FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Daklinza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Daklinza, ara l-fuljett ta' tagħrif.
English: The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks.
Maltese: Il-pazjenti fl-istudju kienu infettati b'ġenotipi 1, 2 jew 3 u kollha rċevew kura għal 12 jew 24 ġimgħa.
English: The most common side effects reported with Daklinza in combination with sofosbuvir with or without ribavirin are fatigue (tiredness), nausea (feeling sick) and headache.
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati b'Daklinza flimkien ma' sofosbuvir bir-ribavirin jew mingħajru huma għeja, nawżja (tħossok ma tiflaħx) u wġigħ ta' ras.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Maltese: Daklinza ma għandux jintuża flimkien ma' ċerti mediċini li jistgħu jnaqqsu l-effetti ta' Daklinza.
English: EMA/601221/2014 EMEA/H/C/002085
Maltese: EMEA/H/C/002085
English: It contains the active substance tilmanocept.
Maltese: Fih is-sustanza attiva tilmanocept.
English: The full EPAR and risk management plan summary for Lymphoseek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Lymphoseek
Maltese: Informazzjoni oħra dwar Lymphoseek
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lymphoseek on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Lymphoseek fid-19 ta' Novembru 2014.
English: In these two studies, doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all of the lymph nodes identified using the blue dye (98% in one study and 100% in the other) were identified using Lymphoseek, while only around 70% and 60%, respectively, of the lymph nodes detected using Lymphoseek were detected with the blue dye.
Maltese: F'dawn iż-żewġ studji, it-tobba kienu kapaċi jindividwaw għadd ta' nodi limfatiċi sentinelli ogħla b'Lymphoseek milli bil-kolorant blu: kważi n-nodi limfatiċi kollha individwati bl-użu tal-kolorant blu (98% fi studju wieħed u 100% fl-ieħor) ġew individwati bl-użu ta' Lymphoseek, filwaqt li madwar 70% u 60% biss, rispettivament, tan-nodi limfatiċi li ġew individwati bl-użu ta' Lymphoseek ġew individwati bil-kolorant blu.
English: This is a summary of the European public assessment report (EPAR) for Lymphoseek.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lymphoseek.
English: Lymphoseek tilmanocept
Maltese: Kif jintuża Lymphoseek?
English: Why is Lymphoseek approved?
Maltese: Għaliex ġie approvat Lymphoseek?
English: Lymphoseek is a diagnostic medicine used in patients with cancer to identify sentinel lymph nodes.
Maltese: Lymphoseek huwa mediċina dijanjostika użata f'pazjenti b'kanċer sabiex jiġu identifikati n-nodi limfatiċi sentinelli.
English: Almost all the patients (38 out of 39) with cancerous lymph nodes were identified by Lymphoseek.
Maltese: Kważi l-pazjenti kollha (38 minn 39) b'nodi limfatiċi kanċerużi ġew individwati b'Lymphoseek.
English: Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) and a type of cancer of the mouth known as squamous cell carcinoma.
Maltese: Lymphoseek jintuża f'pazjenti b'kanċer tas-sider, melanoma (kanċer tal-ġilda) u tip ta' kanċer tal-ħalq magħruf bħala karċinoma taċ-ċelloli skwamużi.
English: What are the risks associated with Lymphoseek?
Maltese: X'inhuma r-riskji assoċjati ma' Lymphoseek?
English: A risk management plan has been developed to ensure that Lymphoseek is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Lymphoseek jintuża bl-aktar mod sigur possibbli.
English: The active substance in Lymphoseek, tilmanocept, attaches to proteins called mannose binding proteins which are found in high amounts in certain immune cells in the lymph nodes.
Maltese: Is-sustanza attiva f'Lymphoseek, tilmanocept, teħel ma' proteini msejħa proteini li jgħaqqdu lmannożju li jinstabu f'ammonti kbar f'ċerti ċelloli immunitarji fin-nodi limfatiċi.
English: How is Lymphoseek used?
Maltese: Kif jaħdem Lymphoseek?
English: The most common side effects with Lymphoseek seen in clinical studies are pain and irritation at the injection site (seen in less than 1 patient in 100).
Maltese: L-effetti sekondarji l-aktar komuni b'Lymphoseek li dehru fl-istudji kliniċi huma uġigħ u irritazzjoni fissit tal-injezzjoni (dehru f'inqas minn pazjent wieħed minn kull 100).
