FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8.
Croatian: Postotci bolesnika liječenih tofacitinibom koji postižu ACR20, ACR50 i ACR70 odgovore u ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start i ORAL Strategy ispitivanjima prikazani su u Tablici 8.
English: RA patients have an increased risk for cardiovascular disorders.
Croatian: Bolesnici s RA imaju povećan rizik od kardiovaskularnih poremećaja.
English: Time to treatment failure in maintenance study OCTAVE sustain (Kaplan-Meier Curves)
Croatian: Slika 2. Vrijeme do neuspjeha liječenja u ispitivanju terapije održavanja OCTAVE Sustain (Kaplan-Meierove krivulje)
English: Study II (O RAL Sync)
Croatian: Ispitivanje II (ORAL Sync)
English: CYP3A & CYP2C19 Inhibitor Fluconazole
Croatian: Inhibitor CYP3A i CYP2C19 Flukonazol
English: In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
Croatian: U ispitivanju OPAL BROADEN nije bilo dozvoljeno prethodno liječenje inhibitorom TNF-a.
English: XELJANZ is used to treat a condition called psoriatic arthritis.
Croatian: XELJANZ se koristi za liječenje stanja koje se naziva psorijatični artritis.
English: Pink, oval tablet of approximate average dimension of 10.8 mm × 5.5 mm × 4.4 mm (length by width by thickness) with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
Croatian: Ružičasta, ovalna tableta približnih prosječnih dimenzija 10,8 mm × 5,5 mm × 4,4 mm (duljina x širina x debljina) s izbušenom rupicom na jednom kraju bočnog obruba tablete i otisnutim „JKI 11“ na jednoj strani tablete.
English: Your doctor will decide whether you need to have herpes zoster vaccination - if you have heart problems, high blood pressure, or high cholesterol - if you have narrowing of the digestive tract tell your doctor as there have been rare reports of blockage in the digestive tract in patients taking other medicines using similar prolonged-release tablets - when you take XELJANZ 11 mg prolonged-release tablets, you may see something in your stool that looks like a tablet.
Croatian: Vaš liječnik će odlučiti trebate li se cijepiti protiv herpes zostera - ako imate problema sa srcem, visoki krvni tlak ili visoki kolesterol - ako imate suženje probavnog trakta obavijestite svog liječnika jer je u rijetkim slučajevima u bolesnika koji su uzimali druge lijekove sa sličnim oblikom tablete s produljenim oslobađanjem zabilježena blokada u probavnom traktu - tijekom uzimanja XELJANZ 11 mg tableta s produljenim oslobađanjem u svojoj stolici možete primijetiti predmet koji nalikuje tableti.
English: Other findings at doses exceeding human exposures included effects on the hepatic and gastrointestinal systems.
Croatian: Drugi nalazi pri dozama koje su premašivale izloženosti u ljudi uključivali su učinke na jetru i probavni sustav.
English: What XELJANZ contains
Croatian: Što XELJANZ sadrži
English: Subjects with mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had 3%, and 65% higher AUC, respectively, compared to subjects with normal hepatic function.
Croatian: Ispitanici s blagim (Child Pugh stadij A) i umjerenim (Child Pugh stadij B) oštećenjem jetre imali su 3% odnosno 65% veći AUC u usporedbi s osobama s normalnom funkcijom jetre.
English: The main objective of the programme is to increase awareness about the risks of the product, specifically in regards to serious infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities.
Croatian: Glavna svrha programa je povećati svijest o rizicima lijeka, osobito vezano uz ozbiljne infekcije, herpes zoster, tuberkulozu (TBC) i druge oportunističke infekcije, malignitete, gastrointestinalne peforacije, intersticijsku bolest pluća i poremećene vrijednosti laboratorijskih testova.
English: Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Croatian: Bolesnici koji su bili randomizirani u skupinu liječenu adalimumabom (aktivnu kontrolnu skupinu) primali su 40 mg supkutano svaka 2 tjedna tijekom 12 mjeseci.
English: The European Medicines Agency has deferred the obligation to submit results of studies with tofacitinib in one or more subsets of the paediatric population in juvenile idiopathic arthritis and in ulcerative colitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja tofacitiniba u jednoj ili više podskupina pedijatrijske populacije u juvenilnom idiopatskom artritisu i ulceroznom kolitisu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Improvement in fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at month 3 in all studies.
Croatian: Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F) u 3. mjesecu u svim ispitivanjima.
English: The clinical significance of this is unknown, however, similar results were obtained in a separate vaccine study with influenza and pneumococcal polysaccharide vaccines in patients receiving long-term tofacitinib 10 mg twice daily.
