FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals.
Croatian: Otopina se nalazi u staklenim ulošcima (kremeno staklo tipa I) zatvorenima zaštitnom butilnom ili halobutilnom pločicom i glavom klipa te osiguranima aluminijskim zaštitnim zatvaračem.
English: Select a new Needle.
Croatian: 2. korak: Odaberite novu iglu.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/028
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/01/195/028
English: Hold your Pen with the Needle pointing up.
Croatian: 6. korak: Držite brizgalicu iglom okrenutom prema gore.
English: USER MANUAL Liprolog 200 units/ml KwikPen, solution for injection in a pre-filled pen insulin lispro
Croatian: Uputa o lijeku: Informacije za korisnika Liprolog 200 jedinica/ml KwikPen, otopina za injekciju u napunjenoj brizgalici inzulin lispro
English: Continue holding your Pen with Needle pointing up.
Croatian: 9. korak: I dalje držite brizgalicu iglom okrenutom prema gore.
English: What Liprolog Mix50 100 units/ml suspension for injection in cartridge contains - The active substance is insulin lispro.
Croatian: Sadržaj pakiranja i druge informacije Što Liprolog Mix50 100 jedinica/ml suspenzija za injekciju u ulošku sadrži - Djelatna tvar je inzulin lispro.
English: What Liprolog 100 units/ml KwikPen solution for injection contains - The active substance is insulin lispro.
Croatian: Sadržaj pakiranja i druge informacije Što Liprolog 100 jedinica/ml KwikPen otopina za injekciju sadrži - Djelatna tvar je inzulin lispro.
English: Liprolog Mix50 100 units/ml suspension for injection in cartridge insulin lispro
Croatian: Uputa o lijeku: Informacije za korisnika Liprolog Mix50 100 jedinica/ml suspenzija za injekciju u ulošku inzulin lispro
English: What Liprolog 100 units/ml solution for injection in vial contains - The active substance is insulin lispro.
Croatian: Sadržaj pakiranja i druge informacije Što Liprolog 100 jedinica/ml otopina za injekciju u ulošku sadrži - Djelatna tvar je inzulin lispro.
English: • rapid heartbeat
Croatian: • Boja brizgalice:
English: You can see how much Liprolog is left by looking at the gauge on the side of the cartridge.
Croatian: Možete vidjeti koliko je inzulina preostalo tako da držite KwikPen brizgalicu iglom okrenutom prema gore.
English: Do not redial.
Croatian: Nemojte ponovno odmjeriti dozu.
English: • The Pen dials 1 unit at a time.
Croatian: • Brizgalica odmjerava dozu u koracima od 1 jedinice.
English: NAME OF THE MEDICINAL PRODUCT Liprolog 100 units/ml KwikPen solution for injection in a pre-filled pen Insulin lispro
Croatian: Uputa o lijeku: Informacije za korisnika Liprolog 100 jedinica/ml KwikPen, otopina za injekciju u napunjenoj brizgalici inzulin lispro
English: Insulin lispro
Croatian: Inzulin iz Liprolog
English: Please see manual text later.
Croatian: Vidjeti Priručnik za uporabu u nastavku.
English: The full EPAR for Urorec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Urorec nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Urorec on 29 January 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Urorec na snazi u Europskoj uniji od 29. siječnja 2010.
English: Urorec silodosin
Croatian: Urorec silodozin
English: What measures are being taken to ensure the safe and effective use of Urorec?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Urorec?
English: Other information about Urorec
Croatian: Ostale informacije o lijeku Urorec
English: In addition, the company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Croatian: Nadalje, proizvođač lijeka Urorec osigurat će da se očnim kirurzima dostave sve informacije vezane uz IFIS u svim državama članicama u kojima se lijek stavlja u promet.
English: In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study.
Croatian: U dva ispitivanja u kojima je Urorec uspoređen samo s placebom, IPSS je iznosio otprilike 21 bod u početku ispitivanja.
