natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtess kot dodatka k standardnima kombinacijama levodope/benserazida oziroma levodope/karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called 
Entakapon blokira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
How does Comtess work? 
Kako zdravilo Comtess deluje?
How has Comtess been studied? 
Kako je bilo zdravilo Comtess raziskano?
What is Comtess used for? 
Za kaj se zdravilo Comtess uporablja?
How is Comtess used? 
Kako se zdravilo Comtess uporablja?
What is Comtess? 
Kaj je zdravilo Comtess?
Patients under 18 years of age. 
Bolniki, mlajši od 18 let.
These beneficial effects were maintained for up to 52 weeks. 
Ti koristni učinki so se vzdrževali do 52 tednov dolgo.
Further to the assessment of: 
v zvezi z vrednotenjem:
On 23 June 2005, the CHMP concluded that: 
Dne 23. junija je CHMP zaključil, da:
The volume of distribution (Vss) is 9 L. 
Porazdelitveni prostor (Vss) je 9 l.
Patients should not exceed this dose. 
Bolniki ne smejo prekoračiti tega odmerka.
The undesirable effects profile was generally similar to that reported in the OA and RA studies. 
Profil neželenih učinkov je bil na splošno podoben tistemu, o katerem so poročali v študijah OA in RA.
However, exposure is limited to clinical trials. 
Vendar pa je izpostavljenost omejena na klinična preizkušanja.
The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 and requested further changes. 
CHMP je potrdil spremembe Informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005 in zahteval še nadaljne spremembe.
[Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare 
[pogosti (>1/100, <1/10) občasni (>1/1.000, <1/100) redki (>1/10.000, <1/1.000) zelo redki
Median tmax is about 2 hours post dose. 
Mediani tmax je okrog 2 uri po odmerku.
Dosage adjustment in the elderly is not necessary. 
Prilagajanje odmerjanja pri starejših osebah ni potrebno.
Plasma clearance is 7.7 L/h. 
Plazemski očistek je 7,7 l/h.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH TER NA NORVEŠKEM IN ISLANDIJI
In elderly subjects (over 65 years old), a 15% increase in AUC was observed as compared to younger subjects. 
Pri starejših osebah (starejših od 65 let) so opazili 15-odstotno zvečanje AUC v primerjavi z mlajšimi osebami.
In addition various conjugates (glucuronides and sulfates) of these metabolites are formed. 
Poleg tega nastajajo različni konjugati(glukuronidi in sulfati) teh presnovkov.
Clear PVC/aluminium blisters in packs containing 2, 4, 5, 6, 10, 20, 30, 50, 100, or 600 film-coated tablets. 
Prozorni pretisni omoti iz PVC/aluminija v škatlah, ki vsebujejo po 2, 4, 5, 6, 10, 20, 30, 50, 100 ali 600 filmsko obloženih tablet.
Therefore, the combination should be administered with caution, especially in the elderly. 
Zato je treba to kombinacijo uporabljati zelo previdno, posebno pri starejših bolnikih.
Elderly: As with other drugs used in the elderly, it is prudent to initiate treatment with the lower recommended dose. 
Starejši bolniki: Podobno kot pri drugih zdravilih, ki se uporabljajo pri starejših bolnikih, je pametno začeti zdravljenje z najmanjšim priporočenim odmerkom.
To support multiple venues for healthcare professionals including prescribers and pharmacists. 
Da se bo zavzel za to, da se poklicni zdravstveni delavci vključno s predpisovalci in farmacevti, večkrat srečajo.
In patients who fail to respond, the dose may be increased to 200 mg daily in one or two divided doses. 
Pri bolnikih, ki se ne odzovejo, se lahko odmerek zveča na 200 mg na dan v enem ali dveh razdeljenih odmerkih.
Camberley Surrey GU16 7SR United Kingdom 
Camberley Surrey GU16 7SR Velika Britanija
Further to the assessment of the data on serious skin reactions, lumiracoxib does not appear to be associated with an unusually large number of reports of serious skin reactions. 
Po vrednotenju podatkov o hudih kožnih reakcijah, se ne zdi, da bi bil lumirakoksib povezan z neobičajno velikim številom poročil o hudih kožnih reakcijah.
The cardiovascular safety of lumiracoxib beyond 1 year of use has not been established. 
Kardiovaskularne varnosti lumirakoksiba za čas uporabe, daljši od enega leta, niso ugotovili.
Randomization was stratified by low-dose ASA use (24% of patients in the overall study population) and age. 
