FrancophonIA/ELRC3.0 huggingface dataset:
English: The principal mode of action is inhibition of cyclooxygenase (COX).
Danish: Den overordnede virkningsmekanisme er cyclooxygenasehæmning (COX).
English: Do not use in case of known hypersensitivity to sulphonamides.
Danish: Bør ikke anvendes, hvis der er kendt overfølsomhed over for sulfonamider.
English: In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Mavacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Danish: Mavacoxib er et non-steroidt antiinflammatorisk lægemiddel (NSAID) af coxib-typen.
English: If an adverse reaction to the administration of Trocoxil occurs, stop using the product, and seek medical advice from your veterinarian immediately.
Danish: Hvis der forekommer en bivirknig efter indgift af Trocoxil, så stop anvendelsen af produktet og søg omgående dyrlægehjælp.
English: Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2) due to its low rate of elimination.
Danish: Mavacoxib udviser en forlænget plasmahalveringstid (op til >80 dage, se pkt.
English: Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Danish: Bør ikke anvendes til hunde med sygdomme i mave-tarmkanalen herunder sår og blødning.
English: To avoid accidental ingestion administer the tablet to the dog immediately after removal from the blister packaging.
Danish: For at undgå utilsigtet indtagelse skal tabletten gives til hunden umiddelbart efter at den er taget ud af blisterpakningen.
English: Concurrent administration of potentially nephrotoxic medicinal products should be avoided.
Danish: Samtidig administration af potentielt nefrotoksiske lægemidler bør undgås.
English: Animals should undergo a thorough clinical examination before commencing treatment with Trocoxil and appropriate laboratory tests to monitor haematology and clinical chemistry are recommended.
Danish: Dyr bør underkastes en nøje klinisk undersøgelse før behandling med Trocoxil indledes, og desuden anbefales det at monitorere relevante hæmatologiske og klinisk kemiske parametre.
English: If an adverse reaction following the administration of Trocoxil occurs, no further tablets should be administered and general supportive therapy, as applied to clinical overdose with NSAIDs, should be applied.
Danish: Hvis der forekommer en bivirkning efter administration af Trocoxil, bør der ikke gives flere tabletter og almen understøttende behandling, som er gældende for en klinisk overdosis med NSAID'ere, bør gives.
English: The initial treatment should be repeated 14 days later, thereafter the dosing interval is one month.
Danish: Den indledende behandling skal gentages efter 14 dage.
English: The rate of body clearance of mavacoxib is slow and the major route of elimination is by biliary excretion of the parent drug.
Danish: Clearance af mavacoxib fra hele legemet er langsom, og den primære elimination sker ved biliær udskillelse af den oprindelig substans.
English: If you have a known hypersensitivity to NSAIDs you should avoid contact with the veterinary medicinal product.
Danish: Hvis du er overfølsom over for NSAID'ere, skal du undgå kontakt med veterinærlægemidlet.
English: Do not administer other NSAIDs or glucocorticoids concurrently or within 1 month of the last administration of Trocoxil.
Danish: Giv ikke andre NSAID'ere eller glukokortikoider samtidigt eller inden for en måned efter den sidste administration af Trocoxil.
English: Similarly adverse reactions occurring at the use dose in the animal population principally involved the gastrointestinal system.
Danish: Lignende bivirkninger, der hovedsagelig involverede mave-tarmkanalen, forekom hos dyrepopulationen ved den anvendte dosering.
English: In common with other NSAIDs, Trocoxil should not be administered simultaneously with other NSAIDs or glucocorticosteroids.
Danish: Som med andre NSAID'ere frarådes det at administrere Trocoxil samtidigt med andre NSAID'ere eller glukokortikoider.
English: Note that Trocoxil has an extended effect of duration (up to 2 months after administration of the second dose and following doses).
Danish: Bemærk at Trocoxil har en forlænget virkningsvarighed (op til 2 måneder efter indgivelse af anden dosis samt efterfølgende doser).
English: Trocoxil has an extended effect duration (up to 2 months after administration of the second dose and following doses).
Danish: Trocoxil har en forlænget virkningsvarighed (op til 2 måneder efter indgift af anden dosis og efterfølgende doser).
English: Adverse reactions of the digestive tract such as vomiting and diarrhoea were commonly reported, loss of appetite, haemorrhagic diarrhoea and melaena have been reported in uncommon cases.
Danish: Gastroenterale bivirkninger såsom diarré og opkastning forekommer lejlighedsvis, mens nedsat appetit, blodig diarré og melena er mindre almindeligt forekommende.
