 14-01-2016
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Public Assessment Report Public Assessment Report English 26-07-2011
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