natgillin/translations-raw huggingface dataset:
The number of discontinuations due to hypertension-related events was also not significantly different between lumiracoxib (37) and NSAIDs (52).
Število prekinitev zdravljenja zaradi dogodkov, povezanih s hipertenzijo, se med lumirakoksibom (37) in NSAR (52) tudi ni signifikantno razlikovalo.
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.
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.
Of the total drug related material in plasma, unchanged lumiracoxib is the major component.
Od vseh snovi v plazmi, ki so povezane z zdravilom, je poglavitna sestavina nespremenjeni lumirakoksib.
There were no significant differences between lumiracoxib and NSAIDs.
Med lumirakoksibom in NSAR ni bilo signifikantnih razlik.
Race: The pharmacokinetics of lumiracoxib are similar in Asians, Blacks and Caucasians.
Rasa: Farmakokinetika lumirakoksiba je pri pripadnikih rumene, črne in bele rase podobna.
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).
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).
Thus when lumiracoxib and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Pri sočasni uporabi lumirakoksiba in litija moramo bolnike skrbno opazovati, da bi pravočasno opazili znake toksičnosti litija.
* 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.
* 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.
Antacids: (aluminium hydroxide/magnesium hydroxide) had no clinically relevant effect on the pharmacokinetics of lumiracoxib.
Antacidi: (aluminijev hidroksid/magnezijev hidroksid) niso klinično pomembno vplivali na farmakokinetiko lumirakoksiba.
Pharmacokinetic Interactions
Farmakokinetične interakcije
Rare: blood bilirubin increased, blood glucose increased
Redki: zvišan bilirubin v krvi, zvišana glukoza v krvi.
Across clinical pharmacology studies, lumiracoxib produced dose-dependent inhibition of COX-2 in plasma without inhibition of COX-1.
V kliničnofarmakoloških študijah je lumirakoksib povzročal od odmerka odvisno inhibicijo COX-2 v plazmi, brez inhibicije COX-1.
Rare: gastrointestinal haemorrhage
Redka: gastrointestinalna krvavitev.
Psychiatric disorders Uncommon: depression, insomnia, anxiety
Psihiatrične motnje Redke: depresivnost, nespečnost, anksioznost.
Renal Insufficiency:
Insuficienca ledvic:
The incidence of resorption was increased in rabbits at approximately 9 times the human exposure following a 200 mg dose.
Incidenca resorpcije se je zvečala pri kuncih pri izpostavljenosti, ki je bila približno 9-krat večja od izpostavljenosti pri človeku po 200-miligramskem odmerku.
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.
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.
However, patients who experience dizziness, vertigo or somnolence while taking lumiracoxib should refrain from driving or operating machinery.
Vendar naj bolniki, ki pri jemanju lumirakoksiba opažajo vrtoglavost, vrtoglavico ali zaspanost, ne upravljajo motornih vozil ali strojev.
For the short-term relief of moderate to severe acute pain associated with: primary dysmenorrhea, dental surgery, orthopaedic surgery.
Za kratkoročno lajšanje zmerne do hude akutne bolečine, povezane s/z: primarno dismenorejo, stomatološkimi operacijami, ortopedskimi operacijami.
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.
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.
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.
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.
In vivo studies suggest that lumiracoxib has low potential for interactions with CYP2C9 substrates.
Študije in vivo kažejo, da ima lumirakoksib majhen potencial za interakcije s substrati CYP2C9.
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.
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.
However, it is prudent to initiate treatment at the lower recommended dose in such patients (see section 4.3, 4.4 and 5.2).
Vendar je pri takih bolnikih pametno uvesti zdravljenje z najmanjšim priporočenim odmerkom (glejte poglavja 4.3, 4.4 in
To monitor and report PSUR of a list of agreed AEs.
Spremljanje in sporočanje seznama potrjenih neželenih učinkov v okviru PSUR.
Dialysis has no effect on the exposure of patients to lumiracoxib or its active metabolite.
Dializa ne vpliva na izpostavljenost bolnikov lumirakoksibu ali njegovemu glavnemu presnovku.
Lumiracoxib is rapidly absorbed following oral administration.
Lumirakoksib se po peroralni uporabi hitro absorbira.
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.
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.
As with other drugs known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking lumiracoxib in clinical trials.
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.
Patients with severe hepatic disease (Child-Pugh >9).
Bolniki s hudim obolenjem jeter (ocena >9 po Child-Pughovi lestvici).
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).
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.
Expedited reporting of a list of agreed SAEs.
