FrancophonIA/ELRC3.0 huggingface dataset:
English: Among patients remaining in the study and treated with Simponi, radiographic effects were similar from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi radiografski učinci bili su slični od 104. do 256. tjedna.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, prije liječenja lijekom Simponi razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi poboljšanje na fizičkoj komponenti upitnika SF-36 bilo je slično od 104. do 256. tjedna.
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected by the enzyme immunoassay (EIA) method in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Croatian: U ispitivanjima faze III u bolesnika s RA, PsA i AS do 52. tjedna protutijela na golimumab, od kojih su gotovo sva bila neutralizirajuća in vitro, otkrivena su imunoenzimskim testom (engl. enzyme immunoassay, EIA) u 5% bolesnika (105/2062) liječenih golimumabom.
English: In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
Croatian: U kontroliranim razdobljima pivotalnih ispitivanja uvodne terapije golimumabom u bolesnika s UC, povećanje razine ALT-a ≥ 5 x iznad GGN nastupilo je u sličnom omjeru u bolesnika koji su primali golimumab i u bolesnika koji su primali placebo (0,3% naspram 1,0% bolesnika).
English: • Liver disorders
Croatian: • poremećaji jetre
English: The long half-life should be taken into consideration if a surgical procedure is planned.
Croatian: Ako se planira kirurški zahvat, treba voditi računa o dugom poluvijeku lijeka.
English: Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.
Croatian: Simptomi infekcije mogu uključivati vrućicu, umor, (uporan) kašalj, kratkoću daha, simptome slične gripi, gubitak tjelesne težine, noćno znojenje, proljev, rane, probleme sa zubima i osjećaj žarenja pri mokrenju.
English: 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
Croatian: U ispitivanju pJIA, medijan najnižih koncentracija golimumaba u stanju dinamičke ravnoteže u djece koja su primala golimumab supkutano u dozi od 30 mg/m2 (maksimalno 50 mg) svaka 4 tjedna bio je sličan u svim dobnim skupinama te je bio sličan ili nešto viši od onog primijećenog u odraslih bolesnika s RA koji su primali 50 mg golimumaba svaka 4 tjedna.
English: For the 50 mg dose, see section 3 “How to use Simponi” of the Simponi 50 mg pre-filled pen or pre-filled syringe package leaflet.
Croatian: "Kako primjenjivati Simponi" u uputi o lijeku za Simponi 50 mg napunjenu brizgalicu ili napunjenu štrcaljku.
English: In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and ulcerative colitis (UC), the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja lijeka Simponi faze IIb i faze III u bolesnika s RA, PsA, AS i ulceroznim kolitisom (UC), incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože), bila je slična u skupini koja je primala golimumab i u kontrolnim skupinama.
English: Simponi 45 mg/0.45 mL injection golimumab
Croatian: Simponi 45 mg/0,45 ml injekcija golimumab s.c.
English: Cases of leukaemia have been reported in patients treated with golimumab.
Croatian: U bolesnika liječenih golimumabom prijavljeni su slučajevi leukemije.
English: Check the liquid in the pre-filled pen
Croatian: Provjerite tekućinu u napunjenoj brizgalici
English: This medicine contains 18.45 mg sorbitol (E420) in each pre-filled pen.
Croatian: Ovaj lijek sadrži 18,45 mg sorbitola (E420) u jednoj napunjenoj brizgalici.
English: Common: Pruritus, rash, alopecia, dermatitis Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous) Musculoskeletal and connective tissue disorders
Croatian: Često: povišene alanin-aminotransferaze, povišene aspartat-aminotransferaze Manje često: kolelitijaza, jetreni poremećaji Poremećaji kože i potkožnog tkiva Često: pruritus, osip, alopecija, dermatitis Manje često: bulozne reakcije na koži, psorijaza (novonastala ili pogoršanje postojeće psorijaze, palmarna/plantarna i pustularna), urtikarija Rijetko: lihenoidne reakcije,eksfolijacija kože, vaskulitis (kožni) Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in 1.2% of golimumab-treated patients and 1.2% of control-treated patients.
