FrancophonIA/ELRC3.0 huggingface dataset:
English: During Inflectra treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Croatian: Tijekom liječenja lijekom Inflectra treba optimalno prilagoditi istodobnu terapiju drugim lijekovima, primjerice kortikosteroidima i imunosupresivima.
English: Date of Inflectra therapy initiation:
Croatian: Datum početka liječenja lijekom Inflectra:
English: If serious reactions occur, symptomatic treatment must be given and further infliximab infusions must not be administered (see section 4.8).
Croatian: Ako se pojave ozbiljne reakcije, mora se primijeniti simptomatska terapija i više se ne smiju davati infuzije infliksimaba (vidjeti dio 4.8).
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Croatian: Infliksimab sa ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom (SONIC) u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću (CDAI ≥ 220 i ≤ 450) koji prethodno nisu primali biološke lijekove niti imunosupresive i u kojih je medijan trajanja bolesti iznosio 2,3 godine.
English: • Tell your doctor before you are given Inflectra if you are a carrier of hepatitis B or have ever had it.
Croatian: • Obavijestite svog liječnika prije liječenja lijekom Inflectra ako ste nositelj virusa hepatitisa B ili ste ikad bolovali od hepatitisa B.
English: Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Ako bolesnik razvije novu ozbiljnu infekciju ili sepsu, treba prekinuti liječenje infliksimabom i uvesti odgovarajuću antimikrobnu ili antimikotičku terapiju sve dok infekcija ne bude pod kontrolom.
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab-treated patients compared with control patients.
Croatian: U eksplorativnom kliničkom ispitivanju u kojem se ocjenjivala primjena infliksimaba u bolesnika sa srednje teškom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB), prijavljeno je više slučajeva zloćudnih bolesti u bolesnika liječenih infliksimabom nego u bolesnika u kontrolnoj skupini.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Croatian: Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, ispitivanja: SPIRIT i EXPRESS.
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Croatian: U tom je ispitivanju 150 bolesnika s kroničnim zatajenjem srca NYHA stupnja III-IV (ejekcijska frakcija lijeve klijetke ≤ 35%) liječeno sa 3 infuzije infliksimaba u dozi od 5 mg/kg, odnosno 10 mg/kg ili je primalo placebo tijekom 6 tjedana.
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 bjelančevine
English: a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Croatian: Podaci za 98. tjedan ispitivanja IMPACT uključuju i bolesnike koji su prebačeni s liječenja placebom i one koji su primali infliksimab i ušli u fazu otvorenog ispitivanja.
English: b CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54
Croatian: CDAI < 150 i u 30. i u 54. tjednu, bez uzimanja kortikosteroida tijekom 3 mjeseca prije 54. tjedna u bolesnika koji su primali kortikosteroide na početku ispitivanja.
English: • Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer.
Croatian: • U nekih žena koje su se liječile infliksimabom zbog reumatoidnog artritisa razvio se rak grlića maternice.
English: Store at 2 °C - 8 °C.
Croatian: Čuvati na temperaturi od 2°C - 8°C.
English: Additional side effects in children and adolescents Children who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Croatian: U djece koja su primala infliksimab za liječenje Crohnove bolesti nuspojave su se ponešto razlikovale u odnosu na odrasle bolesnike koji su primali infliksimab za liječenje Crohnove bolesti.
English: In all situations described below, the benefit/risk balance of infliximab therapy should be very carefully considered.
Croatian: U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja infliksimabom.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT Infliximab b
Croatian: Tablica 3 Učinci na ACR20, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu, ATTRACT
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p<0.001).
Croatian: U 54 je tjedana klinički odgovor imalo 44,9% bolesnika u objema skupinama liječenima infliksimabom, u odnosu na 19,8% ispitanika u skupini koja je primala placebo (p < 0,001).
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of infliximab therapy.
Croatian: U bolesnika s već postojećim ili novonastalim demijelinizacijskim bolestima treba pažljivo procijeniti rizike i koristi anti-TNF terapije prije početka liječenja infliksimabom.
