FrancophonIA/ELRC3.0 huggingface dataset:
English: Eighty-two percent (18/22) of antibody-positive patients had neutralising antibodies in vitro.
Croatian: Osamdeset dva posto (18/22) bolesnika s pozitivnim nalazom protutijela imalo je neutralizirajuća protutijela in vitro.
English: The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Croatian: Sigurnost i djelotvornost lijeka Simponi u djece mlađe od 18 godina za sve indikacije osim pJIA nisu ustanovljene.
English: Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).
Croatian: Iako istodobna primjena metotreksata (MTX) rezultira povećanim koncentracijama golimumaba u stanju dinamičke ravnoteže u bolesnika s RA, PsA ili AS, podaci pokazuju da nema potrebe za prilagodbom doze ni golimumaba niti MTX (vidjeti dio 5.2).
English: GO-AFTER evaluated 445 patients who were previously treated with one or more of the anti-TNF agents adalimumab, etanercept, or infliximab.
Croatian: U ispitivanju GO-AFTER ocijenjeno je 445 bolesnika koji su prethodno liječeni jednim ili više TNF-blokatorima, adalimumabom, etanerceptom ili infliksimabom.
English: Patients should be instructed not to inject a double dose to make up for the forgotten dose.
Croatian: Bolesnike treba upozoriti da ne smiju injicirati dvostruku dozu kako bi nadoknadili propuštenu.
English: Result _______________ • Tell your doctor if you know or suspect you are a carrier of the hepatitis B virus.
Croatian: • Obavijestite liječnika ako znate ili sumnjate da ste zaraženi virusom hepatitisa B.
English: Carriers of HBV who require treatment with golimumab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje virusa hepatitisa B kojima je potrebno liječenje golimumabom treba pažljivo nadzirati kako bi se uočili znakovi i simptomi aktivne HBV infekcije cijelo vrijeme liječenja i još nekoliko mjeseci nakon završetka liječenja.
English: Some orange will still be showing.
Croatian: Dio narančastog štitnika će se i dalje vidjeti.
English: At week 16, 34% of children had inactive disease defined as having the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalised lymphadenopathy attributable to JIA; no active uveitis; normal ESR (< 20 mm/hour) or CRP (< 1.0 mg/dL); physician global assessment of disease activity (≤ 5 mm on the VAS); duration of morning stiffness < 15 minutes.
Croatian: U 16. tjednu, 34% djece imalo je neaktivnu bolest, koja se definirala kao prisutnost svih sljedećih elemenata: nijedan zglob zahvaćen aktivnim artritisom; bez vrućice, osipa, serozitisa, splenomegalije, hepatomegalije ili generalizirane limfadenopatije koja bi se mogla pripisati JIA; bez aktivnog uveitisa; normalna brzina sedimentacije eritrocita (engl. erythrocyte sedimentation rate, ESR) (< 20 mm/sat) ili normalna vrijednost CRP-a (< 1,0 mg/dl); liječnikova opća ocjena aktivnosti bolesti (VAS: ≤ 5 mm); trajanje jutarnje ukočenosti < 15 minuta.
English: • Slowly take your thumb off the plunger head to allow the empty pre-filled syringe to move up until the entire needle is covered by the needle guard, as shown by the figure 9:
Croatian: • Polagano skidajte palac s glave klipa kako bi se prazna napunjena štrcaljka povukla prema gore, sve dok cijela igla nije prekrivena zaštitom, kako je prikazano na slici 9:
English: • Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
Croatian: • nalazi testova jetrene funkcije koji odstupaju od normalnih vrijednosti (povišene vrijednosti jetrenih enzima) ustanovljeni pretragama krvi koje je učinio Vaš liječnik
English: Patients with body weight less than 80 kg
Croatian: Bolesnici s tjelesnom težinom manjom od 80 kg
English: Improvement in C-reactive protein (CRP) levels were observed relative to placebo groups and treatment with Simponi resulted in significant reductions from baseline in serum levels of IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 and vascular endothelial growth factor (VEGF) compared to control treatment.
Croatian: Zabilježeno je sniženje razina C-reaktivnog proteina (CRP) u odnosu na skupine koje su primale placebo, a liječenje lijekom Simponi dovelo je do značajnog smanjenja serumskih razina IL-6, ICAM-1, matriksne metaloproteinaze (MMP)-3 i vaskularnog endotelnog faktora rasta (VEGF) u odnosu na početne vrijednosti, u usporedbi s kontrolnom skupinom.
