FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Croatian: Bolesnici su zatim ponovno započeli liječenje adalimumabom u dozi od 0,8 mg/kg svaki drugi tjedan tijekom dodatnih 16 tjedana, a stope odgovora primijećene tijekom ponovnog liječenja bile su slične onima prethodno zabilježenima tijekom razdoblja dvostruko slijepog liječenja: odgovor PASI 75 postiglo je 78,9% (15 od 19 ispitanika), a PGA rezultat 'bez bolesti' ili 'minimalno' njih 52,6% (10 od 19 ispitanika).
English: Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Croatian: Jedno pakiranje sadrži 1 bočicu (0,8 ml sterilne otopine), 1 sterilnu štrcaljku za injektiranje, 1 sterilnu iglu, 1 nastavak za bočicu i 2 jastučića natopljena alkoholom.
English: The inflammation may lead 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: Ta upala može dovesti do slabljenja vida i/ili pojave „letećih mušica u vidnom polju“ (crnih točkica ili tankih niti koje se kreću vidnim poljem).
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Croatian: Prilagođen OR (kod kojega su uzete u obzir početne razlike) iznosio je 1,10 (95% CI: 0,45 - 2,73) za reumatoidni artritis i Crohnovu bolest zajedno.
English: Thirty-three (18%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Croatian: Na početku je 33 bolesnika (18%) istodobno bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 146 (79%) NSAIL-ovima.
English: Psoriasis study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Croatian: U ispitivanju Psoriasis Study IV uspoređivale su se djelotvornost i sigurnost adalimumaba u odnosu na placebo u 217 odraslih bolesnika s umjerenom do teškom psorijazom noktiju.
English: ACR 70 Week 12 Week 24
Croatian: ACR 70 12. tjedan 24. tjedan
English: All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Croatian: Svi su bolesnici pri uključivanju u ispitivanje 2 tjedna primali standardiziranu dozu prednizona od 60 mg/dan, nakon čega je uslijedilo obavezno postupno smanjivanje doze, uz potpuni prestanak primjene kortikosteroida do 15. tjedna.
English: If your child received Kromeya during her pregnancy, her baby may have a higher risk for getting an infection.
Croatian: Ako Vaše dijete prima lijek Kromeya tijekom trudnoće, njeno dijete može imati povećan rizik od dobivanja infekcije.
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Croatian: U kontroliranim dijelovima pivotalnih ispitivanja terapije adalimumabom koja su trajala barem 12 tjedana u odraslih bolesnika s umjerenim do teškim aktivnim reumatoidnim artritisom, ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, psorijatičnim artritisom, psorijazom, gnojnim hidradenitisom, Crohnovom bolešću, ulceroznim kolitisom i uveitisom, primijećene su zloćudne bolesti, isključujući limfome i nemelanomske tumore kože, u stopi od 6,8 (4,4; 10,5) na 1000 bolesnik-godina (interval pouzdanosti 95%) u 5291 bolesnika liječenog adalimumabom, naspram 6,3 (3,4; 11,8) na 1000 bolesnik-godina u 3444 bolesnika iz kontrolne skupine (medijan trajanja terapije bio je 4,0 mjeseci u bolesnika liječenih adalimumabom i 3,8 mjeseci u kontrolnoj skupini bolesnika).
English: Yellow syringe connector
Croatian: Žuti priključak za štrcaljku
English: Table 12 Ped ACR 30 responses in the JIA study
Croatian: Tablica 12 Pedijatrijski odgovori ACR 30 u ispitivanju kod JIA
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Croatian: U skupinama koje su primale indukcijske režime od 160/80 mg i 80/40 mg uočene su slične stope remisije do 8. tjedna, a stopa pojavljivanja štetnih događaja bila je veća u skupini koja je primala adalimumab 160/80 mg.
English: Week 2
Croatian: 2. tjedan
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Croatian: Nakon 52 tjedna liječenja, klinička remisija postignuta je u 42,9% bolesnika liječenih kombinacijom adalimumaba i metotreksata (DAS28 [CRP] <2,6) u usporedbi s 20,6% bolesnika koji su dobivali monoterapiju metotreksatom, odnosno 23,4% bolesnika koji su dobivali monoterapiju adalimumabom.
English: Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Croatian: Kromeya je indicirana za liječenje aktivnog artritisa povezanog s entezitisom u bolesnika u dobi od 6 godina i starijih u kojih nije postignut zadovoljavajući odgovor ili koji ne podnose konvencionalnu terapiju (vidjeti dio 5.1).