Randomizacija je bila stratificirana po uporabi ASA v majhnih odmerkih (24 % bolnikov v celotni populaciji študije) in po starosti.
Paediatric use: {Invented Name} has not been studied in children and thus is contraindicated in children under 18 years of age. 
Uporaba pri otrocih: Zdravila {IZMIŠLJENO IME} pri otrocih niso proučevali, zato je pri otrocih, mlajših od 18 let, kontraindicirano.
To conduct a Prescription Event Monitoring study. 
Da bo izvedel študijo o spremljanju predpisovanja zdravil.
The use of lumiracoxib in pregnant women has not been studied in adequate and well controlled clinical trials and therefore it should not be used during the first two trimesters of pregnancy unless the potential benefit to the patients justifies the potential risk to the fetus. 
Uporabe lumirakoksiba pri nosečnicah niso proučili v ustreznih in dobro kontroliranih kliničnih preskusih, zato ga v prvih dveh trimesečjih nosečnosti ne smemo uporabljati, razen če možna korist za bolnico upravičuje možno tveganje za plod.
The maximum treatment duration in clinical studies was 12 months. 
Najdaljše trajanje zdravljenja v kliničnih študijah je bilo 12 mesecev.
Hypertensive Patients: 
Hipertenzivni bolniki:
In the post-orthopedic surgery pain studies, anemia was reported more frequently, although the frequency was similar to placebo. 
V študijah bolečin po ortopedskih operacijah so pogosteje poročali o anemiji, čeprav je bila njena pogostost podobna kot pri placebu.
The absolute bioavailability of lumiracoxib is approximately 74%. 
Absolutna biološka uporabnost lumirakoksiba je približno 74 %.
The recommended starting dose is 100 mg once daily. 
Priporočeni začetni odmerek je 100 mg enkrat na dan.
CYP2C9 polymorphism: 
Polimorfizem CYP2C9:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENEGA S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Following 400 mg once daily dosing, Cmax was about 9 µg/ml and AUC was about 31 µg h/ml. 
Po odmerjanju 400 mg enkrat na dan je bila Cmax okrog 9 µg/ml, AUC pa okrog 31 µg h/ml.
Hypromellose, Macrogol, talc, iron oxide red (E172), iron oxide black (E172) and titanium dioxide (E171) 
Hipromeloza, makrogol, smukec, rdeči železov oksid (E172), črni železov oksid (E172) in titanov dioksid (E171).
In a long-term controlled study with lumiracoxib 400 mg daily, rare cases of hepatitis have been reported (see section 4.8). 
V dolgoročni kontrolirani študiji z lumirakoksibom v odmerku 400 mg na dan so poročali o redkih primerih hepatitisa (glejte poglavje 4.8).
Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. 
Možno je, da imajo ledvični prostaglandini kompenzacijsko vlogo pri vzdrževanju perfuzije ledvic.
Between November 2004 and June 2005, the MAH made an oral explanation to the CHMP on cardiovascular and skin safety aspects for lumiracoxib on 18 January 2005. 
Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za lumirakoksib.
Patients with congestive heart failure (NYHA II-IV). 
Bolniki s kongestivnim srčnim popuščanjem (NYHA II-IV).
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see section 4.3 and 4.4). 
Odločitev, da se predpiše selektivni zaviralec COX-2, mora temeljiti na ocenitvi vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
Third trimester of pregnancy and breast feeding (see section 4.6 and 5.3). 
Tretje trimesečje nosečnosti in dojenje (glejte poglavji 4.6 in 5.3).
However, the APTC event rate was numerically higher for lumiracoxib than for naproxen but lower than for ibuprofen. 
Vendar je bila frekvenca APTC dogodkov številčno večja pri lumirakoksibu kot pri naproksenu, a manjša kot pri ibuprofenu.
Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and antihypertensive drugs. 
Diuretiki, zaviralci ACE in antagonisti angiotenzina II: NSAR lahko zmanjšajo učinek diuretikov in antihipertenzivnih zdravil.
Therefore antiplatelet therapies should not be discontinued (see section 4.5 and 5.1). 
Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte poglavji 4.5 in 5.1).
{Invented Name} film-coated tablets are administered orally and may be taken with or without food. 
{IZMIŠLJENO IME} filmsko obložene tablete so za peroralno uporabo in se lahko jemljejo s hrano ali brez nje.
{Invented Name} 100 mg and 200 mg film-coated tablets contain lactose (23.3 mg and 46.6 mg, respectively). 
