FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Croatian: U svih bolesnika treba provesti odgovarajuće probirne testove (tj. tuberkulinski kožni test i rendgen pluća, uz pridržavanje lokalnih preporuka).
English: • do not use the syringe if the seals of the blister are broken, as it may not be safe for you to use.
Croatian: • ne koristite štrcaljku ako je zaštitna naljepnica blistera potrgana jer možda nije sigurna za korištenje.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Croatian: Ipak, nakon stavljanja lijeka u promet zaprimljene su prijave zatajenja jetre kao i manje teških poremećaja jetre koji mogu prethoditi zatajenju jetre, kao što su hepatitis, uključujući autoimuni hepatitis, u bolesnika koji su primali adalimumab.
English: • difficulty sleeping;
Croatian: • tjeskoba, • otežano spavanje,
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Croatian: Sažetak sigurnosnog profila Adalimumab je ispitivan u 9506 bolesnika u pivotalnim kontroliranim i otvorenim ispitivanjima tijekom razdoblja do 60 mjeseci ili dulje.
English: p-valuea p-valueb p-valuec
Croatian: p-vrijednosta p-vrijednostb p-vrijednostc
English: Children and adolescents with Crohn's disease
Croatian: Djeca i adolescenti s Crohnovom bolešću
English: If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hefiya.
Croatian: Ako imate bilo kakvih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri koji je upoznat s lijekom Hefiya.
English: Hefiya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hefiya is indicated.
Croatian: Liječenje lijekom Hefiya moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja je Hefiya indiciran.
English: The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Croatian: Upala izaziva slabljenje vida i/ili plutajuće čestice u vidnom polju (crne točke ili tanke crte koje se pomiču kroz vidno polje).
English: • Do not use the syringe if it is broken or the needle guard is activated.
Croatian: • Ne koristite štrcaljku ako je slomljena ili je štitnik igle aktiviran.
English: Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Croatian: Bolesnici koji su izašli iz ispitivanja zbog razloga koji nisu bili neuspjeh liječenja bili su cenzurirani u trenutku izlaska iz ispitivanja.
English: response
Croatian: odgovor
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Croatian: Tijekom terapije održavanja, doza kortikosteroida može se postupno smanjivati u skladu s kliničkim smjernicama.
English: • new onset or worsening of psoriasis;
Croatian: • gubitak kose, • nova pojava ili pogoršanje psorijaze,
English: • throw away the used syringe right away after use.
Croatian: • bacite korištenu štrcaljku odmah nakon uporabe.
English: Before initiation of therapy with Hefiya, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Croatian: Prije početka liječenja lijekom Hefiya sve bolesnike se mora podvrgnuti pretragama za otkrivanje i aktivnog i neaktivnog (“latentnog“) oblika tuberkuloze.
English: Patients treated with Hefiya should be given the Patient Reminder Card.
Croatian: Bolesnicima koji se liječe lijekom Hefiya treba dati karticu s podsjetnikom za bolesnika.
English: Hefiya is used to treat
Croatian: Hefiya je namijenjen liječenju
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno navesti u zdravstvenom kartonu bolesnika.
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Croatian: Plak psorijaza može zahvatiti i nokte, uzrokujući njihovo mrvljenje, zadebljanje i odizanje od ležišta nokta, što može biti bolno.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hefiya.
Croatian: Doza istodobno primijenjenih kortikosteroida može se postupno smanjivati u skladu s kliničkom praksom, počevši dva tjedna nakon započinjanja liječenja lijekom Hefiya.
English: Rhabdomyolysis, systemic lupus erythematosus
Croatian: Manje često Rabdomioliza, sistemski lupus eritematosus
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78.
Croatian: U 78. tjednu BCVA se ili poboljšao ili održao na istoj razini (pogoršanje za < 5 slova) u 88,4% očiju.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hefiya treatment.
Croatian: • Trebate razmotriti korištenje odgovarajuće kontracepcije kako biste spriječili trudnoću te biste je trebali nastaviti koristiti najmanje 5 mjeseci nakon zadnje doze lijeka Hefiya.
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.
Croatian: Nema očite korelacije prisutnosti protutijela na adalimumab s pojavom štetnih događaja.
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Croatian: Nakon stavljanja lijeka u promet, od siječnja 2003. godine do prosinca 2010. godine, pretežito u bolesnika s reumatoidnim artritisom, prijavljena je stopa zloćudnih bolesti od približno 2,7 na 1000 bolesnik-godina liječenja.
