Cimalgex

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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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:

Hunde

Therapeutic area:

Muskel-skelet-system

Therapeutic indications:

Lindring af smerte og betændelse forbundet med slidgigt. Behandling af perioperativ smerte på grund af ortopædiske eller bløde vævsoperationer.

Product summary:

Revision: 1

Authorization status:

autoriseret

Authorization date:

2011-02-18

Patient Information leaflet

                                16
B. INDLÆGSSEDDEL
17
INDLÆGSSEDDEL TIL:
CIMALGEX 8 MG TYGGETABLETTER TIL HUNDE
CIMALGEX 30 MG TYGGETABLETTER TIL HUNDE
CIMALGEX 80 MG TYGGETABLETTER TIL HUNDE
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Vétoquinol SA
Magny Vernois
70200 Lure
Frankrig
2.
VETERINÆRLÆGEMIDLETS NAVN
Cimalgex 8 mg tyggetabletter til hund
Cimalgex 30 mg tyggetabletter til hund
Cimalgex 80 mg tyggetabletter til hund
Cimicoxib
3.
ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER
Hver tyggetablet indeholder:
Cimicoxib 8 mg
Cimicoxib 30 mg
Cimicoxib 80 mg
Cimalgex 8 mg, tabletter: aflange, hvide til lysebrune, tyggetabletter
med 1 delekærv på begge sider.
Tabletterne kan deles i to ens halvdele.
Cimalgex 30 mg, tabletter: aflange, hvide til lysebrune,
tyggetabletter med 2 delekærve på begge sider.
Tabletterne kan deles i tre lige store dele.
Cimalgex 80 mg, tabletter: aflange, hvide til lysebrune,
tyggetabletter med 3 delekærve på begge sider.
Tabletterne kan deles i fire lige store dele.
4.
INDIKATIONER
Til behandling af smerter og inflammation i forbindelse med slidgigt
samt behandling af peri-operative
smerter (smerter efter operation) efter ortopædkirurgi eller
blødtvævskirurgi hos hunde.
5.
KONTRAINDIKATIONER
Bør ikke anvendes til hunde som er yngre end 10 uger.
Bør ikke anvendes på hunde med mave-tarm lidelser eller
bløder-sygdomme.
Bør ikke anvendes samtidig med kortikosteroider eller andre
non-steroide antiinflammatoriske
lægemidler (NSAIDer).
Bør ikke anvendes i tilfæde af overfølsomhed over for cimicoxib
eller et eller flere af hjælpestofferne.
Bør ikke anvendes til avlstæver, drægtige tæver eller diegivende
tæver (se afsnit 12 ”Drægtighed og
laktation”).
18
6.
BIVIRKNINGER
Milde og forbigående tilfælde af gastrointestinale lidelser
(opkastning og/eller diarré) forekommer
meget hyppigt, men ophører efter kort tid.
I sjældne tilfælde er der observeret alvo
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
VETERINÆRLÆGEMIDLETS NAVN
Cimalgex 8 mg tyggetabletter til hund
Cimalgex 30 mg tyggetabletter til hund
Cimalgex 80 mg tyggetabletter til hund
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver tablet indeholder:
AKTIVT STOF:
Cimalgex 8 mg
cimicoxib 8 mg
Cimalgex 30 mg
cimicoxib 30 mg
Cimalgex 80 mg
cimicoxib 80 mg
Alle hjælpestoffer er anført under pkt. 6.1
3.
LÆGEMIDDELFORM
Tyggetabletter.
Cimalgex 8 mg, tabletter: aflange, hvide til lysebrune, tyggetabletter
med 1 delekærv på begge sider.
Tabletterne kan deles i to ens halvdele.
Cimalgex 30 mg, tabletter: aflange, hvide til lysebrune,
tyggetabletter med 2 delekærve på begge sider.
Tabletterne kan deles i tre lige store dele.
Cimalgex 80 mg, tabletter: aflange, hvide til lysebrune,
tyggetabletter med 3 delekærve på begge sider.
Tabletterne kan deles i fire lige store dele.
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Hund
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Til behandling af smerte og inflammation associeret med osteoarthritis
(slidgigt) og behandling af
peri-oprerative smerter (smerter efter operation) efter
ortopædkirurgi eller blødtvævskirurgi hos hunde.
4.3
KONTRAINDIKATIONER
Bør ikke anvendes til hunde som er yngre end 10 uger.
Bør ikke anvendes til hunde med mave-tarm lidelser eller hæmoragiske
lidelser.
Bør ikke anvendes samtidig med kortikosteroider eller andre
non-steroide antiinflammatoriske
lægemidler (NSAID). Se også pkt. 4.8.
Bør ikke anvendes i tilfæde af overfølsomhed over for cimicoxib
eller over for et eller flere af
hjælpestofferne.
Bør ikke anvendes til avlstæver, under drægtighed og laktation.
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Ingen.
3
4.5
SÆRLIGE FORSIGTIGHEDSREGLER VEDRØRENDE BRUGEN
Særlige forsigtighedsregler vedrørende brug til dyr
Da sikkerheden i forbindelse med brug af lægemidlet ikke er
tilstrækkeligt undersøgt i ungdyr,
anbefales det, at der udføres
                                