English: Care should be taken to provide the right strength to ensure that patients are not underdosed or overdosed.
Croatian: Treba paziti da se upotrijebi odgovarajuća jačina kako bi se osiguralo da bolesnici ne prime premalu ili preveliku dozu.
English: The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) for inflammatory bowel disease.
Croatian: Većina se slučajeva dogodila u adolescenata i mlađih odraslih muškaraca, od kojih su gotovo svi istodobno primali terapiju azatioprinom (AZA) ili 6-merkaptopurinom (6-MP) za liječenje upalne bolesti crijeva.
English: Side effects of which the frequency is not known: • A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)
Croatian: Nuspojave čija je učestalost nepoznata: • rijedak rak krvi koji se uglavnom javlja u mladih osoba (hepatosplenički limfom T-stanica)
English: It is recommended that therapeutic infectious agents not be given concurrently with golimumab.
Croatian: Ne preporučuje se primjenjivati terapijske infektivne agense istodobno s golimumabom.
English: Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.
Croatian: Primjena TNF-blokatora, uključujući golimumab, dovodi se u vezu sa slučajevima novonastalih ili egzacerbacije kliničkih simptoma i/ili radioloških dokaza demijelinizacijskih bolesti središnjeg živčanog sustava, uključujući multiplu sklerozu, i periferne demijelinizacijske bolesti.
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children.
Croatian: Poliartikularni juvenilni idiopatski artritis je upalna bolest koja uzrokuje bolove u zglobovima i oticanje zglobova u djece.
English: If you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Croatian: Ako na te lijekove ne odgovorite dobro, možete dobiti Simponi, koji ćete koristiti u kombinaciji s drugim lijekom, koji se zove metotreksat, kako bi se:
English: • swelling of small blood vessels (vasculitis) (rare).
Croatian: • oticanje malih krvnih žila (vaskulitis) (rijetko).
English: Do not touch the needle or allow it to touch any surface.
Croatian: Ne dirajte iglu i pazite da iglom ništa ne dodirnete.
English: • Remove air bubbles
Croatian: • ukloniti mjehuriće zraka
English: Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Croatian: Pokazalo se da Simponi, prema rendgenskim snimkama, usporava brzinu napredovanja oštećenja perifernih zglobova u bolesnika s poliartikularnim simetričnim tipovima bolesti (vidjeti dio 5.1) i poboljšava fizičku funkciju.
English: Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p < 0.05).
Croatian: U 14. i 24. tjednu bili su primijećeni i statistički značajni odgovori DAS28 (p < 0,05).
English: Turn plunger until the dose line for your prescribed dose lines up with the dose selection notch.
Croatian: Okrećite klip sve dok oznaka koja odgovara propisanoj dozi ne bude poravnata s urezom za odabir doze.
English: • Position the open end of the pre-filled pen straight onto your skin (90 degrees)
Croatian: • Namjestite otvoreni kraj napunjene brizgalice na kožu pod pravim kutem (90 stupnjeva)
English: Because immunogenicity analyses are product- and assay-specific, comparison of antibody rates with those from other products is not appropriate.
Croatian: Budući da su analize imunogenosti specifične za pojedini proizvod i pojedine testove, nije primjereno uspoređivati incidenciju protutijela s incidencijom pri primjeni drugih lijekova.
English: • serious infections (including TB, bacterial infections including serious blood infections and pneumonia, severe fungal infections and other opportunistic infections) (common).
Croatian: • ozbiljne infekcije (uključujući tuberkulozu (TBC), bakterijske infekcije uključujući ozbiljne infekcije krvi i upalu pluća, teške gljivične infekcije i ostale oportunističke infekcije) (često).
English: Injection site selection for caregivers if you are not administering the injection yourself (see figure 3)
Croatian: Odabir mjesta injekcije za njegovatelje ako si injekciju ne primjenjujete sami (vidjeti sliku 3)
English: Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Croatian: Od 146 bolesnika randomiziranih u skupinu koja je primala Simponi 50 mg radiološki podaci iz 52. tjedna bili su dostupni za 126 bolesnika od kojih 77% nije imalo vidljivo napredovanje oštećenja u odnosu na početno stanje.
English: Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter.
Croatian: Bolesnici u kojih se postigne odgovarajući odgovor trebaju primiti dozu od 50 mg u 6. tjednu i zatim svaka 4 tjedna nakon toga.