English: Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Croatian: Simptomi obuhvaćaju uporan kašalj, gubitak tjelesne težine, umor, vrućicu, noćno znojenje.
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Inflectra over 1 hour.
Croatian: • Lijek ćete primiti putem infuzije (kap po kap) (tijekom 2 sata) u jednu od vena, obično venu na ruci.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions (see section 6.3 above).
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija/razrjeđivanje nije provedena u kontroliranim i validiranim aseptičkim uvjetima (vidjeti dio 6.3 iznad).
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Croatian: Infliksimab je kimerično ljudsko-mišje monoklonsko protutijelo koje se vezuje velikim afinitetom za topive i transmembranske oblike faktora nekroze tumora alfa (TNFα), ali ne i za limfotoksin alfa (TNFβ).
English: Beginning at week 14, patients who had responded to treatment, but subsequently lost their clinical benefit, were allowed to cross over to a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Croatian: Počevši od 14. tjedna, bolesnike koji su odgovorili na liječenje, no u kojih se kliničko poboljšanje kasnije izgubilo, bilo je dozvoljeno prebaciti na dozu infliksimaba koja je bila za 5 mg/kg veća od one koju su primali nakon randomizacije.
English: There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Croatian: Nakon stavljanja u promet bilo je prijava pogoršanja zatajenja srca u bolesnika s ili bez utvrđenih precipitirajućih čimbenika koji su primali infliksimab.
English: However, before Inflectra is given to you, it is mixed with a solution that contains sodium.
Croatian: Međutim, prije primjene lijek Inflectra se pomiješa s otopinom koja sadrži natrij.
English: Placebo + MTX
Croatian: Infliksimab + MTX
English: It is recommended that therapeutic infectious agents not be given concurrently with infliximab.
Croatian: Ne preporučuje se primjenjivati terapijske infektivne agense istodobno s infliksimabom.
English: Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Croatian: Počevši od 22. tjedna, bolesnike koji su prvobitno odgovorili na liječenje, no u kojih se klinički odgovor kasnije izgubio, bilo je dozvoljeno prebaciti na aktivno ponovno liječenje svakih 8 tjedana, dozom infliksimaba koja je bila za 5 mg/kg veća od one koju su primali nakon randomizacije.
English: In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Croatian: U ispitivanjima IMPACT i IMPACT 2 klinički su odgovori primijećeni već u 2. tjednu i održali su se do 98. tjedna u ispitivanju IMPACT, odnosno do 54. tjedna u ispitivanju IMPACT 2. Djelotvornost je potvrđena s ili bez istodobne primjene metotreksata.
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)
English: • Some patients receiving infliximab have developed serious liver problems.
Croatian: • Neki bolesnici koji su primali infliksimab razvili su ozbiljne probleme s jetrom.
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Croatian: U djece su se više javljale sljedeće nuspojave: smanjen broj crvenih krvnih stanica (anemija), krv u stolici, smanjen ukupan broj bijelih krvnih stanica (leukopenija), navale vrućine i crvenila (crvenilo praćeno osjećajem užarenosti), virusne infekcije, smanjen broj bijelih krvnih stanica koje se bore protiv infekcije (neutropenija), lom kostiju, bakterijske infekcije te alergijske reakcije dišnog sustava.
English: • Liver problem that causes yellowing of the skin or eyes (jaundice)
Croatian: • problem s jetrom koji uzrokuje žutilo kože ili bjeloočnica (žutica)
English: Cerebrovascular accidents in close temporal association with infusion.
Croatian: cerebrovaskularni inzulti vremenski usko povezani s infuzijom
English: From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Croatian: S mikrobiološkog stajališta, otopinu za infuziju treba primijeniti odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija/razrjeđivanje nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: * ITT-analysis where subjects with missing data were included as non-responders.
