FrancophonIA/ELRC3.0 huggingface dataset:
English: COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: Det er vist, at COX-2 er isoformen af det enzym, som induceres af pro-inflammatoriske stimuli, og som man mener, hovedsagelig har ansvaret for syntese af prostanoide mediatorer af smerte, inflammation og feber.
English: Effects of other drugs on celecoxib
Danish: Virkningen af andre lægemidler på celecoxib
English: For all strokes, there was no increased event rate with celecoxib compared with placebo.
Danish: For alle slagtilfælde ses ingen øget frekvens af hændelser for celecoxib sammenlignet med placebo.
English: Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn), which were started in November 2004.
Danish: I fortsættelse af drøftelserne på CHMP's plenarmøde i oktober 2004 henstillede EuropaKommissionen til, at dette folkesundhedsspørgsmål, der vedrører alle aspekter af den kardiovaskulære sikkerhed, herunder thrombotiske hændelser og kardiorenale hændelser, indbringes for CHMP for at få det behandlet efter artikel 31 (”Referrals”) i direktiv 2001/83/EF, med senere ændringer, når det gælder decentralt godkendte produkter indeholdende celecoxib, etoricoxib og lumiracoxib, og underkastes en en gennemgang af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr. 2309/93, med senere ændringer, når det gælder de centralt godkendte produkter indeholdende celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) og valdecoxib (Bextra/Valdyn), hvilket blev påbegyndt i november 2004.
English: If a woman becomes pregnant during treatment, celecoxib should be discontinued.
Danish: Hvis en kvinde bliver gravid under behandling med celecoxib, bør behandlingen afbrydes.
English: In pregnancy and in women of childbearing potential unless using an effective method of contraception (See 4.5).
Danish: Under graviditet og hoskvinder med mulighed for at blive gravide med mindre der anvendes effektiv antikonception (se pkt.
English: ANNEX III SUMMARY OF THE PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for celecoxib containing medicinal products.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende celecoxib.
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: These effects are expected following inhibition of prostaglandin synthesis.
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 differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics).
Danish: Celecoxib er en diaryl-substitueret pyrazol med kemisk lighed med andre non-arylamin sulfonamider (f.eks. thiazider, furosemid) men adskiller sig fra arylaminsulfonamider (f.eks. sulfamethoxizol og andre sulfonamid-antibiotika).
English: Celecoxib is metabolised in the liver by hydroxylation, oxidation and some glucuronidation.
Danish: Celecoxib metaboliseres i leveren ved hydroxylering, oxidation og til dels glucuronidation.
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Danish: COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
English: Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Danish: Patienter, som tidligere har haft symptomer på astma, akut rhinitis, nasale polypper, angioneurotisk ødem, urticaria eller anden type af allergisk reaktion efter at have taget acetylsalicylsyre eller NSAID herunder COX-2 (cyclooxygenase-2) hæmmere.
English: Examples of drugs which are metabolised by CYP2C19 are diazepam, citalopram and imipramine.
Danish: Eksempler på lægemidler, som metaboliseres af CYP2C19 er diazepam, citalopram og imipramin.
English: Plasma protein binding is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes.
Danish: Plasmaproteinbindingen er ca. 97% ved terapeutiske plasmakoncentrationer og celecoxib har ikke præference for binding til erytrocytterne.
English: The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients.
Danish: Celecoxibs farmakokinetik er ikke undersøgt hos patienter med nedsat nyrefunktion, men det er usandsynligt, at den er meget ændret i denne patientgruppe.
English: Coadministration of NSAIDs and cyclosporin or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Danish: Samtidig behandling med NSAID og ciclosporin eller tacrolimus kan forøge den nyretoksiske effekt af ciclosporin og tacrolimus.
English: Additional reactions reported from post-marketing experience in >70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Danish: Yderligere bivirkninger rapporteret efter markedsføring omfattende > 70 millioner behandlede patienter omfatter hovedpine, kvalme, artralgi samt de bivirkninger, som i følgende liste er skrevet med kursiv, og som er anført under meget sjælden.
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 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: Several clinical studies have been performed confirming efficacy and safety in osteoarthritis and rheumatoid arthritis.
