FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Croatian: Polako gurajte klip dokle je moguće tako da glava klipa bude u potpunosti između krilca štitnika štrcaljke.
English: Compared with exposure after a single dose, the population pharmacokinetic analysis showed that patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) following repeated monthly dosing during maintenance.
Croatian: U usporedbi s izloženošću nakon jednokratne doze, populacijska farmakokinetička analiza pokazala je da su bolesnici imali dvostruko povećanje vršnih koncentracija u serumu i površine ispod krivulje (AUC) nakon ponovljenog mjesečnog doziranja tijekom održavanja.
English: • difficulty breathing or swallowing
Croatian: • poteškoće s disanjem ili gutanjem
English: After the medicine has been injected the syringe guard will be activated to cover the needle.
Croatian: Nakon što je lijek ubrizgan aktivirat će se štitnik štrcaljke koji će prekriti iglu.
English: Improvements in the PASI 75 response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in the anti-TNFα-IR patients.
Croatian: Poboljšanja u odgovoru PASI 75 bila su opažena u obje podskupine, a doza od 300 mg je pokazala statistički značajnu korist u anti-TNFα-NO bolesnika.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na plodnost.
English: Treatment success of “clear” or “almost clear” consisted of no signs of psoriasis or normal to pink colouration of lesions, no thickening of the plaque and none to minimal focal scaling.
Croatian: Uspjeh liječenja „čista“ ili „gotovo čista“ značio je da nema znakova psorijaze ili normalnu do ružičastu boju lezija, bez zadebljanja plaka te bez ili s minimalnim fokalnim ljuštenjem.
English: The percentage of patients achieving ACR 20 response by visit is shown in Figure 2.
Croatian: Postotak bolesnika koji su postigli odgovor ACR 20 po posjetu prikazan je na Slici 2.
English: Statistically significant difference in ACR 20 versus placebo was reached at week 3.
Croatian: Statistički značajna razlika u ACR 20 u odnosu na placebo postignuta je u 3. tjednu.
English: Do not use Cosentyx:
Croatian: Nemojte primjenjivati Cosentyx:
English: If you have ankylosing spondylitis you will first be given other medicines.
Croatian: Ako imate ankilozantni spondilitis, prvo ćete dobiti druge lijekove.
English: The preparation of the solution for subcutaneous injection must be done without interruption and ensuring that aseptic technique is used.
Croatian: Priprema otopine za potkožnu injekciju mora se obaviti bez prekida te uz korištenje aseptične tehnike.
English: This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines, and individuals who assist self-injecting patients from accidental needlestick injuries.
Croatian: Svrha toga je da pomogne u zaštiti zdravstvenih radnika, bolesnika koji si sami ubrizgavaju lijek koji im je propisao liječnik te pojedinaca koji pomažu bolesnicima koji sami ubrizgavaju lijek od ozljeda slučajnim ubodom igle.
English: Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, which is a marker of inflammation.
Croatian: Pokazalo se da sekukinumab snižava (unutar 1 do 2 tjedna liječenja) razine C-reaktivnog proteina, koji je biljeg upale.
English: Forty percent of the participants in studies 1 and 2 completed the Psoriasis Symptom Diary©.
Croatian: Četrdeset posto ispitanika u 1. i 2. ispitivanju ispunjavalo je Dnevnik simptoma psorijaze©.
English: If a patient develops a serious infection, the patient should be closely monitored and secukinumab should not be administered until the infection resolves.
Croatian: Ako se u bolesnika razvije ozbiljna infekcija, bolesnika je potrebno pažljivo motriti, a sekukinumab se ne smije primjenjivati dok se infekcija ne povuče.
English: Based on population pharmacokinetic analysis with a limited number of elderly patients (n=71 for age ≥65 years and n=7 for age ≥75 years), clearance in elderly patients and patients less than 65 years of age was similar.
Croatian: Na temelju populacijske farmakokinetičke analize s ograničenim brojem starijih bolesnika (n=71 za dob ≥65 godina i n=7 za dob ≥75 godina), klirens u starijih bolesnika i u bolesnika mlađih od 65 godina bio je sličan.
