FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms of leukaemia can include fever, feeling tired, frequent infections, easy bruising, and night sweats.
Croatian: Simptomi leukemije mogu uključivati vrućicu, osjećaj umora, učestale infekcije, lako stvaranje modrica i noćno znojenje.
English: Pregnancy and vaccinations
Croatian: Trudnoća i dojenje
English: Table 4 Key efficacy outcomes from GO-REVEAL
Croatian: Tablica 4 Ključni rezultati djelotvornosti iz ispitivanja GO-REVEAL
English: If you have active rheumatoid arthritis you will first be given other medicines.
Croatian: Ako imate aktivni reumatoidni artritis, najprije ćete dobiti druge lijekove.
English: Symptoms of heart failure include shortness of breath or swelling of your feet.
Croatian: Simptomi zatajenja srca su nedostatak zraka ili oticanje stopala.
English: • Menstrual disorders
Croatian: • poremećaji menstrualnog ciklusa
English: For patients weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available.
Croatian: Za bolesnike tjelesne težine manje od 40 kg dostupna je napunjena brizgalica od 45 mg/0,45 ml.
English: Pre-specified subgroup analyses of the primary endpoint by baseline CRP (≥ 1 mg/dL vs < 1 mg/dL) demonstrated higher flare rates in placebo + MTX vs Simponi + MTX treated subjects among subjects with baseline CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068).
Croatian: Prethodno definirane analize primarne mjere ishoda podskupine prema početnim vrijednostima CRP-a (≥ 1 mg/dl naspram < 1 mg/dl) pokazale su više stope razbuktavanja bolesti u skupini ispitanika koja je primala placebo + MTX nego u onoj koja je primala Simponi + MTX među ispitanicima s početnim vrijednostima CRP-a ≥ 1 mg/dl (87% naspram 40%, p = 0,0068).
English: In GO-AFTER, the primary endpoint was the percentage of patients achieving an ACR 20 response at week 14.
Croatian: U ispitivanju GO-AFTER primarni je ishod bio postotak bolesnika koji su postigli odgovor ACR 20 u 14. tjednu.
English: Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).
Croatian: Terapijski infektivni agensi ne smiju se davati istodobno s golimumabom (vidjeti dio 4.4).
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-AHEAD) in 197 adult patients with severe active nr-Axial SpA (defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS).
Croatian: Sigurnost i djelotvornost lijeka Simponi bile su procijenjene u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (GO-AHEAD) u 197 odraslih bolesnika s teškim aktivnim aksijalnim spondiloartritisom bez radiološkog dokaza (definiranih kao oni bolesnici koji zadovoljavaju kriterije klasifikacije ASAS za aksijalni spondiloartritis, ali koji nisu zadovoljili modificirane njujorške kriterije za AS).
English: Know your dose
Croatian: Budite sigurni u svoju dozu
English: Treatment with concomitant MTX resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without MTX (approximately 3% [41/1235] versus 8% [64/827], respectively).
Croatian: Istodobno liječenje metotreksatom rezultiralo je manjim udjelom bolesnika s protutijelima na golimumab (oko 3% [41/1235]), naspram bolesnika koji uz golimumab nisu primali MTX (8% [64/827]).
English: In this study, the incidence (95% CI) per 100 subject-years of follow-up in golimumab-treated subjects was 0.40 (0.01, 2.20) for lymphoma, 0.79 (0.10, 2.86) for non-melanoma skin cancers, and 1.99 (0.64, 4.63) for other malignancies.
Croatian: U tom ispitivanju incidencija (95% CI) limfoma na 100 ispitanik-godina praćenja u bolesnika liječenih golimumabom iznosila je 0,40 (0,01; 2,20), incidencija nemelanomskog raka kože 0,79 (0,10; 2,86), a incidencija drugih zloćudnih tumora 1,99 (0,64; 4,63).
English: • Narrowing of the blood vessels in the heart
Croatian: • suženje krvnih žila srca
English: Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Croatian: Pokazalo se, prema rendgenskim snimkama, da Simponi u kombinaciji s metotreksatom smanjuje brzinu napredovanja oštećenja zglobova i poboljšava fizičku funkciju.
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-RAISE) in 356 adult patients with active ankylosing spondylitis (defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and a VAS for total back pain of ≥ 4, on a scale of 0 to 10 cm).
Croatian: Sigurnost i djelotvornost lijeka Simponi procijenjeni su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (GO-RAISE) na 356 odraslih bolesnika s aktivnim ankilozantnim spondilitisom (definiranim rezultatom ≥ 4 prema Bath indeksu aktivnosti ankilozantnog spondilitisa (BASDAI) i rezultatom ≥ 4 na vizualnoj analognoj skali (VAS) za ukupnu jačinu boli u kralježnici od 0 do 10 cm).
