FrancophonIA/ELRC3.0 huggingface dataset:
English: Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/spasm, muscle pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression,
Slovenian: Občasni (pojavijo se pri več kot 1 od 1000 oseb in manj kot 1 od 100 oseb) Napihnjen trebuh, bolečina v prsnem košu, srčno popuščanje, srčni napad, kap, mala možganska kap (tranzitorna ishemična ataka), motnje srčnega ritma (atrijska fibrilacija), okužba zgornjih dihal, visoke vrednosti kalija v krvi, spremembe krvnih ali urinskih testov za delovanje ledvic, spremembe prebave, vključno z zaprtjem, suha usta, razjede v ustih, spremembe okušanja, vnetje želodca in črevesja, vnetje želodca, želodčna razjeda, slabost (bruhanje), sindrom razdraženega črevesja (sindrom iritabilnega kolona), vnetje požiralnika, zamegljen vid, draženje in rdečina oči, krvavitev iz nosu, zvonjenje v ušesih, vrtoglavica, povečanje ali zmanjšanje apetita, povečanje telesne mase, mišični krči/spazmi,
English: Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepaticrelated adverse experiences than diclofenac.
Slovenian: Uporaba etorikoksiba je bila povezana s statistično pomembno manjšim deležem prekinitev zdravljenja zaradi z jetri povezanih neželenih dogodkov kot uporaba diklofenaka.
English: SIA Merck Sharp & Dohme Latvija Skanstes 13
Slovenian: SIA Merck Sharp & Dohme Latvija Skanstes 13 Riga, LV-1013
English: If necessary, monitor blood lithium closely and adjust the lithium dosage while the combination is being taken and when the NSAID is withdrawn.
Slovenian: Pri uporabi kombinacije in pri ukinitvi NSAR-a je treba skrbno spremljati koncentracije litija v krvi in po potrebi prilagoditi odmerek litija.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION [To be completed nationally.]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: The rates of confirmed lower GI clinical events (small or large bowel perforation, obstruction, or hemorrhage, (POBs)) were not significantly different between etoricoxib and diclofenac.
Slovenian: Delež potrjenih dogodkov v spodnjih prebavilih (perforacija tankega ali debelega črevesa, obstrukcija ali krvavitve (POK) se pri uporabi etorikoksiba ni pomembneje razlikoval od deleža pri uporabi diklofenaka.
English: Paediatric patients
Slovenian: Starejši bolniki
English: The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Slovenian: 30 mg, 60 mg in 120 mg tablete vsebujejo še indigo karmin (E132) in rumeni železov oksid (E172).
English: In patients with rheumatoid arthritis (RA), etoricoxib 90 mg once daily provided significant improvements in pain, inflammation, and mobility.
Slovenian: Pri bolnikih z revmatoidnim artritisom (RA) je etorikoksib v odmerku 90 mg enkrat na dan pomembno olajšal bolečino in vnetje ter izboljšal gibljivost.
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Slovenian: Bolniki, pri katerih so se po jemanju acetilsalicilne kisline ali nesteroidnih protivnetnih zdravil (NSAR-ov), vključno z zaviralci COX-2 (ciklooksigenaze-2), pojavili bronhospazem, akutni rinitis, nosni polipi, angionevrotični edem, urtikarija ali alergijske reakcije.
English: In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Slovenian: V kliničnih študijah izven programa MEDAL se je z etorikoksibom v odmerku ≥ 60 mg zdravilo približno 3.100 bolnikov.
English: Common: gastrointestinal disorders (e.g., abdominal pain, flatulence, heartburn), diarrhea, dyspepsia, epigastric discomfort, nausea.
Slovenian: Pogoste: prebavne motnje (npr. bolečina v trebuhu, vetrovi, zgaga), diareja, dispepsija, neugodje v epigastriju, navzea
English: What <ARCOXIA> contains
Slovenian: Kaj vsebuje zdravilo <ARCOXIA>
English: Marketing Authorisation Holder Invented name Strength Pharmaceutical form
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
English: The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below.
Slovenian: Delež potrjenih resnih trombotičnih kardiovaskularnih neželenih dogodkov (srčni, cerebrovaskularni in periferni žilni dogodki) je bil pri uporabi etorikoksiba primerljiv z deležem pri uporabi diklofenaka.