English: What Cosentyx is and what it is used for What you need to know before you use Cosentyx How to use Cosentyx
Croatian: Što je Cosentyx i za što se koristi Što morate znati prije nego počnete primjenjivati Cosentyx Kako primjenjivati Cosentyx
English: 9/l (CTCAE grade 4) were reported.
Croatian: 9/l (stupanj 4 prema CTCAE-u).
English: Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
Croatian: Polako otpustite klip i pustite da štitnik štrcaljke automatski prekrije izloženu iglu.
English: • Keep holding the pen firmly against your skin.
Croatian: • Nastavite držati brizgalicu čvrsto uz kožu.
English: ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
Croatian: Odgovor ASAS 40, % hsCRP, (omjer nakon PV-a/PV)
English: A new and unused Cosentyx SensoReady pen (2 pens are needed for a 300 mg dose).
Croatian: Nova i neupotrijebljena Cosentyx SensoReady brizgalica (2 brizgalice su potrebne za dozu od 300 mg).
English: The bioavailability of secukinumab in PsA patients was 85% on the basis of the population pharmacokinetic model.
Croatian: Bioraspoloživost sekukinumaba u bolesnika s PsA-om bila je 85% na temelju populacijskog farmakokinetičkog modela.
English: No increased susceptibility to tuberculosis was reported from clinical studies.
Croatian: U kliničkim ispitivanjima nije bila zabilježena povećana osjetljivost na tuberkulozu.
English: Clinically relevant levels of secukinumab reach the skin and reduce local inflammatory markers.
Croatian: Klinički relevantne razine sekukinumaba dopiru do kože i smanjuju lokalne upalne markere.
English: Patient Instructions for Use
Croatian: Upute bolesniku za uporabu
English: There are no adequate data from the use of secukinumab in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni sekukinumaba u trudnica.
English: 9/l (CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases.
Croatian: 9/l (CTCAE stupanj 3) bila je prijavljena u 18 od 3430 (0,5%) bolesnika koji su uzimali sekukinumab, bez ovisnosti o dozi i bez vremenske povezanosti s infekcijama u 15 od 18 slučajeva.
English: Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors.
Croatian: Sekukinumab je monoklonsko protutijelo koje pripada skupini lijekova koji se zovu inhibitori interleukina (IL).
English: The data suggest that secukinumab does not suppress the humoral immune response to the meningococcal or influenza vaccines.
Croatian: Podaci upućuju na to da sekukinumab ne potiskuje humoralni imunološki odgovor na cjepiva protiv meningokoka i protiv influence.
English: Its colour may vary from colourless to slightly yellow.
Croatian: Boja joj može varirati od bezbojne do žućkaste.
English: If an anaphylactic or other serious allergic reactions occur, administration of secukinumab should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako dođe do anafilaktičke ili nekih drugih ozbiljnih alergijskih reakcija, potrebno je odmah prekinuti primjenu sekukinumaba i započeti odgovarajuću terapiju.
English: After reconstitution: The solution can be used immediately or can be stored at 2°C to 8°C for up to 24 hours.
Croatian: Nakon rekonstitucije: Otopina se može upotrijebiti odmah ili se može pohraniti na 2 °C do 8 °C do 24 sata.
English: Cosentyx is used for the treatment of the following inflammatory diseases:
Croatian: Cosentyx se koristi za liječenje sljedećih upalnih bolesti:
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Croatian: Bolesnike je potrebno uputiti da zatraže savjet liječnika ako se pojave znakovi ili simptomi koji upućuju na pojavu infekcije.
English: Because of the potential for adverse reactions in nursing infants from secukinumab, a decision on whether to discontinue breast-feeding during treatment and up to 20 weeks after treatment or to discontinue therapy with Cosentyx must be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Croatian: Zbog potencijala za nuspojave sekukinumaba u dojenčadi, potrebno je odlučiti da li prekinuti dojenje tijekom liječenja i do 20 tjedana nakon liječenja ili prekinuti terapiju Cosentyxom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers:
Croatian: Za bolesnike s psorijatičnim artritisom koji ujedno imaju i umjerenu do tešku plak psorijazu ili bolesnike koji nisu dobro reagirali na lijekove koji se zovu blokatori tumor nekrotičnog faktora (TNF):
English: Trehalose dihydrate Histidine
Croatian: Trehaloza dihidrat Histidin
English: Weeks of treatment n = number of patients evaluable secukinumab 150 mg (n=243)
Croatian: Tjedni liječenja n = broj ocjenjivih bolesnika sekukinumab 150 mg (n=243)
English: You and your doctor should decide if you should inject Cosentyx yourself.