Danish: Adskillige kliniske studier bekræfter effekt og sikkerhed ved behandling af osteoarthrosis og rheumatoid arthritis.
English: The absolute risk for the composite endpoint was 3.0% for the higher dose of celecoxib, 2.2% for the lower dose of celecoxib, and 0.9% for placebo.
Danish: Den absolutte risiko for det kombinerede endepunkt var 3,0% for den høje dosis af celecoxib, 2,2% for den laveste dosis af celecoxib, og 0,9 for placebo.
English: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Danish: Symptomlindring i behandling af osteoarthrosis eller rheumatoid arthritis.
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 for eksempel ventrikeltømning, klinisk overvågning og hvis nødvendigt iværksættes symptomatisk behandling.
English: To provide all ongoing epidemiological studies in accordance with updates on on-going post marketing activities (for example, within PSURs for Celebra).
Danish: Indehaveren af markedsføringstilladelsen fremlægger resultaterne af alle igangværende epidemiologiske undersøgelser i overensstemmelse med opdateringer om igangværende post-marketingaktiviteter (f.eks. inden for PSUR'er for Celebra).
English: Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing celecoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, - recommended to initiate a long term study to investigate the safety of celecoxib relative to non selective NSAIDs.
Danish: CHMP - er af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende celecoxib til de godkendte indikationer fortsat er gunstigt, og at markedsføringstilladelserne bør opretholdes i overensstemmelse med de reviderede produktresuméer (vedlagt i bilag III til CHMP's udtalelse), - konkluderede, at den kardiovaskulære sikkerhed og de alvorlige hudreaktioner løbende skal overvåges nøje og vurderes, - anbefaler at indlede en langtidsundersøgelse af sikkerheden af celecoxib i forhold til ikkeselektive NSAID,
English: Ketoconazole or antacids have not been observed to affect the pharmacokinetics of celecoxib.
Danish: Ketoconazol eller antacida er ikke set at påvirke celecoxibs farmakokinetik.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see 4.4).
Danish: Patienter, der får orale antikoagulantia, bør derfor monitoreres omhyggeligt med hensyn til INR, især i de første dage efter behandling med celecoxib er startet eller hvis dosis af celecoxib ændres (se 4.4).
English: During celecoxib treatment, the plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Danish: Under behandling med celecoxib steg plasmakoncentrationen af CYP2D6-substratet dextromethorphan med 136%.
English: The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
Danish: De følgende hændelser er rapporteret for patienter, som fik celecoxib i 12 kontrollerede undersøgelser med placebo eller aktiv kontrol.
English: Final study reports will be shared with Agencies when available.
Danish: De endelige undersøgelsesrapporter gøres også tilgængelige for de nationale lægemiddelmyndigheder, så snart de foreligger.
English: Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.
Danish: Antikoagulationsparametrene bør monitoreres især i de første dage efter behandlingsstart eller dosisændring af celecoxib hos patienter, som tager warfarin eller andre antikoagulantia, da disse patienter har en øget risiko for blødningskomplikationer.
English: In patients on concurrent therapy with warfarin, serious bleeding events have occurred.
Danish: Hos patienter i samtidig behandling med warfarin, er der set alvorlig blødning.
English: Follow-up measures of the Marketing Authorisation Holder As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below:
Danish: Registreringsindehaverens opfølgende foranstaltninger På CHMP's anmodning indvilgede indehaveren af markedsføringstilladelsen i at træffe følgende opfølgende foranstaltninger:
English: 6.6 Instructions for use and handling, and disposal (if appropriate) No special requirements.
Danish: 6.6 Instruktioner vedrørende håndtering og destruktion Ingen specielle.
English: Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Danish: Celecoxib kan tages sammen med acetylsalicylsyre i lavdosis, men er ikke 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 4.3).
Danish: Patienter, der tidligere har haft sulfonamidallergi eller anden lægemiddelallergi, kan have større risiko for alvorlige hudreaktioner og overfølsomhedsreaktioner (se pkt.
English: Thus caution is advised when treating patients with renal impairment.
Danish: Forsigtighed anbefales ved behandling af patienter med nedsat nyrefunktion.
English: Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.
Danish: Patienter, som mærker svimmelhed, vertigo eller somnolens, bør undlade at føre bil eller betjene maskiner.
