FrancophonIA/ELRC3.0 huggingface dataset:
English: Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses weighing between 450 kg and 600 kg bodyweight.
Danish: Til lindring af smerte og betændelse i forbindelse med osteoarthritis samt reduktion af halthed i tilknytning hertil, hos heste der vejer mellem 450 og 600 kg.
English: The incidence of oral/skin lesions increases with increasing dose.
Danish: Hyppigheden af orale/hudlæsioner stiger med stigende dosis.
English: The peak concentration (Cmax) is 0.075 (± 0.033) µg/ml (equivalent to approximately 0.223 µM), area under the curve (AUC0-24) is 0.96 (± 0.26) µg x hr/ml, and oral bioavailability is 79 (± 31) percent.
Danish: Den højeste koncentration (Cmax) er 0,075 (± 0,033) μg/ml (ækvivalent til ca. 0,223 μM), arealet under kurven (AUC 0-24) er 0,96 (± 0,26) μg x t/ml og oral biotilgængelighed er 79 (± 31) procent.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Danish: Undgå anvendelse til dehydrerede, hypovolæmiske eller hypotensive dyr, da der er en potentiel risiko for forøget nyretoksicitet.
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.
Danish: Efter oral administration hos heste ved anbefalet dosis på 1 tablet pr. hest, absorberes firocoxib hurtigt Og tiden til den maksimale koncentration (Tmax) er 2.43 (± 2,17) timer.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterfolie
English: Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 3.9 (± 4.4) hours.
Danish: Efter oral administration til hest i den anbefalede dosis på 0,1 mg pr. kg. legemsvægt, absorberes firocoxib hurtigt og tiden til maksimal koncentration (Tmax) er 3,9 (± 4,4) timer.
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).
Danish: COX-2 menes også at være involveret i ovulation, implantation og lukningen af ductus arteriosus samt centralnerve funktioner (induktion af feber, smerteopfattelse og kognitiv funktion).
English: Marketing authorisation holder : Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
Danish: Indehaver af markedsføringstilladelsen: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
English: Meat and offal: 26 days.
Danish: Kød og indvolde: 26 dage.
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.
Danish: Den koncentration af firocoxib, der kræves for at hæmme 50% af COX-2 enzymet (dvs. IC50) er 0,0369 til 0,12 μM, hvorimod IC50 for COX-1 er 20,14 til 33,1 μM.
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.
Danish: For at give firocoxib i den korrekte dosering skal den riflede ring på doseringssprøjten låses op ved at dreje den en kvart omgang og lade den glide ned langs stemplets skaft til den vægtinddeling, der passer til hestens vægt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial labelling - 25 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas - 25 ml
English: These lesions are mild and resolve without treatment.
Danish: Disse læsioner er typisk af mild karakter og heler uden behandling.
English: TARGET SPECIES For horses.
Danish: DYREARTER Til heste.
English: No data is available in horses.
Danish: Der foreligger ingen data vedr.
English: Do not use after the expiry date stated on the label after EXP.
Danish: Må ikke anvendes efter den udløbsdato (EXP), som er angivet på etiketten.
English: Brown, round, convex, scored tablets.
Danish: Brune, runde konvekse tabletter med kærv.
English: Horses (450-600 kg)
Danish: Heste-(450 - 600kg)
English: Replace cap after use.
Danish: Sæt hætten på plads efter brug.
English: - 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
Danish: - 1 papæske indeholdende 60 tablets i en 30 ml high density PET beholder .
English: If this occurs, rinse affected area immediately with water.
Danish: Skulle dette ske, bør det berørte område straks skylles med vand.
English: Nonsteroidal antiinflammatory agents
Danish: Antiinflammatoriske midler/Nonsteroide antiinflammatorisk e midler
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.
Danish: For anvendelse af EQUIOXX i en dosis på 0,1 mg firocoxib/kg skal sprøjtens stempel sættes på den vægtinddeling, der passer til hestens vægt.
English: Not authorized for use in animals producing milk for human consumption.
Danish: Må ikke anvendes til lakterende dyr, hvis mælk er bestemt til menneskeføde.
English: Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Danish: Til lindring af smerte og betændelse i forbindelse med osteoarthritis samt reduktion af halthed i tilknytning hertil hos hest.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: No data on use during pregnancy is available in horses.
Danish: Der foreligger ingen data vedr.anvendelse under drægtighed hos hest.