                                Read the complete document

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Active ingredient cimicoxib

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ATC code QM01AH93

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Marketed by Vétoquinol SA

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INN (International Name) cimicoxib

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Documents in other languages

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
Patient Information leaflet Patient Information leaflet Spanish 14-01-2016
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
Summary of Product characteristics Summary of Product characteristics Czech 14-01-2016
Public Assessment Report Public Assessment Report Czech 26-07-2011
Patient Information leaflet Patient Information leaflet German 14-01-2016
Summary of Product characteristics Summary of Product characteristics German 14-01-2016
Public Assessment Report Public Assessment Report German 26-07-2011
Patient Information leaflet Patient Information leaflet Estonian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Estonian 14-01-2016
Public Assessment Report Public Assessment Report Estonian 26-07-2011
Patient Information leaflet Patient Information leaflet Greek 14-01-2016
Summary of Product characteristics Summary of Product characteristics Greek 14-01-2016
Public Assessment Report Public Assessment Report Greek 26-07-2011
Patient Information leaflet Patient Information leaflet English 14-01-2016
Summary of Product characteristics Summary of Product characteristics English 14-01-2016
Public Assessment Report Public Assessment Report English 26-07-2011
Patient Information leaflet Patient Information leaflet French 14-01-2016
Summary of Product characteristics Summary of Product characteristics French 14-01-2016
Public Assessment Report Public Assessment Report French 26-07-2011
Patient Information leaflet Patient Information leaflet Italian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Italian 14-01-2016
Public Assessment Report Public Assessment Report Italian 26-07-2011
Patient Information leaflet Patient Information leaflet Latvian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Latvian 14-01-2016
Public Assessment Report Public Assessment Report Latvian 26-07-2011
Patient Information leaflet Patient Information leaflet Lithuanian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Lithuanian 14-01-2016
Public Assessment Report Public Assessment Report Lithuanian 26-07-2011
Patient Information leaflet Patient Information leaflet Hungarian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Hungarian 14-01-2016
Public Assessment Report Public Assessment Report Hungarian 26-07-2011
Patient Information leaflet Patient Information leaflet Maltese 14-01-2016
Summary of Product characteristics Summary of Product characteristics Maltese 14-01-2016
Public Assessment Report Public Assessment Report Maltese 26-07-2011
Patient Information leaflet Patient Information leaflet Dutch 14-01-2016
Summary of Product characteristics Summary of Product characteristics Dutch 14-01-2016
Public Assessment Report Public Assessment Report Dutch 26-07-2011
Patient Information leaflet Patient Information leaflet Polish 14-01-2016
Summary of Product characteristics Summary of Product characteristics Polish 14-01-2016
Public Assessment Report Public Assessment Report Polish 26-07-2011
Patient Information leaflet Patient Information leaflet Portuguese 14-01-2016
Summary of Product characteristics Summary of Product characteristics Portuguese 14-01-2016
Public Assessment Report Public Assessment Report Portuguese 26-07-2011
Patient Information leaflet Patient Information leaflet Romanian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Romanian 14-01-2016
Public Assessment Report Public Assessment Report Romanian 26-07-2011
Patient Information leaflet Patient Information leaflet Slovak 14-01-2016
Summary of Product characteristics Summary of Product characteristics Slovak 14-01-2016
Public Assessment Report Public Assessment Report Slovak 26-07-2011
Patient Information leaflet Patient Information leaflet Slovenian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Slovenian 14-01-2016
Public Assessment Report Public Assessment Report Slovenian 26-07-2011
Patient Information leaflet Patient Information leaflet Finnish 14-01-2016
Summary of Product characteristics Summary of Product characteristics Finnish 14-01-2016
Public Assessment Report Public Assessment Report Finnish 26-07-2011
Patient Information leaflet Patient Information leaflet Swedish 14-01-2016
Summary of Product characteristics Summary of Product characteristics Swedish 14-01-2016
Public Assessment Report Public Assessment Report Swedish 26-07-2011
Patient Information leaflet Patient Information leaflet Norwegian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Norwegian 14-01-2016
Patient Information leaflet Patient Information leaflet Icelandic 14-01-2016
Summary of Product characteristics Summary of Product characteristics Icelandic 14-01-2016
Patient Information leaflet Patient Information leaflet Croatian 14-01-2016
Summary of Product characteristics Summary of Product characteristics Croatian 14-01-2016

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