English: Rheumatoid arthritis The recommended dose is 90 mg once a day.
Slovenian: Revmatoidni artritis Priporočeni odmerek je 90 mg enkrat na dan.
English: In dogs, renal and gastrointestinal abnormalities were seen at high exposures.
Slovenian: Pri psih so pri veliki izpostavljenosti opazili nenormalnosti ledvic in prebavil.
English: It is not known whether etoricoxib is excreted in human milk.
Slovenian: Ni znano, če se etorikoksib izloča v materino mleko.
English: MEDAL Program Hepatic Safety Results:
Slovenian: Program MEDAL - rezultati varnosti za jetra:
English: There are no clinical or pharmacokinetic data in patients with severe hepatic dysfunction (Child-Pugh score ≥10).
Slovenian: Kliničnih ali farmakokinetičnih podatkov za bolnike s hudo motnjo delovanja jeter (ocena po Child-Pughu ≥ 10) nimamo (glejte poglavji 4.2 in 4.3).
English: Infections and infestations: Uncommon: gastroenteritis, upper respiratory infection, urinary tract infection.
Slovenian: Občasne: gastroenteritis, okužba zgornjih dihal, okužba sečil Bolezni imunskega sistema:
English: In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function.
Slovenian: Pri bolnikih z ankilozirajočim spondilitisom je etorikoksib v odmerku 90 mg enkrat na dan pomembno olajšal bolečine v hrbtenici in pomebno zmanjšal vnetje ter izboljšal okornost in gibljivost hrbtenice.
English: CV mortality, as well as overall mortality, was similar between the etoricoxib and diclofenac treatment groups.
Slovenian: Umrljivost zaradi kardiovaskularnih dogodkov in skupna umrljivost je bila v skupini, ki je prejemala etorikoksib, podobna kot v skupini, ki je prejemala diklofenak.
English: However, concomitant administration of low-dose acetylsalicylic acid with etoricoxib may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone.
Slovenian: Etorikoksib se sme jemati sočasno z acetilsalicilno kislino v odmerkih, ki se uporabljajo za preprečevanje srčno-žilnih bolezni (majhni odmerki acetilsalicilne kisline), vendar pa se pri sočasni uporabi majhnih odmerkov acetilsalicilne kisline in etorikoksiba lahko pojavi večje število ulceracij v prebavilih in drugih zapletov kot pri zdravljenju z etorikoksibom samim.
English: The clinical significance of these increases is unknown, and higher doses of PREMARIN were not studied in combination with etoricoxib.
Slovenian: Večjih odmerkov zdravila PREMARIN v kombinaciji z etorikoksibom niso preučevali.
English: It is caused by deposits of mineral crystals in the joint.
Slovenian: Povzročajo jo kristali, ki se kopičijo v sklepih.
English: Ankylosing spondylitis The recommended dose is 90 mg once a day.
Slovenian: Ankilozirajoči spondilitis Priporočeni odmerek je 90 mg enkrat na dan.
English: General disorders and administration site conditions: Common: asthenia/fatigue, flu-like disease.
Slovenian: Splošne težave in spremembe na mestu aplikacije: Pogoste: astenija/utrujenost, gripi podobna bolezen Občasne: bolečina v prsih
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily.
Slovenian: V kliničnih študijah so pri približno 1 % bolnikov, ki so se do enega leta zdravili s 30, 60 in 90 mg etorikoksiba dnevno, poročali o dvigu alanin aminotransferaze (ALT) in/ali aspartat aminotransferaze (AST) (približno tri- ali več-kratna zgornja meja normalne vrednosti).
English: Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter United Kingdom ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Slovenian: Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter Velika Britanija ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
English: Bottles: Keep the container tightly closed in order to protect from moisture.
Slovenian: Plastenke: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Slovenian: Ni znano, če se etorikoksib dializira s peritonealno dializo.
English: Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section
Slovenian: Varnosti in učinkovitosti etorikoksiba pri otrocih niso dokazali (glejte poglavje 4.2).
English: Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Slovenian: Jedro: brezvodni kalcijev hidrogenfosfat premreženi natrijev karmelozat magnezijev stearat mikrokristalna celuloza
English: Dizziness and sleepiness have been reported in some patients taking <ARCOXIA>.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih, ki so jemali zdravilo <ARCOXIA>, so poročali o vrtoglavici in dremavosti.
