FrancophonIA/ELRC3.0 huggingface dataset:
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 COX-1 hæmmende NSAID og COX-2 selektive hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af tromboemboliske hændelser.
English: It was also evaluated for treatment of the inflammation and pain of RA in approximately 2100 patients in placebo and active controlled trials of up to 24 weeks duration.
Danish: Det er også undersøgt til behandling af inflammation og smerte i RA hos ca. 2100 patienter i kliniske undersøgelser i op til 24 ugers varighed med placebo og aktiv kontrol.
English: Based on conventional studies, genotoxicity or carcinogenicity, no special hazard for humans was observed, beyond those addressed in other sections of the SmPC.
Danish: I prækliniske data fra konventionelle studier er der ikke fundet nogen særlig risiko for mennesker, hvad angår genotoxicitet eller karcinogenicitet ud over dem, der er nævnt i andre afsnit af produktresumeet.
English: In twelve week endoscopy studies celecoxib (100-800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day).
Danish: Endoskopiforsøg over 12 uger med celecoxib (100-800 mg daglig) viste en signifikant lavere risiko for mavesår i forhold til naproxen (1000 mg daglig) og ibuprofen (2400 mg daglig).
English: Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free drug approximately 5X (rat) and 3X (rabbit) higher than those achieved at the maximum recommended daily human dose (400 mg).
Danish: Konventionelle embryo-føtale toksicitetsforsøg viste en dosisafhængig forekomst af diafragmabrok hos rottefostre og af kardiovaskulære misdannelser hos kaninfostre ved plasmakoncentration ca. 5 gange (rotter) og 3 gange (kaniner) højere end opnået ved behandling med den maksimalt anbefalede daglige dosis til mennesker (400 mg).
English: Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent.
Danish: Celecoxib påvirker ikke i klinisk relevant grad farmakokinetikken af tolbutamid (CYP2C9 substrat), eller glibenclamid.
English: To continue to report all ADR frequencies, based on the adverse reaction profile derived from placebo controlled studies, particularly the long-term studies as well as other post marketing experience and make changes to the SPC in accordance with standard Pharmacovigilance reporting and procedures (PSUR, Type II variation within MRP).
Danish: Indehaveren af markedsføringstilladelsen indberetter fortsat alle bivirkninger på grundlag af den bivirkningsprofil, der er udledt af de placebokontrollerede undersøgelser, især langtidsundersøgelser og andre indberettede erfaringer efter udstedelsen af markedsføringstilladelsen, og foretager ændringer i produktresuméet i overensstemmelse med standardprocedurerne for indberetning i forbindelse med lægemiddelovervågning (PSUR, type IIvariationer inden for den gensidige anerkendelsesprocedure).
English: § Further to the assessment of the data on serious skin reactions, celecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in clinical studies and post marketing surveillance, which analysis revealed several risk factors for the occurrence of theseserious skin reactions with celecoxib.
Danish: § efter vurdering af oplysningerne om alvorlige hudreaktioner forbindes celecoxib med meget sjældne tilfælde af alvorlige hudreaktioner som er påvist i kliniske undersøgelser og overvågningen efter markedsføringen - analysen viser flere risikofaktorer for forekomst af disse alvorlige hudreaktioner i forbindelse med celecoxib.
English: Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.
Danish: Celecoxib er undersøgt til behandling af inflammation og smerte ved OA i knæ og hofte hos ca. 4200 patienter i kliniske undersøgelser i op til 12 ugers varighed med placebo og aktiv kontrol.
English: Patients known to be CYP2C9 poor metabolisers should be treated with caution (see 5.2.
Danish: Patienter, som har svært ved at metabolisere via CYP2C9, bør behandles med forsigtighed (se 5.2).
English: History of hypersensitivity to the active substance or to any of the excipients (see 6.1).
Danish: Kendt overfølsomhed over for den aktive substans eller et eller flere af hjælpestofferne (se pkt.
English: Reproductive system and breast disorders Very rare: menstrual disorder NOS
Danish: Lidelser i det reproduktive system og brystsygdomme Meget sjælden: menstruationsforstyrrelser
English: Ear and labyrinth disorders Uncommon: tinnitus Very rare: decreased hearing
Danish: Sygdomme i øre Ikke almindelig: tinnitus Meget sjælden: nedsat hørelse
English: Uncommon: blurred vision, hypertonia, paraesthesia Rare: ataxia, taste alteration
Danish: Ikke almindelig: sløret syn, hypertoni, parestæsi Sjælden: ataksi, smagsforandringer
English: Metabolism and nutrition disorders Uncommon: hyperkalaemia
Danish: Metaboliske og ernæringsmæssige lidelser Ikke almindelig: hyperkaliæmi
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Danish: Der er set øvre gastrointestinale komplikationer (perforationer, ulcera og blødninger (PUB)), nogle med fatal udgang hos patienter behandlet med celecoxib.
