FrancophonIA/ELRC3.0 huggingface dataset:
English: Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/spasm, muscle pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression,
Maltese: Nefħa fl-istonku jew fl-imsaren, uġigħ fis-sider, kollass tal-qalb, attakk tal-qalb, puplesija, puplesija ħafifa (attakk iskemiku temporanju), rittmu tal-qalb anormali (fibrillazzjoni atrijali), infezzjoni filparti respiratorja ta' fuq, livelli għoljin ta' potassju f'demmek, tibdil fit-testijiet tad-demm u ta' lawrina relatat mal-kliewi tiegħek, tibdil fil-mod kif jaħdmu l-imsaren inkluż stitikezza, ħalq xott, ulċeri tal-ħalq, tibdil fit-togħma, gastroenterite, gastrite, ulċera fl-istonku, tħossok ma tiflaħx (rimettar), is-sindrome ta' l-imsaren irritabbli, infjammazjoni ta' l-esofagu, viżta mċajpra, irritazzjoni u ħmura ta' l-għajn, fsada fl-imnieħer, ċempil fil-widnejn, vertiġini, żieda jew tnaqqis fl-aptit, żieda fil-piż, bugħawwiġ/spażmi fil-muskoli, uġigħ/ebusija fil-muskoli, inabilità biex torqod, ħedla, tirżih jew tagħrix, ansjetà, dipressjoni, tnaqqis fil-prontezza mentali, nuqqas ta' nifs, sogħla, nefħa tal-wiċċ, ħmura fil-wiċċ, raxx tal-ġilda jew ħakk fil-ġilda, infezzjoni fil-passaġġ urinarju.
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.
Maltese: Studju bi grupp parallel, ikkontrollat bi plaċebo, double-blind, randomizzat evalwa l-effetti ta' 15-il jum ta' kura ta' etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) u plaċebo fuq ittneħħija ma' l-awrina tas-sodju, pressjoni tad-demm, u parametric oħrajn tal-funzjoni renali f'suġġetti ta' bejn 60 u 85 sena fuq dieta ta' sodju ta' 200-mEq/kuljum.
English: MEDAL Program Gastrointestinal Safety Results:
Maltese: Ir-Riżultati tas-Sigurtà Gastrointestinali tal-Programm MEDAL:
English: The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent) and indigo carmine lake (E132, colouring agent).
Maltese: Il-pilloli ta' 30-, 60- u 120- mg fihom ukoll ferric oxide isfar (E172, kolorant) u carmine lake indigo (E132, kolorant).
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Maltese: Etoricoxib huwa kontraindikat matul it-tqala (ara sezzjoni 4.3).
English: Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Maltese: Iż-żewġ proċeduri ta' referenza kellhom x'jaqsmu mas-sigurtà talprodotti inibituri COX-2, inkluż etoricoxib, b'fokus partikolari fuq is-sigurtà gastrointestinali (GI) u kardjovaskulari (KV).
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Maltese: Id-differenza flattività kontra l-pjastrini bejn xi NSAIDs li jinibixxu COX-1 u inibituri COX-2 selettivi tista' tkun ta' sinjifikat klinikali f'pazjenti f'riskju ta' episodji trombo-emboliċi.
English: Aluminum/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Maltese: Folji ta' l-aluminju/aluminju (dożi singoli) f'pakketti li fihom 50 jew 100 pillola.
English: None of these metabolites inhibit COX-1.
Maltese: Ebda minn dawn il-metaboliti ma jinibixxu COX-1.
English: The geometric mean area under the curve (AUC0-24hr) was 37.8 µg•hr/ml.
Maltese: L-erja medja ġeometrika taħt il-kurva (AUC0-24hr) kienet 37.8 µg•hr/ml.
English: • diuretics (water tablets)
Maltese: • dijuretiċi (pilloli ta' l-ilma)
English: Five metabolites have been identified in man.
Maltese: Ħames metaboliti ġew identifikati fil-bniedem.
English: All active comparators showed an increase relative to placebo with respect to systolic blood pressures; however, etoricoxib was associated with a statistically significant increase at Day 14 when compared to celecoxib and naproxen (mean change from baseline for systolic blood pressure: etoricoxib 7.7 mmHg, celecoxib 2.4 mmHg, naproxen 3.6 mmHg).