English: The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Slovenian: Priporočeni odmerek je 120 mg enkrat na dan. Etorikoksib v odmerku 120 mg se sme uporabljati samo v obdobju akutnih simptomov.
English: [Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data)]
Slovenian: V nadaljevanju so navedeni neželeni učinki, katerih pojavnost v kliničnih preskušanjih pri bolnikih z OA, RA, kronično bolečino v križu ali ankilozirajočim spondilitisom, ki so se z etorikoksibom v odmerkih 30 mg, 60 mg ali 90 mg zdravili do 12 tednov, študijah programa MEDAL ali med spremljanjem zdravila po pridobitvi dovoljenja za promet je bila večja od pojavnosti pri placebu: [Zelo pogosti (≥1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do <1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), pogostnost neznana (iz razpoložljivih podatkov je ni mogoče oceniti)]
English: The upper GI benefit for etoricoxib compared with diclofenac was not statistically significant in patients taking concomitant low-dose aspirin (approximately 33% of patients).
Slovenian: Pri bolnikih, ki so sočasno jemali majhen odmerek acetilsalicilne kisline (približno 33 % bolnikov), korist etorikoksiba za zgornja prebavila v primerjavi z diklofenakom ni bila statistično pomembna.
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib.
Slovenian: Pri bolnikih, ki so jemali etorikoksib, so se pojavili zapleti v zgornjih prebavilih [perforacije, ulkusi ali krvavitve (PUK)], ki so se pri nekaterih bolnikih končali s smrtjo.
English: If you are using <ARCOXIA>, you must not breastfeed.
Slovenian: Med jemanjem zdravila <ARCOXIA> ne smete dojiti.
English: People with liver problems
Slovenian: Bolniki z boleznimi jeter
English: 6.6 Special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za zdstranjevanje in ravnanje z zdravilom
English: Very rare: confusion, hallucinations.
Slovenian: Občasne: tesnoba, depresija, zmanjšana sposobnost jasnega mišljenja Zelo redke: zmedenost, halucinacije
English: 60 mg Tablets: Dark green, apple-shaped, biconvex tablets <debossed ‘200' on one side and ‘ARCOXIA 60' on the other side>.
Slovenian: 60 mg tablete: temno zelene, bikonveksne tablete v obliki jabolka, <z oznako "200" na eni ter "ARCOXIA 60" na drugi strani>.
English: 90 mg Tablets: White, apple-shaped, biconvex tablets <debossed ‘202' on one side and ‘ARCOXIA 90' on the other side>.
Slovenian: 90 mg tablete: bele, bikonveksne tablete v obliki jabolka, <z oznako "202" na eni ter "ARCOXIA 90" na drugi strani>.
English: 30 mg Tablets: Blue-green, apple-shaped biconvex tablets <debossed ‘101' on one side and ‘ACX 30' on the other side>.
Slovenian: 30 mg tablete: modro-zelene, bikonveksne tablete v obliki jabolka, <z oznako "101" na eni ter "ACX 30" na drugi strani>.
English: Rate
Slovenian: Protin
English: Gastrointestinal and hepatic adverse events were observed significantly more frequently with diclofenac than etoricoxib.
Slovenian: O neželenih učinkih v prebavilih in jetrih so pri uporabi diklofenaka poročali pomembno pogosteje kot pri uporabi etorikoksiba.
English: • You have a history of stomach bleeding or ulcers.
Slovenian: • ste kdaj imeli krvavitve ali razjede v želodcu.
English: Caution should be used when initiating treatment with etoricoxib in patients with dehydration.
Slovenian: Pri bolnikih z dehidracijo je treba zdravljenje z etorikoksibom uvesti previdno.
English: However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Slovenian: To povečanje pri večini bolnikov običajno ni pomembno, vendar pa je treba bolnike z večjim tveganjem za pojav toksičnih učinkov digoksina med sočasnim zdravljenjem z etorikoksibom in digoksinom skrbno nadzirati.
English: There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Slovenian: Delež kardiovaskularnih trombotičnih dogodkov se pri uporabi etorikoksiba in diklofenaka ni pomembneje razlikoval.
English: Blisters Store in original package in order to protect from moisture.
