FrancophonIA/ELRC3.0 huggingface dataset:
English: ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
Croatian: ACR20, a rezultat je dobiven izračunavanjem najmanjeg postotka poboljšanja broja otečenih zglobova, broja osjetljivih zglobova i medijana vrijednosti preostalih pet komponenti ACR odgovora.
English: • More children taking infliximab developed infections as compared to adults.
Croatian: • U djece koja su primala infliksimab infekcije su se više javljale u odnosu na odrasle.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study 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 u hospitaliziranih bolesnika (n = 45) sa umjerenim do teškim, aktivnim ulceroznim kolitisom koji nisu odgovorili na intravensko liječenje kortikosteroidima i koji su stoga imali veći rizik za kolektomiju.
English: However, before Zessly is given to you, it is mixed with a solution that contains sodium.
Croatian: Međutim, prije primjene lijek Zessly se pomiješa s otopinom koja sadrži natrij.
English: Zessly is supplied as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate).
Croatian: Zessly je dostupan u staklenoj bočici koja sadrži prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given
Croatian: • Obavijestite svog liječnika ako imate neprirodne otvore na koži (fistule) prije nego počnete primati Zessly.
English: In the paediatric Crohn's disease study, 17.5% of randomised patients experienced 1 or more infusion reactions.
Croatian: U kliničkom ispitivanju Crohnove bolesti u pedijatrijskih bolesnika ukupno je 17,5% randomiziranih bolesnika imalo jednu ili više reakcija na infuziju.
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 od 3 mg/kg infliksimaba, 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: Talk to your doctor before or during treatment with Zessly if you have:
Croatian: Obratite se svom liječniku prije ili za vrijeme liječenja lijekom Zessly u sljedećim situacijama:
English: In a clinical study of patients with Crohn's disease, infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Croatian: U kliničkom ispitivanju bolesnika s Crohnovom bolešću, reakcije vezane uz infuziju javile su se u 16,6% (27/163) bolesnika koji su primali monoterapiju infliksimabom, 5% (9/179) bolesnika koji su primali infliksimab u kombinaciji s AZA i 5,6% (9/161) bolesnika koji su primali AZA kao monoterapiju.
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: infliximab 5 mg/kg
Croatian: infliksimab 5 mg/kg
English: Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11
Croatian: Učinci na ACR i PASI u bolesnika s aktivnim psorijatičnim artritisom, podaci iz ispitivanja 10 i ispitivanja 11
English: In a clinical study of patients with rheumatoid arthritis, infusions were to be administered over 2 hours for the first 3 infusions.
Croatian: U kliničkom ispitivanju bolesnika s reumatoidnim artritisom prve 3 infuzije morale su se davati tijekom 2 sata.
English: Infusion reactions following re-administration of infliximab
Croatian: Reakcije na infuziju nakon ponovne primjene infliksimaba
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 prehrani s ograničenim unosom natrija (vidjeti dio 6.6).
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB
Croatian: • Ako liječnik misli da kod Vas postoji rizik od razvoja TBC-a, prije nego primite Zessly možda ćete dobiti lijekove za liječenje TBC-a.
English: Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Croatian: Bath Ankylosing Spondylitis Disease Activity Index - BASDAI] i ≥ 4 na skali od 1-10 za bol u kralježnici).
English: Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 2 °C - 30 °C.
Croatian: Rekonstituirana otopina je kemijski i fizički stabilna tijekom 24 sata na temperaturi od 2°C do 30°C.
English: • Tell your doctor before you are given Zessly if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Croatian: • Prije nego primite Zessly, obavijestite svog liječnika ako ste ikad živjeli ili putovali u područja u kojima su česte infekcije histoplazmoza, kokcidioidomikoza ili blastomikoza.
English: Placebo (week 24)
Croatian: Placebo (24. tjeda n)
English: • Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Croatian: Osim toga: • U neke djece i mladih bolesnika koji su primali TNF-blokatore kao što je infliksimab razvio se rak, uključujući neuobičajene vrste raka koje su ponekad imale smrtni ishod.
