FrancophonIA/ELRC3.0 huggingface dataset:
English: Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman.
Croatian: Nakon liječenja monoklonskim protutijelom koje blokira TNF tijekom trudnoće protutijelo je bilo prisutno do 6 mjeseci u serumu dojenčeta liječene majke.
English: The majority of lymphomas occurred in study GO-AFTER, which enrolled patients previously exposed to anti-TNF agents who had longer disease duration and more refractory disease (see section 4.4).
Croatian: Većina limfoma zabilježena je u ispitivanju GO-AFTER, koje je uključilo bolesnike prethodno izložene TNF-blokatorima u kojih je bolest dulje trajala i bila otpornija na liječenje (vidjeti dio 4.4).
English: • Talk to your doctor if you are going to have any operations or dental procedures.
Croatian: • Obavijestite liječnika ako planirate neku operaciju ili stomatološki zahvat.
English: Concomitant stable doses of oral aminosalicylates, and/or immunomodulatory agents were permitted.
Croatian: Bila je dopuštena istodobna primjena stabilnih doza peroralnih aminosalicilata i/ili imunomodulatora.
English: Check the expiration date (‘EXP') printed or written on the back panel of the carton.
Croatian: Provjerite datum isteka roka valjanosti ("EXP"), otisnuti ili zapisani na stražnjoj strani kutije.
English: Following a single subcutaneous administration of golimumab to healthy subjects or patients with RA, the median time to reach maximum serum concentrations (Tmax) ranged from 2 to 6 days.
Croatian: Nakon jednokratne supkutane primjene golimumaba u zdravih dobrovoljaca ili bolesnika s reumatoidnim artritisom, medijan vremena za postizanje najveće serumske koncentracije (Tmax) iznosio je 2 do 6 dana.
English: Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Croatian: Nema odgovarajućih podataka o bolesnicima nositeljima HBV-a koji su se liječili antivirusnim lijekovima zajedno s TNF-antagonistima radi sprječavanja reaktivacije virusa hepatitisa B.
English: GO-FORWARD evaluated 444 patients who had active RA despite a stable dose of at least 15 mg/week of MTX and who had not been previously treated with an anti-TNF agent.
Croatian: U ispitivanju GO-FORWARD ocijenjena su 444 bolesnika s aktivnim reumatoidnim artritisom unatoč stabilnoj dozi metotreksata (MTX) od najmanje 15 mg na tjedan, koji prethodno nisu liječeni TNF-blokatorom.
English: Among patients who received Simponi maintenance treatment, the improvement in quality of life as measured by IBDQ was maintained through week 54.
Croatian: Među bolesnicima koji su primali terapiju održavanja lijekom Simponi poboljšanje kvalitete života mjereno upitnikom IBDQ održalo se do 54. tjedna.
English: • That treatment with Simponi may increase the risks of serious infection, opportunistic infections, tuberculosis, hepatitis B reactivation and breakthrough infection after administration of live vaccines in infants exposed to golimumab in utero; and when to seek attention from a
Croatian: • Navod da liječenje lijekom Simponi može povećati rizik od ozbiljne infekcije, oportunističkih infekcija, tuberkuloze, reaktivacije hepatitisa B i probojne infekcije nakon primjene živih cjepiva u dojenčadi koja je bila izložena golimumabu in utero, te kada je potrebno zatražiti medicinsku pomoć od zdravstvenih radnika.
English: • When you are ready to inject, twist the cap slightly to break the security seal.
Croatian: • Kad ste spremni dati injekciju, lagano okrenite poklopac kako bi se prekinula sigurnosna markica.
English: Simponi treatment resulted in significant improvements in physical function as assessed by changes from baseline in BASFI at weeks 14 and 24.
Croatian: Liječenje lijekom Simponi dovelo je do značajnog poboljšanja fizičke funkcije, procijenjene promjenama u odnosu na početne vrijednosti Bath indeksa funkcije u ankilozantnom spondilitisu (BASFI) u 14. i 24. tjednu.
English: Patients receiving golimumab should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.
Croatian: Bolesnike koji primaju golimumab potrebno je pomno nadzirati kako bi se uočili znakovi i simptomi aktivne tuberkuloze, uključujući bolesnike koji su imali negativne rezultate testa na latentnu tuberkulozu, bolesnike koji primaju terapiju za latentnu tuberkulozu ili bolesnike koji su prethodno liječeni zbog tuberkuloze.
