FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients experiencing liver enzyme elevation, modification of treatment regimen, such as interruption of Kevzara or reduction in dose, resulted in decrease or normalization of liver enzymes (see section 4.2).
Croatian: U bolesnika s povišenim vrijednostima jetrenih enzima, prilagodba režima liječenja, kao što je privremeni prekid primjene ili smanjenje doze lijeka Kevzara, dovela je do smanjenja ili normalizacije vrijednosti jetrenih enzima
English: Do not freeze or heat the syringe.
Croatian: Nemojte zamrzavati ni zagrijavati štrcaljku.
English: Consider the risks and benefits of treatment prior to initiating Kevzara in patients who have:
Croatian: Prije početka liječenja lijekom Kevzara razmotrite rizike i koristi liječenja u bolesnika:
English: The parts of the Kevzara pre-filled syringe are shown in this picture.
Croatian: Dijelovi Kevzara napunjene štrcaljke prikazani su na sljedećoj slici.
English: Patients should be closely monitored for the development of signs and symptoms of infection during treatment with Kevzara (see sections 4.2 and 4.8).
Croatian: Tijekom liječenja lijekom Kevzara bolesnike treba pažljivo nadzirati zbog moguće pojave znakova i simptoma infekcije (vidjeti dijelove 4.2 i 4.8).
English: In MOBILITY and TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs in physical component summary (PCS) and no worsening on the mental component summary (MCS) at Week 24.
Croatian: ispitivanjima MOBILITY i TARGET, u bolesnika koji su primali lijek Kevzara u dozi od 200 mg + DMARD-ove svaka dva tjedna i onih koji su primali lijek Kevzara u dozi od 150 mg + DMARD-ove svaka dva tjedna zabilježeno je veće poboljšanje zbirne komponente fizičkog zdravlja (engl. physical component summary, PCS) nego u bolesnika koji su primali placebo + DMARD-ove, bez pogoršanja zbirne komponente mentalnog zdravlja (engl. mental component summary, MCS) u 24. tjednu.
English: In both MOBILITY and TARGET, higher ACR20 response rates were observed within 2 weeks compared to placebo and were maintained for the duration of the studies (see Figures 1 and 2).
Croatian: 2 tjedna u usporedbi s placebom, a održale su se tijekom cijelog trajanja ispitivanja (vidjeti Sliku 1 i Sliku 2).
English: A more than dose-proportional increase in pharmacokinetic exposure was observed in patients with RA.
Croatian: U bolesnika s RA primijećeno je povećanje farmakokinetičke izloženosti koje je bilo veće od povećanja proporcionalnog dozi.
English: For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively.
Croatian: Cmin i Cmax sarilumaba u stanju dinamičke ravnoteže iznosila je 396 ± 194 mg.dan/l, 16,7 ± 13,5 mg/l odnosno 35,4 ± 13,9 mg/l.
English: 150 mg solution for injection
Croatian: 150 mg otopina za injekciju
English: In MOBILITY and TARGET, patients receiving sarilumab 200 mg + DMARDs every two weeks or sarilumab 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs.
Croatian: U ispitivanjima MOBILITY i TARGET, u bolesnika koji su primali sarilumab u dozi od 200 mg + DMARD-ove svaka dva tjedna i onih koji su primali sarilumab u dozi od 150 mg + DMARD-ove svaka dva tjedna primijećeno je veće poboljšanje od početne vrijednosti nego u bolesnika koji su primali placebo + DMARD-ove.
English: • That Kevzara treatment may increase the risks of serious infections, neutropenia and intestinal perforation.
Croatian: • Upozorenje da liječenje lijekom Kevzara može povećati rizik od ozbiljnih infekcija,
English: Liver Enzyme Abnormalities Lab Value
Croatian: Odstupanja u vrijednostima jetrenih enzima Laboratorijska vrijednost Preporuka
English: Hypercholesterolemia Hypertriglyceridemia
Croatian: Poremećaji metabolizma i prehrane često hiperkolesterolemija hipertrigliceridemija
English: Cases of herpes zoster were observed in clinical studies with Kevzara.