English: Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.
Danish: Disse læsioner er typisk af mild karakter og forsvinder uden behandling, men orale læsioner kan være ledsaget af savlen og ødem af læbe og tunge.
English: 4, Chemin du Calquet 31000 Toulouse Cedex France
Danish: 4 chemin du Calquet FR-31057 Toulouse Cedex France
English: Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring.
Danish: Sideløbende behandling med molekyler, der har indvirkning på den renale gennemstrømning (diuretika), bør give anledning til klinisk overvågning.
English: Shelf-life after first opening the syringe: 3 months.
Danish: Opbevaringstid efter første åbning af sprøjten: 3 måneder.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of the solution contains:
Danish: 1 ml af opløsningen indeholder:
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.
Danish: Den anbefalede dosis er 0,09 mg firocoxib pr. kg legemsvægt (svarende til 1 ml af opløsningen pr. 225 kg legemsvægt) én gang dagligt ved intravenøs injektion.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE.
English: TARGET SPECIES For horses
Danish: DYREARTER Til hest
English: Insert the syringe tip into the horse's mouth at the interdental space and deposit the paste on the base of the tongue.
Danish: Før sprøjten ind i munden på hesten mellem for- og kindtænder og anbring pastaen på hestens tunge så langt tilbage som muligt.
English: Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.
Danish: Samtidig anvendelse af potentielt nyretoksiske veterinære lægemidler bør undgås.
English: EXP Once broached use within 1 month.
Danish: EXP Efter anbrud anvendes indenfor 1 måned.
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.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er tilladte hjælpestoffer hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet.
English: Merial Toulouse 4 Chemin du Calquet 31000 Toulouse France
Danish: 4 Chemin du Calquet 31000 Toulouse France
English: Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Danish: 1 tablet dagligt til heste der vejer 450-600 kg.
English: Shelflife after first opening the container : 1 month.
Danish: Opbevaringstid efter første åbning af beholderen: 1 måned.
English: Do not use concomitantly with corticosteroids or other NSAIDs.
Danish: Anvend ikke præparatet samtidig med kortikosteroider eller andre NSAID-præparater.
English: The injection vials are available in the following pack sizes: - carton containing one vial of 25 ml.
Danish: Hætteglassene findes i følgende pakningsstørrelser: - Æske med 1 hætteglas á 25 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: TARGET SPECIES For horses (450-600 kg)
Danish: DYREARTER Til heste (450-600 kg)
English: ROUTE(S) OF ADMINISTRATION Oral use.
Danish: INDGIVELSESVEJ(E) Til oral brug.
English: Special warnings for each target species:
Danish: Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til:
English: ADVERSE REACTIONS Mild injection site swellings associated with perivascular inflammation and pain.
Danish: Mindre hævelse på injektionsstedet ledsaget af perivaskulær betændelse og smerte.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE DER ER ANSVARLIGE FOR BATCHFRIGIVELSE
English: However, studies with laboratory animals have shown embryo-foetotoxicity, malformations, delayed parturition and decreased pup survival.
Danish: Undersøgelser med laboratoriedyr har imidlertid vist embryofoetotoksicitet, misdannelser, forsinket fødsel og nedsat overlevelse af det nyfødte dyr.
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.
Danish: Ravfarvet flerdosis-hætteglas (glas) lukket med gummiprop og forseglet med en foldet aluminiumshætte.
English: Withdrawal period : Meat and offal: 26 days.
Danish: Tilbageholdelsestid: Kød og indvolde: 26 dage.
English: Withdrawal period: Meat and offal: 26 days.
Danish: Tilbageholdelsestid: kød og indvolde: 26 dage.
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.
Danish: EQUIOXX 8,2 mg/g oral pasta i en dosis på 0,1 mg firocoxib pr. kg legemsvægt én gang dagligt kan anvendes til fortsættelse af behandlingen.
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.
Danish: Forfyldt polypropylen-sprøjte til oralt brug, med en polyethylen-hætte, en gummitop og et polypropylen-stempel.
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies.
Danish: Læsioner (erosion/ulceration) af den orale mucosa og huden omkring munden blev ofte (meget almindeligt) observeret hos behandlede dyr under tolerance studierne.
English: The peak concentration (Cmax) is 0.075 (± 0.021) μg/ml, area under the curve (AUC0-inf) is 3.48 (± 1.15) μg x hr/ml.
