FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no specific antidote to this product.
Danish: Det findes ingen specifik modgift mod dette produkt.
English: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011
Danish: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011 EU/2/10/119/012
English: The following table is presented as an example of how the tablets and tablet parts could be used in order to reach the recommended dose.
Danish: Den nedenstående tabel viser et eksempel på, hvordan tabletterne og delte tabletter kan bruges for at nå den anbefalede dosis.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af nærværende markedsføringstilladelse skal informere Europakommissionen om markedsføringsplaner, som autoriseres af denne afgørelse.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/119/001-012
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/119/001-012
English: Wash hands after use of the veterinary medicinal product.
Danish: Vask hænderne efter brug af veterinærlægemidlet.
English: If such use cannot be avoided, these animals require careful veterinary monitoring.
Danish: Hvis en sådan anvendelse ikke kan undgås, kræver dyrene nøje dyrlægeovervågning.
English: The metabolising enzymes have not been fully investigated and slower metabolism (up to four-fold increased exposure) has been noted in some individuals.
Danish: De metaboliserende enzymer er ikke gennemgribende undersøgt og en langsommere metabolisme (op til fire gange øget eksponering) er set hos nogle dyr.
English: The recommended dose of cimicoxib is 2 mg per kg bodyweight, once daily.
Danish: Den anbefalede dosering af cimicoxib er 2 mg pr. kilo kropsvægt, én gang dagligt.
English: The cyclo-oxygenase enzyme (COX) is present in two isoforms.
Danish: Cyclo-oxygenaseenzymet (COX) er til stede i to isoformer.
English: Furthermore, in very rare cases, renal failure has been reported.
Danish: Yderligere er der i meget sjældne tilfælde rapporteret om nyresvigt.
English: Do no use in dogs less than 10 weeks of age.
Danish: Bør ikke anvendes til hunde som er yngre end 10 uger.
English: The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
Danish: Den maksimale koncentration (Cmax) er 0,3918 (± 0,09021) µg/ml, areal under kurven (AUC) er 1,676 (± 0,4735) µg.time/ml og den orale biotilgængelighed er 44,53 (± 10,26) procent.
English: Lactose monohydrate Povidone K25
Danish: Lactosemonohydrat Povidon K25
English: Vétoquinol SA Magny Vernois 70200 Lure France
Danish: Vétoquinol SA Magny Vernois 70200 Lure Frankrig
English: Pack sizes of 8, 32 or 144 tablets.
Danish: Pakningsstørrelser: 8, 32 eller 144 tabletter.
English: The elimination half-life (t1/2) is 1.38 (± 0.24) hours.
Danish: Halveringstiden (t½) er 1,38 ( ±0,24) timer.
English: The tablets are flavoured and studies (in healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.
Danish: Tabletterne har smag og studier (med raske beagle hunde) har vist, at de fleste hunde spiser tabletterne frivilligt.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93
Danish: Farmakoterapeutisk gruppe: Antiinflammatorica og antirheumatica, non-steroid, ATCvet-kode: QM01AH93
English: After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 2.25 (± 1.24) hours.
Danish: Efter oral administration til hunde af den anbefalede dosis på 2 mg/kg kropsvægt uden foder, cimicoxib er hurtigt absorberet og tiden indtil opnåelse af maksimal koncentration (Tmax) er 2,25 ( ±1,24 timer).
English: 8 tablets 32 tablets 144 tablets 45 tablets
Danish: 8 tabletter 32 tabletter 144 tabletter 45 tabletter
English: C. STATEMENT OF THE MRLs Not applicable.
Danish: ANGIVELSE AF MRL-VÆRDIER Ikke relevant.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN “TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: After oral administration in dogs at the recommended doses, cimicoxib is rapidly absorbed.
Danish: Efter oral indgivelse til hunde i de anbefalede doseringer, absorberes cimicoxib hurtigt.
English: Treatment duration:
Danish: Behandlingens varighed
English: As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs.
Danish: Som det er tilfældet med alle NSAIDer, kan overdosering medføre gastrointestinal, nyre- og levertoksicitet hos følsomme eller kompromitterede hunde.
English: Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.
