FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite non-steroidal anti-inflammatory (NSAID) or DMARD therapy.
Croatian: Sigurnost i djelotvornost lijeka Simponi procijenjeni su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (GO-REVEAL) u 405 odraslih bolesnika s aktivnim psorijatičnim artritisom (≥ 3 otečena i ≥ 3 bolna zgloba) unatoč liječenju nesteroidnim antireumaticima ili DMARD terapiji.
English: With concomitant use of MTX, treatment with 50 mg golimumab subcutaneously every 4 weeks resulted in a mean ( standard deviation) steady-state trough serum concentration of approximately 0.6  0.4 g/mL in RA patients with active RA despite MTX therapy, and approximately 0.5  0.4 g/mL in patients with active PsA and approximately 0.8  0.4 g/mL in patients with AS. Steady-state trough mean serum golimumab concentrations in patients with nr-Axial SpA were similar to those observed in patients with AS following subcutaneous administration of 50 mg golimumab every 4 weeks.
Croatian: Uz istodobnu primjenu metotreksata, liječenje golimumabom primijenjenim supkutano u dozi od 50 mg svaka 4 tjedna dovelo je do srednje vrijednosti (± standardna devijacija) koncentracije u stanju dinamičke ravnoteže od približno 0,6 ± 0,4 g/ml u bolesnika s reumatoidnim artritisom aktivnim unatoč liječenju metotreksatom, približno 0,5 ± 0,4 g/ml u bolesnika s aktivnim psorijatičnim artritisom i približno 0,8 ± 0,4 g/ml u bolesnika s ankilozantnim spondilitisom.
English: Remove the pre-filled pen from the carton
Croatian: Izvadite napunjenu brizgalicu iz kutije
English: Injecting the medicine
Croatian: Injiciranje lijeka
English: Do not return this medicine to refrigerator if it has reached room temperature.
Croatian: Ako se lijek zagrijao na sobnu temperaturu, ne vraćajte ga u hladnjak.
English: The co-primary endpoints were the percentage of patients achieving ACR 20 response at week 14 and change from baseline in total PsA modified vdH-S score at week 24.
Croatian: Primarni ishodi bili su postotak bolesnika koji su postigli odgovor ACR 20 u 14. tjednu i promjena u odnosu na početnu vrijednost ukupnog broja vdH-S bodova za psorijatični artritis u 24. tjednu.
English: No animal fertility studies have been conducted with golimumab.
Croatian: Nisu provedena istraživanja utjecaja golimumaba na plodnost u životinja.
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Croatian: • Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove, uključujući bilo koje druge lijekove za liječenje reumatoidnog artritisa, psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez radiološkog dokaza ili ulceroznog kolitisa.
English: Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen are included in the pack.
Croatian: Opsežne upute za pripremu i primjenu lijeka Simponi u napunjenoj brizgalici nalaze se u pakiranju lijeka.
English: • Rheumatoid arthritis
Croatian: • Reumatoidni artritis
English: Solution for injection in pre-filled syringe (injection)
Croatian: Otopina za injekciju u napunjenoj štrcaljki (injekcija)
English: Each pre-filled syringe contains 41 mg sorbitol per 100 mg dose.
Croatian: Jedna napunjena brizgalica sadrži 41 mg sorbitola po dozi od 100 mg.
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (javljaju se u do 1 na 10 osoba):
English: The primary endpoint was the proportion of patients achieving ASAS 20 response at week 16.
Croatian: Primarni ishod bio je udio bolesnika koji su u 16. tjednu postigli odgovor ASAS 20.
English: • Look at the liquid through the viewing window of the pre-filled syringe and make sure that it is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow.
Croatian: • Pogledajte kroz prozorčić napunjene štrcaljke kako bi se uvjerili da je tekućina u napunjenoj štrcaljki bistra do blago opalescentna (ima biserni odsjaj) te bezbojna do žućkasta.
English: Put your used pre-filled pen in a sharps disposal container right away after use.
Croatian: Odmah nakon uporabe odložite upotrijebljenu napunjenu brizgalicu u spremnik za oštri otpad.