Danish: μg/ml, området under kurve (AUC0-inf) er 3.48 (± 1.15) μg x timer /ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Syringe labelling
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Sprøjte
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 veterinary medicinal product.
Danish: Som for andre lægemidler, der inhiberer COX-2, skal gravide kvinder og kvinder, der forsøger at blive gravide, undgå kontakt med produktet eller have handsker på, når det veterinære lægemiddel administreres.
English: Each full dose division on the syringe plunger delivers sufficient firocoxib to treat 100 kg body weight.
Danish: Hver vægtmarkering på dosissprøjtens stempel svarer til behandling af 100 kg legemsvægt.
English: • EQUIOXX 8.2 mg/g oral paste for horses
Danish: • EQUIOXX 8.2 mg/g oral pasta til heste
English: Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.
Danish: Må ikke anvendes til dyr, der lider af gastrointestinale lidelser og blødninger, nedsat lever-, hjerteeller nyrefunktion samt blødningsforstyrrelser.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr:
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.
Danish: Som for andre lægemidler, der inhiberer COX-2, skal gravide kvinder og kvinder, der forsøger at blive gravide, undgå kontakt med produktet eller have handsker på, når produktet administreres.
English: - 1 cardboard box containing 180 tablets in transparent PVC /aluminium foil blisters.
Danish: - 1 papæske indeholdende 180 tablets i gennemsigtige PVC /aluminium folie blistre.
English: Occasional lesions of the oral mucosa and of the skin around the mouth associated with salivation and labial and tongue oedema.
Danish: Læsioner af mundslimhinden og huden omkring munden kan af og til iagttages samtidig med savlen og hævelse af læbe og tunge.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Oral use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
English: In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1.
Danish: I in vitro blodprøver fra hest har firocoxib vist sig at være 222 til 643 gange mere selektiv over for COX-2 end over for COX-1.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intravenøs anvendelse.
English: - carton containing 6 vials of 25 ml
Danish: - Æske med 6 hætteglas á 25 ml.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral brug.
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.
Danish: COX-2 er den isomer af enzymet, der anses at være primært ansvarlig for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
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.
Danish: Firocoxib er et non-steroidt anti-inflammatorisk præparat (NSAID), der tilhører gruppen Coxib, som virker ved selektiv inhibition af den cyclooxygenase-2 (COX-2) - medierede prostaglandinsyntese.
English: PHARMACEUTICAL FORM Chewable tablet
Danish: LÆGEMIDDELFORM Tyggetablet
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 57 mg
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Firocoxib 57 mg
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Danish: Læsioner (erosion/ulceration) af den orale mucosa og huden omkring munden kan af og til iagttages hos behandlede dyr.
English: The safety of the veterinary medicinal product for use in breeding, pregnant or lactating horses has not been evaluated.
Danish: Det veterinære lægemiddels sikkerhed ved anvendelse i avlsdyr, drægtige eller lakterende dyr er ikke undersøgt.
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.
Danish: Firocoxib er et non-steroidt anti-inflammatorisk præparat (NSAID), der tilhører gruppen Coxib, som virker ved selektiv inhibition af den cyclooxygenase-2 (COX-2)-medierede prostaglandinsyntese.
English: - 1 cardboard box containing 10 tablets in transparent PVC /aluminium foil blisters.
Danish: - 1 papæske indeholdende 10 tablets i gennemsigtige PVC /aluminium folie blistre.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 20 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Firocoxib 20 mg/ml
English: Do not use in mares producing milk for human consumption.
Danish: Må ikke anvendes til lakterende hopper, hvis mælk er bestemt til menneskeføde.
English: EQUIOXX 20 mg/ml solution for injection for horses.
Danish: • EQUIOXX 20 mg/ml injektionsvæske, opløsning til heste.
English: EQUIOXX 57 mg chewable tablets for horses.
Danish: EQUIOXX 57 mg tyggetabletter til heste.
English: - 1 cardboard box containing 30 tablets in transparent PVC /aluminium foil blisters.
Danish: - 1 papæske indeholdende 30 tablets i gennemsigtige PVC /aluminium folie blistre.
English: Yellow Iron Oxide (E172)
Danish: Caramel (E150d) Silica, colloidal anhydrous Gul jernoxide (E172) Rød jernoxide (E172)
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed.