Danish: Symptomatisk, understøttende terapi med administration af gastrointestinalt beskyttende midler og infusion af isotonisk saltvand anbefales.
English: COX-2 on the other hand, is mainly inducible and synthesized by macrophages and inflammatory cells after stimulation by cytokines and other mediators of inflammation.
Danish: COX-2, derimod, er hovedsagelig inducerbart og syntetiseres af makrofager og inflammatoriske celler efter stimulation med cytokiner og andre inflammationsmediatorer.
English: Crospovidone Sodium laurylsulfate Macrogol 400
Danish: Crospovidon Natriumlaurilsulfat Macrogol 400
English: Metabolism of cimicoxib is extensive.
Danish: Cimicoxibs metabolisme er omfattende.
English: Although no data are available in dogs, studies with laboratory animals have shown effects on their fertility and foetal development.
Danish: Skønt der ikke foreligger videnskabelige data på hunde, har laboratorieundersøgelser af andre dyr afsløret påvirkninger af fertilitet og fosterudvikling.
English: All strengths of Cimalgex tablets are available in the following pack sizes and types:
Danish: Alle styrker af Cimalgex tyggetabletter er tilgængelige i følgende pakningsstørrelser og pakningstyper:
English: The oral administration of cimicoxib with food did not significantly influence the bioavailability but decreased significantly the observed Tmax.
Danish: Oral administration af cimicoxib sammen med foder gav ingen signifikant ændring i biotilgængeligheden, men medførte en signifikant lavere Tmax.
English: COX-2 is involved in the production of mediators, including PGE2, that induce pain, exudation, inflammation and fever.
Danish: COX-2 medvirker ved produktionen af mediatorer, inklusive PGE2, som forårsager smerte, udsondring, inflammation og feber.
English: The cyclooxygenase 1 enzyme (COX-1) which has protective functions, for example, in the digestive tract and kidneys, is not inhibited by cimicoxib.
Danish: Cyclooxygenase 1 enzymet (COX-1), der har beskyttende funktioner, f.eks. i fordøjelseskanalen og nyrerne hæmmes ikke af cimicoxib.
English: All strengths are available in the following pack sizes and types:
Danish: Alle styrker er tilgængelige i følgende pakningsstørrelser og pakningstyper:
English: STATEMENT OF MRLs
Danish: ANGIVELSE AF MRL-VÆRDIER
English: In an in vivo inflammatory acute pain model, it was shown that the simulated effect of cimicoxib lasted for approximately 10-14 hours.
Danish: I et in vivo inflammatorisk, akut smerteforsøg påvistes det at den simulerede effekt af cimicoxib varede i cirka 10-14 timer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton (for both blisters and bottle)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (både for blister og beholder)
English: Cimicoxib may cause skin sensitisation.
Danish: Cimicoxib kan medføre hudsensibilisering.
English: Cimicoxib is a non-steroidal anti-inflammatory drug belonging to the coxib group and acting by selective inhibition of the enzyme cyclo-oxygenase 2.
Danish: Cimicoxib er et non-steroidt anti-inflammatorisk lægemidddel tilhørende coxib-gruppen og som virker ved selektiv hæmning af enzym cyclo-oxygenase 2.
English: • Plastic (HDPE) bottle with child resistant plastic (PP) closure packaged into an outer cardboard box.
Danish: • Plastic (HDPE) tabletbeholder med børnesikret plastic (PP) låg pakket i en yderkarton.
English: People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for cimicoxib bør undgå kontakt med lægemidlet.
English: Since the safety of the medicinal product has not been adequately demonstrated in young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months.
Danish: Da sikkerheden i forbindelse med brug af lægemidlet ikke er tilstrækkeligt undersøgt i ungdyr, anbefales det, at der udføres nøje overvågning i forbindelse med behandling af unghunde yngre end 6 måneder.
English: Pack sizes of 45 tablets.
Danish: Pakningsstørrelse på 45 tabletter.
English: It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever.
Danish: Det virker ved selektiv hæmning af cyclooxygenase 2 enzymet (COX-2), der er ansvarlig for smerte, inflammation og feber.
