FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will tell you if this applies to you.
Croatian: Liječnik će Vam reći odnosi li se to na Vas.
English: Maximum effects were generally observed within 6 weeks.
Croatian: Maksimalni učinci općenito su zabilježeni unutar 6 tjedana.
English: Talk to your doctor if you smoke.
Croatian: Obratite se svom liječniku ako pušite.
English: • Japanese or Korean patients.
Croatian: • japanskih ili korejskih bolesnika
English: However, this difference is not considered to be clinically relevant.
Croatian: Međutim, ne smatra se da je razlika klinički značajna.
English: Active control (ADA)
Croatian: Aktivna kontrola (ADA)
English: - if you have heart problems, high blood pressure, or high cholesterol
Croatian: - ako imate problema sa srcem, visoki krvni tlak ili visoki kolesterol.
English: Treatment should be symptomatic and supportive.
Croatian: Liječenje treba biti simptomatsko i suportivno.
English: Efficacy may be decreased
Croatian: Može smanjiti djelotvornost
English: SD = Standard Deviation b
Croatian: SD = standardna devijacija b
English: • swelling of the lips, tongue or throat
Croatian: • oticanje usnica, jezika ili grla
English: This treatment difference was consistent between the 2 subgroups (Table 16).
Croatian: Ova razlika u liječenju bila je dosljedna u 2 podskupine (Tablica 16).
English: Women were estimated to have 7% lower AUC compared to men.
Croatian: Ocijenjeno je da žene imaju 7% manji AUC u usporedbi s muškarcima.
English: These responses were similar to those observed in healthy volunteers aged 50 years and older.
Croatian: Ti su odgovori bili vrlo slični onima zabilježenima u zdravih dobrovoljaca u dobi od 50 godina i starijih.
English: The treatment interruption period in clinical studies extended up to 1 year.
Croatian: Razdoblje privremenog prekida liječenja u kliničkim se ispitivanjima produžilo do 1 godine.
English: Some may be serious and need medical attention.
Croatian: Neke nuspojave mogu biti ozbiljne i zahtijevati liječničku skrb.
English: • If your treatment is interrupted, your doctor may decide to restart your treatment.
Croatian: • Ako je Vaše liječenje prekinuto, liječnik može odlučiti ponovno započeti Vaše liječenje.
English: Dose should be maintained.
Croatian: Dozu treba održati.
English: OPAL BEYOND had a duration of 6 months.
Croatian: Ispitivanje OPAL BEYOND trajalo je 6 mjeseci.
English: If lab value confirmed by repeat testing within 7 days, dosing should be discontinued.
Croatian: Ako je laboratorijska vrijednost potvrđena ponovljenim testiranjem unutar 7 dana, doziranje treba prekinuti.
English: Combination with other therapies
Croatian: Kombinacija s drugim terapijama
English: These changes generally resolved within 2-6 weeks after discontinuation of treatment.
Croatian: Te su se promjene općenito povukle unutar 2 do 6 tjedana nakon prekida liječenja.
English: Try to take your tablet at the same time every day (one tablet in the morning and one tablet in the evening).
Croatian: Pokušajte uzeti tabletu svaki dan u isto vrijeme (jednu tabletu ujutro i jednu navečer).
English: BID=twice daily.
Croatian: BID = dva puta dnevno.
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 pokretljivošću utjecati na rizik od razvoja krvnih ugrušaka.
English: Keep this Patient Alert Card with you.
Croatian: Čuvajte tu Karticu s upozorenjima za bolesnika uz sebe.
English: You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:
Croatian: Morate obavijestiti svog liječnika ako koristite lijekove (uzete kroz usta) koji sadrže bilo koju do sljedećih djelatnih tvari:
English: There was no clear relationship between neutropenia and the occurrence of serious infections.
Croatian: Nije bilo jasne povezanosti između neutropenije i pojave ozbiljnih infekcija.
English: The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Croatian: Dostupni podaci također su pokazali da nema većih razlika u AUC tofacitiniba između bolesnika bijele, crne i azijske rase.
English: Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Croatian: Vaš liječnik također može provesti i druge pretrage, primjerice kako bi provjerio Vaše razine kolesterola u krvi ili pratio zdravlje Vaše jetre.
