FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have used more Kevzara than you should, talk to your doctor, pharmacist or nurse.
Croatian: Ako ste primijenili više lijeka Kevzara nego što ste trebali, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Kevzara can affect the way some medicines work: this means the dose of other medicines may need changing.
Croatian: Budući da Kevzara može utjecati na način djelovanja nekih lijekova, možda će trebati promijeniti dozu tih drugih lijekova.
English: Do not use the syringe if it has been out of the refrigerator for more than 14 days.
Croatian: Nemojte upotrijebiti štrcaljku ako je bila izvan hladnjaka više od 14 dana.
English: • slowing down damage to joints
Croatian: • usporiti oštećenje zglobova
English: Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis.
Croatian: Liječenje moraju započeti i nadzirati zdravstveni radnici s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa.
English: Treatment with Kevzara should be discontinued.
Croatian: Liječenje lijekom Kevzara treba obustaviti.
English: Industriepark Höchst 65926 Frankfurt am Main Germany
Croatian: Industriepark Höchst 65926 Frankfurt am Main
English: Patients had at least 8 tender and 6 swollen joints at baseline.
Croatian: Bolesnici su na početku ispitivanja imali najmanje 8 bolnih i 6 otečenih zglobova.
English: Radiographs of hands and feet were obtained at baseline, 24 weeks, and 52 weeks and scored independently by at least two well-trained readers who were blinded to treatment group and visit number.
Croatian: Rendgenske snimke šaka i stopala izrađene su na početku ispitivanja, u 24. tjednu i u 52. tjednu, a neovisno su ih ocjenjivala najmanje dva dobro educirana radiologa koja nisu znala o kojoj se liječenoj skupini i kojem posjetu radi.
English: Treatment with Kevzara was associated with increases in lipid parameters such as LDL cholesterol, HDL cholesterol, and/or triglycerides (see section 4.8).
Croatian: Liječenje lijekom Kevzara bilo je povezano s porastom vrijednosti lipidnih parametara kao što su LDL-kolesterol, HDL-kolesterol i/ili trigliceridi (vidjeti dio 4.8).
English: In a usability study sarilumab exposure after 200 mg Q2W was slightly higher (Cmax + 24-34%, AUC(0-2w) +7-21%) after use of a pre-filled pen compared to the pre-filled syringe.
Croatian: U ispitivanju uporabljivosti, izloženost sarilumabu nakon primjene doze od 200 mg dva puta tjedno bila je neznatno viša (Cmax + 24-34%, AUC(0-2w) +7-21%) kada se koristila napunjena brizgalica u usporedbi s napunjenom štrcaljkom.
English: Distribution In patients with RA, the apparent volume of distribution at steady state was 8.3 L.
Croatian: Prividni volumen distribucije u stanju dinamičke ravnoteže u bolesnika s RA iznosio je 8,3 l.
English: TARGET evaluated 546 patients with RA who had an inadequate clinical response or were intolerant to one or more TNF-α antagonists.
Croatian: U ispitivanju TARGET sudjelovalo je 546 bolesnika s RA koji nisu ostvarili dovoljno dobar odgovor na jedan ili više antagonista TNF-α ili koji nisu podnosili takve lijekove.
English: 81 Columbia Turnpike
Croatian: Regeneron Pharmaceuticals Inc. 81 Columbia Turnpike Rensselaer
English: There are no or limited amount of data from the use of sarilumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni sarilumaba u trudnica ograničeni.
English: Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs).
Croatian: Kevzara je u kombinaciji s metotreksatom (MTX) indicirana za liječenje umjerenog do teškog oblika aktivnog reumatoidnog artritisa (RA) u odraslih bolesnika koji nisu dovoljno dobro odgovorili na jedan ili više antireumatika koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drugs, DMARD) ili koji nisu podnosili takve lijekove.
English: Table 2: Incidence of liver enzyme abnormalities in controlled clinical studies
Croatian: Tablica 2: Incidencija odstupanja u vrijednostima jetrenih enzima u kontroliranim kliničkim ispitivanjima
English: Read all of the instructions carefully before using a pen.
Croatian: Pažljivo pročitajte cijele upute prije nego što upotrijebite brizgalicu.
English: • a history of serious or opportunistic infections;
Croatian: • koji imaju ozbiljne ili oportunističke infekcije u anamnezi
English: There is no specific treatment for Kevzara overdose.
