FrancophonIA/ELRC3.0 huggingface dataset:
English: complications fracture * Hypertension, vomiting and diarrhoea are included in Table 2 because they were reported more frequently in these studies, which were of 3-year duration, compared to Table 1, which includes adverse reactions from studies of 12-week duration.
Slovenian: * Hipertenzija, bruhanje in driska so vključeni v preglednico 2, ker so bili v teh, 3-letnih študijah zabeleženi pogosteje, v primerjavi s preglednico 1, ki obsega neželene učinke 12-tedenskih študij.
English: Treatment with celecoxib in FAP has been studied for up to 6 months and has not been shown to reduce the risk of gastrointestinal or other form of cancer or the need for surgery.
Slovenian: Pri bolnikih s FAP so zdravljenje s celekoksibom proučevali do 6 mesecev; ob tem niso ugotovili, da bi zdravilo zmanjšalo tveganje za karcinom na prebavilih, druge vrste karcinom ali potrebo po operaciji.
English: In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the recommended daily human dose was 2 times more than the recommended daily human
Slovenian: V tej zadnji študiji, je bila ob najmanjši sistemski izpostavljenosti (pri kateri se je ta anomalija pojavila pri eni sami živali) ocenjeno, da je bil mejni odmerek glede na priporočeni dnevni odmerek za človeka 2-krat večji od priporočenega dnevnega odmerka za človeka (800 mg).
English: Special care should be used in such patients (see section 5.2).
Slovenian: Pri takšnih bolnikih je potrebna posebna previdnost (glejte poglavje 5.2).
English: Onsenal 200 mg capsules contain lactose (49.8 mg).
Slovenian: Kapsule Onsenal 200 mg vsebujejo laktozo (49,8 mg).
English: The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients since it is mainly eliminated by hepatic metabolism.
Slovenian: Farmakokinetika celekoksiba pri bolnikih z ledvično okvaro niso raziskali, vendar ni verjetno, da bi bila bistveno spremenjena, ker se zdravilo izloča predvsem s presnovo v jetrih.
English: In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Slovenian: V študiji medsebojnega delovanja celekoksib ni klinično pomembno vplival na farmakokinetiko peroralnih kontraceptivov (1 mg noretisterona/35 mikrogramov etinilestradiola).
English: Experimental evidence shows that the mechanism(s) of action by which celecoxib leads to tumour death may be related to induction of apoptosis and inhibition of angiogenesis.
Slovenian: Eksperimentalne ugotovitve kažejo, da je mehanizem, po katerem celekoksib povzroči odmrtje tumorjev, morda povezan z indukcijo apoptoze in zavrtjem angiogeneze.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR.
Slovenian: Zato je treba pri bolnikih, ki prejemajo peroralne antikoagulante, natančno nadzirati protrombinski čas ali INR.
English: In additional studies using non-selective NSAID comparators, approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2300 patients treated for 1 year or longer.
Slovenian: V dodatnih študijah, v katerih so kot primerjavo uporabljali neselektivna nesteroidna protivnetna zdravila, so približno 7400 bolnikov z artritisom zdravili s celekoksibom v dnevnih odmerkih do 800 mg; med njimi je bilo približno 2300 bolnikov zdravljenih 1 leto ali več.
English: Additional reactions have been reported from actual use of the active ingredient of Onsenal (in post-marketing experience).
Slovenian: Dodatni učinki so bili opisani med dejansko uporabo zdravilne učinkovine zdravila Onsenal (v pomarketinškem obdobju).
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Slovenian: COX-2 so pri človeku našli v tkivu okoli želodčnih ulkusov, a njena vloga pri celjenju ulkusov ni ugotovljena.
English: Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP).
Slovenian: Zdravilo Onsenal se uporablja za zmanjšanje števila polipov v prebavilih pri bolnikih s familiarno adenomatozno polipozo (FAP).
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
Slovenian: Previdnost je potrebna, kadar se celekoksib kombinira z varfarinom in drugimi peroralnimi antikoagulanti (glejte poglavje
English: The increases for both celecoxib dose groups versus placebo were mainly due to an increased incidence of myocardial infarction.
Slovenian: V obeh odmernih skupinah celekoksiba je bilo povečanje v primerjavi s placebom predvsem posledica večje incidence miokardnega infarkta.
English: There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Slovenian: Nadalje obstaja večje tveganje za neželene učinke v prebavilih (razjeda v prebavilih ali drugi gastrointestinalni zapleti), kadar se celekoksib uporablja sočasno z acetilsalicilno kislino (celo pri majhnih odmerkih).
English: Data from pooled analysis of controlled randomized trials also suggest that cardiovascular risk may be associated with the use of celecoxib compared to placebo, with evidence for differences in risk based
Slovenian: Podatki kumulativne analize kontroliranih randomiziranih preskušanj tudi kažejo, da je lahko srčnožilno tveganje povezano z uporabo celekoksiba v primerjavi s placebom, z dokazi za različno
English: Celecoxib can be used with low dose acetylsalicylic acid, however it cannot be considered a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Slovenian: Celekoksib se lahko uporablja z majhnimi odmerki acetilsalicilne kisline, vendar ne more nadomestiti acetilsalicilne kisline v kardiovaskularni profilaksi.