Maltese: Il-komparaturi attivi kollha wrew żieda meta mqabbla ma' plaċebo fir-rigward ta' pressjonijiet sistoliċi fid-demm; madankollu, etoricoxib kien assoċjat ma' żieda statistikament sinjifikanti f'Jum 14 meta mqabbel ma' celecoxib u naproxen (bidla medja mil-linja bażi għal pressjoni sistolika tad-demm: etoricoxib 7.7 mmHg, celecoxib 2.4 mmHg, naproxen 3.6 mmHg).
English: There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Maltese: Ma kien hemm ebda differenza sinjifikanti bejn etoricoxib u diclofenac fir-rata ta' episodji trombotiċi kardjovaskulari.
English: Etoricoxib has not been shown to cause hepatic CYP3A enzyme induction in humans.
Maltese: Etoricoxib ma ntweriex li jikkawża induzzjoni ta' enzim CYP3A epatiku filbniedem.
English: Uncommon: flushing, cerebrovascular accident
Maltese: Mhux komuni: fwawar, aċċident ċerebrovaskulari
English: Events per 100 Patient-Years; CI=confidence interval N=total number of patients included in Per-protocol population
Maltese: Episodji għal kull 100 Pazjent-Sena; CI=intervall ta' fiduċja N=numru totali ta' pazjenti nklużi fil-popolazzjoni Per-protokoll
English: Cardiovascular safety results:
Maltese: Riżultati tas-sigurtà kardjovaskulari:
English: Respiratory, thoracic and mediastinal disorders: Uncommon: cough, dyspnoea, epistaxis.
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: sogħla, dispnea, epistassi.
English: MEDAL Program Hepatic Safety Results:
Maltese: Ir-Riżultati tas-Sigurtà Epatika tal-Programm MEDAL:
English: Route of adminitration
Maltese: Episodji Avversi
English: Very Rare (occurring in less than 1 out of 10,000 people)
Maltese: Rari Ħafna (li jseħħu f'inqas minn persuna 1 minn kull 10,000)
English: Etoricoxib is extensively metabolised with <1% of a dose recovered in urine as the parent drug.
Maltese: Etoricoxib huwa metabolizzat b'mod estensiv b'<1% tad-doża rkuprata fl-awrina bħala l-mediċina prinċipali.
English: Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Maltese: Prostaglandini renali jista' jkollhom rwol kumpensatorju fiż-żamma ta' perfużjoni renali.
English: Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva (bħal anafilassi u anġjoedema) ġew irrapportati f'pazjenti li jirċievu etoricoxib (ara sezzjoni 4.8).
English: The EDGE and EDGE II studies compared the gastrointestinal tolerability of etoricoxib versus diclofenac.
Maltese: L-istudji EDGE u EDGE II qabblu t-tollerabilità gastrointestinali ta' etoricoxib kontra diclofenac.
English: 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.
Maltese: Fi studji kliniċi, l-għoti ta' dożi singoli ta' etoricoxib sa 500 mg u dożi multipli sa 150 mg/jum għal 21 ġurnata ma rriżultawx f'tossiċità sinjifikanti.
English: • birth control pills
Maltese: • pilloli ta' kontroll tat-twelid
English: COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Maltese: Inibituri selettivi COX-2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta' mard tromboemboliku kardjovaskulari minħabba n-nuqqas ta' effett anti-pjastrini tagħhom.
English: 60, 90, 120 mg: Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets in blisters; or 30 and 90 tablets in bottles.
Maltese: Daqsijiet tal-pakketti ta' 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 jew 100 pillola f'folji; jew 30 u 90 pillola fi fliexken.
English: Table 1: Rates of Confirmed Thrombotic CV Events (Pooled MEDAL Program) Etoricoxib (N=16819) 25836 PatientYears
Maltese: Etoricoxib (N=16819) 25836 PazjentSnin
English: Very rare: peptic ulcers including gastrointestinal perforation and bleeding (mainly in the elderly).
Maltese: Rari ħafna: ulċeri peptiċi inkluż perforazzjoni gastrointestinali u fsada (prinċipalment fl-anzjani).
English: In the individual MEDAL Program studies, for etoricoxib (60 mg or 90 mg), the absolute incidence of discontinuation in any treatment group was up to 2.6% for hypertension, up to 1.9% for edema, and up to 1.1% for congestive heart failure, with higher rates of discontinuation observed with etoricoxib 90 mg than etoricoxib 60 mg.
Maltese: Fl-istudji tal-Programm MEDAL individwali, għal etoricoxib (60 mg jew 90 mg), l-inċidenza assoluta ta' waqfien fi kwalunkwe grupp ta' kura kien sa 2.6% għal pressjoni għolja, sa 1.9% għal edema, u sa 1.1% għal kollass konġestiv tal-qalb, b'rati ogħla ta' waqfien osservati b'etoricoxib 90 mg milli b'etoricoxib 60 mg.
