FrancophonIA/ELRC3.0 huggingface dataset:
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%
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Croatian: Tijekom liječenja adalimumabom mogu se razviti protutijela na adalimumab.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Croatian: U bolesnika koji već dulje vrijeme boluju od ozbiljnog reumatoidnog artritisa, rizik obolijevanja od limfoma i leukemije (raka koji zahvaća krvne stanice i koštanu srž) može biti veći od prosječnoga.
English: The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Croatian: Primijećeno je da su razine slobodnog adalimumaba u serumu (onoga koji nije vezan za protutijela na adalimumab) niže u bolesnika s mjerljivim razinama protutijela na adalimumab.
English: After doses of 0.5 mg / kg (~40 mg), clearances ranged from 11 to 15 ml / hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Croatian: Nakon primjene doza od 0,5 mg/kg (~40 mg) klirens je bio u rasponu od 11 do 15 ml/sat, a volumen raspodjele (Vss) je iznosio od 5 do 6 litara.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Croatian: Functional Assessment Of Chronic Illness Therapy, FACIT) zabilježeno je u sva tri ispitivanja u kojima je taj parametar ispitivan (ispitivanja RA I, III, IV).
English: PROBABILITY OF NO FLARE
Croatian: VJEROJATNOST DA NE DOĐE DO
English: The incidence of serious infections was 0.04 per patient year in adalimumab-treated patients and 0.03 per patient year in placebo and active control-treated patients.
Croatian: Incidencija ozbiljnih infekcija bila je 0,04 po bolesnik-godini u bolesnika liječenih adalimumabom, odnosno 0,03 po bolesnik-godini u onih koji su primali placebo ili aktivni kontrolni lijek.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Croatian: Krvarenje u probavnom sustavu, dispepsija, gastroezofagusna refluksna bolest, sicca sindrom
English: Adalimumab-treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Croatian: Bolesnicima koji su primili adalimumab kvaliteta života se u 12. tjednu znatno popravila i održala do 24. tjedna prema upitniku SF36 i upitniku za ocjenu kvalitete života kod ankilozantnog spondilitisa (engl.
English: Fertility Preclinical data on fertility effects of adalimumab are not available.
Croatian: Nisu dostupni pretklinički podaci o utjecaju adalimumaba na plodnost.
English: Tell your doctor as soon as possible, if you notice any of the following:
Croatian: Primijetite li išta od dolje navedenog, obavijestite svog liječnika što je prije moguće:
English: Immunosuppression
Croatian: Imunosupresija
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia hyperglycaemia, hypophosphataemia, dehydration
Croatian: abnormalna razina natrija u krvi, hipokalcijemija, hiperglikemija, hipofosfatemija, dehidracija
English: • if you drop your pen, do not use it if it looks damaged, or if you dropped it with the cap removed.
Croatian: • ako Vam brizgalica padne, ne koristite je ako izgleda oštećena, ili ako Vam je pala nakon što ste skinuli zatvarač igle.
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Croatian: Ispitivanje RA II obuhvatilo je 544 bolesnika s umjereno teškim do teškim aktivnim reumatoidnim artritisom u dobi od 18 godina i starijih u kojih prethodna terapija barem jednim antireumatskim lijekom koji modificira tijek bolesti nije bila uspješna.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Croatian: Ako bolujete od ankilozantnog spondilitisa ili aksijalnog spondiloartritisa bez radiografskog dokaza ankilozantnog spondilitisa, prvo će Vam biti dani drugi lijekovi.
English: Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Croatian: Zglobovi šaka, zapešća i stopala radiografski su snimljeni na početku ispitivanja, u 24. tjednu dvostruko slijepog dijela ispitivanja, kada su bolesnici primali adalimumab ili placebo, te u 48. tjednu otvorenog dijela ispitivanja, kada su svi bolesnici primali adalimumab.
English: • high blood measurements for lactate dehydrogenase;
Croatian: • visoka razina laktat dehidrogenaze u krvi,
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7 % and 59.0 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Croatian: Stopa odgovora PASI 75 i PGA rezultata “bez bolesti” i “minimalno” je u tih bolesnika iznosila 74,7%, odnosno 59,0% nakon dodatnih 108 tjedana otvorene terapije (ukupno 160 tjedana).
English: • do not remove the needle cap until just before you give the injection.
Croatian: • ne skidate zatvarač s igle sve do neposredno prije davanja injekcije.
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 napunjenu štrcaljku izvadili iz hladnjaka i čuvali na sobnoj temperaturi, morate je iskoristiti u roku od 14 dana ili baciti, čak i ako ste je kasnije vratili u hladnjak.
English: In rheumatoid arthritis, methotrexate is continued while using Hefiya.
Croatian: Kod reumatoidnog artritisa, primjena metotreksata se nastavlja za vrijeme uzimanja lijeka Hefiya.
