FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Bulgarian: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske midler, ikke-steroider, koksiber.
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.
Bulgarian: 100%. Etter dosering av 120 mg en gang daglig til steady-state, ble maksimal plasmakonsentrasjon (geometrisk middelverdi Cmax = 3,6 µg/ml) observert etter ca.
English: Invented name
Bulgarian: som ble rapportert
English: The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Bulgarian: 50 ml/min etter en intravenøs dose på 25 mg.
English: Common: oedema/fluid retention Uncommon: appetite increase or decrease, weight gain.
Bulgarian: Mindre vanlige: nedsatt eller økt av appetitt, vektøkning.
English: Bottles: Keep the container tightly closed in order to protect from moisture.
Bulgarian: Boks: Boksen skal være godt lukket.
English: Respiratory, thoracic and mediastinal disorders: Uncommon: cough, dyspnoea, epistaxis.
Bulgarian: Sykdommer i respirasjonsorganer, thorax og mediastinum: Mindre vanlige: hoste, dyspné, neseblødning.
English: Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
Bulgarian: Alvorlige Hypersensitivitetsreaksjoner (som anafylakse og angioødem) har blitt rapportert hos pasienter
English: Psychiatric disorders:
Bulgarian: Psykiatriske lidelser:
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.
Bulgarian: som hemmer prostaglandinsyntesen, kan etorikoksib føre til nedsatt rieaktivitet og prematur lukking av ductus arteriosus i løpet av siste trimester.
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.
Bulgarian: Det bør utvises forsiktighet hos pasienter med tidligere hjertesvikt, venstre ventrikkeldysfunksjon eller hypertensjon, og hos pasienter
English: P.O Box 581
Bulgarian: ATC-kode: MO1 AH05
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Bulgarian: Filmdrasjert tablett.
English: Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction
Bulgarian: Hjertesykdommer: Mindre vanlige: kongestiv hjertesvikt, uspesifikke EKG-forandringer, hjerteinfarkt
English: Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Bulgarian: Det er ukjent om etorikoksib kan dialyseres ved peritoneal dialyse.
English: These interactions should be considered in patients taking etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists.
Bulgarian: som behandles med etorikoksib og ACEhemmere eller angiotensin II antagonist samtidig.
English: Uncommon: proteinuria.
Bulgarian: Mindre vanlig: proteinuri.
English: A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/day sodium diet. Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
Bulgarian: studie med parallelle grupper ble effekten av etorikoksib (90 mg), celekoksib (200 mg to ganger daglig), naproxen (500 mg to ganger daglig) og placebo evaluert etter 15 dagers behandling med hensyn på utskillelse av natrium i urinen, blodtrykk og andre parametre knyttet
English: It is not known whether etoricoxib is excreted in human milk.
Bulgarian: ikke kjent om etorikoksib utskilles i morsmelken hos mennesker.
English: Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Bulgarian: KVALITATIV OG KVANTITATIV SAMMENSETNING Hver filmdrasjerte tablett inneholder 60, 90 eller 120 mg etorikoksib.
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).
Bulgarian: Etorikoksib var ikke teratogen i reproduksjonstoksiske studier utført på rotter ved doser på 15 mg/kg/dag (dette representerer ca.
English: The effect of etoricoxib on the pharmacokinetics of other drugs
Bulgarian: Effekten av etorikoksib på andre legemidlers farmakokinetikk
English: In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Bulgarian: Cirka 3100 pasienter ble behandlet med ≥ 60 mg etorikoksib daglig i tolv uker eller lenger.
English: General
Bulgarian: Generelt
English: Effects of other drugs on the pharmacokinetics of etoricoxib
Bulgarian: Effekten av andre legemidler på farmakokinetikken til etorikoksib
English: Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Bulgarian: NSAIDs kan redusere effekten av diuretika og andre antihypertensive medikamenter.
English: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
Bulgarian: Etorikoksib kan brukes samtidig med acetylsalisylsyre når det gis doser
English: Characteristics in patients
Bulgarian: Forekomst av pasienter
English: An 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).
Bulgarian: En økning i etinyløstradiol-eksponering kan øke insidens av bivirkninger forbundet med orale antikonsepsjonsmidler (f.eks.
English: In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Bulgarian: Hos rotter og kaniner ble ingen fosterskadelige effekter sett ved systemisk eksponering som var lik eller mindre enn den daglige dosen hos mennesker (90 mg).