English: Formal studies of the potential effect on human fertility have not been conducted.
Croatian: Nisu provedena službena ispitivanja potencijalnog učinka na plodnost u ljudi.
English: The virus may become active while you are taking XELJANZ.
Croatian: Virus može postati aktivan dok uzimate XELJANZ.
English: Serious infections in the elderly
Croatian: Ozbiljne infekcije u starijih osoba
English: • blood in the stool
Croatian: • krv u stolici
English: Tofacitinib distributes equally between red blood cells and plasma.
Croatian: Tofacitinib se distribuira podjednako između crvenih krvnih stanica i plazme.
English: Tell your doctor as soon as you notice any signs or symptoms of infections.
Croatian: Obavijestite svog liječnika čim primijetite bilo kakve znakove ili simptome infekcija.
English: 3 Parallel arms:
Croatian: 3 paralelna kraka:
English: Allergic reactions included angioedema and urticaria; serious reactions have occurred.
Croatian: Alergijske reakcije uključivale su angioedem i urtikariju; došlo je do pojave ozbiljnih reakcija.
English: You can take XELJANZ with or without food.
Croatian: XELJANZ možete uzeti s hranom ili bez nje.
English: • unexplained changes in bowel habits
Croatian: • neobjašnjive promjene u crijevnim navikama
English: There is a higher rate of shingles in Japanese and Korean patients.
Croatian: Postoji veća stopa herpes zostera u japanskih i korejskih bolesnika.
English: *Spontaneous reporting data
Croatian: *Podaci iz spontanog prijavljivanja
English: Durability of clinical responses
Croatian: Trajnost kliničkih odgovora
English: The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost tofacitiniba u djece u dobi od 0 godina do manje od 18 godina nisu još ustanovljene.
English: Tofacitinib is a potent, selective inhibitor of the JAK family.
Croatian: Tofacitinib je potentni, selektivni inhibitor obitelji JAK.
English: Tell your doctor right away if you become pregnant while taking XELJANZ.
Croatian: Odmah obavijestite svog liječnika ako zatrudnite dok uzimate XELJANZ.
English: XELJANZ must not be used during pregnancy.
Croatian: XELJANZ se ne smije primjenjivati tijekom trudnoće.
English: • Use of combined hormonal contraceptives or hormone replacement therapy
Croatian: • Primjena kombiniranih hormonskih kontraceptiva ili hormonske nadomjesne terapije
English: Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
Croatian: Farmakokinetički podaci do i uključujući pojedinačnu dozu od 100 mg u zdravih dobrovoljaca pokazuju da se očekuje eliminacija više od 95% primijenjene doze unutar 24 sata.
English: • antibiotics such as rifampicin, used to treat bacterial infections
Croatian: • antibiotike poput rifampicina, koji se koriste u liječenju bakterijskih infekcija
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: There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women.
Croatian: Nema odgovarajućih i dobro kontroliranih ispitivanja o primjeni tofacitiniba u trudnica.
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Croatian: Vrijeme do nastupa bilo je brzo (već u 2. tjednu u ispitivanjima ORAL Solo, ORAL Sync i ORAL Step) i magnituda odgovora nastavila se poboljšavati s trajanjem liječenja.
English: Severe (including patients undergoing haemodialysis)
Croatian: Teško (uključujući bolesnike na hemodijalizi)
English: The median PsA disease duration was 7.5 years.
Croatian: PsA-a iznosio je 7,5 godina.
English: What XELJANZ is and what it is used for
Croatian: Što je XELJANZ i za što se koristi
English: • with a history of a serious or an opportunistic infection,
Croatian: • s anamnezom ozbiljne ili oportunističke infekcije,
English: Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
Croatian: Liječenje treba prekinuti ako bolesnik razvije ozbiljnu infekciju, oportunističku infekciju ili sepsu.
English: Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka XELJANZ u svakoj zemlji članici, nositelj odobrenja mora dogovoriti sadržaj i format edukacijskog programa, uključujući komunikacijska sredstva, modalitete distribucije i svaki od aspekata programa u suradnji s nacionalnim nadležnim tijelom.
