FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use in breeding, pregnant or lactating animals (see section 4.7).
Slovenian: Ne uporabljajte pri vzrejnih živalih, pri brejih živalih ali živalih v laktaciji (glejte poglavje 4.7).
English: PHARMACEUTICAL FORM Oral paste.
Slovenian: FARMACEVTSKA OBLIKA Peroralna pasta.
English: Merial Toulouse 4 Chemin du Calquet 31000 Toulouse France
Slovenian: 4 chemin du Calquet 31000 TOULOUSE France
English: PHARMACEUTICAL FORM Chewable tablet
Slovenian: FARMACEVTSKA OBLIKA Žvečljiva tableta
English: Disodium EDTA, n-propyl gallate, and thiodipropionic acid, are used to stabilize the glycerol formal and therefore are not considered as excipients in the context of MRLs.
Slovenian: Dinatrijev edetat, n-propil galat, tiodipropionska kislina se uporabljajo le za stabilizacijo glicerol formala in zato ne sodijo med pomožne snovi, ki jih zadeva MRL.
English: If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Slovenian: Če se pojavijo stranski učinki, je zdravljenje potrebno prekiniti in se posvetovati z veterinarjem.
English: Remove the cover from the tip of the syringe.
Slovenian: Odstranite pokrovček s konice brizge.
English: The peak plasma levels observed one minute following firocoxib intravenous administration was approximately 3.7 fold greater than the observed peak plasma concentrations reached after administration of the oral paste (oral Tmax = 2.02 hours).
Slovenian: Vrh plazemske koncentracije firokoksiba, dosežen v eni minuti po intravenskem dajanju, je približno 3,7 krat višji kot najvišja plazemska koncentracija po peroralnem dajanju paste (oralni Tmax = 2.02 ure).
English: Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.
Slovenian: Kot pri vseh drugih COX-2 inhibitorjih, naj se nosečnice ali ženske ki poskušajo zanositi, izogibajo stiku z zdravilom, oziroma naj pri dajanju zdravila nosijo zaščitne rokavice.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Slovenian: Izogibajte se uporabi zdravila pri živalih, ki so dehidrirane, hipovolemične ali imajo nizek krvni tlak, ker v teh primerih obstaja potencialna nevarnost za povečano toksičnost za ledvice.
English: Each syringe contains a net weight of 7.32 g of oral paste and is labelled in 100 kg dosing increments.
Slovenian: Vsaka brizga vsebuje 7,32 g peroralne paste in je označena v skladu s povišanjem odmerkov za vsakih dodatnih 100 kg telesne teže.
English: TARGET SPECIES For horses.
Slovenian: CILJNE ŽIVALSKE VRSTE Za konje.
English: Firocoxib 20 mg
Slovenian: Firokoksib 20 mg
English: Not authorized for use in animals producing milk for human consumption.
Slovenian: Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
English: EQUIOXX 8.2 mg/g Oral Paste may be used for continuation of treatment at a dosage of 0.1 mg firocoxib per kg bodyweight once daily.
Slovenian: Za nadaljevanje zdravljenja lahko uporabimo EQUIOXX 8,2 mg/g peroralno pasto v odmerku 0,1 mg firokoksiba/kg telesne mase enkrat dnevno.
English: 4.2 Indications for use, specifying the target species Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Lajšanje bolečine in vnetja, povezanih z osteoartritisom in zmanjšanje šepanja, povezanega z osteoartritisom pri konjih.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box labelling
Slovenian: PODATKI NA ZUNANJI OVOJNINI Označevanje kartonaste škatle
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 7.32 g of oral paste
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 7.32 g peroralne paste.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Slovenian: Farmakoterapevtska skupina: Nesteroidna protivnetna in protirevmatična zdravila.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: D. DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM>
English: Rotate the plunger ring ¼ turn to lock it in place and ensure it is locked.
Slovenian: Obroč zavrtite in pritrdite na batu z zavojem za ¼ , ter se prepričajte, da je pravilno nameščen.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Oral use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE ZDRAVILA
English: TARGET SPECIES For horses (450-600 kg)
Slovenian: CILJNE ŽIVALSKE VRSTE Za konje (450-600 kg).
English: In “in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
Slovenian: V »in vitro« poskusih s celokupno krvjo konjev, firokoksib izraža 222 do 643-krat večjo selektivnost za COX-2 kot za COX-1.
English: To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse's weight.