English: The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Maltese: Id-deċiżjoni jekk għandux jiġi preskritt inibitur selettiv COX-2 għandha tkun ibbażata fuq valutazzjoni tar-riskji ġenerali tal-pazjenti individwali (ara sezzjonijiet 4.3, 4.4).
English: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1, and has been shown to increase the serum concentrations of ethinyl estradiol.
Maltese: Etoricoxib huwa inibitur ta' l-attività ta' sulfotransferase umana, b'mod partikolari SULT1E1, u ntwera li jżid il-konċentrazzjonijiet tas-serum ta' ethinyl estradiol.
English: Czech Rep.
Maltese: Ir-Rep.
English: Common: gastrointestinal disorders (e.g., abdominal pain, flatulence, heartburn), diarrhea, dyspepsia, epigastric discomfort, nausea.
Maltese: Komuni: disturbi gastrointestinali (eż. uġigħ addominali, gass, ħruq ta' stonku, dijarea, dispepsija, skumdità epigastrika, nawseja.
English: Uncommon: facial oedema, pruritus, rash.
Maltese: Mhux komuni: edema fil-wiċċ, prurite, raxx.
English: • minoxidil (a drug used to treat high blood pressure)
Maltese: • minoxidil (mediċina wżata biex tikkura pressjoni tad-demm għolja)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għallglucose, Lapp lactase deficiency jew assorbiment ħażin ta' glucose-galactose ma għandhomx jieħdu din il-mediċina.
English: Effect of etoricoxib on drugs metabolised by CYP isoenzymes
Maltese: L-effett ta' etoricoxib fuq mediċini metabolizzati minn isoenzimi CYP
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Maltese: COX-2 ġiet identifikata fit-tessut madwar ulċeri gastriċi filbniedem iżda r-relevanza tagħha għall-fejqan mill-ulċeri għadha ma ġietx stabbilita.
English: • methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis)
Maltese: • methotrexate (mediċina użata għat-trażżin tas-sistema immunitarja, u spiss użata f'artrite rewmatojde)
English: Across clinical pharmacology studies, <ARCOXIA> produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Maltese: Tul studji farmakoloġiċi kliniċi, <ARCOXIA> ipproduċa inibizzjoni dipendenti fuq id-doża ta' COX2 mingħajr inibizzjoni ta' COX-1 f'dożi ta' mhux aktar minn 150 mg kuljum.
English: The incidence of congestive heart failure adverse events (discontinuations and serious events) occurred at similar rates on etoricoxib 60 mg compared to diclofenac 150 mg but was higher for etoricoxib 90 mg compared to diclofenac 150 mg (statistically significant for 90 mg etoricoxib vs. 150 mg diclofenac in MEDAL OA cohort).
Maltese: L-inċidenza ta' episodji avversi ta' kollass konġestiv tal-qalb (twaqqif u episodji serji) seħħew f'rati simili fuq etoricoxib 60 mg meta mqabbel ma' diclofenac 150 mg iżda kienet ogħla għal etoricoxib 90 mg meta mqabbel ma' diclofenac 150 mg (statistikament sinjifikanti għal 90 mg etoricoxib vs. 150 mg diclofenac fil-ko-orti OA ta' MEDAL).
English: The EDGE II study included 4086 RA patients treated with etoricoxib 90 mg daily or diclofenac 150 mg daily for a mean period of 19.2 months (maximum 33.1 months, median 24 months).
Maltese: L-istudju EDGE II inkluda 4086 pazjent RA ikkurati b'etoricoxib 90 mg kuljum jew diclofenac 150 mg kuljum għal perjodu medju ta' 19.2 xahar (massimu ta' 33.1 xhur, medjan ta' 24 xahar).
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Maltese: Mhux komuni: distensjoni addominali, rifluss aċiduż, tibdil fil-mod kif jaħdmu l-imsaren, stitikezza, ħalq xott, ulċera gastroduwodenali, sindrome ta' imsaren irritabbli, esofaġite, ulċera fil-ħalq, rimettar, gastrite.
English: Confirmed Thrombotic Cardiovascular Serious Adverse Events Per-protocol
Maltese: Kardjovaskulari Trombotiċi Kkonfermati Serji Per-protokoll
English: In March 2006, the marketing authorisation holders (MAH) for Arcoxia (etoricoxib) submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Maltese: F'Marzu 2006, id-detenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għal Arcoxia (etoricoxib) issottomettew applikazzjoni biex jestendu l-indikazzjoni liċenzjata biex tinkludi ttrattament ta' spondilite ankilosanti (AS), f'doża ta' kuljum irrakkomandata ta' 90mg.
