FrancophonIA/ELRC3.0 huggingface dataset:
English: Injecting without pinching the skin is recommended (Figure 5a).
Croatian: Preporučuje se ubrizgavanje bez stiskanja kože (Slika 5a).
English: The pre-filled pen is now ready to use.
Croatian: Napunjena brizgalica sada je spremna za uporabu.
English: The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered.
Croatian: Treba pomno razmotriti potencijalni rizik primjene kombinacije AZA odnosno 6-MP i golimumaba.
English: Ulcerative colitis • The table below shows how you will usually use this medicine.
Croatian: Ulcerozni kolitis • Tablica u nastavku prikazuje kako ćete obično primjenjivati ovaj lijek.
English: Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalno-fetalni razvoj, porod ni postporođajni razvoj (vidjeti dio 5.3).
English: The next dose should be administered based on the following guidance:
Croatian: Sljedeću dozu treba primijeniti na temelju ovih preporuka:
English: Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period.
Croatian: Budući da eliminacija golimumaba može potrajati i do 5 mjeseci, bolesnik mora biti pod nadzorom i tijekom tog razdoblja.
English: The stated reasons for discontinuation of prior anti TNF therapies were lack of efficacy (58%), intolerance (13%), and/or reasons other than safety or efficacy (29%, mostly for financial reasons).
Croatian: Kao razlog prekida prethodne anti-TNF terapije navedeni su nedovoljna djelotvornost (58%), nepodnošenje lijeka (13%) i/ili razlozi koji se ne odnose na sigurnost ili djelotvornost (29%, uglavnom financijski razlozi).
English: You must not be treated with Simponi if you have tuberculosis (TB) or any other severe infection.
Croatian: Ne smijete se liječiti lijekom Simponi ako imate tuberkulozu (TBC) ili drugu tešku infekciju.
English: In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Croatian: U nekih bolesnika organizam može prestati proizvoditi dovoljan broj krvnih stanica koje pomažu organizmu da se bori protiv infekcija ili onih koje zaustavljaju krvarenje.
English: Throughout this section, median duration of follow-up (approximately 4 years) is generally presented for all golimumab use.
Croatian: U cijelom ovom poglavlju, medijan trajanja praćenja (približno 4 godine) uglavnom je prikazan za sve primjene golimumaba.
English: This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Croatian: Ovaj protein sudjeluje u upalnim procesima u organizmu i njegovom blokadom može se smanjiti upala u organizmu.
English: For all of the endpoints described above, statistically significant results were also demonstrated in the OSI population at week 16.
Croatian: Za sve gore opisane ishode također su pokazani statistički značajni rezultati u populaciji OSI u 16. tjednu.
English: Simponi has not been studied in these patient populations.
Croatian: Simponi nije ispitivan u ovim populacijama bolesnika.
English: CHAQ: Child Health Assessment Questionaire ESR (mm/h): erythrocyte sedimentation rate (millimetres per hour)
Croatian: CHAQ (Child Health Assessment Questionaire) = upitnik za ocjenu zdravlja djece ESR (mm/h): brzina sedimentacije eritrocita (milimetara na sat)
English: The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed.
Croatian: Ne preporučuje se primjena golimumaba u trudnica; golimumab se smije dati trudnici samo ako je nužno.
English: After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke u tehnici davanja supkutane injekcije bolesnici mogu sami sebi injicirati lijek ukoliko njihov liječnik utvrdi da je to prikladno, uz liječničku kontrolu po potrebi.
English: At week 48, children entered a long-term extension.
Croatian: U 48. tjednu, djeca su ušla u dugotrajan produžetak ispitivanja.
English: Approximately forty-eight percent of patients continued on stable doses of methotrexate (≤ 25 mg/week).
Croatian: Otprilike 48% bolesnika nastavilo je primati stabilne doze metotreksata (≤ 25 mg na tjedan).
English: 1.2 During and after Simponi treatment:
Croatian: 1.2 Tijekom i nakon liječenja lijekom Simponi:
English: Talk to your child's doctor regarding vaccinations for your child.
Croatian: Razgovarajte s djetetovim liječnikom o cijepljenju Vašeg djeteta.