English: The 45 mg/0.45 mL pre-filled pen is for paediatric patients.
Croatian: Napunjena brizgalica od 45 mg/0,45 ml namijenjena je pedijatrijskim bolesnicima.
English: In the controlled and uncontrolled periods of the pivotal UC trials with a median follow-up of approximately 2 years, the proportion of patients with ALT elevations ≥ 5 x ULN was 0.8% 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 porastom razina ALT-a ≥ 5 x iznad GGN iznosio je 0,8% u bolesnika koji su primali golimumab tijekom razdoblja održavanja u sklopu ispitivanja u bolesnika s UC.
English: In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
Croatian: U kontroliranim ispitivanjima faze IIb i/ili faze III u bolesnika s RA, PsA, AS, aksijalnim spondiloartritisom bez radiološkog dokaza i teškom perzistentnom astmom te ispitivanjima faze II/III u bolesnika s UC ni u jednog bolesnika liječenog golimumabom nije nastupila anafilaktička reakcija.
English: • cancer of the lymph nodes (lymphoma) (rare).
Croatian: • rak limfnih čvorova (limfom) (rijetko).
English: • There may be a small amount of blood or liquid at the injection site.
Croatian: • Na mjestu injekcije možda ćete primijetiti malo krvi ili tekućine.
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 5.
Croatian: Ključni rezultati za dozu lijeka Simponi od 50 mg u 52. tjednu prikazani su u tablici 5.
English: Solution for injection in pre-filled pen (SmartJect) Multipack: 3 (3 packs of 1) pre-filled pens
Croatian: Otopina za injekciju u napunjenoj brizgalici (SmartJect) Višestruko pakiranje: 3 (3 pakiranja s 1 napunjenom brizgalicom)
English: Please contact your doctor or pharmacist.
Croatian: Obratite se svom liječniku ili ljekarniku.
English: • Stomach pain
Croatian: • donji dio trbuha
English: • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
Croatian: • Aksijalni spondiloartritis, uključujući ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza
English: Wait 30 minutes to allow pre-filled syringe to reach room temperature
Croatian: Pričekajte 30 minuta da se napunjena brizgalica zagrije na sobnu temperaturu
English: How to use Simponi
Croatian: Kako primjenjivati Simponi
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Croatian: • Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove, uključujući bilo koje druge lijekove za liječenje reumatoidnog artritisa, poliartikularnog juvenilnog idiopatskog artritisa, psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez radiološkog dokaza ili ulceroznog kolitisa.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Croatian: Liječenje se uvodi i provodi pod nadzorom liječnika specijaliste s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez radiološkog dokaza ili ulceroznog kolitisa.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Croatian: Reumatoidni artritis, psorijatični artritis i aksijalni spondiloartritis, uključujući ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza:
English: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2.
Croatian: Daje se inicijalna doza lijeka Simponi od 200 mg, iza koje u 2. tjednu slijedi doza od 100 mg.
English: In the controlled and uncontrolled periods of the pivotal trials with a median follow-up of up to 3 years, a greater incidence of demyelination was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg (see section 4.4).
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja s medijanom praćenja do 3 godine primijećena je povećana incidencija demijelinizacije u bolesnika liječenih golimumabom u dozi od 100 mg u odnosu na bolesnike liječene golimumabom u dozi od 50 mg (vidjeti dio 4.4).
English: Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose.
Croatian: Jedna napunjena brizgalica sadrži 20,5 mg sorbitola po dozi od 50 mg.
English: • The recommended dose is 50 mg given once a month, on the same date each month.
Croatian: • Preporučena doza je 50 mg primijenjeno jedanput na mjesec, istog datuma u mjesecu.
English: Hold the pre-filled syringe by the body of the pre-filled syringe
Croatian: Uhvatite napunjenu štrcaljku za tijelo napunjene štrcaljke
English: 145 to < 155
Croatian: 145 do < 155
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Croatian: Liječenje se uvodi i provodi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, poliartikularnog juvenilnog idiopatskog artritisa, psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartritisa bez radiološkog dokaza ili ulceroznog kolitisa.
