FrancophonIA/ELRC3.0 huggingface dataset:
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab; cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Croatian: Prijavljeni su događaji (neki sa smrtnim ishodom) ishemije/infarkta miokarda i aritmije, od kojih su neki bili vremenski usko povezani s infuzijom infliksimaba; prijavljeni su i cerebrovaskularni incidenti vremenski usko povezani s infuzijom infliksimaba.
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Croatian: • upala jetre uzrokovana tegobama s imunološkim sustavom (autoimuni hepatitis)
English: Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNF.
Croatian: Histološka analiza uzoraka kolona uzetih biopsijom prije i 4 tjedna nakon primjene infliksimaba pokazala je značajno smanjenje mjerljivog TNFα.
English: There is limited safety experience of Remicade treatment in patients who have undergone surgical procedures, including arthroplasty.
Croatian: Ograničena su iskustva o sigurnosti primjene lijeka Remicade u bolesnika podvrgnutih kirurškim zahvatima, uključujući artroplastiku.
English: • If you received Remicade while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Croatian: • Ako ste primali Remicade za vrijeme trudnoće, kod Vašeg djeteta također može postojati veći rizik za razvoj infekcije kod primjene živih cjepiva u razdoblju do šest mjeseci nakon rođenja.
English: Live vaccines/therapeutic infectious agents
Croatian: Živa cjepiva/terapijski infektivni agensi
English: No time-dependency of the Pharmacokinetics was observed.
Croatian: Nije primijećena ovisnost farmakokinetike o vremenu.
English: Tell your doctor straight away if you notice any of the above.
Croatian: Odmah obavijestite svog liječnika ako primijetite neki od gore navedenih simptoma.
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Croatian: Tablica 2 Udio bolesnika s povišenom aktivnošću ALT-a u kliničkim ispitivanjima
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. perzistirajuća vrućica, modrice, krvarenje, bljedilo).
English: • If you received Remicade during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: • Ako ste primali Remicade tijekom trudnoće, kod Vašeg djeteta može postojati povećan rizik od infekcije.
English: While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups.
Croatian: Iako je postotak bolesnika koji su dobili infekciju također bio veći u mlađoj dobnoj skupini, udio ozbiljnih infekcija bio je sličan u obje dobne skupine.
English: The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Croatian: Udio bolesnika s kliničkim odgovorom u 8. tjednu iznosio je 73,3% (44/60).
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira neaktivna ("latentna") tuberkuloza, prije uvođenja lijeka Remicade mora se započeti liječenje latentne tuberkuloze antituberkuloznom terapijom sukladno lokalnim preporukama.
English: After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Croatian: Nakon 54 tjedna liječenja u obje skupine bolesnika koji su primali infliksimab + metotreksat došlo je do statistički značajnog poboljšanja simptoma i znakova bolesti u odnosu na bolesnike koji su primali samo metotreksat, mjereno udjelom bolesnika koji su postigli odgovor ACR20, 50 i 70.
English: Name patient:
Croatian: Ime bolesnika:
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Croatian: U kliničkom ispitivanju REACH ukupno je 17,5% randomiziranih bolesnika imalo jednu ili više reakcija na infuziju.
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
Croatian: Bolesnici s tuberkulozom ili drugim teškim infekcijama poput sepse, apscesa i oportunističkih infekcija (vidjeti dio 4.4).
English: Administer the infusion solution over a period of not less than the infusion time recommended (see section 4.2).
Croatian: Primijenite otopinu za infuziju tijekom razdoblja koje ne smije biti kraće od preporučenog (vidjeti dio 4.2).
English: Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Croatian: Premda nema usporednih podataka, ograničeni podaci o bolesnicima koji su inicijalno odgovorili na dozu od 5 mg/kg, ali se odgovor potom izgubio, ukazuju na to da se u nekih bolesnika povećanjem doze može ponovno uspostaviti terapijski odgovor (vidjeti dio 5.1).
English: If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines.
Croatian: Ako se nakon primjene lijeka Remicade osjećate umorno, imate omaglicu ili se osjećate loše, nemojte voziti ni rukovati alatima i strojevima.
