FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Simponi je indiciran za liječenje umjerenog do teškog, aktivnog ulceroznog kolitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), odnosno koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: Lymphoma was reported in 1 patient, non-melanoma skin cancer in 2 patients, and other malignancies in 5 patients.
Croatian: Limfom je prijavljen u 1 bolesnika, nemelanomski rak kože u 2, a druge zloćudne bolesti u njih 5. Nije opaženo specifično grupiranje bilo koje vrste malignoma.
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Croatian: Potreban je oprez kad se razmatra liječenje TNF-blokatorima u bolesnika koji su bolovali od maligne bolesti ili nastavak liječenja u bolesnika koji razviju malignu bolest.
English: It is important that the right strength is used to administer the correct dose as indicated in the posology (see section 4.2).
Croatian: Važno je upotrijebiti odgovarajuću jačinu lijeka kako bi se primijenila točna doza, kao što je navedeno u doziranju (vidjeti dio 4.2).
English: If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself.
Croatian: Ako si želite sami injicirati Simponi, zdravstveni radnik Vas mora podučiti kako ćete si pravilno pripremiti i dati injekciju.
English: Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter (see section 5.1).
Croatian: Bolesnicima u kojih se ne postigne odgovarajući odgovor mogao bi koristiti nastavak liječenja dozom od 100 mg u 6. tjednu i svaka 4 tjedna nakon toga (vidjeti dio 5.1).
English: • Hold the pre-filled syringe by its body with the covered needle pointing downward.
Croatian: • Uhvatite napunjenu štrcaljku za tijelo, s pokrivenom iglom okrenutom prema dolje.
English: The needle cover on the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Croatian: Zaštitni poklopac na igli napunjene brizgalice načinjen je od suhe prirodne gume koja sadrži lateks i može izazvati alergijske reakcije u osoba osjetljivih na lateks.
English: A generally greater effect of Simponi 50 mg + MTX versus MTX alone was demonstrated in the indicated population compared with the overall population.
Croatian: Pokazalo se da Simponi 50 mg + MTX općenito ima veći učinak nego sam MTX u navedenoj populaciji u usporedbi s ukupnom populacijom bolesnika.
English: The active substance is golimumab.
Croatian: Djelatna tvar je golimumab.
English: Choose injection site
Croatian: Odaberite mjesto injekcije
English: o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of
Croatian: Ako težite više od 100 kg, liječnik Vam može povećati dozu na 100 mg (sadržaj
English: • Manually press the plunger to inject, like a syringe
Croatian: • ručno potisnuti klip kako biste injicirali lijek, kao kod štrcaljke
English: Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Croatian: Treba ponovno razmotriti nastavak liječenja u djece u koje se unutar tog razdoblja ne uoče dokazi o koristi terapije.
English: Of patients that continued in the study extension and had evaluable samples through week 228, antibodies to golimumab were detected in 4% (23/604) of golimumab treated patients.
Croatian: Među bolesnicima koji su nastavili sudjelovati u produžetku ispitivanja i čiji su se uzorci mogli procijeniti do 228. tjedna, protutijela na golimumab bila su otkrivena u 4% (23/604) bolesnika liječenih golimumabom.
English: Responders, % of patients ACR 20
Croatian: Bolesnici koji su odgovorili na liječenje, % bolesnika ACR 20
English: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: Golimumab treba davati uz oprez bolesnicima s blagim zatajenjem srca (NYHA stupanj I/II).
English: • Wipe the injection site with an alcohol swab.
Croatian: • Obrišite mjesto injekcije tupferom natopljenim alkoholom.
English: In patients with newly diagnosed dysplasia treated with golimumab, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.
Croatian: U bolesnika s novodijagnosticiranom displazijom koji su liječeni golimumabom mora se pažljivo procijeniti rizike i koristi za svakog pojedinog bolesnika te razmotriti treba li nastaviti s liječenjem.
