FrancophonIA/ELRC3.0 huggingface dataset:
English: If you were using Zessly during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Zessly use before the baby receives any vaccines.
Croatian: obavijestite pedijatra Vašeg djeteta ili druge zdravstvene radnike koji skrbe za Vaše dijete da ste uzimali Zessly prije nego što dijete primi bilo koje cjepivo.
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Zessly.
Croatian: Odmah obavijestite svog liječnika ako dobijete nove simptome zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Zessly.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Croatian: Ozbiljne nuspojave infliksimaba u pedijatrijskih bolesnika spontano prijavljene nakon stavljanja lijeka u promet uključivale su zloćudne bolesti među kojima i hepatosplenički limfom T-stanica, prolazne poremećaje vrijednosti jetrenih enzima, sindrome slične lupusu i pozitivan nalaz autoprotutijela
English: • Feeling tired or weak
Croatian: • umor ili slabost
English: In the paediatric Crohn's disease study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Croatian: U kliničkom ispitivanju Crohnove bolesti u pedijatrijskih bolesnika infekcije su prijavljene u 56,3%
English: Paediatric patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and
Croatian: Pedijatrijski bolesnici koji se liječe infliksimabom mogu istodobno primati cjepiva, osim živih cjepiva (vidjeti dijelove 4.5 i 4.6).
English: Zessly 100 mg powder for concentrate for solution for infusion infliximab
Croatian: Zessly 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
English: Excipients: Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: dinatrijev sukcinat heksahidrat, sukcinatna kiselina, saharoza, polisorbat 80.
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Zessly.
Croatian: Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Zessly.
English: In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4).
Croatian: bila je veća u skupini bolesnika liječenih infliksimabom i metotreksatom nego u skupini koja je primala samo metotreksat, osobito pri dozama od 6 mg/kg ili višim (vidjeti dio 4.4).
English: 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age),
Croatian: U djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (terapija započeta u dobi
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Croatian: Juvenilni idiopatski artritis, psorijatični artritis i ankilozantni spondilitis Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa nisu još ustanovljene.
English: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Croatian: Manje često: edem pluća, bronhospazam, pleuritis, pleuralni izljev Rijetko: intersticijska bolest pluća (uključujući brzu progresivnu bolest, fibrozu pluća i pneumonitis)
English: Dilute the total volume of the reconstituted Zessly solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Razrijedite ukupan volumen rekonstituirane otopine lijeka Zessly s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju do ukupnog volumena od 250 ml.
English: Paediatric Crohn's disease (6 to 17 years)
Croatian: Crohnova bolest u pedijatrijskih bolesnika (6 do 17 godina)
English: Number of patients evaluated for ALT.
Croatian: 3 Broj bolesnika uključenih u analizu ALT-a.
English: • Slow down the damage in your joints
Croatian: • usporilo oštećenje zglobova • poboljšala
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Croatian: intravezikalna instilacija BCG-a za liječenje raka) mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: Dizziness may occur following administration of infliximab (see section 4.8).
Croatian: Nakon primjene infliksimaba može nastupiti omaglica (vidjeti dio 4.8).
English: a p < 0.001, for each infliximab treatment group vs. control.
Croatian: 50. tjedan a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
English: • Children should receive recommended vaccinations before starting Zessly treatment.
Croatian: • Prije započinjanja liječenja lijekom Zessly djeca trebaju primiti preporučena cjepiva.
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Croatian: • Znakove infekcije (uključujući TBC) kao što su vrućica, umor, kašalj koji može biti ustrajan, nedostatak zraka, simptomi nalik gripi, gubitak tjelesne težine, noćno znojenje, proljev, rane,
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Croatian: Primarna mjera ishoda bila je udio bolesnika koji su pokazali klinički odgovor, definiran kao ≥ 50%-tno smanjenje početnog broja fistula koje su se cijedile na lagani pritisak u najmanje dva uzastopna posjeta (u razmaku od 4 tjedna),
English: It is recommended that live vaccines not be given concurrently with Zessly.
