FrancophonIA/ELRC3.0 huggingface dataset:
English: GROUNDS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Danish: BEGRUNDELSER FOR ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
English: A prespecified, combined analysis of eight clinical trials of approximately 4000 patients with OA, RA, or chronic low back pain assessed the incidence rate for the following endpoints: 1) discontinuation for upper GI symptoms; 2) discontinuation for any GI adverse experiences; 3) new use of gastroprotective medications; and 4) new use of any GI medications.
Danish: Incidensen for følgende effektmål er vurderet i en præspecificeret, kombineret analyse af 8 kliniske undersøgelser med ca. 4000 patienter med OA, RA eller kroniske lændesmerter: 1) seponering på grund af øvre GI symptomer; 2) seponering på grund af enhver GI hændelse; 3) ny anvendelse af gastroprotektive midler og 4) ny anvendelse af ethvert GI middel.
English: Common: dizziness, headache.
Danish: Almindelig: Svimmelhed, hovedpine.
English: The major route of metabolism to form the 6'-hydroxymethyl derivative is catalyzed by CYP enzymes.
Danish: Den primære metaboliseringsvej for at danne 6'-hydroxymethylderivatet er katalyseret af CYP-enzymer.
English: The event rates for serious thrombotic events were: Etoricoxib 1.25 events per 100 patient years versus 1.15 events per 100 patient years for diclofenac (relative risk 1.07;95% CI: 0.65%, 1.74%).
Danish: Kardiovaskulære data: Forekomsten af alvorlige thrombotiske hændelser var for etoricoxib 1,25 hændelse pr. 100 patientår versus 1,15 hændelse pr. 100 patientår for diclofenac (relativ risiko 1,07; 95% konfidensinterval: 0,65%, 1,74%).
English: However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
Danish: Incidensen af disse hændelser var imidlertid højere hos patienter der fik etoricoxib sammenlignet med de, som fik naproxen 500 mg, 2 gang daglig.
English: The pharmacokinetics of etoricoxib are linear across the clinical dose range.
Danish: Etoricoxibs farmakokinetik er lineær over det kliniske dosisspænd.
English: Infections and infestations: Uncommon: gastroenteritis, upper respiratory infection, urinary tract infection.
Danish: Infektioner og infestationer Ikke-almindelig: Gastroenteritis, øvre luftvejsinfektion, urinvejsinfektion.
English: Etoricoxib was not teratogenic in reproductive toxicity studies conducted in rats at 15 mg/kg/day (this represents approximately 1.5 times the daily human dose [90 mg] based on systemic exposure).
Danish: Etoricoxib var ikke teratogent i reproduktionstoksicitetsundersøgelser med rotter behandlet med 15 mg/kg/dag (dette repræsenterer ca. 1,5 gange den daglige humandosis [90 mg] baseret på systemisk optagelse).
English: Antacids: Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
Danish: Antacida: Antacida påvirker ikke etoricoxibs farmakokinetik i klinisk relevant udstrækning.
English: Renal insufficiency: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥30 ml/min (se afsnit 5.2 ).
English: Eye disorders: Uncommon: blurred vision.
Danish: Lidelser i øjne: Ikke-almindelig: Sløret syn.
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib.
Danish: Der er set øvre gastrointestinale komplikationer [perforation, ulcera eller blødninger (PUB)], nogle med fatal udgang hos patienter behandlet med etoricoxib.
English: Uncommon: proteinuria.
Danish: Ikke-almindelig: Proteinuri.
English: Etoricoxib is excreted in the milk of lactating rats at concentrations approximately two-fold those in plasma.
Danish: Etoricoxib udskilles i rottemælk ved koncentrationer ca. 2 gange større end plasmakoncentrationer.
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 events.
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 thromboemboliske hændelser.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib 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 etoricoxib bør overvejes.
English: Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason.
Danish: Der bør udvises forsigtighed hos patienter med hjertesvigt, dysfunktion af venstre ventrikel eller hypertension i anamnesen og hos patienter med allerede eksisterende ødem af anden årsag.
English: In the rat, gastrointestinal toxicity of etoricoxib increased with dose and exposure time.
Danish: Hos rotter øgedes den gastrointestinale toxicitet af etoricoxib med dosis og doseringsstid.
English: Film-coated tablet/tablet.
Danish: Filmovertrukken tablet
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure,which is usually reversible.
Danish: Hos nogle patienter med kompromitteret nyrefunktion (f.eks. dehydrerede eller ældre patienter med kompromitteret nyrefunktion), kan samtidig administration af ACE-hæmmere eller angiotensin-II-receptorantagonister og stoffer der hæmmer cyclooxygenasen medføre yderligere forværring af nyrefunktionen, inklusiv mulig akut nyresvigt.
