FrancophonIA/ELRC3.0 huggingface dataset:
English: The blinded period was followed by an open-label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Croatian: Nakon slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatnih 28 tjedana.
English: If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg starting two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) i zatim 40 mg nakon dva tjedna.
English: At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Croatian: U 81 od 207 bolesnika koji su uzimali adalimumab 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 8 godina.
English: Idiopathic thrombocytopaenic purpura
Croatian: Manje često Idiopatska trombocitopenična purpura
English: Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: adipatna kiselina, citratna kiselina hidrat, natrijev klorid, manitol, polisorbat 80, kloridna kiselina, natrijev hidroksid, voda za injekcije.
English: The recommended dose of Hefiya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Croatian: Preporučena doza lijeka Hefiya za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (tablica 2).
English: ANNEX II
Croatian: Tablica 24
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Croatian: Učinci povezani s vidom koji nisu brojčano išli u prilog adalimumabu bili su učinci na vid u boji u ispitivanju UV I, odnosno učinci na vid u boji, periferni vid i vid na blizinu u ispitivanju UV II.
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Croatian: Ispitivanje RA III obuhvatilo je 619 bolesnika s umjereno do teško aktivnim reumatoidnim artritisom u dobi
English: Figure H: insert the needle
Croatian: Slika H: ubodite iglu
English: • Merkel cell carcinoma (a type of skin cancer);
Croatian: • karcinom Merkelovih stanica (vrsta raka kože), • zatajenje jetre,
English: Adalimumab-treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Croatian: Nakon 24 tjedna u bolesnika liječenih adalimumabom je u odnosu na bolesnike liječene placebom zabilježeno statistički značajno poboljšanje fizičke funkcije, koja se ocjenjivala uz pomoć upitnika HAQ i kratke zdravstvene ankete SF 36.
English: Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Croatian: Liječnik će možda propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene doze.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Croatian: Medijan vremena do neuspjeha liječenja iznosio je 24,1 tjedan u ispitanika koji su primali placebo, dok se u ispitanika liječenih adalimumabom medijan vremena do neuspjeha liječenja nije mogao procijeniti jer je do neuspjeha liječenja došlo u manje od polovice tih ispitanika.
English: Bath ankylosing spondylitis disease activity index c ankylosing spondylitis disease activity score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L)
Croatian: C-reaktivni protein visoke osjetljivosti (engl. high sensitivity C-Reactive Protein) (mg/l) g n=73 za placebo i n=70 za adalimumab h Kanadski konzorcij za istraživanje spondiloartritisa (engl.
English: SC
Croatian: s.c.
English: Hefiya is indicated for treatment of moderately to severely active Crohn's disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: Hefiya je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima nije postignut odgovor ili kod bolesnika koji ih ne podnose ili im je takva terapija kontraindicirana.
English: • vertigo (sensation of room spinning);
Croatian: • vrtoglavica (osjećaj da se prostorija vrti),
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hefiya.
Croatian: Za vrijeme liječenja lijekom Hefiya može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: The solution should be colourless to slightly yellowish as well as clear to slightly opalescent.
Croatian: Otopina treba biti bezbojna do blago žućkasta te bistra do blago opalescentna.
English: Hefiya is used to treat psoriatic arthritis in adults.
Croatian: Hefiya je namijenjena liječenju psorijatičnog artritisa u odraslih.
English: • psoriasis,
Croatian: • psorijaze
English: Night sweats, scar
Croatian: Manje često Noćno znojenje, ožiljci
English: Package leaflet: Information for the patient Hefiya 40 mg solution for injection in pre-filled pen adalimumab
Croatian: Uputa o lijeku: Informacije za bolesnika Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: Cardiac disorders*
Croatian: Srčani poremećaji*
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Croatian: Ankilozantni spondilitis, aksijalni spondiloartritis bez radiografskog dokaza AS-a te psorijatični artritis
English: In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Croatian: Održavanje kliničke remisije ispitivalo se u ispitivanju CD III (CHARM), u kojem su 854 bolesnika primila 80 mg adalimumaba u nultom tjednu i 40 mg dva tjedna kasnije.
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 8).
Croatian: U ispitivanju RA V, u kojem su obuhvaćeni bolesnici u ranoj fazi reumatoidnog artritisa koji do tada nisu bili liječeni metotreksatom, kombiniranom primjenom adalimumaba i metotreksata tijekom 52 tjedna postignut je brži i statistički značajno bolji ACR odgovor nego uz monoterapiju metotreksatom, odnosno adalimumabom.
English: Hefiya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a 0.8 ml clear to slightly opalescent, colourless to slightly yellowish solution.
Croatian: Hefiya 40 mg otopina za injekciju (injekcija) u napunjenoj brizgalici isporučuje se kao 0,8 ml bistre do blago opalescentne, bezbojne do blago žućkaste otopine.
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti u do 1 na 10 osoba)
English: Thus, it is not possible to administer Hefiya to patients that require less than a full 40 mg dose.
