FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly: No dose adjustment is required in patients over 65 years of age (see section 4.4).
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina (vidjeti dio 4.4).
English: The recommended dose is one 200 mg injection every two weeks.
Croatian: Preporučena doza je jedna injekcija od 200 mg svaka dva tjedna.
English: The most frequently observed serious infections included pneumonia and cellulitis.
Croatian: Najčešće primijećene ozbiljne infekcije uključivale su pneumoniju i celulitis.
English: Liver enzymes
Croatian: Jetreni enzimi
English: Treatment with Kevzara + MTX was associated with significantly less radiographic progression of structural damage as compared with placebo.
Croatian: Liječenje lijekom Kevzara + MTX-om bilo je povezano sa značajno manjom radiološkom progresijom strukturnog oštećenja nego primjena placeba.
English: Kevzara should not be used during pregnancy unless the clinical condition of the woman requires treatment with sarilumab.
Croatian: Kevzara se ne smije primjenjivati tijekom trudnoće, osim u slučajevima kada kliničko stanje žene zahtijeva liječenje sarilumabom.
English: Do not press or touch the yellow needle cover with your fingers.
Croatian: Nemojte prstima pritiskati ni dodirivati žuti pokrov igle.
English: Kevzara has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor Necrosis Factor (TNF) antagonists.
Croatian: Kevzara se nije ispitivala u kombinaciji s inhibitorima Janus kinaze (JAK) ni biološkim DMARD-ovima kao što su antagonisti faktora tumorske nekroze (engl. tumor necrosis factor, TNF).
English: Most patients who developed gastrointestinal perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate.
Croatian: Većina bolesnika u kojih je došlo do gastrointestinalnih perforacija istodobno je uzimala nesteroidne protuupalne lijekove (NSAIL), kortikosteroide ili metotreksat.
English: If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.
Croatian: Ako imate bilo kakvih dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri ili nazovite sanofi na broj naveden u uputi o lijeku.
English: These parallel elimination pathways result in an initial half-life of 8 to 10 days, and at steady-state an effective halflife of 21 days is estimated.
Croatian: Zbog tih usporednih putova eliminacije početni poluvijek lijeka iznosi 8 do 10 dana, a u stanju dinamičke ravnoteže efektivni poluvijek je procijenjen na 21 dan..
English: MOBILITY evaluated 1197 patients with RA who had inadequate clinical response to MTX.
Croatian: U ispitivanju MOBILITY sudjelovalo je 1197 bolesnika s RA koji nisu ostvarili dovoljno dobar odgovor na MTX.
English: In isolated cases, disseminated rather than localised infections were observed in patients often taking concomitant immunosuppressants such as MTX or corticosteroids, which in addition to RA may predispose them to infections.
Croatian: U izoliranim su slučajevima primijećene diseminirane, a ne lokalizirane infekcije u bolesnika koji su često istodobno uzimali imunosupresive poput MTX-a ili kortikosteroida, koji ih uz RA mogu dodatno učiniti podložnijima infekciji.
English: Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Croatian: Kevzara se može primjenjivati i kao monoterapija u slučaju nepodnošenja MTX-a ili kada liječenje MTX-om nije prikladno (vidjeti dio 5.1).
English: When clinically indicated, consider other liver function tests such as bilirubin.
Croatian: Kada je to klinički indicirano, treba razmotriti i provedbu drugih testova funkcije jetre, kao što je određivanje vrijednosti bilirubina.
English: Push the plunger down.
Croatian: Pritisnite klip prema dolje.
English: The excretion of sarilumab in milk has not been studied in animals (see section 5.3).
Croatian: Izlučivanje sarilumaba u mlijeko nije se ispitivalo na životinjama (vidjeti dio 5.3).
English: This is to check if you have a low blood cell count, liver problems, or changes in your cholesterol levels.
Croatian: Tako će se provjeravati je li Vam broj krvnih stanica nizak, imate li jetrenih tegoba te je li došlo do promjena u vrijednostima kolesterola.
English: Prior to launch of Kevzara in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of patient alert card, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Kevzara u svakoj državi članici nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i format kartice s upozorenjima za bolesnika, uključujući medij komunikacije, način distribucije i bilo koji drugi aspekt.
English: As a monoclonal antibody sarilumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Croatian: Budući da je sarilumab monoklonsko protutijelo, očekuje se da će se kataboličkim putovima razgraditi na male peptide i aminokiseline na isti način kao i endogeni IgG.
English: Pinch the skin.
Croatian: Uhvatite nabor kože.