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li si sami ubrizgavati Cosentyx.
English: Do not open the sealed outer box until you are ready to use this medicine.
Croatian: Ne otvarajte originalno zalijepljenu kutiju dok niste spremni upotrijebiti ovaj lijek.
English: How much Cosentyx is given and for how long
Croatian: Koliko se Cosentyxa daje i koliko dugo
English: Table 6 Change in modified Total Sharp Score in psoriatic arthritis
Croatian: Tablica 6 Promjena u modificiranom ukupnom rezultatu po Sharpu kod psorijatičnog artritisa
English: Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate.
Croatian: Cosentyx se koristi u odraslih osoba s aktivnim psorijatičnim artritisom i može se koristiti sam ili s drugim lijekom koji se zove metotreksat.
English: Table 3 Summary of clinical response on psoriasis study 2 (FIXTURE)
Croatian: Tablica 3 Sažetak kliničkih odgovora u 2. ispitivanju psorijaze (FIXTURE)
English: IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Croatian: IL-17A je citokin koji se prirodno javlja i uključen je u normalne upalne i imune odgovore.
English: Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis (PsA) at baseline.
Croatian: Otprilike 15 do 25% bolesnika u ispitivanjima faze III imalo je psorijatični artritis (PsA) na početku.
English: • feeling tired or short of breath, cough which will not go away
Croatian: • osjećaj umora ili nedostatka zraka, kašalj koji ne prolazi
English: Similar responses for primary and key secondary endpoints were seen in PsA patients regardless of whether they were on concomitant MTX treatment or not.
Croatian: Slični odgovori za mjeru primarnog i ključnih sekundarnih ishoda bili su opaženi u bolesnika s PsA-om bez obzira na to jesu li istodobno liječeni MTX-om ili ne.
English: Preparing the Cosentyx pre-filled syringe ready for use Note: For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.
Croatian: Priprema Cosentyx napunjene štrcaljke za uporabu Napomena: Za dozu od 300 mg, pripremite 2 napunjene štrcaljke i ubrizgajte sadržaj obje.
English: ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Body Surface Area
Croatian: ACR: Američki koledž za reumatologiju; PASI: indeks zahvaćenosti kože psorijazom i težine psorijaze; DAS: indeks aktivnosti bolesti; BSA: tjelesna površina
English: PASI % change from baseline
Croatian: PASI % promjene od početne vrijednosti
English: Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.
Croatian: Cosentyx je namijenjen za primjenu pod vodstvom i nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju bolesti za koje je Cosentyx indiciran.
English: Table 4 Summary of clinical response on CLEAR study
Croatian: Tablica 4 Sažetak kliničkog odgovora u CLEAR ispitivanju
English: Not known (frequency cannot be estimated from the available data): • fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
Croatian: Nepoznato (učestalost se ne može se procijeniti iz dostupnih podataka): • gljivične infekcije kože i sluznica (uključujući infekciju jednjaka gljivicom kandidom)
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose.
Croatian: Ako ste žena u reproduktivnoj dobi, preporučuje se da izbjegavate trudnoću te morate koristiti odgovarajuću kontracepciju dok uzimate Cosentyx i najmanje 20 tjedana nakon zadnje doze Cosentyxa.
English: Inspection window Internal needle cover
Croatian: Prozorčić za provjeru Unutarnji pokrov igle
English: The efficacy and safety of secukinumab 150 mg and 300 mg were evaluated versus either placebo or etanercept.
Croatian: Djelotvornost i sigurnost sekukinumaba od 150 mg i 300 mg ocjenjivale su se u usporedbi ili s placebom ili s etanerceptom.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose and reproductive toxicity, or tissue cross-reactivity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i reproduktivne toksičnosti ili testiranja križne reaktivnosti tkiva.