Croatian: U kontroliranom razdoblju ispitivanja u bolesnika s RA, PsA, AS i aksijalnim spondiloartritisom bez radiološkog dokaza, ozbiljne infekcije zabilježene su u 1,2% bolesnika liječenih golimumabom te u 1,2% bolesnika iz kontrolne skupine.
English: Do not use the pre-filled syringe if the expiration date has passed.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako je istekao rok valjanosti.
English: Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab.
Croatian: U bolesnika liječenih golimumabom prijavljene su bakterijske (uključujući sepsu i pneumoniju), mikobakterijske (uključujući TBC), invazivne gljivične i oportunističke infekcije, ponekad sa smrtnim ishodom.
English: In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja lijeka Simponi faze IIb i faze III u bolesnika s RA, PsA, AS i UC, incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože), bila je slična u skupini koja je primala golimumab i u kontrolnim skupinama.
English: Do not touch this area again before giving the injection.
Croatian: Prije nego si date injekciju, ne smijete više dodirivati to mjesto.
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Croatian: Ograničeni su podaci o odgovoru na cijepljenje živim cjepivima ili sekundarnom prijenosu infekcije živim cjepivom u bolesnika koji primaju anti-TNF terapiju.
English: o If your dose is 200 mg, you will get four 50 mg pre-filled pens and you will need to give yourself four injections.
Croatian: o Ako koristite dozu od 200 mg, dobit ćete četiri napunjene brizgalice od 50 mg i morat ćete si dati četiri injekcije.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 and HAQ DI responses were maintained through week 104.
Croatian: U bolesnika koji su nastavili uzimati Simponi koji im je randomizacijom bio dodijeljen na početku ispitivanja odgovori DAS28 i HAQ DI održali su se do 104. tjedna.
English: Subsequent administrations: ______________________________________________
Croatian: Sljedeće primjene: ______________________________________________
English: Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi poboljšanje u HAQ DI bilo je slično od 104. do 256. tjedna.
English: Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Croatian: Ne koristite napunjenu štrcaljku ako Vam je pala nakon što ste skinuli zaštitni poklopac igle.
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 2 and are described below.
Croatian: Ključni rezultati prema ACR kriterijima za dozu lijeka Simponi od 50 mg u 14., 24. i 52. tjednu u ispitivanjima GO-FORWARD, GO-AFTER i GO-BEFORE prikazani su u tablici 2 i opisani u nastavku.
English: Position the pre-filled syringe to inject
Croatian: Namjestite napunjenu štrcaljku u položaj za injiciranje
English: • Bone fractures
Croatian: • prijelomi kosti
English: Simponi has minor influence on the ability to ride bicycles, drive and use machines.
Croatian: Simponi malo utječe na sposobnost vožnje bicikla, upravljanja vozilima i rada sa strojevima.
English: Among those, 40, 33 and 24 patients had ACR 20/50/70 response, respectively at week 104.
Croatian: Među njima je u 104. tjednu 40 bolesnika imalo odgovor ACR 20, 33 je imalo odgovor ACR 50, a 24 je imalo odgovor ACR 70.
English: How Simponi is given
Croatian: Kako se primjenjuje Simponi
English: Adult rheumatoid arthritis
Croatian: Reumatoidni artritis u odraslih
English: • The recommended dose is 50 mg (the content of 1 pre-filled syringe) given once a month, on the same date each month.
Croatian: • Preporučena doza je 50 mg (sadržaj 1 napunjene brizgalice) primijenjeno jedanput na mjesec, istog datuma u mjesecu.
English: Your doctor will test you to see if you have TB.
Croatian: • Vaš liječnik će provesti testove na tuberkulozu.
English: In the controlled and uncontrolled periods of the RA and PsA pivotal trials, with a median follow-up of approximately 5 years, the incidence of mild ALT elevations was similar in golimumab-treated and control patients in RA and PsA studies.
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja u bolesnika s RA i PsA, s medijanom praćenja od približno 5 godina, incidencija blagog porasta razina ALT-a bila je slična u bolesnika koji su primali golimumab i u bolesnika kontrolne skupine u ispitivanjima reumatoidnog artritisa i psorijatičnog artritisa.
