FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason.
Slovenian: Previdnost je potrebna pri bolnikih, ki so kdaj imeli srčno popuščanje, disfunkcijo levega prekata ali visok krvni tlak, ter pri bolnikih z obstoječimi edemi zaradi kateregakoli vzroka.
English: Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended.
Slovenian: Sočasnega zdravljenja z etorikoksibom in acetilsalicilno kislino v odmerkih, večjih od tistih za preprečevanje srčno-žilnih bolezni, ali z drugimi NSAR-i ne priporočamo.
English: Etoricoxib 120 mg given with the same oral contraceptive concomitantly or separated by 12 hours, increased the steady state AUC0-24hr of EE by 50 to 60%.
Slovenian: Etorikoksib 120 mg skupaj z istim peroralnim kontraceptivom, sočasno ali z 12-urnim razmikom, je povečal AUC0-24 ur EE v stanju dinamičnega ravnovesja za 50 do 60 %.
English: There was no discernible difference in the rate of serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or non-naproxen NSAIDs.
Slovenian: Deleži resnih trombotičnih srčno-žilnih zapletov se pri bolnikih, ki so dobivali etorikoksib ≥ 60 mg, placebo ali NSAR-e, razen naproksena, niso opazno razlikovali.
English: In the rat, gastrointestinal toxicity of etoricoxib increased with dose and exposure time.
Slovenian: Pri podganah se je toksičnost za prebavila povečala z odmerkom in časom izpostavitve.
English: Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
Slovenian: Občasne: povečana sečnina v krvi, povečana kreatinfosfokinaza, zmanjšan hematokrit, zmanjšan hemoglobin, hiperkalemija, zmanjšano število levkocitov, zmanjšano število trombocitov, povečan serumski kreatinin, povečana sečna kislina.
English: Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Slovenian: Etorikoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
English: There was an approximate 50% risk reduction for these endpoints in patients treated with etoricoxib (60, 90 or 120 mg daily) as compared to patients treated with naproxen 500 mg twice daily or diclofenac 50 mg three times daily.
Slovenian: Tveganje za te opazovane dogodke je bilo približno za 50 % manjše pri bolnikih, ki so se zdravili z etorikoksibom (60, 90 ali 120 mg dnevno), v primerjavi z bolniki, ki so dobivali naproksen 500 mg dvakrat na dan ali diklofenak 50 mg trikrat na dan.
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 90 mg enkrat na dan pomembno olajšal bolečino in vnetje ter izboljšal gibljivost.
English: Immune system disorder: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions.
Slovenian: Zelo redke: preobčutljivostne reakcije, vključno z angioedemom, anafilaktičnimi/anafilaktoidnimi reakcijami.
English: In a study in healthy subjects, daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test.
Slovenian: V raziskavi pri zdravih preiskovancih, ki so dnevno dobivali 120 mg etorikoksiba, se aktivnost jetrnega CYP3A4, ocenjena z eritromicinskim dihalnim testom, ni spremenila.
English: Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Slovenian: Litij: NSAR-i zmanjšajo izločanje litija preko ledvic in tako povečajo plazemsko koncentracijo litija.
English: Blisters: Store in the original package.
Slovenian: Pretisni omoti: Shranjujte v originalni ovojnini.
English: In patients with osteoarthritis (OA), etoricoxib 60 mg once daily provided significant improvements in pain and patient assessments of disease status.
Slovenian: Pri bolnikih z osteoartrozo (OA) je etorikoksib 60 mg enkrat na dan pomembno olajšal bolečino in izboljšal bolnikovo oceno stanja bolezni.
English: Monitoring of renal function in such patients should be considered.
Slovenian: Pri teh bolnikih moramo razmisliti o spremljanju ledvične funkcije.
English: The recommended dose is 60 mg once daily.
Slovenian: Osteoartroza Priporočeni odmerek je 60 mg enkrat na dan.
English: CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo.
Slovenian: Pokazalo se je, da CYP3A4 sodeluje pri presnovi etorikoksiba in vivo.