Slovenian: Primerni odmerek firokoksiba nastavite z obročem na batu brizge tako, da ga zavrtite za ¼ kroga in ga potegnete vzdolž osi bata do primernega razdelka, glede na telesno maso konja.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ceva Santé Animale
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ceva Santé Animale
English: COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception, and cognitive function).
Slovenian: Za COX-2 se domneva tudi, da je vključen v proces ovulacije, implantacije in zaprtja ductus arteriosusa ter v funkcije osrednjega živčnega sistema (indukcija vročine, zaznavanje bolečine in kognitivne funkcije).
English: Laboratory studies in laboratory animals have shown evidence of embryofoetotoxicity, malformations, delayed parturition and decreased pup survival.
Slovenian: Študije na laboratorijskih živalih so pokazale embriofetotoksičnost, malformacije, zakasnele porode in zmanjšano preživetje mladičev.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
Slovenian: Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili (NSAID) (glejte poglavje 4.8).
English: Following oral administration in horses at the recommended dose of 1 tablet per horses, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 2.43 (± 2,17) hours.
Slovenian: Firokoksib se hitro absorbira po peroralnem dajanju v priporočenem odmerku po 1 tableto na konja, čas do maksimalne koncentracije (Tmax) je 2,43 (± 2,17) ur.
English: To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse's weight.
Slovenian: Za aplikacijo zdravila EQUIOXX v odmerku 0,1 mg firokoksiba/kg telesne mase, nastavite bat brizge na primeren razdelek odmerka, glede na telesno maso konja.
English: However, studies with laboratory animals have shown embryofoetotoxicity, malformations, delayed parturition and decreased pup survival.
Slovenian: Študije na laboratorijskih živalih pa so pokazale embriofetotoksičnost, malformacije, zakasnele porode in zmanjšano preživetje mladičev.
English: PACKAGE SIZE 1 syringe.
Slovenian: VELIKOST PAKIRANJA 1 brizga
English: TARGET SPECIES For horses
Slovenian: CILJNE ŽIVALSKE VRSTE Za konje
English: BATCH NUMBER Lot {number}
Slovenian: ŠTEVILKA SERIJE lot{številka}
English: - 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
Slovenian: - 1 kartonska škatla, ki vsebuje 60 tablet v 30 ml plastenki iz polietilena visoke gostote.
English: The incidence of oral/skin lesions increases with increasing dose.
Slovenian: Incidenca poškodb v ustih in na koži narašča z večanjem odmerka.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycerol formal
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Laktoza monohhidrat
English: White to off-white paste.
Slovenian: Bele do sivo bele barve.
English: 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
Slovenian: IC50) je 0,0369 - 0,12 μM, medtem pa je IC50 za COX-1 enaka 20,14 - 33,1 μM.
English: Muscle Fat
Slovenian: Mišice Maščoba Jetra Ledvice
English: Occasional lesions of the oral mucosa and of the skin around the mouth associated with salivation and labial and tongue oedema.
Slovenian: Pri zdravljenih živalih se občasno pojavijo poškodbe na ustni sluznici in na koži okrog ust, slinjenje in edem ustnic ter jezika.
English: TARGET SPECIES Horses (450-600 kg).
Slovenian: CILJNE ŽIVALSKE VRSTE Konji (450-600 kg).
English: Meat and offal: 26 days.
Slovenian: Meso in organi: 26 dni
English: Do not exceed the recommended dosage.
Slovenian: Ne prekoračite priporočenega odmerka.
English: Replace cap after use.
Slovenian: Po uporabi ponovno namestite pokrovček.
English: - 1 cardboard box containing 180 tablets in transparent PVC /aluminium foil blisters.
Slovenian: - 1 kartonska škatla, ki vsebuje 180 tablet v prozornih PVC/aluminijastih pretisnih omotih.
English: The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1 ml of the solution per 225 kg bodyweight) once daily by intravenous injection.
Slovenian: Priporočen odmerek je 0,09 mg firokoksiba /kg telesne mase intravensko enkrat dnevno (kar ustreza 1 ml raztopine na 225 kg telesne mase).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP
English: ADVERSE REACTIONS Mild injection site swellings associated with perivascular inflammation and pain.
Slovenian: Blage reakcije v obliki otekline in perivaskularnega vnetja in bolečina.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili (NSAID).
English: • EQUIOXX 20 mg/ml solution for injection for horses The excipients listed in section 6.1 of the SPC (Glycerol formal and Macrogol 400) are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: • EQUIOXX 20 mg/ml raztopina za injiciranje za konje Za pomožne snovi, navedene v poglavju 6.1 SPC (glicerol formal in makrogol 400) , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št.