English: For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.
Croatian: Za informacije o indikaciji poliartikularnog juvenilnog idiopatskog artritisa vidjeti sažetak opisa svojstava lijeka za Simponi 50 mg.
English: There was a trend toward higher apparent clearance of golimumab with increasing weight (see section 4.2).
Croatian: Postojao je trend povećanja prividnog klirensa golimumaba s povećanjem tjelesne težine (vidjeti dio 4.2).
English: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n reflects number of patients with baseline and week 16 MRI data SPARCC (Spondyloarthritis Research Consortium of Canada) ** p < 0.0001 for Simponi vs placebo comparisons * p < 0.05 for Simponi vs placebo comparisons
Croatian: Ankiloylosing Spondylitis Disease Activity Score C-Reactive Protein) (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n predstavlja broj bolesnika s MRI podacima na početku i u 16. tjednu ispitivanja SPARCC (Konzorcij za istraživanje spondiloartritisa Kanade) ** p < 0,0001 za usporedbe Simponi naspram placebo * p < 0,05 za usporedbe Simponi naspram placebo
English: Patients enrolled in this study had active disease despite current or previous NSAID or DMARD therapy and had not previously been treated with anti-TNF therapy.
Croatian: Bolesnici uključeni u ovo ispitivanje imali su aktivni oblik bolesti unatoč postojećem ili prethodnom liječenju nesteroidnim antireumaticima ili terapiji DMARD i nisu nikada prije liječeni anti-TNF terapijom.
English: In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following golimumab administration.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljene su ozbiljne sustavne alergijske reakcije (uključujući anafilaktičku reakciju) koje su uslijedile nakon primjene golimumaba.
English: Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:
Croatian: Poliartikularni juvenilni idiopatski artritis u djece u dobi od 2 i više godina:
English: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age.
Croatian: Sigurnost golimumaba ispitivala se u ispitivanju faze III koje je uključivalo 173 bolesnika s pJIA u dobi od 2 do 17 godina.
English: For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8).
Croatian: Za sve gore navedene indikacije u bolesnika s RA, PsA, AS ili aksijalnim spondiloartritisom bez radiološkog dokaza, tjelesne težine veće od 100 kg u kojih se ne postigne odgovarajući klinički odgovor nakon 3 ili 4 doze može se razmotriti povećanje doze golimumaba na 100 mg jedanput na mjesec, ali uzimajući u obzir da se kod primjene doze od 100 mg u odnosu na dozu od 50 mg povećava rizik od određenih ozbiljnih nuspojava (vidjeti dio 4.8).
English: • Pull the cap off and throw it away after your injection.
Croatian: • Povucite poklopac i bacite ga u otpad nakon injekcije.
English: • Place the needle at approximately a 45-degree angle to the pinched skin.
Croatian: • Postavite iglu na stisnuti dio kože pod kutem od približno 45 stupnjeva.
English: defined as a decrease from baseline in the Mayo score by ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or a rectal bleeding subscore of 0 or 1.
Croatian: Definirano kao smanjenje Mayo rezultata za ≥ 30% i ≥ 3 boda u odnosu na početnu vrijednost, uz smanjenje podrezultata rektalnog krvarenja za ≥ 1 ili podrezultat rektalnog krvarenja 0 ili 1.
English: Week 24 14% 37%* Week 52 NA NA NA
Croatian: 24. tjedan 14% 37%* 52. tjedan NP
English: Approximately 63% of patients who were receiving Simponi at the beginning of the study extension (week 56), remained on treatment through the end of the study (last golimumab administration at week 212).
Croatian: Približno je 63% bolesnika koji su primali Simponi na početku produžetka ispitivanja (56. tjedan) nastavilo s liječenjem do kraja ispitivanja (zadnja primjena golimumaba u 212. tjednu).
English: Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis.
Croatian: Odmah obavijestite svog liječnika ako Vam je ikada dijagnosticirana neka demijelinizirajuća bolest poput multiple skleroze, ili ako Vam se pojave neki simptomi takve bolesti.
English: Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi.