English: If the sentinel nodes are found to have no cancer then more extensive lymph nodal surgery can be avoided.
Maltese: Jekk in-nodi sentinelli jinstabu li m'għandhomx kanċer, iktar kirurġija estensiva tan-nodi limfatiċi tista' tiġi evitata.
English: The benefits of Lymphoseek were shown in two main studies in which 311 patients with breast or skin cancer had their lymph nodes first mapped with Lymphoseek and then with another method involving the use of a dye known as ‘vital blue dye'.
Maltese: Il-benefiċċji ta' Lymphoseek intwerew f'żewġ studji ewlenin li fihom, 311-il pazjenti b'kanċer tas-sider jew tal-ġilda kellhom in-nodi limfatiċi tagħhom l-ewwel immappjati b'Lymphoseek imbagħad b'metodu ieħor li jinvolvi l-użu ta' kolorant magħruf bħala ‘kolorant blu vitali'.
English: For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji u restrizzjonijiet b'Lymphoseek, ara l-fuljett ta' tagħrif.
English: In a third study in patients with cancer of the head and neck including mouth cancer, Lymphoseek was used to detect sentinel lymph nodes before patients had their lymph nodes removed surgically.
Maltese: Dan jgħin fid-deċiżjoni jekk hemmx il-ħtieġa ta' iktar kirurġija biex jitneħħew iktar nodi limfatiċi.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku tilmanocept
English: Lymphoseek should only be used by healthcare professionals with expertise in mapping lymph nodes.
Maltese: Lymphoseek għandu jintuża biss minn professjonisti tal-kura tas-saħħa b'kompetenza fl-immappjar tan-nodi limfatiċi.
English: A special camera that detects radiation is then used to see where the lymph nodes are and therefore where the cancer is likely to spread.
Maltese: Imbagħad, kamera speċjali li tindividwa rradjazzjoni tintuża biex jiġi identifikat fejn qegħdin in-nodi limfatiċi u għalhekk fejn x'aktarx jinfirex ilkanċer.
English: Relative Risk (95% CI)
Maltese: Riskju Relattiv (95% CI)
English: • rifampicin (an antibiotic)
Maltese: • rifampicin (antibijotiku)
English: Diclofenac (N=16483) 24766 PatientYears
Maltese: Diclofenac (N=16483) 24766 PazjentSnin
English: Via G. Fabbroni, 6
Maltese: Fabbroni, 6
English: Per-protocol
Maltese: Per-protokoll
English: Box 581
Maltese: P.O. Box 581
English: Very rare: bronchospasm.
Maltese: Rari ħafna: bronkospażmu.
English: (See sections 4.3 and 4.4.)
Maltese: (Ara Sezzjonijiet 4.3 u 4.4.)
English: Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Maltese: Il-kisja tal-pillola: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
English: Common: palpitations.
Maltese: Komuni: palpitazzjonijiet.
English: • The active substance is etoricoxib.
Maltese: • Is-sustanza attiva hija etoricoxib.
English: There was an increase in digoxin Cmax (approximately 33%).
Maltese: Kien hemm żieda f'digoxin Cmax (bejn wieħed u ieħor 33%).
English: Congestive heart failure (NYHA II-IV).
Maltese: Indeboliment konġestiv tal-qalb (NYHA II-IV).
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Maltese: Malfunzjonament severa tal-fwied (albumina tas-serum <25 g/l jew skor Child-Pugh ≥10).
English: The absolute bioavailability is approximately 100%.
Maltese: Il-bijodisponibbiltà assoluta hija madwar 100%.
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Maltese: Ma ntwerietx differenza sinjifikanti fis-sigurtà GI bejn inibituri COX-2 selettivi + acetylsalicylic acid vs.
English: Total number of patients randomised, n= 17412 on etoricoxib and 17289 on diclofenac.
Maltese: Numru totali ta' pazjenti randomizzati, n= 17412 fuq etoricoxib u 17289 fuq diclofenac.
English: Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Maltese: Qalba: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
English: Cardiorenal Events:
Maltese: Episodji Kardjorenali:
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Maltese: Rari ħafna: urtikarja, is-sindrome ta' Stevens-Johnson, nekroliżi epidermali tossika.
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Maltese: Tqala u treddigħ (ara sezzjonijiet 4.6 u 5.3).
