FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal and hepatic adverse events were observed significantly more frequently with diclofenac than etoricoxib.
Maltese: Episodji gastrointestinali u epatiċi avversi ġew osservati b'mod ferm aktar frekwenti b'diclofenac milli b'etoricoxib.
English: A significantly lower rate of discontinuations of treatment for any clinical (e.g., dyspepsia, abdominal pain, ulcer) GI adverse event was observed with etoricoxib compared with diclofenac within each of the three component studies of the MEDAL Program.
Maltese: Rata ferm aktar baxxa ta' waqfien tal-kura minħabba xi episodju GI kliniku avvers (eż. dispepsija, uġigħ addominali, ulċera) ġiet osservata b'etoricoxib meta mqabbla ma' diclofenac fi ħdan kull wieħed mit-tliet studji komponenti tal-Programm MEDAL.
English: The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below.
Maltese: Ir-rata ta' l-episodji avversi serji kardjovaskulari trombotiċi (li jikkonsistu minn episodji kardijaċi, ċerebrovaskulari u episodji vaskulari periferali) kienet komporabbli bejn etoricoxib u diclofenac, u ttagħrif huwa mogħti fil-qosor fit-tabella t'hawn taħt.
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.
Maltese: Etoricoxib 120 mg mogħti darba kuljum għal 10 ijiem lil voluntiera b'saħħithom ma biddilx l-AUC0-24hr tal-plasma fi stat fiss jew l-eliminazzjoni renali tad-digoxin.
English: Therefore:
Maltese: Antaċidi:
English: Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepaticrelated adverse experiences than diclofenac.
Maltese: Etoricoxib kien assoċjat ma' rata li statistikament kienet ferm aktar baxxa ta' waqfien dovut għal esperjenzi avversi relatati mal-fwied milli għal diclofenac.
English: The incidence of discontinuations due to edema-related adverse events was higher for etoricoxib than diclofenac 150 mg, and this effect was dose-dependent (statistically significant for etoricoxib 90 mg, but not for etoricoxib 60 mg).
Maltese: L-inċidenza ta' twaqqif dovut għal episodji avversi relatati ma' edema kienet ogħla għal etoricoxib milli għal diclofenac 150 mg, u dan l-effett kien dipendenti fuq id-doża (statistikament sinjifikanti għal etoricoxib 90 mg, iżda mhux għal etoricoxib 60 mg).
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.
Maltese: F'xi pazjenti b'funzjoni renali kompromessa (eż. pazjenti deidrati jew pazjenti anzjani b'funzjoni renali kompromessa), l-għoti fl-istess ħin ta' inibitur ACE jew antagonista Angiotensin II u aġenti li jinibixxu cyclo-oxygenase jistgħu jirriżultaw f'aktar deterjorament tal-funzjoni renali, inkluż il-possibbiltà ta' kollass renali akut, li normalment ikun wieħed riversibbli.
English: This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.
Maltese: Din l-interazzjoni tista' tirriżulta fir-rikorrenza tas-sintomi meta etoricoxib jingħata ma' rifampicin.
English: Antacids: Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
Maltese: Antaċidi ma jaffettwawx il-farmakokinetiċi ta' etoricoxib sa punt li huwa klinikament relevanti.
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).
Maltese: Listudju EDGE nkluda 7111-il pazjent OA ikkurati b'doża ta' etoricoxib 90 mg kuljum (1.5 drabi ddoża rakkomandata għall-OA) jew diclofenac 150 mg kuljum għal perjodu medju ta' 9.1 xhur (massimu 16.6 xahar, medjan ta' 11.4 xahar).
English: The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and
Maltese: L-użu ta' etoricoxib f'pazjenti bi tneħħija tal-kreatinina <30 ml/min huwa kontraindikat (ara sezzjonijiet 4.3 u 4.4).
English: 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).
Maltese: Filwaqt li fil-preżent, it-tagħrif dwar l-effetti ta' sulfotransferases multipli huwa limitat u l-konsegwenzi kliniċi għal bosta mediċini għad iridu jiġu eżaminati, jista' jkun prudenti li tiġi eżerċitata l-kawtela meta etoricoxib jingħata flistess ħin ma' mediċini oħrajn metabolizzati primarjament minn sulfotransferases umani (eż. salbutamol u minoxidil orali).
English: In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
Maltese: Fi provi kliniċi għal artrite tal-gotta akuta, etoricoxib ingħata għal 8 ijiem.
