natgillin/translations-raw huggingface dataset:
Onsenal contains lactose (a type of sugar). 
Pomembne informacije o nekaterih sestavinah zdravila Onsenal Zdravilo Onsenal vsebuje laktozo (vrsto sladkorja).
− Abnormal or heavy bleeding from the vagina, painful menstruation, breast pain, ovarian cyst, 
- nenormalna ali močna krvavitev iz nožnice, boleča menstruacija, bolečine v dojkah,
Co-administration of NSAIDs and cyclosporine D derivatives or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus. 
Sočasna uporaba NSAID in derivatov ciklosporina D ali takrolimusa naj bi zvečala njun nefrotoksični učinek.
Rare (≥1/10,000 to 
Redki (≥ 1/10.000 do <
Polyps with the APC mutation overexpress COX-2 and left untreated, these polyps continue to form and enlarge in the colon or rectum resulting in essentially a 100% chance of developing colorectal cancer. 
Če polipi ostanejo nezdravljeni, v predelu kolona in danke še naprej nastajajo in se večajo, kar se izteče v dejansko 100-odstotno možnost za kolorektalni karcinom.
Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events. 
Zdravi preiskovanci so devet dni dobivali posamične odmerke do 1.200 mg in večkratne odmerke do 1.200 mg dvakrat na dan brez klinično pomembnih neželenih učinkov.
White, opaque capsules with two green bands marked 7767 and 400. 
Bele, neprozorne kapsule z dvema zelenima črtama in oznakama 7767 in 400.
In a peri-post natal study in rats, pup toxicity was observed. 
Med peri-/postnatalno študijo na podganah so opažali
Clear or opaque PVC/Aclar/Aluminium foil blisters. 
Prozorni ali motni pretisni omoti iz PVC/aclar/aluminijske folije.
White, opaque capsules with two gold bands marked 7767 and 200. 
Bele, neprozorne kapsule z dvema zlatima črtama in oznakama 7767 in 200.
Among patients treated with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure >90 mmHg or cuff diastolic blood pressure increased >10% compared to baseline), compared to 27% of patients treated with placebo; this difference was statistically significant. 
Med bolniki, zdravljenimi z 200 mg celekoksiba dvakrat na dan, je bilo na zadnjem ambulantnem pregledu 48 % ocenjenih kot neodzivnih za lizinopril (to je bilo opredeljeno kot z manšeto izmerjeni diastolični krvni tlak > 90 mmHg ali z manšeto izmerjeni diastolični krvni tlak za > 10 % nad izhodiščnim).
The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated. 
Po uvedbi zdravljenja s celekoksibom bo mogoče treba zmanjšati odmerek substratov CYP2D6, ki se odmerjajo individualno; po koncu zdravljenja s celekoksibom pa bo morda odmerek teh zdravil treba zvečati.
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8). 
Pri bolnikih, ki so dobivali celekoksib, so bile opisane resne preobčutljivostne reakcije (anafilaksija in angioedem) (glejte poglavje 4.8).
− Acetylsalcylic acid or other anti-inflammatory medicines 
• Bolniki, ki so po jemanju acetilsalicilne kisline ali nesteroidnih protivnetnih zdravil (NSAID
Some people will need special care from their doctors when they are taking Onsenal. 
Bodite posebno pozorni pri uporabi zdravila Onsenal Nekateri ljudje potrebujejo med jemanjem zdravila Onsenal posebno skrb svojega zdravnika.
These include some antibiotics (Bactrim and Septra used in combination of sulfamethoxazole and trimethoprim), which can be used to treat infections - if you have a stomach or duodenal ulcer, or bleeding in the stomach or intestines - if after taking aspirin or another anti-inflammatory medicine you have had nasal polyps or severe nasal congestion, or any allergic reaction such as an itchy skin rash, swelling, breathing 
Med ta zdravila spadajo nekateri antibiotiki (Bactrim in Septra uporabljeni v kombinaciji s sulfametoksazolom in trimetoprimom), ki jih lahko uporabljamo za zdravljenje okužb - če imate razjedo na želodcu ali dvanajstniku ali krvavitev v želodcu ali črevesju - če ste kdaj po uporabi acetilsalicilne kisline ali kakšnega drugega protivnetnega zdravila imeli nosne polipe ali zelo zamašen nos ali ste doživeli kakšno alergijsko reakcijo, npr. srbeč kožni izpuščaj, otekanje ali piskajoče dihanje - če ste ženska v rodni dobi in ne uporabljate učinkovite kontracepcijske zaščite
Three metabolites, inactive as COX-1 or COX-2 inhibitors, have been identified in human plasma i.e., a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate. 
