natgillin/translations-raw huggingface dataset:
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).
5. 1).
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration (see section 5.1).
På grund af deres manglende antithrombotiske virkning kan selektive COX- 2 hæmmere ikke erstatte acetylsalicylsyre som profylakse for kardiovaskulær thromboembolisk sygdom.
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.
4. 5 og 5. 1).
Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1.).
Renal effekt Renale prostaglandiner kan spille en kompensatorisk rolle i opretholdelse af renal perfusion.
Renal effects Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Væskeretention, ødem og hypertension Som med andre lægemidler der hæmmer prostaglandinsyntesen, er der set væskeretention, ødem og hypertension hos patienter i behandling med etoricoxib.
Fluid retention, oedema and hypertension As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
Alle nonsteroide antiinflammatoriske midler (NSAID), herunder etoricoxib, kan associeres med debut af eller tilbagevendende venstresidigt
All Nonsteroidal Antiinflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure.
5. 1 angående information om dosisrelateret respons på etoricoxib.
For information regarding a dose related response for etoricoxib see section 5.1.
Etoricoxib er muligvis forbundet med en hyppigere forekomst af og mere alvorlig hypertension end visse andre NSAID og selektive COX- 2 hæmmere, især ved høje doser.
Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses.
4. 3), og der bør udvises særlig opmærksomhed på monitorering af blodtrykket under behandling med etoricoxib.
Therefore, hypertension should be controlled before treatment with etoricoxib (see section 4.3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib.
1% af patienterne i kliniske undersøgelser, behandlet i op til 1 år med etoricoxib 30, 60 eller 90 mg dagligt.
Hepatic effects 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 30, 60 and 90 mg daily.
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.
Generelt 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.
General 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 opretholdes medicinsk relevant supervision, når etoricoxib anvendes til ældre patienter og til patienter med nyre -, lever - eller hjertedysfunktion.
Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.
Det tilrådes at rehydrere patienterne, inden etoricoxib- behandling påbegyndes.
It is advisable to rehydrate patients prior to starting therapy with etoricoxib.
I forbindelse med brugen af NSAID og nogle selektive COX- 2 hæmmere er der efter markedsføringen meget sjældent indberettet alvorlige hudreaktioner, nogle af dem fatale, inklusive exfoliativ dermatitis, Stevens- Johnson syndrom og toksisk epidermisk nekrolyse (se pkt.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance (see section 4.8).
Disse reaktioner optræder i de fleste tilfælde inden for den første måned af behandlingen.
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.
4. 8).
Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
Nogle selektive COX- 2 hæmmere er blevet sat i forbindelse med øget risiko for hudreaktioner hos patienter med enhver form for lægemiddelallergi i anamnesen.
Some selective COX- 2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
4. 5).
Caution should be exercised when co-administering etoricoxib with warfarin or other oral anticoagulants (see section 4.5).
4. 6, 5. 1 og 5. 3).
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).
ARCOXIA- tabletterne indeholder lactose..
14< ARCOXIA > tablets contain lactose.
Patienter med sjældne, arvelige problemer med galaktoseintolerans, lappisk laktasemangel eller glucose- galaktose malabsorption bør ikke tage denne medicin.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
16 Orale antikoagulantia:
Oral anticoagulants:
13% stigning i protrombin- tid (International Normalised Ratio, INR).
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).
4. 4).
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed (see section 4.4).
Diuretika, ACE- hæmmere og angiotensin- II- receptorantagonister:
Diuretics, ACE inhibitors and Angiotensin II Antagonists:
NSAID kan reducere effekten af diuretika og andre antihypertensiva.
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Dette er sædvanligvis reversibelt.
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.
Disse interaktioner bør tages i betragtning hos patienter, som tager etoricoxib samtidig med ACE- hæmmere eller angiotensin- II- receptorantagonister.
These interactions should be considered in patients taking etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists.