Croatian: kliničkim ispitivanjima lijeka Kevzara primijećeni su slučajevi herpesa zoster.
English: After multiple dosing of 150 to 200 mg every two weeks, steady state was reached in 12 to 16 weeks with a 2- to 3-fold accumulation compared to single dose exposure.
Croatian: stanje dinamičke ravnoteže postignuto je nakon 12 do 16 tjedana, uz 2 do 3 puta veću akumulaciju u usporedbi s onom nakon izlaganja jednokratnoj dozi.
English: In MOBILITY, the improvement in physical functioning as measured by HAQ-DI was maintained up to Week 52 (-0.75, -0.71, and -0.46 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX treatment groups, respectively).
Croatian: U ispitivanju MOBILITY poboljšanje fizičke funkcije prema HAQ-DI rezultatu održalo se do 52. tjedna (-0,75 uz lijek Kevzara 200 mg + MTX, -0,71 uz lijek Kevzara 150 mg + MTX i -0,46 uz placebo + MTX).
English: Put your used syringe and the cap into a puncture-resistant container right away after use.
Croatian: Odložite upotrijebljenu brizgalicu i zatvarač u neprobojni spremnik odmah nakon uporabe.
English: Do not use the syringe if the date has passed.
Croatian: Nemojte upotrijebiti štrcaljku ako joj je istekao rok valjanosti.
English: For recommended dose modifications based on ANC results see section 4.2.
Croatian: Za preporučene prilagodbe doze s obzirom na ABN vrijednosti vidjeti dio 4.2.
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant conventional DMARDs (cDMARDs).
Croatian: Kevzara u dozi od 200 mg, lijek Kevzara u dozi od 150 mg ili placebo svaka 2 tjedna, istodobno s konvencionalnim DMARD-ovima (kDMARD).
English: A patient may self-inject Kevzara or the patient's caregiver may administer Kevzara if their healthcare professional determines that it is appropriate.
Croatian: Ako zdravstveni radnik utvrdi da je to prikladno, bolesnik može samostalno injicirati lijek Kevzara ili mu ga može primijeniti skrbnik.
English: • you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB.
Croatian: • ako imate tuberkulozu (TBC), simptome TBC-a (dugotrajan kašalj, gubitak tjelesne težine,
English: • Initiating treatment with Kevzara is not recommended in patients with a platelet count below 150 x103/µL.
Croatian: • Ne preporučuje se započeti liječenje lijekom Kevzara u bolesnika kojima je broj trombocita ispod 150 x 103/µl.
English: *cDMARDs in TARGET included MTX, sulfasalazine, leflunomide and hydroxychloroquine p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo ‡ Primary endpoint § NA=Not Applicable as TARGET was a 24-week study ¶ Major clinical response = ACR70 for at least 24 consecutive weeks during the 52-week period
Croatian: † p-vrijednost < 0,01 za razliku u odnosu na placebo †† p-vrijednost < 0,001 za razliku u odnosu na placebo ††† p-vrijednost < 0,0001 za razliku u odnosu na placebo ‡ Primarna mjera ishoda § NP = nije primjenjivo, jer je ispitivanje TARGET trajalo 24 tjedna
English: Do not re-use the syringe.
Croatian: Nemojte ponovno upotrijebiti istu štrcaljku.
English: TARGET demonstrated significant improvement in HAQ-DI scores at Week 12 compared to placebo (-0.49, -0.50, and -0.29 for Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs, and placebo + DMARDs, every two weeks, respectively).
Croatian: zabilježeno je značajno poboljšanje HAQ-DI rezultata u 12. tjednu u odnosu na placebo (-0,49 uz lijek Kevzara 200 mg + DMARD-ove, -0,50 uz lijek Kevzara 150 mg + DMARD-ove i -0,29 uz placebo + DMARD-ove svaka 2 tjedna).
