FrancophonIA/ELRC3.0 huggingface dataset:
English: Diclofenac (N=16483) 24766 PatientYears
Slovenian: diklofenak (N = 16.483) 24.766 bolnik-let (patient-years)
English: • You have a history of heart failure, heart attack or any other form of heart disease.
Slovenian: • ste kdaj imeli srčno popuščanje, srčni napad ali katerokoli drugo bolezen srca.
English: • You are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
Slovenian: • ste dehidrirani, na primer zaradi dolgotrajnega bruhanja ali driske.
English: This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
Slovenian: To je zaradi tveganja za srčni napad in kap, ki se pri daljšem zdravljenju lahko poveča, še posebej pri velikih odmerkih.
English: If you miss a dose, just resume your usual schedule the following day.
Slovenian: Če ste izpustili odmerek, nadaljujte z jemanjem zdravila naslednji dan ob običajnem času.
English: The CHMP therefore recommends that dose finding studies are explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Slovenian: Zato CHMP priporoča, da se posebej preučijo študije o odmerjanju za ugotovitev, ali bi zdravljenje z odmerkom 60 mg enkrat dnevno zadostovalo za določene bolnike.
English: If you take more <ARCOXIA> than you should You should never take more tablets than the doctor recommends.
Slovenian: Če ste vzeli večji odmerek zdravila <ARCOXIA>, kot bi smeli Nikoli ne vzemite več tablet, kot vam jih je predpisal zdravnik.
English: • if you have high blood pressure that has not been controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled)
Slovenian: • če imate visok krvni tlak, ki kljub zdravljenju ni ustrezno nadzorovan (če niste prepičani, če je vaš tlak ustrezno nadzorovan, se posvetujte s svojim zdravnikom ali z medicinsko sestro).
English: Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Slovenian: Starejši bolniki: Farmakokinetika pri starejših bolnikih (starih 65 let ali več) je podobna kot pri mlajših bolnikih.
English: This leaflet was last approved in (MM/YYYY).
Slovenian: Navodilo je bilo odobreno: (MM/LLLL).
English: Paediatric patients: The pharmacokinetics of etoricoxib in paediatric patients (<12 years old) have not been studied.
Slovenian: Pediatrični bolniki: Farmakokinetike etorikoksiba pri pediatričnih bolnikih (< 12 let) niso preučevali.
English: The cardiorenal results for EDGE and EDGE II were consistent with those described for the MEDAL Study.
Slovenian: Kardiorenalni rezultati študij EDGE in EDGE II so v skladu z rezultati, opisanimi za študijo MEDAL.
English: Patients enrolled in the Program had a wide range of cardiovascular and gastrointestinal risk factors at baseline.
Slovenian: Bolniki, vključeni v program, so v izhodišču imeli raznolike kardiovaskularne in gastrointestinalne dejavnike tveganja.
English: <ARCOXIA> Tablets are available in four strengths:
Slovenian: Zdravilo <ARCOXIA> je na voljo v štirih jakostih:
English: These beneficial effects were maintained over the 12-week treatment periods.
Slovenian: Ti koristni učinki so trajali celotno 12-tedensko obdobje zdravljenja.
English: DK-2600 Glostrup Danmark
Slovenian: DK-2600 Glostrup
English: Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
Slovenian: Zelo redke: ledvična insuficienca, vključno z odpovedjo ledvic, ki je običajno reverzibilna po ukinitvi zdravljenja (glejte poglavje 4.4)
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Slovenian: Ti koristni učinki so se pojavili že drugi dan zdravljenja in se ohranili do 52 tednov.
English: • <ARCOXIA> is one of a group of medicines called selective COX-2 inhibitors.
Slovenian: • Zdravilo <ARCOXIA> je eno izmed zdravil iz skupine zdravil, imenovanih selektivni zaviralci COX-2.
English: LIST OF EXCIPIENTS Lactose (see leaflet for more information).
Slovenian: SEZNAM POMOŽNIH SNOVI Laktoza (za več informacij glejte Navodilo za uporabo).