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Urorec after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Croatian: U trećem ispitivanju IPSS je iznosio otprilike 19 bodova prije liječenja, pri čemu se nakon 12 tjedana smanjio za 7,0 bodova u muškaraca koji su uzimali Urorec i za 6,7 bodova u muškaraca koji su uzimali tamsulozin te 4,7 bodova u muškaraca koji su uzimali placebo.
English: The effects of Urorec were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Urorec po prvi put je testirano u eksperimentalnim modelima prije nego što je provedeno ispitivanje na ljudima.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Urorec, and by around 3.5 points in the men who took placebo.
Croatian: Nakon 12 tjedana, rezultat se smanjio za 6,4 bodova u muškaraca koji su uzimali Urorec i za otprilike 3,5 bodova u muškaraca koji su uzimali placebo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Urorec.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i preporuke o uvjetima primjene za lijek Urorec.
English: Why has Urorec been approved?
Croatian: Zašto je Urorec odobren?
English: For more information about treatment with Urorec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Urorec pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: A risk management plan has been developed to ensure that Urorec is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Urorec.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Urorec, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Urorec nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Urorec?
Croatian: Što je Urorec?
English: What is the risk associated with Urorec?
Croatian: Koji su rizici povezani s lijekom Urorec?
English: Urorec was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.
Croatian: Urorec je bio djelotvorniji od placeba te jednako djelotvoran kao tamsulozin u ublažavanju simptoma BHP-a.
English: Urorec has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Croatian: Urorec je uspoređen s placebom (liječenjem bez djelatne tvari) u tri glavna ispitivanja koja su obuhvatila više od 1 800 muškaraca s BHP-om.
English: The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Croatian: Najčešća nuspojava lijeka Urorec (zabilježena kod više od 1 na 10 osoba) je smanjenje količine sjemena koje se izbacuje prilikom ejakulacije.
English: Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Croatian: Urorec se koristi za liječenje simptoma benigne hiperplazije prostate (BHP, povećane prostate) u odraslih osoba.
English: This is a summary of the European public assessment report (EPAR) for Urorec.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Urorec.
English: Urorec is a medicine that contains the active substance silodosin.
Croatian: Urorec je lijek koji sadrži djelatnu tvar silodozin.
English: The active substance in Urorec, silodosin, is an alpha adrenoreceptor antagonist.
Croatian: Djelatna tvar lijeka Urorec, silodozin, je antagonist alfa adrenoreceptora.
English: The CHMP decided that Urorec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Urorec nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: One of these studies also compared Urorec with tamsulosin (another medicine used for BPH).
Croatian: Urorec je također uspoređen s tamsulozinom (drugim lijekom za liječenje BHP-a).
English: Urorec is not recommended for patients with severe kidney problems.
Croatian: Primjena lijeka Urorec ne preporuča se u bolesnika s ozbiljnim oštećenjem bubrega.
English: What benefit has Urorec shown during the studies?
Croatian: Koje su koristi lijeka Urorec utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Urorec, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Urorec potražite u uputi o lijeku.
English: What is Urorec used for?
Croatian: Za što se Urorec koristi?
English: How does Urorec work?
Croatian: Kako djeluje Urorec?
English: How is Urorec used?
Croatian: Kako se Urorec koristi?
English: How has Urorec been studied?
Croatian: Kako se Urorec ispitivao?
English: D-53859 Niederkassel Germany
Croatian: 9 D-53859 Niederkassel Njemačka
English: Local or regional injection intra-oral Submucosal use
Croatian: Otopina za injekciju Lokalna ili regionalna intraoralna injekcija
English: John Tsaprazis SA 157 Michalakopoulou Str.
Croatian: John Tsaprazis SA 157 Michalakopoulou Str. 11527, Athens Grčka
English: Germany Septodont GmbH Felix-Wankel-Str. 9
Croatian: Septodont GmbH Felix-Wankel-Str.
