FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from a third long-term study, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), did not show a significantly increased cardiovascular risk with celecoxib 200mg BID compared to placebo.
Danish: Data fra et tredje langtidsforsøg, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), viser ikke signifikant øget kardiovaskulær risiko med celecoxib 200 mg 2 gange dagligt sammenlignet med placebo.
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: Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
Danish: Den sædvanlige behandling af FAP-patienter bør derfor ikke ændres på grund af den samtidige administration af celecoxib.
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 svært nedsat leverfunktion (serum-albumin <25 g/l) er ikke undersøgt, hvorfor celecoxib er kontraindiceret til denne patientgruppe.
English: Upper gastrointestinal complications [perforations, ulcers or bleeds (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 (PUBs)], nogle med fatal udgang, hos patienter behandlet med celecoxib.
English: In additional studies using non-selective NSAID comparators, approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2300 patients treated for 1 year or longer.
Danish: I supplerende forsøg, hvor ikke-selektive NSAID blev anvendt som sammenligningsprodukter, blev ca. 7.400 patienter med artrit behandlet med daglige doser af celecoxib på op til 800 mg, heraf blev ca. 2.300 patienter behandlet i 1 år eller mere.
English: Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Danish: Hos rotter udskilles celecoxib i mælken i koncentrationer svarende til plasmakoncentrationerne.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: - Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications).
Danish: - Bivirkninger fra overvågning efter markedsføring er rapporteret som spontane rapporter over en periode, hvor det anslås, at >70 millioner patienter er blevet behandlet med celecoxib (variable doser, varigheder og indikationer).
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 postimplantationsperioden.
English: − if you have had an allergic reaction to any of the ingredients of Onsenal
Danish: hvis du er overfølsom (allergisk) over for et af indholdsstofferne i Onsenal.
English: − The other ingredients are gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30,
Danish: - Øvrige indholdsstoffer: gelatine, lactosemonohydrat, natriumlaurilsulfat, povidon K30,
English: Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly.
Danish: Patienter, som er i størst risiko for at udvikle nyretoksicitet, er patienter med nedsat nyrefunktion, hjertesvigt, nedsat leverfunktion og ældre.
English: Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Danish: Derfor bør celecoxib anvendes med forsigtighed til patienter, der tidligere har haft hjertesvigt, venstre ventrikulær dysfunktion eller hypertension og hos patienter med kendt ødem af anden årsag, da prostaglandin-hæmning kan medføre en forværring af nyrefunktion og væskeretention.
English: Outer carton - 400 mg hard capsules
Danish: Ydre karton - 400 mg hårde kapsler
English: In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high
Danish: I et 2-årigt toksicitetsforsøg er der set øget nonadrenal thrombose hos han-rotter ved høje doser.
English: COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Danish: COX-2-hæmmere mindsker dannelsen af systemisk (og derfor muligvis endotelial) prostacyclin uden at påvirke trombycytternes tromboxan.
English: Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events.
Danish: Enkeltdoser op til 1200 mg og gentagne doser op til 1200 mg 2 gange dagligt er blevet givet til raske personer i 9 dage uden klinisk betydende bivirkninger.
English: In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon polyps, the following additional side effects have been observed (side effects marked with an asterisk were more common in these studies than in arthritis studies):
Danish: I kliniske forsøg, hvor Onsenal blev givet i op til 3 år til forebyggelse af spontane tarmpolypper, blev følgende yderligere bivirkninger set (bivirkninger markeret med en stjerne ses hyppigere i disse forsøg end i forsøg ved gigtrelaterede sygdomme):
English: Heart failure, palpitations, tachycardia
Danish: Hjerte hjertesvigt, palpitationer, takykardi
English: Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Danish: Da celecoxib overvejende metaboliseres af CYP2C9, bør patienter, som får fluconazol, kun have halvdelen af den anbefalede dosis.
English: If an anastomotic ulcer is present, patients should not receive concomitant treatment with anticoagulants or acetyl salicylic acid.
Danish: Patienter med anastomotisk sår bør ikke samtidig behandles med antikoagulerende midler eller acetylsalicylsyre.
English: Onsenal can be taken with low dose acetylsalicylic acid (aspirin).
Danish: Onsenal kan tages sammen med lave doser af acetylsalicylsyre (hjertemagnyl).
English: Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection Lipoma
Danish: helicobacterinfektion, herpes zoster, erysipelas, sårinfektion, gingival infektion, labrynthitis, bakteriel infektion
English: 1 Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications).