English: Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Slovenian: Zelo redke: urtikarija, Stevens-Johnson-ov sindrom, toksična epidermalna nekroliza
English: In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required.
Slovenian: V primeru prevelikega odmerjanja so primerni običajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil ter uvedba kliničnega nadzora in podpornega zdravljenja, če je to potrebno.
English: Very rare: bronchospasm.
Slovenian: Zelo redke: bronhospazem
English: - A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals who prescribe etoricoxib according to national practice.
Slovenian: − Dopis „Spoštovani zdravstveni delavec“ (DHPC) mora biti poslan vsem zdravstvenim delavcem, ki lahko v skladu z nacionalno prakso predpisujejo etorikoksib.
English: What is ankylosing spondylitis?
Slovenian: Kaj je ankilozirajoči spondilitis?
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Slovenian: Huda motnja delovanja jeter (serumski albumin < 25 g/l ali ocena po Child-Pugh ≥ 10).
English: The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Slovenian: Odločitev, da se predpiše selektivni zaviralec COX-2, mora temeljiti na oceni vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Slovenian: Nosečnost in dojenje (glejte poglavji 4.6 in 5.3).
English: Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
Slovenian: Diuretiki, zaviralci ACE in antagonisti angiotenzina II: NSAR-i lahko zmanjšajo učinek diuretikov in drugih antihipertenzivnih zdravil.
English: Take special care with <ARCOXIA> <ARCOXIA> may not be suitable for you, or you may need to be monitored regularly while taking it if any of the following apply to you:
Slovenian: Bodite posebno pozorni pri uporabi zdravila <ARCOXIA> Zdravilo <ARCOXIA> morda ni primerno za vas ali pa morate biti, medtem ko ga jemljete, pod rednim nadzorom zdravnika, če za vas velja kaj od naštetega:
English: In studies specifically designed to measure the onset of action of etoricoxib, the onset of action occurred as early as 24 minutes after dosing.
Slovenian: V študijah, ki so jih zasnovali posebej za določitev začetka delovanja etorikoksiba, je delovanje nastopilo že 24 minut po odmerjanju.
English: Overall upper GI events were defined as perforations, ulcers and bleeds.
Slovenian: Dogodki v zgornjem predelu prebavil so v celoti definirani kot perforacije, ulkusi in krvavitve.
English: These interactions should be considered in patients taking etoricoxib concomitantly with ACE inhibitors or angiotensin II antagonists.
Slovenian: Te interakcije je treba upoštevati pri bolnikih, ki jemljejo etorikoksib sočasno z zaviralci ACE ali antagonisti angiotenzina II.
English: Healthcare professionals were to be reminded of these measures through a communication letter (DHCP).
Slovenian: Zdravstveni delavci bodo o teh ukrepih opozorjeni s posebnim dopisom „Spoštovani zdravstveni delavec“ (DHCP).
English: Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter.
Slovenian: Krvni tlak je treba kontrolirati prva dva tedna po začetku zdravljenja in občasno še po tem.
English: In this trial, only serious adverse events and discontinuations due to any adverse events were recorded.
Slovenian: V tem preskušanju so beležili le resne neželene učinke in prekinitve zdravljenja zaradi kateregakoli neželenega učinka.
English: Acute gouty arthritis
Slovenian: Akutni urični artritis
English: Gender: The pharmacokinetics of etoricoxib are similar between men and women.
Slovenian: Spol: Farmakokinetika etorikoksiba je pri moških in ženskah podobna.
English: Studies with etoricoxib 30 mg once daily demonstrated efficacy superior to placebo over a 12 week treatment period (using similar assessments as the above studies).
Slovenian: Študije z etorikoksibom v odmerku 30 mg enkrat na dan so v 12 tedenskem obdobju zdravljenja pokazale boljšo učinkovitost glede na placebo (uporabili so podobno ocenjevanje kot v zgoraj omenjenih študijah).
English: The 30 mg dose has not been studied in osteoarthritis of hands.
