natgillin/translations-raw huggingface dataset:
Der er indberettet alvorlige hypersensitivitetsreaktioner (så som anafylakse og angioødem) hos patienter som fik etoricoxib (se afsnit 4.8).
Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
2003 PC Haarlem Holland
2003 PC Haarlem The Netherlands
Prednison/prednisolon: I lægemiddelinteraktionsundersøgelser påvirkede etoricoxib ikke farmakokinetikken af prednison/prednisolon i klinisk betydelig grad.
Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Konstateret iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom
Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
I kliniske undersøgelser er bivirkningsprofilen den samme hos patienter med OA eller RA behandlet med etoricoxib i 1 år eller mere.
In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.
Etoricoxib havde en højere incidens af ulceration end placebo.
Etoricoxib had a higher incidence of ulceration as compared to placebo.
I undersøgelser specielt designet til at måle indsættelse af etoricoxibeffekt indtrådte denne så tidligt som 24 minutter efter dosering.
In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
I kliniske undersøgelser blev etoricoxib administreret uden hensyntagen til fødeindtag.
In clinical trials, etoricoxib was administered without regard to food intake.
Patienter, som tidligere har haft bronchospasmer, akut rhinitis, nasale polypper, angioneurotisk ødem, urticaria eller anden type allergisk reaktion efter at have taget acetylsalicylsyre eller NSAIDs herunder COX-2 (cyclooxygenase-2) hæmmere
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Hjælpestoffer er anført under afsnit 6.1.
For excipients, see section 6.1.
Graviditet og amning (se afsnit 4.6 og afsnit5.3)
Pregnancy and lactation (see sections 4.6 and 5.3).
Hovedmetabolitten er 6'-carboxylsyrederivatet af etoricoxib, dannet ved yderligere oxydering af 6'-hydroxymethylderivatet.
The principal metabolite is the 6'-carboxylic acid derivative of etoricoxib formed by further oxidation of the 6'-hydroxymethyl derivative.
Hepatisk effekt
Hepatic effects
14671Nea Erythrea, Athens Grækenland
14671 Nea Erythrea Athens
Indehaveren af markedsføringstilladelsen overvåger fortsat patienteksponeringen for etoricoxib i GPRD og evaluerer mulige resultater fra observationsundersøgelsen(-erne).
To continue to monitor patient exposure to etoricoxib in GPRD and evaluate potential contribution of observational study(-ies).
COX-2 selektive hæmmere reducerer dannelsen af systemiske (og dermed muligvis endotel-deriveret) prostacyclin uden at påvirke thromboxan i blodpladerne.
COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Patienterne synes at have størst risiko for udvikling af disse reaktioner tidligt i behandlingsforløbet.
Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Steady state-koncentrationer af etoricoxib nås inden for 7 dage efter administration af 120 mg, én gang daglig med en akkumuleringsratio på ca. 2, svarende til en halveringstid på ca. 22 timer.
Steady state concentrations of etoricoxib are reached within seven days of once daily administration of 120 mg, with an accumulation ratio of approximately 2, corresponding to a half-life of approximately 22 hours.
Stigningerne i østrogenkoncentrationen skal tages med i overvejelserne, når der vælges et hormon til post-menopausal substitutionsterapi til brug samtidig med etoricoxib, fordi brug af af en øget østrogenmængde kan øge risikoen for bivirkninger forbundet med hormonsubstitutionsbehandling.
These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.
Der bør udvises forsigtighed når behandling med etoricoxib initieres hos patienter med dehydrering.
Caution should be used when initiating treatment with etoricoxib in patients with dehydration.
Der er ingen klinisk erfaring hos patienter med svær leverdysfunktion (Child-Pugh score ≥10), derfor er brug hos disse patienter kontraindiceret (se afsnit 4.3, 4.4, og 5.2).
There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).
Lithium: NSAID nedsætter udskillelsen af lithium i nyrerne og kan derfor øge plasmakoncentrationen af litium.
Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Bivirkningsprofilen for denne undersøgelse var generelt sammenlignelig med den, som sås i undersøgelserne for OA, RA og kronisk lændesmerter.
The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Det tilrådes at rehydrere patienterne inden etoricoxib behandling påbegyndes.
It is advisable to rehydrate patients prior to starting therapy with etoricoxib.