English: In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
Croatian: U kontroliranom razdoblju pivotalnih ispitivanja u bolesnika s RA i PsA blago povećanje razine ALT-a (> 1 i < 3 x iznad gornje granice normale (GGN)) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (22,1% naspram 27,4% bolesnika); u ispitivanju u bolesnika s ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza blago povećanje razine ALT-a imalo je više bolesnika koji su primali golimumab (26,9%) nego onih u kontrolnoj skupini (10,6%).
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 3.
Croatian: Ključni rezultati za dozu lijeka Simponi od 50 mg u 52. tjednu prikazani su u tablici 3.
English: General disorders and administration site conditions Common: Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort Rare: Impaired healing Injury, poisoning and procedural complications
Croatian: Često: pireksija, astenija, reakcije na mjestu injekcije (npr. eritem, urtikarija, induracija, bol, stvaranje modrica, pruritus, iritacija i parestezija na mjestu injekcije), nelagoda u prsištu Rijetko: otežano zacjeljivanje Ozljede, trovanja i proceduralne komplikacije
English: If this happens, talk to your doctor or pharmacist.
Croatian: Ako se to dogodi, javite se svom liječniku ili ljekarniku.
English: Solution for injection in pre-filled syringe Multipack: 3 (3 packs of 1) pre-filled syringes
Croatian: Otopina za injekciju u napunjenoj štrcaljki Višestruko pakiranje: 3 (3 pakiranja s 1 napunjenom štrcaljkom)
English: • Psoriatic arthritis
Croatian: • Psorijatični artritis
English: In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumab-treated and control patients (8.0% to 6.9%, respectively).
Croatian: U kontroliranom razdoblju pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, blago povećanje razine ALT-a (> 1 i < 3 x GGN) nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika u kontrolnoj skupini (8,0% naspram 6,9% bolesnika).
English: By study design, patients in the long-term extension may have switched between the 50 mg and 100 mg Simponi doses at the discretion of the study physician.
Croatian: Prema ustroju ispitivanja, bolesnici u dugotrajnom produžetku ispitivanja mogli su prelaziti s doze lijeka Simponi od 50 mg na 100 mg i obrnuto prema procjeni liječnika ispitivača.
English: 1st administration: _______________________
Croatian: Prva primjena: ___________________________
English: Allow the syringe to sit at room temperature outside the box for 30 minutes before use.
Croatian: Izvadite brizgalicu iz kutije da odstoji na sobnoj temperaturi 30 minuta prije uporabe.
English: Do not pull back on the plunger at any time.
Croatian: • Nikada ne povlačite klip štrcaljke unazad.
English: Common: Hypertension Uncommon: Thrombosis (such as deep venous and aortic), flushing Rare: Raynaud's phenomenon
Croatian: Često: hipertenzija Manje često: tromboza (npr. dubokih vena i aorte), navale crvenila Rijetko: Raynaudov fenomen Poremećaji dišnog sustava, prsišta i sredoprsja
English: 1 mL contains 100 mg golimumab.
Croatian: 1 ml sadrži 100 mg golimumaba.
English: • Tell your doctor if you are a carrier or if you have or have had HBV before you are given
Croatian: • Prije nego Vam primijene Simponi, obavijestite svog liječnika ako imate ili ste imali hepatitis B ili ako ste nositelj virusa HBV.
English: o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of 2 pre-filled syringes) given once a month, on the same date each month.
Croatian: o Ako težite više od 100 kg, liječnik Vam može povećati dozu na 100 mg (sadržaj 2 napunjene brizgalice) jedanput na mjesec, istog datuma u mjesecu.
English: Among patients remaining in the study and treated with Simponi, similar rates of change from baseline in BASDAI were observed from week 24 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi bile su opažene slične stope promjene od početnog stanja u BASDAI indeksu od 24. do 256. tjedna.
English: Set prescribed dose
Croatian: Odaberite propisanu dozu
English: For children with body weight of at least 40 kg, a fixed dose 50 mg pre-filled pen or pre-filled syringe is available.
Croatian: Za djecu tjelesne težine od najmanje 40 kg, dostupna je napunjena brizgalica ili napunjena štrcaljka lijeka Simponi od 50 mg.