English: XELJANZ is used for the treatment of the following inflammatory diseases:
Croatian: XELJANZ se koristi za liječenje sljedećih upalnih bolesti:
English: Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or red blood cell counts.
Croatian: Vaš liječnik također može privremeno ili trajno zaustaviti liječenje ako krvne pretrage pokažu nizak broj bijelih krvnih stanica ili crvenih krvnih stanica.
English: Your doctor will decide whether you need to have herpes zoster vaccination.
Croatian: Vaš liječnik će odlučiti trebate li se cijepiti protiv herpes zostera.
English: The extent of decrease in MTX exposure does not warrant modifications to the individualised dosing of MTX.
Croatian: Opseg smanjenja izloženosti MTX-u ne opravdava izmjene individualiziranog doziranja MTX-a.
English: The efficacy results for important endpoints assessed are shown in Table 12.
Croatian: Rezultati djelotvornosti za ocijenjene važne ishode prikazani su u Tablici 12.
English: Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da tablete pokazuju vidljive znakove kvarenja (primjerice ako su slomljene ili su promijenile boju).
English: If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis.
Croatian: Ako imate aktivni psorijatični artritis, prvo ćete dobiti drugi lijek kojim ćete liječiti psorijatični artritis.
English: The number of patients with arthritis mutilans or axial involvement was too small to allow meaningful assessment.
Croatian: Broj bolesnika s mutilirajućim artritisom ili aksijalnom zahvaćenošću bio je premalen da bi omogućio značajnu procjenu.
English: You may also be at higher risk of certain lung problems.
Croatian: Možete također imati veći rizik od određenih problema s plućima.
English: Nominal p≤0.05;
Croatian: Nominalni p ≤ 0,05;
English: No evidence of stereo conversion in human samples was detected.
Croatian: Nije nađen dokaz stereokonverzije na uzorcima u ljudi.
English: Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Croatian: Pad veći od 2 g/dl ili vrijednost manja od 8,0 g/dl (potvrđeno ponovljenim testiranjem)
English: XELJANZ is not recommended for use in children or adolescents under 18 years of age.
Croatian: XELJANZ se ne preporučuje za primjenu u djece ili adolescenata u dobi do 18 godina.
English: Changes in mean HAQ-DI and DAS28-4(ESR) were maintained in both tofacitinib treatment groups through to the end of the studies.
Croatian: Promjene u HAQ-DI i DAS28-4(ESR) održane su u obje terapijske skupine tofacitiniba do kraja ispitivanja.
English: The median PsA disease duration was 3.8 years.
Croatian: PsA-a iznosio je 3,8 godina.
English: Once daily
Croatian: Primjena jednom dnevno
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Croatian: Promjene u broju cirkulirajućih T-limfocita i podskupini Tlimfocita (CD3+, CD4+ i CD8+) bile su male i nedosljedne.
English: This patient subsequently made a robust, though delayed, humoral and cellular response to the vaccine (see section 4.4).
Croatian: Bolesnik je naknadno ostvario robustni, premda odgođeni humoralni i stanični odgovor na cjepivo (vidjeti dio 4.4).
English: Your doctor may reduce the dose if you have liver or kidney problems or if you are prescribed certain other medicines.
Croatian: Vaš liječnik može sniziti dozu ako imate probleme s jetrom ili bubrezima, ili ako su Vam propisani određeni drugi lijekovi.
English: Patients screened positive for hepatitis B or C were excluded from clinical trials.
Croatian: Bolesnici koji su bili pozitivni na hepatitis B ili C na probiru su isključeni iz kliničkih ispitivanja.
English: Ratio relative to reference
Croatian: Omjer u odnosu na referencu
English: Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Croatian: Farmakoterapijske skupine: Imunosupresivi, selektivni imunosupresivi; ATK oznaka: L04AA29
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, pušački status i imobilizacija.
English: Child Pugh A No dose adjustment required.
Croatian: Child Pugh A Prilagodba doze nije potrebna.
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Croatian: • Aktivna tuberkuloza (TBC), ozbiljne infekcije poput sepse ili oportunističkih infekcija (vidjeti dio 4.4).