English: Patients treated with Simponi should be given the Patient Reminder Card which is included in the pack.
Croatian: Bolesnici koji se liječe lijekom Simponi trebaju dobiti Karticu s podsjetnikom za bolesnika, koja je uključena u pakiranje.
English: IMPORTANT: Do not lift the pre-filled pen from the skin during the injection.
Croatian: VAŽNO: Nemojte podizati napunjenu brizgalicu s kože tijekom injiciranja.
English: Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis)
Croatian: Vrlo često: infekcije gornjih dišnih puteva (nazofaringitis, faringitis, laringitis i rinitis)
English: Use of anti-tuberculosis therapy should also be considered before the initiation of golimumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu antituberkulozne terapije prije početka liječenja golimumabom treba razmotriti i u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi da su bili liječeni na odgovarajući način.
English: CARTON FOR 1 PRE-FILLED SYRINGE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: KUTIJA ZA 1 NAPUNJENU BRIZGALICU KAO MEĐUPAKIRANJE/SASTAVNI DIO VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Storage information Store in refrigerator at 2° to 8°C.
Croatian: Informacije o čuvanju lijeka Čuvati u hladnjaku na temperaturi od 2°C do 8°C.
English: Call your doctor or pharmacist for a new pre-filled pen.
Croatian: Obratite se liječniku ili ljekarniku kako biste dobili novu napunjenu brizgalicu.
English: It is recommended that the conduct of these tests should be recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Podsjećamo propisivače na rizik od lažno negativnih tuberkulinskih kožnih testova, osobito u teško bolesnih i imunokompromitiranih bolesnika.
English: If you have polyarticular juvenile idiopathic arthritis you will first be given other medicines.
Croatian: Ako imate poliartikularni juvenilni idiopatski artritis, prvo ćete primiti druge lijekove.
English: Objective signs of inflammation population (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
Croatian: Populacija s objektivnim znakovima upale (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
English: • Do not use this medicine if you notice that the liquid is not a clear to light yellow colour, cloudy, or contains foreign particles.
Croatian: • Nemojte primijeniti ovaj lijek ako primijetite da otopina nije bistra do žućkasta, ako je zamućena ili sadrži vidljive strane čestice.
English: Golimumab should be used with caution in subjects with impaired hepatic function (see section 4.2).
Croatian: Golimumab treba oprezno primjenjivati u bolesnika s poremećajem jetrene funkcije (vidjeti dio 4.2).
English: n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint.
Croatian: n se odnosi na randomizirane bolesnike; stvarni broj bolesnika koje je bilo moguće ocijeniti za pojedini ishod može se razlikovati po vremenskim točkama procjene.
English: * p < 0.05 for all comparisons; n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Croatian: * p < 0,05 za sve usporedbe; n se odnosi na randomizirane bolesnike; stvarni broj bolesnika koje je bilo moguće ocijeniti za svaki pojedini ishod može se razlikovati po vremenskim točkama procjene.
English: • Inflammation of blood vessels in internal organs
Croatian: • upala krvnih žila unutarnjih organa
English: If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Croatian: Ako niste sigurni, obratite se liječniku ili ljekarniku kako biste dobili novu napunjenu brizgalicu.
English: The needle cover on the pre-filled pen or the pre-filled syringe is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Croatian: Zaštitni poklopac na igli napunjene brizgalice ili napunjene štrcaljke načinjen je od suhe prirodne gume koja sadrži lateks i može izazvati alergijske reakcije u osoba osjetljivih na lateks.
English: Your doctor will record these tests on your Patient Reminder Card.
Croatian: Vaš liječnik će Vas testirati na tuberkulozu i upisati da ste obavili te preglede u Vašu Karticu s podsjetnikom za bolesnika.
English: Psoriatic arthritis (PsA)
Croatian: Psorijatični artritis (PsA)
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed.
