FrancophonIA/ELRC3.0 huggingface dataset:
English: An AMGEVITA 20 mg pre-filled syringe is however available for the 20 mg dose.
Croatian: Međutim, za dozu od 20 mg, dostupan je lijek AMGEVITA 20 mg u napunjenoj štrcaljki.
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Croatian: ≥ 18 godina koji nisu učinkovito odgovorili na prethodnu terapiju metotreksatom u dozi od 12,5 do 25 mg ili koji nisu podnosili metotreksat u dozi od 10 mg jednom tjedno.
English: Week 4 Clinical remission Clinical response (CR-100) All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Croatian: Sve p-vrijednosti odnose se na sparene usporedbe udjela uz adalimumab naspram placeba * p < 0,001 ** p < 0,01
English: The recommended dose of AMGEVITA for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Croatian: Preporučena doza lijeka AMGEVITA za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (Tablica 5).
English: INFORMATION IN BRAILLE AMGEVITA 40 mg syringe
Croatian: 16. PODACI NA BRAILLEOVOM PISMU AMGEVITA 40 mg štrcaljka
English: AMGEVITA 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj štrcaljki Jedna jednodozna napunjena štrcaljka sadrži 40 mg adalimumaba u 0,8 ml otopine (50 mg/ml).
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Croatian: Bolesnici koji su izašli iz ispitivanja zbog razloga koji nisu bili neuspjeh liječenja bili su cenzurirani u trenutku izlaska iz ispitivanja. a HR za adalimumab naspram placeba iz regresije proporcionalnih hazarda, uz liječenje kao faktor.
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg The recommended dose of AMGEVITA is 20 mg every other week.
Croatian: Djeca, adolescenti i odrasli s poliartikularnim juvenilnim idiopatskim artritisom Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine od 10 kg do manje od 30 kg Preporučena doza lijeka AMGEVITA je 20 mg svaki drugi tjedan.
English: Methotrexate should be continued during treatment with AMGEVITA.
Croatian: Za vrijeme liječenja lijekom AMGEVITA treba nastaviti primjenu metotreksata.
English: AMGEVITA single use pre-filled syringe For subcutaneous use
Croatian: AMGEVITA napunjena štrcaljka za jednokratnu primjenu
English: The usual dose for adults with plaque psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Uobičajena doza za odrasle bolesnike s plak psorijazom je početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega slijedi 40 mg svaki drugi tjedan počevši tjedan dana nakon početne doze.
English: Using your AMGEVITA pre-filled syringe
Croatian: Primjena AMGEVITA napunjenih štrcaljki
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli s s poliartikularnim juvenilnim idiopatskim artritisom Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka AMGEVITA je 40 mg svaki drugi tjedan.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the
Croatian: Veća poboljšanja od početka ispitivanja do 12. tjedna u odnosu na placebo zabilježena su za kvalitetu života vezanu uz zdravlje specifičnu za kožne bolesti, koja se određivala indeksom kvalitete života kod dermatoloških bolesti (engl.
English: The recommended dose of AMGEVITA for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: Ankilozantni spondilitis, aksijalni spondiloartritis bez radiološkog dokaza AS-a te psorijatični artritis U bolesnika s ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiološkog dokaza AS- a te u bolesnika sa psorijatičnim artritisom preporučena doza adalimumaba iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
Croatian: U slučaju da postoji potreba za bržim odgovorom na terapiju, terapija se može započeti dozom od 160 mg u nultom tjednu (primijenjenom kao četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjenom kao dvije injekcije od 40 mg u jednom danu), uz napomenu da je rizik od razvoja nuspojava veći prilikom indukcije.
English: Vaccinations: if possible children should be up to date with all vaccinations before using AMGEVITA.
Croatian: • Cijepljenje: ako je moguće, preporučuje se da djeca obave sva cijepljenja prema važećim smjernicama prije započinjanja terapije lijekom AMGEVITA.