Croatian: Zato se Hefiya ne može primijeniti u bolesnika koji zahtijevaju manje od cijele doze od 40 mg.
English: Summary of the safety profile
Croatian: Health Assessment Questionnaire,
English: Hefiya 40 mg injection adalimumab SC
Croatian: Hefiya 40 mg injekcija adalimumab s.c.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Croatian: U kontroliranim i otvorenim ispitivanjima adalimumaba u odraslih i djece zabilježene su ozbiljne infekcije (u rijetkim slučajevima i sa smrtnim ishodom), među kojima i tuberkuloza (uključujući njezin milijarni oblik i izvanplućne lokalizacije) te invazivne oportunističke infekcije (npr.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: There is limited safety experience of surgical procedures in patients treated with adalimumab.
Croatian: Raspoloživi podaci o sigurnosti kirurških zahvata u bolesnika liječenih adalimumabom su ograničeni.
English: ASAS 50 week 2 week 12 week 24
Croatian: BASDAIb 50 2. tjedan 12. tjedan 24. tjedan
English: Polyarticular juvenile idiopathic arthritis
Croatian: Poliartikularni juvenilni idiopatski artritis
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Croatian: Tijekom kliničkih ispitivanja rijetko su prijavljivane ozbiljne alergijske reakcije povezane s primjenom adalimumaba.
English: • vasculitis (inflammation of blood vessels);
Croatian: • vaskulitis (upala krvnih žila),
English: Multipack containing 6 (3 packs of 2) pre-filled syringes in a blister Packs of 1 and 2 pre-filled pens
Croatian: Pakiranja sadrže 1 ili 2 napunjene brizgalice Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih brizgalica
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Croatian: Psoriasis Area and Severity Index, PASI] ≥ 12 ili ≥ 10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
English: Adults with non-infectious uveitis
Croatian: Odrasli s nezaraznim uveitisom
English: • low blood measurements for calcium;
Croatian: • niska razina kalcija u krvi,
English: 10 6336 Langkampfen AUSTRIA
Croatian: Sandoz GmbH Biochemiestr. 10 6336 Langkampfen AUSTRIJA
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Croatian: C-reaktivnog proteina visoke osjetljivosti (hs-CRP) i MR oslikavanjem i sakroilijakalnih zglobova i kralježnice, održalo se do 156. odnosno 104. tjedna.
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 randomized 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: 40 mg svaka dva tjedna (N=152) ili za primanje placeba (N=153) tijekom dodatnih 40 tjedana u dvostruko slijepom, placebom kontroliranom razdoblju (ukupno trajanje ispitivanja: 68 tjedana).
English: − The other ingredients are adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injections.
Croatian: Drugi sastojci su adipatna kiselina, citratna kiselina hidrat, natrijev klorid, manitol, polisorbat 80, kloridna kiselina, natrijev hidroksid i voda za injekcije.
English: In adolescent patients with inadequate response to Hefiya 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Croatian: U adolescentnih bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Hefiya u dozi od 40 mg svaki drugi tjedan može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: Hefiya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Croatian: U svrhu liječenja teškog, aktivnog i progresivnog reumatoidnog artritisa, Hefiya se može primijeniti i bez prethodnog liječenja metotreksatom.
English: Seventy-nine (20.1 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4 %) patients with glucocorticoids.
Croatian: 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: Patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Croatian: Bolesnici su primali placebo ili adalimumab u početnoj dozi od 80 mg, nakon koje je slijedila doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: How to use Hefiya
Croatian: Kako primjenjivati lijek Hefiya
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Croatian: Ako imate simptome infekcije, poput vrućice, rana, osjećaja umora, problema sa zubima, važno je da to kažete svom liječniku (pogledajte dio “Upozorenja i mjere opreza“).
English: Hefiya 40 mg / 0.8 ml injection adalimumab SC
Croatian: Hefiya 40 mg / 0,8 ml injekcija adalimumab s.c.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Croatian: nedostatak zraka ili oticanje stopala), morate se odmah obratiti svome liječniku.
English: Not known
Croatian: I DOHVATA
English: In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg / m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg / ml (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg / ml (71.2 % CV) with concomitant methotrexate.
Croatian: U bolesnika s poliartikularnim JIA u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i starijih i tjelesne težine manje od 15 kg, nakon primjene 24 mg/m2 adalimumaba srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže bila je 6,0 ± 6,1 µg/ml (101% CV)
English: • Gently pinch the skin at the injection site (see Figure H).
Croatian: • Lagano uštipnite kožu na mjestu primjene injekcije (vidjeti
English: Leucopaenia (including neutropaenia and agranulocytosis), anaemia
Croatian: Vrlo često Leukopenija (uključujući neutropeniju i agranulocitozu),
English: • raised bilirubin measurement (liver blood test).
Croatian: • povišena razina bilirubina (vidljivo u nalazima krvne pretrage kojom se provjerava rad jetre).