English: • Read the Simponi package leaflet carefully before you start using this medicine.
Croatian: • Prije započinjanja liječenja molimo pažljivo pročitajte uputu o lijeku Simponi.
English: • Severely decreased number of white blood cells
Croatian: • jako smanjeni broj bijelih krvnih stanica
English: The safety and efficacy of Simponi was evaluated in a randomised, double-blind, placebo-controlled, withdrawal study (GO-KIDS) in 173 children (2 to 17 years of age) with active pJIA with at least 5 active joints and an inadequate response to MTX.
Croatian: Sigurnost i djelotvornost lijeka Simponi ocijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju koje je uključivalo fazu ukidanja aktivne terapije (engl. withdrawal study) (GO-KIDS), provedenom u 173 djece (u dobi od 2 do 17 godina) s aktivnim pJIA i najmanje 5 aktivnih zglobova koji nisu ostvarili odgovarajući odgovor na MTX.
English: In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients.
Croatian: U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA, PsA, AS, aksijalnim spondiloartritisom bez radiološkog dokaza i UC, infekcija gornjih dišnih puteva bila je najčešće prijavljena nuspojava, a pojavila se u 12,6% bolesnika liječenih golimumabom u odnosu na 11,0% bolesnika u kontrolnim skupinama.
English: Treatment with 50 mg or 100 mg golimumab subcutaneous every 4 weeks during maintenance resulted in a mean steady-state trough serum concentration of approximately 0.9 ± 0.5 g/mL and 1.8 ± 1.1 g/mL, respectively.
Croatian: Liječenje golimumabom u supkutanoj dozi od 50 mg odnosno 100 mg svaka 4 tjedna tijekom razdoblja održavanja dovelo je do srednje vrijednosti najnižih koncentracija u serumu u stanju dinamičke ravnoteže od približno 0,9 ± 0,5 µg/ml odnosno 1,8 ± 1,1 µg/ml.
English: • Look through the viewing window to make sure that the liquid in the pre-filled pen is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow.
Croatian: • Pogledajte kroz prozorčić brizgalice kako bi se uvjerili da je tekućina u napunjenoj brizgalici bistra do blago opalescentna (ima biserni odsjaj) te bezbojna do žućkasta.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement of the SF-36 physical component was maintained through week 104.
Croatian: Kod bolesnika koji su nastavili liječenje lijekom Simponi koje im je randomizacijom bilo dodijeljeno na početku ispitivanja, poboljšanje SF-36 fizičke komponente održalo se do 104. tjedna.
English: Ankylosing spondylitis and non-radiographic axial spondyloarthritis Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine.
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza su upalne bolesti kralježnice.
English: Instructions for Use Simponi 45 mg/0.45 mL solution for injection in pre-filled pen, VarioJect For paediatric use
Croatian: Upute za uporabu Simponi 45 mg/0,45 ml otopina za injekciju u napunjenoj brizgalici, VarioJect Za pedijatrijsku primjenu
English: In patients weighing less than 80 kg, a greater proportion of patients who received 50 mg maintenance therapy showed sustained clinical remission compared with those who received placebo.
Croatian: Među bolesnicima tjelesne težine manje od 80 kg, održan klinički odgovor primijećen je u većeg udjela bolesnika koji su primali terapiju održavanja u dozi od 50 mg nego u bolesnika koji su primali placebo.
English: • Low red blood cell counts
Croatian: • smanjeni broj crvenih krvnih stanica
English: Solution for injection in pre-filled pen (injection), VarioJect
Croatian: Otopina za injekciju u napunjenoj brizgalici (injekcija), VarioJect
English: Figure 10
Croatian: Slika 10
English: If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
Croatian: Ako na te lijekove ne odgovorite dobro, za liječenje bolesti dobit ćete Simponi.
English: • Vision disturbances
Croatian: • poremećaji vida
English: • There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death.
Croatian: • U neke djece i adolescenata koji su primali TNF blokatore zabilježeni su slučajevi raka, uključujući neke neuobičajene vrste raka, koji ponekad imaju smrtni ishod.
English: Patients in clinical remission at week 6
Croatian: Bolesnici s cijeljenjem sluznice u 6. tjednu
English: In the controlled period of UC trials of golimumab induction, serious infections were observed in 0.8% of golimumab-treated patients compared with 1.5% of control-treated patients.
