natgillin/translations-raw huggingface dataset:
Therefore, celecoxib 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, since prostaglandin inhibition may result in deterioration of renal function and fluid retention. 
Zato je treba celekoksib uporabljati previdno pri bolnikih z anamnezo srčnega popuščanja, disfunkcijo levega prekata ali hipertenzijo, in pri bolnikih z obstoječimi edemi zaradi kakršnegakoli drugega razloga; zavrtje prostaglandinov namreč lahko poslabša delovanje ledvic in povzroči zastajanje tekočine.
Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers. 
Koncentracija COX-2 je zvečana v številnih predmalignih spremembah (npr. v adenomatoznih kolorektalnih polipih) in epitelijskih karcinomih.
In patients on concurrent therapy with warfarin, serious bleeding events have been reported. 
Pri bolnikih, sočasno zdravljenih z varfarinom, so opisane resne krvavitve.
Inhibition of COX-2 may have consequences on tumour viability that are unrelated to inflammation. 
Zavrtje COX-2 morda vpliva na viabilnost tumorjev z učinki, ki niso povezani z vnetjem.
The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1) 
Ni dokazano, da zmanjšanje števila polipov, doseženo z Onsenalom, vpliva na tveganje za karcinom na črevesu (glejte poglavji 4.4 in 5.1).
Patients with the CYP2C9*3 allele, and, in particular those with CYP2C9*3*3 homozygous genotype, may be exposed to celecoxib levels that are higher than those for which safety has been studied in clinical trials. 
Bolniki z alelom CYP2C9*3 in še posebno bolniki s homozigotnim genotipom CYP2C9*3*3 so lahko izpostavljeni višjim koncentracijam celekoksiba, kot so bile preučene pri raziskavah o varnosti med kliničnimi preskušanji.
Such patients should be carefully monitored while receiving treatment with celecoxib. 
Takšne bolnike je treba med zdravljenjem s celekoksibom natančno nadzirati.
Cytochrome P450 CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*3 polymorphism. 
Aktivnost citokroma P450 CYP 2C9 je manjša pri posameznikih z genetskim polimorfizmom, ki zmanjšuje aktivnost encima, npr. pri tistih s homozigotnostjo za polimorfizem CYP2C9*3.
These effects are expected following inhibition of prostaglandin 
Gre za pričakovane učinke zavrtja sinteze prostaglandinov.
What ONSENAL contains 
Kaj vsebuje zdravilo Onsenal
If an anastomotic ulcer is present, patients should not receive concomitant treatment with anticoagulants or acetyl salicylic acid. 
Bolniki z anastomoznim ulkusom ne smejo biti hkrati zdravljeni z antikoagulanti ali acetilsalicilno kislino.
However, in small multiple dose studies in healthy subjects with 600 mg BID celecoxib had no effect on platelet aggregation and bleeding time compared to placebo. 
Vendar pri zdravih preiskovancih v majhnih študijah večkratnih odmerkov 600 mg dvakrat na dan celekoksib ni vplival na agregacijo trombocitov in čas krvavitve v primerjavi s placebom.
Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly. 
Tveganje za toksične učinke na ledvicah je največje pri bolnikih z okvarjenim delovanjem ledvic, srčnim popuščanjem, motenim delovanjem jeter in pri starejših bolnikih.
Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib. 
Zato se običajne zdravstvene oskrbe bolnikov s FAP ne sme spremeniti zaradi sočasnega jemanja celekoksiba.
COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane. 
Zaviralci COX-2 zmanjšajo sistemsko (in tako morda tudi endotelijsko) nastajanje prostaciklina, ne da bi vplivali na trombocitni tromboksan.
Celecoxib may mask fever and other signs of inflammation. 
Celekoksib lahko prikrije zvišano telesno temperaturo in druge znake vnetja.
The plasma concentrations of medicinal products that are substrates of this enzyme may be increased when celecoxib is used concomitantly. 
Plazemska koncentracija zdravil, ki so substrati tega encima, se lahko med sočasno uporabo s celekoksibom zveča.
- Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications). 
- Neželeni učinki zdravila med pomarketinškim spremljanjem, spontano prijavljeni v obdobju, med katerim je celekoksib po ocenah dobivalo > 70 milijonov bolnikov (različni odmerki, trajanje in indikacije).