English: The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and
Bulgarian: ikke nødvendig å justere dosen for pasienter med kreatininclearance ≥ 30 ml/min (se 5.2 ). Bruk av etorikoksib hos pasienter med kreatininclearance < 30 ml/min er kontraindisert (se 4.3 og 4.4).
English: The major route of metabolism to form the 6'-hydroxymethyl derivative is catalyzed by CYP enzymes.
Bulgarian: substans. Det metaboliseres til 6'-hydroksymetylderivat, hovedsakelig katalysert av CYP-enzymer.
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).
Bulgarian: Ketokonazol: Ketokonazol, en potent hemmer av CYP3A4, dosert med 400 mg én gang daglig i 11 dager
English: The recommended dose is 30 mg once daily.
Bulgarian: Anbefalt dose er 60 mg en gang daglig.
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Bulgarian: til etorikoksib er sammenlignbar hos menn og kvinner.
English: If a woman becomes pregnant during treatment, etoricoxib must be discontinued.
Bulgarian: Behandling med etorikoksib bør avsluttes, hvis kvinnen blir gravid.
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI) and stroke), relative to placebo and some NSAIDs.
Bulgarian: selektive COX-2-hemmere kan være assosiert med en risiko for trombotiske hendelser (spesielt hjerteinfarkt og slag)
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Bulgarian: Leverinsuffisiens: Hos pasienter med svakt nedsatt leverfunksjon (Child-Pugh score 5-6) bør ikke dosen på 60 mg en gang daglig overstiges. Hos pasienter med moderat nedsatt leverfunksjon (ChildPugh score 7-9) er anbefalt dose 60 mg annenhver dag og den bør
English: Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function.
Bulgarian: Etorikoksib hemmet ikke prostaglandinsyntesen i magesekken, og hadde ingen effekt på blodplatefunksjonen.
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.
Bulgarian: Det anbefales å utvise forsiktighet ved behandling av pasienter med økt risiko for å utvikle gastrointestinale komplikasjoner med NSAIDs; eldre, pasienter
English: The dose for RA and ankylosing spondylitis should not exceed 90 mg daily The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
Bulgarian: Dosen ved urinsyregikt skal ikke overskride 120 mg daglig, begrenset
English: <Etoricoxib> Tablets should not be taken by children or adolescents under 16 years of age.
Bulgarian: Barn: Etorikoksib er kontraindisert hos barn og ungdom under 16 år.
English: Cardiovascular safety results:
Bulgarian: Kardiovaskulære data:
English: • rifampicin (an antibiotic)
Bulgarian: i kombinasjon med rifampicin (se 4.2).
English: Arcoxia
Bulgarian: Artrose
English: Etoricoxib may mask fever and other signs of inflammation.
Bulgarian: Etorikoksib kan maskere feber og andre
English: In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Bulgarian: Det ble imidlertid sett redusert fosteroverlevelse ved eksponeringer større enn eller lik 1,5 ganger den menneskelige eksponeringen.
English: The dose for OA should not exceed 60 mg daily
Bulgarian: som anbefales. Dosen ved artrose skal ikke overskride 60 mg daglig.
English: 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.
Bulgarian: sju dager ved administrasjon av 120 mg en gang daglig, med en akkumulasjonsratio på ca.
English: 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).
Bulgarian: sjelden blitt rapportert om alvorlige hudreaksjoner, noen av dem fatale, inkludert exfoliativ dermatitt, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse i sammenheng med bruk av NSAIDs og noen
English: Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis.
Bulgarian: signifikant nedsatt nyrefunksjon, ukompensert hjertesvikt eller cirrhose er spesielt utsatt.
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness.
Bulgarian: : Mindre vanlige: muskelkramper/-spasmer, smerter/stivhet i muskel/skjelett.
English: There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases.
Bulgarian: Det ble ikke rapportert om overdoser av etorikoksib i løpet av de kliniske studiene.
English: 6.1 List of excipients
Bulgarian: 6.1 Fortegnelse over hjelpestoffer
English: Etoricoxib is excreted in the milk of lactating rats.
Bulgarian: Etorikoksib skilles ut i melken hos diegivende rotter. Kvinner
English: Excipient:
Bulgarian: Karsykdommer:
English: The rates per hundred patient-years of confirmed complicated and uncomplicated upper GI clinical events (perforations, ulcers and bleeds (PUBs)) were 0.67 (95% CI 0.57, 0.77) with etoricoxib and 0.97 (95% CI 0.85, 1.10) with diclofenac, yielding a relative risk of 0.69 (95% CI 0.57, 0.83).