English: In an overdose study where 3 times (5.8 to 11.8 mg/kg body weight) and 5 times (9.7 to 19.5 mg/kg body weight) the recommended dose was administered to dogs for a period of 6 months, a dose related increase in gastrointestinal disturbances, which affected all dogs in the highest dose group, was noted.
Danish: Et overdoseringsstudie, hvor der blev givet 3 gange (5,8 til 11,8 mg/kg kropsvægt) og 5 gange (9,7 til 19,5 mg/kg kropsvægt) den anbefalede dosis til hunde i en periode på 6 måneder, blev der observeret en dosisafhængig øgning af de gastrointestinale lidelser.
English: Special precautions for people
Danish: Særlige forholdsregler for mennesker:
English: Cimicoxib is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) drug.
Danish: Cimicoxib er et ikke-narkotisk, non-steroidt anti-inflammatorisk lægemidddel (NSAID).
English: Use in animals suffering from impaired cardiac, renal or hepatic function, may involve additional risk.
Danish: Brug af lægemidlet til hunde, der lider af nedsat hjerte-, nyre- eller leverfunktion kan medføre yderligere risiko.
English: Similar dose related changes to haematology and white blood cell counts, as well as renal integrity, were also noted.
Danish: Lignende, dosisafhængige, ændringer i hæmatologi, antallet af hvide blodlegemer og nyreintegritet blev også observeret.
English: Cimalgex tablets can be given to dogs with or without food.
Danish: Cimalgex tabletter kan gives sammen med eller uden foder.
English: • Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of the attending veterinarian.
Danish: • Behandling af peri-oprerative smerter efter ortopædkirurgi eller blødtvævskirurgi: en dosis 2 timer før kirurgi, efterfulgt af 3-7 dages behandling, afhængig af den behandlende dyrlæges vurdering.
English: • Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box.
Danish: • Aluminiums blisterpakning (hver strip indeholder 8 tyggetabletter) pakket i en yderkarton.
English: COX-1 is usually a constitutive enzyme expressed in tissues, which synthesize products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys).
Danish: COX-1 er sædvanligvis et grundlæggende enzym der findes i vævstyper, som syntetiserer produkter, som er ansvarlige for normale fysiologiske funktioner (d.v.s. i fordøjelseskanalen og nyrerne).
English: Other adverse reactions including loss of appetite or lethargy may also be observed on rare occasions.
Danish: Andre bivirkninger som manglende appetit eller letargi kan også ses i sjældne tilfælde.
English: For longer-term treatment, regular monitoring should be undertaken by the veterinarian.
Danish: Ved længerevarende behandling skal der foretages løbende overvågning af dyrlægen.
English: Do not use in breeding, pregnant or lactating animals (see Section 12 “Special precautions for dogs”).
Danish: Bør ikke anvendes til avlstæver, drægtige tæver eller diegivende tæver (se afsnit 12 ”Drægtighed og laktation”).
English: In an artificially induced pain model in dogs it was shown that the pain and inflammation reducing effects of cimicoxib lasted for approximately 10-14 hours.
Danish: I et provokeret smerteforsøg på hunde påvistes det, at den smertelindrende og inflammationsdæmpende effekt af cimicoxib varede i cirka 10-14 timer.
English: Avoid using this product in any animals which are dehydrated, hypovolaemic or hypotensive, as it may increase the risk of renal toxicity.
Danish: Undgå brugen af dette produkt til dyr, som er dehydrerede, hypovolæmiske eller som har lavt blodtryk, da dette kan øge risikoen for nyresvigt.
English: Other adverse reactions including anorexia or lethargy may also be observed on rare occasions.
Danish: Andre bivirkninger som anoreksi eller letargi kan også ses i sjældne tilfælde.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved et hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Bodyweight kg
Danish: kropsvægt kg
English: If any observed adverse effect persists after stopping treatment, the advice of a veterinarian should be sought.
Danish: Hvis en bivirkning fortsætter efter behandlingens afslutning, skal der søges rådgivning hos en dyrlæge.
English: Pretreatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed before the commencement of treatment with Cimalgex.