English: N ≥ 90% improvement
Croatian: N Poboljšanje ≥ 90%
English: If these medicines do not work well enough, you will be given Zessly which you will take in combinationwith another medicine called methotrexate to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Zessly, koji ćete koristiti u kombinaciji s drugim lijekom koji se zove metotreksat kako bi se: • umanjili znakovi i simptomi bolesti
English: Children may receive some vaccines during treatment with Zessly but should not receive live vaccines while using Zessly.
Croatian: • Tijekom liječenja lijekom Zessly djeca mogu primiti neka cjepiva, ali ne smiju primiti živa cjepiva za vrijeme primjene lijeka Zessly.
English: Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Croatian: U ispitivanju 12 ocjenjivala se djelotvornost uvodne terapije infliksimabom u 249 bolesnika s plak psorijazom koji su prethodno bili liječeni PUVA ili sustavnom terapijom.
English: Use of antituberculosis therapy should also be considered before the initiation of Zessly in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu antituberkulozne terapije treba razmotriti prije početka liječenja lijekom Zessly i u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi da su bili liječeni na odgovarajući način.
English: In the 6 mg/kg group, 2 out of 57 patients had a serious infusion reaction, one of whom had a possible anaphylactic reaction (see section 4.4).
Croatian: skupini koja je primala dozu od 6 mg/kg, 2 od 57 bolesnika imala su ozbiljnu reakciju na infuziju, od kojih se u jednog moglo raditi o anafilaktičkoj reakciji (vidjeti dio 4.4).
English: In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Croatian: U prvom kliničkom ispitivanju (ispitivanje 10) ispitivane su djelotvornost i sigurnost primjene infliksimaba u 104 bolesnika s aktivnim poliartikularnim psorijatičnim artritisom.
English: • Some patients receiving treatment with medicines containing infliximab have developed symptoms of an immune system disorder called lupus.
Croatian: • U nekih bolesnika koji primaju infliksimab razvili su se simptomi poremećaja imunološkog sustava koji se zove lupus.
English: During treatment with Zessly
Croatian: Tijekom liječenja lijekom Zessly
English: • Treatment with TNF blockers such as Zessly may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Croatian: • Liječnik Vas treba testirati na virus hepatitisa B. • Liječenje TNF-blokatorima kao što je Zessly može izazvati ponovnu aktivaciju virusa hepatitisa B u bolesnika koji nose taj virus, što u nekim slučajevima može ugroziti život.
English: The pooled data analysis from study 6 and study 7 and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
Croatian: Zbirni podaci iz ispitivanja 6 i ispitivanja 7 i njihovih nastavaka, analizirani od početka do kraja 54. tjedna, pokazali su da je pri liječenju infliksimabom smanjen broj hospitalizacija kao i kirurških zahvata vezanih uz ulcerozni kolitis.
English: Zessly is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da bi Zessly mogao utjecati na Vašu sposobnost upravljanja vozilima i strojevima i rada sa alatima.
English: The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established.
Croatian: Sigurnost i djelotvornost ponovne primjene, ako je razdoblje u kojemu se infliksimab nije davao bilo dulje od 16 tjedana, nisu ustanovljene.
English: Study 5 (week-14 responders)
Croatian: Ispitivanje 5 (bolesnici s odgovorom u 14. tjednu)
English: Study 3 was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Croatian: 3. Ispitivanje 3 je bilo randomizirano, multicentrično, dvostruko slijepo ispitivanje sigurnosti primjene u 3 paralelne skupine bolesnika.
English: Zessly is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Croatian: Zessly je indiciran za liječenje teškog, aktivnog ankilozantnog spondilitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju.
English: • Severe allergic reaction that may cause loss of consciousness and could be life-threatening
Croatian: • neprirodno oticanje ili bujanje tkiva • teška alergijska reakcija koja može uzrokovati gubitak svijesti i može biti opasna po život
English: This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Croatian: To uključuje multiplu sklerozu, Guillain-Barreov sindrom, epileptičke napadaje ili dijagnozu "optičkog neuritisa".