Croatian: U kontroliranom razdoblju ispitivanja uvodne terapije golimumabom u bolesnika s UC ozbiljne infekcije zabilježene su u 0,8% bolesnika liječenih golimumabom te u 1,5% bolesnika iz kontrolne skupine.
English: • Before starting breast-feeding, your last treatment with Simponi must be at least 6 months ago.
Croatian: • Prije nego što započnete dojiti, mora proći najmanje 6 mjeseci od zadnje injekcije lijeka Simponi.
English: In controlled and uncontrolled periods of the UC pivotal trials with a median follow-up of approximately 2 years, the proportion of patients with mild ALT elevations was 24.7% in patients receiving golimumab during the maintenance portion of the UC study.
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja u bolesnika s UC, s medijanom praćenja od približno 2 godine, udio bolesnika s blagim porastom razina ALT-a iznosio je 24,7% u bolesnika koji su primali golimumab tijekom razdoblja održavanja u sklopu ispitivanja u bolesnika s UC.
English: In GO-FORWARD, among 89 subjects randomised to Simponi 50 mg + MTX, 48 were still on this treatment at week 104.
Croatian: U ispitivanju GO-FORWARD, od 89 ispitanika randomiziranih u skupinu koja je primala Simponi u dozi od 50 mg i MTX, 48 je i dalje primalo tu terapiju u 104. tjednu.
English: In controlled and uncontrolled portions of the trials with a median follow-up of approximately 4 years, the incidence per 100 subject-years of infections was 81.1 events; 95% CI: 79.5, 82.8 for golimumab treated patients.
Croatian: U kontroliranim i nekontroliranim dijelovima ispitivanja s medijanom praćenja približno 4 godine, za bolesnike liječene golimumabom incidencija infekcija na 100 ispitanik-godina iznosila je 81,1 događaja; 95% CI: 79,5; 82,8.
English: During the Simponi Phase IIb and Phase III clinical trials in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), the incidence of lymphoma in golimumab-treated patients was higher than expected in the general population.
Croatian: Tijekom kliničkih ispitivanja lijeka Simponi faze IIb i faze III u bolesnika s reumatoidnim artritisom (RA), psorijatičnim artritisom (PsA) i ankilozantnim spondilitisom (AS), incidencija limfoma u bolesnika liječenih golimumabom bila je viša od one očekivane u općoj populaciji.
English: • 1 Cotton ball or gauze pad
Croatian: • 1 komadić vate ili jastučić gaze
English: It is normal to see some drug still visible in the viewing window.
Croatian: U prozorčiću će se možda i dalje vidjeti mala količina lijeka.
English: Autoimmune disease
Croatian: Autoimune bolesti
English: Result _______________
Croatian: Rezultat _______________
English: 135 to < 145
Croatian: 135 do < 145
English: d MRI sacroiliac joint score n reflects randomised and treated patients
Croatian: Srednja vrijednost promjene u SPARCC MRI rezultatu za sakroilijakalne zglobove n predstavlja randomizirane i liječene bolesnike
English: Discontinuation of golimumab should be considered if these disorders develop (see section 4.8).
Croatian: Ako se razviju ovi poremećaji, potrebno je razmotriti prekid primjene golimumaba (vidjeti dio 4.8).
English: Symptoms of blood disease can include a fever that does not go away, bruising or bleeding very easily or looking very pale.
Croatian: Simptomi bolesti krvi mogu uključivati vrućicu koja ne nestaje, stvaranje modrica ili krvarenje te bljedoću.
English: Of these 70 patients, 64, 46 and 31 patients had an ACR 20/50/70 response, respectively.
Croatian: Od tih 70 bolesnika, 64 je imalo odgovor ACR 20, 46 je imalo odgovor ACR 50, a 31 bolesnik imao je odgovor ACR 70.
English: 165 to < 175
Croatian: 165 do < 175
English: Key results for the 50 mg dose are shown in Table 5 and described below.
Croatian: Najvažniji rezultati za dozu od 50 mg prikazani su u tablici 5 i opisani u daljnjem tekstu.
English: In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of up to 3 years, there was a greater incidence of serious infections, including opportunistic infections and TB in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
Croatian: U kontroliranim i nekontroliranim dijelovima pivotalnih ispitivanja s medijanom praćenja do 3 godine, primijećena je povećana incidencija ozbiljnih infekcija uključujući oportunističke infekcije i tuberkulozu u bolesnika liječenih golimumabom u dozi od 100 mg u odnosu na bolesnike liječene golimumabom u dozi od 50 mg.