English: Oral anticoagulants: In subjects stabilised on chronic warfarin therapy, the administration of etoricoxib 120 mg daily was associated with an approximate 13% increase in prothrombin time International Normalised Ratio (INR).
Danish: Orale antikoagulantia: Hos patienter stabiliseret på kronisk warfarinbehandling, var administration af etoricoxib 120 mg daglig associeret med ca. 13% stigning i protrombin-tid (International Normalised Ratio, INR).
English: Fluid retention, oedema and hypertension
Danish: Væskeretention, ødem og hypertension
English: Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric mean Cmax = 3.6 µg/ml) was observed at approximately 1 hour (Tmax) after administration to fasted adults.
Danish: Efter administration af 120 mg, én gang daglig indtil steady state ses peak plasmakoncentrationen (geometrisk middel Cmax = 3,6 µg/ml) efter ca. 1 time (Tmax) hos fastende voksne.
English: Ketoconazole: Ketoconazole, a potent inhibitor of CYP3A4, dosed at 400 mg once a day for 11 days to healthy volunteers, did not have any clinically important effect on the single-dose pharmacokinetics of 60 mg etoricoxib (43% increase in AUC).
Danish: Ketoconazol: Ketoconazol, en potent hæmmer af CYP3A4, i doser på 400 mg én gang daglig i 11 dage til raske frivillige, påvirkede ikke etoricoxib 60 mg engangsdosis plasma-farmakokinetik i klinisk relevant grad (43% stigning af AUC).
English: Hepatobiliary disorders: Very rare: hepatitis.
Danish: Lever- og galdevejslidelser: Meget sjælden: Hepatitis.
English: Further revisions to the SPC will be promptly communicated to HCPs and promptly incorporated into printed materials and product websites.
Danish: Indehaveren af markedsføringstilladelsen meddeler omgående yderligere ændringer i produktresuméet til fagfolk inden for sundhedssektoren og indføjer omgående sådanne ændringer i trykte materialer og på websteder for produkter.
English: In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
Danish: I kliniske undersøgelser af akut arthritis urica blev etoricoxib doseret i 8 dage.
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: Ældre, som får andre NSAID eller acetylsalicylsyre samtidig, eller patienter, der tidligere har haft gastrointestinal sygdom som f.eks. ulcera og gastrointestinal blødning.
English: However, patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.
Danish: Patienter der oplever svimmelhed, vertigo eller søvnighed, når de anvender <SÆRNAVN>, bør ikke køre bil eller betjene maskiner.
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Danish: Køn Etoricoxibs farmakokinetik er sammenlignelig hos mænd og kvinder.
English: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Danish: Etoricoxib effekt på lægemidler der metaboliseres via CYP-isoenzymer: Baseret på in vitroundersøgelser, forventes etoricoxib ikke at hæmme cytokrom P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 eller 3A4.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
Danish: Hvis der er kliniske tegn på forværring i disse patienters tilstand, bør der tages relevante forbehold og behandlingen med etoricoxib bør seponeres.
English: In the 14-week toxicity study etoricoxib caused gastrointestinal ulcers at exposures greater than those seen in man at the therapeutic dose.
Danish: I en 14ugers toxicitetsundersøgelse forårsagede etoricoxib gastrointestinale ulcera ved eksponering til højere doser end den, der sås hos mennesker i terapeutiske doser.
English: Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Danish: Behandlingen med etoricoxib, bør seponeres ved den første forekomst af hududslæt, slimhindeaffektioner eller andre tegn på overfølsomhed.
English: However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Danish: Monitorering bør foretages hos patienter med høj risiko for digoxintoksicitet ved samtidig administration af etoricoxib og digoxin.
English: Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly.
Danish: Det anbefales at monitorere for methotrexat-relateret toksicitet når etoricoxib administreres samtidig med methotrexat.
English: The dose for acute gout should not exceed 120mg daily, limited to a maximum of 8 days treatment.
Danish: Dosis ved akut arthritis urica bør ikke overstige 120 mg dagligt, og behandlingen bør begrænses til at vare i højst 8 dage.
English: Via Benedetto Croce, 37 I-56125 Pisa Italy
Danish: Via Mazzini, 112 I-56125 Pisa Italien
English: Tablet coating: Carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate.
Danish: Tabletovertræk: Carnaubavoks, hypromellose, lactosemonohydrat, titandioxid (E171), glyceroltriacetat.