English: (maximum 50 mg) subcutaneously every 4 weeks and MTX.
Croatian: (maksimalno 50 mg), primijenjenoj supkutano svaka 4 tjedna, i MTX.
English: Each pack is provided with instructions for use that fully describe the use of the pen or the syringe.
Croatian: U svakom pakiranju nalaze se upute za uporabu u kojima je detaljno opisana uporaba brizgalice ili štrcaljke.
English: • Inflammation of the blood vessels in your skin which results in rash
Croatian: • upala krvnih žila u koži koja rezultira osipom
English: Previous treatment with an anti-TNF agent was not allowed.
Croatian: Nije bilo dopušteno prethodno liječenje TNF-blokatorima.
English: The possibility exists for TNF-blocking agents, including golimumab, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Croatian: Postoji mogućnost da TNF-blokatori, uključujući golimumab, utječu na obranu domaćina protiv infekcija i malignih bolesti, jer je TNF posrednik upale i mijenja stanični imunološki odgovor.
English: Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in health-related quality of life as measured by the physical and mental component summary scores of the SF-36.
Croatian: Liječenje lijekom Simponi dovelo je do značajnog poboljšanja fizičke funkcije, procijenjene upitnikom HAQ DI, kao i do značajnog poboljšanja zdravstvenog aspekta kvalitete života, mjereno zbrojem bodova za fizičku i mentalnu komponentu upitnika SF-36.
English: Simponi is registered in 50 mg and 100 mg strengths for subcutaneous administration.
Croatian: Simponi je registriran u jačinama od 50 mg i 100 mg za supkutanu primjenu.
English: Following a single subcutaneous injection of 100 mg, the absorption of golimumab was similar in the upper arm, abdomen, and thigh, with a mean absolute bioavailability of 51%.
Croatian: Nakon jednokratne supkutane injekcije u dozi od 100 mg golimumaba, apsorpcija golimumaba bila je slična na nadlaktici, abdomenu i bedru, a srednja vrijednost apsolutne bioraspoloživosti iznosila je 51%.
English: For additional assistance refer to the Package Leaflet for your local representative contact information.
Croatian: Za dodatnu pomoć, u uputi o lijeku potražite kontaktne podatke lokalnog predstavnika.
English: Symptoms of skin cancer can include changes in the appearance of your skin or growths on your skin.
Croatian: Simptomi raka kože mogu uključivati promjene u izgledu Vaše kože ili izrasline na Vašoj koži.
English: Please also read the ‘Package Leaflet: Information for the user' carefully before starting your injection.
Croatian: Prije nego što injicirate lijek, pažljivo pročitajte i "Uputu o lijeku: Informacije za korisnika".
English: In GO-BEFORE, major clinical response, defined as the maintenance of an ACR 70 response over a continuous 6-month period, was measured.
Croatian: U ispitivanju GO-BEFORE mjerio se glavni klinički odgovor, koji se definirao kao neprekidno prisutan odgovor ACR 70 tijekom razdoblja od 6 mjeseci.
English: Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis Simponi 50 mg given once a month, on the same date each month.
Croatian: Psorijatični artritis, ankilozantni spondilitis ili aksijalni spondiloartritis bez radiološkog dokaza Daje se 50 mg lijeka Simponi jedanput na mjesec, istoga dana u mjesecu.
English: Common: Bone fractures
Croatian: Često: frakture kostiju
English: Hold pressure on your skin with a cotton ball or gauze pad until any bleeding stops.
Croatian: Držite vatu ili gazu pritisnutom o kožu dok krvarenje ne prestane.
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see figure 8).
Croatian: • Kad ste klip potisnuli do kraja, pritišćući i dalje glavu klipa izvadite iglu iz kože i pustite kožni nabor (vidjeti sliku 8).
English: When you are treated with Simponi, you might get infections more easily.
Croatian: Kad se liječite lijekom Simponi, možete postati osjetljiviji na infekcije.
English: Among patients who entered the study extension, the proportion of subjects who remained corticosteroid free was generally maintained through week 216.
Croatian: Među bolesnicima koji su ušli u produžetak ispitivanja, udio ispitanika kojima i dalje nisu bili potrebni kortikosteroidi uglavnom je ostao isti do 216. tjedna.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Croatian: Bacite ovaj lijek ako se ne upotrijebi do isteka novog roka valjanosti ili roka valjanosti koji je otisnut na kutiji, ovisno o tome što je ranije.
