FrancophonIA/ELRC3.0 huggingface dataset:
English: If an anaphylactic reaction or other serious allergic reactions occur, administration of golimumab should be discontinued immediately and appropriate therapy initiated.
Croatian: Ukoliko nastupi anafilaktička reakcija ili druga ozbiljna alergijska reakcija, primjenu golimumaba treba smjesta prekinuti i započeti s odgovarajućim liječenjem.
English: Health-related quality of life as measured by the physical component score of the SF-36 was also improved significantly at weeks 14 and 24.
Croatian: Zdravstveni aspekt kvalitete života, mjereno zbrojem bodova za fizičku komponentu upitnika SF-36, također je bio značajno poboljšan u 14. i 24. tjednu.
English: If needed, cover injection site with a bandage.
Croatian: Ako je potrebno, mjesto injekcije možete prekriti flasterom.
English: • Front of thighs (recommended)
Croatian: • prednji dio bedara (preporučeno)
English: Figure 5b
Croatian: Slika 5b
English: In a fertility and general reproductive function study in mouse, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, the number of pregnant mice was reduced.
Croatian: U istraživanju plodnosti i opće reproduktivne funkcije na miševima, pri primjeni analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα, smanjio se broj trudnih ženki miševa.
English: Some of these reactions occurred after the first administration of golimumab.
Croatian: Neke od tih reakcija razvile su se nakon prve primjene golimumaba.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Croatian: Primjena terapijskih infektivnih agensa, poput živih atenuiranih bakterija, u druge svrhe (npr. intravezikalna instilacija BCG-a za liječenje raka) mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
English: • Increase in blood cholesterol levels
Croatian: • povećane razine kolesterola u krvi
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Simponi.
Croatian: Ova Kartica s podsjetnikom za bolesnika sadrži važne sigurnosne informacije kojih morate biti svjesni prije i tijekom liječenja lijekom Simponi.
English: Your doctor will also give you a Patient Reminder Card, which contains important safety information you need to be aware of before and during your treatment with Simponi.
Croatian: Liječnik će Vam dati i Karticu s podsjetnikom za bolesnika koja sadrži važne sigurnosne informacije kojih morate biti svjesni prije i tijekom liječenja lijekom Simponi.
English: Dates of Simponi treatment
Croatian: Datumi primjene lijeka Simponi
English: • Your doctor should test you for HBV
Croatian: • Liječnik Vam treba napraviti pretrage na HBV.
English: Remove air bubbles*
Croatian: Uklonite mjehuriće zraka*
English: • Do not hold by the plunger head, plunger, needle guard wings, or needle cover.
Croatian: • Nemojte držati štrcaljku za glavu klipa, klip, krila štitnika igle niti za zaštitni poklopac igle.
English: • Asthma, shortness of breath, wheezing
Croatian: • astma, nedostatak zraka, piskanje pri disanju
English: Week 24 5% 20%*
Croatian: 24. tjedan 5% 20%*
English: • Do not warm the pre-filled pen in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: • Nemojte zagrijavati napunjenu brizgalicu niti na jedan drugi način (na primjer, u mikrovalnoj pećnici ili u vrućoj vodi).
English: • Inject all of the medicine by pushing in the plunger until the plunger head is completely between the needle guard wings (see figure 7).
Croatian: • Ubrizgajte sav lijek pritišćući klip sve dok glava klipa ne uđe između zaštitnih krila igle (vidjeti sliku 7).
English: What you need to know before you use Simponi
Croatian: Što morate znati prije nego počnete primjenjivati Simponi
English: • Increase in blood sugar levels
Croatian: • povećane razine šećera u krvi
English: *CHOKING HAZARD!
Croatian: *OPASNOST OD GUŠENJA!
English: • Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
Croatian: • psorijaza (može se pojaviti na dlanovima i/ili tabanima i/ili u obliku mjehurića na koži)
English: Similar ACR 20 responses at week 14 were observed in patients with polyarticular arthritis with no rheumatoid nodules and asymmetric peripheral arthritis PsA subtypes.