English: In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Croatian: U kontroliranim razdobljima pivotalnih ispitivanja s približno 4 godine praćenja, incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože) bila je slična u skupini koja je primala golimumab i u kontrolnim skupinama.
English: Symptoms can include fever, headache, weight loss, night sweats, rash, and nerve problems such as numbness and tingling.
Croatian: Simptomi mogu uključivati vrućicu, glavobolju, gubitak tjelesne težine, noćno znojenje, osip i tegobe povezane sa živcima kao što su utrnulost i trnci.
English: Take the pre-filled pen out of the carton.
Croatian: Izvadite napunjenu brizgalicu iz kutije.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 24.
Croatian: Općenito, nisu opažene klinički značajne razlike u mjerilima učinkovitosti između režima doziranja lijeka Simponi od 50 mg i 100 mg do 24. tjedna.
English: • 1 Adhesive bandage
Croatian: • 1 flaster
English: The primary endpoint was the percentage of patients achieving Ankylosing Spondylitis Assessment Study Group (ASAS) 20 response at week 14.
Croatian: Primarni ishod bio je postotak bolesnika koji su postigli odgovor ASAS 20 na ljestvici studijske skupine za ocjenu ankilozantnog spondilitisa (engl.
English: Do not inject if the perforations on the carton are broken.
Croatian: Nemojte injicirati lijek ako je kutija otvorena na perforiranom dijelu.
English: Among patients remaining in the study and treated with Simponi, improvements in physical function and health-related quality of life were similar from week 24 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi poboljšanje fizičke funkcije i zdravstvenog aspekta kvalitete života bili su slični od 24. do 256. tjedna.
English: • Feeling weak
Croatian: • osjećaj slabosti
English: Check injection site
Croatian: Provjerite mjesto injekcije
English: In the Phase II and III UC studies through week 54, antibodies to golimumab were detected by the EIA method in 3% (26/946) of golimumab treated patients.
Croatian: U ispitivanjima faze II i III u bolesnika s UC do 54. tjedna, protutijela na golimumab otkrivena su EIA metodom u 3% bolesnika (26/946) liječenih golimumabom.
English: PRE-FILLED PEN FOR PAEDIATRIC USE LABEL
Croatian: NALJEPNICA NAPUNJENE BRIZGALICE ZA PEDIJATRIJSKU PRIMJENU
English: In the Phase II and III UC studies through week 54, antibodies to golimumab were detected in 3% (26/946) of golimumab treated patients.
Croatian: U ispitivanjima faze II i III u bolesnika s UC do 54. tjedna, protutijela na golimumab otkrivena su u 3% bolesnika (26/946) liječenih golimumabom.
English: Efficacy evaluation in the study extension was based on changes in corticosteroid use, Physician's Global Assessment (PGA) of disease activity, and improvement in quality of life as measured by Inflammatory Bowel Disease Questionnaire (IBDQ).
Croatian: Procjena djelotvornosti u produžetku ispitivanja temeljila se na promjenama u primjeni kortikosteroida, aktivnosti bolesti prema općoj procjeni liječnika (engl.
English: Check the liquid in the pre-filled syringe
Croatian: Provjerite tekućinu u napunjenoj štrcaljki
English: Solution for injection in pre-filled pen (injection), SmartJect
Croatian: Otopina za injekciju u napunjenoj brizgalici (injekcija), SmartJect
English: Do not remove the pre-filled syringe's needle cover while allowing it to reach room temperature.
Croatian: Nemojte skidati zaštitni poklopac s igle napunjene štrcaljke dok čekate da se zagrije na sobnu temperaturu.
English: Improvements were observed at the first assessment (week 4) after the initial Simponi administration.
Croatian: Poboljšanja su bila opažena na prvom pregledu (4. tjedan) nakon prve primjene lijeka Simponi.
English: Concurrent administration of TNF-antagonists and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit.
Croatian: Ozbiljne infekcije i neutropenija primijećene su u kliničkim ispitivanjima istodobne primjene anakinre i drugog TNF-blokatora, etanercepta, koja nije dovela do dodatnog kliničkog poboljšanja.
English: Do not ever re-use a pre-filled syringe, for your safety and health and for the safety of others.
Croatian: Radi vlastite sigurnosti i zdravlja kao i radi sigurnosti drugih ljudi nemojte nikada ponovno upotrijebiti istu napunjenu štrcaljku.
English: In the dose confirming portion of the study, 761 patients were randomised to receive either 400 mg Simponi SC at week 0 and 200 mg at week 2, 200 mg Simponi SC at week 0 and 100 mg at week 2, or placebo SC at weeks 0 and 2.