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Croatian: Za bolesnike s početnim rezultatom BSA ≥ 3% i PASI > 0.
English: Tofacitinib binds predominantly to albumin and does not appear to bind to 1-acid glycoprotein.
Croatian: Tofacitinib se pretežno veže na albumin i čini se da se ne veže na 1-kiseli glikoprotein.
English: In addition, safety and efficacy of tofacitinib were assessed in an open-label long-term extension study (OCTAVE Open).
Croatian: Pored toga, sigurnost i djelotvornost tofacitiniba ispitivani su u dugoročnom otvorenom nastavku ispitivanja (OCTAVE Open).
English: CD19+ B cell counts showed no further increases after long-term tofacitinib treatment.
Croatian: Broj CD19+ B stanica nije pokazao daljnji porast nakon dugoročne primjene tofacitiniba.
English: ALC less than 500
Croatian: ALC manji od 500
English: What XELJANZ looks like and contents of the pack
Croatian: Kako XELJANZ izgleda i sadržaj pakiranja
English: • who have resided or travelled in areas of endemic mycoses,
Croatian: • koji su boravili ili putovali u područja s endemskom mikozom,
English: Nominal p<0.001;
Croatian: Nominalni p < 0,001;
English: An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Croatian: Uočen je približno linearni odnos između tjelesne težine i volumena distribucije rezultirajući u višim vršnim (Cmax) i nižim najnižim (Cmin) koncentracijama u bolesnika s manjom tjelesnom težinom.
English: PK Ratio and 90% CI
Croatian: PK Omjer i 90% CI*
English: Patients with RA, particularly those with highly active disease may be at a higher risk (up to several-fold) than the general population for the development of lymphoma.
Croatian: Bolesnici s RA, osobito oni s visoko aktivnom bolešću, mogu biti u (do nekoliko puta) većem riziku od opće populacije za razvoj limfoma.
English: Other medicines and XELJANZ
Croatian: Drugi lijekovi i XELJANZ
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: This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body.
Croatian: To je prazna ovojnica tablete s produljenim oslobađanjem koja je preostala nakon što je Vaše tijelo apsorbiralo lijek.
English: Consultation with a healthcare professional with expertise in the treatment of TB is recommended to aid in the decision about whether initiating antituberculosis therapy is appropriate for an individual patient.
Croatian: Konzultacije sa zdravstvenim radnikom s iskustvom u liječenju tuberkuloze preporučuju se kao pripomoć u donošenju odluke je li uvođenje antituberkulozne terapije odgovarajuće za pojedinog bolesnika.
English: Tofacitinib should not be initiated in patients with active infections, including localised infections.
Croatian: Liječenje tofacitinibom ne smije se započinjati u bolesnika s aktivnim infekcijama, uključujući lokalizirane infekcije.
English: Asian RA patients are known to be at higher risk of interstitial lung disease, thus caution should be exercised in treating these patients.
Croatian: Poznato je da su azijatski bolesnici s RA u većem riziku od intersticijske bolesti pluća, stoga je u liječenju tih bolesnika potreban oprez.
English: Pfizer Europe MA EEIG (as MA holder logo)
Croatian: Pfizer Europe MA EEIG (logo nositelja odobrenja)
English: Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Croatian: Uvodno liječenje tofacitinibom potrebno je prekinuti u svakog bolesnika koji ne pokaže dokaz terapijske koristi do 16. tjedna.
English: There is no specific antidote for overdose with tofacitinib.
Croatian: Nema specifičnog antidota za predoziranje tofacitinibom.
English: (see section 4.2).
Croatian: (vidjeti dio 4.4).
English: Tell your doctor if you notice any breathing difficulties.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakve poteškoće s disanjem.
English: • Pregnancy and lactation (see section 4.6).
Croatian: • Trudnoća i dojenje (vidjeti dio 4.6).
English: XELJANZ may increase your risk of certain cancers.
Croatian: XELJANZ može povećati rizik od određenih vrsta raka.
English: If you do not respond well enough or the medicine is not tolerated, you may be given XELJANZ to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.