English: Enthesitis-related arthritis
Croatian: Artritis povezan s entezitisom
English: Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Croatian: ACR odgovor u placebom kontroliranim ispitivanjima kod psorijatičnog artritisa
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 u obliku 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 u obliku dvije injekcije od 40 mg u jednom danu), uz napomenu da je rizik od razvoja nuspojava veći prilikom indukcije.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiografskog dokaza ankilozantnog spondilitisa
English: Hefiya is used in adults to treat these conditions.
Croatian: Hefiya je namijenjen liječenju takvih zdravstvenih stanja u odraslih.
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: 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: 40 mg adalimumab administered every other week c
Croatian: 40 mg adalimumaba svaki drugi tjedan
English: • high blood pressure;
Croatian: • visok krvni tlak, • navale crvenila,
English: o DO NOT USE the syringe (see Figure D).
Croatian: centimetra oko pupka (vidjeti Sliku D).
English: Hefiya 40 mg solution for injection in pre-filled syringe adalimumab
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici adalimumab
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Croatian: Zbog premalog broja bolesnika uključenih u ispitivanje, nema dovoljno dokaza o djelotvornosti adalimumaba u liječenju bolesnika s psorijatičnom artropatijom sličnoj ankilozantnom spondilitisu.
English: Hefiya is used to treat moderate to severe plaque psoriasis in adults.
Croatian: Hefiya je namijenjena liječenju umjerene do teške plak psorijaze u odraslih.
English: • tremor;
Croatian: • nevoljno drhtanje,
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week
Croatian: Bolesnici koji su primali placebo imali su promjenu mTSS-a u odnosu na početnu vrijednost (srednja vrijednost ± standardno odstupanje) od 0,8 ± 2,5 (24. tjedan), a bolesnici liječeni adalimumabom 0,0 ± 1,9 (p<0,001) (48. tjedan).
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: Hefiya is only available as 40 mg pre-filled syringe / pre-filled pen.
Croatian: Hefiya je dostupan samo kao napunjena štrcaljka od 40 mg/napunjena brizgalica od 40 mg.
English: • abnormal muscle breakdown;
Croatian: • raspadanje mišića,
English: Mood alterations (including depression), anxiety, insomnia
Croatian: Promjene raspoloženja (uključujući depresiju),
English: • non-infectious uveitis.
Croatian: • infekcije uha,
English: Posology
Croatian: BROJEVI
English: How to store Hefiya
Croatian: Kako čuvati lijek Hefiya
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • hepatosplenični T-stanični limfom (rijetki rak krvi, često sa smrtnim ishodom),
English: In period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Croatian: A bolesnici su primali placebo ili adalimumab u početnoj dozi od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim u dozi od 40 mg svaki tjedan, počevši od 4. tjedna pa sve do 11. tjedna.
English: The recommended dose of Hefiya for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U odraslih bolesnika s reumatoidnim artritisom preporučena doza lijeka Hefiya iznosi 40 mg, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: If this dose does not work well enough, 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 ta doza ne djeluje dovoljno dobro, liječnik može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: Hefiya 40 mg solution for injection in pre-filled syringe:
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki:
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Croatian: • reakcije na mjestu ubrizgavanja (uključujući bol, oticanje, crvenilo praćeno svrbežom), • infekcije dišnog sustava (uključujući prehladu, curenje nosa, infekciju sinusa, upalu pluća),
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba)
English: Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
Croatian: Jedna napunjena brizgalica sadrži 40 mg adalimumaba u 0,8 ml otopine.
English: Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at week 56.
Croatian: U 56. tjednu terapije, broj hospitalizacija i operacija povezanih s bolešću bio je statistički značajno smanjen u bolesnika koji su primali adalimumab u odnosu na skupinu bolesnika koja je primala placebo.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I-V.
Croatian: U ispitivanjima (I - V) kod reumatoidnog artritisa, uzorci seruma bolesnika u više su vremenskih točaka testirani na prisutnost autoprotutijela.
English: Giving your injection:
Croatian: Primjena injekcije:
English: Figure B: items not included in the carton
Croatian: Slika B: pribor koji se ne nalazi u kutiji Vidjeti “8.
English: • Tell 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: Visual impairment, conjunctivitis, blepharitis, eye swelling
Croatian: konjunktivitis, blefaritis,
English: Adolescent hidradenitis suppurativa
Croatian: Hidradenitis Suppurativa Clinical Response
English: p-value total Sharp score c erosion score JSN
Croatian: p-vrijednost ukupan zbroj bodova prema Sharpu
English: The recommended Hefiya 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 Hefiya je 80 mg u nultom tjednu, nakon koje se primjenjuje doza od 40 mg svaki drugi tjedan, počevši od prvog tjedna, supkutanom injekcijom.
English: Table 19 Ps study IV efficacy results at 16, 26 and 52 weeks endpoint week 16 placebo-controlled week 26 placebo-controlled week 52 open-label placebo N = 108
Croatian: Ps IV - rezultati djelotvornosti u 16., 26. i 52. tjednu mjera ishoda