English: Luxembourg Merck Sharp&Dohme s.a. 1180, Chaussée de Waterloo B-1135 Bruxelles
Slovenian: Merck Sharp&Dohme s.a. 1180, Chaussée de Waterloo B-1135 Bruxelles Belgija
English: Acute gouty arthritis
Slovenian: Akutni urični artritis (napad protina)
English: The use of etoricoxib, as with any medicinal product known to inhibit cyclooxygenase / prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.6, 5.1, and 5.3).
Slovenian: Pri ženskah, ki nameravajo zanositi, uporabe etorikoksiba kot tudi drugih učinkovin, ki zavirajo ciklooksigenazo / sintezo prostaglandinov, ne priporočamo (glejte 4.6, 5.1 in 5.3).
English: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
Slovenian: Etorikoksib se sme jemati sočasno z acetilsalicilno kislino v odmerkih, ki se uporabljajo za preprečevanje srčno-žilnih bolezni (majhni odmerki acetilsalicilne kisline).
English: Cardiorenal events: Statistically significantly more patients treated with etoricoxib than diclofenac experienced adverse effects associated with hypertension (11.7% versus 5.9%) and oedema (7.5% versus
Slovenian: Srčno-ledvični dogodki: Pri bolnikih, zdravljenih z etorikoksibom, je v primerjavi z diklofenakom prišlo do pomembno več neželenih učinkov, povezanih s hipertenzijo (11,7 % proti 5,9 %) in edemi (7,5 % proti 5,9 %).
English: Caution should be used when initiating treatment with etoricoxib in patients with dehydration.
Slovenian: Pazljivi moramo biti, kadar z etorikoksibom začnemo zdraviti bolnike z dehidracijo.
English: Women who use etoricoxib should not breast feed.
Slovenian: Ženske, ki jemljejo etorikoksib, ne smejo dojiti.
English: Gastrointestinal tolerability and safety results: Etoricoxib was associated with a statistically significantly lower incidence of patient withdrawals due to a predefined composite endpoint of clinical gastrointestinal adverse events and laboratory adverse events related to elevated liver function tests compared to diclofenac.
Slovenian: Prenašanje in varnost v prebavilih: Etorikoksib je bil v primerjavi z diklofenakom povezan s statistično pomembno manjšo pojavnostjo prekinitev zdravljenja pri bolnikih zaradi vnaprej opredeljenega sestavljenega končnega dogodka: kliničnih neželenih učinkov v prebavilih in laboratorijskih neželenih učinkov v povezavi s povišanimi vrednostmi testov jetrne funkcije.
English: Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Slovenian: Aktivna razjeda želodca ali aktivna krvavitev v prebavilih.
English: Etoricoxib MSD 90 mg
Slovenian: Etoricoxib MSD
English: Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 mcg ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Slovenian: Peroralni kontraceptivi: 21 dnevna uporaba etorikoksiba v odmerku 60 mg skupaj s peroralnim kontraceptivom, ki vsebuje 35 µg etinilestradiola (EE) in 0,5 do 1 mg noretindrona, je povečala AUC024 ur EE v stanju dinamičnega ravnovesja za 37 %.
English: Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor within the clinical dose range.
Slovenian: Etorikoksib je znotraj območja kliničnih odmerkov peroralni selektivni zaviralec ciklooksigenaze-2 (COX-2).
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: Občasne: mišični krč/spazem, mišično-skeletna bolečina/okorelost.
English: The effect of etoricoxib on the pharmacokinetics of other drugs
Slovenian: Vpliv etorikoksiba na farmakokinetiko drugih učinkovin
English: A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/day sodium diet. Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
Slovenian: V randomizirani, dvojno slepi, s placebom primerjani, vzporedni raziskavi so ocenjevali učinek 15dnevnega zdravljenja z etorikoksibom (90 mg), celekoksibom (200 mg dvakrat na dan), naproksenom (500 mg dvakrat na dan) in placebom na izločanje natrija v urinu, krvni tlak in druge kazalce delovanja ledvic pri preiskovancih, starih 60 do 85 let, na dieti z 200 mEq natrija na dan.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Slovenian: Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo (glejte poglavja 4.3, 4.4., 4.8 in 5.1).