Croatian: Odmah recite liječniku ako već imate ili razvijete neke simptome infekcije tijekom ili nakon liječenja lijekom Simponi.
English: Through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general population.
Croatian: Tijekom približno 4 godine praćenja incidencija malignih bolesti koje nisu limfomi (osim nemelanomskog raka kože) bila je slična onoj u općoj populaciji.
English: Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Croatian: Bolesnici su tijekom ispitivanja mogli nastaviti istodobnu DMARD terapiju metotreksatom (MTX), sulfasalazinom (SSZ), i/ili hidroksiklorokinom (HCQ).
English: Patients who did not achieve clinical response at week 6 in the PURSUIT-Induction studies were dosed Simponi 100 mg every 4 weeks in the PURSUIT-Maintenance study.
Croatian: Bolesnici u kojih nije postignut klinički odgovor u 6. tjednu ispitivanja PURSUIT-Induction su u ispitivanju PURSUIT-Maintenance primali Simponi u dozi od 100 mg svaka 4 tjedna.
English: Cancer and lymphoma Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Croatian: Rak i limfom Prije nego počnete uzimati Simponi obavijestite liječnika ako Vam je ikada dijagnosticiran limfom (vrsta raka krvi) ili neka druga vrsta raka.
English: Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).
Croatian: To znači da 0,05 ml lijeka sadrži 2,05 mg sorbitola (E420).
English: The combination of golimumab and anakinra is not recommended.
Croatian: Ne preporučuje se kombinirana primjena golimumaba i anakinre.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Croatian: Bila je dopuštena istodobna primjena stabilnih doza peroralnih aminosalicilata, kortikosteroida i/ili imunomodulatora.
English: • blood disease (common).
Croatian: • bolest krvi (često).
English: In children 2 years of age and older, Simponi is used for the treatment of polyarticular juvenile idiopathic arthritis.
Croatian: U djece u dobi od 2 i više godina Simponi se koristi za liječenje poliartikularnog juvenilnog idiopatskog artritisa.
English: Children in this study demonstrated ACR Ped 30, 50, 70, and 90 responses from week 4.
Croatian: Djeca uključena u ovo ispitivanje postizala su odgovore ACR Ped 30, 50, 70 i 90 od 4. tjedna.
English: Renal and hepatic impairment Simponi has not been studied in these patient populations.
Croatian: Oštećenje funkcije bubrega i jetre Simponi nije ispitivan u ovim populacijama bolesnika.
English: Paediatric population Simponi 100 mg is not recommended in children aged less than 18.
Croatian: Ne preporučuje se primjena lijeka Simponi 100 mg u djece mlađe od 18 godina.
English: Patients who developed anti-golimumab antibodies generally had low trough steady-state serum concentrations of golimumab (see section 5.1).
Croatian: Bolesnici u kojih su se razvila protutijela na golimumab općenito su imali niske najmanje serumske koncentracije golimumaba u stanju dinamičke ravnoteže (vidjeti dio 5.1).
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1.
Croatian: Nuspojave zabilježene u kliničkim ispitivanjima i prijavljene širom svijeta nakon stavljanja golimumaba u promet navedene su u Tablici 1.
English: Do not share the pre-filled pen with anyone.
Croatian: Napunjenu brizgalicu nemojte dijeliti s drugima.
English: Patients treated with golimumab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Croatian: Bolesnici liječeni golimumabom mogu istodobno primiti cjepiva, osim živih cjepiva (vidjeti dijelove 4.5 i 4.6).
English: In patients who develop HBV reactivation, golimumab should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika u kojih se dogodi reaktivacija virusa hepatitisa B, terapiju golimumabom treba prekinuti te treba započeti s djelotvornom antivirusnom terapijom i odgovarajućim suportivnim liječenjem.
English: 50 mg) + MTX or placebo + MTX every 4 weeks.
Croatian: (maksimalno 50 mg) + MTX ili placebo + MTX svaka 4 tjedna.
English: • Lift the pre-filled pen from the injection site.
Croatian: • Podignite napunjenu brizgalicu s mjesta injekcije.
English: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers.
Croatian: Ako bolesnik zaboravi primijeniti Simponi predviđenog dana, zaboravljenu dozu treba injicirati čim se sjeti.
English: Simponi or placebo were administered subcutaneously every 4 weeks.
