FrancophonIA/ELRC3.0 huggingface dataset:
English: Compared to healthy subjects, exposure to lumiracoxib was not changed in patients with moderate hepatic impairment (Child-Pugh score 7-8).
Slovenian: V primerjavi z zdravimi osebami se izpostavljenost lumirakoksibu ni spremenila pri bolnikih z zmernimi okvarami jeter (ocena 7-8 po Child-Pughovi lestvici).
English: Lumiracoxib is contraindicated in patients with moderate to severe renal impairment (estimated creatinine clearance <50 ml/min) (see section 4.3, 4.4 and 5.2).
Slovenian: Lumirakoksib je kontraindiciran pri bolnikih z zmernimi do težkimi okvarami ledvic (ocenjeni očistek kreatinina <50 ml/min) (glejte poglavja 4.3, 4.4 in 5.2).
English: Known hypersensitivity to lumiracoxib or to any of the excipients.
Slovenian: Znana preobčutljivost za lumirakoksib ali katerokoli pomožno snov.
English: Core:
Slovenian: Sredica:
English: Any patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Slovenian: Spremljati moramo vsakega bolnika, ki ima simptome in/ali znaki, ki kažejo na moteno delovanje jeter ali nenormalne teste jetrne funkcije.
English: Renal insufficiency: No dose adjustment is necessary for patients with creatinine clearance ≥50 ml/min.
Slovenian: Insuficienca ledvic: Pri bolnikih z očistkom kreatinina ≥50 ml/min ni potrebno prilagajanje odmerjanja.
English: Approximately 1,100 patients were treated with lumiracoxib in analgesia clinical studies (post-surgical dental pain, primary dysmenorrhea, and post-orthopedic surgery pain).
Slovenian: Približno 1.100 bolnikov so zdravili z lumirakoksibom v kliničnih študijah analgezije (bolečine po operaciji zob, primarne dismenoreje in bolečine po ortopedskih operacijah).
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI)and stroke), relative to placebo and some NSAID's.
Slovenian: Klinične raziskave kažejo, da je razred zdravil selektivnih zaviralcev COX-2 lahko povezan s tveganjem za trombotične dogodke (posebno za miokardni infarkt (MI) in možgansko kap) glede na placebo in nekatere NSAR-e.
English: Monitoring of renal function in such patients should be considered.
Slovenian: Pri takih bolnikih je treba pretehtati možnost spremljanja funkcije ledvic.
English: Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Slovenian: Nekateri selektivni zaviralci COX-2 so bili povezani s povečanim tveganjem neželenih učinkov na koži pri bolnikih, ki so v preteklosti imeli alergijo na katerokoli zdravilo.
English: Pharmacodynamic Interactions
Slovenian: Farmakodinamske interakcije
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal functions), the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Slovenian: pri dehidriranih bolnikih ali starejših bolnikih z okvarjenimi funkcijami ledvic) lahko sočasna uporaba zaviralca ACE ali antagonista angiotenzina II in sredstev, ki zavirajo ciklooksigenazo, povzroči nadaljnje poslabšanje ledvične funkcije, vključno z možno akutno ledvično odpovedjo, ki je navadno reverzibilna.
English: Lumiracoxib at 800 mg daily did not lead to clinically meaningful inhibition of gastric prostaglandin synthesis and had no effect on platelet function.
Slovenian: Lumirakoksib v odmerku 800 mg na dan ni povzročil klinično pomembne inhibicije sinteze prostaglandinov v želodcu in ni vplival na funkcijo trombocitov.
English: The number of discontinuations in TARGET due to oedema was not significantly different between lumiracoxib (43) and NSAIDs (55).
Slovenian: Število prekinitev zdravljenja v študiji TARGET zaradi edemov se med lumirakoksibom (43) in NSAR (55) ni signifikantno razlikovalo.
English: Cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, povidone, titanium dioxide, magnesium stearate
Slovenian: Mikrokristalna celuloza, natrijeva kroskarmeloza, monohidrat laktoze, povidon, titanov dioksid, magnezijev stearat.
English: Multiple doses of lumiracoxib 1,200 mg once daily have been administered to patients with rheumatoid arthritis for 4 weeks without clinically significant adverse effects.
Slovenian: Bolnikom z revmatoidnim artritisom so 4 tedne dolgo dajali večkratne odmerke lumirakoksiba po 1.200 mg enkrat na dan brez klinično pomembnih neželenih učinkov.