English: Placebo-controlled efficacy data were collected and analysed through week 16.
Croatian: Placebom kontrolirani podaci o djelotvornosti prikupljeni do 16. tjedna bili su analizirani u 16. tjednu.
English: If your doctor decides that you or a caregiver may be able to give your injections of Simponi at home, you should receive training on the right way to prepare and inject Simponi.
Croatian: Ako liječnik zaključi da si možete sami davati injekcije lijeka Simponi kod kuće ili da Vam ih može davati njegovatelj, morate proći obuku o pravilnoj pripremi i injiciranju lijeka Simponi.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Croatian: Vrlo je važno obavijestiti liječnika ako ste ikada bolovali od tuberkuloze ili ste bili u bliskom kontaktu s osobom koja je bolovala od tuberkuloze.
English: • Flu
Croatian: • gripa
English: • Pain and discolouration in the fingers or toes
Croatian: • bol i promjena boje prstiju na rukama ili nogama
English: • If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using Simponi.
Croatian: • Ako Vaš liječnik misli da postoji rizik od tuberkuloze, prije liječenja lijekom Simponi možda ćete dobiti lijekove protiv tuberkuloze.
English: Thin Hidden Needle
Croatian: Tanka skrivena igla
English: The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Croatian: Ne preporučuje se primjena golimumaba u kombinaciji s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i golimumab, uključujući anakinru i abatacept (vidjeti dio 4.4).
English: Each pack is provided with instructions for use that fully describe the use of the pen.
Croatian: U svakom pakiranju nalaze se upute za uporabu u kojima je detaljno opisana uporaba brizgalice.
English: At week 104, X-ray data were available for 114 patients, and 77% showed no progression from baseline.
Croatian: U 104. tjednu radiološki podaci bili su dostupni za 114 bolesnika od kojih 77% nije imalo vidljivo pogoršanje u odnosu na početno stanje.
English: Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of 0-10 cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
Croatian: Bolesnici uključeni u ovo ispitivanje imali su aktivnu bolest (definiranu kao BASDAI ≥ 4 i rezultat na vizualnoj analognoj ljestvici (VAS) za bol u cijelim leđima ≥ 4, oba na ljestvici od 0 do 10 cm) usprkos trenutnoj ili prethodnoj terapiji NSAIL-om i prethodno nisu bili liječeni nikakvim biološkim lijekovima niti anti-TNF terapijom.
English: In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness.
Croatian: Ako rizični bolesnici liječeni golimumabom razviju ozbiljnu sistemsku bolest, treba posumnjati na invazivnu gljivičnu infekciju.
English: Remove the needle cover (see figure 5)
Croatian: Skinite poklopac s igle (vidjeti sliku 5)
English: Latex sensitivity
Croatian: Osjetljivost na lateks
English: If active tuberculosis is diagnosed, golimumab therapy must not be initiated (see section 4.3).
Croatian: Ako je dijagnosticirana aktivna tuberkuloza, ne smije se započeti liječenje golimumabom (vidjeti dio 4.3).
English: Nervous system disease
Croatian: Bolest živčanog sustava
English: At week 6, Simponi significantly improved quality of life as measured by change from baseline in a disease specific measure, IBDQ (inflammatory bowel disease questionnaire).
Croatian: Simponi je u 6. tjednu značajno poboljšao kvalitetu života, mjereno promjenom u odnosu na početnu vrijednost mjerila specifičnog za bolest, upitniku IBDQ (upitnik za upalne bolesti crijeva).
English: Keep out of reach of children.
Croatian: Čuvati izvan dohvata djece.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Croatian: • lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici)
English: The solution can be used if it contains a few small translucent or white particles of protein.
Croatian: Otopina se može upotrijebiti ako sadrži nekoliko malih prozirnih ili bijelih čestica proteina.
English: Children with polyarticular course JIA (rheumatoid factor positive or negative polyarthritis, extended oligoarthritis, juvenile psoriatic arthritis or systemic JIA with no current systemic symptoms) were included in the study.
Croatian: U ispitivanje su bila uključena djeca s JIA poliartikularnog tijeka (poliartritis pozitivan ili negativan na reumatoidni faktor, prošireni oligoartritis, juvenilni psorijatični artritis ili sistemski JIA bez trenutnih sistemskih simptoma).