English: • Taste disturbances
Croatian: • poremećaji okusa
English: Simponi 45 mg/0.45 mL solution for injection
Croatian: Simponi 45 mg/0,45 ml otopina za injekciju
English: • Low white blood cell counts
Croatian: • smanjeni broj bijelih krvnih stanica
English: In each of the RA studies 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: U svim navedenim ispitivanjima reumatoidnog artritisa, prema ustroju ispitivanja, bolesnici u dugotrajnom produžetku ispitivanja mogli su prijeći s doze lijeka Simponi od 50 mg na 100 mg i obrnuto prema procjeni liječnika ispitivača.
English: In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52.
Croatian: U aksijalnom spondiloartritisu bez radiološkog dokaza, protutijela na golimumab bila su otkrivena u 7% (14/193) bolesnika liječenih golimumabom do 52. tjedna.
English: • the number of pre-filled syringes and strength is correct o If your dose is 100 mg, you will get one 100 mg pre-filled syringe o If your dose is 200 mg, you will get two 100 mg pre-filled syringes and you will need to give yourself two injections.
Croatian: • da su broj napunjenih štrcaljki i njihova jačina točni o ako koristite dozu od 100 mg, dobit ćete jednu napunjenu štrcaljku od 100 mg o ako koristite dozu od 200 mg, dobit ćete dvije napunjene štrcaljke od 100 mg i morat ćete si dati dvije injekcije.
English: • Rash and itching of the skin
Croatian: • ljuskice na koži i ljuštenje kože
English: Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 4 and are described below.
Croatian: Ključni rezultati prema ACR kriterijima za dozu lijeka Simponi od 50 mg u 14., 24. i 52. tjednu u ispitivanjima GO-FORWARD, GO-AFTER i GO-BEFORE prikazani su u tablici 4 i opisani u nastavku.
English: The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Croatian: Otopina je bistra do blago opalescentna, bezbojna do žućkasta i može sadržavati nekoliko malih prozirnih ili bijelih čestica proteina.
English: In GO-FORWARD, the (co-)primary endpoints were the percentage of patients achieving an ACR 20 response at week 14 and the improvement from baseline in Health Assessment Questionnaire (HAQ) at week 24.
Croatian: Jedan primarni ishod u ispitivanju GO-FORWARD bio je postotak bolesnika koji su postigli odgovor ACR 20 u 14. tjednu, a drugi primarni ishod bio je poboljšanje u odnosu na početne vrijednosti u Upitniku procjene zdravlja (engl.
English: Make sure you dispose of the bin as instructed by your doctor or nurse.
Croatian: Taj spremnik morate odložiti u otpad u skladu s preporukama liječnika ili medicinske sestre.
English: Among patients remaining in the study and treated with Simponi, similar rates of ACR 20/50/70 response were observed from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi bile su opažene slične stope odgovora ACR 20/50/70 od 104. sve do 256. tjedna.
English: • Do not use the pre-filled pen if the liquid is the wrong colour, cloudy, or contains larger particles.
Croatian: • Ne koristite napunjenu brizgalicu ako je otopina promijenila boju, ako je zamućena ili sadrži veće čestice.
English: Among patients remaining in the study and treated with Simponi, DAS28 and HAQ DI responses were similar from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi odgovori DAS28 i HAQ DI bili su slični od 104. do 256. tjedna.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement in HAQ DI was maintained through week 104.
Croatian: Kod bolesnika koji su nastavili liječenje lijekom Simponi koje im je randomizacijom bilo dodijeljeno na početku ispitivanja poboljšanje rezultata HAQ DI održalo se do 104. tjedna.
English: Patients with body weight greater than or equal to 80 kg Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter (see section 5.1).
Croatian: Daje se inicijalna doza lijeka Simponi od 200 mg, iza koje nakon 2 tjedna slijedi doza od 100 mg, a nakon toga doza od 100 mg svaka 4 tjedna (vidjeti dio 5.1).
English: Keep the pre-filled pen or pre-filled syringe in the outer carton in order to protect it from light.
Croatian: Napunjenu brizgalicu ili napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The incidence of serious infections per 100 subject-years of follow-up in the controlled period of RA, PsA, AS, and nr-Axial SpA trials was 7.3; 95% CI: 4.6, 11.1 for the golimumab 100 mg group, 2.9; 95% CI: 1.2, 6.0 for the golimumab 50 mg group and 3.6; 95% CI: 1.5, 7.0 for the placebo group.