English: Rare cases of neutropenia <0.5x10
Croatian: Prijavljeni su rijetki slučajevi neutropenije <0,5x10
English: • infection of the external ear (otitis externa)
Croatian: • infekcija vanjskog uha (otitis externa)
English: Inject the Cosentyx solution subcutaneously into the front of thighs, lower abdomen (but not the area 5 centimetres around the navel) or outer upper arms.
Croatian: Ubrizgajte otopinu Cosentyxa potkožno u prednji dio bedara, donji dio trbuha (ali ne područje 5 centimetara oko pupka) ili vanjski dio nadlaktice.
English: In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Croatian: U ispitivanjima psorijaze, sigurnost i djelotvornost sekukinumaba u kombinaciji s imunosupresivima, što uključuje i biološke lijekove, ili s fototerapijom nisu bile ocjenjivane.
English: • signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
Croatian: • znakovi niskih razina bijelih krvnih stanica, kao što su vrućica, grlobolja ili čirevi u ustima uzrokovani infekcijama (neutropenija)
English: Radiographs of hands, wrists, and feet were obtained at baseline, week 16 and/or week 24 and scored independently by at least two readers who were blinded to treatment group and visit number.
Croatian: Radiografske snimke šaka, ručnih zglobova i stopala napravljene su na početku, u 16. i/ili 24. tjednu te neovisno ocijenjene od strane barem dvaju ocjenjivača koji su bili zaslijepljeni za terapijsku skupinu i broj posjeta.
English: Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.
Croatian: Svakako razgovarajte sa svojim liječnikom o tome kada ćete dobiti svoje injekcije i kada ćete imati naknadne preglede.
English: DO NOT USE if the syringe is broken.
Croatian: NE UPOTREBLJAVAJTE ako je štrcaljka razbijena.
English: Cosentyx has no or negligible influence on the ability to drive and use machines.
Croatian: Cosentyx ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Croatian: Važno je da si ne pokušavate sami dati injekciju dok Vas nisu tome poučili Vaš liječnik, medicinska sestra ili ljekarnik.
English: The effect of secukinumab on human fertility has not been evaluated.
Croatian: Učinak sekukinumaba na plodnost u ljudi nije bio ocjenjivan.
English: • warm, red and painful skin, or a painful skin rash with blisters
Croatian: • toplu, crvenu i bolnu kožu, ili bolni kožni osip s mjehurićima
English: Never leave the syringe lying around where others might tamper with it. Do not shake the syringe.
Croatian: Nikada nemojte ostavljati štrcaljku negdje gdje bi je drugi mogli dirati.
English: There was an increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases were mild or moderate in severity, non-serious, responsive to standard treatment and did not necessitate treatment discontinuation.
Croatian: Uočeno je povećanje broja slučajeva mukokutane kandidijaze, što je u skladu s mehanizmom djelovanja, ali slučajevi su bili blage ili umjerene težine, nisu bili ozbiljni, odgovarali su na standardno liječenje te nisu zahtijevali prekid liječenja.
English: • lower respiratory tract infections
Croatian: • infekcije donjih dišnih puteva
English: Similar responses were seen in PsA study 1.
Croatian: Slični odgovori bili su opaženi u 1. ispitivanju PsA.
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja, preporučuje se pratiti kod bolesnika eventualnu pojavu znakova ili simptoma nuspojava te odmah započeti odgovarajuće simptomatsko liječenje.
English: As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Cosentyx tijekom trudnoće.
English: This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis.
Croatian: Ovaj lijek djeluje tako da neutralizira aktivnost proteina koji se zove IL-17A, a prisutan je u povišenim razinama kod bolesti kao što su psorijaza, psorijatični artritis i ankilozantni spondilitis.
English: The majority of patients also had active psoriasis skin lesions or a documented history of psoriasis.
Croatian: Većina bolesnika također je imala aktivne psorijatične kožne lezije ili dokumentiranu psorijazu u anamnezi.
English: Secukinumab was associated with a fast onset of efficacy with a 50% reduction in mean PASI by week 3 for the 300 mg dose.
Croatian: Sekukinumab je bio povezan s brzim nastupom djelotvornosti uz smanjenje od 50% u srednjem PASI-ju do 3. tjedna za dozu od 300 mg.
English: Similar responses were seen in PsA study 1 and efficacy was maintained up to week 52.