English: Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
Croatian: Među bolesnicima koji nisu imali reakciju na infuziju u uvodnom razdoblju liječenja, 9% ih je imalo reakciju na infuziju tijekom terapije održavanja.
English: > 54 weeks
Croatian: > 54 tjedna
English: Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Croatian: Ukupan broj perifernih bijelih krvnih stanica bio je minimalno promijenjen u bolesnika liječenih infliksimabom, iako su promjene u limfocitima, monocitima i neutrofilima odražavale pomak prema normalnim rasponima.
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: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders) ACCENT I (week-2 responders) % of Patients
Croatian: Tablica 5 Učinci na stope odgovora i remisije, podaci iz ACCENT I (bolesnici s odgovorom u 2. tjednu) ACCENT I (bolesnici s odgovorom u 2. tjednu) % bolesnika
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Croatian: S obzirom da otopina za infuziju ne sadržava konzervanse, preporučuje se početi s primjenom što prije, a svakako u roku od 3 sata nakon rekonstitucije otopine i razrjeđivanja.
English: Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Croatian: U nekih će bolesnika interval između doza morati biti kraći da bi se održalo kliničko poboljšanje, dok će u drugih biti dovoljni dulji intervali između doza.
English: Not known: Cerebrovascular accidents in close temporal association with infusion.
Croatian: Nepoznato: cerebrovaskularni incidenti vremenski usko povezani s infuzijom
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Croatian: Infliksimab je monoklonsko protutijelo - jedna vrsta bjelančevine koja se vezuje za specifičan ciljni element u tijelu koji se naziva TNF (faktor nekroze tumora) alfa.
English: • Some children and teenage patients who have received TNF-blockers such as Remicade have developed cancers, including unusual types, which sometimes resulted in death.
Croatian: • U neke djece i mladih bolesnika koji su primali TNF-blokatore kao što je Remicade razvio se rak, uključujući neuobičajene vrste raka koje su ponekad imale smrtni ishod.
English: Placebo (week 24)
Croatian: Placebo (24. tjedan)
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Croatian: Na početku ispitivanja 87% bolesnika imalo je perianalne fistule, 14% abdominalne fistule, a 9% rektovaginalne fistule.
English: The pharmacokinetics of infliximab in elderly patients has not been studied.
Croatian: Nije ispitivana farmakokinetika infliksimaba u starijih bolesnika.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Croatian: Dugoročnim praćenjem sigurnosti u nastavku kliničkih ispitivanja infliksimaba u trajanju do 5 godina, što predstavlja ukupno 6234 bolesnik-godina (3210 bolesnika), prijavljeno je 5 slučajeva limfoma i 38 slučajeva zloćudne bolesti koja nije bila limfom.
English: • Infections due to a weakened immune system
Croatian: • infekcije zbog oslabljenog imunološkog sustava
English: In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Croatian: U ispitivanjima ACT 1 i ACT 2 infliksimab je doveo do poboljšanja kvalitete života, što je potvrđeno statistički značajnim poboljšanjem mjerila specifičnog za bolest (IBDQ) kao i poboljšanjem rezultata generičkog kratkog upitnika SF-36, sa 36 pitanja.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at weeks 8 and 30.
Croatian: Tablica 8 Učinci na klinički odgovor, kliničku remisiju i cijeljenje sluznice u 8. i 30. tjednu.
English: Calculate the total volume of reconstituted Remicade solution required.
Croatian: Izračunajte ukupno potreban volumen rekonstituirane otopine lijeka Remicade.
English: Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Croatian: Čini se da kortikosteroidi nemaju klinički značajan utjecaj na farmakokinetiku infliksimaba.
English: Patients who discontinue immunosuppressants prior to or during Remicade treatment are at greater risk of developing these antibodies.
Croatian: Bolesnici koji prekinu s uzimanjem imunosupresiva prije ili za vrijeme liječenja lijekom Remicade izloženi su većem riziku za razvoj tih protutijela.