Croatian: Simponi ili placebo primijenjeni su supkutano svaka 4 tjedna.
English: Invasive fungal infections
Croatian: Invazivne gljivične infekcije
English: Therapeutic infectious agents
Croatian: Terapijski infektivni agensi
English: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
Croatian: • liječenje umjerenog do teškog oblika aktivnog reumatoidnog artritisa u odraslih čiji je odgovor na antireumatske lijekove koji modificiraju tijek bolesti (terapija DMARD), uključujući metotreksat, neodgovarajući.
English: Structural damage in both hands and feet was assessed radiographically by the change from baseline in the vdH-S score, modified for PsA by addition of hand distal interphalangeal (DIP) joints.
Croatian: Strukturalno oštećenje obiju šaka i stopala procijenilo se radiološki na temelju promjene broja vdH-S bodova u odnosu na početnu vrijednost, s time da se bodovanje prilagodilo za psorijatični artritis dodavanjem distalnih interfalangealnih zglobova šake.
English: Check the number of pre-filled syringes Check the pre-filled syringes to make sure
Croatian: Provjerite broj napunjenih štrcaljki Provjerite napunjene štrcaljke kako biste bili sigurni
English: Table 5 Key efficacy outcomes from GO-RAISE.
Croatian: Tablica 5 Ključni rezultati djelotvornosti iz ispitivanja GO-RAISE.
English: Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Croatian: Ozbiljne infekcije zabilježene u bolesnika liječenih golimumabom uključuju tuberkulozu, bakterijske infekcije, uključujući sepsu i pneumoniju, invazivne gljivične infekcije i druge oportunističke infekcije.
English: Patients should be instructed to inject the prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack.
Croatian: Bolesnike treba podučiti da injiciraju propisanu količinu lijeka Simponi u skladu s detaljnim uputama za uporabu koje se nalaze u pakiranju lijeka.
English: Since golimumab exhibited approximately dose proportional PK following a subcutaneous administration, the absolute bioavailability of a golimumab 50 mg or 200 mg dose is expected to be similar.
Croatian: Budući da golimumab nakon supkutane primjene pokazuje farmakokinetiku otprilike proporcionalnu dozi, očekuje se da je slična apsolutna bioraspoloživost doze od 50 mg ili 200 mg.
English: Physicians global assessment of disease (VAS
Croatian: Liječnikova opća ocjena bolesti (VAS c: 0
English: Responders, % of patients ASAS 20
Croatian: % bolesnika s odgovorom ASAS 20
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 polyarticular juvenile idiopathic arthritis.
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 poliartikularnog juvenilnog idiopatskog artritisa.
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2.
Croatian: Nuspojave zabilježene u kliničkim ispitivanjima i prijavljene širom svijeta nakon stavljanja golimumaba u promet navedene su u Tablici 2.
English: The induction study (PURSUIT-Induction) evaluated patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) who had an inadequate response to or failed to tolerate conventional therapies, or were corticosteroid dependent.
Croatian: U ispitivanju uvodne terapije (PURSUIT-Induction) ocijenjeni su bolesnici s umjerenim do teškim oblikom aktivnog ulceroznog kolitisa (Mayo bodovi 6 do 12; endoskopski podrezultat ≥ 2) koji na konvencionalnu terapiju nisu na odgovarajući način odgovorili ili je nisu podnosili, ili su bili ovisni o kortikosteroidima.
English: Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Croatian: Simponi je indiciran za liječenje teškog oblika aktivnog ankilozantnog spondilitisa u odraslih koji nisu odgovorili na konvencionalnu terapiju na odgovarajući način.
English: In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
Croatian: U ispitivanju faze III u bolesnika s pJIA, do 48. tjedna su EIA metodom otpornom na lijek otkrivena protutijela na golimumab u 40% (69/172) djece liječene golimumabom, od kojih je većina imala titar niži od 1:1000.
English: In a limited number of RA patients treated with subcutaneous golimumab over a 6-month period, concomitant use of MTX reduced the apparent clearance of golimumab by approximately 36%.
Croatian: U ograničenog broja bolesnika s reumatoidnim artritisom liječenih golimumabom primijenjenim supkutano tijekom 6-mjesečnog razdoblja, istodobna primjena MTX smanjila je prividni klirens golimumaba za približno 36%.