English: * Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
Slovenian: Glede na rezultate dolgoročnih, s placebom in drugim zdravilom primerjanih kliničnih raziskav so bili nekateri selektivni zaviralci COX-2 povezani s povečanim tveganjem za resne trombotične dogodke v arterijah, vključno z miokardnim infarktom in možgansko kapjo.
English: The incidence of clinical gastrointestinal events leading to withdrawal was statistically significantly lower for etoricoxib versus diclofenac (7.1% versus 9.1%, respectively).
Slovenian: Pojavnost kliničnih dogodkov v prebavilih, ki so pripeljali do prekinitve zdravljenja, je bila statistično pomembno manjša pri etorikoksibu kot pri diklofenaku (7,1 % proti 9,1 %).
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.2, 4.3, 4.8 and 5.1).
Slovenian: Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo (glejte poglavja 4.2, 4.3, 4.8 in 5.1).
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs.
Slovenian: Klinične raziskave kažejo, da je razred zdravil selektivnih zaviralcev COX-2 lahko povezan s tveganjem za trombotične dogodke (posebno za miokardni infarkt in možgansko kap) glede na placebo in nekatere NSAR-e.
English: Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
Slovenian: Etorikoksiba se ne da odstraniti s hemodializo; ni znano, ali se etorikoksib dializira s peritonealno dializo.
English: However, there was a decrease in embryo/foetal survival at exposures greater than or equal to 1.5 times the human exposure.
Slovenian: Vendar pa se je preživetje zarodka/ploda zmanjšalo pri izpostavitvi, enaki ali večji od 1,5-kratne izpostavitve pri človeku (glejte 4.3 in 4.6).
English: 90 mg Tablets: White, apple-shaped, biconvex tablets <debossed ‘454' on one side and ‘MSD' on the other side>.
Slovenian: 90 mg tablete: Bele, bikonveksne tablete v obliki jabolka, z oznako "454" na eni strani ter "MSD" na drugi strani.
English: Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly.
Slovenian: Pri sočasni uporabi etorikoksiba in metotreksata je priporočljivo ustrezno spremljati z metotreksatom povezano toksičnost.
English: Etoricoxib may mask fever and other signs of inflammation.
Slovenian: Etorikoksib lahko prikrije zvišano telesno temperaturo in druge znake vnetja.
English: In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Slovenian: V dveh 12-tedenskih dvojno slepih endoskopskih raziskavah je bila kumulativna pojavnost razjed želodca in dvanajstnika pomembno manjša pri bolnikih, zdravljenih z etorikoksibom 120 mg enkrat na dan, kot pri bolnikih, zdravljenih z naproksenom 500 mg dvakrat na dan ali ibuprofenom 800 mg trikrat na dan. Pojavnost razjed je bila pri etorikoksibu večja kot pri placebu.
English: Etoricoxib is excreted in the milk of lactating rats.
Slovenian: Etorikoksib se izloča v mleko doječih podgan.
English: In patients experiencing attacks of acute gouty arthritis, etoricoxib 120 mg once daily over an eight-day treatment period, relieved moderate to extreme joint pain and inflammation comparable to indomethacin 50 mg three times daily.
Slovenian: Pri bolnikih z napadi akutnega uričnega artritisa je etorikoksib 120 mg enkrat na dan med osemdnevnim zdravljenjem olajšal zmerno do zelo hudo bolečino in vnetje v sklepih, primerljivo z indometacinom 50 mg trikrat na dan.
English: The major route of metabolism to form the 6'-hydroxymethyl derivative is catalyzed by CYP enzymes.
Slovenian: Glavna presnovna pot je tvorba 6'-hidroksimetil presnovka, ki jo katalizirajo encimi CYP.
English: (See sections 5.1 and 4.4.)
Slovenian: (Glejte poglavji 5.1 in 4.4.)
English: Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone.
Slovenian: Prednizon/prednizolon: V raziskavah interakcij med učinkovinami etorikoksib ni imel klinično pomembnih učinkov na farmakokinetiko prednizona/prednizolona.
English: General disorders and administration site conditions: Common: asthenia/fatigue, flu-like disease.
Slovenian: Splošne težave in spremembe na mestu aplikacije: Pogoste: splošna oslabelost/utrujenost, gripi podobna bolezen.
