natgillin/translations-raw huggingface dataset:
When lumiracoxib was administered to patients with end-stage renal disease, a 33% decrease in lumiracoxib Cmax and a 27% decrease in AUC were observed compared to healthy subjects.
Ko so lumirakoksib dali bolnikom z boleznijo ledvic v končnem stadiju, so ugotovili 33-odstotno znižanje Cmax lumirakoksiba in 27-odstotno zmanjšanje AUC v primerjavi z zdravimi osebami.
It is not known whether lumiracoxib is excreted in human milk.
Ni znano, ali se lumirakoksib izloča v ženskem mleku.
Mean exposure to the active 4'-hydroxy-lumiracoxib metabolite was largely unaffected.
Povprečna izpostavljenost aktivnemu presnovku 4'-hidroksi-lumirakoksibu je bila večinoma nespremenjena.
No studies on the effect of lumiracoxib on the ability to drive or use machines have been performed.
Študije o vplivu lumirakoksiba na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Gender: There is no difference in exposure of lumiracoxib in men and women.
Spol: Pri moških in ženskah se izpostavljenost lumirakoksibu ne razlikuje.
In patients with osteoarthritis, lumiracoxib doses up to 200 mg once daily provided significant improvements in pain, stiffness, function, and patient assessments of disease status.
Pri bolnikih z osteoartrozo je lumirakoksib v odmerkih do 200 mg enkrat na dan signifikantno izboljšal bolečine, otrdelost, funkcijo in bolnikovo oceno stanja bolezni.
After administration of a single dose of lumiracoxib 400 mg to healthy subjects, 54% of drug-related material was excreted in urine and 43% in feces.
Po aplikaciji posameznega 400-miligramskega odmerka lumirakoksiba zdravim osebam se je 54 % z zdravilom povezanih snovi izločilo v urinu in 43 % v blatu.
Ethnic differences: Dosing recommendations are the same for Asians, Blacks and Caucasians (see section 5.2).
Rasne razlike: Priporočila za odmerjanje so za pripadnike rumene, črne in bele rase enaka (glejte poglavje 5.2).
As with other NSAIDs, lumiracoxib may mask fever and other signs of inflammation or infection.
Podobno kot drugi NSAR-I, lahko tudi lumirakoksib zakrije vročino in druge znake vnetja ali infekcije.
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of lumiracoxib therapy should be considered.
Če se med zdravljenjem poslabša delovanje kateregakoli organskega sistema opisanega zgoraj, je treba uvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja z lumirakoksibom.
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).
COX-2 ima vlogo tudi pri ovulaciji, vgnezdenje zarodka in zaprtju duktusa arteriozusa, regulaciji ledvične funkcije ter funkcije v centralnem živčnem sistemu (indukcija vročine, dojemanje bolečine in kognitivna funkcija).
Lumiracoxib is excreted in the milk of lactating rats.
Lumirakoksib se izloča v mleku doječih podgan.
Uncommon: venous insufficiency, hypotension, cerebrovascular accident*
Občasne: venska insuficienca, hipotenzija, cerebrovaskularni incident*.
Hypertension and oedema
Hipertenzija in edemi
Only about 5% of the administered dose was recovered in excreta as unchanged lumiracoxib.
Le okrog 5 % danega odmerka so prestregli iz izločkov v obliki nespremenjenega lumirakoksiba.
Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing lumiracoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, - recommended follow up measures to further investigate the safety of lumiracoxib.
Ob upoštevanju, da je CHMP - mnenja, da razmerje med koristjo in tveganjem za zdravila, ki vsebujejo lumirakoksib za dogovorjene indikacije, ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženih mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natančno spremljati in vrednotiti - priporočil nadaljne ukrepe za raziskovanje varnosti lumirakoksiba v prihodnje.
Follow-up measures of the Marketing Authorisation Holder As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below: Area
Nadaljnji ukrepi imetnika dovoljenja za promet z zdravilom Glede na zahteve CHMP se je imetnik dovoljenja za promet strinjal, da bo izvedel nadaljnje ukrepe kot so navedeni spodaj
Symptomatic relief in the treatment of osteoarthritis.
Simptomatsko zdravljenje osteoartroze.
Food had no significant effect on either Cmax or AUC of lumiracoxib when either 200 mg or 400 mg film-coated tablets of {Invented Name} were taken with a high-fat meal.
Hrana ni pomembno vplivala niti na Cmax niti na AUC lumirakoksiba, če so jemali bodisi 200-miligramske bodisi 400-miligramske filmsko obložene tablete zdravila {IZMIŠLJENO IME} z mastnim obrokom.
Chronic use with 400 mg daily dose was associated with more frequent and more marked elevations in ALT/AST.
Dolgotrajna uporaba odmerka 400 mg na dan je bila povezana s pogostejšim in izrazitejšim zvišanjem ALT/AST.