English: This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Croatian: To se odnosi na bolesnike s Crohnovom bolešću i na bolesnike s reumatoidnim artritisom.
English: • New or worsening heart failure, slow heart rate
Croatian: • novonastalo zatajenje srca ili pogoršanje postojećeg, usporen ritam srca
English: There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Croatian: U kontrolnoj skupini od 77 bolesnika prijavljen je jedan slučaj zloćudne bolesti (medijan trajanja praćenja bio je 0,8 godina; incidencija 1,3% [95% CI 0,03%-7,0%]).
English: In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Croatian: U ispitanika liječenih infliksimabom, značajan odgovor PASI 50 bio je vidljiv pri prvom posjetu liječniku (2. tjedan), a odgovor PASI 75 pri drugom posjetu (6. tjedan).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Remicade in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Remicade u svim podskupinama pedijatrijske populacije u reumatoidnom artritisu, juvenilnom idiopatskom artritisu, psorijatičnom artritisu, ankilozantnom spondilitisu, psorijazi i Crohnovoj bolesti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Croatian: Uvedite iglu u bočicu kroz sredinu gumenog čepa i usmjerite mlaz vode za injekcije na staklenu stijenku bočice.
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Croatian: Antinuklearna protutijela (ANA)/protutijela na dvolančanu DNK (dsDNK) Otprilike polovica bolesnika liječenih infliksimabom u kliničkim ispitivanjima koji su na početku ispitivanja bili negativni na ANA postali su pozitivni na ANA tijekom ispitivanja, u odnosu na približno jednu petinu bolesnika koji su primali placebo.
English: Shortened infusions across adult indications
Croatian: Skraćeno trajanje infuzije u odraslih bolesnika za sve indikacije
English: If you were using Remicade during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Remicade use before the baby receives any vaccines.
Croatian: Ako ste uzimali Remicade tijekom trudnoće, obavijestite pedijatra Vašeg djeteta ili druge zdravstvene radnike koji skrbe za Vaše dijete da ste uzimali Remicade prije nego što dijete primi bilo koje cjepivo.
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: Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
Croatian: Među bolesnicima u kojih je bila potrebna titracija doze, klinički je odgovor postiglo njih 80%, pri čemu je u većini slučajeva (64%) trebalo samo jednom prilagođavati doze za 1,5 mg/kg.
English: The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Croatian: Najčešće prijavljene infekcije bile su infekcije gornjih dišnih puteva i faringitis, a najčešće prijavljena ozbiljna infekcija bio je apsces.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remicade treatment.
Croatian: • Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Remicade.
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Croatian: • ozbiljne alergijske reakcije (npr. anafilaksija), poremećaj imunološkog sustava poznat kao lupus, alergijske reakcije na strane proteine
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Croatian: Psorijatični artritis je upalna bolest zglobova, obično praćena psorijazom.
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Croatian: O tome treba voditi računa u bolesnika na dijeti s ograničenim unosom natrija (vidjeti dio 6.6).
English: In clinical studies, infections have been reported in a higher proportion of paediatric patients compared to adult patients (see section 4.8).
Croatian: U kliničkim ispitivanjima prijavljen je veći udio infekcija u pedijatrijskih bolesnika u odnosu na odrasle bolesnike (vidjeti dio 4.8).
English: Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Croatian: Nepoznato: hepatosplenički limfom T-stanica (prvenstveno u adolescenata i mlađih odraslih muškaraca s Crohnovom bolešću ili ulceroznim kolitisom), karcinom Merkelovih stanica
English: Of these patients, most were teenage boys or young men and most had either Crohn's disease or ulcerative colitis.
Croatian: Od tih bolesnika većina su bili dječaci adolescenti ili mlađi muškarci s Crohnovom bolešću ili ulceroznim kolitisom.
English: Your doctor may recommend temporarily stopping Remicade.
Croatian: Liječnik Vam može preporučiti privremeni prekid liječenja lijekom Remicade.
English: Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Croatian: Prethodno je PUVA terapiju, metotreksat, ciklosporin ili acitretin primalo 71,4% bolesnika, s tim da bolest nije u svih bila rezistentna na takvo liječenje.
