FrancophonIA/ELRC3.0 huggingface dataset:
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis);
Croatian: • imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće kao sarkoidoza),
English: Figure 2: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Croatian: Slika 2: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega (ispitivanje UV II)
English: Efficacy Outcomes
Croatian: Rezultati djelotvornosti
English: For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes before injecting.
Croatian: Za ugodniju primjenu, ostavite napunjenu brizgalicu na sobnoj temperaturi 15 do 30 minuta prije injiciranja.
English: ● If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.
Croatian: Ako imate psorijazu, izbjegavajte injiciranje u uzdignute, zadebljane, crvene i ljuskave dijelove kože ili lezije.
English: Push down
Croatian: Pritisnite prema dolje
English: Radiographic mean changes at week 52 in RA study V
Croatian: Srednje vrijednosti promjena radioloških nalaza nakon 52 tjedna u ispitivanju RA V
English: A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
Croatian: Izvadite onoliko AMGEVITA napunjenih štrcaljki koliko vam je potrebno iz pakiranja.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNFα) inhibitors.
Croatian: Farmakoterapijska skupina: Imunosupresivi, Inhibitori faktora tumorske nekroze alfa (TNF-α).
English: What you need to know before you use AMGEVITA
Croatian: Što morate znati prije nego počnete primjenjivati lijek AMGEVITA
English: Carriers of HBV who require treatment with AMGEVITA should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje HBV-a u kojih je nužna primjena lijeka AMGEVITA mora se pomno pratiti zbog moguće pojave znakova i simptoma aktivne HBV infekcije tijekom cijelog trajanja terapije te nekoliko mjeseci nakon njezina prekida.
English: Patients treated with AMGEVITA should be given the Patient Reminder Card.
Croatian: Bolesnicima koji se liječe lijekom AMGEVITA treba dati posebnu Karticu s podsjetnikom za bolesnika.
English: ACR responses in RA study V (percent of patients)
Croatian: ACR odgovori u ispitivanju RA V (postotak bolesnika)
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Croatian: U 12. je tjednu značajno veći udio bolesnika u ispitivanju HS-II doživio klinički značajno smanjenje kožne boli uzrokovane gnojnim hidradenitisom (vidjeti Tablicu 21).
English: Important: Keep the skin stretched or pinched while injecting.
Croatian: Važno: Važno je držati kožu rastegnutom ili u naboru za vrijeme injiciranja.
English: • AMGEVITA should only be used during a pregnancy if needed.
Croatian: • AMGEVITA se tijekom trudnoće smije primjenjivati samo ako je to neophodno.
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p < 0.001) (Figure 1).
Croatian: Veći udio bolesnika na adalimumabu nije imao pogoršanje bolesit tijekom dvostruko slijepog razdoblja, u usporedbi s onima na placebu (70,4% prema 47,1%, p < 0,001) (Slika 1).
English: Do not give AMGEVITA to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Croatian: • Ne primjenjujte lijek AMGEVITA djeci s poliartikularnim juvenilnim idiopatskim artritisom mlađoj od 2 godine
English: PGA: Clear/minimalc a MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX c P = 0.083, adalimumab 0.8 mg/kg versus MTX
Croatian: PGA: bez bolesti/minimalnoc a MTX = metotreksat b P = 0,027, adalimumab 0,8 mg/kg naspram MTX-a c P = 0,083, adalimumab 0,8 mg/kg naspram MTX-a
English: The 40 mg pre-filled pen cannot be used for the 20 mg dose.
Croatian: Napunjena brizgalica od 40 mg, ne može se primijeniti za dozu od 20 mg.
English: Do not use AMGEVITA:
Croatian: Nemojte primjenjivati lijek AMGEVITA:
English: AMGEVITA should only be used during pregnancy if clearly needed.
Croatian: Adalimumab se tijekom trudnoće smije primjenjivati samo ako je to posve neophodno.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in Cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Croatian: Ispitivanja embriofetalne i perinatalne razvojne toksičnosti provedena na makaki majmunima s dozama od 0, 30 i 100 mg/kg (9-17 majmuna u skupini) nisu pokazala znakove oštećenja fetusa uslijed primjene adalimumaba.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Croatian: Od 68 bolesnika koji su imali pogoršanje u skupini koja je bila određena za prekid liječenja, 65 je završilo liječenje spasa s adalimumabom kroz 12 tjedana, od čega se 37 (56,9%) vratilo u remisiju (ASDAS <1,3) nakon 12 tjedana od ponovnog početka otvorenog liječenja.