Danish: 1 Bivirkninger rapporteret spontant til bivirkningsovervågningsdatabasen i en periode, hvor det anslås, at mere end 70 millioner patienter er blevet behandlet med celecoxib (forskellige doser, varigheder og indikationer).
English: Make sure that your doctor knows before you start taking Onsenal:
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ONSENAL
English: Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Danish: Blodtrykket bør derfor kontrolleres nøje ved opstart af behandling med celecoxib og under
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 effect.
Danish: Selektive COX-2-hæmmere kan ikke erstatte acetylsalicylsyre som profylakse ved kardiovaskulær tromboembolisk sygdom på grund af manglende effekt på blodpladefunktionen.
English: Celecoxib metabolism is primarily mediated via cytochrome P450 CYP2C9.
Danish: Celecoxibs metabolisme medieres hovedsageligt af cytokrom P450 CYP2C9.
English: Uncommon (≥1/1000 to <1/100)
Danish: Ikke almindelig (1/1000 til <1/100)
English: croscarmellose sodium, magnesium stearate and the colouring agent titanium dioxide E171.
Danish: croscarmellosenatrium, magnesiumstearat og farvestoffet titandioxid E171.
English: FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer.
Danish: FAP er en arvelig sygdom, hvor endetarm og tyktarm er dækket med mange polypper, som kan udvikle sig til endetarms- eller tyktarmskræft.
English: You will usually take two 200 mg
Danish: Sædvanligvis skal du tage 2 kapsler på 200 mg 2 gange
English: Such patients should be carefully monitored while receiving treatment with celecoxib.
Danish: Disse patienter bør følges nøje under behandling med celecoxib.
English: In patients on concurrent therapy with warfarin, serious bleeding events have been reported.
Danish: Hos patienter i samtidig behandling med warfarin er der set alvorlig blødning.
English: Co-administration of NSAIDs and ciclosporin D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Danish: Samtidig behandling med NSAID og ciclosporin D-derivater eller tacrolimus synes at kunne øge den nyretoksiske effekt af ciclosporin og tacrolimus.
English: If your capsules are out of date, take them to your pharmacist who will get rid of them safely.
Danish: Hvis kapslerne er for gamle, kan de indleveres på apoteket til destruktion.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Danish: Må ikke opbevares over 30°C
English: The incidence of myocardial infarction was 1.1% (8/717 patients) with celecoxib 200 mg twice daily and 1.2% (13/1070 patients) with placebo.
Danish: Hyppigheden af myokardieinfarkt er 1,1% (8/717 patienter) med celecoxib 200 mg 2 gange dagligt og 1,2% (13/1070 patienter) med placebo.
English: It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3-1.0% among different ethnic groups.
Danish: Det anslås, at hyppigheden af homozygot *3/*3 genotype er
English: In three separate single dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/*3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolizers.
Danish: I 3 separate enkeltdosisforsøg, der omfattede i alt 5 forsøgspersoner med genotype CYP2C9*3/*3, øges enkeltdosis AUC0-24 ca. 3 gange sammenlignet med personer med normal metabolisme.
English: Conventional embryo-foetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat foetuses and of cardiovascular malformations in rabbit foetuses at systemic exposures to free celecoxib approximately 3 times (rat) and 2 times (rabbit) higher than those achieved at the recommended daily human dose (800 mg).
Danish: Konventionelle embryo-føtale toksicitetsforsøg viste en dosisafhængig forekomst af diafragmabrok hos rottefostre og af kardiovaskulære misdannelser hos kaninfostre ved plasmakoncentrationer ca. 3 gange (rotter) og 2 gange (kaniner) højere end opnået ved behandling med den maksimalt anbefalede daglige dosis til mennesker (800 mg).
English: No clinically significant differences were found in pharmacokinetic parameters of celecoxib between African-Americans and Caucasians.
Danish: Der er ikke set klinisk signifikante forskelle i celecoxibs farmakokinetiske parametre mellem negroide og hvide.
English: Paediatric patients: Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see
Danish: Børn: Erfaring med celecoxib hos FAP-patienter under 18 år er begrænset til et enkelt pilotforsøg i en meget lille patientgruppe, hvor patienterne blev behandlet med celecoxibdoser på op til 16 mg/kg dagligt, hvilket svarer til den anbefalede FAP-voksendosis på 800 mg dagligt (se pkt.
