FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use this medicine if it is discoloured or if there are particles present.
Croatian: • Ovaj lijek se ne smije upotrijebiti ako primijetite da je došlo do promjene boje ili su prisutne čestice.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Flixabi, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira neaktivna ("latentna") tuberkuloza, prije uvođenja lijeka Flixabi mora se započeti liječenje latentne tuberkuloze antituberkuloznom terapijom sukladno lokalnim preporukama.
English: If you received Flixabi while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Croatian: Flixabi, primjena BCG cjepiva (primjenjuje se za sprječavanje tuberkuloze) Vašem djetetu unutar 6 mjeseci od rođenja može dovesti do ozbiljnih komplikacija, uključujući smrt.
English: Flixabi and Orencia should not be used together.
Croatian: Flixabi i Orencia ne smiju se istodobno uzimati.
English: Specific studies of infliximab in elderly patients have not been conducted.
Croatian: Nisu provedena posebna ispitivanja infliksimaba u starijih bolesnika.
English: While using Flixabi you should not receive live vaccines.
Croatian: Dok uzimate Flixabi ne smijete primati živa cjepiva.
English: Flixabi may have a minor influence on the ability to drive and use machines.
Croatian: Flixabi malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you were using Flixabi during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Flixabi use before the baby receives any vaccines.
Croatian: Ako ste uzimali Flixabi tijekom trudnoće, obavijestite pedijatra Vašeg djeteta ili druge zdravstvene djelatnike koji skrbe za Vaše dijete da ste uzimali Flixabi prije nego što dijete primi bilo koje cjepivo.
English: Almost all patients had also received medicines containing azathioprine or 6mercaptopurine in addition to TNF-blockers.
Croatian: Skoro svi bolesnici također su uzimali lijekove koji sadrže azatioprin ili 6-merkaptopurin s blokatorom TNF-a.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Croatian: Smanjena incidencija kolektomije ispitivana je i u drugom randomiziranom, dvostruko slijepom kliničkom ispitivanju (C0168Y06) u hospitaliziranih bolesnika (n = 45) s umjerenim do teškim, aktivnim ulceroznim kolitisom koji nisu odgovorili na intravensko liječenje kortikosteroidima i koji su stoga imali veći rizik za kolektomiju.
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Croatian: Populacijska farmakokinetička analiza na temelju podataka prikupljenih u bolesnika s ulceroznim kolitisom (N = 60), Crohnovom bolešću (N = 112), juvenilnim reumatoidnim artritisom (N = 117) i Kawasakijevom bolešću (N = 16), u ukupnom rasponu dobi od 2 mjeseca do 17 godina, pokazala je da izloženost infliksimabu nelinearno ovisi o tjelesnoj težini.
English: Cerebrovascular accidents in close temporal association with infusion.
Croatian: cerebrovaskularni incidenti vremenski usko povezani s infuzijom
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
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, s 36 pitanja.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Flixabi.
Croatian: Obavijestite svog liječnika ako imate ili ste imali neki problem koji je zahvaćao Vaš živčani sustav prije nego počnete primati Flixabi.
English: In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Croatian: U skupini koja je primala dozu infliksimaba od 3 mg/kg, 4 od 60 bolesnika imala su ozbiljnu reakciju na infuziju dok su 3 bolesnika prijavila moguću anafilaktičku reakciju (od kojih su 2 bile među ozbiljnim reakcijama na infuziju).
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Croatian: anafilaktička reakcija, sindrom sličan lupusu, serumska bolest ili reakcije nalik serumskoj bolesti
English: • In case you have received Flixabi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Croatian: • U slučaju da ste primali Flixabi za vrijeme trudnoće, važno je da o tome obavijestite pedijatra svog djeteta prije nego što Vaše dijete primi ikakvo cjepivo.
English: In this situation, Flixabi 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 Flixabi, a zatim nastaviti s dozama održavanja, prema gore opisanim preporukama.
English: Calculate the dose and the number of Flixabi vials needed.
Croatian: Izračunajte dozu i potreban broj bočica lijeka Flixabi.
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
Croatian: PGA čist (0) ili minimalan (1) PGA čist (0), minimalan (1) ili blag (2) Svi nokti bez psorijatičnih promjenac
English: Patients who develop a new infection while undergoing treatment with Flixabi, should be monitored closely and undergo a complete diagnostic evaluation.