Danish: Forudgående behandling med andre anti-inflammatoriske præparater kan resultere i andre eller forøgede bivirkninger.
English: Name and address of the manufacturer responsible for batch release:
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose.
Danish: Læsioner (erosion/ulceration) af den orale mucosa og huden omkring munden kan af og til iagttages hos dyr, der er behandlet med den anbefalede dosis.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 8.2 mg/g
Danish: MÆNGDEN AF AKTIVSTOF(FER) Firocoxib 8,2 mg/g
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis.
Danish: Firocoxib er et non-steroidt anti-inflammatorisk præparat (NSAID), der virker ved selektiv hæmning af den cyclooxygenase-2 (COX-2)-medierede prostaglandinsyntese.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 57 mg
Danish: MÆNGDEN AF AKTIVSTOF(FER) Firocoxib 57 mg
English: Do not use in breeding, pregnant or lactating animals.
Danish: Må ikke anvendes til avlsdyr, drægtige eller lakterende dyr.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection Firocoxib
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 20 mg/ml injektionsvæske, opløsning Firocoxib
English: Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
Danish: Savlen og ødem i læbe og tunge er blevet associeret med læsionerne i et feltstudie, men forekommer ualmindeligt.
English: Shelf life after first opening the immediate packaging: 1 month.
Danish: Opbevaringstid efter første åbning af den indre emballage: 1 måned
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Firocoxib 20 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Firocoxib 20 mg/ml
English: The treatment-free period should take into account the pharmacological properties of the medicinal products used previously.
Danish: De farmakologiske egenskaber af de lægemidler, der er brugt tidligere, bør tages med i overvejelserne for længden af den behandlingsfrie periode.
English: MARKETING AUTHORISATION NUMBER EU/2/08/083/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER EU/2/08/083/001
English: EXPIRY DATE EXP {month/year} Once broached use within 1 month.
Danish: EXP {måneder/år} Efter anbrud anvendes indenfor 1 måned.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: (Se afsnit 4.7) Bør ikke anvendes samtidig med kortikosteroider eller andre non-steroide antiinflammatoriske midler (NSAID-præparater).
English: Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there might be an increased risk of renal toxicity.
Danish: Samtidig anvendelse af potentielt nyretoksiske lægemidler bør undgås, da der kan være forøget risiko for nyretoksicitet.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses Firocoxib
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 8,2 mg/g oral pasta Firocoxib
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.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et (glycerol formal, Macrogol 400) er tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Firocoxib 20 mg/ml
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Firocoxib 20 mg/ml
English: 31000 Toulouse
Danish: 4 chemin du Calquet 31000 Toulouse
English: Magnesium carbonate, heavy
Danish: Titandioxid (E 171) Glyceroltriacetat Silica, kolloid vandfri Magnesiumcarbonat, tungt Macrogol 300
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 60 tablets
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 60 tabletter INDGIVELSESVEJ(E) Til oral anvendelse Læs indlægssedlen inden brug.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains:
Danish: Hver tyggetablet indeholder:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets for horses firocoxib
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 57 mg tyggetabletter til heste Firocoxib
English: Administer 0.1 mg firocoxib per kg bodyweight, once daily.
Danish: 0,1 mg firocoxib pr. kg legemsvægt en gang dagligt i op til 14 dage.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 57 mg chewable tablets firocoxib
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 57 mg tyggetabletter firocoxib
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/006-009
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/083/006-009
English: Therefore, do not use in breeding, pregnant or lactating animals.
Danish: Bør derfor ikke anvendes til avlsdyr, drægtige og lakterende dyr.
English: PACKAGE LEAFLET EQUIOXX 8.2 mg/g oral paste for horses
Danish: INDLÆGSSEDDEL EQUIOXX 8,2 mg/g oral pasta til hest
English: Excipients:
Danish: EXP.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Firocoxib 8.2 mg/g
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Firocoxib 8,2 mg/g.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002-003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/083/002-003
English: TARGET SPECIES Horses (450-600 kg).
Danish: DYREARTER Heste(450-600 kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses.
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 8,2 mg oral pasta til hest.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Firocoxib 8.2 mg/g
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Firocoxib 8,2 mg/g
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,
Danish: COX-2 er den isomer af enzymet, der påstås at være primært ansvarlig for syntesen af prostanoide mediatorer for smerte, inflammation og feber.