English: Methotrexate: Two studies investigated the effects of etoricoxib 60, 90 or 120 mg administered once daily for seven days in patients receiving once-weekly methotrexate doses of 7.5 to 20 mg for rheumatoid arthritis.
Danish: Methotrexat: Der er udført 2 undersøgelser af effekten af etoricoxib 60 mg, 90 mg og 120 mg, administreret 1 gang daglig i 7 dage til patienter der fik methotrexat 1 gang ugentlig i doser på 7,5-20 mg for rheumatoid arthritis.
English: Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
Danish: Etoricoxib er indenfor det kliniske dosisområde en oral aktiv selektiv cyclo-oxygenase-2 (COX-2) hæmmer.
English: History of hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Danish: Kendt hypersensitivitet over for den aktive substans eller et af hjælpestofferne i produktet (se afsnit
English: Core: Calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Danish: Tabletkerne: Calciumhydrogenfosfat (vandfri), croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Gastrointestinal effekt
English: In a study in healthy subjects, daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test.
Danish: I en undersøgelse med raske frivillige, ændrede daglig administration af etoricoxib 120 mg ikke hepatisk CYP3A4-aktivitet, vurderet ved erythromycin-pustetest.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Danish: Patientens behov for symptomlindring samt behandlingsrespons bør genovervejes med jævne mellemrum, især hos patienter med osteoarthrose (se afsnit 4.3, 4.4, 4.8 og 5.1).
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.2, 4.3, 4.8 and 5.1).
Danish: Patientens behov for symptomlindring samt behandlingsrespons bør genovervejes med jævne mellemrum, især hos patienter med osteoarthrose (se afsnit 4.2, 4.3, 4.8 og 5.1).
English: Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 mcg ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Danish: Oral antikonception: Ved samtidig indtagelse af etoricoxib 60 mg og et oralt antikonceptionsmiddel, som indeholder 35 µg ethinyløstradiol (EØ) og 0,5-1 mg norethindron, i 21 dage øgedes steady-state AUC0-24t af EØ med 37 %.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Danish: I langtidsundersøgelser er der ikke vist en signifikant forskel på GI-sikkerheden mellem selektive COX-2 hæmmere + acetylsalicylsyre versus NSAID + acetylsalicylsyre (se afsnit 5.1).
English: The incidence of clinical gastrointestinal events leading to withdrawal was statistically significantly lower for etoricoxib versus diclofenac (7.1% versus 9.1%, respectively).
Danish: Forekomsten af kliniske gastrointestinale hændelser, som førte til tilbagetrækninger, var statistisk signifikant lavere for etoricoxib versus diclofenac (respektivt 7,1% versus 9,1%).
English: Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function.
Danish: Etoricoxib hæmmede ikke den gastriske prostaglandinsyntese og havde ingen effekt på thrombocytfunktionen.
English: * Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Danish: Baseret på analyser af kontrollerede kliniske langtidsundersøgelser med placebo og lægemidler, er selektive COX-2 hæmmere blevet sat i forbindelse med en øget risiko for alvorlige arterielle thrombotiske hændelser, inklusive myokardieinfarkt og apopleksi.
English: There was an approximate 50% risk reduction for these endpoints in patients treated with etoricoxib (60, 90 or 120 mg daily) as compared to patients treated with naproxen 500 mg twice daily or diclofenac 50 mg three times daily.
Danish: Der var en risikoreduktion på ca. 50% for disse effektmål hos patienter behandlet med etoricoxib (60, 90 eller 120 mg daglig) sammenlignet med patienter behandlet med naproxen 500 mg 2 gange daglig eller diklofenak 50 mg 3 gange daglig.
English: Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38
Danish: Merck Sharp & Dohme de Espana, S.A. c/ Josefa Valcarcel 38
English: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and has been shown to increase the serum concentrations of ethinyl estradiol.
Danish: Etoricoxib effekt på lægemidler der metaboliseres via sulfotransferaser: Etoricoxib har en hæmmende effekt på den humane sulfotransferase aktivitet, specielt SULT1E1, og er påvist at øge serum koncentrationen af ethinylestradiol.
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 60 and 90 mg daily.
Danish: Der er rapporteret stigninger i ALAT og/eller ASAT (ca. 3 gange eller mere end den øvre normalgrænse) hos ca. 1% af patienterne i kliniske undersøgelser, behandlet i op til 1 år med etoricoxib 60 eller 90 mg daglig.
English: Acetylsalicylic Acid: In a study in healthy subjects, at steady state, etoricoxib 120 mg once daily had no effect on the anti-platelet activity of acetylsalicylic acid (81 mg once daily).