English: Disposing of used syringes:
Croatian: Zbrinjavanje korištenih štrcaljki:
English: Malignancies and lymphoproliferative disorders
Croatian: Zloćudne bolesti i limfoproliferativni poremećaji
English: • unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
Croatian: • neuobičajene infekcije (uključujući tuberkulozu i druge infekcije) do kojih dolazi kod slabljenja obrambenog sustava organizma,
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Croatian: U 249 pedijatrijskih bolesnika s izloženošću od 655,6 bolesnik-godina tijekom ispitivanja adalimumaba u bolesnika s juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom) nisu primijećene zloćudne bolesti.
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: 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: • do not use the pen if either the seal on the outer carton or the safety seal on the pen is broken.
Croatian: • ne koristite brizgalicu ako je naljepnica vanjske kutije ili zaštitna naljepnica brizgalice potrgana.
English: • benign tumours;
Croatian: • benigni tumori,
English: To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions.
Croatian: Važno je pridržavati se ovih uputa kako bi se spriječile moguće infekcije i osiguralo ispravno korištenje lijeka.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Croatian: Nakon liječenja adalimumabom u bolesnika s reumatoidnim artritisom primijećeno je naglo snižavanje razina reaktanata akutne faze upale (C-reaktivni protein [CRP] i brzina sedimentacije eritrocita [SE]) i serumskih citokina (IL-6) u usporedbi s početnim vrijednostima.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Croatian: Adolescenti s gnojnim hidradenitisom u dobi od 12 do 17 godina tjelesne težine 30 kg ili više
English: During treatment with Hefiya, other concomitant therapies (e.g., corticosteroids and / or immunomodulatory agents) should be optimised.
Croatian: Tijekom liječenja lijekom Hefiya potrebno je prilagoditi ostalu istodobno primijenjenu terapiju (npr. kortikosteroide i/ili imunomodulatore).
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 adalimumabtreated 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: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Croatian: Klinički odgovor Rezultati iz obaju ispitivanja pokazali su statistički značajno smanjenje rizika od neuspjeha liječenja u bolesnika liječenih adalimumabom u odnosu na one koji su primali placebo (vidjeti tablicu 29).
English: Taking these results into consideration, Hefiya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Croatian: Uzevši to u obzir, preporučuje se da se Hefiya daje u kombinaciji s metotreksatom, a monoterapija samo u onih bolesnika u kojih primjena metotreksata nije prikladna (vidjeti dio 4.2).
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: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima i jednom otvorenom produžetku ispitivanja u odraslih bolesnika s umjerenim do teškim gnojnim hidradenitisom (Hidradenitis suppurativa, HS) koji nisu podnosili sistemske antibiotike, koji su imali kontraindikacije za njihovu primjenu ili nisu postigli zadovoljavajući odgovor na liječenje sistemskim antibioticima tijekom najmanje 3 mjeseca.
English: • multiple sclerosis;
Croatian: Multipla skleroza,
English: Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Croatian: Ukupni odgovor na terapiju bio je uglavnom bolji i manje je bolesnika razvilo protutijela kada su bolesnici primali kombiniranu terapiju adalimumabom i metotreksatom u odnosu na monoterapiju adalimumabom.
English: Hefiya is contraindicated in moderate to severe heart failure (see section 4.3).
Croatian: Primjena lijeka Hefiya je kontraindicirana u bolesnika s umjerenim do teškim zatajenjem srca (vidjeti dio 4.3).
English: The recommended adolescent HS dosing schedule is 40 mg every other week.
Croatian: Preporučeni režim doziranja za adolescente s gnojnim hidradenitisom je 40 mg svaki drugi tjedan.
English: • nausea and vomiting;
Croatian: • mučnina i povraćanje,
English: Thereafter, the usual dose is 40 mg every other week.
Croatian: Nakon toga, uobičajena doza je 40 mg svaka dva tjedna.
English: clinical remission clinical response week 52
Croatian: 52. tjedan klinička remisija klinički odgovor
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Croatian: Dostupni podaci upućuju na to da se klinički odgovor obično postiže unutar 12 tjedana liječenja.
English: • Hefiya can be used during breast-feeding.
Croatian: • Hefiya se može primjenjivati tijekom dojenja.
English: Method and route of administration
Croatian: Način i put primjene
English: RA Study IIIa**
Croatian: Ispitivanje RA IIIa**
English: Patients were permitted to be either disease-modifying, antirheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Croatian: U ispitivanje su mogli biti uključeni bolesnici koji prethodno nisu bili liječeni antireumatskim lijekovima koji modificiraju tijek bolesti i oni koji su već dobivali antireumatsku terapiju, pod uvjetom da je ta terapija bila stabilna najmanje 28 dana.
English: • neurological infections (including viral meningitis);
Croatian: • infekcije živčanog sustava (uključujući virusni meningitis),
English: Do not re-use the pen.
Croatian: Nemojte ponovno koristiti istu brizgalicu.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Hefiya therapy.