English: Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Danish: Celecoxib er en oral, selektiv cyclooxygenase-2-hæmmer (COX-2).
English: Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) for placebo.
Danish: Kumulative procenter for det sammensatte endepunkt over 3 år er henholdsvis 3% (20/671 forsøgspersoner) og 2,5% (17/685 forsøgspersoner) sammenlignet med 0,9% (6/679 forsøgspersoner) for placebo.
English: You must not take Onsenal if you are breast feeding.
Danish: Du må ikke tage Onsenal, hvis du ammer.
English: For celecoxib no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for celecoxib under graviditet.
English: Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.
Danish: Onsenal tilhører en medicingruppe, som kaldes cyklooxygenase-2-hæmmere (COX-2).
English: • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema,
Danish: • Patienter, som tidligere har haft symptomer på astma, akut rhinitis, nasale polypper,
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 den største risiko for at udvikle gastrointestinale komplikationer i forbindelse med NSAID-præparater: ældre, patienter, som får andre NSAID-præparater eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft en gastrointestinal sygdom, f.eks.
English: − The active substance is celecoxib
Danish: - Aktivt stof: celecoxib.
English: If a woman becomes pregnant during treatment, celecoxib
Danish: Hvis en kvinde bliver gravid under behandling med
English: The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1.
Danish: De bivirkninger, der sås med celecoxib i disse supplerende forsøg, var de samme som dem, der blev set hos patienterne med osteoarthrosis og reumatoid artritanført i tabel 1.
English: In FAP patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50%.
Danish: Hos FAP-patienter med moderat nedsat leverfunktion (serumalbumin 25-35 g/l) bør den daglige anbefalede dosis af celecoxib reduceres med 50%.
English: Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8).
Danish: Derudover er der indberettet alvorlige overfølsomhedsreaktioner (anafylaksi og angioødem) hos patienter, der fik celecoxib (se pkt.
English: In the APC trial, there was a dose-related increase in the composite endpoint of cardiovascular death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment.
Danish: I APC-forsøget ses en dosisrelateret stigning i det sammensatte endepunkt af kardiovaskulær død, myokardieinfarkt eller slagtilfælde (bekræftet) med celecoxib sammenlignet med placebo over en behandlingsperiode på 3 år.
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: Cumulative rates for this composite endpoint over 3 years were 2.3% (21/933 subjects) and 1.9% (12/628 subjects), respectively.
Danish: Kumulative procenter for det sammensatte endepunkt over 3 år er henholdsvis 2,3% (21/933 forsøgspersoner) og 1,9% (12/628 forsøgspersoner.
English: White, opaque capsules with two gold bands marked 7767 and 200.
Danish: Hvide, uigennemsigtige kapsler med 2 guldbånd mærket 7767 og 200.
English: Blood and lymphatic system disorder / Cardio-vascular disorder 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 200 mg BID and 400 mg BID compared to placebo (see section 5.1).
Danish: Lidelser i blod og lymfesystem / kardiovaskulære lidelser Der er set et øget antal alvorlige kardiovaskulære hændelser, hovedsagelig myokardieinfarkt, i placebokontrollerede langtidsforsøg hos personer med sporadisk adenomatøs polypose behandlet med celecoxib i doser på 200 mg 2 gange dagligt og 400 mg 2 gange dagligt sammenlignet med placebo (se pkt.
English: The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint.
Danish: PreSAP-forsøget viser ikke statistisk signifikant øget
English: Cytochrome P450 CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism.
Danish: Cytokrom P450 CYP2C9-aktivitet er nedsat hos personer med genetisk polymorfisme, som fører til nedsat enzymaktivitet, som f.eks. homozygot ved
English: − Blood clot in the blood vessels in the lungs.
Danish: blodprop i lungerne.
English: Pilot Study in Juvenile FAP Patients: A total of 18 children 10 to 14 years of age who had genotype or phenotype positive FAP were treated with celecoxib 4 mg/kg/day (4 patients, compared to 2 patients treated with placebo), celecoxib 8 mg/kg/day (4 patients, compared to 2 patients treated with placebo), or celecoxib 16 mg/kg/day (4 patients, compared to 2 patients treated with placebo).