English: By Week 68, patients receiving continuous Kromeya treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Croatian: Bolesnici koji su neprekidno primali adalimumab su do 68. tjedna pokazali statistički značajno veće poboljšanje znakova i simptoma aktivnog nr-axSpA u usporedbi s bolesnicima kojima je terapija ukinuta tijekom dvostruko slijepog razdoblja ispitivanja (Tablica 15).
English: 1.2 Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up.
Croatian: 1.2 Ostavite set barem 30 minuta na sobnoj temperaturi da bi se lijek zagrijao.
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Croatian: U otvorenom produžetku ispitivanja, među bolesnicima čija je doza zbog PASI odgovora manjeg od 50% povećana s 40 mg svaka dva tjedna na 40 mg svaki tjedan, odgovor PASI 75 postignut je u 12. tjednu u 26,4% (92/349) bolesnika i u 24. tjednu u 37,8% (132/349) bolesnika.
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Croatian: Bolesnicima koji su primali MTX i koji su u 8. i/ili 12. tjednu postigli odgovor PASI 50 doza se nije dalje povećavala.
English: • injection site reactions (including pain, swelling, redness or itching);
Croatian: • reakcije na mjestu ubrizgavanja (uključujući bol, oticanje, crvenilo ili svrbež),
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Croatian: Za vrijeme liječenja adalimumabom mogu nastati protutijela na adalimumab.
English: If your child becomes pregnant, you should see your child's doctor.
Croatian: Ako zatrudni, Vaše dijete mora posjetiti svog liječnika.
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Croatian: U ispitivanju faze III adalimumaba u pedijatrijskih bolesnika s Chronovom bolešću, koje je ocijenilo djelotvornost i sigurnost dvaju režima terapije održavanja dozom prilagođenom tjelesnoj težini nakon indukcijske terapije prilagođene tjelesnoj težini do 52 tjedna liječenja, povišenje ALT-a ≥ 3 x GGN javilo se u 2,6% (5/192) bolesnika, od kojih je njih četvero na početku liječenja bilo izloženo istodobnoj terapiji imunosupresivima.
English: Immune system disorders* Common
Croatian: Poremećaji imunološkog sustava*
English: Patients receiving MTX who achieved a ≥ PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Croatian: Bolesnicima koji su primali MTX i koji su u 8. i/ili 12. tjednu postigli odgovor ≥ PASI 50 doza se nije dalje povećavala.
English: • A clean cotton ball or gauze, and
Croatian: • čista kuglica od vate ili gaza i
English: 15 kg to < 30 kg
Croatian: 15 kg do < 30 kg
English: ▪ the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: ▪ liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa u odraslih bolesnika koji nisu bili prethodno liječeni metotreksatom.
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Croatian: (pogoršanje za < 5 slova) u 88,4% očiju.
English: • intestinal perforation (hole in the wall of the gut);
Croatian: • perforacija crijeva (rupa u stijenci crijeva),
English: Adalimumab/MTX 40 mg every other week
Croatian: Adalimumab/MTX 40 mg svaka dva tjedna
English: Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Croatian: Nakon što ste je izvadili iz hladnjaka i čuvali na sobnoj temperaturi, Vašu napunjenu štrcaljku morate iskoristiti u roku od 14 dana ili je baciti, čak i ako ste ju kasnije vratili u hladnjak.
English: You should record the date when the syringe is first removed from refrigerator, and the date after which it should be discarded.
Croatian: Zabilježite datum kada ste štrcaljku prvi put izvadili iz hladnjaka i datum nakon kojega je morate baciti.
English: Keep this patient reminder card with you during your treatment and for 4 months after your (or your child's) last injection of Kromeya.
Croatian: Karticu s podsjetnikom za bolesnika držite kod sebe za vrijeme liječenja i 4 mjeseca nakon Vaše posljednje injekcije lijeka Kromeya (ili posljednje injekcije Vašeg djeteta).
English: Do not recycle your used sharps disposal container.
Croatian: Nemojte reciklirati spremnik za odlaganje oštrih predmeta.
English: If you receive Kromeya during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: Ako primate lijek Kromeya tijekom trudnoće, Vaše dijete može imati povećan rizik od dobivanja infekcije.
English: Week 12
Croatian: 12. tjedan
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Croatian: U otvorenoj uvodnoj fazi ispitivanja bolesnici su podijeljeni u dvije skupine, jedna koja je uzimala metotreksat (označena s MTX) i ona koja nije (označena s neMTX).