English: Hepatic insufficiency: Patients with mild hepatic dysfunction (Child-Pugh score 5-6) administered etoricoxib 60 mg once daily had an approximately 16% higher mean AUC as compared to healthy subjects given the same regimen.
Slovenian: Jetrna okvara: pri bolnikih z blago motnjo delovanja jeter (lestvica po Child-Pughu 5-6), ki so dobivali 60 mg etorikoksiba enkrat na dan, je bila povprečna AUC za približno 16 % večja kot pri zdravih preiskovancih, ki so dobivali enak odmerek.
English: 60 mg Tablets: Green, apple-shaped, biconvex tablets <debossed ‘447' on one side and ‘MSD' on the other side>.
Slovenian: 60 mg tablete: Zelene, bikonveksne tablete v obliki jabolka, z oznako "447" na eni strani ter "MSD" na drugi strani.
English: Methotrexate: Two studies investigated the effects of etoricoxib 60, 90 or 120 mg administered once daily for seven days in patients receiving once-weekly methotrexate doses of 7.5 to 20 mg for rheumatoid arthritis.
Slovenian: Metotreksat: V dveh raziskavah so preučili učinke etorikoksiba v odmerkih 60, 90 ali 120 mg, ki so jih enkrat na dan sedem dni jemali bolniki, ki so za zdravljenje revmatoidnega artritisa enkrat tedensko dobivali metotreksat v odmerkih 7,5 do 20 mg. Etorikoksib v odmerkih 60 in 90 mg ni vplival na plazemsko koncentracijo metotreksata ali ledvični očistek.
English: Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali etorikoksib, so poročali o hudih preobčutljivostnih reakcijah (kot na primer anafilaksija in angioedem) (glejte 4.8).
English: Clinical 1
Slovenian: Klinični vidik 1
English: Uncommon: anxiety, depression, mental acuity decreased.
Slovenian: Občasne: tesnoba, depresija, zmanjšana sposobnost jasnega mišljenja.
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting.
Slovenian: Občasne: napihnjen trebuh, refluks kisline, spremenjen vzorec iztrebljanja, zaprtje, suha usta, razjeda želodca in dvanajstnika, sindrom iritabilnega kolona, ezofagitis, razjeda v ustih, bruhanje.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Month Day, Year
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
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 NSAR-ov, vključno z zaviralci COX-2 (ciklooksigenaze-2), pojavili bronhospazem, akutni rinitis, nosni polipi, angionevrotični edem, urtikarija ali alergijske reakcije.
English: Hepatobiliary disorders: Very rare: hepatitis.
Slovenian: Bolezni jeter, žolčnika in žolčevodov Zelo redke: hepatitis.
English: The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Slovenian: Ocenjujejo, da znaša plazemski očistek približno 50 ml/min.
English: Effects of other drugs on the pharmacokinetics of etoricoxib
Slovenian: Vpliv drugih učinkovin na farmakokinetiko etorikoksiba
English: The incidence of congestive heart failure was 0.4% for etoricoxib versus 0.2% for diclofenac.
Slovenian: Pojavnost kongestivnega srčnega popuščanja je bila 0,4 % za etorikoksib, za diklofenak pa 0,2 %.
English: The incidence of patient discontinuations due to oedema was 0.9% for etoricoxib versus 0.7% for diclofenac.
Slovenian: Pojavnost prekinitev zaradi edemov pa je bila 0,9 % za etorikoksib, za diklofenak pa 0,7 %.
English: It is advisable to rehydrate patients prior to starting therapy with etoricoxib.
Slovenian: Pred začetkom zdravljenja z etorikoksibom je bolnike priporočljivo rehidrirati.
English: Hepatic adverse events: Etoricoxib was associated with a statistically significantly lower rate of withdrawals than diclofenac (0.3% versus 5.2%), due largely to elevations in liver function tests.
Slovenian: Neželeni učinki v jetrih: Etorikoksib je bil v primerjavi z diklofenakom povezan s statistično pomembno manjšim deležem prekinitev zdravljenja predvsem zaradi povišanj vrednosti testov jetrne funkcije (0,3 % proti 5,2 %).
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, nelagodje v epigastriju, navzeja.