Croatian: Odgovor PASI 75** * ITT-analiza, analiza svih bolesnika koje se namjeravalo liječiti; ispitanici za koje su nedostajali podaci bili su uključeni kao oni u kojih nije nastupio odgovor.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Croatian: Ozbiljne nuspojave infliksimaba u pedijatrijskih bolesnika spontano prijavljeni nakon stavljanja lijeka u promet uključivali su zloćudne bolesti među kojima i hepatosplenički limfom T-stanica, prolazne poremećaje vrijednosti jetrenih enzima, sindrome nalik lupusu i pozitivan nalaz autoprotutijela (vidjeti dijelove 4.4 i 4.8).
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Croatian: Na zadnjem je pregledu 57% bolesnika liječenih infliksimabom imalo pozitivan nalaz protutijela protiv dvolančane DNK.
English: Inflectra 100 mg powder for concentrate for solution for infusion
Croatian: Inflectra 100 mg prašak za koncentrat za otopinu za infuziju
English: Patients received three doses of either placebo or infliximab at weeks 0, 2 and 6.
Croatian: Bolesnici su primili tri doze ili placeba ili infliksimaba u 0., 2. i 6. tjednu.
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) 50. tjedan
English: Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Croatian: Infekcije su prijavljene češće u ispitanika koji su primali infuzije svakih 8 tjedana (73,6%) nego u onih koji su ih primali svakih 12 tjedana (38,0%), dok su ozbiljne infekcije prijavljene u 3 ispitanika koji su terapiju održavanja primali svakih 8 tjedana i u 4 ispitanika koji su je primali svakih 12 tjedana.
English: p-value
Croatian: (p-vrijednost)
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Croatian: Sigurnost i djelotvornost infliksimaba ispitivane su u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja (ACT 1 i ACT 2) u odraslih bolesnika s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo bodovi 6 do 12; endoskopski ≥ 2), koji nisu odgovorili na konvencionalno liječenje na odgovarajući način [peroralne kortikosteroide, aminosalicilate i/ili imunomodulatore (6-MP, AZA)].
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Croatian: Nepoznato probojna infekcija uzrokovana cjepivom (nakon izlaganja infliksimabu in utero)* Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko:
English: Inflectra may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.
Croatian: Inflectra se može čuvati na temperaturi do najviše 25°C neprekinuto tijekom razdoblja od najviše 6 mjeseci, ali ne izvan originalnog roka valjanosti.
English: The dose and the number of Inflectra vials have to be calculated.
Croatian: Morate izračunati potrebnu dozu i broj bočica lijeka Inflectra.
English: The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Croatian: Sigurnost primjene i djelotvornost infliksimaba ispitivane su u multicentričnom, randomiziranom otvorenom kliničkom ispitivanju s paralelnim skupinama (C0168T72), provedenom u 60 pedijatrijskih bolesnika u dobi od 6 do 17 godina (medijan dobi 14,5 godina) s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo rezultat 6-12, endoskopski ≥ 2) koji nisu odgovorili na konvencionalnu terapiju na odgovarajući način.
English: Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Croatian: U bolesnika liječenih infliksimabom primjećene su smanjene vrijednosti parametara periferne aktivnosti karakterističnih za psorijatični artritis (kao što je broj otečenih zglobova, broj bolnih/osjetljivih zglobova, daktilitis i prisutnost entezopatije).
English: Inflectra is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Međutim, Inflectra se razrjeđuje u 0,9%-tnoj otopini natrijevog klorida za infuziju (9 mg/ml).
English: Inflectra works by selectively attaching to TNF alpha (tumour necrosis factor alpha) and blocking its action.
Croatian: Inflectra djeluje tako što se selektivno veže na TNF-alfa i onemogućuje njegovo djelovanje.
English: Immune system disorder
Croatian: Poremećaj imunološkog sustava
English: Before treatment with Inflectra
Croatian: Prije liječenja lijekom Inflectra
English: During treatment with Inflectra
Croatian: Tijekom liječenja lijekom Inflectra
English: • When starting a new card, keep this card as a reference for 4 months after your last dose of
Croatian: • Kada dobijete novu karticu nastavite čuvati ovu karticu za potrebe provjere još 4 mjeseca nakon posljednje doze lijeka Inflectra.
