Equioxx

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
26-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
26-01-2022
Public Assessment Report Public Assessment Report (PAR)
06-03-2017

Active ingredient:

firocoxib

Available from:

Audevard

ATC code:

QM01AH90

INN (International Name):

firocoxib

Therapeutic group:

Konji

Therapeutic area:

Anti-inflammatory and anti-rheumatic products, non-steroids

Therapeutic indications:

Smanjenje boli i upale povezane s osteoartritisom i smanjenje hromost kod konja.

Product summary:

Revision: 12

Authorization status:

odobren

Authorization date:

2008-06-25

Patient Information leaflet

                                31
B.
UPUTA O VMP
32
UPUTA O VMP
EQUIOXX 8,2 MG/G PERORALNA PASTA ZA KONJE
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA
ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE SERIJE U PROMET,
AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet:
Audevard
37-39 rue de Neuilly
92110, Clichy
France
Nositelj odobrenja za proizvodnju odgovoran za puštanje proizvodne
serije:
Boehringer Ingelheim Animal Health France
4 chemin du Calquet
31000 Toulouse
France
Ceva Santé Animale
10, av. de La Ballastière
33500 Libourne
France
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
EQUIOXX 8,2 mg/g peroralna pasta za konje.
3.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
SASTOJAKA
Firokoksib 8,2 mg/g
4.
INDIKACIJE
Uklanjanje bolova i upala povezanih s osteoartrozom i smanjenje s time
povezane hromosti konja.
5.
KONTRAINDIKACIJE
Ne primjenjivati u životinja koje pate od gastrointestinalnih
poremećaja i krvarenja, oštećenja funkcije
jetre, srca ili bubrega i poremećaja krvarenja.
Ne smije se primjenjivati na rasplodnim, gravidnim ili životinjama u
laktaciji.
Ne upotrebljavati istovremeno s kortikosteroidima ili drugim
nesteroidnim protuupalnim lijekovima
(NSAID).
6.
NUSPOJAVE
U liječenih životinja tijekom ispitivanja podnošljivosti vrlo
često su primijećene lezije
(erozija/ulceracija) na usnoj sluznici i koži oko usta. Te lezije
bile su obično blage i nestajale su bez
33
liječenja,
Slinjenje i edem usnica i jezika manje često su bili povezani s
oralnim lezijama tijekom terenskih
ispitivanja.
Učestalost nuspojava je određena sukladno sljedećim pravilima:
-
vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za
vrijeme trajanja tretmana)
-
česte (više od 1 ali manje od 10 životinja na 100 životinja)
-
manje česte (više od 1 ali manje od 10 životinja na 1.000
životinja)
-
rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja)
-
vrlo rijetke (manje od 1 životinje na 10.000 životinja,
uključujući izolirane slučajeve).
Ako zamijetite bil
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
EQUIOXX 8,2 mg/g peroralna pasta za konje
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka brizgaljka od 7,32 g paste sadrži:
Firokoksib 8,2 mg/g
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Peroralna pasta.
Bijela do bjelkasta pasta.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Konji.
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Uklanjanje bolova i upala povezanih s osteoartrozom i smanjenje s time
povezane hromosti konja.
4.3
KONTRAINDIKACIJE
Ne primjenjivati na životinjama koje pate od gastrointestinalnih
poremećaja i krvarenja, oštećenja
funkcije jetre, srca ili bubrega i poremećaja krvarenja.
Ne smije se primjenjivati na rasplodnim, gravidnim ili životinjama u
laktaciji (vidi odjeljak 4.7).
Ne upotrebljavati istovremeno s kortikosteroidima ili drugim
nesteroidnim protuupalnim lijekovima
(vidi odjeljak 4.8).
4.4
POSEBNA UPOZORENJA
Nema.
4.5
POSEBNE MJERE OPREZA ZA PRIMJENU
Posebne mjere opreza za primjenu na životinjama
Ne primjenjivati na životinjama mlađim od 10 tjedana. U slučaju
nuspojava, liječenje treba prekinuti i
potražiti savjet veterinara. Izbjegavajte primjenu kod dehidrirane,
hipovolemičke ili hipotenzivne
životinje, budući da postoji potencijalna opasnost od povećane
toksičnosti za bubrege. Istovremenu
primjenu potencijalno nefrotoksičkih lijekova treba izbjegavati.
Preporučena doza i trajanje liječenja ne smiju se prekoračiti.
Posebne mjere predostrožnost koje mora poduzeti osoba koja
primjenjuje veterinarsko-medicinski
proizvod na životinjama
U slučaju nehotičnog gutanja, odmah potražite pomoć liječnika i
pokažite mu uputu o VMP ili etiketu.
Izbjegavajte dodir s očima i kožom. Ako se to desi, odmah izložene
dijelove isperite vodom.
3
Nakon upotrebe operite ruke.
Kao i kod ostalih medicinskih proizvoda koji inhibiraju COX-2,
trudnice ili žene reproduktivne dobi
trebaju izbjegavati dodir s proizvodom ili kod primjene trebaju nositi
ruk
                                
                                Read the complete document

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Active ingredient firocoxib

firocoxib

ATC code QM01AH90

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Marketed by Audevard

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INN (International Name) firocoxib

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Summary of Product characteristics Summary of Product characteristics Bulgarian 26-01-2022
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