English: If you use more Simponi than you should
Croatian: Ako primijenite više lijeka Simponi nego što ste trebali
English: Simponi must be discarded if not used within the 30 days of room temperature storage.
Croatian: Simponi se mora baciti ako se ne upotrijebi unutar 30 dana čuvanja na sobnoj temperaturi.
English: The radiographic effects observed at week 52 were maintained through week 104.
Croatian: Radiološki učinci primijećeni u 52. tjednu održali su se do 104. tjedna.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Croatian: Preporučuje se periodički pregled kože, osobito u bolesnika koji imaju čimbenike rizika za rak kože.
English: However, if you prefer, you may pinch the skin to create a firmer surface for your injection (Figure 5b).
Croatian: Međutim, ako Vam je tako lakše, možete stisnuti kožu u nabor da dobijete čvršće mjesto ubrizgavanja (Slika 5b).
English: • Melanoma (a type of skin cancer)
Croatian: • melanom (vrsta raka kože)
English: Plan ahead
Croatian: Planirajte unaprijed
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Croatian: Ostali slučajevi predstavljaju mnoštvo različitih zloćudnih bolesti te uključuju rijetke zloćudne bolesti obično povezane s imunosupresijom.
English: *: Observed with other TNF-blocking agents.
Croatian: *: zabilježeno s drugim TNF-blokatorima.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Croatian: Razgovarajte s liječnikom ako imate bilo kakvih pitanja oko ubrizgavanja lijeka.
English: Ulcerative colitis (UC)
Croatian: Ulcerozni kolitis (UC)
English: If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Croatian: Ako imate tešku trajnu astmu, KOPB, ili ste teški pušač, morate razgovarati sa svojim liječnikom o tome je li za Vas primjereno liječenje TNF blokatorom.
English: Choose different sites for these injections and give the injections one right after the other.
Croatian: Odaberite različita mjesta za primjenu tih injekcija i primijenite ih jednu neposredno nakon druge.
English: Children and adolescents Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Croatian: Djeca i adolescenti Simponi 100 mg se ne preporučuje za primjenu u djece i adolescenata (mlađih od 18 godina).
English: Defined as a Mayo score ≤ 2 points, with no individual subscore > 1
Croatian: Definirano kao Mayo rezultat ≤ 2 boda, pri čemu nijedan podrezultat nije > 1
English: • Tell your doctor if you have an infection.
Croatian: • Obavijestite liječnika ako imate neku infekciju.
English: Cases reported in clinical studies in asthma
Croatian: Slučajevi prijavljeni u kliničkim ispitivanjima u bolesnika s astmom
English: • The second ‘click' means that the injection is finished and the needle has gone back into the pre-filled pen.
Croatian: • Drugi "klik" znači da je injekcija završena i da se igla vratila u napunjenu brizgalicu.
English: An effect on serum golimumab concentrations was seen at titres of > 1:100 while an effect on efficacy was not seen until titres of > 1:1000, though the numbers of children with titres of > 1:1000 were low (N = 8).
Croatian: Učinak na koncentracije golimumaba u serumu primijećen je pri titrima > 1:100, dok učinak na djelotvornost nije primijećen do titara > 1:1000, iako je broj djece s titrima > 1:1000 bio malen (N = 8).
English: It is important that you and your doctor record the brand name and batch number of your medicine.
Croatian: Važno je da Vi i Vaš liječnik zabilježite zaštićeno ime i broj serije lijeka.
English: N = number of patients ** p ≤ 0.001 * p ≤ 0.01
Croatian: N = broj bolesnika ** p ≤ 0,001 * p ≤ 0,01
English: • When you are ready to inject, hold the body of the pre-filled syringe with one hand.
Croatian: • Kad ste spremni dati si injekciju, jednom rukom držite tijelo napunjene štrcaljke.
English: Patients had at least 4 swollen and 4 tender joints.
Croatian: Ti bolesnici imali su najmanje 4 otečena i 4 bolna zgloba.
English: Push the pre-filled pen firmly against the skin (see figures 5 and 6) • Hold the pre-filled pen comfortably in your hand.
Croatian: Pritisnite napunjenu brizgalicu čvrsto na kožu (vidjeti slike 5 i 6) • Napunjenu brizgalicu udobno držite u ruci.
