FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Slovenian: Bolniki s potrjeno ishemično boleznijo srca, boleznijo perifernih arterij in/ali cerebrovaskularno boleznijo.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for lumiracoxib containing medicinal products.
Slovenian: Opomba: Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s členom 31, za zdravila, ki vsebujejo lumirakoksib.
English: Gastrointestinal Effect in TARGET (12-month study) The primary endpoint was time to event distribution of definite or probable upper gastrointestinal tract ulcer (UGIT) complications (POBs).
Slovenian: Gastrointestinalni učinki v študiji TARGET (12-mesečna študija) Primarno končno stanje je bil čas do dogodkovne distribucije definitivnih ali verjetnih komplikacij (POB) ulkusa zgornjih prebavil (UGIT).
English: Paediatric patients: The pharmacokinetics of lumiracoxib in paediatric patients have not been studied.
Slovenian: Pediatrični bolniki: Farmakokinetike lumirakoksiba pri pediatričnih bolnikih niso proučevali.
English: Women who use lumiracoxib should not breastfeed.
Slovenian: Ženske, ki jemljejo lumirakoksib, ne smejo dojiti.
English: In clinical trials, lumiracoxib was evaluated for safety in approximately 7,000 patients, including approximately 4,000 patients with OA and 2,100 patients with RA (approximately 1,100 patients with OA or RA were treated for 6 month, and 530 patients with OA were treated for 1 year).
Slovenian: Lumirakoksib so ovrednotili glede varnosti v kliničnih preskusih na približno 7.000 bolnikih, med drugim na približno 4.000 bolnikih z OA in 2.100 bolnikih z RA (približno 1.100 bolnikov z OA ali RA so zdravili 6 mesecev, 530 bolnikov z OA pa 1 leto).
English: [C]-labeled lumiracoxib in a rat model of inflammation, the ratio of radioactivity detected at the site of inflammation versus that detected in the blood was 2:1, and was 8:1 four hours post dose.
Slovenian: [C], v podganjem modelu vnetja je bilo razmerje radioaktivnosti, izmerjene na mestu vnetja, in tiste, izmerjene v krvi, 2:1, štiri ure po odmerku pa 8:1.
English: While renal insufficiency does not significantly influence the pharmacokinetics of lumiracoxib and its active metabolite, use of lumiracoxib in patients with moderate to severe renal insufficiency is contraindicated because of potential further deterioration of renal function due to cyclooxygenase inhibition (see section 4.3 and
Slovenian: Medtem ko ledvična insuficienca ne vpliva pomembno na farmakokinetiko lumirakoksiba in njegovega aktivnega presnovka, je uporaba lumirakoksiba pri bolnikih z zmerno do težko ledvično insuficienco kontraindicirana zaradi možnega nadaljnjega poslabševanja ledvične funkcije zaradi inhibicije ciklooksigenaze (glejte poglavji 4.3 in 4.4).
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Slovenian: Selektivni zaviralci COX-2 zmanjšajo nastajanje sistemskega (in zato možno endotelijskega) prostaciklina, ne da bi vplivali na trombocitni tromboksan.
English: Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, weight increased.
Slovenian: Občasne: zvišana alanin aminotransferaza, zvišana aspartat aminotransferaza, zvišan kreatinin v krvi, zvišana sečnina v krvi, zvišana gama-glutamiltransferaza, zvečana telesna teža.
English: There is no clinical experience of overdose.
Slovenian: S prevelikim odmerjanjem ni nobenih kliničnih izkušenj.
English: Therefore anticoagulant activity should be monitored in patients taking warfarin or similar agents, particularly in the first few days after initiating or changing the dose of lumiracoxib.