English: • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >10) (Class C).
Slovenian: • Hudo poslabšano delovanje jeter (albumin v serumu < 25 g/l ali ocena po Child-Pughu > 10)
English: Pfizer Luxembourg SARL filiāle Latvijā
Slovenian: Pfizer Luxembourg SARL filialas Lietuvoje
English: In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses).
Slovenian: Pri bolnikih z revmatoidnim artritisom celekoksib ni statistično značilno vplival na farmakokinetiko (plazemski ali ledvični očistek) metotreksata (v revmatoloških odmerkih).
English: Conventional embryo-foetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat foetuses and of cardiovascular malformations in rabbit foetuses at systemic exposures to free celecoxib approximately 3 times (rat) and 2 times (rabbit) higher than those achieved at the recommended daily human dose (800 mg).
Slovenian: Običajne študije embrio-fetotoksičnosti so pokazale od odmerka odvisno pojavljanje diafragmalne hernije pri plodovih podgan ter kardiovaskularnih malformacij pri plodovih kuncev ob sistemski izpostavljenosti prostemu celekoksibu, ki je bila približno 3-krat večja (podgane) oz. 2-krat večja (kunci) od izpostavljenosti, dosežene s priporočenim dnevnim odmerkom za človeka (800 mg).
English: Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Slovenian: Sočasna uporaba induktorjev CYP2C9, npr. rifampicina, karbamazepina ali barbituratov, lahko zmanjša koncentracijo
English: Pilot Study in Juvenile FAP Patients: A total of 18 children 10 to 14 years of age who had genotype or phenotype positive FAP were treated with celecoxib 4 mg/kg/day (4 patients, compared to 2 patients treated with placebo), celecoxib 8 mg/kg/day (4 patients, compared to 2 patients treated with placebo), or celecoxib 16 mg/kg/day (4 patients, compared to 2 patients treated with placebo).
Slovenian: Pilotska študija pri bolnikih z juvenilno FAP: Skupno so 18 otrok, starih od 10 do 14 let in z genotipsko ali fenotipsko pozitivno FAP, zdravili s celekoksibom 4 mg/kg/dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo), 8 mg/kg/dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo) ali 16 mg/kg/dan (4 bolniki v primerjavi z 2 bolnikoma, ki sta dobivala placebo).
English: Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).
Slovenian: Ledvična okvara: Izkušnje s celekoksibom pri bolnikih z blago ali zmerno ledvično okvaro so omejene, zato je treba takšne bolnike zdraviti previdno (glejte točke 4.3, 4.4 in 5.2).
English: Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130% (analogous studies have not been performed with amiodarone or other known CYP2C9 inhibitors).
Slovenian: Sočasna uporaba enkratnega odmerka 200 mg celekoksiba in 200 mg flukonazola, ki je močan zaviralec CYP2C9, enkrat na dan je povzročila povprečno zvečanje Cmax celekoksiba za 60 % in njegove AUC za 130 % (analogne študije z amiodaronom ali ostalimi znanimi zaviralci CYP2C9 niso bile izvedene).
English: 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.
Slovenian: 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.
English: Elevated levels of COX-2 are found in many pre-malignant lesions (such as adenomatous colorectal polyps) and epithelial cancers.
Slovenian: Koncentracija COX-2 je zvečana v številnih predmalignih spremembah (npr. v adenomatoznih kolorektalnih polipih) in epitelijskih karcinomih.
English: In patients on concurrent therapy with warfarin, serious bleeding events have been reported.
Slovenian: Pri bolnikih, sočasno zdravljenih z varfarinom, so opisane resne krvavitve.
English: Inhibition of COX-2 may have consequences on tumour viability that are unrelated to inflammation.
Slovenian: Zavrtje COX-2 morda vpliva na viabilnost tumorjev z učinki, ki niso povezani z vnetjem.
English: 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)
Slovenian: Ni dokazano, da zmanjšanje števila polipov, doseženo z Onsenalom, vpliva na tveganje za karcinom na črevesu (glejte poglavji 4.4 in 5.1).
English: 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.
Slovenian: 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.
English: Such patients should be carefully monitored while receiving treatment with celecoxib.
Slovenian: Takšne bolnike je treba med zdravljenjem s celekoksibom natančno nadzirati.
English: 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.
Slovenian: 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.
English: These effects are expected following inhibition of prostaglandin
Slovenian: Gre za pričakovane učinke zavrtja sinteze prostaglandinov.
English: What ONSENAL contains
Slovenian: Kaj vsebuje zdravilo Onsenal
English: If an anastomotic ulcer is present, patients should not receive concomitant treatment with anticoagulants or acetyl salicylic acid.