English: Two patients on Kevzara (0.2%) discontinued treatment due to injection site reactions.
Croatian: Dva bolesnika koja su primala lijek Kevzara (0,2%) prekinula su liječenje zbog reakcija na mjestu injiciranja.
English: Treatment with immunosuppressants may result in an increased risk of malignancies.
Croatian: Liječenje imunosupresivima može povećati rizik od zloćudnih bolesti.
English: Results at 24 weeks in TARGET were similar to the results at 52 weeks in MOBILITY (see Table 3).
Croatian: Rezultati u 24. tjednu ispitivanja TARGET bili su slični onima u 52. tjednu ispitivanja MOBILITY (vidjeti Tablicu 3).
English: Do not touch the injection site again before the injection.
Croatian: Nemojte ponovno dodirivati mjesto injiciranja prije primjene lijeka.
English: Injection sites (abdomen, thigh and upper arm) should be rotated with each injection.
Croatian: Mjesto injiciranja (abdomen, bedro i nadlaktica) treba mijenjati pri svakoj injekciji.
English: Treatment with sarilumab resulted in decreases in fibrinogen and serum amyloid A, and increases in haemoglobin and serum albumin.
Croatian: Liječenje sarilumabom snizilo je vrijednosti fibrinogena i serumskog amiloida A, a povisilo vrijednosti hemoglobina i serumskog albumina.
English: RA patients have an increased risk for cardiovascular disorders and risk factors (e.g. hypertension, hyperlipidaemia) should be managed as part of usual standard of care.
Croatian: Budući da bolesnici s RA imaju povećan rizik od kardiovaskularnih poremećaja, njihove faktore rizika (npr. hipertenziju, hiperlipidemiju) treba liječiti u sklopu uobičajene standardne skrbi.
English: The subsequent dose should be administered at the regularly scheduled time.
Croatian: Sljedeću dozu treba primijeniti prema uobičajenom rasporedu.
English: Percentage of Patients
Croatian: Postotak bolesnika
English: Low Absolute Neutrophil Count (see section 5.1) Lab Value (cells x 109/L) Recommendation
Croatian: Nizak apsolutni broj neutrofila (vidjeti dio 5.1) Laboratorijska vrijednost (stanice x 109/l)
English: In addition to this leaflet, you will be given a patient alert card, which contains important safety information that you need before and during treatment with Kevzara.
Croatian: Uz ovu uputu o lijeku dobit ćete i karticu s upozorenjima za bolesnika, koja sadrži važne informacije o sigurnosti koje morate znati prije i tijekom liječenja lijekom Kevzara.
English: Ask your healthcare professional to show you the right way to use the syringe before your first injection.
Croatian: Zamolite zdravstvenog radnika da Vam pokaže kako pravilno koristiti štrcaljku prije prve injekcije.
English: Kevzara is given as an injection under the skin (called “subcutaneous” injection).
Croatian: Kevzara se daje injekcijom pod kožu (što se naziva potkožnom injekcijom).
English: Cases of opportunistic infection have been reported (see section 4.4).
Croatian: Prijavljeni su slučajevi oportunističke infekcije (vidjeti dio 4.4).
English: • Based on the pharmacodynamics of the changes in ANC, use results obtained at the end of the dosing interval when considering dose modification (see section 5.1).
Croatian: • S obzirom na farmakodinamiku promjena ABN-a, kada se razmatra prilagodba doze u obzir treba uzeti rezultate dobivene na kraju intervala doziranja (vidjeti dio 5.1).
English: • You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.
Croatian: • Trebat će Vam tupfer natopljen alkoholom, pamučna vata ili gaza i neprobojan spremnik.
English: The MAH shall ensure that in each Member State where Kevzara is marketed, all healthcare professionals who are expected to prescribe Kevzara have access to the patient alert card.
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici gdje je Kevzara stavljena u promet svi zdravstveni radnici za koje se očekuje da će propisivati lijek Kevzara imaju pristup kartici s upozorenjima za bolesnika.
English: • Check the expiry date (EXP), this is shown on the side of the pens.
Croatian: • Provjerite rok valjanosti (EXP), koji je naveden na bočnoj strani brizgalice.
English: • Check that the liquid is clear and colourless to pale yellow.
Croatian: • Provjerite je li otopina bistra te bezbojna do blijedo žuta.