English: There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Croatian: Nije bilo značajne razlike između placeba i infliksimaba s obzirom na udio bolesnika u kojih su fistule ostale zatvorene do kraja 54. tjedna, s obzirom na simptome kao što su proktalgija, apscesi i infekcije mokraćnih puteva, kao ni s obzirom na broj novonastalih fistula tijekom liječenja.
English: In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Croatian: Iskustvo s ponovnom primjenom lijeka u slučaju ponovne pojave znakova i simptoma Crohnove bolesti ograničeno je i nema usporednih podataka o omjeru koristi i rizika alternativnih strategija za nastavak liječenja.
English: In this situation, Remicade should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Croatian: U tom slučaju treba započeti terapiju davanjem jedne doze lijeka Remicade, a zatim nastaviti s dozama održavanja, prema gore opisanim preporukama.
English: Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported (see section 4.4).
Croatian: Prijavljeni su slučajevi tuberkuloze, ponekad sa smrtnim ishodom, uključujući milijarnu tuberkulozu i ekstrapulmonalnu tuberkulozu (vidjeti dio 4.4).
English: Cancer and lymphoma
Croatian: Rak i limfom
English: • Medicines that affect your immune system.
Croatian: • Lijekove koji djeluju na imunološki sustav.
English: Patients who develop a new infection while undergoing treatment with Remicade, should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike koji tijekom liječenja lijekom Remicade razviju novu infekciju treba pažljivo nadzirati i podvrgnuti cjelovitom dijagnostičkom postupku.
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Croatian: Udio bolesnika s infekcijama u ispitivanju C0168T72 bio je sličan kao u ispitivanju Crohnove bolesti u pedijatrijskih bolesnika (REACH), ali veći nego udio u ispitivanjima ulceroznog kolitisa u odraslih (ACT 1 i ACT 2).
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Croatian: Juvenilni idiopatski artritis, psorijatični artritis i ankilozantni spondilitis Sigurnost i djelotvornost lijeka Remicade u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa nisu još ustanovljene.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C to 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Croatian: Međutim, ako se otopina pripremila u sterilnim uvjetima, može se čuvati u hladnjaku na temperaturi od 2°C do 8°C do 28 dana i tijekom dodatna 24 sata nakon vađenja iz hladnjaka na temperaturi od 25°C.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Croatian: Sljedeće nuspojave prijavljene su češće u djece s Crohnovom bolešću uključene u kliničko ispitivanje REACH (vidjeti dio 5.1) nego u odraslih bolesnika s Crohnovom bolešću: anemija (10,7%), krv u stolici (9,7%), leukopenija (8,7%), navale crvenila (8,7%), virusne infekcije (7,8%), neutropenija (6,8%), bakterijske infekcije (5,8%) i alergijske reakcije dišnog sustava (5,8%).
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Croatian: Reaktivacija hepatitisa B dogodila se u bolesnika koji su primali antagonist TNF-a uključujući infliksimab, a kronični su nositelji tog virusa.
English: Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Croatian: Rezultati nakon 54 tjedna (ACR20, HAQ i ukupan rezultat prema van der Heijdeovoj modifikaciji Sharpove bodovne skale) prikazani su u Tablici
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Croatian: Na temelju opservacijskog ispitivanja provedenog u sjevernoj Europi, opažen je povećan rizik (OR, 95% CI; p-vrijednost) za carski rez (1,50; 1,14-1,96; p = 0,0032), prijevremeni porođaj (1,48; 1,05-2,09; p = 0,024), malu veličinu ploda za gestacijsku dob (2,79; 1,54-5,04; p = 0,0007) i novorođenče niske porođajne težine (2,03; 1,41-2,94; p = 0,0002) u žena koje su tijekom trudnoće bile izložene infliksimabu (u kombinaciji s imunomodulatorima/kortikosteroidima ili bez njih, 270 trudnoća) u usporedbi sa ženama koje su bile izložene samo imunomodulatorima i/ili kortikosteroidima (6460 trudnoća).