Croatian: Ne preporučuje se istodobna primjena živih cjepiva s lijekom Zessly.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Croatian: Infliksimab s ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Croatian: Sigurnost i djelotvornost infliksimaba u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa nisu ispitivani.
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p < 0.001).
Croatian: Četvrtog tjedna nakon primjene jednokratne doze ispitivanog lijeka klinički su odgovor postigla 22 od 27 (81%) bolesnika liječenih infliksimabom u dozi od 5 mg/kg naspram 4 od 25 (16%)
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils (furunculosis)
Croatian: • ozbiljne kožne bolesti kao što su toksična epidermalna nekroliza, Stevens-Johnsonov sindrom i akutna generalizirana egzantematozna pustuloza • drugi problemi s kožom kao što su multiformni eritem, lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici), mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
English: • Ankylosing spondylitis (Bechterew's disease)
Croatian: • ankilozantni spondilitis (Bechterewljeva bolest) • psorijazu
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Croatian: U bolesnika liječenih TNF-blokatorima, uključujući infliksimab, prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Croatian: osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis,
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Zessly.
Croatian: Odmah obavijestite Vašeg liječnika ako dobijete simptome smanjenog broja krvnih stanica za vrijeme liječenja lijekom Zessly.
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Croatian: multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), akutna generalizirana egzantematozna pustuloza (AGEP), lihenoidne reakcije Nepoznato: pogoršanje simptoma dermatomiozitisa
English: • Pain.
Croatian: • bol
English: • You may get infections more easily when you are being treated with Zessly.
Croatian: • Tijekom liječenja lijekom Zessly možete postati osjetljiviji na infekcije.
English: • Pain in the joints, muscles or back
Croatian: • bol u zglobovima, mišićima ili leđima • infekcije mokraćnih puteva
English: • Collection of blood outside the blood vessels (haematoma) or bruising
Croatian: • nedostatna opskrba krvlju, oticanje vena • nakupljanje krvi izvan krvnih žila (hematom) ili nastanak modrica
English: Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Croatian: Prosječna vrijednost ± SDa Promjena od početnog ukupnog broja bodova prema van der Heijdeovoj modifikaciji Sharpove bodovne skaleb
English: b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Croatian: Analiza je temeljena na bolesnicima s psorijazom noktiju na početku ispitivanja (81,8% bolesnika).
English: Clinical response at week 8a Clinical response at week 30a Sustained response (clinical response at both week 8 and week 30)a
Croatian: (klinički odgovor i u 8. i u 30. tjednu)a
English: Nervous system disorders Very common:
Croatian: Poremećaji živčanog sustava Vrlo često: glavobolja
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section
Croatian: Nakon stavljanja lijeka u promet, u bolesnika koji su primali infliksimab prijavljeni su slučajevi žutice i hepatitisa, koji je u nekim slučajevima imao obilježja autoimunog hepatitisa (vidjeti dio 4.4).
English: infliximab (week 24)
Croatian: Infliksima b (24. tjeda n)
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Croatian: Na temelju opservacijskog ispitivanja provedenog u sjevernoj Europi, opažen je povećan rizik (OR, 95% CI; p-vrijednost) za carski rez (1,50; 1,14-1,96; p = 0,0032), prijevremeni porođaj
English: Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Croatian: Psorijatični artritis Plak psorijaza 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50.
Croatian: Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50. tjednu, ispitivanje 13
English: infliximab (week 54)
Croatian: Infliksima b (54. tjeda n)
English: Mucosal healing at week 30a a p < 0.001, for each infliximab treatment group vs. placebo.
Croatian: Cijeljenje sluznice u 8. tjednua Cijeljenje sluznice u 30. tjednua a p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s placebom.
English: Fistula Response (%) a Complete fistula response (%) b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Croatian: Odgovor fistula (%) a Potpuni odgovor fistula (%) b a
English: • Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body.