Croatian: Slični odgovori ACR 20 u 14. tjednu opaženi su u bolesnika s poliartikularnim artritisom bez reumatoidnih čvorića i s asimetričnim perifernim artritisom.
English: Before you start using Simponi:
Croatian: Prije nego počnete primjenjivati Simponi:
English: Blood disease
Croatian: Bolesti krvi
English: You will not be able to press in the button unless the pre-filled pen is pushed firmly against your skin and the Safety Sleeve slides into the Clear Cover.
Croatian: Nećete moći utisnuti gumb ako napunjena brizgalica nije čvrsto pritisnuta na kožu i sigurnosni omotač igle ne sklizne u prozirni zatvarač.
English: The potential role of TNF-blocking therapy in the development of malignancies is not known.
Croatian: Nije poznata potencijalna uloga liječenja TNF-blokatorima u razvoju malignih bolesti.
English: Insert needle and hold in place
Croatian: Ubodite iglu i držite brizgalicu na mjestu
English: Therefore, a patient who maintained response was in a state of continuous clinical response at each evaluation through week 54.
Croatian: Dakle, bolesnik s održanim odgovorom imao je kontinuiran klinički odgovor pri svakoj procjeni do 54. tjedna liječenja.
English: • Check the expiration date and the security seal
Croatian: • Provjerite rok valjanosti i sigurnosnu markicu
English: If you are being treated with Simponi, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last Simponi injection.
Croatian: Ako se liječite lijekom Simponi, morate izbjegavati trudnoću korištenjem odgovarajuće kontracepcije tijekom liječenja i najmanje 6 mjeseci nakon zadnje injekcije lijeka Simponi.
English: Patients with each sub-type of psoriatic arthritis were enrolled, including polyarticular arthritis with no rheumatoid nodules (43%), asymmetric peripheral arthritis (30%), distal interphalangeal (DIP) joint arthritis (15%), spondylitis with peripheral arthritis (11%), and arthritis mutilans (1%).
Croatian: Uključeni su bolesnici sa svakim podtipom psorijatičnog artritisa, uključujući poliartikularni artritis bez reumatoidnih čvorića (43%), asimetrični periferni artritis (30%), artritis distalnih interfalangealnih zglobova (15%), spondilitis s perifernim artritisom (11%) i mutilirajući artritis (1%).
English: In this case you will get training on how to inject Simponi.
Croatian: U tom slučaju ćete dobiti poduku kako da si sami ubrizgate Simponi.
English: • Continue to push the pre-filled pen firmly against your skin and press the raised part of the button with your fingers or thumb.
Croatian: • Pritišćući napunjenu brizgalicu i dalje čvrsto na kožu, pritisnite odignuti dio gumba prstima ili palcem.
English: If this happens, do not ride bicycles, drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti bicikl niti upravljati vozilima, alatima ili strojevima.
English: Where golimumab use is described by dose, the median duration of follow-up varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may have switched between doses.
Croatian: Tamo gdje je primjena golimumaba prikazana po dozi, medijan trajanja praćenja varira (približno 2 godine za dozu od 50 mg, približno 3 godine za dozu od 100 mg) jer se bolesnicima jedna doza mogla zamijeniti drugom.
English: There is no relevant use of Simponi in patients aged less than 2 years for the indication of pJIA.
Croatian: Nema relevantnih podataka o primjeni lijeka Simponi u bolesnika mlađih od 2 godine za indikaciju pJIA.
English: No cases were reported in the controlled and uncontrolled periods of the nr-Axial SpA study (up to 1 year).
Croatian: Nije bilo prijavljenih slučajeva u kontroliranim i nekontroliranim razdobljima ispitivanja aksijalnog spondiloartritisa bez radiološkog dokaza (do 1 godine).
English: Before starting treatment with golimumab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Croatian: Prije uvođenja golimumaba sve bolesnike treba testirati na tuberkulozu, aktivnu i neaktivnu ("latentnu").
English: Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo treatment group (n = 79) were reported.
Croatian: Prijavljeno je 8 malignoma u kombiniranoj skupini bolesnika koji su se liječili golimumabom (n = 230), a niti jedan u skupini koja je primala placebo (n = 79).
English: It should be noted that in the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease.