English: • a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid arthritis and cancer)
Croatian: • lijekove iz skupine lijekova koji se zovu inhibitori Janus kinaze (JAK) (koriste se za bolesti kao što su reumatoidni artritis i rak)
English: In particular, do not use Kevzara and tell your doctor or pharmacist if you are using:
Croatian: Osobito je važno da ne primijenite lijek Kevzara i da obavijestite svog liječnika ili ljekarnika ako primjenjujete:
English: Patients presenting with new onset abdominal symptoms such as persistent pain with fever should be evaluated promptly (see section 4.8).
Croatian: Bolesnike u kojih se jave novi abdominalni simptomi, kao što je dugotrajna bol praćena vrućicom, treba procijeniti bez odgađanja (vidjeti dio 4.8).
English: • The active substance is sarilumab.
Croatian: • Djelatna tvar je sarilumab.
English: The total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a subcutaneous injection.
Croatian: Cjelokupan sadržaj (1,14 ml) napunjene štrcaljke/napunjene brizgalice treba primijeniti supkutanom injekcijom.
English: TARGET TNF Inhibitor Inadequate Responders
Croatian: TARGET Bolesnici s nedovoljno dobrim odgovorom na inhibitore TNF-a
English: Decrease in ANC was not associated with higher incidence of infections, including serious infections.
Croatian: Pad ABN-a nije bio povezan s višom incidencijom infekcija, uključujući ozbiljne infekcije.
English: DAS28-ESR remission (< 2.6), n (%)
Croatian: Remisija prema DAS28-ESR rezultatu (< 2,6 ), n (%)
English: Low Platelet Count Lab Value (cells x 103/µL)
Croatian: Nizak broj trombocita Laboratorijska vrijednost (stanice x 103/µl)
English: Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous therapy did not work well enough or was not tolerated.
Croatian: Kevzara se koristi za liječenje odraslih osoba s umjerenim do teškim oblikom aktivnog reumatoidnog artritisa ako prethodna terapija nije djelovala dovoljno dobro ili ako je niste podnosili.
English: • warfarin, used to prevent blood clots.
Croatian: • varfarin, koji se koristi sprječavanje nastanka krvnih ugrušaka
English: • You and your doctor should decide if you should use Kevzara if you are breast-feeding.
Croatian: • Vi i Vaš liječnik morate donijeti odluko o tome hoćete li primjenjivati lijek Kevzara ako dojite.
English: Figure 2: Percent of ACR20 Response by Visit for TARGET
Croatian: Slika 2: Postotak odgovora ACR20 prema posjetu u ispitivanju TARGET
English: Figure 1: Percent of ACR20 Response by Visit for MOBILITY
Croatian: Slika 1: Postotak odgovora ACR20 prema posjetu u ispitivanju MOBILITY
English: ANC less than 0.5
Croatian: ABN ispod 0,5
English: • high cholesterol, high triglycerides shown by blood tests
Croatian: • visoke vrijednosti kolesterola, visoke vrijednosti triglicerida - vidljivo u nalazima krvnih pretraga
English: A patient who develops an infection during treatment with Kevzara should also undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Croatian: U bolesnika u kojeg se tijekom liječenja lijekom Kevzara razvije infekcija također treba odmah provesti cjelovite dijagnostičke pretrage prikladne za imunokompromitiranog bolesnika; potrebno je uvesti odgovarajuću antimikrobnu terapiju i pažljivo nadzirati bolesnika.
English: • underlying conditions that may predispose them to infection;
Croatian: • koji imaju podležeća stanja zbog kojih mogu biti podložniji infekciji
English: Ask your healthcare professional to show you the right way to use the pen before your first injection.
Croatian: Zamolite zdravstvenog radnika da Vam pokaže kako pravilno koristiti brizgalicu prije prve injekcije.
English: Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this.
Croatian: Nemojte baciti upotrijebljen neprobojni spremnik u kućni otpad, osim ako to ne dopuštaju nacionalni propisi.
English: After removing the pre-filled syringe/pre-filled pen from the refrigerator, it should be allowed to reach room temperature (<25°C) before injecting Kevzara.
Croatian: Nakon što se napunjena štrcaljka/napunjena brizgalica izvadi iz hladnjaka, treba pričekati da se ugrije na sobnu temperaturu (< 25°C) prije nego što se Kevzara injicira.
English: • If you see any blood, press a cotton ball or gauze on the site.
Croatian: • Ako vidite krv, pritisnite komad pamučne vate ili gaze na mjesto injiciranja.
English: Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis.
Croatian: Liječenje mora započeti liječnik koji ima iskustva s dijagnosticiranjem i liječenjem reumatoidnog artritisa.