Bulgarian: Hyppigheten av alvorlige kardiovaskulære trombotiske hendelser var: 1,25 hendelser per 100 pasientår for etorikosib mot 1,15 hendelser per 100 pasientår for diklofenak (relativ risiko1,07; 95% CI: 0,65%, 1,74%).
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Bulgarian: 120 mg tabletter: Blekgrønne, epleformede, bikonvekse tabletter preget med "541" på den ene siden og "MSD" på den andre.
English: Very rare: hypertensive crisis.
Bulgarian: Mindre vanlige: rødming, cerebrovaskulær hendelse Svært sjeldne:hypertensiv krise.
English: Pack sizes of 7 and 28 tablets in blisters.
Bulgarian: i pakninger på 50 eller 100 tabletter.
English: 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%.
Bulgarian: samtidig eller med 12 timers mellomrom, viste en økning i steady-state AUC0-24 timer for etinyløstradiol på 50-60%.
English: Renal and urinary disorders:
Bulgarian: Sykdommer i nyre- og urinveier:
English: METHOD OF ADMINISTRATION Oral use.
Bulgarian: sammen orale antikonsepsjonsmiddelet
English: Caution should be used when initiating treatment with etoricoxib in patients with dehydration.
Bulgarian: som er dehydrert starter behandling med etorikoksib.
English: Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised.
Bulgarian: Klinisk erfaring er begrenset spesielt hos pasienter med moderat nedsatt leverfunksjon og forsiktighet bør utvises. Det finnes ingen klinisk erfaring hos pasienter med sterkt nedsatt leverfunksjon (ChildPugh score ≥10).
English: Paediatric patients
Bulgarian: Pasientfaktorer
English: <Etoricoxib containing medicinal products (see Annex I)> 30 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 60 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 90 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 120 mg film-coated tablets
Bulgarian: LEGEMIDLETS NAVN <INVENTED NAME> 60 mg filmdrasjerte tabletter <INVENTED NAME> 90 mg filmdrasjerte tabletter <INVENTED NAME> 120 mg filmdrasjerte tabletter
English: 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.
Bulgarian: som gis ved kardiovaskulær profylakse eller med andre NSAIDs, anbefales ikke.
English: POSSIBLE SIDE EFFECTS
Bulgarian: Mulig risiko under
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION [To be completed nationally.]
Bulgarian: MT-DATO FOR FØRSTE GANG/SISTE FORNYELSE
English: The Netherlands
Bulgarian: til ungene
English: In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
Bulgarian: Studier laget spesielt for å måle når effekten av etorikoksib inntrer, viste at effekten inntrådte
English: Cyclosporin and 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.
Bulgarian: ikke er studert med etorikoksib, kan samtidig bruk av ciklosporin eller takrolimus med enhver NSAID øke den nefrotoksiske effekten av ciklosporin eller takrolimus. Nyrefunksjonen bør overvåkes når etorikoksib og noen av disse legemidlene brukes samtidig.
English: 30mg
Bulgarian: 50 ml/min).
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.
Bulgarian: dehydrerte pasienter eller eldre pasienter med svekket nyrefunksjon) kan samtidig administrasjon av en ACE-hemmer eller angiotensin II antagonist og legemidler
English: 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).
Bulgarian: Derfor er etorikoksib kontraindisert hos disse pasientene (se 4.3, 4.4 og 5.2 ).
English: Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
Bulgarian: Pasienter med hypertensjon hvor blodtrykket ikke er tilfredsstillende kontrollert.
English: Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Bulgarian: Alle de aktive sammenligningspreparatene viste en økning i systolisk blodtrykk
English: In patients experiencing attacks of acute gouty arthritis, etoricoxib 120 mg once daily over an eight-day treatment period, relieved moderate to extreme joint pain and inflammation comparable to indomethacin 50 mg three times daily.
Bulgarian: som fikk akutt urinsyregiktanfall opplevde at etorikoksib 120 mg en gang daglig i en åttedagers behandlingsperiode ga en lindring av moderate
English: The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
Bulgarian: som hemmer COX-2, cyclooksygenase/prostaglandin syntesen, anbefales ikke bruk av etorikoksib hos kvinner
English: There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or nonnaproxen NSAIDs.