English: Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Danish: Der bør udvises forsigtighed ved behandling af patienter, der har høj risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID: ældre, patienter som får andre NSAID eller acetylsalicylsyre samtidig, eller patienter der tidligere har haft en gastrointestinal sygdom, som f.eks. ulceration eller gastrointestinal blødning.
English: Where full study reports are not available to the MAH, it agrees to provide publications/manuscripts in lieu of the study report(s).
Danish: fremskaffer indehaveren af markedsføringstilladelsen publikationer/dokumenter i stedet for undersøgelsesrapporten(-erne).
English: Uncommon: urticaria
Danish: Almindelig: udslæt
English: Opaque, white with two gold bands marked 7767 and 200 (INVENTED NAME 200 mg).
Danish: Hvide, uigennemsigtige kapsler med to gule bånd mærket 7767 og 200 (navn 200 mg).
English: (See 4.3, 4.4 and 5.2).
Danish: 4.4 og 5.2).
English: In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high doses.
Danish: I et 2-årigt toksicitetstudie med høje doser er der set en stigning i ikke-binyrebetinget trombose hos hanrotter.
English: Investigations Uncommon: increased SGOT and SGPT, increased creatinine, BUN increased
Danish: Undersøgelser Ikke almindelig: forhøjet ASAT og ALAT, forhøjet se-kreatinin, forhøjet se-carbamid
English: 7 MARKETING AUTHORISATION HOLDER {Name and address} [Country name in the language of the text, NO telephone, fax numbers, e-mail addresses or websites.]
Danish: Telefonnummer, faxummer, e-mailadresse eller website]
English: Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Danish: Behandlingen med celecoxib bør seponeres ved den første forekomst af hududslæt, slimhindeaffektioner eller andre tegn på overfølsomhed.
English: In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
Danish: I de indsendte studier ses, som for andre NSAID, en øget risiko for gastrointestinal ulceration eller andre gastrointestinale komplikationer, når celecoxib kombineres med lavdosis acetylsalicylsyre (se 5.1).
English: Very rare: gastrointestinal haemorrhage, acute pancreatitis, colitis/colitis aggravated.
Danish: Meget sjælden: gastroinstestinal blødning, akut pankreatitis, colitis/forværret colitis
English: Celecoxib is an inhibitor of CYP2D6.
Danish: Celecoxib er en hæmmer af CYP2D6.
English: Elderly >65 years: As in younger adults, 200 mg per day should be used initially.
Danish: Som hos yngre voksne bør 200 mg være den initiale daglige dosis.
English: Preliminary data from the other two long-term studies did not show a significantly increased cardiovascular risk with celecoxib 200mg BID and 400mg QD compared to placebo.
Danish: Foreløbige data fra 2 andre langtidsstudier viser ingen signifikant øgning af den kardiovaskulære risiko med celecoxib 200 mg 2 gange daglig og 400 mg daglig sammenlignet med placebo.
English: Celecoxib inhibits CYP2D6.
Danish: Celecoxib hæmmer CYP2D6.
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 foldig.
English: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Danish: Celecoxib havde ingen klinisk relevant virkning på farmakokinetikken af orale antikonceptionsmidler (1 mg norethisteron/35 µg ethinylestradiol) i en udført interaktionsundersøgelse.
English: In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium.
Danish: Hos raske frivillige personer, som fik både celecoxib 200 mg 2 gange daglig og 450 mg lithium 2 gange daglig er der for litium set en gennemsnitlig stigning i Cmax på 16% og i AUC på 18%.
English: Capsules 100 mg contain lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium and magnesium stearate.
Danish: Kapslerne indeholder laktosemonohydrat, natriumlaurylsulfat, povidon K30, croscarmellosenatrium og magnesiumstearat.
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Danish: Derudover er der indberettet alvorlige overfølsomshedsreaktioner (anafylaksi og angioødem) hos patienter, der fik celecoxib (se pkt.
English: Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Danish: Meget sjælden: forværret epilepsi, aseptisk meningitis, manglende eller nedsat smagsevne, anosmi
English: Severe renal impairment is contraindicated.
Danish: Svær nedsat nyrefunktion er en kontraindikation.
English: Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations.
Danish: Almindelig: søvnmangel Ikke almindelig: angst, depression, træthed Meget sjælden: konfusion, hallucinationer
English: Infections and infestations Common: sinusitis, upper respiratory tract infection Uncommon: urinary tract infection
Danish: Infektioner og infestationer Almindelig: bihulebetændelse, øvre luftvejsinfektion Ikke almindelig: urinvejsinfektion
English: Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (£325 mg/day),
Danish: 22% af de inkluderede patienter fik samtidig lavdosis acetylsalicylsyre (£ 325 mg/dag), primært som kardiovaskulær profylakse.