English: Traceability of Kevzara
Croatian: Sljedivost lijeka Kevzara
English: Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Croatian: Nakon supkutane (s.c.) primjene jedne doze sarilumaba od 200 mg i 150 mg u bolesnika s RA
English: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Croatian: Sastavnice štrcaljke uložene su u napunjenu brizgalicu za jednokratnu uporabu sa žutim pokrovom igle i svijetlonarančastim zatvaračem.
English: Let the syringe warm up to room temperature for at least 30 minutes before using.
Croatian: Pričekajte najmanje 30 minuta da se štrcaljka ugrije na sobnu temperaturu prije nego što primijenite lijek.
English: Pre-filled syringe 150 mg:
Croatian: Napunjena brizgalica od 150 mg:
English: Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled pen
Croatian: Kevzara 150 mg otopina za injekciju u napunjenoj štrcaljki Kevzara 150 mg otopina za injekciju u napunjenoj brizgalici Kevzara 200 mg otopina za injekciju u napunjenoj štrcaljki Kevzara 200 mg otopina za injekciju u napunjenoj brizgalici
English: Placebo + cDMA RDs* N = 181
Croatian: Placebo + kDMARD* N = 181
English: • low platelet counts shown by blood tests
Croatian: • nizak broj trombocita - vidljivo u nalazima krvnih pretraga
English: Following these instructions, Kevzara can be self-injected or administered by a care-giver.
Croatian: Prema tim uputama možete sami injicirati lijek Kevzara ili Vam ga može injicirati Vaš njegovatelj.
English: If it has been 3 days or less since the missed dose:
Croatian: Ako je od propuštene doze prošlo 3 dana ili manje: • injicirajte propuštenu dozu što prije
English: Table 4: Mean reductions from baseline to Week 24 in components of ACR score
Croatian: Tablica 4: Srednje vrijednosti smanjenja rezultata za sastavnice ACR odgovora od početka ispitivanja do 24. tjedna
English: Check to see if the entire window has turned yellow before you remove the pen.
Croatian: Prije nego što uklonite brizgalicu, uvjerite se da je cijeli prozorčić postao žut.
English: KEVZARA 150 mg injection sarilumab
Croatian: KEVZARA 150 mg injekcija sarilumab
English: This is because Kevzara can affect the way some other medicines work.
Croatian: Naime, Kevzara može utjecati na način djelovanja nekih drugih lijekova, baš kao što i neki drugi lijekovi mogu utjecati na način djelovanja lijeka Kevzara.
English: Do not freeze or heat the pen.
Croatian: Nemojte zamrzavati ni zagrijavati brizgalicu.
English: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange.
Croatian: Napunjena štrcaljka od 200 mg: Napunjena štrcaljka za jednokratnu uporabu ima zatvarač igle načinjen od stiren-butadienskog elastomera, a opremljena je bijelim polistirenskim potisnikom klipa i tamnonarančastim polipropilenskim rubnikom za prste.
English: Various in vitro and limited in vivo human studies have shown that cytokines and cytokine modulators can influence the expression and activity of specific cytochrome P450 (CYP) enzymes (CYP1A2, CYP2C9, CYP2C19, and CYP3A4) and therefore have the potential to alter the pharmacokinetics of concomitantly administered medicinal products that are substrates of these enzymes.
Croatian: (CYP1A2, CYP2C9, CYP2C19 i CYP3A4) i stoga mogu izmijeniti farmakokinetiku istodobno primijenjenih lijekova koji su supstrati tih enzima.
English: • Multipack containing 6 (3 packs of 2) pre-filled pens
Croatian: • Višestruko pakiranje koje sadrži 6 (3 pakiranja od 2) napunjenih brizgalica
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes.
