FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (version 2, Modul 1.8.1), er på plads og fungerer, før og mens produktet
English: The usual dose is 400 mg twice a day.
Danish: Den sædvanlige dosis er 400 mg 2 gange dagligt.
English: Celecoxib may mask fever and other signs of inflammation.
Danish: Celecoxib kan maskere feber og andre tegn på inflammation.
English: Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance.
Danish: Onsenal bør bruges sammen med den sædvanlige behandling til FAP-patienter, såsom kirurgi og endoskopisk kontrol.
English: Thirteen patients had the attenuated FAP phenotype.
Danish: 13 patienter havde den svækkede FAP-fænotype.
English: The plasma concentrations of medicinal products that are substrates of this enzyme may be increased when celecoxib is used concomitantly.
Danish: Plasmakoncentrationerne af lægemidler, der er substrat for dette enzym, kan stige ved samtidig brug af celecoxib.
English: These include some antibiotics (Bactrim and Septra used in combination with sulfamethoxole and trimethoprim), which can be used to treat infections
Danish: Disse omfatter visse antibiotika (Bactrim og Septra, som begge er en kombination af sulfamethoxazol og trimetoprim), som bruges ved behandling af infektioner.
English: As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Danish: Som for alle NSAID kan celecoxib føre til debut af hypertension eller forværring af eksisterende hypertension, som begge kan være medvirkende årsager til øget hyppighed af kardiovaskulære hændelser.
English: Plasma protein binding is about 97% at therapeutic plasma concentrations and celecoxib is not preferentially bound to erythrocytes.
Danish: Plasmaproteinbindingen er ca. 97% ved terapeutiske plasmakoncentrationer, og celecoxib har ikke præference for binding til erytrocytter.
English: Examples of medicinal products which are metabolised by CYP2C19 are diazepam, citalopram and imipramine.
Danish: Eksempler på lægemidler, som metaboliseres af CYP2C19, er diazepam, citalopram og imipramin.
English: As a result, the frequencies of these adverse drug reactions cannot be reliably determined.
Danish: På baggrund af dette kan hyppigheden af disse bivirkninger ikke bestemmes på pålidelig måde.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 28 February 2005 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version dateret 28. februar 2005, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af
English: Therefore, the risk for high celecoxib exposure in poor metabolizers should be considered carefully when treating FAP patients.
Danish: Derfor bør risikoen for høj eksponering for celecoxib hos personer med nedsat metabolisering nøje overvejes ved behandling af FAP-patienter.
English: Pharmacological activity resides in the parent substance.
Danish: Den farmakologiske virkning sidder i modersubstansen.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Danish: Hvis der under behandlingen sker en forværring inden for et af de ovennævnte organsystemer, skal passende forholdsregler tages, og seponering af behandlingen med celecoxib bør overvejes.
English: The MAH has previously committed to undertake a “Phase III placebo-controlled trial with celecoxib in genotype positive subjects with Familial Adenomatous Polyposis” (CHIP trial, Protocol A3191193) to generate further efficacy and safety data.
Danish: Indehaveren af markedsføringstilladelsen har tidligere forpligtet sig til at gennemføre forsøget ”Phase III Placebo-controlled Trial with Celecoxib in Genotype Positive Subjects with Familial Adenomatous Polyposis” (CHIP-forsøg - Protokol A3191193) for at fremskaffe yderligere sikkerheds- og effektdata.
English: FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations.
Danish: FAP-patienter med en ileorektal anastomose eller ileorektal pouch analanastomose kan udvikle anastomotiske ulcerationer.
English: However, patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.
Danish: Dog bør patienter, som mærker svimmelhed, vertigo eller søvnighed under celecoxibbehandling, undlade at føre motorkøretøj eller betjene maskiner.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Danish: COX-2 er også involveret i ovulation, implantation og lukning af ductus arteriosus, regulering af nyrefunktion og funktioner i centralnervesystemet (feber, smerteopfattelse og kognitive funktioner).
English: Two isoforms, COX-1 and COX-2, have been identified.
Danish: Der er identificeret 2 isoformer, COX1 og COX-2.
English: Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells.
Danish: Cyklooxygenase-2 er et enzym, som øges på steder med betændelse og i celler, der vokser unormalt.
English: Polyps with the APC mutation overexpress COX-2 and left untreated, these polyps continue to form and enlarge in the colon or rectum resulting in essentially a 100% chance of developing colorectal cancer.
Danish: Polypper med APC-mutationen udtrykker COX-2 i større grad, og hvis de ikke behandles, vil disse polypper fortsat blive dannet og vokse i colon eller rektum, hvilket vil medføre en risiko på næsten 100% for udvikling af colorektalcancer.