Slovenian: 30 mg odmerka niso preučevali za osteoartrozo rok.
English: Do not take a double dose to make up for the forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadoknadili zamujeni odmerek.
English: especially in high doses, and your doctor will want to check your blood pressure from time to time.
Slovenian: Zato vam bo zdravnik občasno želel preveriti krvni tlak.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Slovenian: Farmakoterapevtska skupina: Nesteroidna protivnetna in protirevmatična zdravila, koksibi, oznaka ATC: M01 AH05
English: Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Slovenian: Potrjena ishemična bolezen srca, bolezen perifernih arterij in/ali cerebrovaskularna bolezen.
English: There is little direct comparative safety data for individual NSAIDs other than diclofenac and naproxen and it is therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Slovenian: Obstaja zelo malo neposrednih primerjalnih podatkov o varnosti posameznih nesteroidnih protivnetnih zdravil, razen za diklofenak in naproksen, zato je težko določiti tveganja v zvezi z etorikoksibom v primerjavi z ibuprofenom, ketoprofenom ali drugimi, manj uporabljenimi nesteroidnimi protivnetnimi zdravili.
English: The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/min.
Slovenian: Ocenjujejo, da znaša plazemski očistek po 25 mg intravenskem odmerku približno 50 ml/min.
English: • You are being treated for an infection.
Slovenian: • se zdravite zaradi okužbe.
English: Like all medicines, <ARCOXIA> can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo <ARCOXIA> neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Slovenian: Zelo redke: preobčutljivostne reakcije, vključno z angioedemom, anafilaktičnimi/anafilaktoidnimi reakcijami, vključno s šokom.
English: Per-protocol: all events on study therapy or within 14 days of discontinuation (excluded: patients who took < 75% of their study medication or took non-study NSAIDs >10% of the time).
Slovenian: Po protokolu (per-protocol): vsi dogodki med zdravljenjem v študiji ali v 14 dneh po prekinitvi zdravljenja (bolniki, ki so vzeli < 75 % zdravila, predvidenega v študiji, ali so > 10 % časa jemali NSAR-e, ki niso bili predvideni v študiji, so izključeni).
English: This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib.
Slovenian: To povečanje koncentracije EE je treba upoštevati pri izboru primernega peroralnega kontraceptiva za uporabo skupaj z etorikoksibom.
English: Hepatocellular and thyroid follicular cell adenomas observed in rats are considered to be a consequence of rat-specific mechanism related to hepatic CYP enzyme induction.
Slovenian: Hepatocelularni adenomi in folikularni adenomi ščitnice, ki so jih opazili pri podganah, so posledica za podgane specifičnega mehanizma, povezanega z indukcijo jetrnih encimov CYP.
English: If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
Slovenian: Če se pojavijo znaki jetrne insuficience ali če trajno merimo nenormalne vrednosti jetrnih testov (trikratna zgornja meja normalne vrednosti), je treba zdravljenje z etorikoksibom ukiniti.
English: Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Slovenian: Podatki o uporabi zdravila so pokazali, da so nekatere bolnike s povišanim krvnim tlakom začeli zdraviti z etorikoksibom.
English: No studies on the effect of etoricoxib on the ability to drive or use machines have been performed.
Slovenian: Študij o vplivu etorikoksiba na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila, posvetujte s svojim zdravnikom.
English: Do not use <ARCOXIA> after the expiry date which is stated on the pack.
Slovenian: Zdravila <ARCOXIA> ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Slovenian: Če se učinkovitost tako ne poveča, je treba razmisliti o drugih možnostih zdravljenja.
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical trials, drug utilisation studies and spontaneous reporting of adverse drug reactions.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je preučil podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom o kliničnih preskusih, študijah uporabe zdravila in spontanih poročilih o neželenih učinkih zdravila.
English: In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.
Slovenian: V kliničnih študijah je bil profil neželenih učinkov podoben pri bolnikih z OA ali RA, ki so jih z etorikoksibom zdravili leto dni ali več.