Croatian: otopina za injekciju Višestruko pakiranje: 6 (3 pakiranja od 2) napunjenih brizgalica.
English: Do not try to put the cap back on the syringe.
Croatian: Nemojte pokušavati vratiti zatvarač na štrcaljku.
English: Talk to your doctor before using Kevzara if you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku prije nego što primijenite lijek Kevzara.
English: The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
Croatian: Otopina se ne smije upotrijebiti ako je mutna, ako je promijenila boju, ako sadrži čestice ili ako bilo koji dio štrcaljke/brizgalice izgleda oštećeno.
English: Adalimumab 40 mg q2w* (N=185)
Croatian: Adalimumab 40 mg svaka 2 tjedna (N=185)
English: Do not use this medicine if the solution in the syringe is cloudy, discoloured or contains particles, or if any part of the pre-filled syringe looks damaged.
Croatian: Nemojte upotrijebiti lijek ako je otopina u brizgalici mutna, ako je promijenila boju, ako sadrži čestice ili ako bilo koji dio napunjene brizgalice izgleda oštećeno.
English: KEVZARA 200 mg injection sarilumab
Croatian: KEVZARA 200 mg injekcija sarilumab
English: Results at 52 weeks in MOBILITY were similar to the results at 24 weeks for TARGET.
Croatian: Rezultati za sastavnice ACR odgovora u 24. tjednu ispitivanja MOBILITY i TARGET prikazani su u Tablici 4. Rezultati u 52. tjednu ispitivanja MOBILITY bili su slični onima u 24. tjednu ispitivanja TARGET.
English: Once removed from the refrigerator, do not store the syringe above 25ºC.
Croatian: Nakon što izvadite štrcaljku iz hladnjaka, nemojte je čuvati na temperaturi iznad 25ºC.
English: In an enhanced pre-/postnatal developmental toxicity study, pregnant Cynomolgus monkeys were administered sarilumab once-weekly intravenously from early gestation to natural birth (approximately 21 weeks) Maternal exposure up to approximately 83 times the human exposure based on AUC after subcutaneous doses of 200 mg every 2 weeks, did not cause any maternal or embryofetal effects.
Croatian: U proširenom ispitivanju toksičnih učinaka na prenatalni i postnatalni razvoj, skotne ženke makaki majmuna primale su sarilumab intravenski jedanput tjedno, od rane gestacije do prirodnog okota (približno 21 tjedan).
English: In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs population.
Croatian: Opažanja u populaciji koja je primala monoterapiju lijekom Kevzara bila su u skladu s onima u populaciji koja je primala lijek Kevzara + DMARD-ove.
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant MTX.
Croatian: Bolesnici su primali lijek Kevzara u dozi od 200 mg, lijek Kevzara u dozi od 150 mg ili placebo svaka 2 tjedna, istodobno s MTX-om.
English: For recommended dose modifications based on transaminase elevations see section 4.2.
Croatian: Za preporučene prilagodbe doze s obzirom na broj trombocita vidjeti dio 4.2.
English: Do not re-use the pen.
Croatian: Nemojte ponovno upotrijebiti istu brizgalicu.
English: Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8).
Croatian: Kod liječenja lijekom Kevzara prijavljene su reakcije preosjetljivosti (vidjeti dio 4.8).
English: kevzara 150 mg pen
Croatian: kevzara 150 mg brizgalica
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with the Blue Box - MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED SYRINGES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE OD 6 (3 PAKIRANJA OD 2) NAPUNJENIH ŠTRCALJKI
English: Laboratory abnormalities
Croatian: Laboratorijski parametri
English: Adverse Reaction
Croatian: Potkožna primjena
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24, changes from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 16, and change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week
Croatian: Primarne mjere ishoda bile su udio bolesnika koji su postigli odgovor ACR20 u 24. tjednu, promjene indeksa onesposobljenosti prema upitniku za ocjenu zdravstvenog stanja (engl.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Croatian: Nositelj odobrenja za stavljanje lijeka u promet sanofi-aventis groupe 54, rue La Boétie Ž -75008 Paris Francuska
English: IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the synovial fluid of patients with rheumatoid arthritis and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA.