Croatian: Ne postoji specifično liječenje za predoziranje lijekom Kevzara.
English: Reduction in platelets was not associated with bleeding events (see section 4.8).
Croatian: Pad broja trombocita nije bio povezan s događajima krvarenja (vidjeti dio 4.8).
English: Patients should be closely monitored for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Croatian: Bolesnike treba pažljivo nadzirati zbog mogućeg razvoja znakova i simptoma tuberkuloze, uključujući bolesnike koji su prije početka liječenja imali negativan nalaz testa na latentnu tuberkulozu.
English: Caution should be exercised in patients who start Kevzara treatment while on therapy with CYP3A4 substrates (e.g., oral contraceptives or statins), as Kevzara may reverse the inhibitory effect of IL-6 and restore CYP3A4 activity, leading to decreased exposure and activity of CYP3A4 substrate.
Croatian: Potreban je oprez u bolesnika koji započnu liječenje lijekom Kevzara dok primjenjuju supstrate enzima CYP3A4 (npr. oralne kontraceptive ili statine) jer Kevzara može neutralizirati inhibicijski učinak IL-6 i obnoviti aktivnost CYP3A4, dovodeći tako do smanjene izloženosti supstratu enzima CYP3A4 i njegove aktivnosti (vidjeti dio 5.2).
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with Kevzara.
Croatian: Kao i svi terapijski proteini, Kevzara može imati imunogeno djelovanje.
English: After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Croatian: Nakon posljednje doze sarilumaba od 150 mg ili 200 mg primijenjene u stanju dinamičke ravnoteže, medijan vremena do nemjerljive koncentracije iznosi 30 odnosno 49 dana.
English: The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids (see section 4.4).
Croatian: Aktivnost sarilumaba u smanjenju upale povezana je s laboratorijskim promjenama poput pada ABN-a i porasta vrijednosti lipida (vidjeti dio 4.4).
English: The use of Kevzara is not expected to affect your ability to drive or use machines.
Croatian: Ne očekuje se da će Kevzara utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Read all of the instructions carefully before using a syringe.
Croatian: Pažljivo pročitajte cijele upute prije nego što upotrijebite štrcaljku.
English: • Take one syringe out of the packaging by holding the middle of the syringe body.
Croatian: • Izvadite jednu štrcaljku iz pakiranja držeći je za srednji dio tijela.
English: If a dose of Kevzara is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible.
Croatian: Ako bolesnik propusti primiti dozu lijeka Kevzara, a prošlo je 3 dana ili manje od kada ju je trebao primiti, propuštenu dozu treba primijeniti što je prije moguće.
English: There are limited data available on overdose with Kevzara.
Croatian: Dostupni su ograničeni podaci o predoziranju lijekom Kevzara.
English: 1.14 ml
Croatian: 200mg/1,14 ml
English: No data are available on the effect of sarilumab on human fertility.
Croatian: Nema dostupnih podataka o učinku sarilumaba na plodnost u ljudi.
English: Patients with severe renal impairment were not studied.
Croatian: Bolesnici s teškim oštećenjem funkcije bubrega nisu se ispitivali.
English: Before you are given Kevzara, your doctor will check you for TB.
Croatian: Prije nego što Vam da lijek Kevzara, liječnik će provesti testiranje na TBC.
English: Viral reactivation has been reported with immunosuppressive biologic therapies.
Croatian: Ponovna aktivacija virusa Kod primjene bioloških imunosupresivnih terapija prijavljena je ponovna aktivacija virusa.
English: Kevzara 200 mg was superior to adalimumab 40 mg in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks (see Table 6).
Croatian: Kevzara u dozi od 200 mg pokazala se superiornom adalimumabu u dozi od 40 mg s obzirom na smanjenje aktivnosti bolesti i poboljšanje fizičke funkcije, a uz nju je i više bolesnika ostvarilo kliničku remisiju tijekom 24 tjedna (vidjeti Tablicu 6).
English: The most frequently observed serious infections with Kevzara included pneumonia and cellulitis (see section 4.8).
Croatian: Najčešće primijećene ozbiljne infekcije kod primjene lijeka Kevzara uključivale su pneumoniju i celulitis (vidjeti dio 4.8).
English: The efficacy of sarilumab with concomitant DMARDs on inhibition of radiographic progression that was assessed as part of the primary endpoints at Week 52 in MOBILITY was sustained up to three years from the start of treatment.