Croatian: Treba naglasiti da je u većini slučajeva ustanovljena ekstrapulmonalna tuberkuloza te da se radilo o lokaliziranom ili diseminiranom obliku bolesti.
English: Check the liquid in the viewing window.
Croatian: Provjerite izgled tekućine u prozorčiću.
English: Cases of active tuberculosis have occurred in patients treated with golimumab during and after treatment for latent tuberculosis.
Croatian: Zabilježeni su slučajevi aktivne tuberkuloze u bolesnika liječenih golimumabom tijekom i nakon liječenja latentne tuberkuloze.
English: The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose.
Croatian: Rizik od određenih nuspojava veći je uz dozu od 100 mg nego uz dozu od 50 mg.
English: The orange needle guard will lock, and you will not receive the full dose.
Croatian: Narančasti štitnik igle će se zaključati i nećete primiti cijelu dozu.
English: The pharmacokinetics of golimumab were determined in 173 children with pJIA with an age range from 2 to 17 years of age.
Croatian: Farmakokinetika golimumaba utvrđivala se u 173 djece s pJIA u dobi od 2 do 17 godina.
English: • Tell your doctor if you think you might be at risk of contracting HBV
Croatian: • Obavijestite svog liječnika ako mislite da ste pod rizikom da se zarazite virusom HBV.
English: The incidence of lymphoma in golimumab-treated patients during the pivotal trials was higher than expected in the general population.
Croatian: Incidencija limfoma u bolesnika liječenih golimumabom tijekom pivotalnih ispitivanja bila je viša nego što se očekuje u općoj populaciji.
English: It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer.
Croatian: Nije poznato utječe li liječenje golimumabom na rizik od razvoja displazije ili karcinoma debelog crijeva.
English: • Eye allergy
Croatian: • alergija oka
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professional(s) treating the patient about ongoing treatment with the product.
Croatian: Kartica je namijenjena i kao podsjetnik za bilježenje datuma i ishoda specifičnih pretraga kao i da olakša razmjenu posebnih informacija o tijeku liječenja ovim lijekom između bolesnika i zdravstvenih radnika koji ih liječe.
English: Based on the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Croatian: Na temelju dosadašnjih spoznaja, ne može se isključiti rizik od pojave limfoma, leukemije ili drugih malignih bolesti u bolesnika koji su liječeni TNF-antagonistom.
English: Consistent efficacy was seen in patients regardless of use of DMARDs (MTX, sulfasalazine and/or hydroxychloroquine), HLA-B27 antigen status or baseline CRP levels as assessed by ASAS 20 responses at week 14.
Croatian: U bolesnika je zabilježena konzistentna djelotvornost bez obzira na DMARD terapiju (MTX, sulfasalazin i/ili hidroksiklorokin), status antigena HLA-B27, ili početne razine CRP, kako je procijenjeno odgovorima ASAS 20 u 14. tjednu.
English: A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).
Croatian: Istraživanja utjecaja na plodnost u miševa pomoću analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα pokazala su da nema važnih učinaka na plodnost (vidjeti dio 5.3).
English: The following additional side effects have been observed with Simponi: Very common side effects (may affect more than 1 in 10 people):
Croatian: Tijekom liječenja lijekom Simponi zabilježene su sljedeće dodatne nuspojave: Vrlo česte nuspojave (javljaju se u više od 1 na 10 osoba):
English: Golimumab should not be given to patients with a clinically important, active infection.
Croatian: Golimumab se ne smije dati bolesnicima s klinički značajnom aktivnom infekcijom.
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 or has TB.
Croatian: • Vrlo je važno da obavijestite svog liječnika ako ste ikada imali tuberkulozu ili bili u bliskom kontaktu s osobom koja je bolovala ili boluje od tuberkuloze.
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
Croatian: Recite liječniku ako uz Simponi uzimate i azatioprin ili 6-merkaptopurin.
English: The use of Simponi in pregnant women is not recommended.
Croatian: Primjena lijeka Simponi se ne preporučuje u trudnica.
English: If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.