English: Infections may progress more rapidly and may be more severe.
Croatian: Infekcije se mogu razvijati brže i biti teže.
English: • nervous system disease such as multiple sclerosis (rare).
Croatian: • bolest živčanog sustava kao što je multipla skleroza (rijetko).
English: If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.
Croatian: Ako odvojite napunjenu brizgalicu od kože, postoji mogućnost da nećete dobiti punu dozu lijeka.
English: The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Croatian: Relativno pomanjkanje TNF, prouzročeno anti-TNF terapijom može pokrenuti autoimuni proces.
English: DO NOT press the button at this time.
Croatian: NEMOJTE još pritisnuti gumb.
English: Confirm with your doctor if you are unsure of your dose.
Croatian: Provjerite s liječnikom ako niste sigurni koja je Vaša doza.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of golimumab, and in accordance with local recommendations.
Croatian: Ako je dijagnosticirana neaktivna ("latentna") tuberkuloza, mora se započeti liječenje latentne tuberkuloze antituberkuloznom terapijom prije uvođenja golimumaba i u skladu s lokalnim preporukama.
English: Table 7 Key efficacy outcomes from PURSUIT - Induction and PURSUIT - Maintenance PURSUIT-Induction
Croatian: Tablica 7 Ključni rezultati djelotvornosti iz ispitivanja PURSUIT - Induction i PURSUIT - Maintenance PURSUIT-Induction
English: • Simponi is given by injection under the skin (subcutaneously).
Croatian: • Simponi se primjenjuje injekcijom pod kožu (supkutano).
English: The systemic clearance of golimumab was estimated to be 6.9  2.0 mL/day/kg.
Croatian: Procjenjuje se da je sistemski klirens golimumaba 6,9 ± 2,0 ml/dan/kg.
English: • Continue to hold the pre-filled pen down firmly against your skin until you hear a second ‘click'.
Croatian: • Nastavite držati napunjenu brizgalicu čvrsto pritisnutu na kožu dok ne čujete drugi "klik".
English: Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Croatian: Budući da lateks može izazvati teške alergijske reakcije, prije uzimanja lijeka Simponi razgovarajte s liječnikom ako ste Vi ili Vaš njegovatelj alergični na lateks.
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Croatian: Ta provjera treba uključivati detaljnu anamnezu s podacima o obolijevanju od tuberkuloze ili mogućem prijašnjem kontaktu s tuberkulozom i prijašnjoj i/ili sadašnjoj imunosupresivnoj terapiji.
English: The results of the maintenance study (PURSUIT-Maintenance) were based on evaluation of 456 patients who achieved clinical response from previous induction with Simponi.
Croatian: Rezultati ispitivanja terapije održavanja (PURSUIT-Maintenance) temeljili su se na ocjeni 456 bolesnika koji su ostvarili klinički odgovor na prethodnu uvodnu terapiju lijekom Simponi.
English: The concomitant use of golimumab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Croatian: Istodobna primjena golimumaba s tim biološkim lijekovima se ne preporučuje zbog mogućeg povećanog rizika od infekcije i drugih mogućih farmakoloških interakcija.
English: Continue to hold until the second ‘click' (see figure 8)
Croatian: Držite brizgalicu dok ne čujete drugi "klik" (vidjeti sliku 8)
English: Simponi, in combination with methotrexate (MTX), is indicated for:
Croatian: Reumatoidni artritis (RA) Simponi, u kombinaciji s metotreksatom (MTX), indiciran je za:
English: For administration instructions, see section 6.6.
Croatian: Za upute o primjeni lijeka vidjeti dio 6.6.
English: Concurrent use with other biological therapeutics
Croatian: Istodobna primjena s drugim biološkim lijekovima
English: • Allow the skin to dry before injecting.
Croatian: • Pustite da se koža osuši prije ubrizgavanja.
English: Use of live vaccines could result in clinical infections, including disseminated infections.
Croatian: Primjena živih cjepiva mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: • Sensation of heart beating irregularly
Croatian: • osjećaj nepravilnog kucanja srca
English: The orange priming band will disappear.
Croatian: Narančasta traka za provjeru protoka će nestati.
English: Figure 5a
Croatian: Slika 5a
English: • You usually inject the medicine into the front of the middle thighs.