English: In rheumatoid arthritis, methotrexate is continued while using AMGEVITA.
Croatian: Kod reumatoidnog artritisa, primjena metotreksata se nastavlja za vrijeme uzimanja lijeka AMGEVITA.
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year versus 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year versus 0.22 per patient year.
Croatian: Broj hospitalizacija zbog bilo kojeg uzroka u skupini liječenoj adalimumabom bio je 0,18 po bolesnik-godini u odnosu na 0,26 po bolesnik-godini u skupini koja je primala placebo, a odgovarajuće vrijednosti za hospitalizaciju povezanu s UC-om bile su 0,12 po bolesnik-godini u odnosu na 0,22 po bolesnik-godini.
English: Multipack: 6 (3 packs of 2) SureClick pre-filled pens.
Croatian: Višestruko pakiranje: 6 (3 pakiranja od 2) SureClick napunjenih brizgalica.
English: You should not take AMGEVITA with medicines containing the active substances, anakinra or abatacept due to increased risk of serious infection.
Croatian: AMGEVITA se ne smije primjenjivati s drugim lijekovima koji sadrže djelatnu tvar anakinru ili abatacept zbog povećanog rizika od ozbiljne infekcije.
English: Yellow cap off
Croatian: Žuti zatvarač skinut
English: Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.
Croatian: Čvrsto rastegnite kožu tako da pomičete palac i prste u suprotnom smjeru, kako biste dobili oko 5 centimetara široko područje.
English: On a clean, well-lit work surface, place a new, pre-filled syringe.
Croatian: Na čistu i dobro osvijetljenu radnu površinu, položite novu napunjenu štrcaljku.
English: By attaching to TNFα, AMGEVITA decreases the process of inflammation in these diseases.
Croatian: Vezivanjem za TNFα, AMGEVITA smanjuje upalni proces kod tih bolesti.
English: Of 342 subjects originally randomised to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Croatian: Od 342 ispitanika izvorno randomizirana za monoterapiju lijekom adalimumab ili liječenje kombinacijom adalimumaba i metotreksata koji su ušli u otvoreni produžetak ispitivanja, 171 ispitanik završio je 10 godina liječenja adalimumabom.
English: After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Croatian: Nakon sljedeća dva tjedna liječenje se nastavlja dozom od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan, kako Vam je propisao Vaš liječnik.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last AMGEVITA treatment.
Croatian: Žene reproduktivne dobi trebaju razmotriti korištenje odgovarajuće kontracepcije kako bi spriječile trudnoću i trebale bi je nastaviti koristiti još najmanje pet mjeseci nakon posljednje doze lijeka AMGEVITA.
English: If you accidentally inject AMGEVITA more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more.
Croatian: Ako slučajno primijenite lijek AMGEVITA češće nego je to preporučio liječnik ili ljekarnik, nazovite ga i obavijestite da ste uzeli veću količinu.
English: ASDASc Inactive Disease
Croatian: ASASa Djelomična remisija ASDASc Neaktivna bolest
English: Erythema multiforme1), Stevens-Johnson syndrome1), Angioedema1), Cutaneous vasculitis1) Lichenoid skin reaction1)
Croatian: Stevens-Johnsonov sindrom1), angioedem1), kutani vaskulitis1) lihenoidne kožne reakcije1) nepoznato pogoršanjesimptomadermatomiozitisa1)
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Croatian: U bolesnika koji već dulje vrijeme boluju od ozbiljnog reumatoidnog artritisa, rizik obolijevanja od limfoma (rak koji zahvaća limfni sustav) i leukemije (rak koji zahvaća krv i koštanu srž) može biti veći od prosječnoga.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Croatian: Zabilježena je reaktivacija hepatitisa B u bolesnika koji su uzimali antagoniste TNF-a, uključujući adalimumab, i koji su bili kronični nositelji tog virusa (tj. pozitivni na površinski antigen), a bilo je i slučajeva sa smrtnim ishodom.
English: • musculoskeletal pain.
Croatian: • mišićno-koštana bol.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Croatian: Poboljšanje rezultata u broju aktivnih zglobova s artritisom održalo se tijekom otvorenog razdoblja kroz 156 tjedana ispitivanja za 26 od 31 (84%) bolesnika u skupini liječenoj lijekom adalimumab koji su ostali u ispitivanju.
English: P value1
Croatian: P vrijednost1
English: Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike u kojih se za vrijeme liječenja lijekom AMGEVITA razviju nove infekcije potrebno je pozorno pratiti i podvrgnuti kompletnoj dijagnostičkoj procjeni.