Danish: Forudgående behandling med andre anti-inflammatoriske midler kan give yderligere eller kraftigere bivirkninger, og man skal derfor observere en behandlingsfri periode med sådanne lægemidler før behandling med Cimalgex påbegyndes.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 45 tablets
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle pack
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Pakke med beholder
English: If adverse reactions such as persistent vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy or worsening of renal or hepatic biochemistry parameters occur, use of the product should be discontinued and appropriate monitoring and/or treatment should be put in place.
Danish: Hvis bivirkninger som kontinuerlig opkastning, gentagne forekomster af diarré, blod i afføringen, pludseligt vægttab, letargi eller forværring af de biokemiske parametre i nyrerne forekommer, skal brugen af produktet umiddelbart ophøre, og passende monitorering og/eller behandling iværksættes.
English: • Relief of pain and inflammation associated with osteoarthritis: 6 months.
Danish: • Smertelindring og behandling af inflammation i forbindelse med slidgigt: 6 måneder.
English: Use this veterinary medicinal product under strict veterinary monitoring where there is a risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to NSAIDs.
Danish: Brug dette veterinærmedicinske produkt under nøje veterinær monitorering hvis der er risiko for gastrointestinal blødning eller hvis dyret tidligere har vist manglende tolerance over for NSAID.
English: If adverse reactions such as persistent vomiting, repeated diarrhoea, blood in the stools, sudden weight loss, loss of appetite, lethargy or worsening of liver or kidney function results occur, use of the product should be discontinued and the advice of your veterinary surgeon should be sought immediately.
Danish: Hvis bivirkninger som kontinuerlig opkastning, gentagne forekomster af diarré, blod i afføringen, pludseligt vægttab, manglende appetit, letargi eller nedsat lever-/nyrefunktion forekommer, skal brugen af produktet umiddelbart ophøre, og dyrlægehjælp søges øjeblikkeligt.
English: Sodium stearyl fumarate Pork liver powder
Danish: Natriumstearylfumarat Svine lever pulver
English: In very rare cases, increases in kidney function results (renal biochemistry parameters) were noted.
Danish: I meget sjældne tilfælde er der observeret ændringer i nyrefunktionen (de biokemiske parametre i nyrerne).
English: The tablets can be divided into equal thirds.
Danish: Tabletterne kan deles i tre lige store dele.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Oral anvendelse.
English: Cimalgex should not be administered in conjunction with corticosteroids or other NSAIDs.
Danish: Cimalgex må ikke administreres samtidig med kortikosteroider eller andre NSAID'er.
English: The treatment-free period should take into account the pharmacokinetic properties of the veterinary medicinal product used previously.
Danish: Længden af den behandlingsfri periode skal afpasses til det tidligere anvendte veterinærlægemiddels famakokinetiske egenskaber.
English: The choice of the most suitable tablet type or tablet parts is left to the discretion of the veterinarian based on the circumstances in each case, without leading to important over- or underdosing.
Danish: Uden at medføre væsentlig over- eller underdosering, er valget af den mest passende type tablet eller dele af tablet op til dyrlægens vurdering baseret på omstændighederne i hvert tilfælde.
English: Disposal: Read Package Leaflet.
Danish: Bortskaffelse: Læs indlægssedlen inden brug.
English: METHOD AND ROUTES OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug.
English: On rare occasions, serious gastrointestinal problems such as bleeding and ulcer formation have occurred.
Danish: I sjældne tilfælde er der observeret alvorlige gastrointestinale lidelser som blødning eller dannelse af mavesår.
English: Use this veterinary medicinal product under strict veterinary monitoring in dogs with a risk of stomach ulcers or if the animal previously displayed intolerance to other NSAIDs.
Danish: Brug dette veterinærmedicinske produkt under nøje veterinær overvågning hvis der er risiko for mavesår eller hvis dyret tidligere har vist manglende tolerance over for NSAID.
English: In very rare cases, increases in renal biochemistry parameters were noted.
Danish: I meget sjældne tilfælde er der observeret ændringer i de biokemiske parametre i nyrerne.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 8 mg cimicoxib
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 8 mg cimicoxib
English: The other metabolite, glucuronide conjugate of the demethylated cimicoxib, is eliminated in urine.