Pri človeku so v plazmi našli tri presnovke: primarni alkohol, ustrezno karboksilno kislino in njen glukuronidni konjugat; vsi ti presnovki so kot zaviralci COX-1 ali COX-2 neaktivni.
Single doses up to 1400 mg and multiple doses up to 1400 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse events. 
Zdravi preiskovanci so devet dni dobivali posamične odmerke do 1.400 mg in večkratne odmerke do 1.400 mg dvakrat na dan brez klinično pomembnih neželenih učinkov.
Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs. 
Klinična preskušanja s celekoksibom so pokazala, da deluje to zdravilo na ledvice podobno kot primerjalna nesteroidna protivnetna zdravila.
− Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness) 
- nizka koncentracija natrija v krvnih izvidih (lahko povzroči izgubo teka, glavobol, navzeo (slabost v želodcu), mišične krče in šibkost)
There is little experience of celecoxib in renal impairment and therefore caution is advised when treating patients with renal impairment. 
Izkušenj s celekoksibom pri bolnikih z ledvično okvaro je malo, zato je pri zdravljenju takšnih bolnikov potrebna previdnost.
Ask your doctor for advice before taking both of these medicines together. 
Preden ti dve zdravili vzamete skupaj, se posvetujte z zdravnikom.
In a pharmacokinetic study of celecoxib 200 mg administered once daily in healthy volunteers, genotyped as either CYP2C9*1/*1, CYP2C9*1/*3, or CYP2C9*3/*3, the median Cmax and AUC 024 of celecoxib on day 7 were approximately 4-fold and 7-fold, respectively, in subjects genotyped as CYP2C9*3/*3 compared to other genotypes. 
V farmakokinetični študiji celekoksiba 200 mg enkrat na dan pri zdravih prostovoljcih, genotipiziranih kot CYP2C9*1/*1, CYP2C9*1/*3 ali CYP2C9*3/*3, je bila pri preiskovancih, genotipiziranih kot CYP2C9*3/*3, sedmi dan mediana Cmax celekoksiba 4-krat tolikšna, njegova mediana AUC 0-24 pa 7krat tolikšna kot pri drugih genotipih.
If a woman becomes pregnant during treatment, celecoxib 
Če ženska med zdravljenjem zanosi, je treba uporabo celekoksiba prekiniti.
Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4). 
Pri bolnikih z artritisom (predvsem starejših), ki so dobivali celekoksib sočasno z varfarinom, so bile opisane krvavitve, povezane s podaljšanjem protrombinskega časa; nekatere od teh krvavitev so bile smrtne (glejte poglavje 4.4).
In the APC trial, the relative risks compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 - 8.5) with celecoxib 400 mg twice daily and 2.8 (95% CI 1.1 - 7.2) with celecoxib 200 mg twice daily. 
V preskušanju APC je bilo relativno tveganje za sestavljeni opazovani dogodek (presojeno) srčnožilne smrti, miokardnega infarkta ali možganske kapi v primerjavi s placebom pri celekoksibu 400 mg dvakrat na dan 3,4 (95 % IZ: 1,4-8,5) in pri celekoksibu 200 mg dvakrat na dan in 2,8 (95 % IZ: 1,17,2.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be 
Prizadeto delovanje ledvic ali jeter, še posebej pa moteno delovanje srca so verjetnejši pri starejših bolnikih.
Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance. 
Zdravilo Onsenal je treba pri bolnikih s FAP uporabljati hkrati z običajno zdravstveno oskrbo, npr. operacijami
Heart failure, palpitations, tachycardia 
Srčne bolezni srčno popuščanje, palpitacije, tahikardija miokardni infarkt
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8). 
Pri uporabi celekoksiba so zelo redko poročali o resnih kožnih reakcijah, nekatere od njih so bile smrtne, vključno z eksfoliacijskim dermatitisom, Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo (glejte poglavje 4.8).
In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes. 
V kumulativni analizi 20 s placebom kontroliranih študij pri bolnikih z OA in RA, ki so trajale več kot 2 tedna in do 1 leta, je bil presežni delež miokardnega infarkta pri bolnikih, ki so dobivali 200 mg ali 400 mg celekoksiba na dan, v primerjavi s placebom 0,7 dogodka na 1000 bolnikov (redko).
You should check with your doctor or pharmacist if you are unsure. 