English: AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Croatian: AMGEVITA se koristi za liječenje gnojnog hidradenitisa u odraslih i adolescenata u dobi od 12 godina i starijih.
English: Improved physical function continued during the open-label extension up to week 136.
Croatian: Poboljšana fizička funkcija održala se i u otvorenom produžetku ispitivanja do 136. tjedna.
English: No clinical data are available on the use of a AMGEVITA loading dose in children < 6 years of age (see section 5.2).
Croatian: Nisu dostupni klinički podaci o primjeni udarne doze lijeka AMGEVITA u djece u dobi od < 6 godina (vidjeti dio 5.2).
English: - On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome.
Croatian: • U rijetkim slučajevima liječenje lijekom AMGEVITA može dovesti do pojave sindroma sličnog lupusu.
English: If you stop using AMGEVITA
Croatian: Ako prestanete uzimati lijek AMGEVITA
English: ● Plaster
Croatian: ● Flaster
English: Blue start button
Croatian: Plavo dugme za injiciranje
English: Multiple sclerosis,
Croatian: • multipla skleroza,
English: AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Croatian: AMGEVITA se može davati kao monoterapija u slučajevima nepodnošenja metotreksata ili kada nastavak terapije metotreksatom nije prikladan (za djelotvornost monoterapije vidjeti dio 5.1).
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in psoriasis study I, and continued adalimumab in the open-label extension trial.
Croatian: Ukupno su 233 bolesnika s odgovorom PASI 75 u 16. i 33. tjednu primala kontinuiranu terapiju adalimumabom kroz 52 tjedna u ispitivanju Psoriasis Study I te su nastavila s primanjem adalimumaba u otvorenom produžetku ispitivanja.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE LIJEKA U PROMET
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 AMGEVITA 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 koristi liječenja lijekom AMGEVITA (vidjeti Druge oportunističke infekcije).
English: Concomitant administration of AMGEVITA with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Croatian: Istodobna primjena lijeka AMGEVITA i drugih bioloških antireumatika koji modificiraju tijek bolesti (npr. anakinra i abatacept) ili drugih antagonista TNF-a se ne preporučuje zbog mogućeg povećanog rizika od razvoja infekcija, uključujući ozbiljne infekcije, i drugih potencijalnih farmakoloških interakcija (vidjeti dio 4.5).
English: Adalimumab /MTX 40 mg every other week
Croatian: Adalimumab/MTX 40 mg svaka dva tjedna
English: The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Croatian: Djelatna tvar u lijeku AMGEVITA, adalimumab, ljudsko je monoklonsko protutijelo.
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Croatian: Ispitivanje nr-axSpA II bilo je ispitivanje prekida liječenja u bolesnika s aktivnim nr-axSpA koji su postigli remisiju tijekom otvorenog liječenja adalimumabom.
English: Important: Keep the skin pinched while injecting.
Croatian: Važno: Držite nabor kože za vrijeme injiciranja.
English: AMGEVITA contains the active substance adalimumab.
Croatian: AMGEVITA sadrži djelatnu tvar adalimumab.
English: AMGEVITA reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function.
Croatian: AMGEVITA smanjuje brzinu progresije oštećenja perifernih zglobova mjerene radiološki u bolesnika s poliartikularnim simetričnim podtipovima bolesti (vidjeti dio 5.1) te poboljšava funkciju zglobova.
English: 14 weeks a Paediatric ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Croatian: 14 tjedana a Pedijatrijski odgovori ACR 30/50/70 nakon 48 tjedana terapije bili su značajno veći nego u skupini koja je uzimala placebo b p = 0,015 c p = 0,031
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given (see section 4.8).
Croatian: Ako bolesnik nakon primjene lijeka AMGEVITA razvije simptome koji upućuju na sindrom nalik lupusu i pozitivan je na protutijela usmjerena protiv dvolančane DNK, terapija lijekom AMGEVITA ne smije se nastaviti (vidjeti dio 4.8).
English: Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Croatian: Dostupni podaci za adalimumab pokazuju da se klinički odgovor obično postiže unutar 12 tjedana liječenja.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.
Croatian: Ciljna tvar za adalimumab je protein koji se naziva faktor tumorske nekroze (TNFα) koji sudjeluje u radu imunološkog (obrambenog) sustava i čije su razine povišene pri gore navedenim upalnim bolestima.
English: Usually, AMGEVITA is used with methotrexate.