Croatian: diferencijacija, preživljenje i apoptoza, te može aktivirati hepatocite da otpuštaju proteine akutne faze, uključujući C-reaktivni protein (CRP) i serumski amiloid A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with the Blue Box - MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED PENS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE OD 6 (3 PAKIRANJA OD 2) NAPUNJENIH BRIZGALICA
English: Store in a refrigerator (2ºC - 8ºC).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2ºC - 8ºC).
English: • Once taken out of the refrigerator, do not store Kevzara above 25 ºC.
Croatian: • Nakon što se izvadi iz hladnjaka, Kevzara se ne smije čuvati na temperaturi iznad 25ºC.
English: How to store Kevzara
Croatian: Kako čuvati lijek Kevzara
English: In MOBILITY, a greater proportion of patients treated with Kevzara 200 mg or 150 mg every two weeks plus MTX achieved remission, defined as Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) < 2.6 compared with placebo + MTX at Week 52.
Croatian: U ispitivanju MOBILITY, veći udio bolesnika liječenih lijekom Kevzara u dozi od 200 mg ili 150 mg svaka dva tjedna plus MTX-om nego onih koji su primali placebo + MTX je u 52. tjednu ostvario remisiju, koja se definirala kao indeks aktivnosti bolesti prema vrijednosti C-reaktivnog proteina (engl.
English: • Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., ANC less than 2 x 109/L.
Croatian: • Ne preporučuje se započeti liječenje lijekom Kevzara u bolesnika s niskim brojem neutrofila, tj. apsolutnim ABN-om manjim od 2 x 109/l.
English: Do not put the cap back on. Do not throw the used pens in household waste.
Croatian: Nemojte baciti upotrijebljenu štrcaljku u kućni otpad.
English: Always keep the container out of the sight and reach of children.
Croatian: Uvijek čuvajte spremnik izvan pogleda i dohvata djece.
English: The rates of discontinuations due to hypersensitivity in the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population were consistent with the placebo-controlled population.
Croatian: Stope prekida liječenja zbog preosjetljivosti u populaciji za ocjenu dugoročne sigurnosti koja je primala lijek Kevzara + DMARD-ove i onoj koja je primala monoterapiju lijekom Kevzara bile su u skladu s onima zabilježenima u placebom kontroliranoj populaciji.
English: In the placebo-controlled population, 4.0%, 5.6%, and 2.0% of patients treated with Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs and placebo + DMARDs respectively, exhibited a positive response in the anti-drug antibody (ADA) assay.
Croatian: U placebom kontroliranoj populaciji je 4,0% bolesnika koji su primali lijek Kevzara u dozi od 200 mg + DMARD-ove, 5,6% bolesnika koji su primali lijek Kevzara u dozi od 150 mg + DMARD-ove te 2,0% bolesnika koji su primali placebo + DMARD-ove imalo pozitivan nalaz testa na protutijela na lijek.
English: Do not put the needle cap back on. Do not throw the used syringe in household waste.
Croatian: Nemojte baciti upotrijebljenu brizgalicu u kućni otpad.
English: At Week 52, 55.6% of patients receiving Kevzara 200 mg and 47.8% of patients receiving Kevzara 150 mg had no progression of structural damage (as defined by a change in the TSS of zero or less) compared with 38.7% of patients receiving placebo.
Croatian: Izostanak progresije strukturnog oštećenja (definiran kao promjena ukupnog rezultata prema Sharpovoj ljestvici za 0 ili manje bodova) u 52. tjednu zabilježen je u 55,6% bolesnika koji su primali lijek Kevzara u dozi od 200 mg i 47,8% onih koji su primali lijek Kevzara u dozi od 150 mg, u usporedbi s 38,7% bolesnika koji su primali placebo.