English: The MEDAL Study, was an endpoint driven CV Outcomes study in 17,804 OA and 5,700 RA patients treated with etoricoxib 60 (OA) or 90 mg (OA and RA) or diclofenac 150 mg daily for a mean period of 20.3 months (maximum of 42.3 months, median 21.3 months).
Maltese: L-Istudju MEDAL, kien studju tar-riżultati CV immexxi minn punt ta' tmiem fi 17,804 pazjenti OA u 5,700 pazjent RA ikkurati b'etoricoxib 60 (OA) jew 90 mg (OA u RA) jew diclofenac 150 mg kuljum għal perjodu medju ta' 20.3 xahar (massimu ta' 42.3 xahar, medjan ta' 21.3 xahar).
English: Paediatric patients: The pharmacokinetics of etoricoxib in paediatric patients (<12 years old) have not been studied.
Maltese: Il-farmakokinetiċi ta' etoricoxib f'pazjenti pedjatriċi (<12-il sena) ma ġewx studjati.
English: The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Maltese: Fis-26 ta' Ġunju 2008 is-CHMP ikkonkluda li d-dejta tikkonferma l-profil ta' sigurtà renovaskulari relattivament avvers magħruf ta' etoricoxib (ipertensjoni, edema u falliment konġestiv tal-qalb), iżda riskju trombotiku KV simili għal dak ta' diclofenac u ċertu grad ta' vantaġġ ta' sigurtà tal-parti GI ta' fuq, fuq naproxen u diclofenac (iżda l-ebda vantaġġ ta' sigurtà partikolari tal-parti GI t'isfel).
English: Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Luxembourg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Malta
Maltese: Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės Il-Lussemburgu Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Malta
English: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
Maltese: Etoricoxib jista' jintuża fl-istess ħin ma' acetylsalicylic acid f'dożi użati għal profilassi kardjovaskulari (acetylsalicylic acid ta' doża baxxa).
English: Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.
Maltese: Pazjenti b'malfunzjonament moderat tal-fwied (skor ta' Child-Pugh 7-9) mogħtijin etoricoxib 60 mg darba iva u darba le kellhom AUC medju simili għal dak ta' suġġetti b'saħħithom li ngħataw etoricoxib 60 mg darba kuljum; etoricoxib 30 mg darba kuljum ma ġiex studjat f'din il-popolazzjoni.
English: Hepatobiliary disorders: Very rare: hepatitis.
Maltese: Rari ħafna: epatite.
English: 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.
Maltese: Studji in vitro jindikaw li CYP2D6, CYP2C9, CYP1A2 u CYP2C19 ukoll jistgħu jikkatalizzaw il-mogħdija metabolika prinċipali, iżda lirwoli kwantitattivi tagħhom ma ġewx studjati in vivo.
English: This should be considered when rapid symptomatic relief is needed.
Maltese: Dan għandu jitqies meta jkun hemm bżonn ta' serħan rapidu mis-sintomi.
English: 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.
Maltese: L-effetti ta' etoricoxib 120 mg fuq l-espożizzjoni (AUC0-24hr) għal dawn il-komponenti estroġeniċi ta' PREMARIN kienu inqas minn nofs ta' dawk osservati meta PREMARIN ingħata waħdu u d-doża żdiedet minn 0.625 għal 1.25 mg.
English: Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Maltese: Dijuretiċi, inibituri ACE u Antagonisti Angiotensin II: NSAIDs jistgħu jnaqqsu l-effett ta' dijuretiċi u ta' mediċini oħrajn ta' kontra l-pressjoni għolja.
English: 90 Film coated tablets (HDPE bottles)
Maltese: 90 pillola miksijin b'rita (fliexken HDPE)
English: Acute gouty arthritis
Maltese: Artrite tal-gotta akuta
English: Cardiac disorders:
Maltese: Disturbi kardijaċi:
English: Additional Thrombotic Cardiovascular Safety Data
Maltese: Tagħrif Addizzjonali dwar is-Sigurtà Kardjovaskulari Trombotika
English: Rifampicin: Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations.
Maltese: L-għoti fl-istess ħin ta' etoricoxib ma' rifampicin, induttur qawwi ta' enzimi CYP, ipproduċa tnaqqis ta' 65 % fil-konċentrazzjonijiet fil-plasma ta' etoricoxib.