English: Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Slovenian: Lajšanje bolečine in vnetja povezanih z osteoartritisom in za zmanjšanje sočasnega šepanja pri konjih.
English: 6.5 Nature and composition of immediate packaging Pre-filled oral syringe made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Slovenian: Že napolnjena brizga za peroralno uporabo iz polipropilena s polietilenskim pokrovčkom, gumijastim čepom za konico in polipropilenskim batom
English: Shelflife after first opening the container : 1 month.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 1 mesec
English: Mild reactions at the injection site characterised by swelling and associated with perivascular inflammation have been reported in clinical studies following administration of the product at the recommended dose.
Slovenian: Po dajanju zdravila v priporočenih odmerkih so bile med kliničnimi študijami na mestu injiciranja opažene blage reakcije v obliki otekline in perivaskularnega vnetja.
English: The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes - 1 carton box containing 14 syringes
Slovenian: Pakiranja peroralne paste: - Kartonska škatla z 1 brizgo - Kartonska škatla s 7 brizgami - Kartonska škatla s 14 brizgami
English: These lesions are mild and resolve without treatment.
Slovenian: Običajno so to manjše poškodbe, ki preidejo brez zdravljenja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: NAČIN IN POT(I) UPORABE Peroralna uporaba.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 8.2 mg/g
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Firokoksib 8,2 mg/g
English: Do not use concomitantly with corticosteroids or other NSAIDs.
Slovenian: Ne uporabljajte sočasno s kortikosteroidi ali drugimi nesteroidnimi priotivnetnimi zdravili.
English: The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to
Slovenian: Koncentracija firokoksiba, ki je potrebna, da se inhibira 50% encima COX-2 (t.j.
English: EXP {month/year} Once opened use within 3 months.
Slovenian: Odprto zdravilo uporabite znotraj 3 mesecev.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 57 mg
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Firokoksib 57 mg
English: Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
Slovenian: Slinjenje in edem ustnic ter jezika so bili občasni, povezani s poškodbami v ustih v kliničnih študijah.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 57 mg
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Firokoksib 57 mg
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 8.2 mg/g
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE (UČINKOVIN) Firokoksib 8.2 mg/g
English: The safety of the veterinary medicinal product for use in breeding, pregnant or lactating horses has not been evaluated.
Slovenian: Varnost uporabe zdravila pri živalih v času razploda, med brejostjo in pri kobilah v laktaciji ni bila preučena.
English: The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Slovenian: Varnost uporabe zdravila pri vzrejnih, brejih kobilah ali pri kobilah v laktaciji ni bila preučena.
English: - 1 cardboard box containing 30 tablets in transparent PVC /aluminium foil blisters.
Slovenian: - 1 kartonska škatla, ki vsebuje 30 tablet v prozornih PVC/aluminijastih pretisnih omotih.
English: Administer 0.1 mg firocoxib per kg bodyweight, once daily.
Slovenian: 0.1 mg firokoksiba na kg telesne mase, enkrat dnevno največ 14 dni.
English: Shelf-life after first opening the syringe: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 je izoforma encima, za katerega se je izkazalo, da je induciran s pro-vnetnimi dražljaji, in za katerega se domneva, da je primarno odgovoren za sintezo prostanoidnih mediatorjev za bolečino, vnetje in vročino.
English: Pregnancy and lactation:
Slovenian: Uporaba v obdobju brejosti, laktacije:
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št. 470/2009.
English: MARKETING AUTHORISATION NUMBER EU/2/08/083/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/001
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 je izoformna oblika encima, ki je primarno odgovoren za sintezo prostanoidnih mediatorjev za bolečino, vnetje in vročino.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 20 mg/ml
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Firokoksib 20mg/ml
English: EQUIOXX 57 mg chewable tablets for horses.
Slovenian: • EQUIOXX 57 mg žvečljive tablete za konje
English: The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e., the IC50) is 0.0369 to 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
Slovenian: IC50) je 0,0369 - 0,12 µM, medtem ko je IC50 za COX-1 20,14 - 33,1 µM.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Firocoxib 20 mg/ml
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Firokoksib 20mg/ml
English: Lactose monohydrate Microcrystalline cellulose Chartor hickory smoke flavour Hydroxypropyl cellulose Croscarmellose sodium
Slovenian: dinatrijev edetat, n-propil galat, tiodipropionska kislina
English: - carton containing 6 vials of 25 ml
Slovenian: Velikosti pakiranja: - škatlica z eno vialo s 25 ml - škatla s 6 vialami s 25 ml
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Slovenian: Firokoksib je nesteroidno protivnetno zdravilo (NSAID), ki selektivno zavira delovanje ciklooksigenaze-2 (COX-2) v sintezi prostaglandinov.