English: Side effects may occur up to 4 months or more after the last Hefiya injection.
Croatian: Nuspojave se mogu javiti još 4 mjeseca ili više nakon ubrizgavanja zadnje doze lijeka Hefiya.
English: Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Croatian: Adalimumab može prijeći preko posteljice u serum djece čije su majke tijekom trudnoće liječene adalimumabom.
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Croatian: Djelovanje adalimumaba ispitivano je u više od 3000 bolesnika u svim kliničkim ispitivanjima reumatoidnog artritisa (RA).
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hefiya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu profilakse tuberkuloze također treba razmotriti prije početka liječenja lijekom Hefiya u bolesnika s nekoliko faktora rizika ili sa značajnim faktorima rizika od tuberkuloze unatoč negativnom nalazu na tuberkulozu i u bolesnika s latentnom ili aktivnom tuberkulozom u anamnezi u kojih se ne može utvrditi adekvatan tijek liječenja.
English: • You may see a few drops of liquid come out of the needle.
Croatian: • Možda ćete vidjeti nekoliko kapljica tekućine na vrhu igle.
English: With current data it is not known if adalimumab treatment influences the risk for developing dysplasia or colon cancer.
Croatian: Prema trenutnim podacima nije poznato utječe li liječenje adalimumabom na rizik od pojave displazije ili raka debelog crijeva.
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Croatian: U otvorenom produžetku ispitivanja poboljšanje znakova i simptoma održalo se uz terapiju adalimumabom do 156. tjedna.
English: o In this configuration the needle guard is
Croatian: U ovoj konfiguraciji štitnik igle
English: • serious infections (including blood poisoning and influenza);
Croatian: • ozbiljne infekcije (uključujući trovanje krvi i gripu),
English: The proportions of subjects with PedACR50 / 70 / 90 at week 12 and week 24 were 90.3 % / 61.3 % / 38.7 % and 83.3 % / 73.3 % / 36.7 %, respectively.
Croatian: Udio ispitanika s pedijatrijskim odgovorom ACR50/70/90 u 12. i 24. tjednu bio je 90,3%/61,3%/38,7%, odnosno 83,3%/73,3%/36,7%.
English: • raised liver enzymes.
Croatian: • povišena razina jetrenih enzima.
English: • that Hefiya treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Croatian: • liječenje lijekom Hefiya može povećati potencijalne rizike od o infekcija, uključujući tuberkulozu o raka o problema živčanog sustava o cijepljenja
English: If you have ulcerative colitis you will first be given other medicines.
Croatian: Ukoliko bolujete od ulceroznog kolitisa, prvo ćete dobiti druge lijekove.
English: These patients also had objective evidence of inflammation in the sacroiliac joints or spine on MRI or elevated hs-CRP.
Croatian: Ti su bolesnici imali i objektivne dokaze upale sakroilijakalnih zglobova ili kralježnice na MR snimkama ili povišene razine hs-CRP-a.
English: • Do not store the syringes in extreme heat or cold.
Croatian: • Ne čuvati štrcaljke na krajnje toplom ili hladnom.
English: None of these patients experienced rebound during the withdrawal period.
Croatian: Niti jedan od tih bolesnika nije doživio povrat (rebound) bolesti u razdoblju kada je terapija bila ukinuta.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Croatian: Razvojna toksičnost ispitivana je kod majmuna, ali nisu zabilježeni znakovi toksičnosti za majku, embriotoksičnosti ni teratogenosti.
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and wellcontrolled studies.
Croatian: Djelotvornost i sigurnost adalimumaba ocijenjena je u pet randomiziranih, dvostruko slijepih, dobro kontroliranih ispitivanja.
English: Maintenance dose starting at week 4
Croatian: Doza održavanja počevši od
English: Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici/blisteru/kutiji iza oznake „Rok valjanosti“ ili „EXP“.
English: Store in a refrigerator (2°C-8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNF-α was seen.
Croatian: U bolesnika s Crohnovom bolešću primijećeno je smanjenje broja stanica u debelom crijevu koje eksprimiraju markere upale, uključujući i značajno sniženje ekspresije TNFα.
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Croatian: Za informacije o istodobnoj primjeni s antireumatskim lijekovima koji modificiraju tijek bolesti, a nisu metotreksat, vidjeti dijelove 4.4 i 5.1.
English: Muscle spasms (including blood creatine phosphokinase increased)
Croatian: Spazmi mišića (uključujući povećanje razine kreatin fosfokinaze)
English: Adalimumab has not been studied in patients aged less than 2 years.