Acetylsalicylsyre:
Acetylsalicylic Acid:
I en undersøgelse med raske frivillige, havde etoricoxib 120 mg én gang dagligt, ved steady- state ingen effekt på den anti- thrombotiske effekt af acetylsalicylsyre (81 mg én gang dagligt).
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).
Etoricoxib kan anvendes samtidig med acetylsalicylsyre i doser anvendt til kardiovaskulær profylakse (lav- dosis acetylsalicylsyre).
Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
Samtidig administration af lav- dosis acetylsalicylsyre og etoricoxib kan dog medføre øget risiko for GI- ulceration eller andre komplikationer sammenlignet med anvendelse af etoricoxib alene.
However, concomitant administration of low-dose acetylsalicylic acid with etoricoxib may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone.
5. 1 og 4. 4).
Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended (see sections 5.1 and 4.4.).
Ciclosporin og tacrolimus:
Cyclosporin and tacrolimus:
Selvom denne interaktion ikke er undersøgt med etoricoxib, kan samtidig administration af ciclosporin eller tacrolimus og et hvilket som helst NSAID øge den nefrotoksiske effekt af ciclosporin eller tacrolimus.
Although this interaction has not been studied with etoricoxib, coadministration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus.
NSAID nedsætter udskillelsen af lithium i nyrerne og kan derfor øge plasmakoncentrationen af lithium.
NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Methotrexat:
Methotrexate:
Der er udført 2 undersøgelser af effekten af etoricoxib 60, 90 og 120 mg, administreret 1 gang dagligt i 7 dage til patienter, der fik methotrexat 1 gang ugentligt i doser på 7, 5- 20 mg for rheumatoid arthritis.
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.
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.
Oral antikonception:
Oral contraceptives:
Ved samtidig indtagelse af etoricoxib 60 mg og et oralt antikonceptionsmiddel, som indeholder 35 mikrogram ethinyløstradiol (EØ) og 0, 5- 1 mg norethindron i 21 dage øgedes steady- state AUC0- 24t af EØ med 37%.
Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Etoricoxib 120 mg, som blev givet, enten samtidig med eller 12 timer forskudt, med det samme orale antikonceptionsmiddel, øgede steady- state AUC0- 24t af EØ med 50 - 60%.
Etoricoxib 120 mg given with the same oral contraceptive concomitantly or separated by 12 hours, increased the steady state AUC0-24hr of EE by 50 to 60%.
Denne øgning af EØ- koncentrationen bør overvejes, når der vælges oral antikonception til anvendelse sammen med etoricoxib.
This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib.
En øgning i EØ- eksponering kan øge bivirkningsfrekvensen i forbindelse med oral antikonception (f. eks. venøse thromboemboliske tilfælde hos kvinder i risikogruppen).
An 15 increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e. g., venous thrombo-embolic events in women at risk).
17 Hormonsubstitutionsbehandling:
Hormone Replacement Therapy (HRT):
Anvendelse af etoricoxib 120 mg sammen med hormonsubstitutionsbehandling bestående af konjugerede østrogener (0, 625 mg PremarinTM), i 28 dage, øgede den gennemsnitlige steady- state AUC0- 24t af ukonjugeret estron (41%), equilin (76%) og 17- ß- østradiol (22%).
Administration of etoricoxib 120 mg with hormone replacement therapy consisting of conjugated estrogens (0.625 mg PREMARINTM) for 28 days, increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-β -estradiol (22%).
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.
The effects of etoricoxib 120 mg on the exposure (AUC0-24hr) to these estrogenic components of PREMARIN were less than half of those observed when PREMARIN was administered alone and the dose was increased from 0.625 to 1.25 mg.
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 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.
I lægemiddelinteraktionsundersøgelser påvirkede etoricoxib ikke farmakokinetikken af prednison/ prednisolon i klinisk betydelig grad.
In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/ prednisolone.
Etoricoxib 120 mg, administreret én gang dagligt i 10 dage til raske frivillige, ændrede ikke steady- state plasma AUC0- 24t eller renal elimination af 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.