English: Gastrointestinal ulceration was reported in rare cases.
Danish: Ulcerationer i mavetarmkanalen er set i sjældne tilfælde.
English: Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Danish: Bør ikke anvendes samtidigt med glukokortikoider eller andre non-steroide antiinflammatoriske lægemidler (NSAID'ere).
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Danish: Undgå anvendelse hos dyr med nedsat blodvolumen (hypovolæmi) eller lavt blodtryk (hypotension), da der er en potentiel risiko for nyresvigt.
English: It is recommended to repeat the clinical examination one month after commencing treatment with Trocoxil and prior to administration of the third dose with additional monitoring of clinical pathology as appropriate during treatment.
Danish: Det anbefales at gentage den kliniske undersøgelse en måned efter initiering af behandlingen med Trocoxil samt før administration af tredie dosis.
English: Trocoxil must not be used in pregnant, breeding or lactating animals.
Danish: Trocoxil må ikke anvendes til drægtige, avlende eller diegivende dyr.
English: The treatment should be repeated 14 days later, thereafter the dosing interval is ONE MONTH.
Danish: Behandlingen skal gentages efter 14 dage.
English: Apathy, degradation of renal biochemistry parameters and impaired renal function have been reported in uncommon cases.
Danish: Apati, påvirkning af nyreværdier og nedsat nyrefunktion er lejlighedsvis blevet rapporteret.
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Danish: Ved overfølsomhed over for NSAID'ere bør kontakt med lægemidlet undgås.
English: Patients with underlying renal disease may experience exacerbation or decompensation of their renal disease while on NSAID therapy.
Danish: Patienter med underliggende nyrelidelser kan opleve en forværring af tilstanden eller en ændret kompensation for nedsat nyrefunktion mens de er i NSAID behandling (se også pkt.
English: Blister packs containing two tablets of the same strength per pack, each tablet containing 6 mg, 20 mg, 30 mg, 75 mg or 95 mg of mavacoxib.
Danish: Blisterpakninger, der indeholder to tabletter af samme styrke i hver pakning, henholdsvis 6 mg, 20 mg, 30 mg, 75 mg eller 95 mg mavacoxib.
English: Mavacoxib acts by preferential inhibition of COX-2-mediated prostaglandin synthesis.
Danish: Mavacox virker fortrinsvis ved at hæmme COX-2 medieret prostaglandinsyntese.
English: Gastrointestinal protectants and parenteral fluids, as appropriate, may be required for animals that experienced gastrointestinal or renal adverse reactions.
Danish: Gastroprotektive lægemidler og parenteral væsketerapi kan være nødvendige til dyr med mave-tarm relaterede eller renale bivirkninger.
English: In the overdose studies, in common with other NSAIDs, adverse pharmacodynamic events occur affecting the gastrointestinal system.
Danish: I lighed med andre NSAID'ere er der i overdoseringsundersøgelser forekommet farmakodynamiske bivirkninger, som har påvirket mave-tarmkanalen.
English: PHARMACEUTICAL FORM Chewable tablets
Danish: LÆGEMIDDELFORM Tyggetablet
English: Based on the results of canine whole blood assays, plasma concentrations producing 20% COX-1 inhibition and 80% COX-2 inhibition were 2.46 µg/mL and 1.28 µg/mL, respectively, so that the IC20COX-1:IC80COX-2 potency ratio is approximately 2:1, whilst the IC80COX-1:IC80COX-2 potency ratio is approximately 40:1.
Danish: Det betyder at IC20 COX-1:IC80 COX-2 styrkeforholdet er ca. 2:1, mens IC80 COX-1:IC80 COX-2 styrkeforholdet er ca. 40:1.
English: Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs
Danish: Trocoxil 6 mg tyggetabletter til hunde Trocoxil 20 mg tyggetabletter til hunde Trocoxil 30 mg tyggetabletter til hunde Trocoxil 75 mg tyggetabletter til hunde Trocoxil 95 mg tyggetabletter til hunde
English: Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs Mavacoxib
Danish: Trocoxil 6 mg tyggetabletter til hunde Trocoxil 20 mg tyggetabletter til hunde Trocoxil 30 mg tyggetabletter til hunde Trocoxil 75 mg tyggetabletter til hunde Trocoxil 95 mg tyggetabletter til hunde mavacoxib
English: Do not administer other NSAIDs or glucocorticoids concurrently or within at least 1 month of the last administration of Trocoxil.
Danish: Giv ikke hunden andre NSAID'ere eller glukokortikoider samtidigt eller inden for mindst 1 måned efter den sidste Trocoxil-indgivelse.