English: Overall Safety:
Maltese: Sigurtà Ġenerali:
English: 30 mg: lactose 1.4 mg 60 mg: lactose 2.8 mg 90 mg: lactose 4.2 mg 120 mg: lactose 5.6 mg
Maltese: Sustanzi mhux attivi: 30 mg: lactose 1.4 mg 60 mg: lactose 2.8 mg 90 mg: lactose 4.2 mg 120 mg: lactose 5.6 mg
English: 30 mg Aluminum/aluminium blisters in packs containing 7 and 28 tablets.
Maltese: 30 mg Folji ta' l-aluminju/aluminju f'pakketti li fihom 7 u 28 pillola.
English: Nervous system disorder:
Maltese: Disturbi fis-sistema nervuża:
English: Uncommon: anxiety, depression, mental acuity decreased.
Maltese: Mhux komuni: ansjetà, depressjoni, ċarezza mentali mnaqqsa.
English: What is ankylosing spondylitis?
Maltese: X'inhi ankylosing spondylitis?
English: Uncommon: proteinuria.
Maltese: Mhux komuni: proteinurja.
English: • You are being treated for an infection.
Maltese: • Qed tiġi kkurat/a għal infezzjoni.
English: Osteoarthritis
Maltese: Osteoartrite
English: Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05 to 5 µg/ml.
Maltese: Etoricoxib huwa bejn wieħed u ieħor 92% marbut mal-proteina tal-plasma umana fuq il-medda ta' konċentrazzjonijiet ta' 0.05 sa 5 µg/ml.
English: 3 avenue Hoche 75114 Paris Cedex 8 France
Maltese: 3 avenue Hoche 75114
English: • hormone replacement therapy
Maltese: • terapija ta' sostituzzjoni ta' l-ormoni
English: Cyclooxygenase is responsible for generation of prostaglandins.
Maltese: Cyclooxygenase huwa responsabbli għall-ġenerazzjoni ta' prostaglandins.
English: Luxemburg Merck Sharp & Dohme Chaussee de Waterloo 1135
Maltese: Il-Lussemburgu Merck Sharp & Dohme Chaussee de Waterloo 1135
English: Two isoforms, COX-1 and COX-2, have been identified.
Maltese: Ġew identifikati żewġ isoforom, COX-1 u COX -2.
English: Do not take <ARCOXIA>:
Maltese: Tiħux <ARCOXIA>:
English: Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Maltese: Etoricoxib kien inkluż fir-referenzi ta' qabel tas-CHMP dwar is-sigurtà ta' inibituri selettivi ta' COX2 li ġew konklużi fl-2004 u fl-2005.
English: • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)
Maltese: • jekk inti allerġiku għal mediċini anti-infjammatorji mhux sterojdi (NSAIDs), inkluż aspirina u inibituri COX-2 (ara Effetti Sekondarji Possibbli, sezzjoni 4)
English: Very rare: confusion, hallucinations.
Maltese: Rari ħafna: konfużjoni, alluċinazzjonijiet.
English: Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Maltese: Ulċerazzjoni peptika attiva jew fsada gastro-intestinali (GI).
English: • ciclosporin or tacrolimus (drugs used for suppressing the immune system)
Maltese: • ciclosporin jew tacrolimus (mediċini użati għat-trażżin tas-sistema immunitarja)
English: What is osteoarthritis?
Maltese: X'inhi l-osteoartrite?
English: Pack sizes of 7 and 28 tablets in blisters.
Maltese: Daqsijiet tal-pakkett ta' 7 u 28 pillola f'folji.
English: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Maltese: Fuq il-bażi ta' studji in vitro, etoricoxib mhuwiex mistenni li jinibixxi cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 jew 3A4.
English: NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Maltese: NSAIDs + acetylsalicylic acid fi provi kliniċi fuq perjodu ta' żmien twil (ara sezzjoni 5.1).
English: The principal metabolite is the 6'-carboxylic acid derivative of etoricoxib formed by further oxidation of the 6'-hydroxymethyl derivative.
Maltese: Il-metabolit prinċipali huwa d-derivattiv 6'-carboxylic acid ta' etoricoxib iffurmat b'ossidazzjoni ulterjuri tad-derivattiv 6'-hydroxymethyl.
English: 60, 90 and 120 mg Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Maltese: 60, 90 u 120 mg Folji ta' l-aluminju/aluminju f'pakketti li fihom 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 jew 100 pillola.
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Maltese: Rari ħafna: insuffiċjenza renali, inkluż indeboliment tal-kliewi, normalment riversibbli malli titwaqqaf il-kura (ara sezzjoni 4.4).