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
Outer carton - 400 mg hard capsules 
Zunanja ovojnina - trde kapsule 400 mg
Take special care with ONSENAL 
KAKO JEMATI ZDRAVILO ONSENAL
Outer carton - 200 mg hard capsules (clear, opaque blister) 
Zunanja ovojnina - trde kapsule 200 mg (prozoren, moten pretisni omot)
Printing ink contains: shellac propylene glycol iron oxide (E172) 
Črnilo vsebuje: šelak propilenglikol železov oksid (E172)
You will usually take two 200 mg 
Ponavadi boste jemali po dve 200-mg kapsuli dvakrat na dan.
6.3 Shelf life 3 years. 
6.3 Rok uporabnosti
SPECIAL STORAGE CONDITIONS Do not store above 30°C 
Shranjujte pri temperaturi do 30 C.
− The printing ink contains also shellac, propylene glycol and iron oxide E172. 
Črnilo vsebuje tudi šelak, propilenglikol in železov oksid E172.
Each capsule contains 200 mg celecoxib 
Ena kapsula vsebuje 200 mg celekoksiba.
Such combinations should be avoided in known CYP2C9 poor metabolisers (see sections 4.2 and 5.2). 
Pri bolnikih, za katere je znano, da slabopresnavljajo s CYP2C9, ne uporabljajte takšnih kombinacij (glejte poglavji 4.2 in 5.2).
− The printing ink contains also shellac, propylene glycol and iron oxide E172, Brilliant Blue FCF 
Črnilo vsebuje tudi šelak, propilenglikol, železov oksid E172 in modro FCF E133.
Hypertension, hypertension aggravated 
Žilne bolezni hipertenzija,
In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring. 
stopnje, urejeno z lizinoprilom, uporaba 200 mg celekoksiba dvakrat na dan v primerjavi s placebom ni klinično pomembno zvišala povprečnega sistoličnega ali diastoličnega krvnega tlaka med stalnim 24-urnim merjenjem.
Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: - Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. 
- Neželeni učinki, opisani pri bolnikih z osteoartritisom in revmatoidnim artritisom z incidenco nad 0,01 % in večjo kot pri placebu v 12 s placebom in/ali učinkovino kontroliranih kliničnih preskušanjih, v katerih so do 12 tednov prejemali od 100 do 800 mg celekoksiba.
Blood levels increased: potassium, sodium, hemoglobin Blood levels decreased: hematocrit, testosterone 
Zvišanje kalija, natrija, hemoglobina v krvi Znižanje hematokrita, testosterona v krvi
Renal function should be monitored when celecoxib and any of these medicinal products are combined. 
Med kombinirano uporabo celekoksiba in katerega od teh zdravil je treba nadzirati delovanje
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1). 
Zato je treba odziv bolnikov s FAP na celekoksib redno preverjati, da bi preprečili nepotrebno izpostavljanje zdravilu pri bolnikih s FAP, pri katerih celekoksib ni učinkovit (glejte poglavja 4.2, 4.3, 4.8 in 5.1).
No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in healthy volunteers at the FAP therapeutic dose of 400 mg BID. 
Pri zdravih prostovoljcih, ki so dobivali odmerek 400 mg dvakrat na dan, kot se terapevtsko uporablja pri FAP, niso opazili statistično značilnega zavrtja COX-1 (ocenjenega z zavrtjem nastajanja tromboksana B2 [TxB2] ex
Each capsule contains 400 mg celecoxib 
Ena kapsula vsebuje 400 mg celekoksiba.
Safety data were reviewed in detail by a Data Safety Monitoring Committee, which concluded that celecoxib 16 mg/kg/day was a safe dose to recommend for further studies in juvenile 
Ta je presodil, da je odmerek celekoksiba 16 mg/kg/dan mogoče varno priporočiti za nadaljnje študije bolnikov z juvenilno FAP.
The majority of the interaction studies have been performed with celecoxib doses of 200 mg BID (i.e. those used for osteoarthritis/rheumatoid arthritis). 
Večina študij interakcij je bila opravljena s celekoksibom v odmerkih 200 mg dvakrat na dan (to je odmerkih, ki se uporabljajo pri osteoartritisu/revmatoidnem artritisu), zato ni mogoče izključiti, da ima odmerek 400 mg dvakrat na dan izrazitejše učinke.
In individuals who are CYP2C9 poor metabolisers and demonstrate increased systemic exposure to celecoxib, concomitant treatment with CYP2C9 inhibitors (eg. 
Pri posameznikih, ki slabo presnavljajo s CYP2C9 in imajo večjo sistemsko izpostavljenost celekoksibu, lahko sočasno zdravljenje z zaviralci CYP2C9 (npr. flukomazol, amiodaron) dodatno poveča izpostavljenost celekoksibu.