Croatian: Ako mislite da je došlo do greške pri davanju injekcije, ili niste sigurni, posavjetujte se s liječnikom ili ljekarnikom.
English: The higher incidence of antibodies with the drug-tolerant EIA method, because they were mainly low titre antibodies, did not have an apparent impact on drug levels, efficacy and safety and therefore does not represent any new safety signal.
Croatian: Budući da se uglavnom radilo o niskim titrima protutijela, veća incidencija protutijela otkrivena EIA metodom otpornom na lijek nije imala vidljivog utjecaja na razine lijeka, djelotvornost i sigurnost te stoga ne predstavlja nikakav novi sigurnosni signal.
English: Tell your doctor straight away if you get new or worsening symptoms of heart failure.
Croatian: Odmah obavijestite svog liječnika ako Vam se pojave ili pogoršaju simptomi zatajenja srca.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions.
Croatian: Prisustvo protutijela na golimumab može povećati rizik od reakcije na mjestu injekcije.
English: • Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever
Croatian: • poremećaji želuca i crijeva koji uključuju upalu želučane sluznice i debelog crijeva, koja može izazvati vrućicu
English: Responses observed in the Simponi treated groups were similar in patients receiving and not receiving concomitant MTX.
Croatian: Zabilježeni odgovori u skupinama liječenim lijekom Simponi bili su slični u bolesnika koji su istodobno primali MTX i u onih koji ga nisu uzimali.
English: In this study, the type and frequency of adverse events reported were generally similar to those seen in adult RA studies.
Croatian: U ovom su ispitivanju vrsta i učestalost prijavljenih štetnih događaja bile slične onima primijećenima u ispitivanjima provedenima u odraslih bolesnika s RA.
English: For paediatric patients < 40 kg
Croatian: Za pedijatrijske bolesnike tjelesne težine < 40 kg
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Croatian: Psorijatični artritis je upalna bolest zglobova, obično praćena psorijazom, upalnom bolešću kože.
English: • Pain and ulcers in the mouth
Croatian: • bol i ranice u ustima
English: • Inject the dose promptly after removing the needle cover.
Croatian: • Injicirajte dozu odmah nakon što ste skinuli zaštitni poklopac s igle.
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i na kutiji iza oznake "EXP".
English: You will find detailed “Instructions for Use” at the end of this leaflet.
Croatian: Detaljne "Upute za uporabu" navedene su na kraju ove upute o lijeku.
English: The new expiry date must be written on the carton (up to 30 days from the date removed from the refrigerator).
Croatian: Novi rok valjanosti mora se zapisati na kutiji (do 30 dana nakon datuma vađenja iz hladnjaka).
English: The presence of antibodies to golimumab may increase the risk of injection site reactions (see section 4.4).
Croatian: Prisutnost antitijela na golimumab može povećati rizik od reakcija na mjestu injekcije (vidjeti dio 4.4).
English: Operations or dental procedures
Croatian: Operacije ili stomatološki zahvati
English: Do not rub the injection site.
Croatian: Nemojte trljati mjesto injekcije.
English: In a developmental toxicity study conducted in mice following administration of the same analogous antibody, and in cynomolgus monkeys using golimumab, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Croatian: U istraživanju razvojne toksičnosti na miševima nakon primjene istog analognog protutijela, kao niti u cynomolgus majmuna nakon primjene golimumaba, nije bilo znakova toksičnosti za ženku, embriotoksičnosti niti teratogenosti.
English: Your doctor will determine if you should continue Simponi treatment.
Croatian: Liječnik će odlučiti trebate li nastaviti liječenje lijekom Simponi.
English: Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother's last golimumab injection during pregnancy (see sections 4.4 and 4.5).
Croatian: Ne preporučuje se primjena živih cjepiva u dojenčadi izloženoj golimumabu in utero u razdoblju od 6 mjeseci nakon posljednje injekcije golimumaba koju je majka primila tijekom trudnoće (vidjeti dijelove 4.4 i 4.5).
English: Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi.
Croatian: Odmah obavijestite svog liječnika ako Vam se pojave simptomi alergijske reakcije nakon primanja lijeka Simponi.