English: Acetylsalicylic Acid: In a study in healthy subjects, at steady state, etoricoxib 120 mg once daily had no effect on the anti-platelet activity of acetylsalicylic acid (81 mg once daily).
Maltese: Fi studju b'suġġetti b'saħħithom, fi stat fiss, etoricoxib 120 mg kuljum ma kellu ebda effett fuq l-attività kontra l-pjastrini ta' acetylsalicylic acid (81 mg darba kuljum).
English: The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Maltese: Ir-rata ta' assorbiment kienet affettwata, u rriżultat fi tnaqqis ta' 36% f'Cmax u f'żieda fit-Tmax b'sagħtejn.
English: National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Maltese: Awtoritajiet kompetenti nazzjonali (NCA) sejrin jassiguraw li l-kundizzjonijiet li ġejjin huma ssodisfati mid-detenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq:
English: NL 2031 BN Haarlem The Netherlands
Maltese: NL 2031 BN Haarlem
English: Belgium Merck Sharp and Dohme Chasussée de Waterloo 1135
Maltese: Merck Sharp and Dohme Chasussée de Waterloo 1135 B-1180 Brussels Belgium
English: Etoricoxib was not carcinogenic in mice.
Maltese: Etoricoxib ma kienx karċinoġeniku fil-ġrieden.
English: What is rheumatoid arthritis?
Maltese: X'inhi l-artrite rewmatojde?
English: The rate per hundred patient-years was 0.22 on etoricoxib and 1.84 for diclofenac (p-value was <0.001 for etoricoxib vs. diclofenac).
Maltese: 001 għal etoricoxib vs. diclofenac).
English: 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).
Maltese: Fi provi kliniċi, etoricoxib ġie evalwat għas-sigurtà f'7152 individwu, inkluż 4614-il pazjent b'OA, RA, uġigħ kroniku fil-parti ta' isfel tad-dahar jew ankylosing spondylitis (bejn wieħed u ieħor 600 pazjent b'OA jew RA ġew ikkurati għal sena jew iktar).
English: • aspirin, the risk of stomach ulcers is greater if you take <ARCOXIA> with aspirin.
Maltese: • aspirina, ir-riskju ta' ulċeri fl-istonku huwa ikbar jekk tieħu <ARCOXIA> ma' l-aspirina.
English: EXP
Maltese: Glostrup
English: Methotrexate: Two studies investigated the effects of etoricoxib 60, 90 or 120 mg administered once daily for seven days in patients receiving once-weekly methotrexate doses of 7.5 to 20 mg for rheumatoid arthritis.
Maltese: Żewġ studji investigaw l-effetti ta' etoricoxib 60, 90 jew 120 mg mogħti darba kuljum għal sebat ijiem f'pazjenti li jirċievu dożi ta' methotrexate ta' 7.5 sa 20 mg darba fil-ġimgħa għal artrite rewmatojde.
English: Each film coated tablet contains 90 mg etoricoxib.
Maltese: Kull pillola fiha 90 mg etoricoxib.
English: Czech Republic Merck Sharp & Dohme B.V. Waanderweg NL-2031 BN Haarlem
Maltese: Waanderweg 39 NL-2031 BN Haarlem
English: Each film coated tablet contains 30 mg etoricoxib.
Maltese: Kull pillola fiha 30 mg etoricoxib.
English: Blisters Store in original package in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: In one study, etoricoxib 120 mg had no effect, but in the other study, etoricoxib 120 mg increased methotrexate plasma concentrations by 28% and reduced renal clearance of methotrexate by 13%.
Maltese: Fi studju wieħed, etoricoxib 120 mg ma kellu ebda effett, iżda fi studju ieħor, etoricoxib 120 mg żied il-konċentrazzjonijiet ta' plasma ta' methotrexate bi 28 % u naqqas it-tneħħija mill-kliewi ta' methotrexate bi 13%.
English: What <ARCOXIA> looks like and contents of the pack
Maltese: Id-dehra ta' <ARCOXIA> u l-kontenut tal-pakkett
English: • Keep this leaflet.
Maltese: • Inti mara li tixtieq tinqabad tqila.
English: Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction
Maltese: Mhux komuni: fibrillazzjoni atrijali, kollass konġestiv tal-qalb, tibdil mhux speċifiku fl-ECG, infart mijokardijaku
English: The rates of discontinuations due to adverse clinical GI events per hundred patient-years over the entire period of study were as follows: 3.23 for etoricoxib and 4.96 for diclofenac in the MEDAL Study; 9.12 with etoricoxib and 12.28 with diclofenac in the EDGE study; and 3.71 with etoricoxib and 4.81 with diclofenac in the EDGE II study.