Croatian: Djelotvornost sarilumaba u kombinaciji s DMARD-ovima s obzirom na inhibiciju radiološke progresije, koja se ocjenjivala kao dio primarnih mjera ishoda u 52. tjednu ispitivanja MOBILITY,
English: The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg subcutaneous doses every two weeks for up to 52 weeks.
Croatian: Farmakokinetika sarilumaba okarakterizirana je u 2186 bolesnika s RA liječenih sarilumabom, od kojih je 751 bolesnik primao dozu od 150 mg, a 891 dozu od 200 mg supkutano svaka dva tjedna tijekom do 52 tjedna.
English: Patients treated with Kevzara should be given the patient alert card.
Croatian: Bolesnicima liječenima lijekom Kevzara treba dati karticu s upozorenjima za bolesnika.
English: What Kevzara is and what it is used for What Kevzara is
Croatian: Što je Kevzara i za što se koristi Što je Kevzara
English: Blockade of IL-6 signalling by IL-6Rα antagonists such as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered medicinal products concentrations.
Croatian: Blokada signalizacije putem IL-6 izazvana djelovanjem antagonista IL-6Rα, kao što je sarilumab, može neutralizirati inhibicijski učinak IL-6 i ponovno uspostaviti aktivnost CYP enzima te tako izmijeniti koncentracije lijekova.
English: Consider anti-tuberculosis therapy prior to initiation of Kevzara in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.
Croatian: Potrebno je razmotriti terapiju za tuberkulozu prije uvođenja lijeka Kevzara u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi provedba odgovarajućeg liječenja, kao i u bolesnika s negativnim nalazom testa na tuberkulozu koji imaju faktore rizika za tu bolest.
English: • Take one pen out of the packaging by holding the middle of the pen body.
Croatian: • Izvadite jednu brizgalicu iz pakiranja držeći je za srednji dio tijela.
English: Prior to initiating Kevzara, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Croatian: Prije uvođenja lijeka Kevzara preporučuje se da svi bolesnici prime sva cjepiva predviđena važećim smjernicama za imunizaciju.
English: Patients receiving Kevzara 200 mg + DMARDs reported greater improvement relative to placebo in the domains of Physical Functioning, Role Physical, Bodily Pain, General Health Perception, Vitality, Social Functioning, and Mental Health.
Croatian: Bolesnici koji su primali lijek Kevzara u dozi od 200 mg + DMARD-ove prijavili su veće poboljšanje u domenama fizičke funkcije, ograničenja zbog fizičkih tegoba, tjelesne boli, percepcije općeg zdravstvenog stanja, vitalnosti, društvene funkcije i mentalnog zdravlja nego oni koji su primali placebo.
English: For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steadystate area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively.
Croatian: Uz režim doziranja 150 mg svaka dva tjedna, procijenjene srednje vrijednosti (± standardno odstupanje [engl. standard deviation, SD]) područja ispod krivulje (engl. area under the curve, AUC), Cmin i Cmax sarilumaba u stanju dinamičke ravnoteže iznosile su 210 ± 115 mg.dan/l, 6,95 ± 7,60 mg/l odnosno 20,4 ± 8,27 mg/l.
English: • You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel).
Croatian: • Lijek možete injicirati u bedro ili trbuh (abdomen) osim područja 5 cm oko pupka.
English: Do not get rid of any air bubbles in the syringe.
Croatian: Nemojte uklanjati mjehuriće zraka iz štrcaljke.
English: • Use your thumb and first (index) finger to pinch a fold of skin at the injection site.
Croatian: • Palcem i kažiprstom uhvatite nabor kože na mjestu injiciranja.
English: The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in patients older than 18 years with moderately to severely active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Croatian: kontrolirana, multicentrična ispitivanja (MOBILITY i TARGET bila su placebom kontrolirana ispitivanja, a MONARCH ispitivanje kontrolirano aktivnim lijekom) provedena u bolesnika starijih od 18 godina s umjerenim do teškim oblikom aktivnog reumatoidnog artritisa dijagnosticiranog prema kriterijima Američkog reumatološkog društva (engl.
English: If you miss a dose of Kevzara
Croatian: Ako ste propustili dozu lijeka Kevzara
English: The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
Croatian: Najčešće nuspojave primijećene kod primjene lijeka Kevzara u kliničkim ispitivanjima bile su neutropenija, povišene vrijednosti ALT-a, eritem na mjestu injiciranja, infekcije gornjih dišnih putova i infekcije mokraćnih putova.