English: Press button to inject (see figure 7)
Croatian: Pritisnite gumb kako biste ubrizgali lijek (vidjeti sliku 7)
English: • Contact details of the prescriber.
Croatian: • Kontakt podatke liječnika koji je propisao lijek.
English: Check security seal
Croatian: Provjerite sigurnosnu markicu
English: • Balance disorders
Croatian: • poremećaji ravnoteže
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with golimumab and is positive for antibodies against double-stranded DNA, treatment with golimumab should be discontinued (see section 4.8).
Croatian: Ako bolesnik nakon liječenja golimumabom razvije simptome koji ukazuju na sindrom sličan lupusu i ako ima pozitivan nalaz protutijela na dvolančanu DNK, treba prekinuti liječenje golimumabom (vidjeti dio 4.8).
English: At week 52, patients entered an open label long-term extension in which patients receiving placebo + MTX who had at least 1 tender or swollen joint were switched to Simponi 50 mg + MTX.
Croatian: U 52. tjednu, bolesnici su ušli u otvorenu fazu dugotrajnog nastavka tog ispitivanja u kojem se bolesnicima koji su primali placebo i MTX te koji su imali najmanje jedan osjetljivi ili otečeni zglob bili prebačeni na Simponi 50 mg i MTX.
English: Patients with RA, PsA or AS who did not receive concomitant MTX had approximately 30% lower steady-state trough concentrations of golimumab than those who received golimumab with MTX.
Croatian: Bolesnici s RA, PsA ili AS koji istodobno nisu primali MTX imali su oko 30% manje koncentracije golimumaba u stanju dinamičke ravnoteže od onih koji su uz golimumab primali i MTX.
English: • Some of these reactions occurred after the first administration of Simponi.
Croatian: • Neke od ovih reakcija pojavile su se nakon prve primjene lijeka Simponi.
English: The majority of children did not experience a flare between week 16 and week 48 (59% in the Simponi + MTX and 53% in the placebo + MTX groups, respectively; p = 0.41).
Croatian: Većina djece nije doživjela razbuktavanje bolesti između 16. i 48. tjedna (59% u skupini koja je primala Simponi + MTX te 53% u skupini koja je primala placebo + MTX; p-vrijednost = 0,41).
English: If you forget to use Simponi If you forget to use Simponi on your planned date, inject the forgotten dose as soon as you remember.
Croatian: Ako ste zaboravili primijeniti Simponi planiranog datuma, ubrizgajte zaboravljenu dozu čim se sjetite.
English: The dose should be given once a month, on the same date each month.
Croatian: Dozu treba primijeniti jedanput na mjesec, istoga dana u mjesecu.
English: Patients who completed the maintenance study through week 54 continued treatment in a study extension, with efficacy evaluated through week 216.
Croatian: Bolesnici koji su završili sva 54 tjedna ispitivanja terapije održavanja nastavili su liječenje u produžetku ispitivanja, a djelotvornost se procjenjivala do 216. tjedna.
English: • Upper respiratory tract infections, sore throat or hoarseness, runny nose
Croatian: • infekcije gornjih dišnih puteva, grlobolja ili promuklost, curenje nosa
English: At week 16, patients entered an open label period in which all patients received Simponi 50 mg administered subcutaneously every 4 weeks through week 48 with efficacy assessments performed through week 52 and safety follow-up through week 60.
Croatian: U 16. tjednu, bolesnici su ušli u razdoblje otvorenog liječenja u kojem su, do 48. tjedna, svi primali Simponi u supkutanoj dozi od 50 mg svaka 4 tjedna s time da se procjena djelotvornosti provodila do 52. tjedna, a sigurnost pratila do 60. tjedna.
English: Do not lift the pre-filled pen up yet.
Croatian: Nemojte još dizati napunjenu brizgalicu.
English: b < 1.3 BASDAI 50 Inhibition of inflammation in sacroiliac (SI) joints as measured by MRI Placebo Simponi 50 mg Placebo Simponi 50 mg
Croatian: b < 1,3 BASDAI 50 Inhibicija upale u sakroilijačnim (SI) zglobovima mjereno pomoću MRI Placebo Simponi 50 mg Placebo Simponi 50 mg n