Croatian: Klinički značaj ovog nalaza nije poznat, međutim slični rezultati dobiveni su u zasebnom ispitivanju cjepiva gdje je ispitivano cjepivo za influencu i polisaharidno cjepivo protiv pneumokoka u bolesnika koji primaju 10 mg tofacitiniba dva puta dnevno dugoročno.
English: As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly (see section 4.4).
Croatian: S obzirom da postoji veća incidencija infekcija u starijih osoba općenito, potreban je oprez u liječenju starijih bolesnika (vidjeti dio 4.4).
English: TNFi-IR Monotherapy, Active comparator (MT X),
Croatian: RTG TNFi-IR Monoterapi ja, aktivni komparator (MTX),
English: Your doctor should perform liver tests periodically.
Croatian: Vaš liječnik periodički treba provoditi pretrage jetrene funkcije.
English: If you stop taking XELJANZ You should not stop taking XELJANZ without discussing this with your doctor.
Croatian: Ako prestanete uzimati XELJANZ Ne smijete prestati uzimati lijek XELJANZ bez savjetovanja sa svojim liječnikom.
English: Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
Croatian: U bolesnika u kojih se po prvi puta pojave abdominalni znakovi i simptomi treba odmah napraviti procjenu u svrhu rane identifikacije gastrointestinalne perforacije.
English: The frequency of serious infection among tofacitinib-treated patients 65 years of age and older was higher than those under the age of 65 (4.8 per 100 patient-years versus 2.4 per 100 patient-years, respectively).
Croatian: Učestalost ozbiljnih infekcija među bolesnicima liječenim tofacitinibom u dobi od 65 godina i starijih bila je viša nego u bolesnika u dobi do 65 godina (4,8 na 100 bolesnik-godina naspram 2,4 na 100 bolesnik-godina).
English: Tablet core sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
Croatian: Jezgra tablete sorbitol (E420) hidroksietilceluloza kopovidon magnezijev stearat
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
Croatian: Cjelokupno iskustvo liječenja tofacitinibom pokazalo je da je ukupna stopa incidencije infekcija bila 60,3 događaja na 100 bolesnik-godina (uključujući 49,4% bolesnika; ukupno 572 bolesnika).
English: • Heart failure
Croatian: • Zatajenje srca
English: Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
Croatian: Ozbiljne infekcije mogu se češće javiti u osoba koje također uzimaju kortikosteroide (npr. prednizon).
English: Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis, patients with concomitant use of corticosteroids and/or nonsteroidal anti-inflammatory drugs).
Croatian: Tofacitinib treba koristiti uz oprez u bolesnika koji bi mogli biti u povećanom riziku od gastrointestinalnih perforacija (npr. u bolesnika s anamnezom divertikulitisa i u bolesnika koji istodobno koriste kortikosteroide i/ili nesteroidne protuupalne lijekove).
English: Tofacitinib has no or negligible influence on the ability to drive and use machines.
Croatian: Tofacitinib ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Croatian: * p < 0,0001; **p < 0,001; †p < 0,05 za tofacitinib naspram placeba.
English: Each pack contains 28 or 91 prolonged-release tablets.
Croatian: Jedno pakiranje sadrži 28 ili 91 tabletu s produljenim oslobađanjem.
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: The efficacy and safety of tofacitinib were assessed in 6 randomised, double-blind, controlled multicentre studies in patients greater than 18 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria.
Croatian: Djelotvornost i sigurnost tofacitiniba ocijenjena je u 6 randomiziranih, dvostruko slijepih, kontroliranih multicentričnih ispitivanja u bolesnika starijih od 18 godina s aktivnim RA dijagnosticiranim prema kriterijima Američkog društva za reumatologiju (engl.
English: Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
Croatian: Limfomi i drugi oblici raka (poput raka pluća, dojke, kože (melanoma), prostate i gušterače) prijavljeni su u bolesnika liječenih lijekom XELJANZ.
English: Study IV (O RAL Scan)
Croatian: Ispitivanje IV (ORAL Scan)
English: *p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Croatian: *p < 0,05 **p < 0,001 ***p < 0,0001 naspram placeba (naspram MXT-a za ORAL Start) ǂp < 0,05 - tofacitinib u dozi od 5 mg + MTX naspram tofacitiniba u dozi od 5 mg za ORAL Strategy (normalne p-vrijednosti bez prilagodbe za višestruku usporedbu)
English: 56 film-coated tablets 112 film-coated tablets 182 film-coated tablets
Croatian: 56 filmom obloženih tableta 112 filmom obloženih tableta 182 filmom obložene tablete
English: It is recommended that live vaccines not be given concurrently with tofacitinib.
Croatian: Preporučuje se živa cjepiva ne davati istodobno s tofacitinibom.
English: Patients were to be in clinical response at baseline of the maintenance study OCTAVE Sustain.