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 po potrebi skrbno spremljajte količino litija v krvi in prilagodite odmerek litija.
English: Respiratory, thoracic and mediastinal disorders: Uncommon: cough, dyspnoea, epistaxis.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: Občasne: kašelj, dispneja, epistaksa.
English: The dose for OA should not exceed 60mg daily
Slovenian: Odmerek za osteoartrozo ne sme preseči 60 mg na dan.
English: Uncommon: ecchymosis, facial oedema, pruritus, rash.
Slovenian: Občasne: ekhimoza, edemi obraza, pruritus, izpuščaj.
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 60 and 90 mg daily.
Slovenian: V kliničnih raziskavah so pri približno 1 % bolnikov, ki so se do enega leta zdravili s 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: The dose for RA should not exceed 90mg daily
Slovenian: Odmerek za revmatoidni artritis ne sme preseči 90 mg na dan.
English: MSD Hungary Ltd. Alkotás utca 48-50 H-1123 Budapest Hungary
Slovenian: MSD Hungary Ltd. Alkotás utca 50
English: The recommended dose is 90 mg once daily.
Slovenian: Revmatoidni artritis Priporočeni odmerek je 90 mg enkrat na dan.
English: Clinical 4
Slovenian: Klinični vidik 4
English: Effect of etoricoxib on drugs metabolised by CYP isoenzymes
Slovenian: Vpliv etorikoksiba na zdravila, ki jih presnavljajo izoencimi CYP
English: Ear and labyrinth disorders: Uncommon: tinnitus.
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: Občasne: tinitus.
English: - Addition of a warning on clinical trials which suggest that selective Cox-2 inhibitors may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs.
Slovenian: - Dodano je opozorilo v zvezi z kliničnimi raziskavami, ki navaja, da je selektivni zaviralec COX-2 (v primerjavi s placebom in nekaterimi nestereoidnimi protivnetnimi zdravili) lahko povezan s tveganjem za trombotiče dogodke (posebno za, miokardn infarktom in možgansko kap).
English: Clinical 2
Slovenian: Klinični vidik 2
English: GROUNDS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
Slovenian: PODLAGA ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: Common: hypertension.
Slovenian: Zelo redke:hipertenzivna kriza.
English: Clinical 3
Slovenian: Klinični vidik 3
English: The rates of myocardial infarction were 0.68 versus 0.42 events per 100 patient years on etoricoxib and diclofenac respectively.
Slovenian: Deleža miokardnih infarktov sta bila 0,68 proti 0,42 na 100 bolnikov-let za etorikoksib oz. diklofenak.
English: 6.6 Instructions for use and handling
Slovenian: 6.6 Navodila za uporabo in ravnanje z zdravilom Ni posebnih zahtev.
English: This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib.
Slovenian: Pri izboru primernega peroralnega kontraceptiva za uporabo z etorikoksibom je treba upoštevati to povečanje koncentracije EE.
English: Merck sharp & Dohme Ltd. Šmartinska cesta 140 SI-1000 Ljubljana Slovenia
Slovenian: Merck Sharp & Dohme Ltd. Šmartinska cesta 140
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 in krvavitve (PUK)]; nekateri so imeli smrtni izid.
English: Uncommon: chest pain.
Slovenian: Občasne: bolečina v prsih.
English: Nervous system disorder:
Slovenian: Bolezni živčevja:
English: The rates of ischemic stroke were 0.14 versus 0.23 per 100 patient years on etoricoxib versus diclofenac respectively.
Slovenian: Deleža ishemičnih možganskih kapi sta bila 0,14 proti 0,23 na 100 bonikov-let za etorikoksib oz. diklofenak.
English: There was a decrease in pup body weight following exposure of pups to milk from dams administered etoricoxib during lactation.
Slovenian: Mladičem samic, ki so v obdobju dojenja dobivale etorikoksib, se je zaradi izpostavitve mleku zmanjšala njihova telesna teža.
English: (See sections 4.3 and 5.3.)
Slovenian: (Glejte 4.3 in 5.3.)
English: (See sections 4.2 and 4.3.)
Slovenian: (Glejte 4.2 in 4.3.)