Slovenian: Zato je treba pri bolnikih, ki jemljejo varfarin ali podobna sredstva, posebno prvih nekaj dni po uvedbi lumirakoksiba ali spremembi njegovega odmerka spremljati antikoagulantno aktivnost.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 predstavlja izoobliko encima, za katero so je pokazalo, da jo inducirajo provnetni dražljaji in za katerega domnevajo, da je odgovoren predvsem za sintezo prostanoidnih mediatorjev bolečine, vnetja in vročine.
English: These interactions should be given consideration in patients taking lumiracoxib concomitantly with ACE-inhibitors or angiotensin II antagonists.
Slovenian: Te reakcije je treba upoštevati pri bolnikih, ki jemljejo lumirakoksib sočasno z zaviralci ACE ali antagonisti angiotenzina II.
English: The following rare serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for lumiracoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome and renal failure; hepatotoxicity including hepatic failure and jaundice; cutaneomucosal adverse effects and severe skin reactions.
Slovenian: O naslednjih redkih resnih neželenih učinkih so poročali v zvezi z uporabo NSAR-ov in jih ne moremo izključiti za lumirakoksib: nefrotoksičnost vključno z intersticijskim nefritisom in nefrotskim sindromom in ledvično odpovedjo; hepatotoksičnost vključno z odpovedjo jeter in zlatenico; kožnosluznični neželeni učinki in hude kožne reakcije.
English: Plasma protein binding of lumiracoxib was similar in healthy subjects and in patients with end-stage renal disease.
Slovenian: Vezava lumirakoksiba na plazemske beljakovine je bila pri zdravih osebah in bolnikih z boleznijo ledvic v končnem stadiju podobna.
English: NAME OF THE MEDICINAL PRODUCT {INVENTED NAME} 100 mg film-coated tablets {INVENTED NAME} 200 mg film-coated tablets {INVENTED NAME} 400 mg film-coated tablets
Slovenian: {IZMIŠLJENO IME} 100 mg filmsko obložene tablete {IZMIŠLJENO IME} 200 mg filmsko obložene tablete {IZMIŠLJENO IME} 400 mg filmsko obložene tablete
English: Based on in vitro studies, interactions involving plasma protein binding are not expected to have any clinically relevant effects on lumiracoxib or co-administered drugs.
Slovenian: Na podlagi študij in vitro ne pričakujemo, da bi interakcije, v katere je vpletena vezava na plazemske beljakovine, imele klinično pomembne učinke na lumirakoksib ali sočasno uporabljana zdravila.
English: Reproductive system disorders Rare: erectile dysfunction
Slovenian: Motnje reprodukcije in dojk Redka: erektilna disfunkcija.
English: 6.6 Instructions for use and handling and disposal Not applicable.
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom in odlaganje
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
Slovenian: Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo.
English: Concomitant administration of lumiracoxib with high doses of aspirin, other NSAIDs or COX-2 inhibitors should be avoided.
Slovenian: Sočasni uporabi lumirakoksiba z velikimi odmerki aspirina, drugimi NSAR ali zaviralci COX-2 se je treba izogibati.
English: In a pre- and post-natal development study in rats, an increase in stillborn pups and reduced embryo/fetal survival was seen at maternally toxic doses ≥3 mg/kg.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah so ugotovili zvečanje incidence mrtvorojenih mladičev in zmanjšano preživetje zarodkov/plodov pri odmerkih ≥3 mg/kg, ki so bili toksični za mater.
English: As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used.
Slovenian: Ker se srčnožilno tveganje lumirakoksiba lahko poveča z odmerkom in trajanjem zdravljenja, mora biti trajanje zdravljenja najkrajše, uporabiti pa moramo najmanjši učinkovit dnevni odmerek.
English: Lumiracoxib is highly bound to plasma proteins, (≥98%), and binding is independent of concentration over a range of 0.1 to 100 µg/mL.
Slovenian: Lumirakoksib se v veliki meri veže na plazemske beljakovine (≥98 %), vezava pa je v mejah med 0,1 in 100 µg/ml neodvisna od koncentracije.