Danish: Pilotforsøg hos børn med FAP: I alt 18 børn i alderen 10-14 år med positiv FAP-geno- eller FABfænotype blev behandlet med celecoxib 4 mg/kg dagligt (4 patienter sammenlignet med 2 behandlet med placebo), celecoxib 8 mg/kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo) eller celecoxib 16 mg/kg dagligt (4 patienter sammenlignet med 2 patienter behandlet med placebo).
English: The capsules are white with ‘7767‘ and ‘400‘ marked in green ink.
Danish: Kapslerne er hvide og mærket ”7767” og ”400” med grønt blæk.
English: White, opaque capsules with two green bands marked 7767 and 400.
Danish: Hvide, uigennemsigtige kapsler med 2 grønne bånd mærket 7767 og 400.
English: A meaningful reduction in duodenal adenoma area was also observed compared with placebo (14.5% celecoxib 400 mg BID versus 1.4% placebo), which however was not statistically significant.
Danish: Der blev set en betydelig reduktion af det adenomatøse område i duodenum sammenlignet med placebo (14,5 % for celecoxib 400 mg 2 gange dagligt versus 1,4 % for placebo), hvilket dog ikke er statistisk signifikant.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
English: Experience with celecoxib in patients with mild or moderate renal or hepatic impairment is limited, therefore such patients should be treated with caution (see sections 4.2 and 5.2).
Danish: Erfaring med celecoxib til patienter med mildt eller moderat nedsat nyre- eller leverfunktion er begrænset, derfor bør disse patienter behandles med forsigtighed (se pkt.
English: Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).
Danish: Andet Patienter med nedsat CYP2C9-metabolisering bør behandles med forsigtighed (se pkt.
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% (analogous studies have not been performed with amiodarone or other known CYP2C9 inhibitors).
Danish: Samtidig brug af 200 mg celecoxib taget som én enkeltdosis og 200 mg fluconazol, en potent CYP2C9-hæmmer, én gang dagligt resulterede i en gennemsnitlig stigning i celecoxibs Cmax på 60% og i AUC på 130% (analoge forsøg er ikke gennemført med amiodaron eller andre kendte CYP2C9-hæmmere).
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 både fik celecoxib 200 mg 2 gange dagligt og 450 mg lithium 2 gange dagligt, steg Cmax af lithium i gennemsnit med 16% og AUC med 18%.
English: Usual medical care for FAP patients should be continued while on celecoxib.
Danish: Sædvanlig medicinsk behandling af FAP-patienter bør fortsættes under behandlingen med celecoxib.
English: 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 section 5.1).
Danish: Som for andre NSAID-præparater ses en øget risiko for gastrointestinal ulceration eller andre gastrointestinale komplikationer ved samtidig administration af lave doser acetylsalicylsyre sammenlignet med brugen af celecoxib alene (se
English: Before you start taking Onsenal make sure your doctor knows if you are taking: - ACE inhibitors or Angiotensin II receptor antagonists (used for high blood pressure and heart
Danish: Tal med lægen, inden du tager Onsenal, hvis du tager: - ACE-hæmmere eller Angiotensin II-receptorantagonister (medicin mod højt blodtryk og
English: In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring.
Danish: I et klinisk forsøg af 28 dages varighed med patienter med lisinoprilkontrolleret stadie I og II hypertension førte administration af celecoxib 200 mg 2 gange dagligt ikke til klinisk signifikante stigninger i det gennemsnitlige daglige systoliske eller diastoliske blodtryk beregnet ud fra 24-timers ambulant blodtryksmåling sammenlignet med placebo.
English: Data from pooled analysis of controlled randomized trials also suggest that cardiovascular risk may be associated with the use of celecoxib compared to placebo, with evidence for differences in risk based
Danish: Data fra samlet analyse af kontrollerede, randomiserede forsøg tyder også på, at der kan være kardiovaskulær risiko forbundet med brug af celecoxib sammenlignet med placebo.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Onsenal til dig personligt.
English: - Acetylsalcylic acid or other anti-inflammatory medicines - Cyclosporin and tacrolimus (used for immune system suppression e.g. after transplants) - Dextromethorphan (used as an antitussive in cough mixtures) - Diuretics (used to treat fluid retention) - Fluconazole (used to treat fungal infections)
Danish: - acetylsalicylsyre eller anden medicin, der dæmper betændelse - medicin, der nedsætter immunforsvaret f.eks. efter transplantationer (ciclosporin og tacrolimus) - hostestillende medicin i hostesaft (dextromethorphan ) - vanddrivende medicin (medicin mod væskeophobning)