Croatian: 100 ispitanik-godina praćenja iznosila je: 7,3; 95% CI: 4,6; 11,1 za grupu liječenu golimumabom u dozi od 100 mg; 2,9; 95% CI: 1,2; 6,0 za grupu liječenu golimumabom u dozi od 50 mg te 3,6; 95% CI: 1,5; 7,0 za placebo grupu.
English: Keep holding the pre-filled pen upright.
Croatian: I dalje držite napunjenu brizgalicu uspravno.
English: Polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg For children with body weight of at least 40 kg, a 50 mg pre-filled pen or pre-filled syringe is available.
Croatian: Za primjenu lijeka u djece s poliartikularnim juvenilnim idiopatskim artritisom i tjelesnom težinom manjom od 40 kg dostupna je napunjena brizgalica od 45 mg/0,45 ml.
English: Symptoms can include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.
Croatian: Simptomi mogu uključivati žutilo kože i bjeloočnica, tamnosmeđu boju mokraće, bol na desnoj strani trbuha, vrućicu, mučninu, povraćanje i osjećaj velikog umora.
English: Viewing Window
Croatian: Prozorčić
English: In the controlled and uncontrolled periods of RA, PsA and AS pivotal trials, with a median follow-up of 5 years, the incidence of ALT elevations ≥ 5 x ULN was similar in both golimumab-treated and control patients.
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja u bolesnika s RA, PsA i AS, s medijanom praćenja od 5 godina, incidencija porasta razina ALT-a ≥ 5 x iznad GGN bila je slična u bolesnika koji su primali golimumab te u bolesnika kontrolne skupine.
English: Simponi contains the active substance called golimumab.
Croatian: Simponi sadrži djelatnu tvar golimumab.
English: EU/1/09/546/009 1 pre-filled pen
Croatian: EU/1/09/546/009 1 napunjena brizgalica
English: It should be clear to slightly opalescent (having pearl-like shine) and colourless to light yellow and may contain a few small translucent or white particles of protein.
Croatian: Tekućina mora biti bistra do blago opalescentna (ima biserni odsjaj) te bezbojna do žućkasta, a može sadržavati i nekoliko malih prozirnih ili bijelih čestica proteina.
English: Preparing injection site
Croatian: Pripremite mjesto injekcije
English: 16% 31% p = 0.002 49% 62% Week 52 NA NA NA
Croatian: 24. tjedan 28% 60%* 16% 31% p = 0,002
English: Simponi 100 mg injection golimumab SC
Croatian: Simponi 100 mg injekcija golimumab s.c.
English: For all of the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses).
Croatian: Prema dostupnim podacima za sve gore navedene indikacije, klinički se odgovor obično postiže unutar 12 do 14 tjedana liječenja (nakon 3-4 doze).
English: Polyarticular juvenile idiopathic arthritis:
Croatian: Poliartikularni juvenilni idiopatski artritis:
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Croatian: U ispitivanjima faze III u bolesnika s RA, PsA i AS do 52. tjedna protutijela na golimumab, od kojih su gotovo sva bila neutralizirajuća in vitro, otkrivena su u 5% bolesnika (105/2062) liječenih golimumabom.
English: Golimumab has not been studied in patients with CHF.
Croatian: Golimumab nije ispitivan u bolesnika s kongestivnim zatajenjem srca.
English: Preparing for use of the pre-filled syringe
Croatian: Priprema za uporabu napunjene štrcaljke
English: • the number of pre-filled pens and strength is correct o If your dose is 100 mg, you will get one 100 mg pre-filled pen o If your dose is 200 mg, you will get two 100 mg pre-filled pens and you will need to give yourself two injections.
Croatian: • da su broj napunjenih brizgalica i njihova jačina točni o ako koristite dozu od 100 mg, dobit ćete jednu napunjenu brizgalicu od 100 mg o ako koristite dozu od 200 mg, dobit ćete dvije napunjene brizgalice od 100 mg i morat ćete si dati dvije injekcije.
English: Among those, 85, 66 and 53 patients had ACR 20/50/70 response, respectively, at week 104.
Croatian: Među njima je u 104. tjednu 85 bolesnika imalo odgovor ACR 20, 66 je imalo odgovor ACR 50, a 53 je imalo odgovor ACR 70.
