Cimalgex

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

Buy It Now

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:

cimikoksib

Available from:

Vétoquinol SA

ATC code:

QM01AH93

INN (International Name):

cimicoxib

Therapeutic group:

Psi

Therapeutic area:

Mišično-skeletni sistem

Therapeutic indications:

Olajšanje bolečine in vnetja, povezanih z osteoartritisom. Obvladovanje perioperativne bolečine zaradi ortopedskih ali operacij mehkih tkiv.

Product summary:

Revision: 1

Authorization status:

Pooblaščeni

Authorization date:

2011-02-18

Patient Information leaflet

                                15
B. NAVODILO ZA UPORABO
16
NAVODILO ZA UPORABO
CIMALGEX 8 MG ŽVEČLJIVE TABLETE ZA PSE
CIMALGEX 30 MG ŽVEČLJIVE TABLETE ZA PSE
CIMALGEX 80 MG ŽVEČLJIVE TABLETE ZA PSE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
Vétoquinol SA
Magny Vernois
70200 Lure
Francija
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Cimalgex 8 mg žvečljive tablete za pse
Cimalgex 30 mg žvečljive tablete za pse
Cimalgex 80 mg žvečljive tablete za pse
Cimikoksib
3.
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
Vsaka tableta vsebuje:
Cimikoksib 8 mg
Cimikoksib 30 mg
Cimikoksib 80 mg
Cimalgex 8 mg, tablete: podolgovate, bele do svetlo rjave, žvečljive
tablete z 1 zarezo za lomljenje na
obeh straneh. Tablete se lahko razdeli na enake polovice.
Cimalgex 30 mg, tablete: podolgovate, bele do svetlo rjave,
žvečljive tablete z 2 zarezama za lomljenje
na obeh straneh. Tablete se lahko razdeli na enake tretjine.
Cimalgex 80 mg, tablete: podolgovate, bele do svetlo rjave,
žvečljive tablete s 3 zarezami za lomljenje
na obeh straneh. Tablete se lahko razdeli na enake četrtine.
4.
INDIKACIJE
Zdravljenje bolečine in vnetja povezanega z osteoartritisom,
upravljanje peri-operativne bolečine pri
ortopedskih operacijah in operacijah mehkih tkiv pri psih.
5.
KONTRAINDIKACIJE
Ne uporabite pri psih mlajših od 10 tednov.
Ne uporabite pri psih z želodčnimi in prebavnimi motnjami ali pri
psih s težavami s krvavitvami.
Ne uporabite istočasno s kortikosteroidi ali ostalimi nesteroidnimi
protivnetnimi zdravili (NSAID).
Ne uporabite v primeru preobčutljivosti na cimikoksib ali na katero
koli drugo sestavino zdravila.
Ne uporabite pri vzrejnih živalih ali pri živalih v obdobju brejosti
ali laktacije (glej Poglavje 12
“Posebna opozorila pri psih ”).
6.
NEŽELENI UČINKI
Zelo pogosto so poročali o blagih prebavnih motnjah (bruhanje in/ali
driska), vendar pa trajajo kratek
čas.
17
V redkih primerih so se poj
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
_ _
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Cimalgex 8 mg žvečljive tablete za pse
Cimalgex 30 mg žvečljive tablete za pse
Cimalgex 80 mg žvečljive tablete za pse
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsaka tableta vsebuje:
ZDRAVILNA UČINKOVINA:
Cimalgex 8 mg
cimikoksib 8 mg
Cimalgex 30 mg
cimikoksib 30 mg
Cimalgex 80 mg
cimikoksib 80 mg
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Žvečljive tablete.
Cimalgex 8 mg, tablete: podolgovate, bele do svetlo rjave, žvečljive
tablete z 1 zarezo za lomljenje na
obeh straneh. Tablete se lahko razdeli na enake polovice.
Cimalgex 30 mg, tablete: podolgovate, bele do svetlo rjave,
žvečljive tablete z 2 zarezama za lomljenje
na obeh straneh. Tablete se lahko razdeli na enake tretjine.
Cimalgex 80 mg, tablete: podolgovate, bele do svetlo rjave,
žvečljive tablete s 3 zarezami za lomljenje
na obeh straneh. Tablete se lahko razdeli na enake četrtine.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Psi
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Zdravljenje bolečine in vnetja povezanega z osteoartritisom in
upravljanje peri-operativne bolečine pri
ortopedskih operacijah in operacijah mehkih tkiv pri psih.
4.3
KONTRAINDIKACIJE
Ne uporabite pri psih mlajših od 10 tednov.
Ne uporabite pri psih z gastrointestinalnimi in hemoragičnimi
motnjami.
Ne uporabite istočasno s kortikosteroidi ali ostalimi nesteroidnimi
protivnetnimi zdravili (NSAID).
Glej tudi poglavje 4.8.
Ne uporabite v primeru preobčutljivosti na cimikoksib ali na katero
koli pomožno snov.
Ne uporabite pri vzrejnih živalih ter živalih v obdobju brejosti in
laktacije.
4.4.
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Jih ni.
4.5
POSEBNI PREVIDNOSTNI UKREPI
Posebni previdnostni ukrepi za uporabo pri živalih
Varnost zdravila pri mladih živalih ni bila ustrezno raziskana, zato
se priporoča skrbno spremljanje
zdravljenja mladih psov mlajših od 6 mesecev.
3
Uporaba pri živalih s prizad
                                
                                Read the complete document

Similar products

Active ingredient cimikoksib

cimikoksib

ATC code QM01AH93

QM01AH93

Marketed by Vétoquinol SA

Vétoquinol SA

INN (International Name) cimicoxib

cimicoxib

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 Danish 14-01-2016
Summary of Product characteristics Summary of Product characteristics Danish 14-01-2016
Public Assessment Report Public Assessment Report Danish 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 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

Search alerts related to this product

Alerts Cimalgex cimikoksib cimicoxib

Cimalgex cimikoksib cimicoxib

View documents history

Documents history Documents history

Cimalgex