English: 1.7 Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).
Croatian: 1.7 Ostavite brizgalicu 30 minuta na sobnoj temperaturi da bi se lijek zagrijao (Slika F).
English: Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy.
Croatian: Stvaranje protutijela bilo je manje kada se adalimumab davao zajedno s metotreksatom nego kada se primjenjivala kao monoterapija.
English: • Top of the thighs or
Croatian: • prednjoj strani bedara ili
English: • Continue to HOLD the pre-filled pen firmly.
Croatian: • Nastavite čvrsto DRŽATI brizgalicu.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Croatian: Farmakoterapijska skupina: Imunosupresivi, Inhibitori faktora tumorske nekroze alfa (TNF-α).
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Croatian: Ispitivanje UV II ocjenjivalo je 226 bolesnika s neaktivnim uveitisom kojima je na početku ispitivanja za kontrolu bolesti bilo potrebno kronično liječenje kortikosteroidima (oralni prednizon u dozi od 10 do 35 mg/dan).
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Croatian: rijetko leukemija nepoznato hepatosplenični T-stanični limfom karcinom Merkelovih stanica (neuroendokrini karcinom kože)
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Croatian: Kromeya je namijenjena liječenju poliartikularnog juvenilnog idiopatskog artritisa i artritisa povezanog s entezitisom.
English: 7.3 When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
Croatian: 7.3 Kada je spremnik za odlaganje oštrih predmeta gotovo pun, trebate slijediti nacionalne smjernice za pravilan način odlaganja spremnika oštrih predmeta.
English: Kromeya is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Croatian: Kromeya je namijenjena liječenju djece u dobi od 2 i više godina s kroničnim nezaraznim uveitisom kod kojega upala zahvaća prednji dio oka
English: 1.5 Check your records for injection dates and injection sites to figure out the injection site for this session.
Croatian: U svojim bilješkama provjerite datum i mjesta injiciranja kako biste odlučili gdje ćete sada injicirati.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Croatian: • Imate li alergijske reakcije sa simptomima poput stezanja u prsima, ''piskanja pri disanju'', omaglice, oticanja ili osipa, prestanite ubrizgavati lijek Kromeya i odmah se javite liječniku, jer te reakcije u rijetkim slučajevima mogu biti opasne po život.
English: Week 26
Croatian: 26. tjedan
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 µg/mL for the Standard Dose group and 3.5±2.2 µg/mL for the Low Dose group.
Croatian: U bolesnika koji su nastavili terapiju na koju su randomizirani, srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u 52. tjednu bile su 9,5 ± 5,6 g/ml za skupinu koja je primala standardnu dozu i 3,5 ± 2,2 g/ml za skupinu koja je primala nisku dozu.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially 'sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 0,8 ml, odnosno zanemarive količine natrija.
English: Preclinical data on fertility effects of adalimumab are not available.
Croatian: Nisu dostupni pretklinički podaci o utjecaju adalimumaba na plodnost.
English: Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Croatian: Bolesnici koji primaju adalimumab mogu istodobno primiti cjepiva, ali ne živa cjepiva.
English: Consequently, Kromeya can be used during breast-feeding.
Croatian: Stoga se Kromeya može primjenjivati tijekom dojenja.
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table
Croatian: Rezultati u 12. tjednu pokazali su značajno poboljšanje znakova i simptoma aktivnog nr-axSpA u bolesnika koji su liječeni adalimumabom u odnosu na placebo
English: When Kromeya therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Croatian: Kad se uvodi liječenje lijekom Kromeya može se primijeniti udarna doza od 40 mg za bolesnike tjelesne težine < 30 kg ili 80 mg za bolesnike tjelesne težine ≥ 30 kg tjedan dana prije početka terapije održavanja.
English: This will allow the needle to move up into the clear needle guard and cover the entire needle (Figure S).
Croatian: Tako će se igla pomaknuti prema gore u prozirni štitnik igle te će cijela biti pokrivena (slika S).
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Croatian: Sigurnost i djelotvornost primjene adalimumaba ocijenjena je u multicentričnom, randomiziranom, dvostruko-slijepom ispitivanju s paralelnim skupinama koje je uključivalo 171 dijete (u dobi od 4-17 godina) s poliartikularnim JIA.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA<10% and ≥5% (40% of patients)).