{IZMIŠLJENO IME}100 mg in 200 mg filmsko obložene tablete vsebujejo laktozo (23,3 mg oziroma 46,6 mg).
In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment. 
V primeru suma na prevelik odmerek je treba nuditi ustrezno podporno medicinsko oskrbo, na primer odstranitev želodčne vsebine, klinični nadzor, po potrebi pa tudi uvesti simptomatsko zdravljenje.
Other NSAIDs: Lumiracoxib can be used with low-dose aspirin. 
Drugi NSAR: Lumirakoksib se lahko uporablja z majhnimi odmerki aspirina.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC code: M01 AH 06 
Farmakoterapevtska skupina: Nesteroidna protivnetna in protirevmatična zdravila, koksibi, Oznaka ATC: M01 AH 06.
Administration of 100 mg, 200 mg or 400 mg once daily leads to >90% peak inhibition of COX-2. 
Uporaba 100 mg, 200 mg ali 400 mg enkrat na dan povzroči >90 % največje inhibicije COX-2.
Acute pain 
Akutna bolečina
Over the range of 25 to 800 mg, extent of exposure (AUC) increases in a dose-proportional manner and the peak plasma concentration (Cmax) was roughly dose-proportional. 
V mejah med 25 in 800 mg se obseg izpostavljenosti (AUC) zvečuje sorazmerno odmerku, najvišja koncentracija v plazmi (Cmax) je bila približno sorazmerna odmerku.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take 100 mg and 200 mg film-coated tablets. 
Bolniki z redkimi dednimi boleznimi: intoleranco galaktoze, laponskim pomanjkanjem laktaze ali glukozno-galaktozno malabsorpcijo ne smejo jemati 100-miligramskih in 200-miligramskih filmsko obloženih tablet.
No special precautions for storage. 
Za shranjevanje zdravila niso potrebna posebna navodila.
In vitro studies indicate that lumiracoxib is not a significant inhibitor of other cytochrome P450 isoforms, including CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1, and CYP3A4. 
Študije in vitro kažejo, da lumirakoksib ni pomemben zaviralec drugih izoform citokroma P450, na primer CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1 in CYP3A4.
This indicates lumiracoxib and/or its metabolites are preferentially distributed and retained in inflamed tissue. 
To kaže, da se lumirakoksib in/ali njegovi presnovki prednostno porazdeljujejo in zadržujejo v vnetem tkivu.
Compared to a daily dose of 200 mg, a daily dose of 400 mg of lumiracoxib is associated with a relatively higher frequency of drug-related adverse events, especially the gastrointestinal, neurological and psychiatric events. 
V primerjavi z dnevnim odmerkom 200 mg je dnevni odmerek 400 mg lumirakoksiba povezan z relativno večjo pogostostjo neželenih učinkov, povezanih z zdravilom, posebno gastrointestinalnih, nevroloških in psihiatričnih dogodkov.
At 15 minutes post 400 mg dose, the plasma concentration reached 0.6 µg/ml, which is sufficiently high to achieve over 90% inhibition of COX-2. 
15 minut po 400-miligramskem odmerku je plazemska koncentracija dosegla 0,6 µg/ml, ki zadostuje za preko 90-odstotno inhibicijo COX-2.
Two isoforms, COX-1 and COX-2 have been identified. 
Identificirali so dve izoobliki, COX-1 in COX-2.
Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. 
Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja: v večini primerov so reakcije nastopile v prvem mesecu zdravljenja.
The concentration of 4'-hydroxy metabolite in plasma and synovial fluid is low, thus it is unlikely to contribute to efficacy. 
Koncentracija 4'-hidroksi presnovka v plazmi in sinovialni tekočini je nizka, zato ni verjetno, da bi ta presnovek prispeval k učinkovitosti zdravila.
If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of lumiracoxib should be taken. 
Če se pri teh bolnikih pojavijo klinični znaki poslabšanja stanja, so potrebni ustrezni ukrepi, vključno z ukinitvijo lumirakoksiba.
These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors. 
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišč umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja o kardiovaskularni varnosti drugih zaviralcev Cox-2.
The use of lumiracoxib is contraindicated in the last trimester of pregnancy because, as with other drugs known to inhibit prostaglandin synthesis, it may cause uterine inertia and premature closure of the ductus arteriosus. 
Uporaba lumirakoksiba je kontraindicirana v zadnjem trimesečju nosečnosti, ker, podobno kot druga zdravila, za katera je znano, da zavirajo sintezo prostaglandinov, lahko povzroča inertnost maternice in prezgodnje zapiranje duktusa arteriozusa.
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.