English: There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Croatian: Nema relevantne primjene lijeka adalimumab u bolesnika mlađih od 2 godine u ovoj indikaciji.
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg The recommended dose of AMGEVITA is 20 mg every other week.
Croatian: Djeca, adolescenti i odrasli s artritisom povezanim s entezitisom Djeca i adolescenti u dobi od 6 i više godina, tjelesne težine od 15 kg do manje od 30 kg Preporučena doza lijeka AMGEVITA je 20 mg svaki drugi tjedan.
English: ● Do not remove the yellow cap from the pre-filled pen yet.
Croatian: Ne uklanjajte još žuti zatvarač igle s napunjene brizgalice.
English: The recommended AMGEVITA dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.
Croatian: Preporučena doza lijeka AMGEVITA je 80 mg u nultom tjednu, nakon koje se primjenjuje doza od 40 mg svaki drugi tjedan, počevši od prvog tjedna, supkutanom injekcijom.
English: • dyspepsia (indigestion, bloating, heart burn);
Croatian: • dispepsija (probavne tegobe, nadutost, žgaravica),
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new onset lupus-like syndrome.
Croatian: Klinički simptomi koji upućuju na razvoj sindroma sličnog lupusu zabilježeni su u dva od ukupno 3441 bolesnika liječenog adalimumabom iz svih ispitivanja reumatoidnog artritisa i psorijatičnog artritisa.
English: AMGEVITA 40 mg solution for injection in pre-filled pen adalimumab
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: Adalimumab N = 151
Croatian: Adalimum ab N = 151
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Croatian: Bath Ankylosing Spondilitis Disease Activity Index, BASDAI)] bila je 6,4 u skupini bolesnika koji su primali adalimumab i 6,5 u skupini koja je primala placebo) koji nisu imali zadovoljavajući odgovor ili nisu podnosili ≥ 1 NSAIL-a, ili su imali kontraindikaciju za primjenu NSAIL-a.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED SYRINGE (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VIŠESTRUKOG PAKIRANJA ZA NAPUNJENE BRIZGALICE (s plavim okvirom)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka napunjena brizgalica sadrži 40 mg adalimumaba u 0,8 ml otopine.
English: AMGEVITA 40 mg solution for injection in pre-filled pen Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici Jedna jednodozna napunjena brizgalica sadrži 40 mg adalimumaba u 0,8 ml otopine (50 mg/ml).
English: Certain vaccines may cause infections and should not be given while receiving AMGEVITA.
Croatian: • Za vrijeme liječenja lijekom AMGEVITA ne smiju se primiti određena cjepiva jer mogu uzrokovati infekcije.
English: ● Do not reuse the pre-filled pen.
Croatian: Nemojte ponovno upotrebljavati iskorištenu napunjenu brizgalicu.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Croatian: Bath Ankylosing Spondilitis Disease Activity Index, BASDAI] bila je 6,3 u svim skupinama) koji nisu imali adekvatan odgovor na konvencionalnu terapiju. 79 bolesnika (20,1%) istodobno je bilo liječeno antireumatskim lijekovima koji modificiraju tijek bolesti, a 37 bolesnika (9,4%) glukokortikoidima.
English: Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli s artritisom povezanim s entezitisom Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka AMGEVITA je 40 mg svaki drugi tjedan.
English: Vascular disorders
Croatian: Spremnik štrcaljke
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka AMGEVITA je 40 mg svaki drugi tjedan.
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Croatian: Djeca, adolescenti i odrasli u dobi od 6 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka AMGEVITA je 40 mg svaki drugi tjedan.
English: The recommended dose of AMGEVITA for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Preporučena doza lijeka AMGEVITA u odraslih bolesnika s uveitisom je početna doza od 80 mg, nakon koje slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Uobičajena doza za odrasle s nezaraznim uveitisom je početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: There is no relevant use of AMGEVITA in children aged less than 2 years in this indication.