Danish: Acetylsalicylsyre: I en undersøgelse med raske frivillige, havde etoricoxib 120 mg, én gang daglig, ved steady-state ingen effekt på den anti-thrombotiske effekt af acetylsalicylsyre (81 mg én gang daglig).
English: Psychiatric disorders:
Danish: Psykiatriske lidelser:
English: The effects of etoricoxib 120 mg on the exposure (AUC0-24hr) to these estrogenic components of PREMARIN <or local TRADEMARK> were less than half of those observed when PREMARIN <or local TRADEMARK> was administered alone and the dose was increased from 0.625 to 1.25 mg.
Danish: Effekten af etoricoxib 120 mg (AUC0-24t) sammen med Premarins østrogene komponenter var mindre end halvdelen af den observerede effekt, når Premarin blev givet alene og dosis blev øget fra 0,625 mg til 1,25 mg.
English: 6.6 Instructions for use and handling
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering Ikke relevant.
English: Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Danish: NSAID og nogle selektive COX-2 hæmmere er blevet sat i forbindelse med en øget risiko for hudreaktioner hos patienter med enhver form for lægemiddelallergi i anamnesen.
English: Cardiorenal events: Statistically significantly more patients treated with etoricoxib than diclofenac experienced adverse effects associated with hypertension (11.7% versus 5.9%) and oedema (7.5% versus
Danish: Kardiorenale hændelser: Statistisk signifikant flere patienter, som blev behandlet med etoricoxib, i forhold til diclofenac, oplevede bivirkninger forbundet med hypertension (11,7% versus 5,9%) og ødemer (7,5% versus 5,9%).
English: In a pharmacokinetic study (n=16) conducted in adolescents (aged 12 to 17) the pharmacokinetics in adolescents weighing 40 to 60 kg given etoricoxib 60 mg once daily and adolescents >60 kg given etoricoxib 90 mg once daily were similar to the pharmacokinetics in adults given etoricoxib 90 mg once daily.
Danish: I en farmakokinetisk undersøgelse (n = 16) udført med unge (i aldersgruppen 12-17 år), svarede farmakokinetikken hos unge med en vægt på 40-60 kg, der fik etoricoxib 60 mg én gang daglig, og unge med en vægt > 60 kg, der fik etoricoxib 90 mg én gang daglig til farmakokinetikken hos voksne, der fik etoricoxib 90 mg, én gang daglig.
English: Etoricoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Danish: I lighed med andre lægemidler der hæmmer prostaglandinsyntesen, kan etoricoxib forårsage inertia uteri og præmatur lukning af ductus arteriosus i 3. trimester.
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: Area
Danish: Registreringsindehaverens opfølgende foranstaltninger På CHMP's anmodning indvilgede indehaveren af markedsføringstilladelsen i at træffe følgende opfølgende foranstaltninger:
English: There was a decrease in pup body weight following exposure of pups to milk from dams administered etoricoxib during lactation.
Danish: Der var et fald i ungernes kropsvægt efter de havde fået mælk fra hunner, som havde fået etorixocib under amning.
English: - 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,
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: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting.
Danish: Ikke-almindelig: Abdominal udspilning, syrerefluks, ændringer i tarmmotilitetsmønstret, obstipation, tør mund, gastroduodenal ulcera, colon irritabile, esophagitis, orale ulcera, opkastning.
English: Ear and labyrinth disorders: Uncommon: tinnitus.
Danish: Lidelser i ører: Ikke-almindelig: Tinnitus.
English: Paediatric patients: The pharmacokinetics of etoricoxib in paediatric patients (<12 years old) have not been studied.
Danish: Børn Etoricoxibs farmakokinetik hos børn (< 12 år) er ikke undersøgt.
English: Uncommon: anxiety, depression, mental acuity decreased.
Danish: Ikke-almindelig: Angst, depression, nedsat koncentration.
English: Uncommon: dysgeusia, insomnia, paresthaesia/hypaesthesia, somnolence.
Danish: Ikke-almindelig: Smagsforstyrrelser, søvnløshed, paræstesi/hypæstesi, somnolens.
English: The use of etoricoxib, as with any medicinal product known to inhibit cyclooxygenase / prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.6, 5.1, and 5.3).
Danish: <SÆRNAVN> kan, ligesom andre lægemidler, som hæmmer cyclooxygenase/prostaglandinsyntesen, ikke anbefales til kvinder, der forsøger at blive gravide (se afsnit 4.6, 5.1 og 5.3).
English: No overdoses of etoricoxib were reported during clinical trials.
Danish: Der har ikke været rapporter vedrørende overdosering med etoricoxib i kliniske undersøgelser.