English: Oral anticoagulants: In a drug-drug interaction study in healthy subjects stabilised on warfarin therapy, the administration of lumiracoxib 400 mg once daily for five days was associated with an approximate 15% increase in prothrombin time.
Slovenian: Peroralni antikoagulanti: V študiji interakcij med zdravili pri zdravih osebah, stabiliziranih na zdravljenju z varfarinom, je bila uporaba lumirakoksiba v odmerku 400 mg enkrat na dan pet dni dolgo povezana s približno 15-odstotnimpodaljšanjem protrombinskega časa.
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Slovenian: Razlika v antiagregacijski aktivnosti med nekaterimi NSAR-i, ki zavirajo COX-1, in selektivnimi zaviralci COX-2 je lahko klinično pomembna pri bolnikih s tveganjem za tromboembolične reakcije.
English: Patients with moderate to severe renal dysfunction (estimated creatinine clearance <50 ml/min).
Slovenian: Bolniki z zmerno do težko disfunkcijo ledvic (ocenjeni očistek kreatinina <50 ml/min).
English: Other metabolites are not active as COX-1 or COX-2 inhibitors.
Slovenian: Drugi presnovki niso aktivni kot zaviralci COX-1 ali COX-2.
English: In short-term, multiple-dose clinical studies of post-orthopaedic surgical pain and pain from primary dysmenorrhea, lumiracoxib 400 mg once daily was effective in relieving pain.
Slovenian: V kratkoročnih kliničnih študijah večkratnih odmerkov pri bolečini po ortopedskih operacijah in bolečini zaradi primarne dismenoreje je bil lumirakoksib v odmerku 400 mg enkrat na dan učinkovit pri lajšanju bolečin.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Slovenian: COX-2 so odkrili v tkivu okrog želodčnih razjed pri ljudeh, vendar njenega pomena celjenje razjed še niso dokazali.
English: Selective inhibition of COX-2 by lumiracoxib provides anti-inflammatory and analgesic effects.
Slovenian: Selektivna inhibicija COX-2 z lumirakoksibom povzroča protivnetne in analgetične učinke.
English: Caution should be exercised in elderly osteoarthritis patients when increasing from a 100 mg to a 200 mg daily dose (see section 4.4 and 5.2).
Slovenian: Pri starejših bolnikih z osteoartrozo je pri zvečevanju dnevnega odmerka s 100 mg na 200 mg potrebna previdnost (glejte poglavji 4.4 in 5.2).
English: The mean plasma half-life of lumiracoxib is approximately 4 hours.
Slovenian: Povprečni razpolovni čas lumirakoksiba v plazmi je približno 4 ure.
English: If signs of hepatic insufficiency occur, or if abnormal liver function tests (ALT or AST>3xULN) persist, lumiracoxib should be discontinued.
Slovenian: Če se pojavijo znaki jetrne insuficience ali trajno nenormalne vrednosti jetrnih testov (ALT ali AST>3xULN), moramo zdravljenje z lumirakoksibom ukiniti.
English: In rats the incidence of pre-implantation loss was increased at a dose of 100 mg/kg/day, (10.4 times the human therapeutic exposure following a dose of 200 mg), which caused maternal toxicity.
Slovenian: Pri podganah se je incidenca izgube plodov pred ugnezditvijo zvečala pri odmerku 100 mg/kg/dan (ki je 10,4-krat večji od terapevtske izpostavljenosti pri človeku po 200-miligramskem odmerku), ki je povzročil toksičnost za mater.
English: To conduct a database study of drug utilisation of lumiracoxib and other marketed NSAIDs and COX-2 inhibitors.
Slovenian: Da bo izvedel študijo zbirke podatkov o uporabi zdravila lumirakoksib in drugih odobrenih nesteroidnih protivnetnih zdravil (NSAIDs) in zaviralcev COX-2.
English: There were no cases of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme reported in association with the use of lumiracoxib.