Therefore, the risk for high celecoxib exposure in poor metabolizers should be considered carefully when treating FAP patients. 
Zato je potrebno tveganje za visoko izpostavljenost celekoksibu skrbno upoštevati pri zdravljenju bolnikov s FAP, ki so slabi presnavljalci.
The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years). 
Pri starejših ženskah (> 65 let) je koncentracija celekoksiba v plazmi za približno 100 % večja.
Uncommon (≥1/1000 to <1/100) 
Občasni (≥ 1/1000 do < 1/100)
For celecoxib no clinical data on exposed pregnancies are available. 
Kliničnih podatkov o izpostavljenosti celekoksibu med nosečnostjo ni.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. 
Bolniki morajo biti zadostno hidrirani, razmisliti pa je treba tudi o tem, da po uvedbi sočasnega zdravljenja preverimo delovanje ledvic in nadzor pozneje v intervalih ponavljamo.
- Neuroleptics (used to treat some mental disorders) - Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia) - Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression) - Barbiturates ( used to treat epilepsy/seizures and some sleep disorders) 
- nevroleptike (uporabljajo se za zdravljenje nekaterih duševnih motenj) - metotreksat (uporablja se za zdravljenje revmatoidnega artritisa, psoriaze in levkemije) - karbamazepin (uporablja se za zdravljenje epilepsije/napadov krčev in nekaterih motenj spanja) - barbiturate (uporabljajo se za zdravljenje epilepsije/napadov krčev in nekaterih motenj spanja)
The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2). 
Priporočeni peroralni odmerek je dve 200 mg kapsuli dvakrat na dan, zaužiti s hrano (glejte poglavje
− if you have severe kidney disease 
- če imate hudo bolezen jeter - če imate hudo bolezen ledvic
The MAH shall continue to submit Periodic Safety Update Reports (PSURs) on a yearly basis. 
Imetnik dovoljenja za promet z zdravilom bo še naprej vlagal letna redna posodobljena poročila o varnosti zdravila (PSUR).
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn. 
Bolnike, ki prejemajo litij, je zato treba po uvedbi ali opustitvi celekoksiba natančno nadzirati.
Hepatic impairment: In patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2). 
Jetrna okvara: Pri bolnikih z zmerno jetrno okvaro (albumin v serumu od 25 do 35 g/l) je treba dnevni priporočeni odmerek celekoksiba zmanjšati za 50 % (glejte poglavji 4.3 in 5.2).
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 acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding. 
Previdnost je priporočljiva pri zdravljenju bolnikov, pri katerih obstaja največja možnost za pojav zapletov na prebavilih, povzročenih z NSAID: starejši, bolniki, ki sočasno uporabljajo katerikoli drugo NSAID ali acetilsalicilno kislino, in bolniki s predhodno anamnezo gastrointestinalnih obolenj, kot so
1 Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications). 
Neželeni učinki zdravila, spontano prijavljeni v podatkovno bazo za spremljanje varnosti v obdobju, med katerim je celekoksib po ocenah dobivalo > 70 milijonov bolnikov (različni odmerki, trajanje in indikacije).
Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. 
Celekoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole. 
Celekoksib se pretežno presnavlja s CYP2C9, zato je treba pri bolnikih, ki prejemajo flukonazol, uporabiti le polovico priporočenega odmerka celekoksiba.
Celecoxib metabolism is primarily mediated via cytochrome P450 CYP2C9. 
Presnova celekoksiba poteka predvsem prek citokroma P450 CYP2C9.
In FAP patients with moderate hepatic impairment (serum albumin of 25-35 g/l), the daily recommended dose of celecoxib should be reduced by 50%. 
Pri bolnikih s FAP, ki imajo zmerno jetrno okvaro (albumin v serumu od 25 do 35 g/l), je treba priporočeni dnevni odmerek celekoksiba zmanjšati za 50 %.
Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors. 
Onsenal sodi med zdravila, ki jih imenujemo zaviralci ciklooksigenaze-2 (COX-2).
Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor. 
Celekoksib je peroralen, selektiven zaviralec ciklooksigenaze-2 (COX-2).