Croatian: Bolesnike koji tijekom liječenja lijekom Flixabi razviju novu infekciju treba pažljivo nadzirati i podvrgnuti cjelovitom dijagnostičkom postupku.
English: Your doctor may recommend temporarily stopping Flixabi.
Croatian: Liječnik Vam može preporučiti privremeni prekid liječenja lijekom Flixabi.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Croatian: U skupini 2, nakon infuzije u 36. tjednu, bolesnici koji su imali BASDAI ≥ 3 na dva uzastopna pregleda primali su dozu od 7,5 mg/kg infliksimaba svakih 6 tjedana do 96. tjedna.
English: Ask your doctor to record the type and date of last screening(s) for TB below:
Croatian: Zamolite liječnika da ovdje zabilježi vrstu i datum posljednjeg testiranja na tuberkulozu (TBC): Test:
English: Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Croatian: U tablici 1 navedene su nuspojave koje se temelje na iskustvu iz kliničkih ispitivanja kao i nuspojave prijavljene nakon stavljanja lijeka u promet, od kojih su neke imale smrtni ishod.
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Croatian: bakterijske infekcije (npr. sepsa, celulitis, apsces)
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximab-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Croatian: Nema dovoljno podataka o incidenciji reakcija kasne preosjetljivosti nakon prekida davanja infliksimaba u trajanju duljem od jedne godine, ali ograničeni podaci iz kliničkih ispitivanja ukazuju na povećanje rizika od kasne preosjetljivosti što je dulje razdoblje u kojemu se infliksimab ne primjenjuje (vidjeti dio 4.4).
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Croatian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), akutna generalizirana egzantematozna pustuloza (AGEP), lihenoidne reakcije
English: Placebo Maintenance (n=99)
Croatian: Terapija održavanja placebom (n = 99)
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: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Croatian: meningitis, oportunističke infekcije (kao što su invazivne gljivične infekcije [pneumocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske infekcije [atipična mikobakterijska infekcija, listerioza, salmoneloza] i virusne infekcije [citomegalovirus]), parazitske infekcije, reaktivacija hepatitisa B
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Croatian: Smanjenje brzine napredovanja strukturnog oštećenja zglobova (erozije i sužavanje zglobnog prostora) primijećeno je nakon 54 tjedna u svim skupinama bolesnika koji su primali infliksimab (tablica 3).
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 na to 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: Table 7 Effects on response rate, data from ACCENT II (week-14 responders)
Croatian: Tablica 7 Učinci na stopu odgovora, podaci iz ispitivanja ACCENT II (bolesnici s odgovorom u 14. tjednu)
English: Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Croatian: Psorijatični artritis je upalna bolest zglobova, obično praćena psorijazom.
English: 2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Croatian: 2 Bolesnici u placebo skupini u dva klinička ispitivanja faze III u Crohnovoj bolesti, ACCENT I i ACCENT II, primili su inicijalnu dozu infliksimaba od 5 mg/kg na početku ispitivanja, dok su u fazi održavanja primali placebo.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Croatian: U eksplorativnom kliničkom ispitivanju u bolesnika sa srednje teškim do teškim KOPB-om koji su bili aktivni ili bivši pušači, 157 odraslih bolesnika liječilo se sličnim dozama infliksimaba kakve su se primjenjivale u bolesnika s reumatoidnim artritisom i onih s Crohnovom bolešću.
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Croatian: Gotovo svi ti bolesnici liječeni su azatioprinom (AZA) ili 6-MP istodobno ili neposredno prije primjene blokatora TNF-a.
English: • Tell your doctor before you are given Flixabi if you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker.
Croatian: • Prije nego što počnete primati Flixabi, obavijestite svog liječnika ako bolujete od bolesti pluća koja se zove kronična opstruktivna plućna bolest (KOPB) ili ste teški pušač.
English: Children may receive some vaccines during treatment with Flixabi but should not receive live vaccines while using Flixabi.
Croatian: Tijekom liječenja lijekom Flixabi djeca mogu primiti neka cjepiva, ali ne smiju primiti živa cjepiva za vrijeme primjene lijeka Flixabi.