Hitrejše sporočanje seznama potrjenih resnih neželenih učinkov (SAE).
Common: cough, pharyngitis
Pogosti: kašelj, faringitis.
Compared to healthy subjects, exposure to lumiracoxib was not changed in patients with moderate hepatic impairment (Child-Pugh score 7-8).
V primerjavi z zdravimi osebami se izpostavljenost lumirakoksibu ni spremenila pri bolnikih z zmernimi okvarami jeter (ocena 7-8 po Child-Pughovi lestvici).
Lumiracoxib is contraindicated in patients with moderate to severe renal impairment (estimated creatinine clearance <50 ml/min) (see section 4.3, 4.4 and 5.2).
Lumirakoksib je kontraindiciran pri bolnikih z zmernimi do težkimi okvarami ledvic (ocenjeni očistek kreatinina <50 ml/min) (glejte poglavja 4.3, 4.4 in 5.2).
Known hypersensitivity to lumiracoxib or to any of the excipients.
Znana preobčutljivost za lumirakoksib ali katerokoli pomožno snov.
Core:
Sredica:
Any patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Spremljati moramo vsakega bolnika, ki ima simptome in/ali znaki, ki kažejo na moteno delovanje jeter ali nenormalne teste jetrne funkcije.
Renal insufficiency: No dose adjustment is necessary for patients with creatinine clearance ≥50 ml/min.
Insuficienca ledvic: Pri bolnikih z očistkom kreatinina ≥50 ml/min ni potrebno prilagajanje odmerjanja.
Approximately 1,100 patients were treated with lumiracoxib in analgesia clinical studies (post-surgical dental pain, primary dysmenorrhea, and post-orthopedic surgery pain).
Približno 1.100 bolnikov so zdravili z lumirakoksibom v kliničnih študijah analgezije (bolečine po operaciji zob, primarne dismenoreje in bolečine po ortopedskih operacijah).
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 NSAID's.
Klinične raziskave kažejo, da je razred zdravil selektivnih zaviralcev COX-2 lahko povezan s tveganjem za trombotične dogodke (posebno za miokardni infarkt (MI) in možgansko kap) glede na placebo in nekatere NSAR-e.
Monitoring of renal function in such patients should be considered.
Pri takih bolnikih je treba pretehtati možnost spremljanja funkcije ledvic.
Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Nekateri selektivni zaviralci COX-2 so bili povezani s povečanim tveganjem neželenih učinkov na koži pri bolnikih, ki so v preteklosti imeli alergijo na katerokoli zdravilo.
Pharmacodynamic Interactions
Farmakodinamske interakcije
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal functions), the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
pri dehidriranih bolnikih ali starejših bolnikih z okvarjenimi funkcijami ledvic) lahko sočasna uporaba zaviralca ACE ali antagonista angiotenzina II in sredstev, ki zavirajo ciklooksigenazo, povzroči nadaljnje poslabšanje ledvične funkcije, vključno z možno akutno ledvično odpovedjo, ki je navadno reverzibilna.
Lumiracoxib at 800 mg daily did not lead to clinically meaningful inhibition of gastric prostaglandin synthesis and had no effect on platelet function.
Lumirakoksib v odmerku 800 mg na dan ni povzročil klinično pomembne inhibicije sinteze prostaglandinov v želodcu in ni vplival na funkcijo trombocitov.
The number of discontinuations in TARGET due to oedema was not significantly different between lumiracoxib (43) and NSAIDs (55).
Število prekinitev zdravljenja v študiji TARGET zaradi edemov se med lumirakoksibom (43) in NSAR (55) ni signifikantno razlikovalo.
Cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, povidone, titanium dioxide, magnesium stearate
Mikrokristalna celuloza, natrijeva kroskarmeloza, monohidrat laktoze, povidon, titanov dioksid, magnezijev stearat.
Multiple doses of lumiracoxib 1,200 mg once daily have been administered to patients with rheumatoid arthritis for 4 weeks without clinically significant adverse effects.
Bolnikom z revmatoidnim artritisom so 4 tedne dolgo dajali večkratne odmerke lumirakoksiba po 1.200 mg enkrat na dan brez klinično pomembnih neželenih učinkov.
Invented name Strength
Lastniško ime Jakost
Blood and lymphatic system disorders Uncommon: anaemia
Bolezni krvi in limfatičnega sistema Občasna: anemija.
Patients who have experienced asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Bolniki, pri katerih so se po jemanju acetilsalicilne kisline ali NSAR-ov, pojavili astma, akutni rinitis, nosni polipi, angioedem, urtikarija ali druge alergijske reakcije.