English: Packs of 10 or 60 capsules.
Danish: Leveres i pakninger med 10 eller 60 kapsler.
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Danish: Samtidig brug af CYP2C9-induktorer som rifampicin, carbamazepin og barbiturater kan nedsætte plasmakoncentrationen af celecoxib.
English: It may also play a role in ulcer healing.
Danish: Det kan også spille en rolle i sårheling.
English: When dosed at 200 mg per day the corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Danish: Ved en dosering på 200 mg dagligt var tilsvarende værdier for patienter med moderat nedsat leverfunktion henholdsvis 41% og 146%.
English: Results demonstrated a statistically significant reduction in polyp burden in all celecoxib treatment groups compared to the corresponding placebo treatment groups.
Danish: Resultaterne viste en statistisk signifikant reduktion i antallet af polypper i alle grupper behandlet med celecoxib sammenlignet med de tilsvarende grupper behandlet med placebo.
English: Frequency Not Known (Post-marketing experience)1
Danish: Frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data; postmarketing erfaring)
English: The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients since it is mainly eliminated by hepatic metabolism.
Danish: Celecoxibs farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion, men det er usandsynligt, at den er markant ændret hos disse patienter, idet elimineringen hovedsagelig sker ved levermetabolisme.
English: Renal function should be monitored when celecoxib and any of these medicinal products are combined.
Danish: Nyrefunktionen bør derfor monitoreres, når celecoxib kombineres med et af disse lægemidler.
English: Women who take celecoxib should not breastfeed.
Danish: Kvinder i behandling med celecoxib bør ikke amme.
English: Inhibition of COX-2 may have consequences on tumour viability that are unrelated to inflammation.
Danish: Hæmning af COX-2 kan have konsekvenser for tumorlevedygtighed, som ikke er relateret til inflammation.
English: Additional reactions have been reported from actual use of the active ingredient of Onsenal (in post-marketing experience).
Danish: Yderligere bivirkninger er set efter brug af det aktive stof i Onsenal (efter markedsføring).
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Danish: Antithrombotisk behandling bør derfor ikke seponeres (se pkt.
English: Do not take the capsule after the ‘expiry date' shown on the blister and carton.
Danish: Brug ikke Onsenal efter den udløbsdato (EXP), der står på pakningen.
English: During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Danish: Under behandling med celecoxib steg den gennemsnitlige plasmakoncentration af CYP2D6-substratet dextromethorphan med 136%.
English: NSAIDs, including celecoxib, may cause renal toxicity.
Danish: NSAID, herunder celecoxib, kan forårsage nyretoksicitet.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1).
Danish: Patienter med særlige risikofaktorer for kardiovaskulære hændelser (f.eks. hypertension, hyperlipidæmi, diabetes mellitus, rygning) bør kun behandles med celecoxib efter nøje overvejelse (se pkt.
English: Anticoagulant activity should be monitored in patients taking warfarin or other anticoagulants, particularly in the first few days after initiating or changing the dose of celecoxib, since these patients have an increased risk of bleeding complications.
Danish: Koagulationsparametrene bør monitoreres hos patienter, som tager warfarin eller andre antikoagulantia, især i de første få dage efter behandlingsstart eller ændring af celecoxibdosis, da disse patienter har en øget risiko for blødningskomplikationer.
English: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Danish: I et interaktionsforsøg havde celecoxib ikke havde nogen klinisk relevant virkning på farmakokinetikken af orale kontraceptiva (1 mg norethisteron/35 μg ethinylestradiol).
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
Danish: Forsigtighed bør udvises, når celecoxib kombineres med warfarin og andre antikoagulantia (se pkt.
English: The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Danish: Hovedmetabolitterne, som findes i cirkulationen, har ingen målelig COX-1- eller
English: The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i.e. those used for osteoarthritis/rheumatoid arthritis).
Danish: Størstedelen af interaktionsforsøgene er blevet udført med celecoxibdoser på 200 mg 2 gange dagligt (dvs. de doser, der anvendes ved osteoarthritis/reumatoid artrit).
English: Safety data were reviewed in detail by a Data Safety Monitoring Committee, which concluded that celecoxib 16 mg/kg/day was a safe dose to recommend for further studies in juvenile
Danish: Sikkerhedsdata er blevet gennemgået i detaljer af en data-sikkerheds-monitorerings-komité, som konkluderede, at celecoxib 16 mg/kg dagligt er en sikker dosis, som kan anbefales ved fremtidige forsøg hos børn med FAP.