English: MEDAL Program Gastrointestinal Tolerability Results:
Maltese: Ir-Riżultati tat-Tollerabilità Gastrointestinali tal-Programm MEDAL:
English: DK-2600 Glostrup Danmark
Maltese: DK-2600
English: The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, cardiorenal events).
Maltese: L-aktar esperjenzi avversi osservati b'mod frekwenti kienu konsistenti mal-profil tas-sigurtà għal etoricoxib (eż. episodji gastrointestinali, episodji kardorenali).
English: Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
Maltese: Etoricoxib huwa inibitur cyclo-oxygenase-2 (COX-2) selettiv orali fi ħdan il-medda tad-dożaġġ kliniku.
English: Children and adolescents under 16 years of age.
Maltese: Tfal u adoloxxenti taħt l-età ta' 16-il sena.
English: • salbutamol tablets or oral solution (a medicine for asthma)
Maltese: • pilloli salbutamol jew soluzzjoni orali (mediċina għall-ażżma)
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).
Maltese: Ir-rati għal kull mitt pazjent sena ta' episodji kliniċi GI ta' fuq ikkomplikati u mhux ikkomplikati kkonfermati (perforazzjonijiet, ulċeri u fsada (PUBs)) kienu 0.67 (95% CI 0.57, 0.77) b'etoricoxib u 0.97 (95% CI 0.85, 1.10) b'diclofenac, u dan ta' riskju relattiv ta' 0.69 (95% CI 0.57, 0.83).
English: ∗, transient ischaemic attack.
Maltese: ∗, attakk iskemiku temporanju.
English: The volume of distribution at steady state (Vdss) was approximately 120 l in humans.
Maltese: Il-volum tad-distribuzzjoni f'rata fissa (Vdss) kien bejn wieħed u ieħor 120 l fl-umani.
English: Merck Sharp & Dohme GmbH Donau - City - Straße 6 A-1220 Wien
Maltese: Merck Sharp & Dohme GmbH Donau - City - Straße 6
English: Less than 2% was recovered as unchanged drug.
Maltese: Inqas minn 2% ġiet irkuprata bħala mediċina mhux mibdula.
English: -<ARCOXIA> can be taken with low-dose aspirin.
Maltese: - <ARCOXIA> jista' jittieħed ma' aspirina ta' doża baxxa.
English: Confirmed Peripheral Vascular Events Per-protocol
Maltese: Episodji Vaskulari Periferali Kkonfermati Per-protokoll
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Maltese: Pazjenti li esperjenzaw bronkospażmu, rinite akuta, qarnita nasali, edema anġjonewrotika, urtikarja jew reazzjonijiet tat-tip allerġiċi wara t-teħid ta' acetylsalicylic acid jew NSAIDs inkluż inibituri COX-2 (cyclooxygenase-2).
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.
Maltese: Fi studju farmakokinetiku (n=16) li sar fuq adoloxxenti (ta' bejn 12 u 17-il sena) il-farmakokinetiċi fladoloxxenti li jiżnu bejn 40 u 60 kg mogħtijin etoricoxib 60 mg darba kuljum u adoloxxenti >60 kg mogħtijin etoricoxib 90 mg darba kuljum kienu simili għall-farmakokinetiċi fl-adulti mogħtijin etoricoxib 90 mg darba kuljum.
English: Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Maltese: Fi studji ta' interazzjoni tal-mediċina, etoricoxib ma kellux effetti klinikament importanti fuq il-farmakokinetiċi ta' prednisone/prednisolone.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Maltese: COX-2 hija involuta wkoll fl-ovulazzjoni, impjantazzjoni u għeluq tad-ductus arteriosus, regolazzjoni tal-funzjoni renali, u funzjonijiet tassistema nervuża ċentrali (induzzjoni ta' deni, perċezzjoni ta' uġigħ u funzjonament konoxxittiv).
English: The rate for confirmed upper GI events in elderly patients was evaluated and the largest reduction was observed in patients ≥ 75 years of age (1.35 [95% CI 0.94, 1.87] vs. 2.78 [95% CI 2.14, 3.56] events per hundred patient-years for etoricoxib and diclofenac, respectively.
Maltese: Ir-rata għal episodji GI ikkonfermati f'pazjenti anzjani ġiet evalwata u l-akbar tnaqqis ġie osservat f'pazjenti ≥ 75 sena (1.35 [95% CI 0.94, 1.87] vs. 2.78 [95% CI 2.14, 3.56] (episodji għal kull mitt pazjent-sena għal etoricoxib u diclofenac, rispettivament).