Croatian: Slični odgovori su uočeni u 1. ispitivanju PsA, a djelotvornost se održala do 52. tjedna.
English: ASAS partial remission, %
Croatian: ASAS djelomična remisija, %
English: In two additional placebo-controlled studies, improvement was seen in both nail psoriasis (TRANSFIGURE, 198 patients) and palmoplantar plaque psoriasis (GESTURE, 205 patients).
Croatian: U dva dodatna placebom kontrolirana ispitivanja, poboljšanje je uočeno i u psorijazi noktiju (TRANSFIGURE, 198 bolesnika) i u palmoplantarnoj plak psorijazi (GESTURE, 205 bolesnika).
English: Cases of new or exacerbations of Crohn's disease and ulcerative colitis have been reported.
Croatian: Prijavljeni su novi slučajevi ili egzarcebacije Chronove bolesti i ulceroznog kolitisa.
English: In a study in subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP3A4 substrate).
Croatian: U ispitivanju u bolesnika s plak psorijazom nije uočena interakcija između sekukinumaba i midazolama (CYP3A4 supstrat).
English: If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room temperature, not above 30°C.
Croatian: Ako je potrebno, Cosentyx može biti ostavljen izvan hladnjaka tijekom jednokratnog razdoblja od najviše 4 dana na sobnoj temperaturi, ne iznad 30 °C.
English: The needle cap of the syringe may contain dry rubber (latex), which should not be handled by persons sensitive to this substance.
Croatian: Poklopac igle na štrcaljki mogao bi sadržavati suhu gumu (lateks), s kojom ne bi smjele dolaziti u kontakt osobe osjetljive na ovu tvar.
English: What you need to know before you use Cosentyx
Croatian: Što morate znati prije nego počnete primjenjivati Cosentyx
English: The powder for solution for injection must be reconstituted before use.
Croatian: Prašak za otopinu za injekciju mora se rekonstituirati prije primjene.
English: Patients receiving secukinumab may receive concurrent inactivated or non-live vaccinations.
Croatian: Bolesnici koji primaju sekukinumab mogu istodobno primati inaktivirana ili neživa cjepiva.
English: ADRs from clinical studies and post-marketing reports (Table 1) are listed by MedDRA system organ class.
Croatian: Nuspojave iz kliničkih ispitivanja i prijava nakon stavljanja lijeka u promet (Tablica 1) navedene su prema MedDRA-inoj klasifikaciji organskih sustava.
English: For both studies, the primary endpoint was at least a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) criteria at week 16.
Croatian: Za oba ispitivanja mjera primarnog ishoda bila je poboljšanje od najmanje 20% u kriterijima Međunarodnog društva za procjenu spondiloartritisa (engl.
English: You and your doctor should decide if you will breast-feed or use Cosentyx.
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li dojiti ili koristiti Cosentyx.
English: Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
Croatian: Ne zaboravite izvaditi štrcaljku iz hladnjaka i pustiti da dosegne sobnu temperaturu prije nego što je pripremite za injekciju (15-30 minuta).
English: Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Croatian: Cosentyx, sam ili u kombinaciji s metotreksatom (MTX), indiciran je za liječenje aktivnog psorijatičnog artritisa u odraslih bolesnika kada je odgovor na prethodnu terapiju antireumatskim lijekom koji modificira tijek bolesti (engl. disease-modifying anti-rheumatic drug, DMARD) bio neodgovarajući (vidjeti dio 5.1).
English: Improvement in both endpoints was sustained for secukinumab patients who continued treatment through to week 24.
Croatian: Poboljšanje u obje mjere ishoda održalo se u bolesnika na sekukinumabu koji su nastavili liječenje do 24. tjedna.
English: The condition is an inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints.
Croatian: To je upalna bolest koja u prvom redu zahvaća kralježnicu, što uzrokuje upalu kralježničnih zglobova.
English: Over 17,900 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions), representing 29,978 patient years of exposure.
Croatian: Više od 17 900 bolesnika je bilo liječeno sekukinumabom u slijepim i otvorenim kliničkim ispitivanjima u raznim indikacijama (plak psorijaza, psorijatični artritis, ankilozantni spondilitis i druga autoimuna stanja), što predstavlja 29 978 bolesnik-godina izloženosti.