English: Do not use where there is evidence of a haemorrhagic disorder.
Danish: Bør ikke anvendes, hvis der er påvist en hæmorrhagisk lidelse.
English: Each blister contains two tablets of 6 mg, 20 mg, 30 mg, 75 mg or 95 mg mavacoxib, respectively.
Danish: Hver blisterpakning indeholder to tabletter på henholdsvis 6 mg, 20 mg, 30 mg, 75 mg eller 95 mg mavacoxib.
English: Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), see section 4.8.
Danish: Bør ikke anvendes samtidigt med glukokortikoider eller andre non-steroide antiinflammatoriske lægemidler (NSAID'ere ), se pkt.
English: Population pharmacokinetic data derived from studies in dogs with a predominantly older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population (<5%) having an elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Danish: Populationsbaserede farmakologiske data blev indsamlet fra studier med hunde, der typisk var ældre og tungere end i de eksperimentelle studier (hvor gennemsnitsalderen var 9 år).
English: Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced elimination and thus excessive accumulation could occur.
Danish: Hos hunde med leversygdomme kan eliminationen være nedsat med for stor akkumulering til følge.
English: Do not use in cases of impaired kidney or liver function.
Danish: Bør ikke anvendes ved nedsat nyre- eller leverfunktion.
English: 6 mg 20 mg 30 mg 75 mg 95 mg
Danish: Antal og styrke af de tabletter, der skal administreres 6 mg 20 mg 30 mg 75 mg 95 mg
English: Mavacoxib
Danish: Tyggetablet
English: Do not use in pregnant, breeding or lactating dogs.
Danish: Bør ikke anvendes til drægtige, avlende eller diegivende hunde.
English: Do not use in pregnant, breeding or lactating animals.
Danish: Må ikke anvendes til drægtige, avlende eller diegivende dyr.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients Do not use in case of known hypersensitivity to sulphonamides.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Carton
Danish: INDIKATIONER
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 20 January 2012
Danish: Dato for første markedsføringstilladelse: 21. marts 2007 Dato for seneste fornyelse: 20. januar 2012
English: It is important to stay on the diet and exercise recommended by your doctor while taking Xelevia.
Danish: Det er vigtigt at forblive på den diæt og motion, som lægen anbefaler, mens De tager Xelevia.
English: STOP taking Xelevia and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Xelevia og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger:
English: Due to lack of human data, Xelevia should not be used during pregnancy.
Danish: På grund af mangel på humane data bør Xelevia ikke anvendes under graviditet.
English: Your doctor may ask you to stop Xelevia.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Xelevia.
English: - an allergic reaction to Xelevia (see section 4).
Danish: - Allergisk reaktion over for Xelevia (se punkt 4).
English: The level of digoxin in your blood may need to be checked if taking with Xelevia.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Xelevia.
English: Xelevia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Xelevia bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Treatment by stratum (metformin and insulin use) interactions were not significant (p > 0.10).
Danish: Behandling baseret på stratum- (anvendelse af metformin og insulin) interaktioner var ikke signifikant (p > 0,10).
English: Method of administration Xelevia can be taken with or without food.
Danish: Administration Xelevia kan tages med eller uden mad.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Xelevia and periodically thereafter.
Danish: Da der er dosisjustering på baggrund af nyrefunktionen, anbefales det at vurdere nyrefunktionen før initiering af Xelevia og med mellemrum derefter.
English: If a dose of Xelevia is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis Xelevia glemmes, bør den tages, så snart patienten kommer i tanke om det.
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Xelevia may be administered with or without food.
Danish: Eftersom samtidig administration af et fedtrigt måltid sammen med sitagliptin ikke havde nogen effekt på farmakokinetikken, kan Xelevia administreres med eller uden mad.
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Danish: Fortsæt med at tage Xelevia, så længe Deres læge ordinerer det, så De fortsat kan få hjælp til at kontrollere Deres blodsukker.
English: If pancreatitis is suspected, Xelevia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Xelevia should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Xelevia og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Xelevia ikke genoptages.
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Xelevia administered concomitantly.
Danish: Ved anvendelse sammen med metformin og/eller en PPAR-agonist bør dosis af metformin og/eller PPAR-agonisten opretholdes, og Xelevia administreres samtidigt.
English: Do not take Xelevia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Xelevia: - hvis De er allergisk over for sitagliptin eller et af de øvrige indholdsstoffer i lægemidlet
English: What Xelevia contains
Danish: Xelevia indeholder:
English: Two studies were conducted to evaluate the efficacy and safety of sitagliptin monotherapy.