Danish: Den anden metabolit, glucuronide konjugerede af det demetylerede cimicoxib, udskilles gennem urin.
English: Mild gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly reported but these only lasted for a short time.
Danish: Milde og forbigående tilfælde af gastrointestinale lidelser (opkastning og/eller diarré) forekommer meget hyppigt, men ophører efter kort tid.
English: Mild and transient gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly reported.
Danish: Milde og forbigående tilfælde af gastrointestinale lidelser (opkastning og/eller diarré) forekommer meget almindelig.
English: For the treatment of pain and inflammation associated with osteoarthritis, and the management of perioperative pain due to orthopaedic or soft tissue surgery, in dogs.
Danish: Til behandling af smerte og inflammation associeret med osteoarthritis (slidgigt) og behandling af peri-oprerative smerter (smerter efter operation) efter ortopædkirurgi eller blødtvævskirurgi hos hunde.
English: ROUTES OF ADMINISTRATION Oral use
Danish: INDGIVELSESVEJ(E) Oral anvendelse
English: Any divided tablets should be stored in the blister pack/bottle.
Danish: Tilbageværende, delte tyggetabletter skal opbevares i blisterpakning/tabletbeholder.
English: The major metabolite, demethylated cimicoxib is mainly eliminated in faeces by the biliary route and, to a lesser extent, in urine.
Danish: Hovedmetabolitten, de-metyleret cimicoxib udskilles hovedsagelig i fæces via galdekanalerne, og i mindre grad gennem urin.
English: As for any long term NSAID treatment, kidney function should be monitored.
Danish: Som ved enhver længerevarende NSAID-behandling, skal nyrefunktionen overvåges.
English: Any remaining divided tablets should be discarded after 90 days storage in the bottle.
Danish: Tilbageværende delte tyggetabletter skal bortkastes efter 90 dages opbevaring i tabletbeholderen.
English: Any remaining divided tablets should be discarded after 2 days storage in the blisters.
Danish: Tilbageværende delte tyggetabletter skal bortkastes efter 2 dages opbevaring i blisterpakningen.
English: D. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER FOR VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 8 mg cimicoxib
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 8 mg cimicoxib
English: Do not use at the same time as corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Bør ikke anvendes samtidig med kortikosteroider eller andre non-steroide antiinflammatoriske lægemidler (NSAIDer).
English: To be supplied only on veterinary prescription.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Må kun udleveres efter veterinærrecept.
English: Each tablet contains: Cimicoxib 8 mg Cimicoxib 30 mg Cimicoxib 80 mg
Danish: Hver tyggetablet indeholder: Cimicoxib 8 mg Cimicoxib 30 mg Cimicoxib 80 mg
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vétoquinol EXPIRY DATE EXP {month/year}
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Vétoquinol
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Do not use in dogs suffering from stomach or digestive system disorders or in dogs with bleeding problems.
Danish: Bør ikke anvendes på hunde med mave-tarm lidelser eller bløder-sygdomme.
English: Do not use in case of hypersensitivity to cimicoxib or to any of the excipients.
Danish: Bør ikke anvendes i tilfæde af overfølsomhed over for cimicoxib eller over for et eller flere af hjælpestofferne.
English: Do not use in dogs suffering from gastrointestinal disorders or haemorrhagic disorders.
Danish: Bør ikke anvendes til hunde med mave-tarm lidelser eller hæmoragiske lidelser.
English: Cimalgex 30 mg, tablets: oblong, white to pale brown, chewable tablets with 2 break-lines on both sides.
Danish: Cimalgex 30 mg, tabletter: aflange, hvide til lysebrune, tyggetabletter med 2 delekærve på begge sider.
English: ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUME
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE STATEMENT OF MRLs
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: 4.11 Withdrawal period Not applicable.
Danish: 4.11 Tilbageholdelsestid
English: Cimalgex 80 mg, tablets: oblong, white to pale brown, chewable tablets with 3 break-lines on both sides.
Danish: Cimalgex 80 mg, tabletter: aflange, hvide til lysebrune, tyggetabletter med 3 delekærve på begge sider.