Bulgarian: som fikk ≥ 60 mg etorikoksib, placebo eller naproksen-frie NSAIDs.
English: 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60' on one side and ‘200' on the other.
Bulgarian: 60 mg tabletter: Grønne, epleformede, bikonvekse tabletter preget med "447" på den ene siden og "MSD" på den andre.
English: OTHER
Bulgarian: Forskjellen
English: Efficacy
Bulgarian: Svært
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.
Bulgarian: som veide 4060 kg gitt 60 mg etorikoksib en gang daglig, og ungdommer > 60 kg ble gitt 90 mg etorikoksib en gang daglig.
English: • if you have serious kidney disease
Bulgarian: Dersom det foreligger kliniske bevis på forverret
English: Skanstes 13
Bulgarian: VEDLEGG III PREPARATOMTALE
English: There was no significant difference between etoricoxib and diclofenac in the rate of complicated events.
Bulgarian: Det var ingen statistisk signifikante forskjeller mellom etorikoksib og placebo.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Bulgarian: ikke avsluttes (se pkt.
English: Aluminum/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Bulgarian: Aluminium/aluminiumblister i pakninger
English: Uncommon: anxiety, depression, mental acuity decreased.
Bulgarian: Mindre vanlige: angst, depresjon, nedsatt mental klarhet/årvåkenhet. Svært sjeldne: forvirring, hallusinasjoner.
English: It may also cause inflammation in other areas of the body.
Bulgarian: Det var en reduksjon i kroppsvekten
English: 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.
Bulgarian: ikke steady-state plasma AUC0-24timer eller renal eliminasjon av digoksin.
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).
Bulgarian: som var stabilisert på langvarig warfarinbehandling, resulterte administrering av 120 mg etorikoksib daglig i ca.
English: The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
Bulgarian: 7100 pasienter med artrose ble gastrointestinal toleranse av etorikoksib 90 mg (1,5 ganger den anbefalte OA dose) sammenlignet med diklofenak 150 mg.
English: In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Bulgarian: Det var omtrent 50% risikoreduksjon for disse endepunktene hos pasienter behandlet med etorikoksib (60, 90 eller 120 mg daglig) sammenlignet med pasienter behandlet med naproxen 500 mg to ganger daglig eller diklofenak 50 mg tre ganger daglig.
English: 6.6 Special precautions for disposal No special requirements.
Bulgarian: 6.6 Instruksjoner vedrørende bruk og håndtering Ingen
English: Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Bulgarian: tegn som tyder på leverdysfunksjon, eller
English: The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Bulgarian: i de kombinerte studiene for pasienter med OA, RA og kroniske smerter i korsryggen.
English: Additional Thrombotic Cardiovascular Safety Data
Bulgarian: Gastrointestinale og kardiovaskulære sikkerhetsdata er sammenfattet under.
English: Vascular disorders:
Bulgarian: Orale antikoagulasjonsmidler:
English: Eye disorders: Uncommon: blurred vision, conjunctivitis.
Bulgarian: Øyesykdommer: Mindre vanlige: tåkesyn.
English: This increase is not generally important for most patients.
Bulgarian: Hyppigheten av disse lidelsene var likevel høyere hos pasienter
English: Etoricoxib is excreted in the milk of lactating rats at concentrations approximately two-fold those in plasma.
Bulgarian: Etorikoksib utskilles i melk hos diegivende rotter i konsentrasjoner
English: In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
Bulgarian: som avbrøt behandlingen på grunn av ødem, var 0,9% for etorikoksib mot 0,7% for diklofenak.
English: Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepaticrelated adverse experiences than diclofenac.
Bulgarian: Leverbivirkninger: Etorikoksib ble assosiert med statistisk signifikant lavere hyppighet i avbrudd av behandlingen enn diklofenak (0,3% mot 5,2%) på grunn av forhøyede leverfunksjonstester.
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 30, 60 and 90 mg daily.
Bulgarian: tre eller flere ganger høyere enn øvre normalgrense) er rapportert hos cirka 1 % av pasientene
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
Bulgarian: tilstand hos disse pasientene, bør det settes i gang hensiktsmessige tiltak, inkludert
English: Confirmed Thrombotic Cardiovascular Serious Adverse Events Per-protocol
Bulgarian: i hyppigheten av alvorlige trombotiske kardiovaskulære forstyrrelser mellom pasienter