Croatian: U dijelu ispitivanja namijenjenom potvrđivanju doze, 761 bolesnik randomiziran je u skupinu koja je u 0. tjednu primila Simponi u supkutanoj dozi od 400 mg, a zatim u 2. tjednu dozu od 200 mg, skupinu koja je u 0. tjednu primila Simponi u supkutanoj dozi od 200 mg, a zatim u 2. tjednu dozu od 100 mg ili u skupinu koja je i u 0. i u 2. tjednu primila supkutanu dozu placeba.
English: Figure 9
Croatian: Slika 9
English: • Leukaemia
Croatian: • leukemija
English: Remove cap Keep holding the pre-filled pen upright, then twist and pull the cap to remove.
Croatian: Skinite poklopac Nastavite uspravno držati napunjenu brizgalicu, a zatim okrenite poklopac i povucite ga s brizgalice.
English: After removing the pre-filled pen from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi.
Croatian: Nakon što se napunjena brizgalica izvadi iz hladnjaka, treba pričekati 30 minuta prije injiciranja lijeka Simponi kako bi lijek postigao sobnu temperaturu.
English: The incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
Croatian: Incidencija svih ozbiljnih infekcija na 100 ispitanik-godina iznosila je 4,1 događaja; 95% CI: 3,6; 4,5 za bolesnike liječene golimumabom u dozi od 100 mg te 2,5 događaja; 95% CI: 2,0; 3,1 za bolesnike liječene golimumabom u dozi od 50 mg.
English: Percentage of patients Patients in clinical response at week 6
Croatian: Postotak bolesnika Bolesnici s kliničkim odgovorom u 6. tjednu Bolesnici u kliničkoj remisiji u 6. tjednu
English: The dose you delivered can be confirmed by viewing the dose selection notch.
Croatian: Za provjeru isporučene doze pogledajte urez za odabir doze.
English: Tap air bubbles to top Hold the pre-filled pen upright with the blue cap pointing up.
Croatian: Lupkanjem dovedite mjehuriće zraka na vrh Držite napunjenu brizgalicu uspravno tako da je plavi poklopac usmjeren prema gore.
English: Simponi 50 mg given once a month, on the same date each month.
Croatian: Daje se 50 mg lijeka Simponi jedanput na mjesec, istoga dana u mjesecu.
English: • To ensure proper injection, allow the pre-filled syringe to sit at room temperature outside the box for 30 minutes, out of the reach of children.
Croatian: • Kako biste osigurali ispravnu primjenu lijeka, ostavite napunjenu brizgalicu 30 minuta izvan kutije na sobnoj temperaturi izvan dohvata djece.
English: In the controlled period of RA and AS pivotal trials, ALT elevations ≥ 5 x ULN were uncommon and seen in more golimumab-treated patients (0.4% to 0.9%) than control patients (0.0%).
Croatian: U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i AS povećanje razine ALT-a ≥ 5 x iznad GGN nije bilo često te je primijećeno u više bolesnika koji su primali golimumab (0,4% naspram 0,9%) nego u kontrolnoj skupini (0,0%).
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (javljaju se u do 1 na 100 osoba):
English: How much Simponi is given Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Croatian: Koliko lijeka Simponi treba primijeniti Reumatoidni artritis, psorijatični artritis i aksijalni spondiloartritis, uključujući ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza:
English: Simponi should not be used if the solution is discoloured, cloudy or containing visible foreign particles.
Croatian: Simponi se ne smije primijeniti ako je otopina promijenila boju, ako je zamućena ili sadrži vidljive strane čestice.
English: 155 to < 165
Croatian: 155 do < 165
English: The solution is clear to slightly opalescent, colourless to light yellow.
Croatian: Otopina je bistra do blago opalescentna, bezbojna do žućkasta.
English: How to store Simponi
Croatian: Kako čuvati Simponi
English: • If you are less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original schedule.
Croatian: • Ako ste s dozom zakasnili manje od 2 tjedna, ubrizgajte propuštenu dozu čim se sjetite i nastavite uzimati lijek prema dotadašnjem rasporedu.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 104.
Croatian: Općenito, nisu opažene klinički značajne razlike u mjerilima djelotvornosti između režima doziranja lijeka Simponi od 50 mg i 100 mg do 104. tjedna.
English: Keep pushing the pre-filled pen against the skin for approximately 5 seconds.
Croatian: Nastavite držati brizgalicu pritisnutom o kožu, a zatim je podignite Nastavite držati napunjenu brizgalicu pritisnutom o kožu još približno 5 sekundi.