English: If you are using any of the following medicines, tell your doctor or pharmacist before using Kevzara:
Croatian: Ako primjenjujete bilo koji od sljedećih lijekova, obavijestite svog liječnika ili ljekarnika prije nego što primijenite lijek Kevzara:
English: In the event of an overdose, the patient should be closely monitored, treated symptomatically, and supportive measures instituted as required.
Croatian: U slučaju predoziranja potrebno je pažljivo nadzirati bolesnika i liječiti ga simptomatski te po potrebi uvesti potporne mjere.
English: Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Croatian: Sarilumab je humano monoklonsko protutijelo selektivno za receptor interleukina-6 (IL-6), koje se proizvodi u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: Fertility studies conducted in male and female mice using a murine surrogate antibody against mouse IL-6Rα showed no impairment of fertility.
Croatian: Ispitivanja učinaka na plodnost provedena na mužjacima i ženkama miševa uz pomoć mišjeg zamjenskog protutijela na mišji IL-6Rα nisu pokazala štetne učinke na plodnost.
English: Do not heat the pen; let it warm up on its own.
Croatian: Nemojte zagrijavati štrcaljku; pričekajte da se sama ugrije.
English: The percentages of Kevzara + DMARDs-treated patients achieving ACR20, ACR50, and ACR70 responses in MOBILITY and TARGET are shown Table 3.
Croatian: Postoci bolesnika liječenih lijekom Kevzara + DMARD-ovima koji su postigli odgovore ACR20, ACR50 i ACR70 u ispitivanjima MOBILITY i TARGET prikazani su u Tablici 3.
English: Events of gastrointestinal perforation have been reported in clinical studies, primarily as complications of diverticulitis.
Croatian: U kliničkim su ispitivanjima prijavljeni događaji gastrointestinalne perforacije, prvenstveno kao komplikacije divertikulitisa.
English: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, France
Croatian: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, Francuska
English: Before you use Kevzara, your doctor will do a blood test to check your liver function.
Croatian: Prije nego što počnete primjenjivati lijek Kevzara, liječnik će provesti krvnu pretragu kako bi Vam provjerio rad jetre.
English: In patients with higher body weight (>100 Kg) both 150 mg and 200 mg doses demonstrated efficacy; however, patients weighing >100 Kg had greater therapeutic benefit with the 200 mg dose.
Croatian: U bolesnika veće tjelesne težine (> 100 kg) djelotvorne su bile i doza od 150 mg i ona od 200 mg; međutim, bolesnici tjelesne težine > 100 kg ostvarili su veću terapijsku korist uz dozu od 200 mg.
English: In vitro and in vivo studies with sarilumab using human tumour cell lines showed inhibition of STAT-3 activation and inhibition of tumour growth in human tumour xenograft animal models.
Croatian: Ispitivanja sarilumaba in vitro i in vivo na humanim tumorskim staničnim linijama pokazala su inhibiciju aktivacije STAT-3 i inhibiciju rasta tumora u životinjskim ksenotransplantacijskim modelima humanih tumora.
English: No correlation was observed between ADA development and either loss of efficacy or adverse events.
Croatian: Nije primijećena korelacija između nastanka protutijela na lijek i gubitka djelotvornosti ili nastupa nuspojava.
English: These elevations were not associated with clinically relevant increases in direct bilirubin, nor were they associated with clinical evidence of hepatitis or hepatic insufficiency (see section 4.4).
Croatian: Ta povišenja nisu bila povezana s klinički značajnim porastom vrijednosti direktnog bilirubina niti s kliničkim dokazima hepatitisa ili jetrene insuficijencije (vidjeti dio 4.4).
English: • Change injection site each time you inject.
Croatian: • Mijenjajte mjesto primjene pri svakoj injekciji.
English: If anaphylaxis or other hypersensitivity reaction occurs, administration of Kevzara should be stopped immediately.
Croatian: Ako nastupi anafilaksija ili neka druga reakcija preosjetljivosti, primjenu lijeka Kevzara treba odmah prekinuti.
English: Do not use if the window is solid yellow.
Croatian: Nemojte primijeniti lijek ako je prozorčić posve žut.
English: Population pharmacokinetic analyses in adult patients with RA (ranging in age from18 to 88 years with 14% over 65 years) showed that age, gender and race did not meaningfully influence the pharmacokinetics of sarilumab.
Croatian: 18 do 88 godina; 14% bolesnika bilo je u dobi iznad 65 godina) pokazala su da dob, spol i rasa nisu značajno utjecali na farmakokinetiku sarilumaba.