English: Septodont GmbH Felix-Wankel-Str. 9 D - 53859
Croatian: Septodont GmbH Felix-Wankel-Str. 9 D - 53859 NiederkasselMondorf
English: Injektionslösung
Croatian: Injektionslösun g
English: Septanest Z Adrenaliną
Croatian: Septanest Cu Adrenalină
English: Dental use Submucosal use
Croatian: Otopina za injekciju Dentalno Submukozno
English: Septanest Forte 40 mg/10 mikrogrami/ml šķīdums injekcijām kārtridžā
Croatian: Forte 40 mg/10 mikrogrami/ml šķīdums injekcijām kārtridžā
English: Submucosal use Infiltration and perineural use
Croatian: Infiltracijom i perineuralno
English: Adrenaline 5 microg/ml
Croatian: Adrenalin 5 µg/ml
English: Adrenaline 0.01 mg/ml adrénaline (tartrate d') : non précisé
Croatian: Adrenalin 0,01 mg/ml adrenalină (tartrat): nespecificată
English: Belgium Septodont Nv-Sa 87 Avenue de la Constitution
Croatian: Nv-Sa 87 Avenue de la Constitution B-1083 Brussel
English: Dental use Infiltration and perineural use in the oral cavity
Croatian: Otopina za injekciju Dentalno Primjena infiltracijom i perineuralno u usnoj šupljini
English: Adrenaline 0.005mg/ml adrénaline (tartrate d') : non précisé
Croatian: 0,005 mg/ml adrenalină (tartrat): nespecificată
English: 40 mg/0,01 mg v 1 ml raztopina za injiciranje
Croatian: Septanestepi 40 mg/0,01 m g v 1 ml raztopina za injiciranje
English: Adrenaline bitartrate 0.005 mg/ml
Croatian: Artikainklorid 40 mg/ml Adrenalin 0,005 mg/ml
English: 94107 Saint-Maur-DesFossés Cedex France
Croatian: 58, rue du Pont de Créteil 94107 Saint-Maur-DesFossés Cedex Francuska
English: Infiltration
Croatian: Submukozno
English: Submucosal use Articaine hydrochloride 40 mg/ml
Croatian: Infiltracijom Artikainklorid 40 mg/ ml
English: Solution for injection in cartridge
Croatian: Otopina za injekciju u ulošku
English: Articaína, cloridrato 40 mg/ml
Croatian: Artikain klorid 40 mg/ml
English: 58, rue du Pont de Créteil
Croatian: 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Spécialités Septodont 58 rue du Pont de Créteil
Croatian: Spécialités Septodont 58 rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Francija
Croatian: Njemačka
English: 94107 Saint-Maur-desFossés Cedex France
Croatian: Septodont SAS 58, rue du Pont de Créteil 94107 Saint-Maur-DesFossés Cedex Francuska
English: Septodont SAS 58, rue du Pont de Créteil
Croatian: Specialites Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Lithuania Septodont 58 rue du Pont de Créteil
Croatian: Rumunjska Septodont 58 rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Adrenaline 10 microg/ml
Croatian: Artikainklorid 40 mg/ml Adrenalin 10 µg/ml
English: Dental use
Croatian: Otopina za injekciju Dentalno
English: B-1083 Brussel
Croatian: Nv-Sa 87 Avenue de la Constitution B-1083 Brussel Belgija
English: Infiltration Periodontal use
Croatian: Otopina za injekciju Infiltracijom Parodontno
English: Not Known (cannot be estimated from the available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Take your next tablet at the usual time and continue as before.
Croatian: Sljedeću tabletu uzmite u uobičajeno vrijeme i nastavite dalje uzimati kao i prije.
English: Women were estimated to have 7% lower AUC compared to men.
Croatian: Procijenjeno je da žene imaju 7% manji AUC u usporedbi s muškarcima.
English: b.Antimalarials were allowed.
Croatian: Antimalarici su bili dozvoljeni.
English: He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.
Croatian: On/ona će također procijeniti hoće li vaša tjelesna težina, dob ili problemi s pokretnošću utjecati na rizik od razvoja krvnih ugrušaka.
English: Keep this Patient Alert Card with you.
Croatian: Čuvajte ovu Karticu s upozorenjima za bolesnika uz sebe.