Oral contraceptives: Co-administration of lumiracoxib did not affect the steady state pharmacokinetics or the efficacy of ethinylestradiol and of levonorgestrel.
Peroralni kontraceptivi: Sočasna uporaba lumirakoksiba ni vplivala na farmakokinetiko v stanju ravnovesja ali na učinkovitost etinilestradiola in levonorgestrola.
Methotrexate: Co-administration of lumiracoxib at doses of 400 mg once daily had no clinically significant effects on the plasma pharmacokinetics, plasma protein binding or urinary excretion of methotrexate and of the 7-hydroxy methotrexate metabolite.
Metotreksat: Sočasna uporaba lumirakoksiba v odmerkih po 400 mg enkrat na dan ni klinično pomembno vplivala na plazemsko farmakokinetiko, vezavo na plazemske beljakovine ali izločanje v urinu metotreksata in njegovega presnovka 7-hidroksimetotreksata.
There is no significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2) up to 800 mg in healthy volunteers.
Pri zdravih prostovoljcih do odmerka 800 mg ni signifikantne inhibicije COX-1 (ocenjene kot ex vivo inhibicija tromboksana B2).
The oxidative metabolism of lumiracoxib is mainly CYP2C9 mediated.
Oksidativno presnovo lumirakoksiba posreduje predvsem CYP2C9.
- the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
- novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in, ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom; - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
The use of lumiracoxib, as with any drug to inhibit COX-2, is not recommended in women attempting to conceive.
Uporabe lumirakoksiba, podobno kot drugih zdravil, ki zavirajo COX-2, ne priporočajo ženskam, ki poskušajo zanositi.
Common: abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, flatulence Uncommon: gastroduodenal ulcer, gastroduodenitis, oesophagitis, abdominal distension, aphthous stomatitis, dry mouth, dysphagia, epigastric discomfort, eructation, gastrooesophageal reflux disease, gingivitis, hyperacidity, toothache
Občasne: gastroduodenalni ulkus, gastroduodenitis, ezofagitis, raztezanje trebuha, aftozni stomatitis, suha usta, disfagija, bolečine v epigastriju, kolcanje, bolezen gastroezofagealnega refluksa, gingivitis, hiperacidnost, zobobol.
Cellulose microcrystalline, croscarmellose sodium, povidone, magnesium stearate
Mikrokristalna celuloza, natrijeva kroskarmeloza, povidon, magnezijev stearat.
Caution should be used when initiating treatment with lumiracoxib in patients with dehydration.
Pri uvajanju zdravljenja z lumirakoksibom pri dehidriranih bolnikih je potrebna previdnost.
Lumiracoxib, should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Lumirakoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
Compared to placebo treatment, recovery of the S-7-OH warfarin metabolite in urine was about 25% lower in subjects treated with lumiracoxib.
V primerjavi s tistimi, ki so dobivali placebo, so pri osebah, zdravljenih z lumirakoksibom, prestregli v urinu okrog 25 % manj presnovka S-7-OH varfarina.
In clinical studies, lumiracoxib 400 mg relieved pain in acute analgesic models of post-operative dental pain, post-orthopaedic surgical pain, and primary dysmenorrhea.
V kliničnih raziskavah je lumirakoksib v odmerku 400 mg olajšal bolečine v akutnih analgetičnih modelih postoperativnega zobobola, bolečine po ortopedskih operacijah in primarne dismenoreje.
Patients should not exceed this dose and the treatment duration should not exceed 5 days.
Priporočeni odmerek je 400 mg enkrat na dan. Bolniki tega odmerka ne smejo prekoračiti, trajanje zdravljenja pa ne sme preseči 5 dni.
In repeat dose toxicity studies in rats and monkeys, target organs were the gastrointestinal tract and kidney.
V študijah toksičnosti ponavljajočih se odmerkov na podganah in opicah so bili tarčni organi prebavila in ledvica.
Systemic exposure at levels with no adverse effect for these targets in rat (26-week study) and monkey (39-week study) were 6.5 and 22 times that in man following a 200 mg therapeutic dose, respectively.
Sistemska izpostavljenost, pri kateri pri podganah (26-tedenska študija) oziroma opicah (39-tedenska študija) v teh tarčah ni bilo neželenih učinkov, je bila 6,5-krat oziroma 22-krat večja od sistemske izpostavljenosti pri človeku po 200-miligramskem terapevtskem odmerku.