English: Particular caution should be exercised in elderly with a body weight less than 50 kg. (See 4.4 and 5.2).
Danish: Særlig forsigtighed bør udvises hos ældre patienter, der vejer mindre end 50 kg. (se pkt.
English: Pharmacological activity resides in the parent drug.
Danish: Den farmakologiske virkning sidder i modersubstansen.
English: In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the maximum recommended daily human dose was 3X.
Danish: I dette forsøg var den laveste plasmakoncentration, hvor der sås anomali i ét eneste dyr, 3 gange større end den beregnede sikkerhedsmargin som ses ved maksimalt anbefalede daglige dosis til mennesker.
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 med høje doser af celecoxib.
English: The incidence of clinically significant decreases in haemoglobin (>2 g/dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48.
Danish: Hyppigheden af klinisk betydende fald i hæmoglobin (> 2 g/dl), bekræftet ved gentagne målinger, var signifikant lavere hos patienter med celecoxib i forhold til NSAID-gruppen (relativ risiko 0,29, 95% CI 0,17-0,48).
English: Pfizer AB Nytorpsvägen 36 P.O.
Danish: Pfizer AB Nytorpsvägen 36 P.O. Box 501
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 rheumatoid arthritis havde celecoxib ingen signifikant effekt på farmakokinetikken (plasma- eller renal clearence) af methotrexat (i reumatologiske doser).
English: Ongoing Clinical Trials: Preliminary safety information from three long-term studies involving patients with Sporadic Adenomatous Polyps or who were predisposed to developing Alzheimer's disease treated with celecoxib is available.
Danish: Igangværende kliniske studier: Foreløbige sikkerhedsdata fra 3 langtidsstudier med celecoxib til patienter med sporadisk adenomatøs polypose eller patienter, som er i særlig risiko for at udvikle Alzheimers sygdom er tilgængelige.
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 angiotension II receptor antagonister kombineres med NSAID, inklusive celecoxib.
English: Approximately 7400 patients were treated with celecoxib in controlled trials and of those approximately 2300 have received it for 1 year or longer.
Danish: Der er i kontrollerede undersøgelser behandlet ca. 7400 patienter med celecoxib, heraf har ca. 2300 fået celecoxib i et år eller længere.
English: Pharmacotherapeutic group: ATC code: M01AH01.
Danish: Farmakoterapeutisk gruppe: M 01 AH 01
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.
English: No clinical data on exposed pregnancies are available for celecoxib.
Danish: Der foreligger ingen kliniske data på graviditet og celecoxib.
English: Those patients on celecoxib and concomitant lowdose acetylsalicylic acid experienced 4 fold higher rates of complicated ulcers as compared to those on celecoxib alone.
Danish: De patienter, som fik celecoxib og lavdosis acetylsalicylsyre samtidig, oplevede 4 gange hyppigere komplicerede mavesår i forhold til dem, der fik celecoxib alene.
English: Also for the combined NSAID group there was no statically significant difference for complicated ulcers (relative risk 0,77, 95 % CI 0.41-1.46, based on entire study duration).
Danish: Også for den kombinerede NSAID-gruppe var der ingen statistisk signifikant forskel for komplicerede mavesår (relativ risiko 0,77, 95%, CI 0,411,46, set over hele studieperioden).
English: Very rare: angioedema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis,
Danish: Meget sjælden: angioødem, dermatitis exfoliativa, erythema multiforme, Stevens-Johnsons syndrom, epidermal nekrolyse
English: Immune system disorders: Very rare: serious allergic reactions, anaphylactic shock
Danish: Forstyrrelser i immunsystemet Meget sjælden: alvorlige allergiske reaktioner, anafylaktisk shock
English: Examples of drugs which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, antiarrhythmic drugs, etc.
Danish: Sådanne lægemidler, der metaboliseres af CYP2D6, omfatter antidepressiva (tricycliske og SSRI), neuroleptika, antiarrytmika og andre.
English: In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 OA and 2,200 RA patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg TID or diclofenac 75 mg BID (both at therapeutic doses).