Maltese: 12 b'etoricoxib u 12.28 b'diclofenac fl-istudju EDGE; u 3.71 b'etoricoxib u 4.81 b'diclofenac fl-istudju EDGE II.
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.
Maltese: Fil-Programm MEDAL bit-tagħrif miġbur flimkien, 0.3% tal-pazjenti fuq etoricoxib u 2.7% tal-pazjenti fuq diclofenac waqfu minħabba esperjenzi avversi relatati mal-fwied.
English: 30 mg Tablets: Blue-green, apple-shaped biconvex tablets <debossed ‘101' on one side and ‘ACX 30' on the other side>.
Maltese: Pilloli ġejjin għat-tond miż-żewġ naħat f'għamla ta' tuffieħa blu fl-aħdar <imnaqqxin b'‘101' fuq naħa u b'‘ACX 30' fuq in-naħa l-oħra>.
English: Etoricoxib 120 mg should be used only for the acute symptomatic period.
Maltese: Etoricoxib 120 mg għandu jintuża għall-perjodu sintomatiku akut.
English: Each film coated tablet contains 60 mg etoricoxib.
Maltese: Kull pillola fiha 60 mg etoricoxib.
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Maltese: Il-farmakokinetiċi ta' etoricoxib huma simili bejn l-irġiel u n-nisa.
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Maltese: Għas-serħan mis-sintomi ta' osetoartrite (OA), artrite rewmatojde (RA), ankylosing spondylitis u luġigħ u s-sinjali ta' infjammazzjoni assoċjati ma' artrite tal-gotta akuta.
English: 90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other.
Maltese: 90 mg pilolli miksijin b'rita, ġejjin għat-tond miż-żewġ naħat, f'għamla ta' tuffieħa, blu-ħodor immarkati ‘ARCOXIA 90' fuq naħa u b'‘202' fuq in-naħa l-oħra.
English: There was no significant difference between etoricoxib and diclofenac in the rate of complicated events.
Maltese: Ma kien hemm ebda differenza sinjifikanti bejn etoricoxib u diclofenac fir-rata ta' episodji kkumplikati.
English: • lithium (a medicine used to treat some types of depression)
Maltese: • litju (mediċina użata sabiex tikkura xi tipi ta' dipressjoni)
English: Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Maltese: Inibituri COX-2 selettivi jnaqqsu lformazzjoni ta' prostacyclin sistemiku (u għalhekk possibbilment endoteljali) mingħajr ma jaffettwaw it-thromboxane tal-pjastrini.
English: It is caused by deposits of mineral crystals in the joint.
Maltese: Hija kkawżata minn depożiti ta' kristalli minerali fil-ġog.
English: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Maltese: Ebda aġġustament fid-doża ma huwa meħtieġ għal pazjenti bi tneħħija tal-kreatinina ≥30 ml/min (ara sezzjoni 5.2).
English: In patients with rheumatoid arthritis (RA), etoricoxib 90 mg once daily provided significant improvements in pain, inflammation, and mobility.
Maltese: F'pazjenti b'artrite rewmatojde (RA), etoricoxib 90 mg kuljum ipprovda titjib sinjifikanti fl-uġigħ, infjammazzjoni u mobilità.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Maltese: Il-ħtieġa tal pazjent għal serħan mis-sintomi u għar-rispons għat-terapija għandhom jiġu evalwati mill-ġdidperjodikament f'pazjenti b'osteoartrite (ara sezzjonijiet 4.3, 4.4, 4.8 u 5.1).
English: Very rare: hypertensive crisis.
Maltese: Rari ħafna: kriżi ipertensiva.
English: • <ARCOXIA> is one of a group of medicines called selective COX-2 inhibitors.
Maltese: • <ARCOXIA> huwa wieħed minn grupp ta' mediċini msejħa inibituri selettivi cox-2. dawn jappartjenu għal familja ta' mediċini msejħa mediċini anti-infjammatorji mhux sterojdi (nsaids).
English: Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 6 (12) of Commission Regulation EC No 1084/2003 was started on 20 September 2007.
Maltese: Għalhekk, Franza bagħtet notifika li waslet għand l-EMEA fid-19 ta' Settembru 2007 u fl-20 ta' Settembru 2007, inbdiet referenza skond l-Artikolu 6(12) tar-Regolament tal-Kummissjoni KE Nru 1084/2003.