CYP2C9 poor metabolisers: No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers (see section 5.2).
Osebe z upočasnjeno presnovo s CYP2C9: Pri osebah, za katere je znano, da imajo upočasnjeno presnovo s CYP2C9, ni potrebno prilagajanje odmerjanja (glejte poglavje 5.2).
COX-2 selective inhibitors are not a substitute for ASA for prophylaxis of cardiovascular thromboembolic diseases because of their lack of antiplatelet effect.
Selektivni zaviralci COX-2 pri preprečevanju srčnožilnih tromboembolijskih bolezni niso nadomestilo za acetilsalicilno kislino, ker nimajo učinka na trombocite.
Haemodialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Zaradi velike vezave na beljakovine ni verjetno, da bi bila hemodializa učinkovita metoda odstranjevanja zdravila.
Rare: pancytopenia, neutropenia, leucopenia
Redke: pancitopenija, nevtropenija, levkopenija.
Patients with active peptic ulceration or gastrointestinal bleeding.
Bolniki z aktivno razjedo želodca ali krvavitvijo v prebavilih.
It is advisable to rehydrate patients prior to starting therapy with lumiracoxib.
Pred začetkom zdravljenja z lumirakoksibom je priporočljivo bolnike rehidrirati.
Common: dizziness, headache
Pogosti: vrtoglavost, glavobol.
Relief of pain due to primary dysmenorrhea: the maximum treatment duration in clinical studies was 3 days.
Lajšanje akutne bolečine zaradi primarne dismenoreje: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 3 dni.
TARGET, a 12-month, double-blind, phase III study included 18,325 OA patients randomized to lumiracoxib 400 mg once daily (two to four times the recommended OA dose), naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Preskus Terapevtska raziskava artritisa in gastrointestinalnih dogodkov (TARGET) Študija TARGET, 12-mesečna dvojno slepa študija III. faze, je zajela 18.325 bolnikov z OA, randomiziranih na lumirakoksib 400 mg enkrat na dan (ta odmerek je dvakrat do štirikrat večji od priporočenega odmerka pri OA), naproksen 500 mg dvakrat na dan ali ibuprofen 800 mg trikrat na dan. TARGET je zajel bolnike, ki so jemali ASA v majhnih odmerkih (75-100 mg na dan) za primarno ali sekundarno preventivo koronarne bolezni srca.
For diastolic blood pressure, mean change from baseline were0.1 mmHg for lumiracoxib and +0.5 mmHg for NSAIDs (p<0.0001).
Za diastolični krvni tlak je bila povprečna sprememba od izhodne vrednosti -0,1 mmHg pri lumirakoksibu in +0,5 mmHg pri NSAR (p<0,0001).
Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.
Lajšanje akutne bolečine zaradi stomatološke operacije: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 24 ur.
Thus, no dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Zato pri bolnikih z blagimi ali zmernimi okvarami jeter ni potrebno prilagajanje odmerjanja.
Relief of acute pain due to orthopaedic surgery: the maximum treatment duration in clinical studies was 5 days.
Lajšanje akutne bolečine zaradi ortopedske operacije: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 5 dni.
At the level with no embryo/fetal effect, the systemic exposure was 8.6 (rat) and 2.2 (rabbit) times that in man following a 200 mg therapeutic dose.
Pri ravni, ki ni vplivala na zarodek/plod, je bila sistemska izpostavljenost 8,6-krat (podgana) oziroma 2,2-krat (kunec) večja kot pri človeku po 200-miligramskem terapevtskem odmerku.
Hepatic impairment: No dose adjustment is necessary for patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-8) hepatic impairment.
Okvare jeter: Pri bolnikih z blagimi (ocena 5-6 po Child-Pughovi lestvici) do zmernimi (ocena 7-8 po Child-Pughovi lestvici) okvarami jeter ni potrebno prilagajanje odmerjanja.
Uncommon: dyspnoea, epistaxis, rhinitis, sinus congestion, asthma
Občasne: dispneja, epistaksa, rinitis, kongestija sinusov, astma.
Hepatobiliary disorders Rare: cholecystitis, cholelithiasis, hepatitis
Bolezni jeter, žolčnika in žolčevodov Redke: holecistitis, holelitiaza, hepatitis.
Lumiracoxib does not accumulate in plasma under once or twice daily administration and steady state is achieved on the first day of administration with no increase in Cmax or AUC after extended dosing.
Stanje ravnovesja se doseže prvega dne uporabe, po dolgotrajnejšem odmerjanju se niti Cmax niti AUC ne zvišata.