English: Invented name Strength
Slovenian: Lastniško ime Jakost
English: Blood and lymphatic system disorders Uncommon: anaemia
Slovenian: Bolezni krvi in limfatičnega sistema Občasna: anemija.
English: Patients who have experienced asthma, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs.
Slovenian: Bolniki, pri katerih so se po jemanju acetilsalicilne kisline ali NSAR-ov, pojavili astma, akutni rinitis, nosni polipi, angioedem, urtikarija ali druge alergijske reakcije.
English: Oral contraceptives: Co-administration of lumiracoxib did not affect the steady state pharmacokinetics or the efficacy of ethinylestradiol and of levonorgestrel.
Slovenian: Peroralni kontraceptivi: Sočasna uporaba lumirakoksiba ni vplivala na farmakokinetiko v stanju ravnovesja ali na učinkovitost etinilestradiola in levonorgestrola.
English: Methotrexate: Co-administration of lumiracoxib at doses of 400 mg once daily had no clinically significant effects on the plasma pharmacokinetics, plasma protein binding or urinary excretion of methotrexate and of the 7-hydroxy methotrexate metabolite.
Slovenian: Metotreksat: Sočasna uporaba lumirakoksiba v odmerkih po 400 mg enkrat na dan ni klinično pomembno vplivala na plazemsko farmakokinetiko, vezavo na plazemske beljakovine ali izločanje v urinu metotreksata in njegovega presnovka 7-hidroksimetotreksata.
English: There is no significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2) up to 800 mg in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih do odmerka 800 mg ni signifikantne inhibicije COX-1 (ocenjene kot ex vivo inhibicija tromboksana B2).
English: The oxidative metabolism of lumiracoxib is mainly CYP2C9 mediated.
Slovenian: Oksidativno presnovo lumirakoksiba posreduje predvsem CYP2C9.
English: - the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events, - the data on celecoxib presented in the APC study, which suggested a dose-related increased risk of serious CV events, - the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass Graft) and in the CABG II studies, which showed a higher rate of serious CV thromboembolic events in the parecoxib/valdecoxib treatment arm compared to the group of patients receiving placebo, - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Slovenian: - novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in, ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom; - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
English: The use of lumiracoxib, as with any drug to inhibit COX-2, is not recommended in women attempting to conceive.
Slovenian: Uporabe lumirakoksiba, podobno kot drugih zdravil, ki zavirajo COX-2, ne priporočajo ženskam, ki poskušajo zanositi.
English: Common: abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, flatulence Uncommon: gastroduodenal ulcer, gastroduodenitis, oesophagitis, abdominal distension, aphthous stomatitis, dry mouth, dysphagia, epigastric discomfort, eructation, gastrooesophageal reflux disease, gingivitis, hyperacidity, toothache
Slovenian: Občasne: gastroduodenalni ulkus, gastroduodenitis, ezofagitis, raztezanje trebuha, aftozni stomatitis, suha usta, disfagija, bolečine v epigastriju, kolcanje, bolezen gastroezofagealnega refluksa, gingivitis, hiperacidnost, zobobol.
English: Cellulose microcrystalline, croscarmellose sodium, povidone, magnesium stearate
Slovenian: Mikrokristalna celuloza, natrijeva kroskarmeloza, povidon, magnezijev stearat.
English: Caution should be used when initiating treatment with lumiracoxib in patients with dehydration.
Slovenian: Pri uvajanju zdravljenja z lumirakoksibom pri dehidriranih bolnikih je potrebna previdnost.
English: Lumiracoxib, should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Slovenian: Lumirakoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
English: Compared to placebo treatment, recovery of the S-7-OH warfarin metabolite in urine was about 25% lower in subjects treated with lumiracoxib.
Slovenian: V primerjavi s tistimi, ki so dobivali placebo, so pri osebah, zdravljenih z lumirakoksibom, prestregli v urinu okrog 25 % manj presnovka S-7-OH varfarina.
English: In clinical studies, lumiracoxib 400 mg relieved pain in acute analgesic models of post-operative dental pain, post-orthopaedic surgical pain, and primary dysmenorrhea.
Slovenian: V kliničnih raziskavah je lumirakoksib v odmerku 400 mg olajšal bolečine v akutnih analgetičnih modelih postoperativnega zobobola, bolečine po ortopedskih operacijah in primarne dismenoreje.