English: The incidence of serious infections in infliximab-treated patients 65 years and older was greater than in those under 65 years of age.
Croatian: Incidencija ozbiljnih infekcija u bolesnika u dobi od 65 ili više godina koji su liječeni infliksimabom bila je veća nego u bolesnika mlađih od 65 godina.
English: Autoimmune hepatitis, jaundice.
Croatian: autoimuni hepatitis, žutica
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Croatian: Analiza mononuklearnih stanica u lamini propriji, dobivenih biopsijom sluznice crijeva, pokazala je da je liječenje infliksimabom dovelo do smanjenja broja stanica koje mogu izraziti TNFα i interferon .
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common:
Croatian: Tablica 1 Nuspojave u kliničkim ispitivanjima i nakon stavljanja lijeka u promet Infekcije i infestacije Vrlo često:
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Flixabi should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Croatian: Ako se razvije žutica i/ili je koncentracija ALT ≥ 5 puta veća od gornje granice normale, liječenje lijekom Flixabi treba prekinuti te provesti temeljite pretrage i utvrditi razlog poremećaja.
English: Placebo Maintenance (n=110)
Croatian: Terapija održavanja placebom (n = 110)
English: Cases of TB have been reported in patients treated with Flixabi, even in patients who have already been treated with medicines for TB.
Croatian: U bolesnika liječenih lijekom Flixabi prijavljeni su slučajevi tuberkuloze, čak i u bolesnika koji su već bili liječeni lijekovima protiv TBC-a.
English: ACR response (% of patients) N
Croatian: ACR odgovor (% bolesnika)
English: The combination of Flixabi and abatacept is not recommended.
Croatian: Ne preporučuje se kombinirana primjena lijeka Flixabi i abatacepta.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
Croatian: • poremećaji imunološkog sustava koji mogu zahvatiti pluća, kožu i limfne čvorove (kao što je sarkoidoza)
English: • Tell your doctor before you are given Flixabi if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Croatian: • Prije nego što primite Flixabi, obavijestite svog liječnika ako ste ikad živjeli ili putovali u područja u kojima su česte infekcije histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: Use of TNF-blocking agents, including infliximab, 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, including Guillain-Barré syndrome.
Croatian: Primjena blokatora TNF-a, uključujući infliksimab dovodi se u vezu sa slučajevima nastajanja novih ili egzacerbacije postojećih kliničkih simptoma i/ili radioloških nalaza demijelinizacijskih bolesti središnjeg živčanog sustava, uključujući multiplu sklerozu, te demijelinizacijskih poremećaja perifernog živčanog sustava, uključujući Guillain-Barréov sindrom.
English: Symptoms included, but were not limited to, dyspnoea, urticaria, facial oedema, and hypotension.
Croatian: Simptomi su uključivali, ali nisu bili ograničeni na dispneju, urtikariju, edem lica i hipotenziju.
English: • Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems
Croatian: • Znakove neuroloških problema (uključujući poremećaje oka) kao što su znakovi moždanog udara (iznenadna utrnulost ili slabost lica, ruke ili noge, osobito na jednoj strani tijela; iznenadna smetenost, otežan govor ili razumijevanje; tegobe s vidom koje zahvaćaju jedno ili oba oka, otežan hod, omaglica, gubitak ravnoteže ili koordinacije ili jaka glavobolja), napadaji, trnci/obamrlost bilo kojeg dijela tijela ili slabost u rukama ili nogama, promjene vida poput dvostruke slike ili drugi problemi s očima.
English: • You should avoid getting pregnant when you are being treated with Flixabi and for 6 months after you stop being treated with it.
Croatian: • Potrebno je izbjegavati trudnoću tijekom liječenja lijekom Flixabi i 6 mjeseci nakon završetka liječenja.
English: Appropriate screening tests, e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Croatian: U svih bolesnika treba provesti odgovarajuće pretrage (npr. kožni tuberkulinski test, rendgen pluća i/ili test oslobađanja interferona gama) (sukladno lokalnim preporukama).
English: Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Croatian: Faktor nekroze tumora alfa (TNFα) posreduje upalu i modulira stanične imunološke odgovore.
English: In patients who develop HBV reactivation, Flixabi should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.