Croatian: Adalimumab je ostvario povoljan terapijski učinak u bolesnika s psorijazom noktiju i različitim stupnjevima zahvaćenosti kože (≥ 10% tjelesne površine [60% bolesnika] te < 10% i ≥ 5% tjelesne površine [40% bolesnika]).
English: Step 3 Prepare Syringe
Croatian: 3. korak Pripremite štrcaljku
English: In study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
Croatian: I uočeno je i značajno poboljšanje rezultata za cjelokupnu fizičku i mentalnu komponentu iz upitnika SF-36 u usporedbi s placebom.
English: Among patients who were not in response at week 4, 43% of adalimumab maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Croatian: Među bolesnicima koji u 4. tjednu nisu imali klinički odgovor, 43% bolesnika koji su primali dozu održavanja adalimumaba imalo je klinički odgovor do 12. tjedna u odnosu na 30% u skupini bolesnika koji su uzimali placebo kao terapiju održavanja.
English: Step 7
Croatian: 6. korak
English: Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Croatian: Napomena: Neuspjeh liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega (ispitivanje UV II) smatrao se događajem.
English: bleeding, paleness.
Croatian: krvarenja, bljedila.
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Croatian: Health Assessment Questionnaire, HAQ) u četiri originalna adekvatna i dobro kontrolirana klinička ispitivanja, a to je bio i unaprijed određen primarni ishod nakon 52 tjedna liječenja u ispitivanju RA III.
English: Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Croatian: Bolesnici liječeni adalimumabom pokazali su statistički značajna poboljšanja DLQI rezultata u 26. tjednu u odnosu na placebo.
English: Once removed from the refrigerator for room temperature storage, your pre-filled pen must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Croatian: Nakon što ste je izvadili iz hladnjaka i čuvali na sobnoj temperaturi, Vašu napunjenu brizgalicu morate iskoristiti u roku od 14 dana ili je baciti, čak i ako ste ju kasnije vratili u hladnjak.
English: Figure 1: Kaplan-Meier curves summarizing time to flare in study nr-axSpA II
Croatian: Slika 1: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do egzacerbacije u ispitivanju nr-axSpA II
English: Median time to disease flare
Croatian: Medijan vremena do egzacerbacije bolesti
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Croatian: Stopa trudnoća koje su završile najmanje jednim živorođenim djetetom s velikom urođenom manom iznosila je 6/69 (8,7%) među ženama liječenima adalimumabom koje su imale reumatoidni artritis i 5/74 (6,8%) među ženama s reumatoidnim artritisom koje nisu primale liječenje (neprilagođen OR: 1,31; 95% CI: 0,38 - 4,52) te 16/152 (10,5%) među ženama liječenima adalimumabom koje su imale Crohnovu bolest i 3/32 (9,4%) među ženama s Crohnovom bolešću koje nisu primale liječenje (neprilagođen OR: 1,14; 95% CI: 0,31 - 4,16).
English: Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Croatian: Kromeya je, u kombinaciji s metotreksatom, indicirana za liječenje aktivnog poliartikularnog juvenilnog idiopatskog artritisa u bolesnika u dobi od 2 godine i starijih u kojih prethodnim liječenjem jednim ili više antireumatika koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drug, DMARD) nije postignut zadovoljavajući odgovor.
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Croatian: Raspored bolesnika prema dobi te minimalnoj i maksimalnoj dozi i medijanu doze tijekom ove faze prikazan je u Tablici 11.
English: Minimum, median and maximum dose
Croatian: Početni broj bolesnika n (%) Minimalna doza, medijan doze i maksimalna doza
English: • If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Croatian: • Ako Vaše dijete ima alergijske reakcije sa simptomima poput stezanja u prsima, ''piskanja pri disanju'', omaglice, oticanja ili osipa, prestanite ubrizgavati lijek Kromeya i odmah se javite liječniku, jer te reakcije u rijetkim slučajevima mogu biti opasne po život.
English: OL-LI 16 weeks
Croatian: Otvorena uvodna16 tjedana
English: • The liquid is clear, colorless, and free of particles (Figure H).
Croatian: • Tekućina je bistra, bezbojna i bez čestica (slika H).
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Kromeya.
Croatian: • Bolujete li od infekcije, uključujući dugotrajnu ili lokaliziranu infekciju (primjerice, ulceraciju na nozi), obratite se liječniku prije nego počnete primjenjivati lijek Kromeya.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open- label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Croatian: Po završetku prva 52 tjedna, 457 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem su se adalimumab u dozi od 40 mg/MTX primjenjivali svaka dva tjedna do 10 godina.