6.6 Special precautions for disposal and other handling 
6.6 Navodila za pripravo in ravnanje z zdravilom
In final data (adjudicated) from the APC trial in patients treated with celecoxib 800 mg daily for up to 3 years, the excess rates over placebo were 11 events per 1000 patients for myocardial infarction (common); and 5 events per 1000 patients for stroke (uncommon; types of stroke not differentiated). 
Po oceni končnih podatkov preskušanj APC in PreSAP pri bolnikih, zdravljenih z 800 mg celekoksiba na dan do 3 leta, je bil presežni delež miokardnih infarktov v primerjavi s placebom 11 dogodkov na 1000 bolnikov (pogosto) in možganskih kapi 5 dogodkov na 1000 bolnikov (občasno; kapi
If you have heart problems such as pain in the chest If you have liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow) 
- če imate težave s srcem, npr. bolečine v prsih - če imate odpoved jeter (med simptomi so lahko navzea (slabost v želodcu), driska, zlatenica
Very Common side-effects (affecting more than 1 person in every 10): 
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov): - visok krvni tlak*, driska*
Pfizer ApS Tlf: +45 44 20 11 00 
Tlf: +45 44 20 11 00
Symptoms may include sudden breathlessness, sharp pains when you breathe or collapse 
Znaki lahko vključujejo nanadno zadihanost, ostre bolečine pri dihanju ali nagel padec krvnega tlaka, zaradi katerega se lahko nenadoma zgrudite
− if you are being treated for an infection, because Onsenal may mask a fever which is a sign of 
- če imate intoleranco za nekatere sladkorje - če se zdravite zaradi okužbe, kajti zdravilo Onsenal lahko prikrije zvišano telesno temperaturo,
• Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, 
(ciklooksigenaze-2), kdaj imeli astmo, akutni rinitis, nosne polipe, angionevrotični edem,
Compared to subjects with normal hepatic function, patients with mild hepatic impairment had a mean increase in Cmax of 53% and in AUC of 26% of celecoxib. 
Pri bolnikih z blago jetrno okvaro je bila Cmax celekoksiba v povprečju za 53 % večja, AUC pa za 26 % večja kot pri preiskovancih z normalnim delovanjem jeter.
Serious allergic reactions, anaphylactic shock, anaphylaxis 
levkopenija, trombocitopenija pancitopenija resne alergijske reakcije, anafilaktični šok, anafilaksija zmedenost halucinacije
- Acetylsalcylic acid or other anti-inflammatory medicines - Cyclosporin and tacrolimus (used for immune system suppression e.g. after transplants) - Dextromethorphan (used as an antitussive in cough mixtures) - Diuretics (used to treat fluid retention) - Fluconazole (used to treat fungal infections) 
- zaviralce ACE ali antagoniste receptorjev angiotenzina II (uporabljajo se za zdravljenje visokega krvnega tlaka in srčnega popuščanja) - acetilsalicilno kislino ali druga protivnetna zdravila - ciklosporin ali takrolimus (uporabljata se za zaviranje imunskega sistema, npr. po presaditvah) - dekstrometorfan (uporablja se kot sredstvo proti kašlju v kombinacijah proti kašlju) - diuretike (uporabljajo se za zdravljenje zastajanja tekočine) - flukonazol (uporablja se za zdravljenje glivičnih okužb) - litij (uporablja se za zdravljenje depresije) - rifampicin (uporablja se za zdravljenje bakterijskih okužb) - varfarin (uporablja se za preprečevanje strjevanja krvi) ali druge antikoagulante - druga zdravila proti depresiji, nespečnosti, visokemu krvnemu tlaku ali nerednemu srčnemu
- if you have severe kidney disease - if you have heart failure, established heart disease and /or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain - if you have had an operation to clear or bypass blockages 
- če imate vnetje kolona (ulcerozni kolitis) ali črevesja (Crohnovo bolezen) - če imate hudo bolezen jeter - če imate hudo bolezen ledvic - če imate srčno popuščanje, potrjeno srčno bolezen ali cerebrovaskularno bolezen ali oboje, npr. ste imeli srčni infarkt, kap, lažjo obliko kapi (tranzitorna ishemična ataka - TIA), ali zamašitev krvnih žil srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela, ali če imate oz. ste imeli težave s krvnim obtokom (bolezen perifernih arterij) ali operacijo na arterijah nog
In the APC trial, there was a dose-related increase in the composite endpoint of cardiovascular death, myocardial infarction, or stroke (adjudicated) with celecoxib compared to placebo over 3 years of treatment. 