Slovenian: Ni bilo primerov Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize ali multiformnega eritema, ki bi bili povezani z uporabo lumirakoksiba.
English: There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when lumiracoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Slovenian: Obstaja večje tveganje za neželene učinke v prebavilih (razjeda v prebavilih ali drugi zapleti prebavil), kadar se lumirakoksib uporablja sočasno z acetilsalicilno kislino (tudi če so njeni odmerki majhni).
English: Infections
Slovenian: Infekcijske bolezni
English: Based on these studies, lumiracoxib appears to have a low potential for interactions with compounds cleared by cytochrome P450 except for CYP2C9 where there is possibility of decreased clearance of concomitantly administered substrates of CYP2C9.
Slovenian: Na podlagi teh študij se zdi, da ima lumirakoksib majhen potencial za interakcije s spojinami, ki se presnavljajo preko citokroma P450, razen CYP2C9, pri katerem obstaja možnost zmanjšanega očistka sočasno uporabljenih substratov CYP2C9.
English: No difference was observed in the plasma protein binding between the two groups.
Slovenian: Med obema skupinama niso ugotovili razlik v vezavi na plazemske beljakovine.
English: Use of lumiracoxib, as with any drug known to inhibit COX-2, is not recommended in women attempting to conceive (see section 4.6).
Slovenian: Uporabe lumirakoksiba, tako kot drugih zdravil, za katera je znano, da zavirajo COX-2, ne priporočajo pri ženskah, ki poskušajo zanositi (glejte poglavje 4.6).
English: Ciclosporin or tacrolimus: Although this interaction has not been studied with lumiracoxib, coadministration of ciclosporin or tacrolimus and any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
Slovenian: Ciklosporin ali takrolimus: Čeprav te kombinacije z lumirakoksibom niso proučili, utegne sočasna uporaba ciklosporina ali takrolimusa in kateregakoli NSAR zvečati nefrotoksični učinek ciklosporina ali takrolimusa.
English: However care should be exercised when lumiracoxib is co-administered with substrates of CYP2C9 that have very narrow therapeutic index, such as phenytoin and warfarin.
Slovenian: Vendar je potrebna previdnost, kadar lumirakoksib uporabljamo sočasno s substrati CYP2C9, ki imajo zelo majhno terapevtsko okno, na primer fenitoin in varfarin.
English: The number of discontinuations due to hypertension-related events was also not significantly different between lumiracoxib (37) and NSAIDs (52).
Slovenian: Število prekinitev zdravljenja zaradi dogodkov, povezanih s hipertenzijo, se med lumirakoksibom (37) in NSAR (52) tudi ni signifikantno razlikovalo.
English: Cardiovascular Effect in TARGET (12-month study) The primary cardiovascular (CV) endpoint studied was the Antiplatelet Trialists' Collaboration (APTC) endpoint: confirmed or probable myocardial infarction (clinical or silent), stroke (ischemic or haemorrhagic) and CV death.
Slovenian: Kardiovaskularni učinki v študiji TARGET (12-mesečna študija) Primarno kardiovaskularno (CV) končno stanje, ki so ga proučevali, je bilo končno stanje po Antiplatelet Trialists' Collaboration (APTC): potrjen ali verjeten miokardni infarkt (klinični in tihi), možganska kap (ishemična ali hemoragična) in CV smrt.
English: Of the total drug related material in plasma, unchanged lumiracoxib is the major component.
Slovenian: Od vseh snovi v plazmi, ki so povezane z zdravilom, je poglavitna sestavina nespremenjeni lumirakoksib.
English: There were no significant differences between lumiracoxib and NSAIDs.
Slovenian: Med lumirakoksibom in NSAR ni bilo signifikantnih razlik.
English: Race: The pharmacokinetics of lumiracoxib are similar in Asians, Blacks and Caucasians.