Croatian: Bolesnici su trebali imati klinički odgovor na početku ispitivanja terapije održavanja OCTAVE Sustain.
English: Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Croatian: Među oportunističkim infekcijama, TBC i ostale mikobakterijske infekcije, kriptokokna infekcija, histoplazmoza, ezofaringealna kandidijaza, multidermatomski herpes zoster, citomegalovirus, infekcija BK virusom i listerioza bile su prijavljene uz tofacitinib.
English: When ANC is greater than 1,000, treatment should be resumed as clinically appropriate.
Croatian: Kad je ABN veći od 1000, nastaviti s liječenjem kako je klinički primjereno.
English: Ulcerative colitis is an inflammatory disease of the large bowel.
Croatian: Ulcerozni kolitis je upalna bolest debelog crijeva.
English: Concomitant stable doses of oral aminosalicylates and corticosteroids (prednisone or equivalent daily dose up to 25 mg) were permitted with taper of corticosteroids to discontinuation mandated within 15 weeks of entering the maintenance study.
Croatian: Istodobno primijenjene stabilne doze peroralnih aminosalicilata i kortikosteroida (prednizon ili ekvivalentni lijek u dnevnoj dozi do 25 mg) bile su dozvoljene uz postupno smanjivanje doze kortikosteroida do obaveznog trajnog prekida primjene u roku od 15 tjedana od uključivanja u ispitivanje terapije održavanja.
English: Improvements were also observed in the EuroQoL 5-Dimension (EQ-5D) and various domains of the Work Productivity and Activity Impairment (WPAI-UC) questionnaire in both induction and maintenance studies compared to placebo.
Croatian: Poboljšanja su ujedno opažena i u upitniku EuroQoL 5-Dimension (EQ-5D) i raznim područjima Upitnika o radnoj učinkovitosti i smetnjama u radu (engl.
English: XELJANZ is a medicine that contains the active substance tofacitinib.
Croatian: XELJANZ je lijek koji sadrži djelatnu tvar tofacitinib.
English: In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Croatian: U bolesnika s RA, oralni klirens tofacitiniba ne mijenja se s vremenom što upućuje na zaključak da liječenje tofacitinibom ne normalizira aktivnost CYP enzima.
English: • Patients undergoing major surgery
Croatian: • Bolesnici koji se podvrgavaju velikom operativnom zahvatu.
English: Study V (O RAL Step)
Croatian: Ispitivanje V (ORAL Step)
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals o Prescriber checklist o Patient alert card o A reference to the website with the educational material and patient alert card
Croatian: • Edukacijski materijali za liječnika trebaju sadržavati: o Sažetak opisa svojstava lijeka o Vodič za zdravstvene radnike o Kontrolnu listu za propisivača o Karticu s upozorenjima za bolesnika o Referencu na internetsku stranicu s edukacijskim materijalima i karticom s upozorenjima za bolesnika
English: Tofacitinib should not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Tofacitinib se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: In ORAL Start, tofacitinib monotherapy resulted in significantly greater inhibition of the progression of structural damage compared to MTX at months 6 and 12 as shown in Table 10, which was also maintained at month 24.
Croatian: U ORAL Start ispitivanju, tofacitinib u monoterapiji rezultirao je značajno većom inhibicijom progresije strukturnog oštećenja u usporedbi s MTX-om u 6. i 12. mjesecu kako je prikazano u Tablici 10, što je također održano do 24. mjeseca.
English: Tofacitinib was administered as monotherapy (i.e., without concomitant use of biologics and immunosuppressants) for UC.
Croatian: Tofacitinib se primjenjivao kao monoterapija (odnosno, bez istodobne primjene bioloških lijekova i imunosupresiva) za liječenje ulceroznog kolitisa.
English: The primary endpoint in OCTAVE Sustain was the proportion of patients in remission at week 52.
Croatian: Primarna mjera ishoda u ispitivanju OCTAVE Sustain bio je udio bolesnika u remisiji u 52. tjednu.
English: Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
Croatian: Koprimarne mjere ishoda su sljedeće: srednja promjena u odnosu na početne vrijednosti u mTSS (engl. modified Total Sharp Score); postotak ispitanika koji su postigli ACR20 ili ACR70 odgovore; srednja promjena u odnosu na početne vrijednosti u HAQ-DI; postotak ispitanika koji postižu DAS28-4(ESR) < 2,6 (remisija).
English: Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development.
Croatian: Dokazano je da je tofacitinib teratogen u štakora i kunića te da ima učinke na plodnost ženki štakora (smanjena stopa gravidnosti; smanjenje broja žutih tijela, mjesta implantacije i živućih fetusa; i porast u ranoj resorpciji), okot i peri-/postnatalni razvoj.