English: Patients should not exceed this dose and the treatment duration should not exceed 5 days.
Slovenian: Priporočeni odmerek je 400 mg enkrat na dan. Bolniki tega odmerka ne smejo prekoračiti, trajanje zdravljenja pa ne sme preseči 5 dni.
English: In repeat dose toxicity studies in rats and monkeys, target organs were the gastrointestinal tract and kidney.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov na podganah in opicah so bili tarčni organi prebavila in ledvica.
English: Systemic exposure at levels with no adverse effect for these targets in rat (26-week study) and monkey (39-week study) were 6.5 and 22 times that in man following a 200 mg therapeutic dose, respectively.
Slovenian: Sistemska izpostavljenost, pri kateri pri podganah (26-tedenska študija) oziroma opicah (39-tedenska študija) v teh tarčah ni bilo neželenih učinkov, je bila 6,5-krat oziroma 22-krat večja od sistemske izpostavljenosti pri človeku po 200-miligramskem terapevtskem odmerku.
English: CYP2C9 poor metabolisers: No dose adjustment is necessary in patients known to be CYP2C9 poor metabolisers (see section 5.2).
Slovenian: Osebe z upočasnjeno presnovo s CYP2C9: Pri osebah, za katere je znano, da imajo upočasnjeno presnovo s CYP2C9, ni potrebno prilagajanje odmerjanja (glejte poglavje 5.2).
English: COX-2 selective inhibitors are not a substitute for ASA for prophylaxis of cardiovascular thromboembolic diseases because of their lack of antiplatelet effect.
Slovenian: Selektivni zaviralci COX-2 pri preprečevanju srčnožilnih tromboembolijskih bolezni niso nadomestilo za acetilsalicilno kislino, ker nimajo učinka na trombocite.
English: Haemodialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Slovenian: Zaradi velike vezave na beljakovine ni verjetno, da bi bila hemodializa učinkovita metoda odstranjevanja zdravila.
English: Rare: pancytopenia, neutropenia, leucopenia
Slovenian: Redke: pancitopenija, nevtropenija, levkopenija.
English: Patients with active peptic ulceration or gastrointestinal bleeding.
Slovenian: Bolniki z aktivno razjedo želodca ali krvavitvijo v prebavilih.
English: It is advisable to rehydrate patients prior to starting therapy with lumiracoxib.
Slovenian: Pred začetkom zdravljenja z lumirakoksibom je priporočljivo bolnike rehidrirati.
English: Common: dizziness, headache
Slovenian: Pogosti: vrtoglavost, glavobol.
English: Relief of pain due to primary dysmenorrhea: the maximum treatment duration in clinical studies was 3 days.
Slovenian: Lajšanje akutne bolečine zaradi primarne dismenoreje: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 3 dni.
English: TARGET, a 12-month, double-blind, phase III study included 18,325 OA patients randomized to lumiracoxib 400 mg once daily (two to four times the recommended OA dose), naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
Slovenian: Preskus Terapevtska raziskava artritisa in gastrointestinalnih dogodkov (TARGET) Študija TARGET, 12-mesečna dvojno slepa študija III. faze, je zajela 18.325 bolnikov z OA, randomiziranih na lumirakoksib 400 mg enkrat na dan (ta odmerek je dvakrat do štirikrat večji od priporočenega odmerka pri OA), naproksen 500 mg dvakrat na dan ali ibuprofen 800 mg trikrat na dan. TARGET je zajel bolnike, ki so jemali ASA v majhnih odmerkih (75-100 mg na dan) za primarno ali sekundarno preventivo koronarne bolezni srca.
English: For diastolic blood pressure, mean change from baseline were0.1 mmHg for lumiracoxib and +0.5 mmHg for NSAIDs (p<0.0001).
Slovenian: Za diastolični krvni tlak je bila povprečna sprememba od izhodne vrednosti -0,1 mmHg pri lumirakoksibu in +0,5 mmHg pri NSAR (p<0,0001).
English: Relief of acute pain due to dental surgery: the maximum treatment duration in clinical studies was 24 hours.
Slovenian: Lajšanje akutne bolečine zaradi stomatološke operacije: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 24 ur.
English: Thus, no dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Slovenian: Zato pri bolnikih z blagimi ali zmernimi okvarami jeter ni potrebno prilagajanje odmerjanja.