English: The weight of evidence for IL-6Rα inhibition mainly indicates anti-tumour effects mediated by multiple mechanisms predominantly involving STAT-3 inhibition.
Croatian: Većina dokaza za inhibiciju IL-6Rα uglavnom ukazuje na protutumorske učinke posredovane većim brojem mehanizama, koji prvenstveno uključuju inhibiciju STAT-3.
English: Table 1: ADRs in controlled clinical studies
Croatian: Tablica 1: Nuspojave u kontroliranim kliničkim ispitivanjima
English: Avoid concurrent use of live vaccines as well as live attenuated vaccines during treatment with Kevzara as clinical safety has not been established.
Croatian: Treba izbjegavati istodobnu primjenu živih cjepiva kao i živih atenuiranih cjepiva tijekom liječenja lijekom Kevzara jer nije ustanovljena klinička sigurnost.
English: IL-6 is involved in diverse physiological processes such as migration and activation of T-cells, B-cells, monocytes, and osteoclasts leading to systemic inflammation, synovial inflammation, and bone erosion in patients with RA.
Croatian: IL-6 sudjeluje u različitim fiziološkim procesima kao što su migracija i aktivacija T-stanica, B-stanica, monocita i osteoklasta te tako dovodi do sistemske upale, upale sinovijske tekućine i koštane erozije u bolesnika s RA.
English: In MOBILITY, structural joint damage was assessed radiographically and expressed as change in van der Heijde-modified Total Sharp Score (mTSS) and its components, the erosion score, and joint space narrowing score at Week 52.
Croatian: U ispitivanju MOBILITY, strukturno oštećenje zglobova ocjenjivalo se radiološki, a izraženo je kao promjena rezultata prema van der Heijdeovoj modifikaciji Sharpove ljestvice (mTSS) i njegovih pojedinačnih sastavnica, stupnja erozije i stupnja suženja zglobnog prostora u 52. tjednu.
English: Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 10 people).
Croatian: Ozbiljne nuspojave Odmah obavijestite svog liječnika ako mislite da imate infekciju (koja se može javiti u do
English: Press down and hold the pen firmly against your skin.
Croatian: Pritisnite brizgalicu prema dolje i držite je čvrsto priljubljenom uz kožu.
English: Industriepark Hochst 65926 Frankfurt am Main Germany
Croatian: Industriepark Hochst 65926 Frankfurt am Main
English: Kevzara has no or negligible influence on the ability to drive or operate machinery.
Croatian: Kevzara ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Croatian: Svi oblici sadrže 1,14 ml otopine u štrcaljki (staklo tipa 1) opremljenoj pričvršćenom iglom od nehrđajućeg čelika i elastomerskim čepom klipa.
English: Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3).
Croatian: Sarilumab je humano monoklonsko protutijelo (IgG1 podtipa) koje se specifično vezuje i za topljive i za membranski vezane IL-6 receptore (IL-6Rα) te inhibira signalizaciju putem IL-6, u kojoj sudjeluju sveprisutan prijenosnik signala glikoprotein 130 (gp130) te prijenosnik signala i aktivator transkripcije-3 (engl. signal transducer and activator of transcription-3, STAT-3),
English: ALT > 5 x ULN
Croatian: ALT > 5 x GGN
English: • cold sores (oral herpes)
Croatian: • herpes (oralni)
English: In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6.
Croatian: U funkcionalnim testovima na ljudskim stanicama sarilumab je uspio blokirati signalizaciju putem IL-6 (koja se mjeri kao inhibicija STAT-3) isključivo u prisutnosti IL-6.
English: What you need to know before you use Kevzara 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek Kevzara
English: The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
Croatian: Modulacija učinka IL-6 na CYP enzime koju uzrokuje sarilumab može biti klinički značajna za supstrate CYP enzima uskog terapijskog indeksa, čija se doza individualno prilagođava.
English: • Use the pre-filled syringe exactly as described in the “Instructions for Use”.
Croatian: • Napunjenu štrcaljku koristite točno onako kako je opisano u ‘Uputama za uporabu'.
English: To allow for a direct comparison of frequency of laboratory abnormalities between placebo and active treatment, data from weeks 0-12 were used as this was prior to patients being permitted to switch from placebo to Kevzara.
Croatian: Da bi se omogućila izravna usporedba učestalosti odstupanja u laboratorijskim nalazima kod primjene placeba i aktivnog lijeka, upotrijebljeni su podaci prikupljeni od 0. do 12. tjedna, jer u tom razdoblju bolesnici nisu smjeli prijeći s placeba na lijek Kevzara.