English: Signs of allergic reactions (rare) include
Croatian: Znakovi alergijskih reakcija (rijetko) uključuju
English: You may also be at higher risk of certain lung problems.
Croatian: Možete također biti u većem riziku od određenih problema s plućima.
English: c OPAL BEYOND had a duration of 6 months.
Croatian: Ispitivanje OPAL BEYOND trajalo je 6 mjeseci.
English: Lab Value (g/dL)
Croatian: Laboratorijska vrijednost (g/dl)
English: There is a higher rate of shingles in Japanese and Korean patients.
Croatian: Postoji veća stopa herpesa zostera u japanskih i korejskih bolesnika.
English: Tell your doctor immediately if you feel unwell.
Croatian: Odmah se obratite svom liječniku ako se ne osjećate dobro.
English: Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Croatian: Dodatni čimbenici rizika koji bi se trebali uzeti u obzir pri određivanju rizika bolesnika za PE su starija dob, pretilost, status pušenja i imobilizacija.
English: • unexplained changes in bowel habits
Croatian: • neobjašnjive promjene crijevnih navika
English: In addition to this leaflet, your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ.
Croatian: Pored ove upute Vaš liječnik će Vam također dati Karticu s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije kojih morate biti svjesni prije nego uzmete XELJANZ i tijekom liječenja lijekom XELJANZ.
English: (E171), macrogol 3350, and triacetin (E1518).
Croatian: makrogol 3350 i triacetin (E1518).
English: XELJANZ can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection - if you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis.
Croatian: XELJANZ može umanjiti sposobnost Vašeg organizma da odgovori na infekcije i može pogoršati postojeću infekciju ili povećati šansu za razvoj nove infekcije - ako trenutno ili u povijesti bolesti imate tuberkulozu ili ste bili u bliskom kontaktu s osobom koja boluje od tuberkuloze.
English: • antibiotics such as clarithromycin and rifampicin, used to treat bacterial infections
Croatian: • antibiotike koji sadrže klaritromicin i rifampicin, koji se koriste u liječenju bakterijskih infekcija
English: Taking XELJANZ with these medicines may increase your risk of side effects including infection.
Croatian: Uzimanje lijeka XELJANZ s tim lijekovima može povećati Vaš rizik od nuspojava uključujući infekcije.
English: Tofacitinib binds predominantly to albumin and does not appear to bind to α1-acid glycoprotein.
Croatian: Tofacitinib se pretežno veže na albumin i čini se da se ne veže na α1-kiseli glikoprotein.
English: Your doctor should perform liver tests periodically.
Croatian: Vaš liječnik treba povremeno napraviti test jetrene funkcije.
English: Possible serious side effects In rare cases, infection may be life-threatening
Croatian: U rijetkim slučajevima infekcije mogu biti opasne po život
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pfizer Europe MA EEIG (logo nositelja odobrenja)
English: In a human radiolabeled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
Croatian: U ispitivanju radioaktivno obilježenim lijekom u ljudi, više od 65% ukupne cirkulirajuće radioaktivnosti pripadalo je nepromijenjenoj djelatnoj tvari, dok se preostalih 35% pripisuje 8 metabolita, pri čemu na svaki otpada manje od 8% ukupne radioaktivnosti.
English: P Ratio and 90% CI
Croatian: PK Omjer i 90% CI*
English: Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury.
Croatian: Nakon inicijacije, preporučuju se rutinsko praćenje jetrene funkcije i hitna ispitivanja uzroka svakog zamjećenog povišenja jetrenih enzima, kako bi se identificirali potencijalni slučajevi jatrogene ozljede jetre.
English: Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL
Croatian: Pad manji od ili jednak 2 g/dl ili vrijednost veća od ili jednaka 9,0 g/dl
English: Each film-coated tablet contains 118.88 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 118,88 mg laktoze.
English: X-Ray TNFi-IR Monotherapy, Active comparator (MTX),
Croatian: RTG TNFi-IR Monoterapi ja, aktivni komparator (MTX),
English: Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Croatian: Vrlo rijetko (može se javiti u manje od 1 na 10 000 osoba): tuberkuloza koja zahvaća mozak i leđnu moždinu, meningitis.