English: Relief of acute pain due to orthopaedic surgery: the maximum treatment duration in clinical studies was 5 days.
Slovenian: Lajšanje akutne bolečine zaradi ortopedske operacije: najdaljše trajanje zdravljenja v kliničnih študijah je bilo 5 dni.
English: At the level with no embryo/fetal effect, the systemic exposure was 8.6 (rat) and 2.2 (rabbit) times that in man following a 200 mg therapeutic dose.
Slovenian: Pri ravni, ki ni vplivala na zarodek/plod, je bila sistemska izpostavljenost 8,6-krat (podgana) oziroma 2,2-krat (kunec) večja kot pri človeku po 200-miligramskem terapevtskem odmerku.
English: Hepatic impairment: No dose adjustment is necessary for patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-8) hepatic impairment.
Slovenian: Okvare jeter: Pri bolnikih z blagimi (ocena 5-6 po Child-Pughovi lestvici) do zmernimi (ocena 7-8 po Child-Pughovi lestvici) okvarami jeter ni potrebno prilagajanje odmerjanja.
English: Uncommon: dyspnoea, epistaxis, rhinitis, sinus congestion, asthma
Slovenian: Občasne: dispneja, epistaksa, rinitis, kongestija sinusov, astma.
English: Hepatobiliary disorders Rare: cholecystitis, cholelithiasis, hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov Redke: holecistitis, holelitiaza, hepatitis.
English: Lumiracoxib does not accumulate in plasma under once or twice daily administration and steady state is achieved on the first day of administration with no increase in Cmax or AUC after extended dosing.
Slovenian: Stanje ravnovesja se doseže prvega dne uporabe, po dolgotrajnejšem odmerjanju se niti Cmax niti AUC ne zvišata.
English: Medically appropriate supervision should be maintained when using lumiracoxib in the elderly and in patients with mild renal, hepatic, or cardiac dysfunction.
Slovenian: Pri uporabi lumirakoksiba pri starejših bolnikih in pri bolnikih z blago disfunkcijo ledvic, jeter ali srca je potreben ustrezen medicinski nadzor.
English: No difference was observed in the extent of lumiracoxib protein binding in synovial fluid compared to plasma.
Slovenian: Razlik v obsegu vezave lumirakoksiba na beljakovine v sinovialni tekočini in v plazmi niso opazili.
English: Fluconazole: Co-administration of lumiracoxib with the potent CYP2C9 inhibitor fluconazole had no clinically relevant effect on the pharmacokinetics or the COX-2 selectivity of lumiracoxib.
Slovenian: Vpliv drugih zdravil na farmakokinetiko lumirakoksiba Flukonazol: Sočasna uporaba lumirakoksiba z močnim zaviralcem CYP2C9 flukonazolom ni klinično pomembno vplivala na farmakokinetiko ali selektivnost za COX-2 lumirakoksiba.
English: There is no additional benefit by increasing the dose to 400 mg daily.
Slovenian: Zvečanje odmerka na 400 mg na dan ne prinese dodatnih koristi.
English: Chromosome aberrations were induced in V79 cells at high, cytotoxic concentrations of lumiracoxib,
Slovenian: V celicah V79 so povzročili kromosomske aberacije z visokimi, citotoksičnimi koncentracijami lumirakoksiba, za katere menimo, da za ljudi nimajo biološkega pomena.
English: Lumiracoxib is an orally active, selective cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range.
Slovenian: Lumirakoksib je znotraj območja kliničnih odmerkov peroralni selektivni zaviralec ciklooksigenaze-2 (COX-2).
English: Omeprazole: Omeprazole had no effect on the pharmacokinetics of lumiracoxib.
Slovenian: Omeprazol: Omeprazol ni vplival na farmakokinetiko lumirakoksiba.
English: Coating:
Slovenian: Prevleka:
English: Thus no alteration in oral contraceptive medication is necessary when lumiracoxib is co-administered.
Slovenian: Zato ob sočasni uporabi lumirakoksiba ni potrebno spreminjanje peroralnega kontraceptiva.
English: Uncommon: syncope, hypoaesthesia, migraine, paraesthesia, dysgeusia, vertigo, tinnitus
Slovenian: Redke: sinkopa, hipestezija, migrena, parestezije, disgevzija, vrtoglavica, tinitus.