English: Symptoms can include a persistent cough, being short of breath, chest pain, fever, swelling of your lymph nodes, weight loss, skin rashes, and blurred vision.
Croatian: Simptomi mogu uključivati uporan kašalj, nedostatak zraka, bol u prsištu, vrućicu, oticanje limfnih čvorova, gubitak tjelesne težine, osipe na koži i zamagljen vid.
English: Throw the pre-filled syringe away (see figure 10)
Croatian: Bacite napunjenu brizgalicu u otpad (vidjeti sliku 10)
English: During the Simponi Phase IIb and Phase III clinical trials in RA, PsA and 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 RA, PsA i AS, incidencija limfoma u bolesnika liječenih golimumabom bila je viša od one očekivane u općoj populaciji.
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 2).
Croatian: U 52. tjednu u ukupnoj je populaciji postotak bolesnika koji su postigli odgovor ACR u skupini koja je primala Simponi 50 mg i MTX bio općenito veći, ali ne i statistički značajno različit od onog u skupini koja je primala samo MTX (vidjeti Tablicu 2).
English: Patients were randomised to receive placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX or Simponi 100 mg + placebo.
Croatian: Bolesnici su randomizirani u skupine koje su primale placebo i MTX, Simponi 50 mg i MTX, Simponi 100 mg i MTX ili Simponi 100 mg i placebo.
English: Golimumab exhibited approximately dose-proportional pharmacokinetics in patients with RA over the dose range of 0.1 to 10.0 mg/kg following a single intravenous dose.
Croatian: Nakon pojedinačne intravenske doze u bolesnika s reumatoidnim artritisom golimumab je pokazao farmakokinetiku otprilike proporcionalnu dozi u rasponu doza od 0,1 do 10,0 mg/kg.
English: Remove the cap (figure 4)
Croatian: Skinite poklopac (vidjeti sliku 4)
English: Patients were randomly assigned to placebo or Simponi 50 mg administered subcutaneously every 4 weeks.
Croatian: Bolesnici su bili nasumično raspoređeni da primaju placebo ili Simponi u supkutanoj dozi od 50 mg svaka 4 tjedna.
English: Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Croatian: Simptomi infekcije uključuju vrućicu, kašalj, nedostatak zraka, simptome slične gripi, proljev, rane, probleme sa zubima ili osjećaj žarenja pri mokrenju.
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 4).
Croatian: U 52. tjednu u ukupnoj je populaciji postotak bolesnika koji su postigli odgovor ACR u skupini koja je primala Simponi 50 mg i MTX bio općenito veći, ali ne i statistički značajno različit od onog u skupini koja je primala samo MTX (vidjeti Tablicu 4).
English: Among patients remaining in the study and treated with Simponi, the proportion of patients with an ASAS 20 and ASAS 40 response were similar from week 24 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi, udio bolesnika s odgovorom ASAS 20 i ASAS 40 bio je sličan od 24. do 256. tjedna
English: Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses).
Croatian: Dostupni podaci pokazuju da se klinički odgovor obično postiže u roku od 12 do 14 tjedana liječenja (nakon 3-4 doze).
English: Within the RA, PsA, AS, and nr-Axial SpA pivotal trials, one patient in an RA trial with pre-existing liver abnormalities and confounding medicinal products treated with golimumab developed non-infectious fatal hepatitis with jaundice.
Croatian: U sklopu pivotalnih ispitivanja u bolesnika s RA, PsA, AS i aksijalnim spondiloartritisom bez radiološkog dokaza, u jednog bolesnika s postojećim oštećenjem jetre iz RA ispitivanja, koji je uz golimumab primao i druge lijekove koji su mogli tome pridonijeti, razvio se neinfektivni hepatitis uz žuticu, sa smrtnim ishodom.
English: • Do not touch this area again before giving the injection.
Croatian: • Prije nego si date injekciju, ne smijete više dodirivati to mjesto.