English: Blood and the lymphatic system disorders Uncommon: anaemia Rare: leucopenia, thrombocytopenia Very rare: pancytopenia.
Danish: Lidelser i blod og lymfe Ikke almindelig: anæmi Sjælden: leukopeni, trombocytopeni Meget sjælden: pancytopeni
English: In one of the three studies, the APC (Prevention of Sporadic Colorectal Adenomas with Celecoxib), there was a dose-related increase in cardiovascular events (mainly myocardial infarction, MI) at celecoxib doses of 200 mg BID and 400 mg BID compared to placebo.
Danish: I et af de 3, APC-studiet (Prevention of Sporadic Colorectal Adenomas with Celecoxib) ses en dosis-relateret øgning i kardiovaskulære hændelser (hovedsagelig myokardieinfarkt, MI) ved doser på 200 mg 2 gange daglig og 400 mg 2 gange daglig sammenlignet med placebo.
English: Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Danish: Sygdomme i nyre og urinveje Meget sjælden: akut nyresvigt, interstitial nefritis
English: *In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Danish: I en samlet analyse af 20 placebo-kontrollerede studier med en varighed på mere en 2 uger op til 1 år på patienter med osteoarthrosis og rheumatoid arthritis ses en overrepræsentation af myokardieinfarkt hos patienter behandlet med celecoxib 200 eller 400 mg daglig i forhold til placebo på 0,7 hændelser pr. 1000 patienter (sjælden) og der ses ingen overrepræsentation af slagtilfælde.
English: Very rare: myositis
Danish: Meget sjælden: vaskulitis
English: Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.
Danish: Blødning i forbindelse med forhøjet INR er især rapporteret hos ældre og hos patienter, som samtidig med celecoxib fik warfarin; nogle tilfælde var fatale.
English: § Further to the assessment of: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Danish: § efter vurdering af: - de nye oplysninger om rofecoxib fra den kliniske undersøgelse APPROVe, der viste risiko for thrombotiske kardiovaskulære hændelser, - oplysningerne om celecoxib i APC-undersøgelsen, som tydede på en dosisrelateret øget risiko for alvorlige kardiovaskulære hændelser, - oplysningerne om valdecoxib og parecoxib i CABG- (koronararterie-bypass transplantation) og CABG II-undersøgelserne, der viste en højere forekomst af alvorlige kardiovaskulære thromboemboliske hændelser i parecoxib/valdecoxib-behandlingsformen sammenlignet med patienter, der får placebo, - oplysningerne om etoricoxib i EDGE-undersøgelsen og i samlede analyser af andre kliniske undersøgelser, som tyder på, at den tilknyttede thromboserisiko er højere end for naproxen,
English: In two of the 12-week studies the percentage of patients with endoscopic gastroduodenal ulceration were not significantly different between placebo and celecoxib 200 mg BID and 400 mg BID.
Danish: I to 12-ugers forsøg var andelen af patienter med endoskopisk mavesår ikke signifikant forskellig mellem placebo og celecoxib 200 mg 2 gange daglig eller 400 mg 2 gange daglig.
English: Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Danish: Celecoxib er inden for det kliniske dosisinterval (200-400 mg daglig) en oral, selektiv cyclooxygenase-2 (COX-2) hæmmer.
English: Capsule shells contain gelatin, titanium dioxide E171; ink contains iron oxide E172.
Danish: Kapslerne består af gelatine og titandioxid (E171).
English: In a peri-post natal study in rats, pup toxicity was observed.
Danish: I et peri/post-natalt rotteforsøg er der set toksicitet i afkommet.
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Danish: Plasmakoncentrationen af celecoxib kan reduceres ved samtidig brug af CYP2C9-induktorer som rifampicin, carbamazepin og barbiturater.
English: Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.
Danish: celecoxib er i kliniske undersøgelser vist at have samme effekt på nyrerne som det NSAID, der blev sammenlignet med.
English: Clear or opaque PVC blisters or aluminium cold-formed blisters.
Danish: 6.5 Emballage Klar PVC blister eller aluminiumblister.
English: The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years).
Danish: Hos ældre kvinder (over 65 år) er plasmakoncentrationen af celecoxib ca. 100% forhøjet.
English: However, in healthy subjects, in small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet aggregation and bleeding time compared to placebo.
Danish: Dog havde gentagne doser af celecoxib 600 mg BID (3 gange den højest anbefalede dosis) ingen effekt på trombocytaggregation og blødningstid i sammenligning med placebo i mindre undersøgelser med raske forsøgspersoner.