Croatian: • Lijek obično ubrizgavate na prednju stranu srednjeg dijela bedra.
English: • Talk to your doctor before you take the fourth dose.
Croatian: • Porazgovarajte s liječnikom prije primjene četvrte doze.
English: • Infections may progress more rapidly and may be more severe.
Croatian: • Infekcije se mogu razvijati brže i biti teže.
English: The first ‘click' means that the needle has been inserted and the injection has started.
Croatian: Prvi "klik" znači da je igla ušla pod kožu i da je ubrizgavanje počelo.
English: Marketing Authorisation Holder and Manufacturer Janssen Biologics B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Janssen Biologics B.V.
English: • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
Croatian: • teška infekcija koja zahvaća cijelo tijelo (sepsa), ponekad praćena niskim krvnim tlakom
English: Table 1: Simponi dose in millilitres (mL) by height and weight of patients with pJIA Total Body Weight (kg)
Croatian: Tablica 1: Doza lijeka Simponi u mililitrima (ml) prema visini i težini bolesnika s pJIA Ukupna tjelesna težina (kg)
English: • Children weighing at least 40 kg:
Croatian: • Djeca tjelesne težine od najmanje 40 kg:
English: Some patients may experience serious side effects and may require treatment.
Croatian: U nekih bolesnika nuspojave mogu biti ozbiljne i zahtijevati liječenje.
English: Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Croatian: Obavijestite liječnika ako ste nedavno primili ili trebate primiti liječenje terapijskim infektivnim agensom (poput primjene BCG-a koji se koristi za liječenje raka).
English: Do not use Simponi:
Croatian: Nemojte primjenjivati Simponi:
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Croatian: Ova rijetka vrsta limfoma T-stanica ima vrlo agresivan tijek i obično smrtni ishod.
English: Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:
Croatian: Odmah se javite svom liječniku ako primijetite neke od sljedećih ozbiljnih nuspojava lijeka Simponi koje uključuju:
English: *Removing air bubbles helps make sure the right dose is given.
Croatian: *Uklanjanjem mjehurića zraka osigurava se primjena točne doze.
English: • If you have moderate or severe heart failure.
Croatian: • Ako imate umjereni ili teški stupanj zatajenja srca.
English: The pen or the syringe should not be shaken.
Croatian: Brizgalicu ili štrcaljku se ne smije tresti.
English: Wipe your chosen injection site with an alcohol swab and allow it to dry.
Croatian: Odabrano mjesto injekcije obrišite tupferom natopljenim alkoholom i pustite da se osuši.
English: Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Croatian: Aktivna tuberkuloza (TBC) ili druge teške infekcije poput sepse i oportunističkih infekcija (vidjeti dio 4.4).
English: Within the designated system organ classes, the ARs are listed under headings of frequency and using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Unutar svakog organskog sustava nuspojave su razvrstane prema učestalosti pojavljivanja prema sljedećoj konvenciji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply).
Croatian: Odgovarajuće pretrage, kao što su tuberkulinski kožni test ili krvne pretrage te rendgen pluća, treba provesti u svih bolesnika (uvažavajući lokalne preporuke).
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti niti upravljati alatima ili strojevima.
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after your last Simponi injection during pregnancy.
Croatian: Vaše dijete ne smije primiti „živo cjepivo” kao što je BCG (koristi se za prevenciju tuberkuloze) unutar 6 mjeseci od zadnje injekcije lijeka Simponi koju ste primili tijekom trudnoće.
English: The primary endpoint, the proportion of children who were ACR Ped 30 responders at week 16 and who did not experience a flare between week 16 and week 48, was not achieved.
Croatian: Primarna mjera ishoda, udio djece koja su postigla odgovor ACR Ped 30 u 16. tjednu i koja nisu doživjela razbuktavanje bolesti između 16. i 48. tjedna, nije postignuta.
English: The number of patients with other PsA subtypes was too small to allow meaningful assessment.
Croatian: Broj bolesnika s drugim podtipovima psorijatičnog artritisa bio je premalen da bi omogućio smislenu procjenu.
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Croatian: Ako se sumnja na latentnu tuberkulozu, treba potražiti savjet liječnika specijaliziranog za liječenje tuberkuloze.