English: Estimated renal creatinine clearance <30 ml/min.
Maltese: Stima tat-tneħħija tal-kreatina mill-kliewi <30 ml/min.
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).
Maltese: Ketoconazole, inibitur qawwi ta' CYP3A4, iddożat f'400 mg darba kuljum għal 11-il jum lil voluntiera b'saħħithom, ma kellux xi effett klinikament importanti fuq il-farmakokinetiċi ta' doża waħda ta' 60 mg etoricoxib (żieda ta' 43% fl-AUC).
English: [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)]
Maltese: Mhux komuni (≥1/1000 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: Hormone Replacement Therapy (HRT): 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%).
Maltese: L-għoti ta' etoricoxib 120 mg b'terapija ta' sostituzzjoni ta' l-ormoni magħmula minn estroġeni konjugati (0.625 mg PREMARINTM ) għal 28 jum, naqqas l-AUC0-24hr fl-istat fiss medju ta' estrone mhux konjugat (41%), equilin (76%), u 17-βestradiol (22%).
English: • digoxin (a medicine for heart failure and irregular heart rhythm)
Maltese: • digoxin (mediċina għall-kollass tal-qalb u għal ritmu irregolari tal-qalb)
English: The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Maltese: Il-pilloli ta' 30, 60 u 120 mg ukoll fihom carmine lake indigo (E132) u ferric oxide isfar (E172).
English: Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Program The MEDAL Program was a prospectively designed Cardiovascular (CV) Safety Outcomes Program of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
Maltese: Il-Programm MEDAL kien Programm tar-Riżultati tas-Sigurtà Kardjovaskulari (CV) imfassal prospettivament ta' tagħrif miġbur flimkien minn tliet provi randomizzati, double-blind ikkontrollati b'komparatur, l-istudju MEDAL, EDGE II u EDGE.
English: 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.
Maltese: L-effetti serji mhux mixtieq li ġejjin ġew irrapportati f'assoċjazzjoni ma' l-użu ta' NSAIDs u ma jistgħux ma jiġux ikkunsidrati għal etoricoxib: nefrotossiċità inkluż nefrite interstitjali u sindrome nefrotiku; tossiċità tal-fwied inkluż indeboliment epatiku, suffejra u pankreatite.
English: Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Maltese: Etoricoxib huwa inibitur selettiv ta' COX-2 (cyclooxygenase 2) indikat fis-serħan sintomatiku ta' losteoartrite (OA, 30-60mg darba kuljum (od)), artrite rewmatojde (RA, 90mg od) u l-uġigħ u s-sinjali ta' infjammazzjoni assoċjata ma' artrite akuta tal-gotta (120mg od).
English: Effect of etoricoxib on drugs metabolised by sulfotransferases
Maltese: L-effett ta' etoricoxib fuq mediċini metabolizzati minn sulfotransferases
English: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Maltese: Rari ħafna: reazzjonijiet ta' sensittività eċċessiva, inkluż anġjoedema, reazzjonijiet anafilattiċi/anafilaktojde inkluż xokk.
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).
Maltese: Antikoagulanti orali: F'suġġetti stabilizzati fuq terapija ta' warfarina kronika, l-għoti ta' etoricoxib 120 mg kuljum kien assoċjat ma' żieda ta' madwar 13% fil-prothrombin time International Normalised Ratio (INR).
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.
Maltese: Żidiet ta' alanine aminotransferase (ALT) u/jew aspartate aminotransferase (AST) (bejn wieħed u ieħor tliet darbiet u iktar il-limitu ta' fuq tan-normal) ġew irrapportati f'madwar 1% tal-pazjenti fi provi kliniċi kkurati għal sena b'etoricoxib 30, 60 u 90 mg kuljum.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojde, coxibs, Kodiċi ATC:
English: Oral contraceptives: 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%.
Maltese: Kontraċettivi orali: Etoricoxib 60 mg mogħti fl-istess ħin ma' kontraċettiv orali li fih 35 mikrogrammi ta' ethinyl estradiol (EE) u 0.5 sa 1 mg norethindrone għal 21 jum żied l-AUC0-24hr b'rata fissa ta' EE b'37%.
English: SIA Merck Sharp & Dohme Latvija Skanstes 13
Maltese: SIA Merck Sharp & Dohme Latvija Skanstes Riga, LV-1013