Patienter med symptomer og/eller tegn på leverinsufficiens eller med unormal leverfunktionstest bør monitoreres.
Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Denne interaktion kan resultere i genopblussen af symptomerne ved samtidig administration af etoricoxib og rifampicin.
This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.
Rotter udviklede hepatocellulære og thyroide follikulære celleadenomer ved doser > 2 gange den daglige humandosis [90 mg] baseret på systemisk optagelse ved daglig dosering i ca. 2 år.
Rats developed hepatocellular and thyroid follicular cell adenomas at >2-times the daily human dose [90 mg] based on systemic exposure when dosed daily for approximately two years.
Der sås øgning i digoxin Cmax (ca.
There was an increase in digoxin Cmax (approximately 33%).
2003 PC Haarlem Holand
2003 PC Haarlem
Digoxin: Etoricoxib 120 mg, administreret én gang daglig i 10 dage til raske frivillige ændrede ikke steady-state plasma AUC0-24t eller renal elimination af digoxin.
Digoxin: Etoricoxib 120 mg administered once daily for 10 days to healthy volunteers did not alter the steady-state plasma AUC0-24hr or renal elimination of digoxin.
Symptomlindring i behandling af osteoarthrose (OA), rheumatoid arthritis (RA) samt ved smerter og tegn på inflammation i forbindelse med akut arthritis urica.
For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA) and the pain and signs of inflammation associated with acute gouty arthritis.
FAGLIGE KONKLUSIONER VEDRØRENDE ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Gastrointestinal tolerabilitet og sikkerhedsresultater: Etoricoxib var forbundet med en statistisk signifikant lavere forekomst af patienttilbagetrækninger på grund af et prædefineret, sammensat effektmål for kliniske gastrointestinale hændelser og laboratoriemæssige hændelser relateret til leverfunktionstest sammenlignet med diclofenac.
Gastrointestinal tolerability and safety results: Etoricoxib was associated with a statistically significantly lower incidence of patient withdrawals due to a predefined composite endpoint of clinical gastrointestinal adverse events and laboratory adverse events related to elevated liver function tests compared to diclofenac.
Plasmaclearance estimeres til ca. 50 ml/min for en intravenøs dosis på 25 mg.
The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Hos patienter med osteoarthrose (OA) gav etoricoxib 60 mg én gang daglig, signifikant forbedring af smerter og patientens vurdering af sygdomsstatus.
In patients with osteoarthritis (OA), etoricoxib 60 mg once daily provided significant improvements in pain and patient assessments of disease status.
Gastrointestinale lidelser:
Gastrointestinal disorders:
BEGRUNDELSER FOR ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
GROUNDS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
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.
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.
Almindelig: Svimmelhed, hovedpine.
Common: dizziness, headache.
Den primære metaboliseringsvej for at danne 6'-hydroxymethylderivatet er katalyseret af CYP-enzymer.
The major route of metabolism to form the 6'-hydroxymethyl derivative is catalyzed by CYP enzymes.
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%).
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%).
Incidensen af disse hændelser var imidlertid højere hos patienter der fik etoricoxib sammenlignet med de, som fik naproxen 500 mg, 2 gang daglig.
However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
Etoricoxibs farmakokinetik er lineær over det kliniske dosisspænd.
The pharmacokinetics of etoricoxib are linear across the clinical dose range.
Infektioner og infestationer Ikke-almindelig: Gastroenteritis, øvre luftvejsinfektion, urinvejsinfektion.
Infections and infestations: Uncommon: gastroenteritis, upper respiratory infection, urinary tract infection.
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).
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).
Antacida: Antacida påvirker ikke etoricoxibs farmakokinetik i klinisk relevant udstrækning.
Antacids: Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
Dosisjustering er ikke nødvendig hos patienter med creatininclearance ≥30 ml/min (se afsnit 5.2 ).
Renal insufficiency: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Lidelser i øjne: Ikke-almindelig: Sløret syn.
Eye disorders: Uncommon: blurred vision.
Der er set øvre gastrointestinale komplikationer [perforation, ulcera eller blødninger (PUB)], nogle med fatal udgang hos patienter behandlet med etoricoxib.
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib.
Ikke-almindelig: Proteinuri.