English: • Hair loss
Croatian: • gubitak kose
English: Sorbitol intolerance
Croatian: Nepodnošenje sorbitola
English: Corticosteroids were to be tapered at the start of the maintenance study.
Croatian: Primjena kortikosteroida morala se postupno smanjivati na početku ispitivanja terapije održavanja.
English: At week 54, the clinical outcomes observed in these patients were similar to the clinical outcomes reported for the patients achieving clinical response at week 6.
Croatian: Klinički ishodi opaženi u tih bolesnika u 54. tjednu bili su slični kliničkim ishodima prijavljenima za bolesnike u kojih je postignut klinički odgovor u 6. tjednu.
English: What Simponi contains
Croatian: Što Simponi sadrži
English: Terminal half-life value was estimated to be approximately 12  3 days in healthy subjects and similar values were observed in patients with RA, PsA, AS, or UC.
Croatian: Terminalni poluvijek se procjenjuje na oko 12 ± 3 dana u zdravih dobrovoljaca, a slične vrijednosti zabilježene su u bolesnika s RA, PsA, AS ili UC.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Simponi in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Simponi u jednoj ili više podskupina pedijatrijske populacije s ulceroznim kolitisom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
Croatian: Dokazano je da se golimumab izlučuje u mlijeko majmuna, a budući da se majčini imunoglobulini izlučuju u mlijeku, žene ne smiju dojiti za vrijeme liječenja i najmanje 6 mjeseci nakon primjene golimumaba.
English: baseline = week 0 “n” reflects enrolled patients
Croatian: početak ispitivanja = 0. tjedan “n” označava broj uključenih bolesnika
English: Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).
Croatian: Umjereno ili teško zatajenje srca (NYHA stupanj III/IV) (vidjeti dio 4.4).
English: The educational programme consists of a Patient Reminder Card to be held by the patient.
Croatian: Edukacijski program sastoji se od Kartice s podsjetnikom za bolesnika koju čuva bolesnik.
English: Ask your doctor to record the type and date of the last screening(s) for TB below: Test _______________
Croatian: Zamolite liječnika da na ovu karticu upiše vrstu i datum zadnjeg(ih) testiranja na TBC:
English: Additional analyses were performed in subsets representative of the indicated population of patients with severe, active and progressive RA.
Croatian: Dodatne analize provedene su u podskupinama reprezentativnima za navedenu populaciju bolesnika s teškim, aktivnim i progresivnim reumatoidnim artritisom.
English: Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use.
Croatian: Napunjena brizgalica namijenjena je za jednokratnu uporabu kod samo jednog bolesnika i mora se baciti odmah nakon uporabe.
English: Do not rub your skin.
Croatian: Nemojte trljati kožu.
English: At week 14, 28% of these patients achieved response defined by partial Mayo score (decreased by ≥ 3 points compared with start of induction).
Croatian: U 14. tjednu ispitivanja, u 28% tih bolesnika postignut je odgovor koji se definirao djelomičnim Mayo rezultatom (smanjenjem za ≥ 3 boda u odnosu na rezultat na početku uvodnog liječenja).
English: * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Croatian: * Humano monoklonsko protutijelo IgG1κ proizvedeno na staničnoj liniji mišjeg hibridoma tehnologijom rekombinantne DNK.
English: • You are pregnant or are planning to become pregnant while using Simponi.
Croatian: • Ako ste trudni ili planirate trudnoću za vrijeme liječenja lijekom Simponi.
English: In general these elevations were asymptomatic and the abnormalities decreased or resolved with either continuation or discontinuation of golimumab or modification of concomitant medicinal products.
Croatian: Općenito su ta povišenja bila asimptomatična, a abnormalne vrijednosti su se smanjile ili vratile na normalu bilo nastavkom ili prekidom liječenja golimumabom, ili modifikacijom istodobno propisanih lijekova.
English: • If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako ste primili Simponi za vrijeme trudnoće, Vaše dijete može imati povećani rizik od dobivanja infekcije.
English: The safety and efficacy of golimumab have not been established in patients with pJIA below the age of 2 years.
Croatian: Sigurnost i djelotvornost golimumaba nisu ustanovljene u bolesnika s pJIA mlađih od 2 godine.