By about 5 hour post dose, concentrations of lumiracoxib in human synovial fluid of rheumatoid arthritis patients were higher than plasma and remained substantially higher for the remainder of the dose interval (AUC12-24 in synovial fluid was 2.6 times higher than that for plasma).
Približno 5 ur po odmerku so bile koncentracije lumirakoksiba v človeški sinovialni tekočini bolnikov z revmatoidnim artritisom višje kot v plazmi in so ostale znatno višje v času do naslednjega odmerka (AUC12-24 v sinovialni tekočini je bila 2,6-krat višja kot v plazmi).
Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with lumiracoxib after careful consideration (see section 5.1).
Bolnike s pomembnimi dejavniki tveganja srčnožilnih dogodkov (npr. visok krvni tlak, hiperlipidemija, sladkorna bolezen, kajenje) lahko z lumirakoksibom zdravimo le po skrbnem premisleku (glejte poglavje 5.1).
Patients at greatest risk of this response are those with pre-existing renal dysfunction, uncompensated heart failure, or cirrhosis and those receiving diuretics or ACE inhibitors.
Bolniki, ki jih ta odziv najbolj ogroža, so tisti z obstoječo disfunkcijo ledvic, nekompenziranim popuščanjem srca ali cirozo in tisti, ki prejemajo diuretike ali zaviralce ACE.
Three major metabolites were identified in plasma: 4'-hydroxy-lumiracoxib, 5-carboxy-lumiracoxib and 4'hydroxy-5-carboxy-lumiracoxib.
V plazmi so identificirali tri glavne presnovke: 4'-hidroksi-lumirakoksib, 5-karboksi lumirakoksib in 4'-hidroksi-5-karboksi-lumirakoksib.
In single dose post-operative dental pain trials, the onset of analgesia occurred within 45 minutes and persisted for as long as 24 hours after dosing.
V preskusih enkratnih odmerkov pri postoperativnem zobobolu je analgezija nastopila v 45 minutah in trajala do 24 ur po odmerjanju.
{Invented Name} filmcoated tablets can be administered without regard to timing of meals.
{IZMIŠLJENO IME} filmsko obložene tablete se lahko jemljejo brez ozira na čas obrokov.
Marked elevations (>8xULN) have been observed in 0.3% with 100 mg once or twice daily and 0.6% of patients at 200 mg once daily.
Izrazito zvišanje (>8xULN) so opazili pri 0,3 % bolnikov, ki so jemali po 100 mg enkrat ali dvakrat na dan, in pri 0,6 % bolnikov, ki so jemali po 200 mg enkrat na dan.
The 4'-hydroxy metabolite has similar potency and COX-2 selectivity to lumiracoxib.
4'-hidroksi presnovek ima podobno potenco in selektivnost za COX-2 kot lumirakoksib.
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn), which were started in November 2004.
V zvezi z razpravo Odbora za zdravila za uporabo v humani medicini (CHMP) na plenarni seji oktobra 2004 je Evropska komisija priporočila, da se za to javno zdravstveno vprašanje o vseh vidikih kardiovaskularne varnosti, vključno s trombotičnimi dogodki in kardiorenalnimi dogodki, sproži napotitveni postopek Skupnosti v skladu z 31. členom Direktive 2001/83/ES, z vsemi dodatki za zdravila, odobrena po decentraliziranem postopku in vsebujejo celekoksib, etorikoksib in lumirakoksib, ter revizijski postopek v skladu z 18. členom Uredbe Sveta (EGS) št. 2309/93 z vsemi dodatki za zdravila, odobrena po centraliziranem postopku in vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/Rayzon) in valdekoksib (Bextra/Valdyn).
Patients with inflammatory bowel disease.
Bolniki z vnetno boleznijo črevesa.
To conduct physician surveys to monitor appropriate use.
Da bo izvajal nadzor nad zdravniki in spremljal primernost uporabe zdravila.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Bolnike moramo zadostno hidrirati, pretehtati pa je treba tudi možnost spremljanja delovanja ledvic, in to po uvedbi kombiniranega zdravljenja in nato v rednih presledkih.
It may also play a role in ulcer healing.
Mogoče ima vlogo tudi pri celjenju razjed.
Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.
Litij: NSAR-i so povzročili zvišanje plazemskih koncentracij litija in zmanjšanje ledvičnega očistka litija.
In preclinical studies, lumiracoxib has been demonstrated to be neither mutagenic nor carcinogenic.
V predkliničnih študijah so dokazali, da lumirakoksib ni niti mutagen niti kancerogen.
Patients with established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Bolniki s potrjeno ishemično boleznijo srca, boleznijo perifernih arterij in/ali cerebrovaskularno boleznijo.
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.
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.
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).
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).
Paediatric patients: The pharmacokinetics of lumiracoxib in paediatric patients have not been studied.
Pediatrični bolniki: Farmakokinetike lumirakoksiba pri pediatričnih bolnikih niso proučevali.