V preskušanju APC so med 3-letnim zdravljenjem pri celekoksibu v primerjavi s placebom ugotovili z odmerkom povezan porast sestavljenega opazovanega dogodka srčnožilne smrti, miokardnega infarkta ali možganske kapi (presojeno).
The capsules are white with ‘7767‘ and ‘200‘ marked in gold ink. 
Kapsule so bele in na njih je z zlatim črnilom napisano "7767" in "200".
− if you are over 65 years of age your doctor may want to keep a regular check on you As with other non-steroidal, anti-inflammatory drugs (NSAIDs; eg, ibuprofen or diclofenac), this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood 
Tako kot druga nesteroidna protivnetna zdravila (npr. ibuprofen ali diklofenak) lahko tudi do zdravilo povzroči zvišanje krvnega tlaka, zato vam bo zdravnik morda naročil, da morate redno kontrolirati
CYP2C9 Poor Metabolizers: Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased. 
Bolniki, ki slabo presnavljajo s CYP2C9: Celekoksib morate previdno uporabljati pri bolnikih, za katere na podlagi anamneze ali izkušenj z drugimi substrati CYP2C9 veste ali sumite, da slabo presnavljajo s CYP2C9.
The capsules are white with ‘7767‘ and ‘400‘ marked in green ink. 
Kapsule so bele in na njih je z zlatim črnilom napisano "7767" in "400".
The relative risk compared to placebo for a similar composite endpoint (CV death, MI, stroke) was 1.14 (95% CI 0.61 - 2.12) with celecoxib 200 mg twice daily. 
Relativno tveganje za podoben sestavljeni opazovani dogodek (srčnožilna smrt, miokardni infarkt, možganska kap) je bilo za celekoksib 200 mg dvakrat na dan v primerjavi s placebom 1,14 (95 % IZ: 0,61-2,12).
− High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test 
- velika koncentracija natrija ali hemoglobina in majhna koncentracija hematokrita ali
croscarmellose sodium, magnesium stearate and the colouring agent titanium dioxide E171. 
- Pomožne snovi so želatina, laktoza monohidrat, natrijev lavrilsulfat, povidon K30, premreženi natrijev karmelozat, magnezijev stearat in barvilo titanov dioksid E171.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1).The concomitant use of celecoxib and a non-aspirin NSAID should be avoided. 
Glede varnosti za prebavila v dolgoročnih kliničnih preskušanjih niso ugotovili pomembne razlike med uporabo selektivnih zaviralcev COX-2 in acetilsalicilne kisline v primerjavi z uporabo nesteroidnih protivnetnih zdravil in acetilsalicilne kisline (glejte poglavje 5.1).
urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. 
„non steroidal antiinflammatory drugs“), vključno s selektivnimi zaviralci COX-2
Confusion 
Drugo
− Skin discolouration (bruising), muscle pain and weakness, painful joints 
(slabost v želodcu), mišične krče in šibkost)
Patients who are known or suspected to be CYP2C9 poor metabolizers based on previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution (see Section 4.2). 
Celekoksib morate previdno uporabljati pri bolnikih, za katere na podlagi anamneze ali izkušenj z drugimi substrati CYP2C9 veste ali sumite, da slabo presnavljajo s CYP2C9 (glejte poglavje 4.2).
Excipients: Lactose Monohydrate 99.6 mg For a full list of excipients, see section 6.1. 
Pomožne snovi: laktoza monohidrat 99,6 mg.
− if you have heart failure, established heart disease and /or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain 
- če imate srčno popuščanje, potrjeno srčno bolezen ali cerebrovaskularno bolezen ali oboje, npr. ste imeli srčni infarkt, kap, lažjo obliko kapi (tranzitorna ishemična ataka - TIA), ali zamašitev krvnih žil, srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela, ali če imate oz. ste imeli težave s krvnim obtokom (bolezen perifernih arterij) ali operacijo na arterijah nog
Always take Onsenal exactly as your doctor has told you. 
Pri jemanju zdravila Onsenal natančno upoštevajte zdravnikova navodila.
Ganglion 
PSUR
In the PreSAP trial, the relative risk compared to placebo for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 - 2.4) with celecoxib 400 mg once daily compared to placebo. 
V preskušanju PreSAP je bilo relativno tveganje za isti sestavljeni opazovani dogodek (presojeno) pri celekoksibu 400 mg enkrat na dan v primerjavi s placebom 1,2 (95 % IZ: 0,6-2,4).