Examples of medicines which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmics, etc. 
Primeri zdravil, ki se presnavljajo s CYP2D6, so antidepresivi (triciklični in selektivni zaviralci privzema serotonina), nevroleptiki, antiaritmiki.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Consider starting treatment at a reduced dose (see section 5.2). 
V poštev pride uvedba zdravljenja z manjšim odmerkom (glejte poglavje 5.2).
In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high titanium dioxide (E171) 
V dveletni študiji toksičnosti so pri podganjih samcih ob velikih odmerkih opažali več neadrenalne želatino titanov dioksid (E171)
Usual medical care for FAP patients should be continued while on celecoxib. 
Običajna zdravstvena oskrba bolnikov s FAP se mora nadaljevati tudi med uporabo celekoksiba.
In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium. 
Pri zdravih preiskovancih je sočasna uporaba 200 mg celekoksiba dvakrat na dan in 450 mg litija dvakrat na dan povzročila povprečno zvečanje Cmax litija za 16 % in njegove AUC za 18 %.
Anticoagulant activity should be monitored in patients taking warfarin or other anticoagulants, particularly in the first few days after initiating or changing the dose of celecoxib, since these patients have an increased risk of bleeding complications. 
Pri bolnikih, ki jemljejo varfarin ali druge antikoagulante, je treba nadzirati antikoagulantno aktivnost, posebno prve dni po začetku zdravljenja s celekoksibom ali po spremembi njegovega odmerka.
• Active peptic ulceration or gastrointestinal (GI) bleeding. 
• Aktiven peptični ulkus ali krvavitev v prebavilih.
The European Medicines Agency (EMA) will review any new information which may become available every year and this SPC will be updated as necessary. 
Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
A meaningful reduction in duodenal adenoma area was also observed compared with placebo (14.5% celecoxib 400 mg BID versus 1.4% placebo), which however was not statistically significant. 
V primerjavi s placebom so ugotovili tudi pomembno zmanjšanje števila adenomov na dvanajstniku (celekoksib 400 mg dvakrat na dan 14,5 %, placebo 1,4 %), kar pa ni bilo statistično značilno.
The additional adverse reactions listed by system organ class and ranked by frequency in Table 2 were reported at incidence rates greater than placebo for subjects treated with celecoxib 400 mg to 800 mg daily in long-term polyp prevention trials of duration up to 3 years (the APC and PreSAP trials; see Section 5.1, Pharmacodynamic properties: Cardiovascular Safety - Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps). 
Dodatni neželeni učinki, navedeni po organskih sistemih in razvrščeni po pogostnosti v preglednici 2, so bili opisani z incidenco večjo kot pri placebu med preiskovanci, zdravljenimi s celekoksibom od 400 do 800 mg na dan v dolgoročnih preskušanjih preprečevanja polipov, ki so trajala do 3 leta (preskušanji APC in PreSAP; glejte poglavje 5.1, Farmakodinamične lastnosti: Srčnožilna varnostdolgoročne študije pri bolnikih s sporadičnimi adenomatoznimi polipi).
FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations. 
Pri bolnikih s FAP, ki imajo ileorektalno anastomozo ali analno anastomozo ilealnega žepa, se lahko pojavijo anastomozni ulkusi.
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide 
Celekoksib ne vpliva klinično pomembno na farmakokinetiko tolbutamida (substrat CYP2C9) ali
When dosed at 200 mg per day the corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively. 
Ob odmerku 200 mg na dan je bila Cmax pri bolnikih z zmerno jetrno okvaro 41 % in AUC 146 %.
However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two 
Vendar je med sočasno uporabo teh dveh zdravil priporočljivo ustrezno spremljati toksične učinke metotreksata.
Celecoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. 
Tako kot druga zdravila, ki zavirajo sintezo prostaglandinov, lahko tudi celekoksib v zadnjem trimesečju povzroči inertnost maternice in prezgodnje zaprtje arterioznega duktusa.
Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group. 
Študij pri bolnikih s hudo jetrno okvaro (albumin v serumu < 25 g/l) niso izvedli, zato je celekoksib pri teh bolnikih kontraindiciran.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Tega zdravila ne smejo jemati bolniki z redkimi prirojenimi motnjami, kot na primer intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcijo glukoze in galaktoze.