English: • You should avoid getting pregnant when you are being treated with Zessly and for 6 months after you stop being treated with it.
Croatian: • Potrebno je izbjegavati trudnoću tijekom liječenja lijekom Zessly i 6 mjeseci nakon završetka liječenja.
English: Zessly contains Sodium
Croatian: Zessly sadrži natrij
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Zessly 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 Zessly treba prekinuti te provesti temeljite pretrage i utvrditi razlog poremećaja.
English: Side effects may also occur after your treatment with Zessly has stopped.
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja lijekom Zessly.
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke: mogu se javiti u do 1 na 1000 osoba
English: 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: N/Aa
Croatian: N/Pa
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 • otežano zacjeljivanje rana
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C for 24 hours.
Croatian: Međutim, ako se otopina pripremila u sterilnim uvjetima, može se čuvati 24 sata u hladnjaku na temperaturi od 2°C do 8°C.
English: ≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Croatian: placebo infliksima b placebo infliksima b placebo infliksima b placebo infliksimab
English: Infections were reported in 31 (51.7%) of 60 treated patients in the paediatric ulcerative colitis trial and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Croatian: Infekcije su prijavljene u 31 od 60 liječenih bolesnika (51,7%) u ispitivanju ulceroznog kolitisa u pedijatrijskih bolesnika, od kojih je u njih 22 (36,7%) bila potrebna peroralna ili parenteralna antibiotska terapija.
English: If you are given too much Zessly
Croatian: Ako primite previše lijeka Zessly
English: Median follow-up (wks)4
Croatian: Medijan (interkvartilni raspon)
English: The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulas that were of at least 3 months' duration.
Croatian: Djelotvornost lijeka ispitivala se i u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju koje je uključilo 94 bolesnika s fistulirajućim oblikom Crohnove bolesti u kojih su fistule bile prisutne najmanje 3 mjeseca.
English: Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Croatian: Ponovna primjena u psorijazi Ograničeno iskustvo ponovne primjene lijeka u bolesnika s psorijazom davanjem jedne doze lijeka infliksimab nakon 20 tjedana ukazuje na smanjenu djelotvornost i povećanu incidenciju blagih do umjereno jakih reakcija vezanih uz infuziju u odnosu na one tijekom prvobitne primjene uvodnog režima liječenja (vidjeti dio 5.1).
English: In all situations described below, the benefit/risk balance of Zessly therapy should be very carefully considered.
Croatian: U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Zessly.
English: Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'.
Croatian: Zessly sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: How to store Zessly
Croatian: Kako čuvati Zessly
English: Administration of Zessly 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 lijekom Zessly i uvesti odgovarajuću antimikrobnu ili antimikotičku terapiju sve dok infekcija ne bude pod kontrolom.
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Croatian: Ti su bolesnici klasificirani kao bolesnici s odgovorom u 2. tjednu te su uključeni u primarnu analizu (vidjeti
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Croatian: Manje često: anafilaktička reakcija, sindrom sličan lupusu, serumska bolest ili reakcije nalik serumskoj bolesti
English: In a subset of 90 adult patients with rheumatoid arthritis from the study 2 a similar proportion of patients in each treatment group (methotrexateplus: placebo [n=17], 3mg/kg [n=27] or 6mg/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 2, 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: Concurrent administration of TNF-alpha inhibitor and abatacept
Croatian: Istodobna primjena inhibitora TNFα i abatacepta
English: In study 10 and study 11 in patients with active psoriatic arthritis, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Croatian: U ispitivanju 10 i ispitivanju 11 u bolesnika s aktivnim psorijatičnim artritisom klinički su odgovori primijećeni već u 2. tjednu i održali su se do 98. tjedna odnosno do 54. tjedna.Djelotvornost je potvrđena s ili bez istodobne primjene metotreksata.
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Croatian: Drugi znakovi alergijskih nuspojava koji se mogu javiti i do 12 dana nakon infuzije su bol u mišićima, vrućica, bol u zglobovima ili čeljusti,
English: Total scored (van der Heijde-modified Sharp score)
Croatian: Ukupan broj bodovad (van der Heijdeova modifikacija Sharpove bodovne skale)
English: How to use Zessly Rheumatoid arthritis
Croatian: Kako primjenjivati Zessly Reumatoidni artritis
English: b Absence of any draining fistulas.