Croatian: često s mjehurima u sredini, koje se javljaju na području trupa, zatim velika područja na kojima se koža ljušti i peruta (eksfolijativni poremećaj), vrijedovi u ustima, grlu i nosu te na spolnim organima i očima ili gnojni prištići koji se mogu proširiti po tijelu.
English: Common (may affect up to 1 in 10 people)
Croatian: Česte: mogu se javiti u do 1 na 10 osoba
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
Croatian: PGA čist (0) ili minimalan (1) PGA čist (0), minimalan (1) ili blag (2) Svi nokti bez psorijatičnih promjenac
English: During the 24-week double blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22
Croatian: Tijekom 24 tjedana dvostruko slijepe faze ispitivanja, bolesnici su primali ili infliksimab u dozi od 5 mg/kg ili placebo u 0., 2., 6., 14. i 22. tjednu (100 bolesnika u svakoj skupini).
English: • Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
Croatian: • Bolesnici s teškim oblikom reumatoidnog artritisa, koji već dugo vremena boluju od te bolesti,
English: Discontinuation of Zessly should be considered if these disorders develop.
Croatian: Ako se razviju ovakvi poremećaji, treba razmotriti prekid primjene lijeka Zessly.
English: • Kidney infections
Croatian: • infekcije bubrega
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies 12 and 13.
Croatian: Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa,
English: The following side effects have been observed with medicines containing infliximab:
Croatian: Kod primjene lijeka infliksimab opažene su sljedeće nuspojave:
English: • Some patients receiving treatment with medicines containing infliximab have developed serious liver problems.
Croatian: Jetrene tegobe • U nekih bolesnika koji primaju infliksimab razvile su se ozbilljne jetrene tegobe.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Croatian: poremećaj pigmentacije Rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom,
English: Package leaflet: Information for the user Zessly 100 mg powder for concentrate for solution for infusion infliximab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Zessly 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Croatian: (zbirni podaci) u 54. je tjednu zabilježen veći udio bolesnika u kliničkoj remisiji u odnosu na skupinu koja je primala placebo (34,6% naspram 16,5%, p < 0,001), kao i veći udio bolesnika u kojih je nastupilo cijeljenje sluznice (46,1% liječenih infliksimabom naspram 18,2% bolesnika koji su primali placebo, p < 0,001).
English: ACR 20 response* 5 (10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0 (0%) 24 (46%) 35 (45%) ACR 70 response* 0 (0%) 15 (29%) 27 (35%) PASI response (% of patients)b
Croatian: ACR odgovor (% bolesnika) N Odgovor ACR 20* Odgovor ACR 50* Odgovor ACR 70* PASI odgovor (% bolesnika)b
English: Induction treatment in fistulising active Crohn's disease
Croatian: Uvodna terapija u fistulirajućoj, aktivnoj Crohnovoj bolesti
English: Neutropenia, leukopenia, anaemia, lymphadenopathy.
Croatian: leukopenija, neutropenija i trombocitopenija.
English: including infliximab in the post-marketing setting.
Croatian: ≤ 18 godina), uključujući infliksimab, nakon stavljanja tih lijekova u promet.
English: Myocardial ischaemia/myocardial infarction.
Croatian: sinkopa, bradikardija Rijetko: cijanoza, perikardijalni izljev Nepoznato: ishemija miokarda/infarkt miokarda
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
Croatian: • Te infekcije mogu biti ozbiljne, a uključuju tuberkulozu, virusne infekcije, gljivične infekcije,
English: • You should receive recommended vaccinations before starting Zessly treatment.
Croatian: • Prije početka liječenja lijekom Zessly trebate primiti sva preporučena cjepiva.
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience
Croatian: Nuspojave u kliničkim ispitivanjima i nakon stavljanja lijeka u promet
English: Zessly is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Croatian: Zessly je indiciran za liječenje umjerene do teške plak psorijaze u odraslih bolesnika u kojih je druga sustavna terapija, uključujući ciklosporin, metotreksat ili PUVA terapiju, nedjelotvorna,
English: Heart problems
Croatian: Srčani poremećaji
English: Paediatric ulcerative colitis (6 to 17 years)
Croatian: Ulcerozni kolitis u pedijatrijskih bolesnika (6 do 17 godina)
English: Twenty four of these patients (75.0%) regained clinical response after crossing over.