English: Immune system disorder:
Maltese: Disturbi fis-sistema immunitarja:
English: There were no statistically significant differences in thrombotic event rates between etoricoxib and diclofenac across all subgroups analyzed including patient categories across a range of baseline cardiovascular risk.
Maltese: Ma kien hemm ebda differenza statistikament sinjifikanti fir-rati ta' episodji trombotiċi bejn etoricoxib u diclofenac fis-subgruppi kollha analizzati nkluż kategoriji ta' pazjenti tul firxa ta' riskji kardjovaskulari tal-linja bażi.
English: When considered separately, the relative risks for confirmed thrombotic cardiovascular serious adverse events with etoricoxib 60 mg or 90 mg compared with diclofenac 150 mg were similar.
Maltese: Meta kkunsidrati separatament, ir-riskji relattivi għal episodji avversi serji kardjovaskulari trombotiċi kkonfermati b'etoricoxib 60 mg jew 90 mg meta mqabbla ma' diclofenac 150 mg kienu simili.
English: Confirmed Cerebrovascular Events Per-protocol
Maltese: Episodji Ċerebrovaskulari Kkonfermati Per-protokoll
English: There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Maltese: Hemm żieda addizzjonali fir-riskju ta' effetti avversi gastrointestinali (ulċerazzjoni gastrointestinali jew kumplikazzjonijiet gastrointestinali) meta etoricoxib jittieħed fl-istess ħin ma' acetylsalicylic acid (anki f'dożi baxxi).
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).
Maltese: Reazzjonijiet serji tal-ġilda, uħud minnhom fatali, inkluż dermatite esfoljattiva, is-sindrome ta' Stevens-Johnson, u nekroliżi epidermali tossika, ġew irrapportati fuq bażi rari ħafna f'assoċjazzjoni ma' l-użu ta' NSAIDs u xi inibituri selettivi ta' COX-2 matul sorveljanza ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: <ARCOXIA> tablets contain lactose.
Maltese: Il-pilloli ta' <ARCOXIA> fihom il-lactose.
English: Etoricoxib did not inhibit gastric prostaglandin synthesis and had no effect on platelet function.
Maltese: Etoricoxib ma inibixxix sinteżi prostaglandin gastrika u ma kellux effet fuq il-funzjoni tal-pjastrini.
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).
Maltese: Etoricoxib ma kienx teratoġeniku fl-istudji dwar it-tossiċità riproduttiva li sar fuq firien bi 15 mg/kg/kuljum (dan jirrappreżenta madwar 1.5 drabi d-doża umana kuljum [90 mg] abbażi ta' espożizzjoni sistemika).
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.
Maltese: Provi kliniċi jissuġġerixxu li l-klassi ta' l-inibitur selettiv COX-2 ta' mediċini tista' tkun assoċjata ma' riskju ta' episodji trombotiċi (b'mod speċjali infart mijokardijaku (MI) u puplesija), meta mqabbla ma' plaċebo u ma' xi NSAIDs.
English: For the subset of upper GI hemorrhage events (complicated and uncomplicated combined), there was no significant difference between etoricoxib and diclofenac.
Maltese: Għassubsett ta' episodji ta' emorraġija GI ta' fuq (ikkumplikati u mhux ikkumplikati flimkien), ma kien hemm ebda differenza sinjifikanti bejn etoricoxib u diclofenac.
English: Cardiovascular effects
Maltese: Effetti kardjo vaskulari
English: Effects of other drugs on the pharmacokinetics of etoricoxib
Maltese: Effetti ta' mediċini oħrajn fuq il-farmakokinetiċi ta' etoricoxib
English: • medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan
Maltese: • mediċini użati biex jgħinu jikkontrollaw pressjoni tad-demm għolja u indeboliment tal-qalb imsejħin inibituri ACE u imblokkaturi ta' riċetturi angiotensin, eżempji jinkludu enalapril u ramipril, u losartan u valsartan
English: The pharmacokinetics of etoricoxib are linear across the clinical dose range.
Maltese: Il-farmakokinetiċi ta' etoricoxib huma lineari tul il-medda klinika kollha tad-doża.
English: No clinical data on exposed pregnancies are available for etoricoxib.
Maltese: Ebda tagħrif kliniku fuq tqala esposta ma huwa disponibbli għal etoricoxib.
English: Excipient:
Maltese: Methotrexate:
English: Each film coated tablet contains 120 mg etoricoxib.
Maltese: Kull pillola fiha 120 mg etoricoxib.