English: A dose-dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Danish: Der er observeret en dosisafhængig effekt på TxB2-dannelse ved høje doser af celecoxib.
English: Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see
Danish: Onsenal er indiceret til reduktion af antallet af adenomatøse intestinale polypper ved familiær adenomatøs polypose (FAP), som et supplement til kirurgi og yderligere endoskopisk kontrol (se
English: The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Europæiske Lægemiddelagentur (EMA) vurderer hvert år ny information vedrørende Onsenal, og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Experimental evidence shows that the mechanism(s) of action by which celecoxib leads to tumour death may be related to induction of apoptosis and inhibition of angiogenesis.
Danish: Eksperimentelle data viser, at den/de virkningsmekanisme(r) for celecoxib, som medfører tumordød, kan relateres til induktion af apoptose og hæmning af angiogenese.
English: Administration of celecoxib to a limited number of lactating women has shown a very low transfer of celecoxib into breast milk.
Danish: Anvendelse af celecoxib til et begrænset antal ammende kvinder har vist, at celecoxib udskilles i modermælken i meget små mængder.
English: Consider starting treatment at a reduced dose (see section 5.2).
Danish: Det bør overvejes at starte behandlingen med lavere dosis (se pkt.
English: In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Danish: Ved mistanke om overdosering skal relevant medicinsk behandling iværksættes f.eks. ventrikeltømning, klinisk overvågning, og om nødvendigt iværksættes symptomatisk behandling.
English: Celecoxib can be used with low dose acetylsalicylic acid, however it cannot be considered a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Danish: Celecoxib kan tages sammen med lave doser acetylsalicylsyre, men det kan ikke betragtes som en erstatning for acetylsalicylsyre ved kardiovaskulær profylakse.
English: Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3).
Danish: Patienter, der tidligere har haft sulfonamidallergi eller anden lægemiddelallergi, kan have større risiko for alvorlige hudreaktioner eller overfølsomhedsreaktioner (se pkt.
English: Celecoxib was excreted in rat milk.
Danish: Celecoxib bliver udskilt i rottemælk.
English: The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
Danish: Samtidig behandling med celecoxib og et ikke-acetylsalicylsyreholdigt NSAID bør undgås.
English: A more pronounced effect at 400 mg BID therefore
Danish: En mere udtalt effekt med 400 mg 2
English: Studies in animals (rats and rabbits) have shown reproductive toxicity (see sections 4.3 and 5.3).
Danish: Dyreforsøg (rotter og kaniner) har påvist reproduktionstoksicitet (se pkt.
English: • Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se pkt.
English: In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Danish: Hos patienter med reumatoid artrit havde celecoxib ingen signifikant virkning på farmakokinetikken (plasma- eller renal clearance) af methotrexat (i reumatologiske doser).
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Danish: Forskellen i antitrombocytaktivitet mellem nogle COX-1-hæmmende NSAID-præparater og selektive COX-2-hæmmere kan være af klinisk betydning for patienter med risiko for tromboemboliske hændelser.
English: Very Common side-effects (affecting more than 1 person in every 10):
Danish: Meget almindelige bivirkninger, som forekommer hos mere end 1 person ud af 10):
English: Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation.
Danish: Celecoxib hæmmer tumordannelsen i prækliniske coloncancer-modeller, som udtrykker COX-2 i større grad, hvad enten det er induceret ved kemisk mutation (rotte AOM-model) eller genetisk mutation (MIN musemodel).
English: These effects are expected following inhibition of prostaglandin
Danish: Disse virkninger er forventet for hæmmere af prostaglandinsyntesen.
English: Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differing from arylamine sulfonamides (e.g. sulfamethoxizole and
Danish: Celecoxib er en diarylsubstitueret pyrazol og kemisk ligner det andre non-arylaminsulfonamider (f.eks. thiazider, furosemid), men det adskiller sig fra arylaminsulfonamider (f.eks. sulfamethoxizol
English: The greatest reduction was observed in patients treated with celecoxib 16 mg/kg/day, which corresponds to the recommended adult FAP dose of 800 mg daily.
Danish: Det største reduktion blev set i gruppen af patienter behandlet med 16 mg/mg dagligt, som svarer til den anbefalded FAP-voksendosis på 800 mg dagligt.
English: Patients with the CYP2C9*3 allele, and, in particular those with CYP2C9*3*3 homozygous genotype, may be exposed to celecoxib levels that are higher than those for which safety has been studied in clinical trials.
Danish: Patienter med CYP2C9*3 allel og især patienter med homozygot CYP2C9*3/*3 genotype kan blive udsat for celecoxib-niveauer, som er højere end dem, hvor sikkerheden er blevet undersøgt i kliniske forsøg.