English: More Simponi-treated patients demonstrated sustained mucosal healing (patients with mucosal healing at both week 30 and week 54) in the 50 mg group (42%, nominal p < 0.05) and 100 mg group (42%, p < 0.005) compared with patients in the placebo group (27%).
Croatian: Održano cijeljenje sluznice (bolesnici s cijeljenjem sluznice i u 30. i u 54. tjednu) primijećeno je u većeg broja bolesnika liječenih lijekom Simponi u dozi od 50 mg (42%, nominalna p-vrijednost < 0,05) i 100 mg (42%, p < 0,005) nego u bolesnika koji su primali placebo (27%).
English: The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein.
Croatian: Otopina je bistra do blago opalescentna (ima biserni odsjaj), bezbojna do žućkasta i može sadržavati nekoliko malih prozirnih ili bijelih čestica proteina.
English: Lift the pre-filled pen away from the skin.
Croatian: Podignite napunjenu brizgalicu s kože.
English: INSIDE OF CARTON
Croatian: UNUTRAŠNJOST KUTIJE
English: Colon dysplasia/carcinoma
Croatian: Displazija/karcinom debelog crijeva
English: Do not inject into skin that is tender, bruised, red, scaly, hard or has scars.
Croatian: Nemojte injicirati lijek u mjesta na kojima je koža bolna, crvena, ljuskasta, tvrda te prekrivena modricama ili ožiljcima.
English: Statistically significant improvements in spinal mobility as assessed by BASMI (Bath Ankylosing Spondylitis Metrology Index) and in physical function as assessed by the BASFI were demonstrated in Simponi 50 mg-treated patients as compared to placebo-treated patients (p < 0.0001).
Croatian: U usporedbi s bolesnicima koji su primali placebo, u bolesnika liječenih lijekom Simponi u dozi od 50 mg pokazana su statistički značajna poboljšanja u mobilnosti kralježnice procijenjenoj pomoću BASMI (Bath metrološki indeks aktivnosti ankilozantnog spondilitisa) i fizičkoj funkciji procijenjenoj pomoću BASFI (p < 0,0001).
English: • You should not receive certain (live) vaccines while using Simponi.
Croatian: • Za vrijeme liječenja lijekom Simponi ne smijete primiti neka (živa) cjepiva.
English: Please contact your doctor or pharmacist for assistance.
Croatian: Obratite se za pomoć svom liječniku ili ljekarniku.
English: Available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses).
Croatian: Dostupni podaci pokazuju da se klinički odgovor obično postiže u roku od 12 do 14 tjedana liječenja (nakon 4 doze).
English: Pregnancy and breast-feeding Talk to your doctor before using Simponi if:
Croatian: Razgovarajte sa svojim liječnikom prije primjene lijeka Simponi:
English: 1 pre-filled syringe) given once a month, on the same date each month.
Croatian: 1 napunjene brizgalice) jedanput na mjesec, istog datuma u mjesecu.
English: • Do not remove the pre-filled pen's cap while allowing it to reach room temperature.
Croatian: • Nemojte skidati poklopac s napunjene brizgalice dok čekate da se zagrije na sobnu temperaturu.
English: One pre-filled pen contains 45 mg golimumab* in 0.45 mL.
Croatian: Jedna napunjena brizgalica sadrži 45 mg golimumaba* u 0,45 ml otopine.
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab (see section 4.8).
Croatian: U bolesnika liječenih TNF-blokatorima, uključujući golimumab, prijavljeni su melanom i karcinom Merkelovih stanica (vidjeti dio 4.8).
English: Simponi should be given concomitantly with MTX.
Croatian: Simponi se mora primijeniti istodobno s metotreksatom.
English: In controlled and uncontrolled portions of the studies with a median follow-up of approximately 4 years, the incidence per 100 subject-years of upper respiratory tract infections was 34.9 events; 95% CI: 33.8, 36.0 for golimumab treated patients.
Croatian: U kontroliranim i nekontroliranim dijelovima ispitivanja s medijanom praćenja približno 4 godine, za bolesnike liječene golimumabom je incidencija infekcija gornjih dišnih puteva na 100 ispitanik-godina iznosila 34,9 događaja; 95% CI: 33,8; 36,0.