Croatian: Adalimumab nije ispitivan u bolesnika mlađih od 2 godine.
English: Intestinal perforation1)
Croatian: Intestinalna perforacija1)
English: A single Hefiya pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Croatian: Jedna napunjena štrcaljka / napunjena brizgalica lijeka Hefiya može se čuvati na temperaturama do maksimalno 25°C u trajanju do 14 dana.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Croatian: Bolesnici su i dalje uzimali stabilne doze NSAIL-a i/ili prednizona (≤0,2 mg/kg/dan ili najviše 10 mg/dan).
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hefiya should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako se pojavi anafilaktička reakcija ili kakva druga ozbiljna alergijska reakcija, primjenu lijeka Hefiya treba odmah obustaviti i započeti odgovarajuću terapiju.
English: Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Croatian: ≥ 30% od početnog stanja u ≥ 3 od 6 ključnih kriterija za pedijatrijski ACR, ≥ 2 aktivna zgloba i poboljšanje veće od 30% u najviše 1 od 6 kriterija.
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Croatian: Korišten je modificirani TSS (mTSS), koji je uključivao i distalne interfalangealne zglobove (tj. nije jednak TSS-u korištenom u ispitivanjima kod reumatoidnog artritisa).
English: Administration of Hefiya should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Primjena lijeka Hefiya mora se obustaviti ako bolesnik razvije novu ozbiljnu infekciju ili sepsu te je potrebno započeti odgovarajuću antimikrobnu ili antifungalnu terapiju sve dok se infekcija ne stavi pod kontrolu.
English: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Croatian: U vremenu kada je terapija bila ukinuta, simptomi psorijaze su se s vremenom vratili uz medijan vremena do relapsa od oko 5 mjeseci (pogoršanje na PGA rezultat “umjereno” ili gore).
English: Table 13 efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms response placebo N=107
Croatian: Tablica 13 Djelotvornost u placebom kontroliranom ispitivanju kod AS-a - ispitivanje I Smanjenje znakova i simptoma odgovor placebo N=107
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Croatian: Postotak bolesnika liječenih adalimumabom u kojih je postignut terapijski odgovor ACR 20, 50 i 70 bio je podjednak u ispitivanjima RA I, II i III.
English: • You may see a drop of liquid at the end of the needle.
Croatian: • Možda ćete vidjeti kapljicu tekućine na vrhu igle.
English: failure (months)
Croatian: medijan vremena do neuspjeha (mjeseci)
English: This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
Croatian: To obuhvaća detaljnu medicinsku procjenu, uključujući uzimanje povijesti bolesti i provođenje odgovarajućih testova za otkrivanje bolesti (na primjer rendgenska snimka pluća i tuberkulinski test).
English: Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Croatian: Plak psorijaza je upalna kožna bolest koja uzrokuje crvene, perutave, krastave mrlje na koži prekrivene srebrnastim ljuskicama.
English: Children and adolescents with plaque psoriasis
Croatian: Djeca i adolescenti s plak psorijazom
English: Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Croatian: Egzacerbacija se definirala kao ASDAS rezultat ≥ 2,1 pri dva uzastopna posjeta u razmaku od četiri tjedna.
English: week 26
Croatian: 26. tjedan
English: Blood and the lymphatic system disorders*
Croatian: Poremećaj krvi i limfnog sustava*
English: Ankylosing spondylitis (AS)
Croatian: Ankilozantni spondilitis (AS)
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Croatian: Zbog toga je potreban oprez kod primjene antagonista TNF-a u bolesnika s KOPB-om, kao i u bolesnika koji imaju povećan rizik od razvoja zloćudnih bolesti zbog teškog pušenja.
English: Hefiya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Croatian: Hefiya sadrži djelatnu tvar adalimumab, lijek koji djeluje na imunološki (obrambeni) sustav tijela.
English: These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Croatian: Ove infekcije mogu biti ozbiljne i uključuju tuberkulozu, infekcije uzrokovane virusima, gljivicama, parazitima ili bakterijama ili drugim neuobičajenim infektivnim organizmima i sepsu (trovanje krvi).
English: • if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Croatian: • Ako bolujete od teške infekcije, uključujući tuberkulozu, sepsu (trovanje krvi) ili druge oportunističke infekcije (neuobičajene infekcije povezane s oslabljenim imunološkim sustavom).