English: Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Croatian: Tobacitinib se izlučivao u mlijeko ženki štakora u laktaciji (vidjeti dio 5.3).
English: There is a higher rate of infections in patients aged 65 years and older.
Croatian: Postoji veća stopa infekcija u starijih bolesnika u dobi od 65 godina naviše.
English: Results from population PK analysis in patients with active PsA or moderate to severe UC were consistent with those in patients with RA.
Croatian: Rezultati analize populacijske farmakokinetike u bolesnika s aktivnim PsA-om ili umjerenim do teškim ulceroznim kolitisom bili su dosljedni onima u bolesnika s RA-om.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Croatian: Liječenje treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju stanja za koja je tofacitinib indiciran.
English: The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Croatian: Nuspojave navedene u tablici u nastavku dobivene su iz kliničkih ispitivanja na bolesnicima s RA-om, PsA-om i UC-om te su prikazane prema klasifikaciji organskih sustava i kategorijama učestalosti koje su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Erythema Pruritus
Croatian: Eritem Pruritus
English: In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
Croatian: Nasuprot uočenom padu nakon kratkoročnog doziranja, broj NK stanica CD16/56+ pokazao je medijan porasta od 73% u odnosu na početne vrijednosti.
English: In an RA controlled clinical trial, elevations in LDL cholesterol and ApoB decreased to pretreatment levels in response to statin therapy.
Croatian: U kontroliranom kliničkom ispitivanju RA-a, povišenja LDL kolesterola i ApoB smanjila su se na razine prije liječenja kao odgovor na terapiju statinima.
English: Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of tofacitinib.
Croatian: Bolesnike treba procijeniti i testirati na latentnu ili aktivnu infekciju prije i prema primjenjivim smjernicama tijekom primjene tofacitiniba.
English: There have been reports of patients treated with XELJANZ who have developed blood clots.
Croatian: Postoje izvješća o bolesnicima liječenim lijekom XELJANZ u kojih je došlo do pojave krvnih ugrušaka.
English: • fluconazole, ketoconazole, used to treat fungal infections
Croatian: • flukonazol i ketokonazol, koji se koriste u liječenju gljivičnih infekcija.
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 (DAS28-4(ESR) < 2,6) u ispitivanjima ORAL Step, ORAL Sync i ORAL Standard prikazan je u Tablici 9.
English: You should not receive XELJANZ if your white blood cell (neutrophil or lymphocyte) count or red blood cell count is too low.
Croatian: Ne smijete primiti XELJANZ ako je broj Vaših bijelih krvnih stanica (neutrofila ili limfocita) ili crvenih krvnih stanica previše nizak.
English: After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission.
Croatian: Nakon dodatnih 8 tjedana uzimanja 10 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Open, 53% (154/293) bolesnika postiglo je klinički odgovor, a 14% (42/293) bolesnika postiglo je remisiju.
English: The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Croatian: Djelotvornost i sigurnost primjene tofacitiniba ocijenjeni su u 2 randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 provedena u odraslih bolesnika s aktivnim PsA-om (≥ 3 otečena i ≥ 3 osjetljiva zgloba).
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section 4.3).
Croatian: Kao mjera opreza, primjena tofacitiniba tijekom trudnoće je kontraindicirana (vidjeti dio 4.3).
English: All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
Croatian: Svi bolesnici morali su istodobno primati 1 csDMARD; 71,6% bolesnika istodobno je primalo MTX, 15,7% bolesnika istodobno je primalo sulfasalazin i 8,6% bolesnika istodobno je primalo leflunomid.
English: Upon withdrawal of tofacitinib treatment, lipid levels returned to baseline.
Croatian: Nakon prekida liječenja tofacitinibom, razine lipida vratile su se na početne vrijednosti.
English: Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
Croatian: Upravljanje vozilima i strojevima XELJANZ ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Croatian: Istodobna primjena ketokonazola i flukonazola povećala je Cmax tofacitiniba dok su takrolimus, ciklosporin i rifampicin smanjili Cmax tofacitiniba.
English: Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Croatian: Vaš liječnik će Vas testirati na tuberkulozu prije početka liječenja lijekom XELJANZ i može Vas ponovno testirati tijekom liječenja - ako imate bilo kakvu kroničnu bolest pluća - ako imate problema s jetrom - ako trenutno imate ili ste imali hepatitis B ili hepatitis C (virusi koji zahvaćaju jetru).
English: - The 11 mg prolonged-release tablets are provided in blisters containing 7 prolonged-release tablets.
Croatian: - Tablete s produljenim oslobađanjem od 11 mg dolaze u blisterima koji sadrže 7 tableta s produljenim oslobađanjem.
English: Number of patients enrolled
Croatian: Broj bolesnika uključenih u ispitivanje