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Danish: Ændringerne i produktinformationen vedrørende SCAR kan sammenfattes således: - tilføjelse af en advarsel med oplysning om, at de fleste tilfælde af hudreaktioner forekommer inden for den første måned af behandlingen, - tilføjelse af en advarsel til patienter med tidligere lægemiddelallergi af enhver art, - skærpelse af en advarsel for at fremhæve, at der nu med celecoxib er forekommet alvorlige hudreaktioner med dødelig udgang, - tilføjelse af en mere detaljeret beskrivelse af de første tegn på hudreaktioner, som fører til behandlingsophør.
English: Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Danish: Som for andre lægemidler, der hæmmer prostaglandinsyntesen, kan celecoxib i tredje trimester af graviditeten hæmme uterus kontraktioner og give præmatur lukning af ductus arteriosus.
English: Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200mg BID and 400mg BID compared to placebo (see 5.1).
Danish: Der er set et øget antal alvorlige kardiovaskulære hændelser, hovedsagelig myokardieinfarkt, i placebokontrollerede langtidsstudier hos personer med sporadisk adenomatøs polypose behandlet med celecoxib ved doser på 200 mg 2 gange daglig og 400 mg 2 gange daglig sammenlignet med placebo (se pkt.
English: There is little experience of celecoxib in renal impairment.
Danish: Der er begrænset erfaring med celecoxib hos patienter med nedsat nyrefunktion.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: {navn} bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Danish: Generelle symptomer og forstyrrelser ved applicationssted Almindelig: perifert ødem/væskeretention
English: As with other drugs known to inhibit prostaglandin synthesis fluid retention and oedema have been observed in patients taking celecoxib.
Danish: Ligesom for andre lægemidler, som hæmmer prostaglandinsyntesen, er der set væskeretention og ødem hos patienter, som har taget celecoxib.
English: Celecoxib at daily doses of 200 mg - 400 mg provided pain relief within 24 hours of dosing.
Danish: Daglig dosis på 200-400 mg celecoxib gav smertelindring inden for 24 timer efter indtagelsen.
English: No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.
Danish: Inden for dette dosisinterval er der hos raske frivillige personer ikke observeret nogen statistisk signifikant hæmning af COX-1 (vurderet som ex vivo hæmning af tromboxan B2 (TxB2) dannelse).
English: Respiratory, thoracic and mediastinal disorders Common: pharyngitis, rhinitis Uncommon: cough, dyspnoea Very rare: bronchospasm.
Danish: Respiratoriske lidelser, lidelser i thorax og mediastinum Almindelig: svælgkatar, næsekatar Ikke almindelig: hoste, dyspnø Meget sjælden: bronkospasme
English: Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Danish: Ældre har hyppigere nedsat nyre- og leverfunktion og især nedsat hjertefunktion, og patienterne bør derfor kontrolleres løbende.
English: Osteoarthritis: The usual recommended daily dose is 200 mg taken once daily or in two divided doses.
Danish: Anbefalet daglig dosis er 200 mg én gang daglig eller fordelt på 2 doser.
English: Rheumatoid arthritis: The initial recommended daily dose is 200 mg taken in two divided doses.
Danish: Anbefalet initial daglig dosis er 200 mg fordelt på 2 doser.
English: Five randomised double-blind controlled studies have been conducted including scheduled upper gastrointestinal endoscopy in approximately 4500 patients free from initial ulceration (celecoxib doses from 50 mg-400 mg BID).
Danish: kontrollerede studier omfattende ca. 4500 patienter uden primært mavesår bekræftet ved øvre gastroskopi (celecoxibdoser på 50-400 mg 2 gange daglig).
English: Clinical 5
Danish: Klinisk aspekt 5
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use ofcelecoxib (see 4.8).
Danish: I forbindelse med brugen af celecoxib er der meget sjældent indberettet alvorlige hudreaktioner, nogle fatale, inklusiv dermatitis exfoliativa, Stevens-Johnsons syndrom, og toksisk epidermal nekrolyse (se pkt.
English: Hepato-biliary disorders Uncommon: abnormal hepatic function Very rare: hepatitis, jaundice, hepatic failure.
Danish: Lever og galdevejslidelser Ikke almindelig: påvirket leverfunktion Meget sjælden: hepatitis, gulsot, leversvigt
English: COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Danish: På grund af deres manglende virkning på trombocytfunktionen kan selektive COX-2 hæmmere ikke erstatte acetylsalicylsyre som profylakse mod kardiovaskulær tromboembolisk sygdom.
English: Side-effects listed have a rate equal or greater than placebo, and the discontinuation rate due to side effects was 7.1% in patients receiving celecoxib and 6.1% in patients receiving placebo.
Danish: Afbrydelse af behandlingen på grund af bivirkninger skete for 7,1% af celecoxibpatienterne og for 6,1% af placebopatienterne.