English: Among the patients who discontinued the study prior to week 78, 11 % discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Croatian: Među bolesnicima koji su prekinuli sudjelovanje u ispitivanju prije 78. tjedna, njih 11% to je učinilo zbog nuspojava, a njih 5% zbog nedovoljno dobrog odgovora na liječenje adalimumabom.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Croatian: Bolujete li od umjereno do teško aktivnog reumatoidnog artritisa, moguće je da će Vam prvo biti propisani drugi lijekovi koji mijenjaju tijek bolesti, kao što je metotreksat.
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Croatian: Stevens-Johnsonov sindrom1), angioedem1), kutani vaskulitis1), lihenoidne kožne reakcije1)
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Croatian: 79 (73,1) a, b a p<0,001 adalimumab naspram placeba b p<0,001 adalimumab naspram metotreksata c p<0,01 adalimumab naspram placeba d p<0,05 adalimumab naspram metotreksata
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hefiya in case they cause infections.
Croatian: • Određena cjepiva sadrže živuće ali oslabljene oblike bakterija ili virusa koji uzrokuju bolest pa se ne smiju primiti za vrijeme liječena lijekom Hefiya jer mogu uzrokovati infekcije.
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Croatian: Bolesnici u kojih nije bilo odgovora nakon prve doze isključeni su iz daljnjeg tijeka istraživanja i stoga ti bolesnici nisu bili dalje procjenjivani.
English: Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Croatian: U bolesnika liječenih adalimumabom rizik od razbuktavanja bolesti značajno se smanjio tijekom prvih 12 tjedana liječenja.
English: • Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).
Croatian: • Držite klip pritisnut do kraja dok pažljivo podižete iglu ravno iz mjesta primjene injekcije i otpustite kožu (vidjeti Sliku J)
English: 2 pre-filled syringes
Croatian: 2 napunjene štrcaljke
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Hefiya should be considered prior to initiating therapy (see Other opportunistic infections).
Croatian: U bolesnika koji su bili izloženi tuberkulozi ili bolesnika koji su putovali u područja visokog rizika od tuberkuloze ili endemskih mikoza, kao što su histoplazmoza, kokcidioidomikoza ili blastomikoza, prije započinjanja liječenja treba razmotriti rizike i prednosti liječenja lijekom Hefiya (vidjeti Druge oportunističke infekcije).
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Croatian: Tijekom ispitivanja, 19,3% bolesnika nastavilo je terapiju oralnim antibioticima koje su uzimali pri uključivanju u ispitivanje.
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg / dl) values) improved at 24 or 26 weeks compared to placebo.
Croatian: U ispitivanjima RA I - IV sve pojedinačne komponente kriterija ACR odgovora (broj bolnih i otečenih zglobova, liječnikova i bolesnikova ocjena aktivnosti bolesti i boli, indeks onesposobljenosti (HAQ) i razine CRP-a (mg/dl)) pokazale su poboljšanje nakon 24 ili 26 tjedana primjene adalimumaba u odnosu na placebo.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Croatian: U nekih bolesnika koji su bili uspješno liječeni zbog aktivne tuberkuloze, za vrijeme liječenja adalimumabom ponovno se razvila tuberkuloza.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp Score (see table 10).
Croatian: U ispitivanju RA V, strukturno oštećenje zglobova procjenjivalo se radiografski, a izraženo je promjenom ukupnog zbroja bodova prema Sharpu (tablica 10).
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
Croatian: • pogoršanje stanja koje se naziva dermatomiozitis (zapaženo kao kožni osip praćen s mišićnom slabošću).
English: Leave it to dry before injecting (see Figure E).
Croatian: Pustite da se osuši prije primjene injekcije (vidjeti Sliku E).
English: Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Croatian: Neki od tih bolesnika su također uzimali i lijekove azatioprin ili merkaptopurin.
English: Table 17 Ps study I (REVEAL) - efficacy results at 16 weeks placebo N = 398 n (%)
Croatian: Tablica 17 Ispitivanje Ps I (REVEAL) - rezultati djelotvornosti nakon 16 tjedana placebo N=398 n (%)
English: In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s Crohnovom bolešću i ulceroznim kolitisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 52 tjedna,
English: • Alcohol wipe
Croatian: • Alkoholni jastučić
English: • reactivation of hepatitis B infection;
Croatian: • reaktivacija infekcije hepatitisa B,
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an openlabel extension study.
Croatian: Ukupno je 347 bolesnika sa stabilnim odgovorom na terapiju sudjelovalo u procjeni ukidanja i ponovnog uvođenja terapije u otvorenom produžetku ispitivanja.