Slovenian: Bolniki z anastomoznim ulkusom ne smejo biti hkrati zdravljeni z antikoagulanti ali acetilsalicilno kislino.
English: 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.
Slovenian: 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.
English: Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly.
Slovenian: Tveganje za toksične učinke na ledvicah je največje pri bolnikih z okvarjenim delovanjem ledvic, srčnim popuščanjem, motenim delovanjem jeter in pri starejših bolnikih.
English: Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
Slovenian: Zato se običajne zdravstvene oskrbe bolnikov s FAP ne sme spremeniti zaradi sočasnega jemanja celekoksiba.
English: COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Slovenian: Zaviralci COX-2 zmanjšajo sistemsko (in tako morda tudi endotelijsko) nastajanje prostaciklina, ne da bi vplivali na trombocitni tromboksan.
English: Celecoxib may mask fever and other signs of inflammation.
Slovenian: Celekoksib lahko prikrije zvišano telesno temperaturo in druge znake vnetja.
English: The plasma concentrations of medicinal products that are substrates of this enzyme may be increased when celecoxib is used concomitantly.
Slovenian: Plazemska koncentracija zdravil, ki so substrati tega encima, se lahko med sočasno uporabo s celekoksibom zveča.
English: - 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).
Slovenian: - 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).
English: Therefore, the risk for high celecoxib exposure in poor metabolizers should be considered carefully when treating FAP patients.
Slovenian: Zato je potrebno tveganje za visoko izpostavljenost celekoksibu skrbno upoštevati pri zdravljenju bolnikov s FAP, ki so slabi presnavljalci.
English: The plasma concentration of celecoxib is approximately 100% increased in elderly women (>65 years).
Slovenian: Pri starejših ženskah (> 65 let) je koncentracija celekoksiba v plazmi za približno 100 % večja.
English: Uncommon (≥1/1000 to <1/100)
Slovenian: Občasni (≥ 1/1000 do < 1/100)
English: For celecoxib no clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o izpostavljenosti celekoksibu med nosečnostjo ni.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Slovenian: 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.
English: - 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)
Slovenian: - 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)
English: The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2).
Slovenian: Priporočeni peroralni odmerek je dve 200 mg kapsuli dvakrat na dan, zaužiti s hrano (glejte poglavje
English: − if you have severe kidney disease
Slovenian: - če imate hudo bolezen jeter - če imate hudo bolezen ledvic
English: The MAH shall continue to submit Periodic Safety Update Reports (PSURs) on a yearly basis.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo še naprej vlagal letna redna posodobljena poročila o varnosti zdravila (PSUR).
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
English: Therefore, patients on lithium treatment should be closely monitored when celecoxib is introduced or withdrawn.
Slovenian: Bolnike, ki prejemajo litij, je zato treba po uvedbi ali opustitvi celekoksiba natančno nadzirati.
English: 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).
Slovenian: 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).
English: Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs: the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Slovenian: 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
English: 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).
Slovenian: 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).
English: Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Slovenian: Celekoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
English: Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Slovenian: Celekoksib se pretežno presnavlja s CYP2C9, zato je treba pri bolnikih, ki prejemajo flukonazol, uporabiti le polovico priporočenega odmerka celekoksiba.
English: Celecoxib metabolism is primarily mediated via cytochrome P450 CYP2C9.
Slovenian: Presnova celekoksiba poteka predvsem prek citokroma P450 CYP2C9.
English: 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%.
Slovenian: 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 %.
English: Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.
Slovenian: Onsenal sodi med zdravila, ki jih imenujemo zaviralci ciklooksigenaze-2 (COX-2).
English: Celecoxib is an oral, selective cyclooxygenase-2 (COX-2) inhibitor.
Slovenian: Celekoksib je peroralen, selektiven zaviralec ciklooksigenaze-2 (COX-2).
English: Examples of medicines which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti-arrhythmics, etc.
Slovenian: Primeri zdravil, ki se presnavljajo s CYP2D6, so antidepresivi (triciklični in selektivni zaviralci privzema serotonina), nevroleptiki, antiaritmiki.
English: If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Consider starting treatment at a reduced dose (see section 5.2).
Slovenian: V poštev pride uvedba zdravljenja z manjšim odmerkom (glejte poglavje 5.2).
English: In a two-year toxicity study an increase in nonadrenal thrombosis was observed in male rat at high titanium dioxide (E171)
Slovenian: V dveletni študiji toksičnosti so pri podganjih samcih ob velikih odmerkih opažali več neadrenalne želatino titanov dioksid (E171)
English: Usual medical care for FAP patients should be continued while on celecoxib.
Slovenian: Običajna zdravstvena oskrba bolnikov s FAP se mora nadaljevati tudi med uporabo celekoksiba.
English: 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.
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: • Active peptic ulceration or gastrointestinal (GI) bleeding.
Slovenian: • Aktiven peptični ulkus ali krvavitev v prebavilih.
English: The European Medicines Agency (EMA) will review any new information which may become available every year and this SPC will be updated as necessary.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).