33%).
There was an increase in digoxin Cmax (approximately 33%).
Det er vigtigt at udvise forsigtighed, når etoricoxib administreres samtidig med andre lægemidler, der primært metaboliseres af humane sulfotransferaser (f. eks. oral salbutamol og minoxidil).
While knowledge about effects of multiple sulfotransferases is presently limited and the clinical consequences for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e. g., oral salbutamol and minoxidil).
Etoricoxibs effekt på lægemidler, der metaboliseres via CYP- isoenzymer
Effect of etoricoxib on drugs metabolised by CYP isoenzymes
Baseret på in vitro- undersøgelser 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.
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.
Etoricoxibs primære metaboliseringsvej er afhængig af CYP- enzymer.
The main pathway of etoricoxib metabolism is dependent on CYP enzymes.
In vitro- undersøgelser indikerer, at CYP2D6, CYP2C9, CYP1A2 og CYP2C19 også kan katalysere den primære metaboliseringsvej, men deres kvantitative roller in vivo er ikke undersøgt.
In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles have not been studied in vivo.
Når ketoconazol, der er en potent hæmmer af CYP3A4, blev givet i doser à 400 mg én gang dagligt i 11 dage til raske frivillige, havde det ingen klinisk relevant effekt på farmakokinetikken for etoricoxib 60 mg én gang dagligt (43% stigning af AUC).
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).
Samtidig administration af etoricoxib og rifampicin, en potent CYP- enzyminduktor, medførte et fald på 65% i etoricixibs plasmakoncentration.
Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations.
4. 2).
While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
Antacida påvirker ikke etoricoxibs farmakokinetik i klinisk relevant udstrækning.
Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
18 4. 6 Graviditet og amning
16 4.6 Pregnancy and lactation
Graviditet Etoricoxib kan, ligesom andre COX- 2 hæmmende lægemidler, ikke anbefales til kvinder, der forsøger at blive gravide.
The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
4. 3).
Etoricoxib is contraindicated in pregnancy (see section 4.3).
Amning Det vides ikke, om etoricoxib udskilles i modermælk.
It is not known whether etoricoxib is excreted in human milk.
4. 3 og 5. 3).
Women who use etoricoxib must not breast feed (see sections 4.3 and 5.3).
600 patienter med OA eller RA blev behandlet i 1 år eller mere).
In clinical trials, etoricoxib was evaluated for safety in 7152 individuals, including 4614 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).
I et kardiovaskulært "safety outcomes" - program med poolede data fra tre aktive komparatorkontrollerede undersøgelser blev 17. 412 patienter med OA eller RA behandlet med etoricoxib (60 mg eller 90 mg) i en gennemsnitlig periode på ca.
In a cardiovascular safety outcomes program of pooled data from three active comparator controlled trials, 17, 412 patients with OA or RA were treated with etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months.
5. 1.
The safety data and details from this program are presented in section 5.1.
Følgende lægemiddelrelaterede bivirkninger er i kliniske undersøgelser, i MEDAL- undersøgelserne eller efter markedsføring rapporteret med højere incidens end for placebo hos patienter med OA, RA kroniske lændesmerter eller ankylosis spondylitis i behandling med etoricoxib 60 mg eller 90 mg i op til 12 uger.
The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks, or in the MEDAL Program studies, or in post-marketing experience:
[Meget almindelig (≥1/ 10), Almindelig (> 1/ 100 til < 1/ 10), Ikke- almindelig (> 1/ 1000 til < 1/ 100), Sjælden (> 1/ 10. 000 til < 1/ 1000), Meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
[Very Common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)]
Gastroenteritis, øvre luftvejsinfektion, urinvejsinfektion.
Uncommon: gastroenteritis, upper respiratory infection, urinary tract infection.
Meget sjælden:
Immune system disorder:
Overfølsomhedsreaktioner omfattende angioødem, anafylaktiske/ anafylaktoide reaktioner, herunder shock.