Slovenian: Pretisni omoti Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Each film coated tablet contains 120 mg etoricoxib.
Slovenian: Ena filmsko obložena tableta vsebuje 120 mg etorikoksiba.
English: In the pooled MEDAL Program, 34,701 patients with OA or RA were treated for a mean duration of 17.9 months (maximum 42.3 months, median 16.3 months) with approximately 12,800 patients receiving treatment for more than 24 months.
Slovenian: Zdravljenje je v povprečju trajalo 17,9 mesecev (največ 42,3 meseca, mediana 16,3 meseca).
English: Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Slovenian: Ena filmsko obložena tableta vsebuje 30, 60, 90 ali 120 mg etorikoksiba.
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Slovenian: Vendar je bil delež teh zapletov večji pri bolnikih, ki so prejemali etorikoksib, kot pri bolnikih, ki so prejemali naproksen v odmerku 500 mg dvakrat na dan. Razlika v antitrombotičnem delovanju med nekaterimi NSAR-i, ki zavirajo COX-1, in selektivnimi zaviralci COX-2 je pri bolnikih s tveganjem za trombembolične dogodke lahko klinično pomembna.
English: There were no statistically significant differences in thrombotic event rates between etoricoxib and diclofenac across all subgroups analyzed including patient categories across a range of baseline cardiovascular risk.
Slovenian: Delež trombotičnih dogodkov se v vseh analiziranih podskupinah bolnikov, vključno z bolniki z različnimi stopnjami kardiovaskularnega tveganja v izhodišču, pri uporabi etorikoksiba ni statistično pomembneje razlikoval od deleža pri uporabi diklofenaka.
English: In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Slovenian: Pri kuncih so pri izpostevljenosti, ki je bila manjša od izpostavljenosti človeka pri klinični uporabi dnevnega odmerka (90 mg), opazili z zdravljenjem povezano večjo pojavnost kardiovaskularnih malformacij, niso pa opazili nobenih z zdravljenjem povezanih malformacij na zunanjosti ali skeletu plodov.
English: Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see section 4.3).
Slovenian: Otroci Pri otrocih in mladostnikih, mlajših od 16 let, je uporaba etorikoksiba kontraindicirana (glejte poglavje
English: There was a decrease in pup body weight following exposure of pups to milk from dams administered etoricoxib during lactation.
Slovenian: Telesna masa mladičev, katerih matere so v obdobju dojenja dobivale etorikoksib, se je zaradi izpostavljenosti mleku zmanjšala.
English: • The active substance is etoricoxib.
Slovenian: • Zdravilna učinkovina je etorikoksib.
English: Tablet coating:
Slovenian: Bolezni sečil:
English: 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60' on one side and ‘200' on the other.
Slovenian: 60 mg filmsko obložene tablete so temno zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 60" na eni strani in oznako "200" na drugi strani.
English: 30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30' on one side and ‘101' on the other.
Slovenian: 30 mg filmsko obložene tablete so modro-zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ACX 30" na eni in oznako "101" na drugi strani.
English: HOW TO STORE <ARCOXIA>
Slovenian: SHRANJEVANJE ZDRAVILA <ARCOXIA>
English: 60 mg - 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
Slovenian: 100 filmsko obloženih tablet 50 filmsko obloženih tablet (enoodmerni pretisni omot) 100 filmsko obloženih tablet (enoodmerni pretisni omot) 30 filmsko obloženih tablet (HDPE plastenke) 90 filmsko obloženih tablet (HDPE plastenke)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE BOTTLE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: 120 mg Tablets: Pale-green, apple-shaped, biconvex tablets <debossed ‘204' on one side and ‘ARCOXIA 120' on the other side>.
Slovenian: 120 mg tablete: svetlo zelene, bikonveksne tablete v obliki jabolka, <z oznako "204" na eni ter "ARCOXIA 120" na drugi strani>.
English: NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Slovenian: Pomembne razlike v varnosti za prebavila med zdravljenjem s selektivnimi zaviralci COX-2 v kombinaciji z acetilsalicilno kislino in zdravljenjem z NSAR-i v kombinaciji z acetilsalicilno kislino v dolgoročnih kliničnih študijah niso dokazali (glejte poglavje 5.1).
English: 90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other.
Slovenian: 90 mg filmsko obložene tablete so bele, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 90" na eni strani in oznako "202" na drugi strani.
