Cimalgex

Country: European Union

Language: Icelandic

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

Active ingredient:

cimicoxib

Available from:

Vétoquinol SA

ATC code:

QM01AH93

INN (International Name):

cimicoxib

Therapeutic group:

Hundar

Therapeutic area:

Stoðkerfi

Therapeutic indications:

Léttir á sársauka og bólgu í tengslum við slitgigt. Stjórnun verkjalyfja vegna bæklunar eða mjúkvefgerðar.

Product summary:

Revision: 1

Authorization status:

Leyfilegt

Authorization date:

2011-02-18

Patient Information leaflet

                                16
B. FYLGISEÐILL
17
FYLGISEÐILL FYRIR:
CIMALGEX 8 MG TUGGUTÖFLUR FYRIR HUNDA
CIMALGEX 30 MG TUGGUTÖFLUR FYRIR HUNDA
CIMALGEX 80 MG TUGGUTÖFLUR FYRIR HUNDA
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Vétoquinol SA
Magny Vernois
70200 Lure
Frakklandi
2.
HEITI DÝRALYFS
Cimalgex 8 mg tuggutöflur fyrir hunda
Cimalgex 30 mg tuggutöflur fyrir hunda
Cimalgex 80 mg tuggutöflur fyrir hunda
Cimicoxib
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Hver tafla inniheldur:
Cimicoxib 8 mg
Cimicoxib 30 mg
Cimicoxib 80 mg
Cimalgex 8 mg, töflur: aflangar, hvítar til ljósbrúnar
tuggutöflur með 1 deiliskoru á báðum hliðum.
Töflunum er hægt að skipta í jafna helminga.
Cimalgex 30 mg, töflur: aflangar, hvítar til ljósbrúnar,
tuggutöflur með 2 deiliskorur á báðum hliðum.
Töflunum er hægt að skipta í jafna þriðjunga.
Cimalgex 80 mg, töflur: aflangar, hvítar til ljósbrúnar,
tuggutöflur með 3 deiliskorur á báðum hliðum.
Töflunum er hægt að skipta í jafna fjórðunga.
4.
ÁBENDING(AR)
Til meðferðar við slitgigtarverkjum og -bólgu og við
aðgerðartengdum verkjum við stoðkerfis- eða
mjúkvefjaaðgerðir hjá hundum.
5.
FRÁBENDINGAR
Gefið ekki hundum yngri en 10 vikna.
Gefið ekki hundum með meltingarfæra- eða blæðingakvilla.
Gefið ekki samtímis barksterum eða öðrum bólgueyðandi
verkjalyfjum (NSAIDs).
Gefið ekki dýrum sem hafa ofnæmi fyrir cimicoxib eða einhverju
hjálparefnanna.
Gefið ekki dýrum sem notuð eru til undaneldis, á meðgöngu eða
mjólkandi dýrum (sjá kafla 12
_Sérstakar varúðarreglur við notkun hjá dýrum_
).
18
6.
AUKAVERKANIR
Mjög algengt var að tilkynnt væri um vægar truflanir í
meltingarfærum (uppköst og/eða niðurgangur)
en þær vöruðu aðeins í skamman tíma.
Í mjög sjaldgæfum tilvikum hafa sést alvarlegir
meltingafærakvillar eins og blæðingar og sáramyndun.
Ennfremur geta aðrar aukaverkanir þar á meðal lystarleysi eða
svefnhöfgi komið f
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Cimalgex 8 mg tuggutöflur fyrir hunda
Cimalgex 30 mg tuggutöflur fyrir hunda
Cimalgex 80 mg tuggutöflur fyrir hunda
2.
INNIHALDSLÝSING
Hver tafla inniheldur:
VIRKT(T) INNIHALDSEFNI:
Cimalgex 8 mg
cimicoxib 8 mg
Cimalgex 30 mg
cimicoxib 30 mg
Cimalgex 80 mg
cimicoxib 80 mg
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Tuggutöflur.
Cimalgex 8 mg, töflur: aflangar, hvítar til ljósbrúnar
tuggutöflur með 1 deiliskoru á báðum hliðum.
Töflunum er hægt að skipta í jafna helminga.
Cimalgex 30 mg, töflur: aflangar, hvítar til ljósbrúnar
tuggutöflur með 2 deiliskorum á báðum hliðum.
Töflunum er hægt að skipta í jafna þriðjunga.
Cimalgex 80 mg, töflur: aflangar, hvítar til ljósbrúnar
tuggutöflur með 3 deiliskorum á báðum hliðum.
Töflunum er hægt að skipta í jafna fjórðunga.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hundar
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til meðferðar við slitgigtarverkjum og -bólgu og við
aðgerðartengdum verkjum við stoðkerfis- eða
mjúkvefjaaðgerðir hjá hundum.
4.3
FRÁBENDINGAR
Gefið ekki hundum yngri en 10 vikna.
Gefið ekki hundum með meltingarfæra- eða blæðingakvilla.
Gefið ekki samtímis barksterum eða öðrum bólgueyðandi
verkjalyfjum (NSAIDs). Sjá einnig
kafla 4.8.
Gefið ekki dýrum sem hafa ofnæmi fyrir cimicoxib eða einhverju
hjálparefnanna.
Gefið ekki dýrum sem notuð eru til undaneldis, á meðgöngu eða
mjólkandi dýrum.
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Engin.
3
4.5
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN
Sérstakar varúðarreglur við notkun hjá dýrum
Fylgjast skal vel með meðferð á ungum hundum, á aldrinum innan
við 6 mánaða, því ekki hefur verið
nægilega sýnt fram á öryggi lyfsins hjá ungum dýrum.
Notkun hjá dýrum með skerta hjarta-, nýrna- eða lifrarstarfsemi
getur haft aukna áhættu í för með sér.
Ef ekki er hægt að komast hjá slíkri notkun, þarf dýralæknir
                                
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Similar products

Active ingredient cimicoxib

cimicoxib

ATC code QM01AH93

QM01AH93

Marketed by Vétoquinol SA

Vétoquinol SA

INN (International Name) cimicoxib

cimicoxib

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