Danish: I et prospektivt langtidsstudie (6-15 måneders varighed, CLASS studiet), fik 5.800 OA og 2.200 RA patienter celecoxib 400 mg 2 gange daglig (4 gange og 2 gange den anbefalede dosis til henholdsvis OA og RA), ibuprofen 800 mg 3 gange daglig eller diclofenac 75 mg 2 gange daglig (begge i terapeutiske doser).
English: 8 MARKETING AUTHORISATION NUMBER(S) [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER [Punkt indsættes af indehaver af markedsføringstilladelsen, når markedsføringstilladelsen er udstedt]
English: In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Danish: Dyreforsøg med celecoxib i den tidlige fosterudvikling medførte abort i præ- og post implantationsperioden.
English: There are no studies on the excretion of celecoxib in human milk.
Danish: Der er ingen undersøgelser om udskillelse af celecoxib i mælken hos ammende kvinder.
English: Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%.
Danish: Samtidig brug af 200 mg celecoxib taget som én enkelt dosis og 200 mg fluconazol, en potent CYP2C9-hæmmer, en gang daglig, resulterede i en gennemsnitlig stigning i celecoxibs Cmax på 60% og i AUC på 130%.
English: Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Danish: Hvide, uigennemsigtige kapsler med to blå bånd mærket 7767 og 100 (navn 100 mg).
English: There is further increase in the risk of gastrointestinal adverse effects for celecoxib (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 with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Danish: Patienter med svær nedsat leverfunktion (serumalbumin under 25 g/l) er ikke undersøgt, hvorfor celecoxib er kontraindiceret til denne patientgruppe.
English: The relative risk (RR) for the composite endpoint (cardiovascular death, MI or stroke) was 3.4 (95% CI 1.4 - 8.5) for the higher dose and 2.5 (95% CI 1.0 - 6.4) for the lower dose of celecoxib, compared to placebo.
Danish: Den relative risiko (RR) for det kombinerede endepunkt (kardiovaskulær død, MI eller slagtilfælde) var henholdsvis 3,4 (95% CI 1,4-8,5) for den høje dosis og 2,5 (95% CI 1,0-6,4) for den laveste dosis af celecoxib sammenlignet med placebo.
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: Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Danish: Derfor bør patienter, som behandles med lithium, følges omhyggeligt, når behandling med celecoxib begyndes eller afbrydes.
English: In the same studies, the excess rate for clearly identified ischaemic stroke for the 400 mg daily dose (not including events that were haemorrhagic or of unknown aetiology) was 0.5 event per 1000 over 3 years (Rare).
Danish: I de samme studier ses en overrepræsentation af klart identificerede iskæmiske slagtilfælde ved 400 mg daglig dosis (ikke omfattende hændelser som er hæmoragiske eller af ukendt oprindelse) på 0,5 hændelser pr. 1000 efter 3 år (sjælden).
English: Common: abdominal pain, diarrhoea, dyspepsia, flatulence Uncommon: constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation
Danish: Almindelig: abdominalsmerter, diarré, dyspepsi, flatulens Ikke almindelig: obstipation, opstød, gastrit, stomatit, opkastning, forværring af gastrointestinal inflammation
English: {INVENTED NAME, see Annex I } 200 mg capsule, hard.
Danish: {navn, se Annex 1} 100 mg hårde kapsler {navn, se Annex 1} 200 mg hårde kapsler
English: The MAH commits to performing a global CV study to confirm long term CV safety of Celecoxib.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at foretage en global kardiovaskulær undersøgelse med henblik på at bekræfte den langsigtede kardiovaskulære sikkerhed ved Celecoxib.
English: For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95% CI 0.45-0.97 but not between celecoxib and diclofenac.
Danish: Ved det kombinerede endepunkt, komplicerede og symptomatiske mavesår, var hyppigheden i celecoxib-gruppen signifikant lavere i forhold til NSAID-gruppen (relativ risiko 0,66, 95% CI 0,45-0,97), men ikke mellem celecoxib og diclofenac.
English: Treatment should be initiated at half the recommended dose in patients with moderate liver impairment (with serum albumin 25-35g/L).
Danish: Behandlingen skal initieres med halvdelen af den anbefalede dosis hos patienter med moderat nedsat leverfunktion (serumalbumin 2535 g/l).