Uncommon: proteinuria.
Etoricoxib udskilles i rottemælk ved koncentrationer ca. 2 gange større end plasmakoncentrationer.
Etoricoxib is excreted in the milk of lactating rats at concentrations approximately two-fold those in plasma.
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.
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.
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.
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.
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.
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.
Hos rotter øgedes den gastrointestinale toxicitet af etoricoxib med dosis og doseringsstid.
In the rat, gastrointestinal toxicity of etoricoxib increased with dose and exposure time.
Filmovertrukken tablet
Film-coated tablet/tablet.
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.
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.
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).
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).
Væskeretention, ødem og hypertension
Fluid retention, oedema and hypertension
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.
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.
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).
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).
Lever- og galdevejslidelser: Meget sjælden: Hepatitis.
Hepatobiliary disorders: Very rare: hepatitis.
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.
Further revisions to the SPC will be promptly communicated to HCPs and promptly incorporated into printed materials and product websites.
I kliniske undersøgelser af akut arthritis urica blev etoricoxib doseret i 8 dage.
In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
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.
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.
Patienter der oplever svimmelhed, vertigo eller søvnighed, når de anvender <SÆRNAVN>, bør ikke køre bil eller betjene maskiner.
However, patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.
Køn Etoricoxibs farmakokinetik er sammenlignelig hos mænd og kvinder.
Gender: The pharmacokinetics of etoricoxib are similar between men and women.
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.
Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Hvis der er kliniske tegn på forværring i disse patienters tilstand, bør der tages relevante forbehold og behandlingen med etoricoxib bør seponeres.
If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
I en 14ugers toxicitetsundersøgelse forårsagede etoricoxib gastrointestinale ulcera ved eksponering til højere doser end den, der sås hos mennesker i terapeutiske doser.
In the 14-week toxicity study etoricoxib caused gastrointestinal ulcers at exposures greater than those seen in man at the therapeutic dose.
Behandlingen med etoricoxib, bør seponeres ved den første forekomst af hududslæt, slimhindeaffektioner eller andre tegn på overfølsomhed.
Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Monitorering bør foretages hos patienter med høj risiko for digoxintoksicitet ved samtidig administration af etoricoxib og digoxin.
However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Det anbefales at monitorere for methotrexat-relateret toksicitet når etoricoxib administreres samtidig med methotrexat.
Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly.
Dosis ved akut arthritis urica bør ikke overstige 120 mg dagligt, og behandlingen bør begrænses til at vare i højst 8 dage.
The dose for acute gout should not exceed 120mg daily, limited to a maximum of 8 days treatment.
Via Mazzini, 112 I-56125 Pisa Italien
Via Benedetto Croce, 37 I-56125 Pisa Italy
Tabletovertræk: Carnaubavoks, hypromellose, lactosemonohydrat, titandioxid (E171), glyceroltriacetat.
Tablet coating: Carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate.
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.
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.
Etoricoxib er indenfor det kliniske dosisområde en oral aktiv selektiv cyclo-oxygenase-2 (COX-2) hæmmer.
Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
Kendt hypersensitivitet over for den aktive substans eller et af hjælpestofferne i produktet (se afsnit
History of hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Tabletkerne: Calciumhydrogenfosfat (vandfri), croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose.
Core: Calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Gastrointestinal effekt
4.4 Special warnings and precautions for use
I en undersøgelse med raske frivillige, ændrede daglig administration af etoricoxib 120 mg ikke hepatisk CYP3A4-aktivitet, vurderet ved erythromycin-pustetest.
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.
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).
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).
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).
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).
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 %.
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%.
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).
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).
Forekomsten af kliniske gastrointestinale hændelser, som førte til tilbagetrækninger, var statistisk signifikant lavere for etoricoxib versus diclofenac (respektivt 7,1% versus 9,1%).
The incidence of clinical gastrointestinal events leading to withdrawal was statistically significantly lower for etoricoxib versus diclofenac (7.1% versus 9.1%, respectively).
Etoricoxib hæmmede ikke den gastriske prostaglandinsyntese og havde ingen effekt på thrombocytfunktionen.
Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function.
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.
* 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.
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.
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.
Merck Sharp & Dohme de Espana, S.A. c/ Josefa Valcarcel 38
Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38