Women who use lumiracoxib should not breastfeed.
Ženske, ki jemljejo lumirakoksib, ne smejo dojiti.
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).
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).
[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.
[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.
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
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).
COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Selektivni zaviralci COX-2 zmanjšajo nastajanje sistemskega (in zato možno endotelijskega) prostaciklina, ne da bi vplivali na trombocitni tromboksan.
Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, weight increased.
Občasne: zvišana alanin aminotransferaza, zvišana aspartat aminotransferaza, zvišan kreatinin v krvi, zvišana sečnina v krvi, zvišana gama-glutamiltransferaza, zvečana telesna teža.
There is no clinical experience of overdose.
S prevelikim odmerjanjem ni nobenih kliničnih izkušenj.
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.
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.
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.
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.
These interactions should be given consideration in patients taking lumiracoxib concomitantly with ACE-inhibitors or angiotensin II antagonists.
Te reakcije je treba upoštevati pri bolnikih, ki jemljejo lumirakoksib sočasno z zaviralci ACE ali antagonisti angiotenzina II.
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.
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.
Plasma protein binding of lumiracoxib was similar in healthy subjects and in patients with end-stage renal disease.
Vezava lumirakoksiba na plazemske beljakovine je bila pri zdravih osebah in bolnikih z boleznijo ledvic v končnem stadiju podobna.
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
{IZMIŠLJENO IME} 100 mg filmsko obložene tablete {IZMIŠLJENO IME} 200 mg filmsko obložene tablete {IZMIŠLJENO IME} 400 mg filmsko obložene tablete
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.
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.
Reproductive system disorders Rare: erectile dysfunction
Motnje reprodukcije in dojk Redka: erektilna disfunkcija.
6.6 Instructions for use and handling and disposal Not applicable.
6.6 Navodila za pripravo in ravnanje z zdravilom in odlaganje
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo.
Concomitant administration of lumiracoxib with high doses of aspirin, other NSAIDs or COX-2 inhibitors should be avoided.
Sočasni uporabi lumirakoksiba z velikimi odmerki aspirina, drugimi NSAR ali zaviralci COX-2 se je treba izogibati.
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.
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.
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.
Ker se srčnožilno tveganje lumirakoksiba lahko poveča z odmerkom in trajanjem zdravljenja, mora biti trajanje zdravljenja najkrajše, uporabiti pa moramo najmanjši učinkovit dnevni odmerek.
Lumiracoxib is highly bound to plasma proteins, (≥98%), and binding is independent of concentration over a range of 0.1 to 100 µg/mL.
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.
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.
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.
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.
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.
Patients with moderate to severe renal dysfunction (estimated creatinine clearance <50 ml/min).
Bolniki z zmerno do težko disfunkcijo ledvic (ocenjeni očistek kreatinina <50 ml/min).
Other metabolites are not active as COX-1 or COX-2 inhibitors.
Drugi presnovki niso aktivni kot zaviralci COX-1 ali COX-2.
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.
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.
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
COX-2 so odkrili v tkivu okrog želodčnih razjed pri ljudeh, vendar njenega pomena celjenje razjed še niso dokazali.
Selective inhibition of COX-2 by lumiracoxib provides anti-inflammatory and analgesic effects.
Selektivna inhibicija COX-2 z lumirakoksibom povzroča protivnetne in analgetične učinke.
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).
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).
The mean plasma half-life of lumiracoxib is approximately 4 hours.
Povprečni razpolovni čas lumirakoksiba v plazmi je približno 4 ure.
If signs of hepatic insufficiency occur, or if abnormal liver function tests (ALT or AST>3xULN) persist, lumiracoxib should be discontinued.
Če se pojavijo znaki jetrne insuficience ali trajno nenormalne vrednosti jetrnih testov (ALT ali AST>3xULN), moramo zdravljenje z lumirakoksibom ukiniti.
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.
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.
To conduct a database study of drug utilisation of lumiracoxib and other marketed NSAIDs and COX-2 inhibitors.
Da bo izvedel študijo zbirke podatkov o uporabi zdravila lumirakoksib in drugih odobrenih nesteroidnih protivnetnih zdravil (NSAIDs) in zaviralcev COX-2.
There were no cases of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme reported in association with the use of lumiracoxib.
Ni bilo primerov Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize ali multiformnega eritema, ki bi bili povezani z uporabo lumirakoksiba.
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).
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).
Infections
Infekcijske bolezni
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.
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.
No difference was observed in the plasma protein binding between the two groups.
Med obema skupinama niso ugotovili razlik v vezavi na plazemske beljakovine.
Use of lumiracoxib, as with any drug known to inhibit COX-2, is not recommended in women attempting to conceive (see section 4.6).
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).
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.
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.
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.
Vendar je potrebna previdnost, kadar lumirakoksib uporabljamo sočasno s substrati CYP2C9, ki imajo zelo majhno terapevtsko okno, na primer fenitoin in varfarin.