English: Signs of stomach problems (uncommon: ulcers or holes in your stomach or intestines) include • fever
Croatian: Znakovi problema sa želucem (manje često: čirevi ili rupe u želucu ili crijevima) uključuju • vrućicu
English: Treatment groups (Randomisation ratio)
Croatian: Ispitivane skupine (Omjer randomizacije)
English: Store in the original, bottle and/or blister, in order to protect from moisture.
Croatian: Čuvati u originalnoj boci i/ili blisteru radi zaštite od vlage.
English: The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies.
Croatian: Kancerogeni potencijal tofacitiniba procijenjen je u šestomjesečnoj studiji na rasH2 transgeničnim miševima te u dvogodišnjoj studiji kancerogenosti na štakorima.
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Croatian: U slučaju predoziranja preporučuje se nadzirati bolesnika zbog moguće pojave znakova i simptoma nuspojava.
English: Caution should be exercised when considering initiation of tofacitinib treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST), particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
Croatian: Potreban je oprez prilikom razmatranja početka terapije tofacitinibom u bolesnika s povišenom alanin aminotransferazom (ALT) ili aspartat aminotransferazom (AST), osobito kad se započinje u kombinaciji s potencijalno hepatotoksičnim lijekovima poput MTX-a.
English: • The centralised website shall contain: o The educational material in digital format o The patient alert card in digital format
Croatian: • Centralizirana internetska stranica će sadržavati: o Edukacijske materijale u digitalnom obliku o Karticu s upozorenjima za bolesnika u digitalnom obliku
English: Signs of serious infections (common) include
Croatian: Znakovi teških infekcija (često) uključuju
English: OTHER Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Croatian: Pon., Uto., Sri., Čet., Pet., Sub., Ned.
English: Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years.
Croatian: Procijenjeno je kako je AUC u starijih bolesnika u dobi od 80 godina veći za manje od 5% u odnosu na bolesnike prosječne dobi od 55 godina.
English: The proportion of patients achieving a DAS28 clinical remission (DAS28-4(ESR) < 2.6) in ORAL Step, ORAL Sync, and ORAL Standard is shown in Table 9.
Croatian: Udio bolesnika koji su postigli kliničku remisiju prema DAS28 (DAS284(ESR) < 2,6) u ispitivanjima ORAL Step, ORAL Sync i ORAL Standard prikazan je u Tablici 9.
English: f For patients with Baseline score > 0.
Croatian: f Za bolesnike s početnim rezultatom od > 0.
English: Certain types of vaccines should not be given when taking XELJANZ.
Croatian: Određene vrste cjepiva ne smiju se davati kad se uzima XELJANZ.
English: Do not use this medicine after the expiry date which is stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake „EXP“.
English: Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Croatian: Povišenja u lipidnim parametrima (ukupni kolesterol, LDL kolesterol, HDL kolesterol, trigliceridi) prvo su procjenjivana nakon 1 mjesec od početka liječenja tofacitinibom u kontroliranim, dvostruko slijepim kliničkim ispitivanjima RA.
English: Table 8: Proportion (%) of Patients with an ACR Response ORAL Solo: DMARD Inadequate Responders
Croatian: Tablica 8: Udio (%) bolesnika s ACR odgovorom ORAL Solo: Bolesnici s neodgovarajućim odgovorom na DMARD
English: The efficacy results for important endpoints assessed are shown in Table 12.
Croatian: Rezultati djelotvornosti za procijenjene važne ishode prikazani su u Tablici
English: Do not take XELJANZ: - if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6) - if you have a severe infection such as bloodstream infection or active tuberculosis - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Croatian: Nemojte uzimati XELJANZ: - ako ste alergični na tofacitinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate tešku infekciju poput infekcije krvi, ili aktivnu tuberkulozu - ako znate da imate teših problema s jetrom, uključujući cirozu (ožiljkaste promjene jetre) - ako ste trudni ili dojite
English: Study III (ORAL Standard)
Croatian: Ispitivanje III (ORAL Standard)