Croatian: AMGEVITA se obično primjenjuje u kombinaciji s metotreksatom.
English: Thus additional caution should be exercised in considering AMGEVITA treatment of these patients (see section 4.8).
Croatian: Zbog toga je potreban dodatan oprez prilikom razmatranja liječenja lijekom AMGEVITA u takvih bolesnika (vidjeti dio 4.8).
English: AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated.
Croatian: Liječenje lijekom AMGEVITA moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja je AMGEVITA indicirana.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your AMGEVITA therapy, your doctor may decide to give 40 mg every week or 80 mg every other week.
Croatian: Ako imate reumatoidni artritis i ne dobivate metotreksat zajedno s lijekom AMGEVITA, Vaš liječnik može odlučiti davati Vam 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: AMGEVITA is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Croatian: AMGEVITA se koristi i za liječenje teške plak psorijaze u djece i adolescenata u dobi od 4 do 17 godina kod kojih topikalna terapija i fototerapije nisu djelovale jako dobro ili nisu prikladne.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor i koji su nastavili terapiju adalimumabom svaki tjedan, stopa HiSCR-a u 48. tjednu iznosila je 68,3%, a u 96. tjednu 65,1%.
English: ● Do not use the syringe if: - The medicine is cloudy or discoloured or contains flakes, or particles.
Croatian: Nemojte koristiti štrcaljku ako: - Lijek je mutan ili je promijenio boju ili sadrži pahuljice ili čestice.
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Croatian: 673 bolesnika s aktivnim nr-axSpA (srednja početna vrijednost aktivnosti bolesti [BASDAI] bila je 7,0) koji su imali neodgovarajući odgovor na  2 NSAIL-a, ili netoleranciju ili kontraindikaciju za NSAIL-e bili su uključeni u otvoreno razdoblje ispitivanja nr-axSpA II tijekom kojeg su primali adalimumab 40 mg svaki drugi tjedan tijekom 28 tjedana.
English: Some of those patients were also treated with azathioprine or 6mercaptopurine.
Croatian: Neki od tih bolesnika su također uzimali i azatioprin ili 6-merkaptopurin.
English: Response, remission and mucosal healing in study UC-II (percent of patients)
Croatian: Tablica 28. Odgovor, remisija i cijeljenje sluznice u ispitivanju UC-II (postotak bolesnika)
English: Bacterial infections,
Croatian: • bakterijske infekcije,
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Croatian: Ispitivanje nr-axSpA I evaluiralo je bolesnike s aktivnim nr-axSpA.
English: Maintenance of clinical remission and response (percent of patients)
Croatian: Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Croatian: 36. tjedan a Bolesnici koji su ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan nakon 12 tjedana liječenja b Bolesnici koji su ispunjavali protokolom utvrđene kriterije za gubitak odgovora ili izostanak poboljšanja morali su prekinuti ispitivanja i vodili su se kao bolesnici bez odgovora
English: If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive AMGEVITA.
Croatian: • Ako bolujete ili obolite od demijelinizirajuće bolesti, poput multiple skleroze, odluku o tome smijete li početi ili nastaviti primati lijek AMGEVITA donijet će Vaš liječnik.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% versus 13.9%, respectively).
Croatian: Približno dvostruko veći udio bolesnika u skupini koja je u prvih 12 tjedana ispitivanja HS-I i HS-II primala placebo, naspram onih koji su liječeni adalimumabom, doživio je pogoršanje apscesa (23,0% naspram 11,4%) i drenirajućih fistula (30,0% naspram 13,9%).
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomised to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Croatian: Bolesnici koji su postigli trajnu remisiju kroz najmanje 12 tjedana (N = 305) (ASDAS <1,3 u tjednima 16, 20, 24 i 28) tijekom otvorenog razdoblja bili su zatim randomizirani da bi primali bilo kontinuirano liječenje s adalimumabom 40 mg svaki drugi tjedan (N = 152) ili placebo (N = 153) tijekom dodatnih 40 tjedana u dvostruko slijepom, placebom kontroliranom razdoblju (ukupno trajanje ispitivanja 68 tjedana).
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
Croatian: Klinička remisija Klinički odgovor (CR-100) Bolesnici u remisiji bez primjene steroida > = 90 danaa
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet zabilježene su zloćudne bolesti, neke sa smrtnim ishodom, u djece, adolescenata i mlađih odraslih osoba (u dobi do 22 godine) liječenih antagonistima TNF-a (početak terapije u 18. godini života ili ranije), uključujući adalimumab.