English: In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Slovenian: V 53- in 106-tedenskih študijah toksičnosti so razjede v prebavilih opazili tudi pri izpostavljenostih, ki so bile primerljive z izpostavljenostjo človeka pri terapevtskem odmerku.
English: The CHMP recommended the granting of the variation of the Marketing Authorisations for which the summaries of product characteristics, labelling and package leaflets are set out in Annex III and under the conditions set out in Annex IV.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) priporoča odobritev spremembe dovoljenj za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III, in po pogojih, določenih v Dodatku IV.
English: Common: palpitations.
Slovenian: Pogoste: palpitacije
English: What <ARCOXIA> is and what it is used for Before you take <ARCOXIA> How to take <ARCOXIB> Possible side effects
Slovenian: Kaj je zdravilo <ARCOXIA>in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo <ARCOXIA> Kako jemati zdravilo <ARCOXIA> Možni neželeni učinki
English: • hormone replacement therapy
Slovenian: • hormonsko nadomestno zdravljenje,
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Slovenian: COX-2 ima vlogo tudi pri ovulaciji, nidaciji in zaprtju arterioznega duktusa, regulaciji delovanja ledvic ter funkcije v centralnem živčnem sistemu (indukcija vročine, zaznavanje bolečine in kognitivna funkcija).
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] MSD
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica] MSD
English: Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses.
Slovenian: Etorikoksib je lahko povezan s pogostejšo in hujšo hipertenzijo kot nekateri drugi NSAR-i in selektivni zaviralci COX-2, še posebej pri uporabi velikih odmerkov.
English: What is rheumatoid arthritis?
Slovenian: Kaj je revmatoidni artritis?
English: Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) Program The MEDAL Program was a prospectively designed Cardiovascular (CV) Safety Outcomes Program of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
Slovenian: Mednarodni program vrednotenja dolgotrajne uporabe etorikoksiba in diklofenaka pri zdravljenju artritisa (Program MEDAL - Multinational Etoricoxib and Diclofenac Arthritis Long-term Program) Program MEDAL je bil prospektivno zasnovan program vrednotenja kardiovaskularne varnosti na osnovi združenih podatkov iz treh randomiziranih, dvojno slepih, s primerjalno učinkovino primerjanih preskušanj, študije MEDAL, študije EDGE II in študije EDGE.
English: Etoricoxib is contraindicated in pregnancy (see section 4.3).
Slovenian: Etorikoksib je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: The onset of the effect of the medicinal product may be faster when <ARCOXIA> is administered without food.
Slovenian: Učinek lahko nastopi hitreje, če bolnik zdravilo <ARCOXIA> vzame brez hrane.
English: Table 1: Rates of Confirmed Thrombotic CV Events (Pooled MEDAL Program) Etoricoxib (N=16819) 25836 PatientYears
Slovenian: Tabela 1: Deleži potrjenih trombotičnih kardiovaskularnih dogodkov (združeni podatki programa MEDAL) etorikoksib (N = 16.819) 25.836 bolnik-let (patient-years)
English: Confirmed Cardiac Events
Slovenian: Potrjeni srčni dogodki
English: WHAT <ARCOXIA> IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO <ARCOXIA> IN ZA KAJ GA UPORABLJAMO
English: • if you have inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis
Slovenian: • če imate vnetno bolezen črevesa, kot so Crohnova bolezen, ulcerozni kolitis ali kolitis.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.
Slovenian: Če se pri teh bolnikih pojavijo klinični znaki poslabšanja, je treba ustrezno ukrepati, vključno z ukinitvijo zdravljenja z etorikoksibom.
English: There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases.
Slovenian: Poročali so o primerih akutnega prevelikega odmerjanja etorikoksiba, vendar pa v večini primerov o neželenih učinkih niso poročali.
English: Important information about some of the ingredients of <ARCOXIA> <ARCOXIA> contains lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila <ARCOXIA> Zdravilo <ARCOXIA> vsebuje laktozo.