English: Talk to your doctor, pharmacist, or nurse if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri:
English: • injection site reactions (including redness and itching)
Croatian: • reakcije na mjestu injiciranja (uključujući crvenilo i svrbež)
English: Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations (see sections 4.4 and 4.8):
Croatian: Preporučene prilagodbe doze u slučaju neutropenije, trombocitopenije ili povišenih vrijednosti jetrenih enzima (vidjeti dijelove 4.4 i 4.8):
English: Upon initiation or discontinuation of Kevzara in patients being treated with CYP substrate medicinal products, therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) should be performed and the individual dose of the medicinal product should be adjusted as needed.
Croatian: Nakon uvođenja ili prekida liječenja lijekom Kevzara u bolesnika koji se liječe supstratom CYP enzima potrebno je kontrolirati terapijski učinak (npr. varfarina) ili koncentraciju lijeka (npr. teofilina) i po potrebi prilagoditi dozu lijeka.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku.
English: • you have any infection or, you get a lot of infections.
Croatian: • ako trenutno imate infekciju ili ako često imate infekcije.
English: Ask your doctor, pharmacist or nurse how to throw away the container.
Croatian: Pitajte svog liječnika, ljekarnika ili medicinsku sestru kako zbrinuti spremnik.
English: Current dose of Kevzara should be maintained.
Croatian: Treba zadržati dosadašnju dozu lijeka Kevzara.
English: Treatment with Kevzara should be withheld if a patient develops a serious infection or an opportunistic infection.
Croatian: Primjenu lijeka Kevzara potrebno je odgoditi ako se u bolesnika razvije ozbiljna ili oportunistička infekcija.
English: Do not use the pen if it has been out of the refrigerator for more than 14 days.
Croatian: Nemojte upotrijebiti brizgalicu ako je bila izvan hladnjaka više od 14 dana.
English: Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
Croatian: Smanjenje doze s 200 mg jedanput svaka 2 tjedna na 150 mg jedanput svaka 2 tjedna preporučuje se za zbrinjavanje neutropenije, trombocitopenije i povišenih vrijednosti jetrenih enzima.
English: >3 x ULN5 x ULN >5 x ULN
Croatian: > 3 x GGN5 x GGN > 5 x GGN
English: • you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.
Croatian: • ako ste ikada imali divertikulitis (bolest donjeg dijela debelog crijeva) ili čireve u želucu ili crijevima ili ako se pojave simptomi koji uključuju vrućicu i bol u trbuhu (abdomenu) koja ne prolazi
English: Body weight influenced the pharmacokinetics of sarilumab.
Croatian: Tjelesna težina utjecala je na farmakokinetiku sarilumaba.
English: • infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection)
Croatian: • infekcije sinusa ili grla, začepljen nos ili curenje iz nosa i grlobolja (infekcija gornjih dišnih putova)
English: • Low white blood cell counts shown by blood tests
Croatian: • nizak broj bijelih krvnih stanica - vidljivo u nalazima krvnih pretraga
English: The impact of treatment with Kevzara on the development of malignancies is not known but malignancies were reported in clinical studies (see section 4.8).
Croatian: Utjecaj liječenja lijekom Kevzara na razvoj zloćudnih bolesti nije poznat, no zloćudne su bolesti prijavljene u kliničkim ispitivanjima (vidjeti dio 4.8).
English: Lipid parameters should be assessed approximately 4 to 8 weeks following initiation of treatment with Kevzara, then at approximately 6 month intervals.
Croatian: Vrijednosti lipidnih parametara treba ocijeniti približno 4 do 8 tjedana nakon početka liječenja lijekom Kevzara, a zatim ih kontrolirati u intervalima od približno 6 mjeseci.
English: In 17 patients with RA, one week following a single 200-mg subcutaneous administration of sarilumab, exposure of simvastatin and simvastatin acid decreased by 45% and 36%, respectively (see section 4.5).
Croatian: Tjedan dana nakon supkutane primjene jedne doze sarilumaba od 200 mg u 17 bolesnika s RA izloženost simvastatinu smanjila se za 45%, a izloženost simvastatinskoj kiselini za 36% (vidjeti dio 4.5).
English: Treatment with Kevzara should be withheld in patients who develop a serious infection until the infection is controlled.
Croatian: Potrebno je odgoditi primjenu lijeka Kevzara u bolesnika u kojih se razvije ozbiljna infekcija, sve dok se ona ne stavi pod kontrolu.