Croatian: U kliničkim ispitivanjima s drugim TNF-antagonistom zabilježeni su pogoršanje kongestivnog zatajenja srca i povećana smrtnost zbog kongestivnog zatajenja srca.
English: IMPORTANT: Do not press on the orange needle guard before the injection.
Croatian: VAŽNO: Nemojte pritiskati narančasti štitnik igle prije injiciranja.
English: Dose selections: 0.1 mL
Croatian: Odabir doze: 0,1 ml
English: If possible, it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines (see Vaccinations/therapeutic infectious agents above).
Croatian: Ako je moguće, preporučuje se da pedijatrijski bolesnici prije započinjanja terapije golimumabom prime sva potrebna cjepiva u skladu s važećim programom imunizacije (vidjeti iznad odlomak ″Cijepljenje/terapijski infektivni agensi″).
English: 175 to < 180
Croatian: 175 do < 180
English: Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage.
Croatian: Nakon čuvanja na sobnoj temperaturi, Simponi se ne smije ponovno čuvati u hladnjaku.
English: The role of golimumab as a contributing or aggravation factor cannot be excluded.
Croatian: Ne može se isključiti da je golimumab pridonio ili pogoršao stanje.
English: It is important that the correct dose is administered as indicated in the posology (see section 4.2).
Croatian: Važno je primijeniti točnu dozu, kao što je navedeno u doziranju (vidjeti dio 4.2).
English: Defined as 0 or 1 on the endoscopy subscore of the Mayo score.
Croatian: Definirano kao endoskopski podrezultat 0 ili 1 u sklopu
English: • Do not put the cap back on because it may damage the needle inside the pre-filled pen.
Croatian: • Nemojte vraćati poklopac na brizgalicu jer može oštetiti iglu u napunjenoj brizgalici.
English: Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritis and irritation)
Croatian: Manje često: poremećaji vida (npr. zamagljen vid i smanjena oštrina vida), konjunktivitis, alergija oka (npr. pruritus i iritacija)
English: Among 146 patients randomised to Simponi 50 mg, 70 were still on this treatment at week 104.
Croatian: Od 146 bolesnika randomiziranih u skupinu koja je primala Simponi 50 mg, 70 ih je i dalje uzimalo tu terapiju u 104. tjednu.
English: Patients treated with Simponi should be given the Patient Reminder Card.
Croatian: Bolesnici koji se liječe lijekom Simponi trebaju dobiti Karticu s podsjetnikom za bolesnika.
English: If you stop using Simponi If you are considering stopping Simponi, talk to your doctor or pharmacist first.
Croatian: Ako razmišljate o prestanku uzimanja lijeka Simponi, najprije o tome razgovarajte sa svojim liječnikom ili ljekarnikom.
English: How much Simponi is given Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:
Croatian: Koliko lijeka Simponi treba primijeniti Poliartikularni juvenilni idiopatski artritis u djece u dobi od 2 i više godina:
English: Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m2 body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month.
Croatian: Poliartikularni juvenilni idiopatski artritis u djece tjelesne težine manje od 40 kg Preporučena doza lijeka Simponi u djece s poliartikularnim juvenilnim idiopatskim artritisom čija je tjelesna težina manja od 40 kg iznosi 30 mg/m2 tjelesne površine, do maksimalne pojedinačne doze od
English: • Check the security seal around the cap of the pre-filled pen.
Croatian: • Provjerite sigurnosnu markicu oko poklopca napunjene brizgalice.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su rijetki slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih drugim TNF-blokatorima (vidjeti dio 4.8).
English: In the controlled portions of clinical trials of all the TNF-blocking agents including golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja TNF-blokatora, uključujući golimumab, zabilježeno je više slučajeva limfoma u bolesnika koji su primali anti-TNF terapiju u odnosu na kontrolnu skupinu bolesnika.
English: Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection.
Croatian: Potreban je oprez kad se razmatra mogućnost primjene golimumaba u bolesnika s kroničnim ili rekurentnim infekcijama u anamnezi.