Data from a third long-term study, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), did not show a significantly increased cardiovascular risk with celecoxib 200mg BID compared to placebo. 
Podatki tretje dolgoročne študije, ADAPT (The Alzheimer's Disease Anti-inflammatory Prevention Trial), med uporabo celekoksiba 200 mg dvakrat na dan niso pokazali statistično pomembno večjega srčnožilnega tveganja kot s placebom.
Celecoxib is mainly eliminated by metabolism. 
Celekoksib se izloča predvsem s presnovo.
The concomitant use of celecoxib and a non-aspirin NSAID should be avoided. 
Celekoksiba ne uporabljajte sočasno z ne-aspirinskimi nesteroidnimi protivnetnimi zdravili.
In three separate single dose studies, involving a total of 5 subjects genotyped as CYP2C9*3/*3, single-dose AUC 0-24 increased by approximately 3-fold compared to normal metabolizers. 
V treh ločenih študijah posamičnih odmerkov, ki so zajele 5 preiskovancev, genotipiziranih kot CYP2C9*3/*3, je bila AUC 0-24 po posamičnem odmerku približno 3-krat tolikšna kot pri bolnikih, ki normalno presnavljajo.
During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%. 
Povprečna plazemska koncentracija dekstrometorfana, substrata CYP2D6, se je med zdravljenjem s celekoksibom zvečala za 136 %.
Pharmacological activity resides in the parent substance. 
Farmakološko aktivna je osnovna spojina.
The recommended oral dose is one 400 mg capsule twice per day, taken with food (see section 5.2). 
Priporočeni peroralni odmerek je ena 400 mg kapsula dvakrat na dan zaužita s hrano (glejte poglavje
The incidence of myocardial infarction was 1.1% (8/717 patients) with celecoxib 200 mg twice daily and 1.2% (13/1070 patients) with placebo. 
Incidenca miokardnega infarkta je bila z 200 mg celekoksiba dvakrat na dan 1,1 % (8/717 bolnikov) in s placebom 1,2 % (13/1070) bolnikov.
Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) for placebo. 
Kumulativna deleža za ta sestavljeni opazovani dogodek v 3-letnem obdobju sta bila 3,0 % (20/671 preiskovancev) in 2,5 % (17/685 preiskovancev) v primerjavi z 0,9 % (6/679 preiskovancev) pri placebu.
Celecoxib inhibits tumour formation in preclinical models of colon cancer, which overexpress COX-2, whether induced by chemical (rat AOM model) or genetic (MIN mouse model) mutation. 
V predkliničnih modelih karcinoma na kolonu s prekomerno izraženo COX-2 celekoksib zavira nastanek tumorjev, izzvanih s kemično (model podgan AOM) ali genetsko (model miši MIN)
No clinically significant differences were found in pharmacokinetic parameters of celecoxib between African-Americans and Caucasians. 
Med Afroameričani in belci niso ugotovili klinično pomembnih razlik v farmakokinetičnih parametrih celekoksiba.
You must not take Onsenal if you are breast feeding. 
Zdravila Onsenal ne smete jemati, če dojite.
Cumulative rates for this composite endpoint over 3 years were 2.3% (21/933 subjects) and 1.9% (12/628 subjects), respectively. 
Kumulativna deleža za ta sestavljeni opazovani dogodek v 3-letnem obdobju sta bila 2,3 % (21/933 preiskovancev) in 1,9 % (12/628 preiskovancev).
The mean reduction in the number of colorectal polyps following six months of treatment was 28% (SD + 24%) for celecoxib 400 mg BID which was statistically superior to placebo (mean 5%, SD +16%). 
Število kolorektalnih polipov se je po šestmesečnem zdravljenju s 400 mg celekoksiba dvakrat na dan v povprečju zmanjšalo za 28 % (SD ± 24 %), kar je statistično bolje kot s placebom (povprečje 5 %, SD ±16 %).
Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2). 
Bolnike, za katere je znano, da slabo presnavljajo s CYP2C9, je treba zdraviti previdno (glejte poglavje 5.2).