English: Therefore, do not use in breeding, pregnant or lactating animals.
Slovenian: Zdravila zato ne uporabljajte pri vzrejnih in brejih živalih ali živalih v laktaciji.
English: The injection vials are available in the following pack sizes: - carton containing one vial of 25 ml.
Slovenian: Žvečljive tablete so na voljo v naslednjih pakiranjih: - 1 kartonska škatla, ki vsebuje 10 tablet v pretisnih omotih.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Firocoxib 8.2 mg/g
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Firokoksib 8,2 mg/g
English: PACKAGE LEAFLET EQUIOXX 8.2 mg/g oral paste for horses
Slovenian: NAVODILO ZA UPORABO EQUIOXX 8.2 mg/g peroralna pasta za konje
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such medicinal products should therefore be observed.
Slovenian: Predhodno zdravljenje z drugimi protivnetnimi snovmi se lahko odraža v dodatnih ali povečanih neželenih učinkih, zato je potrebno upoštevati časovno obdobje, ko ne zdravimo s takimi zdravili.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/006-009
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/006-009
English: Do not use in breeding, pregnant or lactating animals.
Slovenian: Ne uporabljajte pri vzrejnih živalih, pri brejih živalih ali živalih v laktaciji.
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets firocoxib
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 57 mg žvečljive tablete
English: PACKAGE LEAFLET EQUIOXX 20 mg/ml solution for injection for horses
Slovenian: NAVODILO ZA UPORABO ZA: EQUIOXX 20 mg/ml raztopina za injiciranje za konje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste .
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta Firokoksib
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002-003
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/083/002-003
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Slovenian: Firokoksib je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino koksibov in deluje po mehanizmu selektivne inhibicije sinteze prostaglandinov, ki jo posreduje ciklooksigenaza-2 (COX-2).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses Firocoxib
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta za konje Firokoksib
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection Firocoxib
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje Firokoksib
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 20 mg/ml
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Firokoksib 20 mg/ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets for horses firocoxib
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 57 mg žvečljive tablete za konje Firokoksib
English: EXP Once broached use within 1 month.
Slovenian: Odprto zdravilo uporabite znotraj 1 meseca.
English: PACKAGE LEAFLET EQUIOXX 57 mg chewable tablets for horses
Slovenian: NAVODILO ZA UPORABO EQUIOXX 57 mg žvečljive tablete za konje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje za konje
English: Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there might be an increased risk of renal toxicity.
Slovenian: Izogibajte se sočasnemu dajanju zdravil, ki so potencialno toksična za ledvice, saj je v teh primerih povečana nevarnost toksičnosti za ledvice.
English: Withdrawal period: Meat and offal: 26 days.
Slovenian: Karenca: meso in notranji organi: 26 dni
English: 6.5 Nature and composition of immediate packaging Multi-dose amber-coloured glass injection vials closed with rubber stopper and sealed with an aluminium crimped top.
Slovenian: Večodmerna viala jantarne barve z gumijastim pokrovčkom in aluminijasto zaporko.
English: Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM LyonCeva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France
English: EXPIRY DATE
Slovenian: Firokoksib Ekvidi
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Slovenian: Pri zdravljenih živalih se občasno pojavijo poškodbe (erozije /ulkusi) na ustni sluznici in na koži okrog ust.
English: Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Slovenian: Dajte eno tableto enkrat na dan konjem, ki tehtajo od 450 do 600 kg. Trajanje zdravljenja je odvisno od učinka, vendar naj ne bi preseglo 14 dni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses Firocoxib
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 20 mg/ml raztopina za injiciranje za konje Firokoksib
English: Shelf life after first opening the immediate packaging: 1 month.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 1 mesec.
English: ADVICE ON CORRECT ADMINISTRATION Avoid the introduction of contamination during use.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Držite se običajnih pravil asepse.
English: Yellow Iron Oxide (E172)
Slovenian: Mikrokristalna celuloza Chartor dimni hikori okus Hidroksipropilceluloza Natrijev karmelozat, premreženi Magnezijev stearat Karamelni sladkor (E150d) silicijev dioksid, koloidni, brezvodni Rumeni železov oksid (E172) Rdeči železov oksid (E172)