English: Concurrent administration with other biological therapeutics There is insufficient information regarding the concomitant use of golimumab with other biological therapeutics used to treat the same conditions as golimumab.
Croatian: Nema dovoljno podataka o istodobnoj primjeni golimumaba s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i golimumab.
English: Approximately 93% of patients who were receiving Simponi at the beginning of the open-label extension (week 16) remained on treatment through the end of the study (week 52).
Croatian: Približno je 93% bolesnika koji su primali Simponi na početku otvorenog produžetka ispitivanja (16 tjedana) nastavilo primati liječenje do kraja ispitivanja (52 tjedna).
English: Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Croatian: Simptomi alergijske reakcije mogu uključivati oticanje lica, usana, usta ili grla koje može izazvati poteškoće pri gutanju ili disanju, osip kože, koprivnjaču, oticanje ruku, stopala ili gležnjeva.
English: These changes were observed at the first assessment (week 4) after the initial Simponi administration and were generally maintained through week 24.
Croatian: Ove su promjene zabilježene na prvoj kontroli (u 4. tjednu) nakon početne primjene lijeka Simponi i općenito su se održale do 24. tjedna.
English: * p ≤ 0.001 for all comparisons n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Croatian: * p ≤ 0,001 za sve usporedbe n se odnosi na randomizirane bolesnike; stvarni broj bolesnika koje je bilo moguće ocijeniti za pojedini ishod može se razlikovati po vremenskim točkama procjene
English: • 1 Alcohol swab
Croatian: • 1 tupfer natopljen alkoholom
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.
Croatian: U ispitivanju GO-FORWARD pokazano je klinički vrijedno i statistički značajno poboljšanje zdravstvenog aspekta kvalitete života u 24. tjednu, mjereno rezultatom fizičke komponente upitnika SF-36 u bolesnika liječenih lijekom Simponi naspram onih koji su primali placebo.
English: Placebo-controlled efficacy data were collected and analysed through week 24.
Croatian: Prikupljeni su i analizirani podaci o djelotvornosti s kontrolom placeba do 24. tjedna.
English: 2% 9% p = 0.009 16% 24% Week 52 NA NA NA
Croatian: 2% 9% p = 0,009 16% 24%
English: The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections.
Croatian: Drugi sastojci su: sorbitol (E420), histidin, histidinklorid hidrat, polisorbat 80 i voda za injekcije.
English: However, you and your doctor may decide that you may inject Simponi to yourself or to your child.
Croatian: Vaš liječnik možete se dogovoriti da sljedeće doze lijeka Simponi sami dajete sebi ili svome djetetu.
English: The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells.
Croatian: Ispitivanja su pokazala da vezanje humanog TNF-a golimumabom neutralizira ekspresiju adhezijskih molekula E-selektina, adhezijske molekule krvožilnih stanica (VCAM)-1 i međustanične adhezijske molekule (ICAM)-1 na staničnoj površini ljudskih endotelnih stanica, koju izaziva TNF-α.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
Croatian: Ne može se isključiti rizik od razvoja hepatospleničkog limfoma T-stanica u bolesnika koji se liječe TNF-blokatorima.
English: Use a cotton ball or gauze
Croatian: Upotrijebite vatu ili gazu
English: • Wait 30 minutes to allow the product to reach room temperature
Croatian: • Pričekajte 30 minuta kako bi lijek postigao sobnu temperaturu
English: For placebo subjects, the incidence (95% CI) per 100 subject-years of follow-up of these malignancies was 0.00 (0.00, 2.94).
Croatian: Među ispitanicima koji su primali placebo incidencija tih malignoma (95% CI) na 100 ispitanik-godina praćenja bila je 0,00 (0,00; 2,94).
English: Patients treated with Simponi experienced significantly more improvements in health-related quality of life as assessed by ASQoL, EQ-5D, and physical and mental components of SF-36, and experienced significantly more improvements in productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI questionnaire than patients receiving placebo.