English: • Do not shake the product
Croatian: • Nemojte tresti lijek
English: Do not attempt to recap the needle.
Croatian: Nemojte vraćati zaštitni poklopac na iglu.
English: • Place your pen in a sharps container straight away.
Croatian: • Odmah odložite brizgalicu u spremnik za oštri otpad.
English: In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52 by the EIA method.
Croatian: U aksijalnom spondiloartritisu bez radiološkog dokaza, protutijela na golimumab otkrivena su EIA metodom u 7% (14/193) bolesnika liječenih golimumabom do 52. tjedna.
English: Tell your doctor straight away if symptoms of TB appear during or after your treatment.
Croatian: Tuberkuloza (TBC) Odmah obavijestite liječnika ako se tijekom ili poslije liječenja lijekom Simponi pojave simptomi tuberkuloze.
English: • Place your pre-filled syringe in a sharps container straight away.
Croatian: • Odmah odložite napunjenu brizgalicu u spremnik za oštri otpad.
English: • Do not remove the needle cover from the pre-filled syringe until instructed to do so.
Croatian: • Ne skidajte zaštitni poklopac s igle štrcaljke dok nije vrijeme za to.
English: In addition, levels of TNF- were reduced in RA and AS patients and levels of IL-8 were reduced in PsA patients.
Croatian: Nadalje, razine TNF- smanjene su u bolesnika s reumatoidnim artritisom i ankilozantnim spondilitisom, a razine IL-8 u bolesnika s psorijatičnim artritisom.
English: Among patients remaining in the study and treated with Simponi, DAS28 responses were similar from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi odgovori DAS28 bili su slični od 104. do 256. tjedna.
English: • While you are waiting you can get the rest of your equipment ready, including an alcohol swab,
Croatian: • Dok čekate, možete pripremiti ostali potreban materijal za injekciju, uključujući tupfer natopljen alkoholom, komadić vate ili gazu i spremnik za oštre otpatke.
English: After disease flare, children received Simponi 30 mg/m2 (maximum 50 mg) + MTX.
Croatian: Nakon razbuktavanja bolesti djeca su primala Simponi u dozi od 30 mg/m
English: In the controlled and uncontrolled period of pivotal trials with a median follow-up of up to 3 years, malignancies besides melanoma, non-melanoma skin cancer and lymphoma were diagnosed in 5 placebo-treated, 21 golimumab 50 mg-treated and 34 golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.48 (0.36, 0.62) for combined golimumab and 0.87 (0.28, 2.04) for placebo (see section 4.4).
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja s medijanom praćenja do 3 godine druge zloćudne bolesti osim melanoma, nemelanomskog raka kože i limfoma dijagnosticirane su u 5 ispitanika koji su primali placebo, 21 ispitanika liječenih golimumabom u dozi od 50 mg te 34 ispitanika liječenih golimumabom u dozi od 100 mg, s incidencijom (95%, CI) na 100 ispitanik-godina praćenja od 0,48 (0,36; 0,62) za obje doze golimumaba, a 0,87 (0,28; 2,04) događaja za placebo (vidjeti dio 4.4).
English: • On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers.
Croatian: • U bolesnika koji su uzimali druge TNF-blokatore u rijetkim je slučajevima opažen specifičan i težak oblik limfoma zvan hepatosplenički limfom T-stanica.
English: • Do not use the pre-filled pen if the seal is broken.
Croatian: • Ne koristite napunjenu brizgalicu ako je sigurnosna markica oštećena.
English: • skin cancer (uncommon).
Croatian: • rak kože (manje često).
English: Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes.
Croatian: Simponi je dostupan u pakiranju koje sadrži 1 napunjenu štrcaljku i višestrukom pakiranju koje sadrži 3 napunjene štrcaljke (3 pakiranja s 1 napunjenom štrcaljkom).
English: • Do not use the pre-filled pen if the expiration date has passed.
Croatian: • Ne koristite napunjenu brizgalicu ako je istekao rok valjanosti.
English: • Kidney infection
Croatian: • infekcija bubrega
English: Simponi 50 mg injection golimumab SC
Croatian: Simponi 50 mg injekcija golimumab s.c.