Croatian: b Nisu prisutne fistule iz kojih se cijedi sadržaj.
English: Study 13 evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Croatian: U ispitivanju 13 ocjenjivala se djelotvornost uvodne terapije i terapije održavanja infliksimabom u 378 bolesnika s plak psorijazom.
English: If serious reactions occur, symptomatic treatment must be given and further Zessly 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 lijeka Zessly (vidjeti dio 4.8).
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re administration' below and section 4.4).
Croatian: • ponovna primjena: infuzija u dozi od 5 mg/kg ako se ponovno pojave znakovi i simptomi bolesti (vidjeti "Ponovna primjena" u daljnjem tekstu i dio 4.4).
English: Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Croatian: Ozbiljne infekcije i neutropenija zabilježene su u kliničkim ispitivanjima istodobne primjene anakinre i drugog inhibitora TNFα, etanercepta, koja nije dovela do dodatnog kliničkog poboljšanja u odnosu na primjenu samo etanercepta.
English: Intravenous use after reconstitution and dilution.
Croatian: NAČIN PRIMJENE LIJEKA Intravenska primjena nakon rekonstitucije i razrjeđivanja.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba
English: Zessly may have a minor influence on the ability to drive and use machines.
Croatian: Zessly malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Croatian: U kliničkim ispitivanjima istodobna primjena inhibitora TNFα i abatacepta bila je povezana s povećanim rizikom od razvoja infekcija, uključujući i ozbiljne infekcije, u odnosu na primjenu samo TNF-antagonista, a pritom nije došlo do povećanja kliničkog učinka.
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial and adult ulcerative colitis studies were generally consistent.
Croatian: Ukupno uzevši, nuspojave prijavljene u ispitivanjima ulceroznog kolitisa u pedijatrijskih bolesnika i odraslih općenito su bile konzistentne.
English: If these medicines do not work well enough, you will be given Zessly to treat your disease.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, za liječenje bolesti dobit ćete Zessly.
English: Sustained Steroid-Free Remissionb a
Croatian: Održana remisija bez steroidab a
English: Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Zessly therapy until a source for possible infection, specifically abscess, has been excluded (see section
Croatian: Bolesnici s fistulirajućim oblikom Crohnove bolesti s akutnim, gnojnim fistulama ne smiju započeti liječenje lijekom Zessly dok se ne otkloni izvor moguće infekcije, osobito apsces (vidjeti dio 4.3).
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6, and 14 weeks) following disease flare.
Croatian: Provedeno je kliničko ispitivanje bolesnika s umjerenom do teškom psorijazom kako bi se ocijenile djelotvornost i sigurnost dugotrajne terapije održavanja u odnosu na ponovno davanje uvodnog režima liječenja infliksimabom (najviše četiri infuzije u 0., 2., 6. i 14. tjednu) nakon ponovnog izbijanja bolesti.
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentrationtime curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Croatian: Nakon primjene infliksimaba u dozi od 5 mg/kg svakih 8 tjedana, predviđena izloženost infliksimabu u stanju dinamičke ravnoteže (područje pod krivuljom koncentracija-vrijeme u stanju dinamičke ravnoteže, AUCss) u pedijatrijskih bolesnika u dobi od 6 do 17 godina bila je približno 20% niža nego predviđena izloženost lijeku u stanju dinamičke ravnoteže u odraslih.
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Croatian: • Znakove alergijske reakcije kao što su oticanje lica, usana, usta ili grla, koje može izazvati poteškoće pri gutanju ili disanju, osip, koprivnjaču, oticanje šaka, stopala ili gležnjeva.
English: • Some patients who have received TNF-blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Croatian: • U nekih bolesnika koji su liječeni TNF-blokatorima uključujući infliksimab razvio se rijedak oblik raka zvan hepatosplenički limfom T-stanica.