Croatian: U usporedbi s bolesnicima koji su primali placebo, bolesnici liječeni lijekom Simponi imali su značajno veće poboljšanje zdravstvenog aspekta kvalitete života procijenjenog pomoću ASQoL, EQ-5D i fizičke i mentalne komponente na upitniku SF-36, te su osjetili značajno veće poboljšanje u produktivnosti procijenjeno većim smanjenjem narušenosti ukupne radne sposobnosti i aktivnosti procijenjeno pomoću upitnika WPAI.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Croatian: U razdoblju nakon stavljanja u promet prijavljene su zloćudne bolesti, ponekad sa smrtnim ishodom u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
English: The needle cover should not be removed until you are ready to inject the medicine.
Croatian: Ne smijete skinuti zaštitni poklopac s igle štrcaljke dok niste spremni injicirati lijek.
English: In GO-FORWARD and GO-AFTER, clinically meaningful and statistically significant responses in Disease Activity Scale (DAS)28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001).
Croatian: Disease Activity Scale, DAS) 28 opaženi su u svakoj prethodno određenoj vremenskoj točki, u 14. i 24. tjednu ( p ≤ 0,001).
English: Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Croatian: Simponi, u kombinaciji s metotreksatom (MTX), indiciran je za liječenje poliartikularnog juvenilnog idiopatskog artritisa u djece u dobi od 2 i više godina koja nisu na odgovarajući način odgovorila na prethodno liječenje metotreksatom.
English: Common: Dizziness, headache, paraesthesia Uncommon: Balance disorders Rare: Demyelinating disorders (central and peripheral), dysguesia
Croatian: Često: omaglica, glavobolja, parestezija Manje često: poremećaji ravnoteže, Rijetko: demijelinizirajući poremećaji (centralni i periferni), disgeuzija
English: In GO-BEFORE the primary analysis in patients with moderate to severe rheumatoid arthritis (combined Simponi 50 and 100 mg + MTX groups vs MTX alone for ACR50) was not statistically significant at week 24 (p = 0.053).
Croatian: U ispitivanju GO-BEFORE primarna analiza bolesnika s umjerenim do teškim reumatoidnim artritisom (kombinirale su se skupine koje su primale Simponi od 50 i 100 mg i MTX nasuprot skupini koja je primala samo MTX za odgovor ACR 50) nije pokazala statistički značajnu razliku u 24. tjednu (p = 0,053).
English: Uncommon: Breast disorders, menstrual disorders
Croatian: Manje često: poremećaji dojki, menstrualni poremećaji
English: Simponi Patient Reminder Card
Croatian: Simponi Kartica s podsjetnikom za bolesnika
English: In an exploratory clinical trial evaluating the use of golimumab in patients with severe persistent asthma, more malignancies were reported in patients treated with golimumab compared with control patients (see section 4.8).
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena golimumaba u bolesnika s teškom perzistentnom astmom, prijavljeno je više slučajeva zloćudnih bolesti u bolesnika liječenih golimumabom nego u bolesnika u kontrolnoj skupini (vidjeti dio 4.8).
English: Care should be taken to ensure that patients are not underdosed or overdosed.
Croatian: Treba paziti kako bi se osiguralo da bolesnici ne prime premalu ili preveliku dozu.
English: The efficacy of Simponi was demonstrated in three multi-centre, randomised, double-blind, placebo-controlled studies in over 1500 patients ≥ 18 years of age with moderately to severely active RA diagnosed according to American College of Rheumatology (ACR) criteria for at least 3 months prior to screening.
Croatian: Djelotvornost lijeka Simponi dokazana je u tri multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u više od 1500 bolesnika u dobi od ≥ 18 godina, kojima je dijagnosticiran umjereno do vrlo aktivan reumatoidni artritis prema kriterijima Američkog reumatološkog društva (ACR) najmanje 3 mjeseca prije probira u ispitivanje.