Croatian: Nakon toga se klinički odgovor vratio u 24 bolesnika (75,0%).
English: * P-values represent each infliximab treatment group vs. AZA monotherapy.
Croatian: (p < 0,001)* * p-vrijednosti odnose se na usporedbu svake skupine koja je primala infliksimab sa skupinom koja je primala monoterapiju AZA.
English: In patients who develop HBV reactivation, Zessly should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Croatian: Zessly te uvesti djelotvorne antivirusne lijekove uz odgovarajuće suportivno liječenje.
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Croatian: Često: novonastala psorijaza ili pogoršanje postojeće uključujući pustularnu psorijazu (primarno palmarnu i plantarnu), urtikarija,
English: usually in your arm. After the third treatment, your doctor may decide to give your dose of
Croatian: Nakon treće doze liječnik može odlučiti primijeniti dozu lijeka Zessly tijekom jednog sata.
English: Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap. Zessly is available in packs containing 1, 2, 3, 4 or 5 vials.
Croatian: Staklena bočica (staklo tip 1) s gumenim čepom i aluminijskim prstenom zaštićenim plastičnom kapicom.
English: • Infection due to a live vaccine because of a weakened immune system.
Croatian: • privremeni gubitak vida tijekom ili unutar 2 sata od infuzije • infekcija uzrokovana primjenom živog cjepiva zbog oslabljenog imunološkog sustava
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Croatian: Istodobna primjena inhibitora TNFα i anakinre
English: Zessly infliximab
Croatian: Monoterapija infliksimabom
English: infliximab (week 16)
Croatian: Infliksima b (16. tjeda n)
English: Study 1 evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Croatian: tjedna u 428 bolesnika koji su imali aktivni reumatoidni artritis usprkos liječenju metotreksatom.
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30, and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Croatian: u 59,1% (13/22) u 30. tjednu te u 68,2% (15/22) bolesnika u 54. tjednu.
English: Percentage of subjects in clinical response and in sustained clinical response
Croatian: Postotak ispitanika s kliničkim odgovorom i održanim kliničkim odgovorom Klinički odgovor u 8. tjednua
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Zessly.
Croatian: Odmah obavijestite Vašeg liječnika ako dobijete simptome jetrenih tegoba za vrijeme liječenja lijekom Zessly.
English: Each Zessly vial contains 100 mg infliximab.
Croatian: Jedna bočica lijeka Zessly sadrži 100 mg infliksimaba.
English: • Chills, a build up of fluid under the skin causing swelling
Croatian: • zimica, nakupljanje tekućine ispod kože koje uzrokuje oticanje • osjećaj utrnulosti i trnci
English: It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth (see section 4.4).
Croatian: Također se ne preporučuje davati živa cjepiva dojenčadi koja su in utero bila izložena infliksimabu, najmanje 6 mjeseci nakon rođenja
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Croatian: Vrlo često: infekcija gornjih dišnih puteva, sinusitis Često: infekcija donjih dišnih puteva (npr. bronhitis, pneumonija), dispneja, epistaksa
English: Discontinuation of Zessly therapy should be considered in patients with confirmed significant haematologic abnormalities.
Croatian: U bolesnika s potvrđenim značajnim hematološkim poremećajima treba razmotriti prekid liječenja lijekom Zessly.
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Croatian: (CDAI ≥ 220 i ≤ 400) primilo jednokratnu infuziju infliksimaba u dozi od 5 mg/kg u nultom tjednu.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled study 6 & study 7 data) and week 54 (21.0% vs. 8.9%, p = 0.022, study 6 data).
Croatian: kako u 30. tjednu (22,3% naspram 7,2%, p < 0,001, zbirni podaci iz ispitivanja 6 i ispitivanja 7) tako i u 54. tjednu (21,0% naspram 8,9%, p = 0,022, podaci iz ispitivanja 6).