English: Name and address of the manufacturer of the biological active substance Regeneron Pharmaceuticals Inc.
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: There were no reports of gastrointestinal perforation in the Kevzara monotherapy population.
Croatian: U populaciji koja je primala monoterapiju lijekom Kevzara nije prijavljen nijedan slučaj gastrointestinalne perforacije.
English: Twist or pull off the orange cap.
Croatian: Zakrenite ili povucite narančasti zatvarač i skinite ga.
English: Decreases in platelet counts below 100 x 103/µL occurred in 1.2% and 0.6% of patients on 200 mg and 150 mg Kevzara + DMARDs, respectively, compared to no patients on placebo + DMARDs.
Croatian: Pad broja trombocita ispod 100 x 103/µl zabilježen je u 1,2% i 0,6% bolesnika koji su primali lijek Kevzara u dozi od 200 mg odnosno 150 mg + DMARD-ove, dok u bolesnika koji su primali placebo +
English: kevzara 200 mg pen
Croatian: kevzara 200 mg brizgalica
English: Do not use a pen if it has been damaged or the cap is missing or not attached.
Croatian: Nemojte upotrijebiti brizgalicu ako je oštećena, ako joj nedostaje zatvarač ili ako zatvarač nije pričvršćen.
English: Keep the carton in an insulated bag with an ice pack when travelling.
Croatian: Kada putujete, kutiju čuvajte u prijenosnom hladnjaku s ledenim uloškom.
English: • A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using Kevzara.
Croatian: • Poruku upozorenja za zdravstvene radnike koji liječe bolesnika u bilo kojem trenutku,
English: Kevzara is available as 150 mg or 200 mg pre-filled syringes.
Croatian: Kevzara dolazi u napunjenim štrcaljkama koje sadrže 150 mg ili 200 mg lijeka.
English: In the placebo-controlled population, the rates of infections were 84.5, 81.0, and 75.1 events per 100 patient-years, in the 200 mg and 150 mg Kevzara + DMARDs and placebo + DMARDs groups respectively.
Croatian: Stopa infekcija u placebom kontroliranoj populaciji iznosila je 84,5 događaja na 100 bolesnik-godina u skupini koja je primala lijek Kevzara u dozi od 200 mg + DMARD-ove, 81,0 događaja na 100 bolesnik-godina u skupini koja je primala lijek Kevzara u dozi od 150 mg + DMARD-ove te 75,1 događaj na 100 bolesnik-godina u skupini koja je primala placebo + DMARD-ove.
English: Do not inject if the liquid is cloudy, discoloured or contains particles.
Croatian: Nemojte injicirati lijek ako je otopina mutna, ako je promijenila boju ili ako sadrži čestice.
English: ≥0.3 units) at Week 52 compared to 26.1% in the placebo + MTX treatment group.
Croatian: 26,1% bolesnika koji su primali placebo + MTX.
English: MOBILITY demonstrated significant improvement in physical function, as measured by the HAQ-DI at Week 16 compared to placebo (-0.58, -0.54, and -0.30 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX, every two weeks, respectively).
Croatian: rezultatu u 16. tjednu u odnosu na placebo (-0,58 uz lijek Kevzara 200 mg + MTX, -0,54 uz lijek Kevzara 150 mg + MTX i -0,30 uz placebo + MTX svaka 2 tjedna).
English: In the Kevzara + DMARDs long-term safety population, the rate of GI perforations was 0.14 events per 100 patient-years.
Croatian: Stopa GI perforacija u populaciji za ocjenu dugoročne sigurnosti koja je primala lijek Kevzara + DMARD-ove iznosila je 0,14 događaja na
English: Kevzara is available as 150 mg or 200 mg pre-filled pens.
Croatian: Kevzara dolazi u napunjenim brizgalicama koje sadrže 150 mg ili 200 mg lijeka.