English: Uncommon: palpitations, myocardial infarction* Rare: cardiac failure, atrioventricular block of first degree Vascular disorders
Slovenian: Redki: popuščanje srca, atrioventrikularni blok prve stopnje.
English: 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 NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance.
Slovenian: Med postmarketinškim spremljanjem so v zvezi z uporabo NSAR in nekaterih selektivnih zaviralcev COX-2 zelo redko poročali o hudih kožnih reakcijah, od katerih so bile nekatere smrtne, med drugim o eksfoliativnem dermatitisu, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi.
English: Clinical 5
Slovenian: Klinični vidik 5
English: The changes of the Product Information related to the CV can be summarised as follows: - Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.
Slovenian: Spremembe Informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo, kot sledi: - dodana je izjava, da mora odločitev, da se predpiše selektiven zaviralec COX-2, temeljiti na vrednotenju celotnega tveganja posameznega bolnika; - dodana je izjava, da naj predpisovalci zdravila uporabljajo najnižji učinkovit odmerek za najkrajši možni čas trajanja ter da je potrebo za lajšanje bolečin potrebno pogosto ponovno oceniti.
English: There was no indication of genotoxic potential in three in vivo rat studies (micronucleus tests in bone marrow and liver and liver comet assay).
Slovenian: V treh študijah in vivo na podganah (mikronukleusna testa v kostnem mozgu in jetrih in jetrni kometni preskus) niso našli znakov genotoksičnega potenciala.
English: Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving lumiracoxib.
Slovenian: Pri bolnikih, ki so prejemali lumirakoksib, so poročali o resnih preobčutljivostnih reakcijah (na primer anafilaksiji in angioedemu).
English: There was no statistically significant difference between lumiracoxib and NSAIDs for incidence of MI (clinical MI and silent MI).
Slovenian: MI dogodki v študiji TARGET (12-mesečna študija) Med lumirakoksibom in NSAR glede incidence MI (klinični MI in tihi MI) ni bilo statistično signifikantne razlike.
English: 400 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OD” on the other side.
Slovenian: 400 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OD”.
English: 200 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OC” on the other side.
Slovenian: 200 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OC”.
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment.
Slovenian: Spremembe Informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi: - dodano je opozorilo k poročilu, da se kožne reakcije v večini primerov pojavijo v prvem mesecu zdravljenja; - dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo; - dodano je opozorilo, ki poudarja, da so se pri uporabi zaviralcev Cox-2 pojavile usodno hude kožne reakcije; - dodan je podroben opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
English: Each 100 mg film-coated tablet contains 100 mg lumiracoxib.
Slovenian: Ena 100-miligramska filmsko obložena tableta vsebuje 100 mg lumirakoksiba.
English: Each 200 mg film-coated tablet contains 200 mg lumiracoxib.
Slovenian: Ena 200-miligramska filmsko obložena tableta vsebuje 200 mg lumirakoksiba.
English: Each 400 mg film-coated tablet contains 400 mg lumiracoxib.
Slovenian: Ena 400-miligramska filmsko obložena tableta vsebuje 400 mg lumirakoksiba.
English: 100 mg film-coated tablets: Ovaloid, red, tablets with “NVR” debossed on one side and “OB” on the other side.
Slovenian: 100 mg filmsko obložene tablete: ovalne, rdeče, tablete, na eni strani je vtisnjen napis “NVR”, na drugi pa “OB”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12th September 2003
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: To develop and disseminate a Physician Decision Treatment Guide for prescribers of lumiracoxib.
Slovenian: Da bo za vse, ki predpisujejo lumirakoksib, pripravil in jim posredoval Vodnik za zdravnike o izbiri zdravljenja
English: Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in a fatal outcome, have occurred in patients treated with lumiracoxib.
Slovenian: Pri bolnikih, zdravljenih z lumirakoksibom, so se pojavljali zapleti v zgornjih prebavilih [perforacije, ulkusi ali krvavitve (PUK)]; nekateri so imeli smrtni izid.
English: For systolic blood pressure, mean change from baseline were +0.4 mmHg for lumiracoxib and +2.1 mmHg for NSAIDs (p<0.0001).
Slovenian: Kardiorenalni učinki v študiji TARGET (12-mesečna študija) Za sistolični krvni tlak je bila povprečna sprememba od izhodne vrednosti +0,4 mmHg pri lumirakoksibu in +2,1 mmHg pri NSAR (p<0,0001).