Slovenian: Rasa: Farmakokinetika lumirakoksiba je pri pripadnikih rumene, črne in bele rase podobna.
English: The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see section 4.2, 4.3, 4.8 and 5.1).
Slovenian: Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartritisom (glejte poglavja 4.3, 4.4, 4.8 in 5.1).
English: Thus when lumiracoxib and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Slovenian: Pri sočasni uporabi lumirakoksiba in litija moramo bolnike skrbno opazovati, da bi pravočasno opazili znake toksičnosti litija.
English: * Based on analyses of long-term placebo and active controlled clinical trials, some selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Slovenian: * Glede na rezultate dolgoročnih, s placebom in drugim zdravilom primerjanih kliničnih raziskav so bili nekateri selektivni zaviralci COX-2 povezani s povečanim tveganjem za resne trombotične dogodke v arterijah, vključno z miokardnim infarktom in možgansko kapjo.
English: Antacids: (aluminium hydroxide/magnesium hydroxide) had no clinically relevant effect on the pharmacokinetics of lumiracoxib.
Slovenian: Antacidi: (aluminijev hidroksid/magnezijev hidroksid) niso klinično pomembno vplivali na farmakokinetiko lumirakoksiba.
English: Pharmacokinetic Interactions
Slovenian: Farmakokinetične interakcije
English: Rare: blood bilirubin increased, blood glucose increased
Slovenian: Redki: zvišan bilirubin v krvi, zvišana glukoza v krvi.
English: Across clinical pharmacology studies, lumiracoxib produced dose-dependent inhibition of COX-2 in plasma without inhibition of COX-1.
Slovenian: V kliničnofarmakoloških študijah je lumirakoksib povzročal od odmerka odvisno inhibicijo COX-2 v plazmi, brez inhibicije COX-1.
English: Rare: gastrointestinal haemorrhage
Slovenian: Redka: gastrointestinalna krvavitev.
English: Psychiatric disorders Uncommon: depression, insomnia, anxiety
Slovenian: Psihiatrične motnje Redke: depresivnost, nespečnost, anksioznost.
English: Renal Insufficiency:
Slovenian: Insuficienca ledvic:
English: The incidence of resorption was increased in rabbits at approximately 9 times the human exposure following a 200 mg dose.
Slovenian: Incidenca resorpcije se je zvečala pri kuncih pri izpostavljenosti, ki je bila približno 9-krat večja od izpostavljenosti pri človeku po 200-miligramskem odmerku.
English: On the basis of both plasma exposure to lumiracoxib and pharmacogenetic analysis, no evidence has been found to suggest that exposure to lumiracoxib is increased in subjects with genotypes of CYP2C9 associated with reduced metabolic clearance.
Slovenian: Niti na podlagi plazemske izpostavljenosti lumirakoksibu niti s farmakogenetsko analizo niso našli dokazov, ki bi kazali, da se izpostavljenost lumirakoksibu zveča pri osebah s tistimi genotipi CYP2C9, ki so povezani z manjšim presnovnim očistkom.
English: However, patients who experience dizziness, vertigo or somnolence while taking lumiracoxib should refrain from driving or operating machinery.
Slovenian: Vendar naj bolniki, ki pri jemanju lumirakoksiba opažajo vrtoglavost, vrtoglavico ali zaspanost, ne upravljajo motornih vozil ali strojev.
English: For the short-term relief of moderate to severe acute pain associated with: primary dysmenorrhea, dental surgery, orthopaedic surgery.
Slovenian: Za kratkoročno lajšanje zmerne do hude akutne bolečine, povezane s/z: primarno dismenorejo, stomatološkimi operacijami, ortopedskimi operacijami.
English: Therefore, under conditions of compromised renal perfusion, administration of lumiracoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Slovenian: Zato v razmerah ogrožene perfuzije ledvic uporaba lumirakoksiba lahko zmanjša nastajanje prostaglandinov in s tem sekundarno pretok krvi skozi ledvica, s čimer zmanjša delovanje ledvic.