Croatian: Preporučuje se da se pedijatrijske bolesnike, ako je moguće, cijepi u skladu sa svim važećim smjernicama za cijepljenje prije započinjanja liječenja lijekom Hefiya.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22).
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili barem djelomičan odgovor na liječenje adalimumabom u dozi od 40 mg svaki tjedan, stopa HiSCR-a zabilježena u 36. tjednu bila je veća u onih bolesnika koji su nastavili primati adalimumab svaki tjedan nego u bolesnika kojima je učestalost doziranja smanjena na jednom svaki drugi tjedan ili onih kojima je liječenje ukinuto (vidjeti tablicu 22).
English: How should you store Hefiya?
Croatian: Kako čuvati Hefiya?
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Croatian: U analizi u kojoj su se svi bolesnici koji su izašli iz ispitivanja zbog štetnih događaja ili nedostatka djelotvornosti ili kojima je doza povećavana smatrali bolesnicima bez odgovora na terapiju, stopa odgovora PASI 75 i PGA rezultata“bez bolesti” ili “minimalno” nakon dodatnih 108 tjedana otvorene terapije (ukupno 160 tjedana) iznosila je 69,6%, odnosno 55,7%.
English: The results for the 40 mg every other week dose are summarised in table 7.
Croatian: Rezultati zabilježeni u skupini koja je dobivala 40 mg svaka dva tjedna prikazani su u tablici 7.
English: Hospitalisation rates
Croatian: Stope hospitalizacije
English: • Look at the expiration date (EXP) on your syringe.
Croatian: • Provjerite rok valjanosti (EXP) na štrcaljki.
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Croatian: < 40 kg • 40 mg u nultom tjednu i 20 mg u drugom tjednu
English: Demyelinating disease
Croatian: Demijelinizirajuća bolest
English: Do not shake.
Croatian: Ne tresti.
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: Cleaning your injection site:
Croatian: Čišćenje mjesta primjene injekcije:
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: Table 22 proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Croatian: Tablica 22 Udio bolesnikaa koji su postigli HiSCRb u 24. i 36. tjednu nakon preraspodjele liječenja u 12. tjednu, do kada su primali adalimumab svaki tjedan placebo
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba)
English: solution for injection 1 pre-filled pen (SensoReady) 2 pre-filled pens (SensoReady)
Croatian: 1 napunjena brizgalica (SensoReady) 2 napunjene brizgalice (SensoReady)
English: At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 < 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: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja, provedena u bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a (nr-axSpA).
English: ALT elevations ≥ 3 x ULN occurred in 0.9 % of adalimumab-treated patients and 0.9 % of controlled-treated patients.
Croatian: povišenje razine ALT-a ≥3 x GGN zabilježeno je u 0,9% bolesnika liječenih adalimumabom i 0,9% bolesnika iz kontrolne skupine.
English: Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Croatian: Gnojni hidradenitis (Hidradenitis suppurativa) Hefiya je indiciran za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u odraslih i adolescenata u dobi od 12 godina i starijih u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa (vidjeti dijelove 5.1 i 5.2).
English: • severe allergic reaction with shock;
Croatian: • teška alergijska reakcija uz šok, • multipla skleroza,
English: • inflammation of the skin (such as eczema);
Croatian: • upala kože (primjerice ekcem),
English: • Hefiya pre-filled syringe/s (see Figure A).
Croatian: • Hefiya napunjena/e štrcaljka/e (vidjeti Sliku A).
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Croatian: Dodatni primarni ishod ispitivanja RA III i V bilo je usporavanje progresije bolesti (na temelju radiografskih nalaza) nakon 52 tjedna liječenja.
English: Particular attention regarding the risk for infection should be paid when treating the elderly.
Croatian: Stoga se tijekom liječenja starijih osoba mora obratiti posebna pažnja na mogući rizik od infekcije.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Rheumatoid arthritis
Croatian: Reumatoidni artritis
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: What is in this leaflet
Croatian: Što se nalazi u ovoj uputi:
English: The Hefiya 40 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn's disease, since it is not possible to administer doses less than 40 mg.
Croatian: Napunjena brizgalica lijeka Hefiya od 40 mg ne smije se koristiti u djece i adolescenata tjelesne težine manje od 40 kg s Chronovom bolesti jer se ne mogu primijeniti doze manje od 40 mg.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Croatian: Djelovanje adalimumaba ispitivano je u bolesnika s reumatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom i psorijatičnim artritisom koji su dobivali adalimumab kao monoterapiju i u onih koji su istodobno uzimali i metotreksat.
English: • do not open the outer box until you are ready to use the syringe.
Croatian: • ne otvarate vanjsku kutiju dok niste spremni za korištenje štrcaljke.
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Croatian: Nisu provedena ispitivanja u bolesnika sa zloćudnim bolestima u anamnezi ili u bolesnika koji su nastavili liječenje adalimumabom nakon obolijevanja od zloćudne bolesti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)