English: Kevzara Monotherapy Any Dose N = 467
Croatian: Kevzara u monoterapiji (bilo koja doza) N = 467
English: The most common serious adverse reactions were infections (see section 4.4).
Croatian: Najčešće ozbiljne nuspojave bile su infekcije (vidjeti dio 4.4).
English: MONARCH was a 24 -week randomised double-blind, double-dummy study that compared Kevzara 200 mg monotherapy with adalimumab 40 mg monotherapy administered subcutaneously every two weeks in 369 patients with moderately to severely active RA who were inappropriate for treatment with MTX including those who were intolerant of or inadequate responders to MTX.
Croatian: Ispitivanje kontrolirano aktivnim usporednim lijekom MONARCH je bilo 24-tjedno randomizirano, dvostruko slijepo, dvostruko maskirano ispitivanje u kojem se monoterapija lijekom Kevzara u dozi od 200 mg uspoređivala s monoterapijom adalimumabom u dozi od 40 mg supkutano svaka dva tjedna u 369 bolesnika s umjerenim do teškim oblikom aktivnog RA koji nisu bili pogodni za liječenje MTX-om, uključujući bolesnike koji nisu podnosili MTX ili na njega nisu dovoljno dobro odgovorili.
English: If it has been 4 days or more since the missed dose, the subsequent dose should be administered at the next regularly scheduled time, the dose should not be doubled.
Croatian: Ako je prošlo 4 ili više dana otkad je bolesnik trebao primiti dozu, sljedeću dozu treba primijeniti prema uobičajenom rasporedu i ne smije se primijeniti dvostruka doza.
English: Monoclonal antibodies are not eliminated via renal or hepatic pathways.
Croatian: Monoklonska protutijela ne eliminiraju se ni putem bubrega ni putem jetre.
English: If it has been 4 days or more, inject the next dose at your regular time.
Croatian: Ako je od propuštene doze prošlo 4 ili više dana, injicirajte sljedeću dozu u uobičajeno vrijeme.
English: Treatment with Kevzara should be withheld until >1 x 109/L.
Croatian: Primjenu lijeka Kevzara treba odgoditi dok vrijednost ne bude > 1 x 109/l.
English: Treatment with Kevzara should be withheld until >100 x 103/µL.
Croatian: Primjenu lijeka Kevzara treba odgoditi dok vrijednost ne bude > 100 x 103/µl.
English: Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
Croatian: Sanofi Winthrop Industrie Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
English: Increased frequency and magnitude of these elevations were observed when potentially hepatotoxic medicinal products (e.g., MTX) were used in combination with Kevzara.
Croatian: Učestalost i težina tih povišenih vrijednosti bile su povećane kada su se u kombinaciji s lijekom Kevzara primjenjivali potencijalno hepatotoksični lijekovi (npr.
English: • Using the syringe at room temperature may make the injection more comfortable.
Croatian: • Ako pričekate da se štrcaljka ugrije na sobnu temperaturu, injekcija bi Vam mogla biti ugodnija.
English: • abnormal liver function tests
Croatian: • odstupanja u nalazima testova jetrene funkcije
English: The contribution of these concomitant medications relative to Kevzara in the development of gastrointestinal perforations is not known (see section 4.4).
Croatian: Doprinos tih istodobno primijenjenih lijekova razvoju gastrointestinalnih perforacija u odnosu na lijek Kevzara nije poznat (vidjeti dio 4.4).
English: p-value versus adalimumab *Includes patients who increased the frequency of dosing of adalimumab 40 mg to every week because of an inadequate response
Croatian: *Uključuje bolesnike kojima je zbog nedovoljno dobrog odgovora povećana učestalost primjene adalimumaba na 40 mg svaki tjedan
English: Less progression of both erosion and joint space narrowing scores at 24 and 52 weeks was reported in the sarilumab treatment groups compared to the placebo group.
Croatian: Prijavljeno je manje pogoršanje rezultata i za eroziju i za suženje zglobnog prostora u 24. i 52. tjednu u skupinama liječenima sarilumabom nego u skupini koja je primala placebo.
English: Table 5: Mean Radiographic Change from Baseline at Week 24 and Week 52 in MOBILITY
Croatian: Tablica 5: Srednja vrijednost radiološke promjene od početka ispitivanja do 24. tjedna i 52. tjedna u ispitivanju MOBILITY