English: Estimated renal creatinine clearance <30 ml/min.
Slovenian: Kreatininski očistek, ocenjen < 30 ml/min.
English: While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended (see section 4.2).
Slovenian: Čeprav ta podatek lahko kaže na potrebo po povečanju odmerka, odmerkov etorikoksiba, večjih od tistih, navedenih za posamezno indikacijo, v kombinaciji z rifampicinom niso preučevali in jih zato ne priporočamo (glejte poglavje
English: Selective COX-2 inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Slovenian: Zaviralci COX-2 zmanjšajo tvorbo sistemskega (in zato možno tudi endotelijskega) prostaciklina, ne da bi vplivali na tromboksan.
English: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4.
Slovenian: Na podlagi študij in vitro ne pričakujemo, da bi etorikoksib zaviral citokrome P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 ali 3A4.
English: In March 2006, the marketing authorisation holders (MAH) for Arcoxia (etoricoxib) submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Slovenian: Imetniki dovoljenj za promet z zdravilom Arcoxia (etorikoksib) so marca 2006 predložili vlogo za razširitev odobrene indikacije, da bi se vključilo zdravljenje ankilozirajočega spondilitisa s priporočenim dnevnim 90-miligramskim odmerkom.
English: • digoxin (a medicine for heart failure and irregular heart rhythm)
Slovenian: • digoksin (zdravilo za zdravljenje srčnega popuščanja in motenj srčnega ritma),
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 je izooblika encima, za katero se je pokazalo, da jo inducirajo provnetni dražljaji in za katero domnevajo, da je odgovorna predvsem za sintezo prostanoidnih mediatorjev bolečine, vnetja in vročine.
English: Box 581
Slovenian: P.O. Box 581
English: Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Slovenian: Etorikoksib je bil vključen v predhodna napotitvena postopka Odbora za zdravila za uporabo v humani medicini (CHMP) o varnosti selektivnih zaviralcev COX-2, ki sta bila zaključena leta 2004 oziroma 2005.
English: Patients with a recent history of myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within 6 months preceding enrollment were excluded.
Slovenian: Bolniki z nedavnim miokardnim infarktom in bolniki s premostitveno operacijo koronarnih arterij ali perkutano koronarno intervencijo v 6 mesecih pred vključitvijo, so bili izključeni.
English: In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
Slovenian: Pri nekaterih bolnikih, pri katerih ta odmerek simptomov ne ublaži dovolj, lahko zvišani odmerek 60 mg enkrat na dan poveča učinkovitost zdravila.
English: The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, cardiorenal events).
Slovenian: Najpogostejši neželeni učinki so bili v skladu z varnostnim profilom etorikoksiba (npr. gastrointestinalni dogodki, kardiorenalni dogodki).
English: • medicines that thin your blood (anticoagulants), such as warfarin
Slovenian: • zdravila za redčenje krvi (antikoagulanti), kot je varfarin,
English: Intent-to-treat: all confirmed events up to the end of the trial (included patients potentially exposed to non-study interventions following discontinuation of study medication).
Slovenian: Vključeni bolniki, z namenom zdravljenja (intent-to-treat): vsi potrjeni dogodki do konca preskušanja (vključno z bolniki, pri katerih bi po prekinitvi zdravljenja lahko bila izvedena intervencija, ki ni bila predvidena v študiji).
English: Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised.
Slovenian: Klinične izkušnje so še posebej omejene pri bolnikih z zmerno motnjo delovanja jeter, zato svetujemo previdnost.
English: • aspirin, the risk of stomach ulcers is greater if you take <ARCOXIA> with aspirin.
Slovenian: • acetilsalicilno kislino; tveganje za želodčne razjede je večje, če jemljete zdravilo <ARCOXIA>
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thrombo-embolic events in women at risk).
Slovenian: Zaradi povečane izpostavljenosti EE se lahko poveča pojavnost neželenih učinkov peroralnih kontraceptivov (npr. venske tromboembolije pri ženskah s tveganjem).