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 ASA concomitantly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Slovenian: Previdnost priporočamo pri zdravljenju bolnikov, pri katerih je nevarnost, da bo prišlo do zapletov na prebavilih pri zdravljenju z NSAR-i največja: starejši bolniki, bolniki, ki sočasno jemljejo kakšne druge NSAR ali acetilsalicilno kislino in bolniki, ki so kdaj imeli bolezni prebavil, kot sta razjeda ali krvavitev v prebavilih.
English: In vivo studies suggest that lumiracoxib has low potential for interactions with CYP2C9 substrates.
Slovenian: Študije in vivo kažejo, da ima lumirakoksib majhen potencial za interakcije s substrati CYP2C9.
English: The effect of lumiracoxib on the PK of other drugs Warfarin: In a study with warfarin, which is considered to be a CYP2C9 substrate sensitive to drug interactions, co-administration with lumiracoxib 400 mg had no effect on plasma AUC, Cmax or Tmax of R-warfarin or S-warfarin.
Slovenian: Vpliv lumirakoksiba na farmakokinetiko drugih zdravil Varfarin: V študiji z varfarinom, ki velja za substrat CYP2C9, občutljiv za interakcije z drugimi zdravili, sočasna uporaba lumirakoksiba v odmerku 400 mg ni vplivala na plazemsko AUC, Cmax ali Tmax R-varfarina ali S-varfarina.
English: However, it is prudent to initiate treatment at the lower recommended dose in such patients (see section 4.3, 4.4 and 5.2).
Slovenian: Vendar je pri takih bolnikih pametno uvesti zdravljenje z najmanjšim priporočenim odmerkom (glejte poglavja 4.3, 4.4 in
English: To monitor and report PSUR of a list of agreed AEs.
Slovenian: Spremljanje in sporočanje seznama potrjenih neželenih učinkov v okviru PSUR.
English: Dialysis has no effect on the exposure of patients to lumiracoxib or its active metabolite.
Slovenian: Dializa ne vpliva na izpostavljenost bolnikov lumirakoksibu ali njegovemu glavnemu presnovku.
English: Lumiracoxib is rapidly absorbed following oral administration.
Slovenian: Lumirakoksib se po peroralni uporabi hitro absorbira.
English: Therefore, lumiracoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason.
Slovenian: Zato je treba lumirakoksib previdno uporabljati pri bolnikih, ki so kdaj imeli srčno popuščanje, disfunkcijo levega prekata ali hipertenzijo, ter pri bolnikih z obstoječimi edemi iz kakršnegakoli drugega vzroka.
English: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking lumiracoxib in clinical trials.
Slovenian: Tako kot pri drugih zdravilih, ki zavirajo sintezo prostaglandinov, so tudi pri bolnikih, ki so v kliničnih preskušanjih jemali lumirakoksib, opazili zadrževanje tekočine in edeme.
English: Patients with severe hepatic disease (Child-Pugh >9).
Slovenian: Bolniki s hudim obolenjem jeter (ocena >9 po Child-Pughovi lestvici).
English: In clinical studies the following undesirable effects were reported at an incidence greater than placebo in patients with OA or RA treated with lumiracoxib 200 mg daily for up to one year (approximately 920 patients for three months and approximately 250 patients for one year).
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih, katerih incidenca je bila pri bolnikih z OA ali RA, zdravljenih z lumirakoksibom v odmerku 200 mg na dan do eno leto (približno 920 bolnikov tri mesece in približno 250 bolnikov eno leto), večja kot pri bolnikih na placebu.
English: Expedited reporting of a list of agreed SAEs.
Slovenian: Hitrejše sporočanje seznama potrjenih resnih neželenih učinkov (SAE).
English: Common: cough, pharyngitis
Slovenian: Pogosti: kašelj, faringitis.