Very rare: hypersensitivity reactions, including angioedema, anaphylactic/ anaphylactoid reactions including shock.
Ændring af appetit, vægtøgning.
17 Common: oedema/ fluid retention Uncommon: appetite increase or decrease, weight gain.
Angst, depression, nedsat koncentration.
Uncommon: anxiety, depression, mental acuity decreased.
Konfusion, hallucinationer.
Very rare: confusion, hallucinations.
Almindelig:
Nervous system disorder:
Ikke almindelig:
Common: dizziness, headache.
Smagsforstyrrelser, søvnløshed, paræstesi/ hypæstesi, somnolens.
Uncommon: dysgeusia, insomnia, paresthaesia/ hypaesthesia, somnolence.
Sløret syn, conjunctivitis.
Uncommon: blurred vision, conjunctivitis.
Ikke almindelig:
Ear and labyrinth disorders:
Tinnitus, vertigo.
Uncommon: tinnitus, vertigo.
Ikke almindelig:
Common: palpitations.
Atrieflimren, venstresidig hjerteinsufficiens, uspecifikke EKG- forandringer, myokardieinfarkt∗.
Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction∗.
Hypertension.
Common: hypertension.
Rødmen, cerebrovaskulære tilfælde *, forbigående iskæmisk anfald.
Uncommon: flushing, cerebrovascular accident∗, transient ischaemic attack.
Hypertensiv krise.
Very rare: hypertensive crisis.
Ikke almindelig:
Respiratory, thoracic and mediastinal disorders:
Hoste, dyspnø, epistaxis.
Uncommon: cough, dyspnoea, epistaxis.
Bronchospasmus.
Very rare: bronchospasm.
Ikke almindelig:
Common: gastrointestinal disorders (e. g., abdominal pain, flatulence, heartburn), diarrhea, dyspepsia, epigastric discomfort, nausea.
Meget sjælden:
Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Peptisk ulcera inklusive gastrointestinal perforation og blødning (hovedsageligt hos ældre).
Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Hepatitis.
Very rare: hepatitis.
Almindelig:
Common: ecchymosis.
Ikke almindelig:
Uncommon: facial oedema, pruritus, rash.
Ansigtsødem, pruritus, udslæt.
Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Meget sjælden:
Musculoskeletal, connective tissue and bone disorders:
Urticaria, Steven- Johnsons syndrom, toksisk epidermisk nekrolyse.
Uncommon: muscular cramp/ spasm, musculoskeletal pain/ stiffness.
∗ 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 myokardie - infarkt og stroke.
* 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.
Ikke almindelig:
18 Uncommon: proteinuria.
4. 4).
Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Almindelige symptomer og reaktioner administrationsstedet:
General disorders and administration site conditions:
Asteni/ træthed, influenzalignende symptomer.
Common: asthenia/ fatigue, flu-like disease.
Ikke almindelig:
Uncommon: chest pain.
Ikke almindelig:
ALT increased, AST increased.
Øget serum carbamid, øget creatininkinase, fald i hæmatokrit, fald i hæmoglobin, hyperkalæmi, fald i leukocyttal, fald i thrombocyttal, øget serum creatinin, øget urinsyre.
Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
Nedsat natrium i blodet.
Rare: blood sodium decreased.
Nefrotoksicitet, herunder interstitiel nefritis og nefrotisk syndrom; hepatotoksicitet, herunder leversvigt, icterus og pancreatitis.
The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome; hepatotoxicity including hepatic failure, jaundice and pancreatitis.
I kliniske undersøgelser resulterede administration af enkeltdoser etoricoxib på op til 500 mg og gentagne doser på op til 150 mg/ dag i 21 dage ikke i signifikant toksicitet.
In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/ day for 21 days did not result in significant toxicity.
De hyppigst observerede bivirkninger var i overensstemmelse med etoricoxibs sikkerhedsprofil (f. eks. gastrointestinale hændelser, kardiorenale hændelser).
The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e. g. gastrointestinal events, cardiorenal events).