Croatian: Nema relevantne primjene lijeka AMGEVITA u djece mlađe od 2 godine u ovoj indikaciji.
English: The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Croatian: Preporučena indukcijska doza lijeka AMGEVITA u odraslih bolesnika s umjerenim do teškim ulceroznim kolitisom je 160 mg u nultom tjednu (primijenjena kao četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjena kao dvije injekcije od 40 mg u jednom danu).
English: Hypersensitivity, Allergies (including seasonal allergy)
Croatian: često preosjetljivost, alergije (uključujući sezonske alergije) manje često sarkoidoza1), vaskulitis rijetko anafilaksija1)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU (bez plavog okvira)
English: The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Croatian: Preporučen režim doziranja lijeka AMGEVITA za odrasle bolesnike s gnojnim hidradenitisom je početna doza od 160 mg prvoga dana (primijenjena u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon koje slijedi doza od 80 mg dva tjedna kasnije, 15. dana (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 160 mg (4 injekcije od 40 mg u jednom danu ili 2 injekcije od 40 mg na dan u dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 20 mg adalimumaba u 0,4 ml otopine.
English: • tingling;
Croatian: • trnce,
English: The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Croatian: Uobičajena početna doza lijeka je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/006 1 pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1164/006 1 pakiranje
English: Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
Croatian: često rak kože, isključujući melanom (uključujući bazocelularni karcinom i karcinom skvamoznih stanica), benigne neoplazme manje često limfom**, novotvorine na solidnim organima (uključujući rak dojke, novotvorine na plućima i štitnjači), melanom**
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at week 2 and week 4.
Croatian: Nakon primjene adalimumaba u dozi od 160 mg u nultom tjednu i 80 mg u 2. tjednu u odraslih bolesnika s gnojnim hidradenitisom, najniže koncentracije adalimumaba u serumu u 2. i 4. tjednu iznosile su približno 7 do 8 µg/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU BRIZGALICU
English: Adalimumabb n = 113
Croatian: Adalimum abb n = 113
English: combined.
Croatian: stupnjeva.
English: B. Inspect the AMGEVITA pre-filled pen.
Croatian: Pregledajte AMGEVITA napunjenu brizgalicu.
English: AMGEVITA 40 mg solution for injection in pre-filled pen.
Croatian: AMGEVITA 40 mg otopina za injekciju u napunjenoj brizgalici.
English: Aortic aneurysm, Vascular arterial occlusion, Thrombophlebitis
Croatian: Krvožilni poremećaji često hipertenzija, navale crvenila, hematomi manje često aneurizma aorte, okluzije arterijskih žila, tromboflebitis
English: EU/1/16/1164/007 - 2 pack
Croatian: EU/1/16/1164/007 2 pakiranja
English: EU/1/16/1164/003 - 2 pack
Croatian: EU/1/16/1164/003 2 pakiranja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/002 1 pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1164/002 1 pakiranje
English: Some patients who experience decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA every week or 80 mg every other week.
Croatian: U nekih bolesnika u kojih dođe do slabljenja odgovora na terapiju lijekom AMGEVITA 40 mg svaki drugi tjedan, možda će biti korisno povećati doziranje na 40 mg lijeka AMGEVITA svaki tjedan ili 80 mg svaki drugi tjedan.
English: Patients who maintained ≥ PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Croatian: A bili randomizirani za terapiju aktivnim lijekom, ponovno su randomizirani u razdoblju C tako da su tijekom dodatnih 19 tjedana primali ili adalimumab 40 mg svaki drugi tjedan ili placebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1164/009
English: 0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.
Croatian: Jedna napunjena štrcaljka sadrži 20 mg adalimumaba u 0,4 ml otopine ili 40 mg adalimumaba u 0,8 ml otopine.