Pharmacotherapeutic group: Antineoplastic, ATC code: L01XX33 
Oznaka ATC: L01XX33
Because not all adverse drug reactions are reported to the MAH and included in the safety database, the frequencies of these reactions cannot be reliably determined. 
Ker imetniku dovoljenja za promet niso prijavljeni vsi neželeni učinki zdravila, tudi niso vsi zajeti v podatkovno bazo o varnosti.
Blood and lymphatic system disorder / Cardio-vascular disorder Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and 400 mg BID compared to placebo (see section 5.1). 
Bolezni krvi in limfatičnega sistema / Srčne in žilne bolezni V dolgotrajni, s placebom nadzorovani študiji, so odkrili povečano število nevarnih srčnožilnih dogodkov, v glavnem miokardni infarkt, pri osebah s sporadičnimi adenomatoznimi polipi, zdravljenih s celekoksibom, v odmerkih po 200 mg dvakrat na dan in 400 mg dvakrat na dan v primerjavi s placebom (glejte poglavje 5.1).
COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect. 
Ker selektivni zaviralci COX-2 nimajo antiagregacijskega delovanja, niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombemboličnih bolezni.
Adverse drug reactions listed for the post-marketing population are only those that are not already listed for the arthritis trials (Table 1) or the polyp 
Za pomarketinško populacijo so navedeni le tisti neželeni učinki zdravila, ki niso navedeni že za preskušanja pri artritisu (preglednica 1) ali za preskušanja pri preprečevanju polipov (preglednica 2).
The long-term cardiovascular toxicity in children exposed to celecoxib has not been evaluated and it is unknown if the long-term risk may be similar to that seen in adults exposed to celecoxib or other COX-2 selective and non-selective NSAIDs (see section 4.4; cardiovascular effects. 
Tako ni znano, ali je dolgoročno tveganje morda podobno, kot je ugotovljeno pri odraslih osebah, izpostavljenih celekoksibu ali drugim COX-2 selektivnim in neselektivnim nesteroidnim protivnetnim zdravilom (glejte poglavje 4.4, Srčnožilni učinki).
In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism. 
Študije in vitro so pokazale, da lahko celekoksib do neke mere zavre presnovo, katalizirano s CYP2C19.
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3). 
Resne kožne reakcije ali preobčutljivostne reakcije lahko bolj ogrožajo bolnike z anamnezo alergije na sulfonamide ali alergije na kakršnakoli zdravila (glejte poglavje 4.3).
− Meningitis (inflammation of the membrane around the brain and spinal cord) 
- meningitis (vnetje ovojnic možganov in hrbtenjače)
The side effects listed below were observed in arthritis patients who took medicines with the same 
Spodaj navedene neželene učinke so zabeležili pri bolnikih z artritisom, ki so jemali zdravila z isto učinkovino, kot jo vsebuje zdravilo Onsenal:
Results demonstrated a statistically significant reduction in polyp burden in all celecoxib treatment groups compared to the corresponding placebo treatment groups. 
V primerjavi s skupinami, ki so dobivale placebo, so rezultati pokazali statistično pomembno zmanjšanje bremena polipov v vseh treh skupinah, zdravljenih s celekoksibom.
As with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1). 
Tako kot pri drugih NSAID je tudi sočasno uporabo celekoksiba in majhnih odmerkov acetilsalicilne kisline spremljalo večje tveganje za ulkuse in druge zaplete na prebavilih kot pri uporabi celekoksiba samega (glejte poglavje 5.1).
The incidence of myocardial infarction (adjudicated) was 1.0% with (9/933 subjects) with celecoxib 400 mg once daily and 0.6% (4/628 subjects) with placebo. 
Incidenca miokardnega infarkta (presojeno) je bila 1,0 % (9/933 preiskovancev) pri celekoksibu 400 mg enkrat na dan in 0,6 % (4/628 preiskovancev) pri placebu.
− The active substance is celecoxib 
- Zdravilna učinkovina je celekoksib.
FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer. 
FAP je prirojena bolezen, pri kateri sta danka in debelo črevo (kolon) prekrita s številnimi polipi, iz katerih se lahko razvije rak debelega črevesa ali danke.