English: Following a single SC dose in healthy subjects, approximately dose-proportional pharmacokinetics were also observed over a dose range of 50 mg to 400 mg.
Croatian: Nakon pojedinačne supkutane doze primijenjene u zdravih ispitanika također je opažena farmakokinetika koja je bila približno proporcionalna dozi u rasponu doza od 50 mg do 400 mg.
English: It is used in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis.
Croatian: Koristi se u djece u dobi od 2 i više godina za liječenje poliartikularnog juvenilnog idiopatskog artritisa.
English: • if the dose is more than 2 weeks late, the patient should inject the forgotten dose and a new schedule should be established from the date of this injection.
Croatian: • ako se s dozom kasni više od 2 tjedna, bolesnik treba injicirati zaboravljenu dozu i uspostaviti novi raspored počevši od datuma te injekcije.
English: Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike koji tijekom liječenja golimumabom razviju novu infekciju treba pažljivo pratiti i podvrgnuti cjelovitoj dijagnostičkoj procjeni.
English: Select from the following areas for your injection:
Croatian: Odaberite jedno od sljedećih mjesta injekcije:
English: In both the AT and OSI populations, the improvements in signs and symptoms, spinal mobility, physical function, quality of life, and productivity observed at week 16 among patients treated with Simponi 50 mg continued in those remaining in the study at week 52.
Croatian: U populaciji AT kao i u populaciji OSI, poboljšanje znakova i simptoma, mobilnosti kralježnice, fizičke funkcije, kvalitete života i produktivnosti opaženo u 16. tjednu u bolesnika liječenih lijekom Simponi u dozi od 50 mg nastavilo se u onih koji su ostali u ispitivanju u 52. tjednu.
English: Uncommon: Arrhythmia, ischemic coronary artery disorders Rare: Congestive heart failure (new onset or worsening)
Croatian: Manje često: aritmija, ishemijski poremećaji koronarnih arterija Rijetko: kongestivno zatajenje srca (novonastalo ili pogoršanje postojećeg)
English: In GO-AFTER, the percentage of patients achieving an ACR 20 response was greater for patients receiving Simponi than for patients receiving placebo regardless of the reason reported for discontinuation of one or more prior anti-TNF therapies.
Croatian: U ispitivanju GO-AFTER, postotak bolesnika koji su postigli odgovor ACR 20 bio je veći u skupini koja je primala Simponi nego u skupini koja je primala placebo, bez obzira na navedeni razlog za prekid jedne ili više prethodnih anti-TNF terapija.
English: If possible, your child should be up to date with all vaccinations before using Simponi.
Croatian: Ako je moguće, Vaše bi dijete prije primjene lijeka Simponi trebalo primiti sva potrebna cjepiva.
English: The pre-filled pen is a manual injection pen that allows you to set a specific, prescribed dose.
Croatian: Napunjena brizgalica je ručna injekcijska brizgalica koja omogućuje odabir upravo one doze koja je propisana.
English: • Push the open end of the pre-filled pen firmly against the skin at a 90-degree angle until the Safety Sleeve slides fully into the Clear Cover (Figure 6).
Croatian: • Čvrsto pritisnite otvoreni kraj napunjene brizgalice na kožu pod kutem od 90 stupnjeva, sve dok sigurnosni omotač igle do kraja ne sklizne u prozirni zatvarač (Slika 6).
English: Simponi is for subcutaneous use.
Croatian: Simponi se primjenjuje supkutano.
English: Patients with body weight greater than 100 kg
Croatian: Bolesnici s tjelesnom težinom većom od 100 kg
English: While you are waiting you can get the rest of your equipment ready, including an alcohol swab, a cotton ball or gauze and a sharps container.
Croatian: Dok čekate, možete pripremiti ostali potreban materijal za injekciju, uključujući tupfer natopljen alkoholom, komadić vate ili gazu i spremnik za oštre otpatke.
English: The number of patients with no new erosions or a change from baseline in total vdH-S Score ≤ 0 was significantly higher in the Simponi treatment group than in the control group (p = 0.003).
Croatian: Broj bolesnika u kojih nije bilo novih erozija ili je promjena u odnosu na početno stanje ukupnog broja bodova na vdH-S ljestvici iznosila ≤ 0 bio je značajno veći u skupini liječenoj lijekom Simponi nego u kontrolnoj skupini (p = 0,003).