Croatian: Ako ne budete dovoljno dobro reagirali na lijek ili ne podnosite taj lijek, možda ćete dobiti lijek XELJANZ za smanjenje znakova i simptoma aktivnog psorijatičnog artritisa i poboljšanje sposobnosti obavljanja svakodnevnih aktivnosti.
English: Try to take your tablet (one 11 mg prolonged-release tablet) at the same time each day, e.g., morning or evening.
Croatian: Pokušajte uzeti Vašu tabletu (jednu tabletu s produljenim oslobađanjem od 11 mg) svaki dan u isto vrijeme, npr. ujutro ili navečer.
English: Particular consideration should be given to patients with longstanding RA who have previously received two or more biological DMARDs.
Croatian: Osobitu pažnju treba posvetiti bolesnicima s dugotrajnim RA koji su prethodno primili dva ili više bioloških DMARD-ova.
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 na pojavu znakova i simptoma nuspojava.
English: Pfizer Biofarmacêutica, Sociedade Unipessoal,
Croatian: Pfizer Biofarmacêutica, Sociedade Unipessoal, Lda.
English: In a human radiolabelled 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: Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Croatian: Populacijska analiza farmakokinetike u bolesnika s RA ukazuje da je sistemska izloženost (AUC) tofacitinibu uz ekstremne tjelesne težine (40 kg, 140 kg) bila slična (unutar 5%) onoj u bolesnika od 70 kg.
English: Table 14 provides additional information regarding pertinent study design and population characteristics.
Croatian: Tablica 14 prikazuje dodatne informacije značajne s obzirom na ustroj ispitivanja i karakteristike populacije.
English: Tofacitinib is not mutagenic or genotoxic based on the results of a series of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Croatian: Tofacitinib nije ni mutagen niti genotoksičan na temelju rezultata serije in vitro i in vivo testova na genske mutacije i kromosomske aberacije.
English: The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Croatian: Najčešće prijavljene infekcije bile su infekcije gornjeg respiratornog trakta i nazofaringitis (3,7%, odnosno 3,2%).
English: What XELJANZ is and what it is used for What you need to know before you take XELJANZ How to take XELJANZ
Croatian: Što je XELJANZ i za što se koristi Što morate znati prije nego počnete uzimati XELJANZ Kako uzimati XELJANZ
English: • who have underlying conditions that may predispose them to infection.
Croatian: • koji imaju osnovnu bolest zbog koje mogu biti skloniji infekciji.
English: Tell your doctor if you notice any painful blisters on your skin.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakve bolne mjehure na svojoj koži.
English: Evidence of persistence of efficacy with tofacitinib treatment for up to 7 years is also provided from data in the one ongoing and one completed open-label, long-term follow-up studies.
Croatian: Dokaz postojanosti djelotvornosti s terapijom tofacitinibom do 7 godina također je dobiven iz podataka iz jednog aktivnog i iz jednog dovršenog, otvorenog ispitivanja dugoročnog praćenja.
English: Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Croatian: Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba): tuberkuloza koja zahvaća mozak i leđnu moždinu, meningitis.
English: Of the 4,271 patients who enrolled in RA studies I-VI (see section 5.1), a total of 608 RA patients were 65 years of age and older, including 85 patients 75 years and older.
Croatian: Od 4271 bolesnika koji su bili uključeni u ispitivanja RA-a I-VI (vidjeti dio 5.1), ukupno je 608 bolesnika s RA bilo u dobi od 65 godina i stariji, uključujući 85 bolesnika u dobi od 75 godina i starije.
English: This condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Croatian: Ovo stanje je upalna bolest zglobova koju često prati psorijaza.
English: CYP3A Inhibitor Ketoconazole
Croatian: CYP3A inhibitor Ketokonazol
English: As described in Tables 1, 2 and 3 below, recommendations for temporary dose interruption or permanent discontinuation of treatment are made according to the severity of laboratory abnormalities (see section 4.4).
Croatian: Kako je opisano u Tablicama 1, 2 i 3 u nastavku, preporuke za privremeni prekid doziranja ili trajni prekid liječenja su napravljene s obzirom na težinu poremećaja vrijednosti laboratorijskih nalaza (vidjeti dio 4.4).