English: In clinical studies 36% of infliximab-treated patients were treated for infections compared with 25% of placebo-treated patients.
Croatian: U kliničkim su se ispitivanjima infekcije javile u 36% bolesnika liječenih infliksimabom, u odnosu na s 25% bolesnika koji su dobivali placebo.
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI < 150) and clinical response over time.
Croatian: Sekundarne mjere ishoda obuhvaćale su udio bolesnika u kliničkoj remisiji nakon 4 tjedna liječenja (CDAI < 150) te održivost kliničkog odgovora tijekom vremena.
English: Carriers of HBV who require treatment with infliximab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje virusa hepatitisa B koji se moraju liječiti infliksimabom treba pažljivo nadzirati za vrijeme i nekoliko mjeseci nakon završetka liječenja kako bi se uočili mogući znakovi i simptomi aktivne HBV infekcije.
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Croatian: Kod primjene infliksimaba velika većina ovakvih slučajeva dogodila se u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom i to najviše u adolescenata ili mlađih odraslih muškaraca.
English: • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis(serious bacterial infection of the blood),
Croatian: • ako imate tuberkulozu (TBC) ili neku drugu ozbiljnu infekciju kao što je upala pluća ili sepsa
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after infliximab treatment.
Croatian: Sve bolesnike treba uputiti da se jave liječniku ako se tijekom ili nakon liječenja infliksimabom pojave znakovi/simptomi koji bi mogli ukazivati na tuberkulozu (npr. uporan kašalj, gubitak tjelesne težine, subfebrilnost).
English: It is recommended that therapeutic infectious agents not be given concurrently with infliximab (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena terapijskih infektivnih agenasa istodobno s infliksimabom (vidjeti dio 4.4).
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils
Croatian: • drugi problemi s kožom kao što su multiformni eritem, mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako rekonstitucija/razrjeđivanje nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Inflectra is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da će lijek Inflectra utjecati na Vašu sposobnost upravljanja vozilima i strojevima i rada sa alatima.
English: Patients treated with Inflectra should be given the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Inflectra moraju dobiti karticu s podsjetnikom za bolesnika.
English: Warnings and precautions Talk to your doctor before or during treatment with Inflectra if you have:
Croatian: Obratite se svom liječniku prije ili tijekom liječenja lijekom Inflectra u sljedećim situacijama:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti nuspojave su u padajućem nizu prema ozbiljnosti.
English: Inflectra 100 mg powder for concentrate for solution for infusion infliximab
Croatian: Inflectra 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
English: In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p<0.001).
Croatian: U ispitivanju SPIRIT, udio bolesnika koji su postigli PASI 75 u 10. tjednu bio je 71,7% u skupini koja je primala infliksimab u dozi od 3 mg/kg, 87,9% u skupini koja je primala infliksimab u dozi od 5 mg/kg te 5,9% u skupini koja je primala placebo (p < 0,001).
English: • slow down the damage in your joints,
Croatian: • usporilo oštećenje zglobova
English: Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Croatian: Protutijela protiv dvolančane DNK po prvi puta su otkrivena u oko 17% bolesnika liječenih infliksimabom, u odnosu na 0% bolesnika koji su primali placebo.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Croatian: Udio bolesnika koji su mogli prestati uzimati kortikosteroide i pritom ostati u kliničkoj remisiji bio je veći u zbirnoj skupini bolesnika liječenih infliksimabom u odnosu na skupinu koja je primala placebo, kako u 30. tjednu (22,3% naspram 7,2%, p < 0,001, zbirni podaci iz ispitivanja ACT 1 i ACT 2) tako i u 54. tjednu (21,0% naspram 8,9%, p = 0,022, podaci iz ispitivanja ACT 1).