English: In a dose ranging study, etoricoxib 60 mg demonstrated significantly greater improvement than 30 mg for all 3 primary endpoints over 6 weeks of treatment.
Maltese: Fi studju b'doża li tvarja, etoricoxib 60 mg wera titjib ferm iktar sinjifikanti milli 30 mg għat-3 punti ta' tmiem kollha fuq 6 ġimgħat ta' kura.
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.
Maltese: Wara dożaġġ ta' 120 mg darba kuljum b'rata fissa, il-konċentrazzjoni massima tal-plasma (medja ġeometrika Cmax = 3.6 µg/ml) kienet osservata wara madwar siegħa (Tmax) wara li ngħatat lil adulti msajmin.
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).
Maltese: Żieda fl-espożizzjoni ta' EE tista' żżid l-inċidenza ta' episodji avversi assoċjati ma' kontraċettivi orali (eż. episodji trombo-emboliċi venużi f'nisa li jkunu f'riskju).
English: Common: ALT increased, AST increased.
Maltese: Komuni: żieda fl-ALT, żieda fl-AST.
English: Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/risk profile of Arcoxia was needed.
Maltese: Wara tħassib ta' żieda fir-riskju kardjovaskulari (KV) possibbli relatat ma' l-użu ta' doża ta' 90mg ta' etoricoxib, Franza ikkunsidrat li kien meħtieġ eżami mill-ġdid tal-profil benefiċċju/riskju ta' Arcoxia.
English: P.O.
Maltese: Via G.
English: • <ARCOXIA> helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Maltese: • <ARCOXIA>Etoricoxib jgħin biex inaqqas l-uġigħ u n-nefħa (infjammazzjoni) fil-ġogi u lmuskoli ta' persuni li jbatu bl-osteoartrite, l-artrite rewmatojde, ankylosing spondylitis u l-gotta.
English: • if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including ministroke, transient ischaemic attack or TIA).
Maltese: • jekk it-tabib tiegħek ikun iddijanjostika problemi tal-qalb inkluż kollass tal-qalb (tipi moderati jew severi), anġina (uġigħ fis-sider) jew jekk kellek attakk tal-qalb, kirurġija tal-bypass, marda arterjali periferali (ċirkolazzjoni batuta fir-riġlejn jew fis-saqajn minħabba arterji dojoq jew imblokkati), jew kwalunkwe tip ta' puplesija (inkluż mini-puplesija, attakk iskemiku temporanju jew TIA).
English: Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Maltese: Wara għoti ta' doża ġol-vini radju-tikkettjata ta' 25 mg waħdanija ta' etoricoxib lil suġġetti b'saħħithom, 70 % tar-radju-attività ġiet irkuprata fl-awrina u 20% fil-feċi, l-aktar bħala metabolite.
English: This causes swelling (inflammation), pain, tenderness, stiffness and disability.
Maltese: Din tikkawża nefħa (infjammazzjoni), uġigħ, tenerezza, ebusija tal-ġisem u diżabilità.
English: The cardiorenal results for EDGE and EDGE II were consistent with those described for the MEDAL Study.
Maltese: Ir-riżultati kardjorenali għal EDGE u EDGE II kienu konsistenti ma' dawk deskritti għall-Istudju ta' MEDAL.
English: Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1.
Maltese: Għalhekk terpiji kontra l-pjastrini ma għandhomx jitwaqqfu (ara sezzjonijiet fuq, 4.5 u 5.1).
English: The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Maltese: It-tneħħija mill-plasma wara doża ġol-vini ta' 25 mg hija stmata li tkun madwar 50 ml/min.
English: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten Belgium Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Bulgaria
Maltese: Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Ranacox 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
English: Hertsfordshire EN11 9BU
Maltese: EN11 9BU
English: Ear and labyrinth disorders: Uncommon: tinnitus, vertigo.
Maltese: Mhux komuni: tinnite, vertiġini.
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness.
Maltese: Mhux komuni: bugħawwiġ/spażmi muskolari, uġigħ/ebusija muskuloskeletali.
English: In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Maltese: Fl-istudju tat-tossiċità ta' 53 ġimgħa u ta' 106 ġimgħa, ulċeri gastrointestinali dehru wkoll f'espożizzjonijiet komparabbli ma' dawk li dehru fil-bniedem fiddoża terapewtika.
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%.