Danish: Der blev udført to undersøgelser, der vurderede effekt og sikkerhed af sitagliptin-monoterapi.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Xelevia (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får Xelevia (se punkt 4).
English: The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
Danish: Den forbedring i den glykæmisk kontrol, som blev observeret med dette lægemiddel, medieres via en stigning i de aktive inkretinhormoners niveauer.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Xelevia is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienterne være opmærksomme på risikoen for hypoglykæmi, når Xelevia anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: Xelevia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Danish: Xelevia er også indiceret som tillægsbehandling til insulin (med eller uden metformin), når diæt og motion plus stabil dosering af insulin ikke giver tilstrækkelig glykæmisk kontrol.
English: No dose adjustment for Xelevia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Danish: Dosisjustering af Xelevia er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
English: Xelevia should not be used during breast-feeding.
Danish: Xelevia bør ikke anvendes under amning.
English: If a hypersensitivity reaction is suspected, Xelevia should be discontinued.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Xelevia seponeres.
English: If you stop taking Xelevia
Danish: Hvis De holder op med at tage Xelevia
English: In patients taking non-pre-mixed (intermediate/long-acting) insulin, the mean daily dose was 44.3 U/day.
Danish: Hos patienter, der tog ikke-forblandet insulin (middellangt/langtidsvirkende) insulin, var den gennemsnitlige daglige dosis 44,3 E/dag.
English: In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
Danish: I denne undersøgelse forbedredes proinsulin/insulin ratioen, der er en markør for effektiviteten af insulinsyntese og -sekretion, med sitagliptin og forværredes med glipizidbehandling.
English: If you forget to take Xelevia
Danish: Hvis De har glemt at tage Xelevia
English: Placebo-corrected mean change in HbA1c (%) (95 % CI)
Danish: Placebokorrigert gennemsnitlig ændring i HbA1c (%) (95% CI)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xelevia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Xelevia hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Danish: Forbedring af surrogatmarkører for betacellefunktionen, inklusive HOMA-β (homøostatisk modelvurdering-β), proinsulin/insulin-ratio samt resultater for betacellereaktioner fra en frequently sampled meal tolerance test blev observeret.
English: If you take more Xelevia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Danish: Hvis De har taget for meget Xelevia Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
English: What you need to know before you take Xelevia
Danish: Det skal De vide, før De begynder at tage Xelevia
English: Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
Danish: Abnormiteter af fortænderne observeredes hos rotter ved en eksponering, der var 67 gange højere end det kliniske eksponeringsniveau: No-effect-niveauet for dette fund var 58 gange højere på basis af 14-ugersrotteundersøgelsen.
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Danish: Seks metabolitter blev påvist på sporstofniveau og forventes ikke at bidrage til sitagliptins plasma DPP-4-hæmmende aktivitet i plasma.
English: Xelevia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Danish: Xelevia tilhører en klasse af orale anti-hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase4-(DPP-4)-hæmmere.
English: When Xelevia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Xelevia anvendes i kombination med et sulfonylurinstof eller sammen med insulin, kan en lavere dosis af sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
English: Xelevia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Danish: Xelevia er ikke undersøgt hos patienter med svær leverinsufficiens, og der bør udvises forsigtighed (se pkt.
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Xelevia is 25 mg once daily.
Danish: Til patienter med svær nyreinsufficiens (GFR ≥15 til <30 ml/min) eller med nyresygdom i slutstadiet (ESRD) (GFR <15 ml/min), inklusive patienter som har behov for hæmodialyse eller peritonealdialyse, er dosis 25 mg Xelevia en gang dagligt.
English: Xelevia has no or negligible influence on the ability to drive and use machines.
Danish: Xelevia påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
Danish: Hvis De tager dette lægemiddel sammen med medicin, der kaldes sulfonylurinstof eller sammen med insulin, kan det medføre for lavt blodsukker (hypoglykæmi), som kan påvirke Deres evne til at køre bil og betjene maskiner eller hvis De arbejder uden sikkert fodfæste.
English: If bullous pemphigoid is suspected, Xelevia should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Xelevia seponeres.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Xelevia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Danish: Hypoglykæmi i kombination med andre anti-hyperglykæmiske lægemidler Der er foretaget kliniske undersøgelser af Xelevia som monoterapi og som del af kombinationsbehandling med lægemidler, der ikke er kendt for at medføre hypoglykæmi (dvs. metformin og/eller en PPAR-agonist).