English: Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.
Slovenian: Pri uporabi etorikoksiba pri starejših bolnikih in pri bolnikih z okvaro funkcije ledvic, jeter ali srca je treba te bolnike ustrezno nadzorovati.
English: Each film coated tablet contains 30 mg etoricoxib.
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg etorikoksiba.
English: • birth control pills
Slovenian: • kontracepcijske tablete,
English: NL 2031 BN Haarlem The Netherlands
Slovenian: NL 2031 BN Haarlem
English: Each film coated tablet contains 90 mg etoricoxib.
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg etorikoksiba.
English: Belgium Merck Sharp and Dohme Chasussée de Waterloo 1135
Slovenian: Merck Sharp and Dohme Chasussée de Waterloo 1135 B-1180 Brussels Belgium
English: In a cardiovascular safety outcomes program of pooled data from three active comparator controlled trials, 17, 412 patients with OA or RA were treated with etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months.
Slovenian: V ta preskušanja je bilo vključenih 17.412 bolnikov z OA ali RA, ki so se z etorikoksibom (v odmerku 60 mg ali 90 mg) zdravili v povprečju približno 18 mesecev.
English: Bottles Keep the container tightly closed in order to protect from moisture.
Slovenian: Plastenke Plastenke shranjujte tesno zaprte za zagotovitev zaščite pred vlago.
English: Czech Republic Merck Sharp & Dohme B.V. Waanderweg NL-2031 BN Haarlem
Slovenian: Waanderweg 39 NL-2031 BN Haarlem
English: Titanium dioxide (E171)
Slovenian: Obloga tablete: karnauba vosek laktoza monohidrat hipromeloza titanov dioksid (E171) triacetin
English: Each film coated tablet contains 60 mg etoricoxib.
Slovenian: Ena filmsko obložena tableta vsebuje 60 mg etorikoksiba.
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Slovenian: 120 mg filmsko obložene tablete so svetlo zelene, na obeh straneh izbočene, v obliki jabolka, z oznako "ARCOXIA 120" na eni strani in oznako "204" na drugi strani.
English: A significantly lower rate of overall upper GI events was observed with etoricoxib compared to diclofenac.
Slovenian: Pri uporabi etorikoksiba je bil delež vseh dogodkov v zgornjem predelu prebavil pomembno manjši kot pri uporabi diklofenaka.
English: The EDGE II study included 4086 RA patients treated with etoricoxib 90 mg daily or diclofenac 150 mg daily for a mean period of 19.2 months (maximum 33.1 months, median 24 months).
Slovenian: V študijo EDGE II je bilo vključenih 4.086 bolnikov z RA, ki so se zdravili z etorikoksibom v odmerku 90 mg na dan ali diklofenakom v odmerku 150 mg na dan.
English: MARKETING AUTHORISATION NUMBER [To be completed nationally.]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
English: Route of adminitration
Slovenian: NAVODILO ZA UPORABO
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Slovenian: Občasne: napihnjen trebuh, refluks kisline, spremenjen vzorec iztrebljanja, zaprtje, suha usta, razjeda želodca in dvanajstnika, sindrom iritabilnega kolona, ezofagitis, razjeda v ustih, bruhanje, gastritis Zelo redke: peptična razjeda, vključno s perforacijami in krvavitvami v prebavilih (večinoma pri starejših bolnikih)
English: Blisters: Store in the original package in order to protect from moisture.
Slovenian: Pretisni omoti: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: Uncommon: flushing, cerebrovascular accident
Slovenian: Občasne: zamegljen vid, konjunktivitis
English: Psychiatric disorders:
Slovenian: Žilne bolezni:
English: decreases in mental sharpness, breathlessness, cough, swelling of the face, flushing, skin rash or itchy skin, urinary tract infection.
Slovenian: mišična bolečina/okorelost, nespečnost, zaspanost, odrevenelost ali mravljinčenje, tesnoba, depresija, zmanjšana sposobnost jasnega mišljenja, zasoplost, kašelj, otekanje obraza, zardevanje, kožni izpuščaj ali srbenje, okužba sečil.
English: Hertsfordshire EN11 9BU
Slovenian: EN11 9BU
English: Microcrystalline cellulose
Slovenian: HDPE PLASTENKA