Maltese: Etoricoxib 120 mg mogħti ma' l-istess kontraċettiv orali fl-istess ħin jew b'differenza ta' 12-il siegħa bejniethom, żied l-AUC0-24hr ta' stat fiss ta' EE b'50 sa 60%.
English: 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).
Maltese: Pazjenti b'fatturi ta' riskju sinjifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, lipidemija għolja, dijabete mellitus, tipjip) għandhom jiġu kkurati b'etoricoxib wara kunsiderazzjoni attenta (ara sezzjoni 5.1).
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).
Maltese: Ma hemm ebda esperjenza klinika f'pazjenti b'malfunzjonament severa tal-fwied (skor Child-Pugh ≥10); għalhekk, l-użu tiegħu huwa kontra-indikat f'dawn il-pazjenti (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: <ARCOXIA (see Annex 1)> 30 mg film-coated tablets <ARCOXIA (see Annex 1)> 60 mg film-coated tablets <ARCOXIA (see Annex 1)> 90 mg film-coated tablets <ARCOXIA (see Annex 1)> 120 mg film-coated tablets [See Annex 1- To be completed nationally]
Maltese: <ARCOXIA (ara l-Anness 1)> 30 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 60 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 90 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 120 mg pilloli miksijin b'rita [Ara l-Anness 1- Għandha timtela fuq livell nazzjonali]
English: The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied.
Maltese: L-effett tad-dożi kroniċi rrakkomandati (30, 60 u 90 mg) ma ġiex studjat.
English: The subset of overall upper GI events considered complicated included perforations, obstructions, and complicated bleeding; the subset of upper GI events considered uncomplicated included uncomplicated bleeds and uncomplicated ulcers.
Maltese: Issubsett ta' l-episodji GI ta' fuq ġenerali meqjusin bħala kkumplikati kien jinkludi perforazzjonijiet, ostruzzjonijiet u fsada kkomplikata; is-subsett ta' episodji GI ta' fuq meqjusin bħala mhux ikkumplikati inkludew fsada mhux ikkumplikata u ulċeri mhux ikkumplikati.
English: <ARCOXIA> 30 mg film-coated tablets <ARCOXIA> 60 mg film-coated tablets < ARCOXIA > 90 mg film-coated tablets < ARCOXIA > 120 mg film-coated tablets
Maltese: ARCOXIA 30 mg pilloli miksijin b'rita ARCOXIA 60 mg pilloli miksijin b'rita ARCOXIA 90 mg pilloli miksijin b'rita ARCOXIA 120 mg pilloli miksijin b'rita
English: Common: ecchymosis.
Maltese: Komuni: ekkimożi.
English: - The Committee considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Arcoxia and associated names.
Maltese: - Il-Kumitat ikkunsidra r-referenza magħmula skond l-Artikolu 6(12) tar-Regolament talKummissjoni KE Nru 1084/2003, għal Arcoxia u ismijiet assoċjati.
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Maltese: 120 mg pilolli miksijin b'rita ġejjin għat-tond miż-żewġ naħat, f'għamla ta' tuffieħa, blu-ħodor immarkati ‘ARCOXIA 120' fuq naħa u b'‘204' fuq in-naħa l-oħra.
English: 60 mg - 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
Maltese: Fil-Programm MEDAL bit-tagħrif kollu miġbur flimkien, 34,701 pazjent b'OA jew b'RA kienu kkurati għal tul ta' żmien medju ta' 17.9 xahar (masismu ta' 42.3 xahar, medjan ta' 16.3 xahar) b'bejn wieħed u ieħor 12,800 pazjent jirċievi kura għal aktar minn 24 xahar.
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).
Maltese: Fil-fniek, żieda relatata mal-kura f'malformazzjonijiet kardjovaskulari ġiet osservata f'livelli ta' espożizzjoni taħt l-espożizzjoni klinika fid-doża umana ta' kuljum (90 mg).
English: <ARCOXIA (see Annex 1)> 30 mg film-coated tablets <ARCOXIA (see Annex 1)> 60 mg film-coated tablets <ARCOXIA (see Annex 1)> 90 mg film-coated tablets <ARCOXIA (see Annex 1)> 120 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: <ARCOXIA (ara l-Anness 1)> 30 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 60 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 90 mg pilloli miksijin b'rita <ARCOXIA (ara l-Anness 1)> 120 mg pilloli miksijin b'rita [Ara l-Anness I - Għandha timtela fuq livell nazzjonali]