English: As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Danish: Som for NSAID kan risikoen for akut nyreinsufficiens, som sædvanligvis er reversibel, muligvis være øget hos nogle patienter med kompromitteret nyrefunktion (f.eks. dehydrerede patienter eller ældre patienter), hvis ACE-hæmmere eller angiotensin II-receptorantagonister kombineres med NSAID, inklusive celecoxib.
English: Celecoxib is a weak inhibitor of CYP2D6.
Danish: Celecoxib er en svag hæmmer af CYP2D6.
English: Common (≥1/100 to <1/10)
Danish: Almindelig (1/100 til <1/10)
English: Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers.
Danish: Der er set forhøjede COX-2-niveauer i mange præmaligne læsioner (såsom adenomatøse colorektale polypper) og epitelcancer.
English: complications fracture * Hypertension, vomiting and diarrhoea are included in Table 2 because they were reported more frequently in these studies, which were of 3-year duration, compared to Table 1, which includes adverse reactions from studies of 12-week duration.
Danish: * Hypertension, opkastning og diarré er indkluderet i Tabel 2, fordi de er hyppigere rapporteret i disse forsøg, som forløb over 3 år, end bivirkninger i Tabel 1, som omfatter bivirkninger fra forsøg af 12 ugers varighed.
English: There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Danish: Der er yderligere øget risiko for gastrointestinale bivirkninger (gastrointestinale ulcera eller andre gastrointestinale komplikationer), hvis celecoxib tages samtidig med acetylsalicylsyre (selv ved lave doser).
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienter bør være normalhydrerede, og det bør overvejes at kontrollere nyrefunktionen efter start af kombinationsbehandling, og med
English: Special care should be used in such patients (see section 5.2).
Danish: Særlig forsigtighed bør udvises over for disse patienter (se pkt.
English: The inter-subject variability in the exposure of celecoxib is about 10-fold.
Danish: Den interindividuelle variation i plasmakoncentrationen af celecoxib er ca. 10-dobbelt.
English: There is little experience of celecoxib in renal impairment and therefore caution is advised when treating patients with renal impairment.
Danish: Der er kun lidt erfaring med celecoxib ved nedsat nyrefunktion, og forsigtighed anbefales derfor ved behandling af patienter med nedsat nyrefunktion.
English: Outer carton - 200 mg hard capsules (clear, opaque blister)
Danish: Ydre karton - 200 mg hårde kapsler (klar, uigennemsigtig blister)
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Danish: COX-2 er påvist i væv omkring mavesår hos mennesker, men dets relevans i forbindelse med sårheling er ikke kendt.
English: Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib.
Danish: Sammenlignet med personer med normal leverfunktion havde patienter med let nedsat leverfunktion en gennemsnitlig stigning af celecoxib i Cmax på 53% og i AUC på 26%.
English: No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in healthy volunteers at the FAP therapeutic dose of 400 mg BID.
Danish: Der er ikke observeret nogen statistisk signifikant hæmning af COX-1 (vurderet som ex vivo hæmning af tromboxan B2 [TxB2] dannelse) hos raske frivillige personer ved den terapeutiske dosis til FAP på 400 mg 2 gange dagligt.
English: − if you have had an allergic reaction to a group of medicines called “sulphonamides”.
Danish: hvis du er overfølsom (allergisk) over for den type medicin som kaldes sulfonamider.
English: Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP).
Danish: Onsenal bruges til at reducere antallet af mave- og tarmpolypper hos patienter med familiær adenomatøs polypose (FAP).
English: Celecoxib is contraindicated in pregnancy and in women who can become pregnant unless using an effective method of contraception (see section 4.3).
Danish: Celecoxib er kontraindiceret under graviditet og til kvinder i den fødedygtige alder, medmindre de anvender effektiv kontraception (se pkt.
English: Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Danish: Patienterne synes at have størst risiko for udvikling af disse reaktioner tidligt i behandlingsforløbet.
English: Clear or opaque PVC/Aclar/Aluminium foil blisters.
Danish: Klar eller uigennemsigtig PVC/Aclar/aluminiumfolieblister.
English: In the event of elderly patients with mild to moderate cardiac dysfunction requiring therapy, special care and follow up is warranted.
Danish: Ved behandling af ældre patienter med mild til moderat behandlingskrævende hjertesygdom er særlig forsigtighed og opfølgning påkrævet.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt i [måned/år].
English: In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Danish: In vitro-forsøg har vist mulighed for, at celecoxib kan hæmme CYP2C19-katalyseret metabolisme.