Croatian: U bolesnika u kojih se ponovno aktivira HBV treba prekinuti primjenu lijeka Flixabi te uvesti djelotvorne antivirusne lijekove uz odgovarajuće suportivno liječenje.
English: There are no known side effects of having too much of Flixabi.
Croatian: Nisu poznate nuspojave kod primjene prevelike količine lijeka Flixabi.
English: With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded (see section 4.8).
Croatian: S obzirom na dosadašnje spoznaje, ne može se isključiti rizik od pojave limfoma ili drugih zloćudnih bolesti u bolesnika koji se liječe blokatorom TNF-a (vidjeti dio 4.8).
English: If you forget or miss your Flixabi infusion If you forget or miss an appointment to receive Flixabi, make another appointment as soon as possible.
Croatian: Ako ste zaboravili ili propustili doći na infuziju lijeka Flixabi, dogovorite novi pregled što je prije moguće.
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Croatian: U kliničkim ispitivanjima primjene jednokratnih i višekratnih doza infliksimaba u rasponu od 1 do 20 mg/kg, protutijela na infliksimab otkrivena su u 14% bolesnika koji su primali neku imunosupresivnu terapiju te u 24% bolesnika koji nisu primali imunosupresivnu terapiju.
English: The combination of Flixabi with other biological therapeutics used to treat the same conditions as Flixabi, including anakinra and abatacept, is not recommended (see section 4.4).
Croatian: Ne preporučuje se primjena lijeka Flixabi u kombinaciji s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i Flixabi, uključujući anakinru i abatacept (vidjeti dio 4.4).
English: Keep this card with you for 4 months after your dose of Flixabi, or in case of pregnancy for at least 6 months after the birth of your baby.
Croatian: Nosite ovu karticu sa sobom još 4 mjeseca nakon doze lijeka Flixabi ili, u slučaju trudnoće, još najmanje 6 mjeseci nakon porodaNuspojave se mogu javiti dugo vremena nakon zadnje doze lijeka.
English: Limited experience from re-treatment following disease flare by a re-induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment (see section 4.8).
Croatian: Ograničeno iskustvo ponovne primjene lijeka zbog novog izbijanja bolesti ponavljanjem uvodnog režima liječenja, pokazuje veću incidenciju reakcija na infuziju, uključujući i ozbiljne reakcije, u odnosu na terapiju održavanja svakih 8 tjedana (vidjeti dio 4.8).
English: Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
Croatian: Mogu se razviti protutijela na infliksimab koja su povezana s povećanom učestalošću reakcija na infuziju.
English: Placebo + MTX 3 mg/kg
Croatian: Infliksimab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Kombinirano
English: If active tuberculosis is diagnosed, Flixabi therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Flixabi (vidjeti dio 4.3).
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Croatian: anafilaktički šok, vaskulitis, reakcija nalik na sarkoidozu
English: Store in a refrigerator Can be stored at room temperature (up to 25°C) for a single period up to 6 months.
Croatian: Može se čuvati na sobnoj temperaturi (do 25C) u jednokratnom razdoblju do 6 mjeseci.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Flixabi use before your baby is given any vaccine.
Croatian: • Važno je da djetetovog pedijatra i druge zdravstvene radnike obavijestite o svojem primanju lijeka Flixabi prije nego što Vaše dijete primi bilo koje cjepivo.
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Croatian: U šestomjesečnom istraživanju toksičnosti ponovljenih doza na miševima pomoću istog analognog protutijela na mišji TNFα, u nekih su mužjaka miševa uočeni kristalični depoziti na kapsuli leće.
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Croatian: U podskupini od 90 odraslih bolesnika s reumatoidnim artritisom iz ispitivanja ASPIRE, sličan je udio bolesnika u svim liječenim skupinama (metotreksat plus: placebo [n = 17], infliksimab u dozi od 3 mg/kg [n = 27] ili infliksimab u dozi od 6 mg/kg [n = 46]) ostvario učinkovito dvostruko povećanje titra kao odgovor na polivalentno pneumokokno cjepivo, što ukazuje na to da infliksimab nije utjecao na humoralne imunološke odgovore neovisne o T-stanicama.
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Croatian: 3,0 do 4,1 litre) nije ovisio o veličini primijenjene doze i pokazao je da se infliksimab pretežno distribuira unutar vaskularnog odjeljka.