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
Croatian: • liječenje teškog, aktivnog i progresivnog reumatoidnog artritisa u odraslih koji prethodno nisu bili liječeni metotreksatom.
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Croatian: U svih bolesnika s ulceroznim kolitisom koji imaju povećan rizik za razvoj displazije ili karcinoma debelog crijeva (primjerice, bolesnici s dugotrajnim ulceroznim kolitisom ili primarnim sklerozirajućim kolangitisom) ili su ranije imali displaziju ili karcinom debelog crijeva, mora se u redovitim intervalima prije početka liječenja i tijekom čitavog trajanja bolesti vršiti probir na displaziju.
English: Please read this Instructions for Use before using the Simponi pre-filled pen and each time you get a new pre-filled pen.
Croatian: Pročitajte ove upute za uporabu prije nego što prvi put upotrijebite Simponi napunjenu brizgalicu te svaki put kada dobijete novu napunjenu brizgalicu, jer u upute mogu biti dodane neke nove informacije.
English: • blood cancer (leukaemia) (rare).
Croatian: • rak krvi (leukemija) (rijetko).
English: Patients in this study had a diagnosis of PsA for at least 6 months and had at least mild psoriatic disease.
Croatian: Bolesnici su u tom ispitivanju imali dijagnozu psorijatičnog artritisa najmanje 6 mjeseci i najmanje blagi stupanj bolesti.
English: The efficacy of Simponi was evaluated in two randomised, double-blind, placebo-controlled clinical studies in adult patients.
Croatian: Djelotvornost lijeka Simponi ispitana je u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja u odraslih bolesnika.
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
Croatian: Stoga je potreban oprez kada se bilo koji TNF-antagonist primjenjuje u bolesnika s KOPB-om kao i u bolesnika koji imaju povećan rizik od razvoja maligne bolesti jer su teški pušači.
English: • If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.
Croatian: • Ako ste s dozom zakasnili više od 2 tjedna, ubrizgajte propuštenu dozu čim se sjetite i upitajte svog liječnika ili ljekarnika kada trebate uzeti sljedeću dozu.
English: N = number of patients ** p ≤ 0.001 * p ≤ 0.01 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: N = broj bolesnika ** p ≤ 0,001 * p ≤ 0,01 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: Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity.
Croatian: U kliničkom ispitivanju primijenjene su pojedinačne intravenske doze do 10 mg/kg i nije došlo do toksičnosti koja bi ograničavala dozu.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor).
Croatian: Sve bolesnike treba upozoriti da odmah potraže liječničku pomoć ako razviju znakove i simptome koji ukazuju na krvnu diskraziju (npr. perzistentna vrućica, stvaranje modrica, krvarenje, bljedilo).
English: Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure (see section 4.3).
Croatian: Bolesnike treba pomno pratiti, a davanje golimumaba prekinuti u onih bolesnika u kojih se pojave novi ili pogoršaju postojeći simptomi zatajenja srca (vidjeti dio 4.3).
English: • Cases of TB have been reported in patients treated with Simponi, in rare occasions even in patients who have been treated with medicines for TB.
Croatian: • U bolesnika liječenih lijekom Simponi prijavljeni su slučajevi tuberkuloze, u rijetkim slučajevima čak i u bolesnika koji su primali lijekove za tuberkulozu.
English: Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun. sarcoidosis (rare).
Croatian: Simptomi mogu uključivati bol u zglobovima, osip na obrazima ili rukama koji je osjetljiv na sunce. sarkoidoza (rijetko).
English: Simponi is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group.
Croatian: Simponi se ne preporučuje za primjenu u djece s poliartikularnim juvenilnim idiopatskim artritisom koja su mlađa od 2 godine jer nije ispitan u toj skupini bolesnika.
English: Always take the outer carton and this leaflet with you, even if it is empty.
Croatian: Uvijek sa sobom ponesite pakiranje lijeka, čak i ako je prazno i ovu uputu o lijeku.
English: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
Croatian: Žene reproduktivne dobi moraju koristiti odgovarajuću kontracepciju radi sprječavanja trudnoće za vrijeme liječenja i najmanje 6 mjeseci nakon primjene posljednje doze golimumaba.