English: Intestinal infections (including gastroenteritis viral), Skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), Ear infections,
Croatian: često sistemske infekcije (uključujući sepsu, kandidijazu i gripu), intestinalne infekcije (uključujući virusni gastroenteritis), infekcije kože i mekog tkiva (uključujući paronihiju, celulitis, impetigo, nekrotizirajući fasciitis i herpes zoster), infekcije uha, infekcije usne šupljine (uključujući herpes simpleks, herpes usne šupljine i infekcije zuba), infekcije reproduktivnog sustava (uključujući vulvovaginalne mikoze), infekcije mokraćnog sustava (uključujući pijelonefritis), gljivične infekcije, infekcije zglobova manje često neurološke infekcije (uključujući virusni meningitis), oportunističke infekcije i tuberkuloza (uključujući kokcidioidomikozu, histoplazmozu i infekciju kompleksom mycobacterium avium), bakterijske infekcije, infekcije oka, divertikulitis1)
English: The recommended dose of AMGEVITA for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Croatian: U odraslih bolesnika preporučena početna doza lijeka AMGEVITA je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Croatian: • Ako ste ranije bolovali od infekcija koje su se ponavljale, ili drugih stanja koja povisuju rizik od infekcije, recite to svom liječniku.
English: • scar;
Croatian: • svrbež,
English: ● Do not grasp the plunger rod.
Croatian: Ne hvatajte klip.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Croatian: U bolesnika liječenih adalimumabom prijavljeni su rijetki slučajevi hepatospleničnog T-staničnog limfoma nakon stavljanja lijeka u promet.
English: There is no relevant use of AMGEVITA in children aged less than 12 years in this indication.
Croatian: Nema relevantne primjene lijeka AMGEVITA u djece mlađe od 12 godina za ovu indikaciju.
English: • Non-infectious uveitis
Croatian: • nezaraznog uveitisa
English: Mean exposure in all adalimumab population was 762 days.
Croatian: Prosječna izloženost u cjelokupnoj populaciji na adalimumabu iznosila je 762 dana.Tijekom sva 3 ispitivanja bolesnici su svakodnevno koristili topikalnu antiseptičku otopinu.
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 radiološkog dokaza ankilozantnog spondilitisa, prvo će Vam biti dani drugi lijekovi, no ukoliko na njih ne reagirate dovoljno dobro, bit će Vam propisan lijek AMGEVITA kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias
Croatian: Bolesnike treba upozoriti da se odmah obrate liječniku ako se za vrijeme liječenja lijekom AMGEVITA
English: Nerve root compression
Croatian: Joint Space Narrowing)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1164/005
English: PROBABILITY OF NO FLARE
Croatian: VJEROJATNOST DA NEĆE DOĆI DO POGORŠANJA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED PEN (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU BRIZGALICU (bez plavog okvira)
English: Tell your doctor immediately if you notice any of the following
Croatian: Primijetite li išta od dolje navedenog, odmah obavijestite svog liječnika
English: Week 104
Croatian: 4. tjedan
English: EU/1/16/1164/004 4 pack
Croatian: EU/1/16/1164/004 4 pakiranja
English: Beyond 16 weeks, patients with inadequate response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek AMGEVITA 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Analysis Treatment
Croatian: Prekid terapije
English: NEc
Croatian: NPc
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later.
Croatian: Odrasli s gnojim hidradenitisom (Hidradenitis suppurativa) Uobičajen režim doziranja za gnojni hidradenitis je početna doza od 160 mg (u obliku 4 injekcije od 40 mg u jednom danu ili 2 injekcije od 40 mg na dan, tijekom dva uzastopna dana), nakon koje se dva tjedna kasnije primjenjuje doza od 80 mg (u obliku 2 injekcije od 40 mg u jednom danu).
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 20 mg solution for injection in pre-filled syringe adalimumab
Croatian: AMGEVITA 20 mg otopina za injekciju u napunjenoj štrcaljki adalimumab
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1164/001
English: B. PACKAGE LEAFLET
Croatian: Tablica 6. Nuspojave
English: Thigh
Croatian: JSN