FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Croatian: Djelotvornost i sigurnost infliksimaba ocjenjivale su se u dva multicentrična, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s aktivnim ankilozantnim spondilitisom (rezultat ≥ 4 prema Bath indeksu aktivnosti ankilozantnog spondilitisa [engl.
English: d p = 0.030 and <0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs.
Croatian: p = 0,030 za skupinu koja je primala dozu od 3 mg/kg i p < 0,001 za skupinu koja je primala dozu od 6 mg/kg u usporedbi s placebo + MTX.
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Croatian: Udio bolesnika kojima je sluznica zacijelila u 26. tjednu bio je značajno veći u skupini koja je primala infliksimab + AZA (43,9%, p < 0,001) i skupini koja je primala monoterapiju infliksimabom (30,1%, p = 0,023) nego u skupini koja je primala monoterapiju AZA (16,5%).
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
Croatian: • Znakove infekcije (uključujući TBC) kao što su vrućica, umor, kašalj koji može biti ustrajan, kratkoća daha, simptomi nalik gripi, gubitak tjelesne težine, noćno znojenje, proljev, rane, nakupljanje gnoja u crijevima ili oko anusa (apsces), problemi sa zubima ili osjećaj žarenja pri mokrenju.
English: • Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis).
Croatian: • Znakove poremećaja imunološkog sustava kao što su bol u zglobovima ili osip na obrazima ili rukama osjetljiv na sunce (lupus) ili kašalj, kratkoća daha, vrućica ili osip kože (sarkoidoza).
English: Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Croatian: Simptomi obuhvaćaju žutilo kože i bjeloočnica, tamnosmeđu boju mokraće, bol ili oteklinu u gornjem desnom dijelu trbuha, bol u zglobovima, osip kože ili vrućicu.
English: There are no known side effects of having too much of Inflectra.
Croatian: Nisu poznate nuspojave kod primjene prevelike količine lijeka Inflectra.
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group
Croatian: Kolektomiji je podvrgnut manji broj bolesnika koji su primali infliksimab u dozama od 5 mg/kg (28/242 ili 11, 6% [N.S.]) i 10 mg/kg (18/242 ili 7,4% [p = 0, 011]) nego onih koji su primali placebo (36/244; 14,8%).
English: Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Croatian: Inflectra je indicirana za liječenje aktivnog i progresivnog psorijatičnog artritisa u odraslih bolesnika u kojih odgovor na prethodno liječenje antireumatskim lijekovima koji modificiraju tijek bolesti nije bio odgovarajući.
English: Therefore, the combination of infliximab and anakinra is not recommended.
Croatian: Stoga se ne preporučuje kombinirana primjena infliksimaba i anakinre.
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Croatian: • Znakove smanjenog broja krvnih stanica kao što su stalna vrućica, krvarenje ili lakše stvaranje modrica, male crvene ili ljubičaste pjege nastale zbog krvarenja pod kožom ili bljedoća.
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Croatian: Tablica 10 Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50. tjednu, EXPRESS
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion from the 250-mL glass bottle or infusion bag equal to the volume of reconstituted Inflectra.
Croatian: Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s otopinom natrijevog klorida od 9 mg/ml (0,9%) za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Inflectra.
English: • Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Croatian: • Znakove srčanih problema kao što su nelagoda ili bol u prsnom košu, bol u ruci, bol u trbuhu, nedostatak zraka, tjeskoba, ošamućenost, omaglica, nesvjestica, znojenje, mučnina, povraćanje, podrhtavanje ili lupanje u prsnom košu, ubrzani ili usporeni otkucaji srca i oticanje stopala ili promjene otkucaja srca.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX
Croatian: Tablica 4 Učinci na ACRn, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu, ASPIRE
English: The required volume of the reconstituted Inflectra solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Croatian: Potrebni volumen rekonstituirane otopine lijeka Inflectra trebate razrijediti s otopinom natrijevog klorida od 9 mg/ml (0,9%) za infuziju do ukupnog volumena od 250 ml.
English: 3 mg/kg 6 mg/kg Combined
Croatian: 6 mg/kg Kombinirano
English: • Psoriasis.
Croatian: • psorijaza
English: Side effects may also occur after your treatment with Inflectra has stopped.
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja lijekom Inflectra.
English: Discontinuation of infliximab should be considered if these disorders develop.
Croatian: Ako se razviju ovakvi poremećaji, treba razmotriti prekid primjene infliksimaba.
English: In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Croatian: U oba ispitivanja bolesnici su bili randomizirani u skupine koje su primale placebo, infliksimab u dozi od 5 mg/kg ili infliksimab u dozi od 10 mg/kg i to u 0., 2., 6., 14. i 22. tjednu, a u ispitivanju ACT 1 još i u 30., 38. i 46. tjednu.
English: Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Croatian: Djelotvornost i sigurnost primjene infliksimaba ispitivane su u dva multicentrična, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s aktivnim psorijatičnim artritisom.
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p<0.001).
Croatian: U 24. tjednu, klinički odgovor ASAS 20 imalo je 15 od 78 (19%) bolesnika u skupini koja je primala placebo i 123 od 201 (61%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,001).
English: • treat active Crohn's disease,
Croatian: • liječila aktivna Crohnova bolest
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use before your baby is given any vaccine.
Croatian: Važno je obavijestiti pedijatra i druge zdravstvene radnike o Vašem primanju lijeka Inflectra prije nego što Vaše dijete primi bilo koje cjepivo.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Blood and lymphatic system disorders Common:
Croatian: Poremećaji krvi i limfnog sustava
English: Rheumatoid arthritis Crohn's disease Paediatric Crohn's disease
Croatian: Reumatoidni artritis Crohnova bolest
English: Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Croatian: Inflectra je indicirana za liječenje teške, aktivne Crohnove bolesti u djece i adolescenata u dobi između 6 i 17 godina, koji nisu odgovorili na konvencionalnu terapiju uključujući kortikosteroid, imunomodulator i primarnu nutritivnu terapiju te onih koji ne podnose takve vrste terapija ili su im one kontraindicirane.
English: In phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Croatian: U kliničkim ispitivanjima faze III reakciju vezanu uz infuziju razvilo je 18% bolesnika liječenih infliksimabom u odnosu na 5% bolesnika koji su dobivali placebo.
English: Inflectra contains sodium
Croatian: Inflectra sadrži natrij
English: • Blood problems such as anaemia or low white blood cell count
Croatian: • poremećaji krvne slike kao što je anemija ili smanjen broj bijelih krvnih stanica (leukocita)
English: What Inflectra looks like and contents of the pack Inflectra is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Croatian: Lijek Inflectra je dostupan u staklenoj bočici koja sadrži prašak za koncentrat za otopinu za infuziju.
English: Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Croatian: Simptomi obuhvaćaju vrućicu, krvarenje ili lakše stvaranje modrica, male crvene ili ljubičaste pjege nastale zbog krvarenja pod kožom ili bljedoću.
English: * including bovine tuberculosis (disseminated BCG infection), see section 4.4
Croatian: odstupanje od normalne vrijednosti faktora komplementa * uključujući goveđu tuberkulozu (diseminiranu BCG infekciju), vidjeti dio 4.4.
English: A patient who requires surgery while on infliximab should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnika kojemu je za vrijeme liječenja infliksimabom potrebna operacija nužno je pomno nadzirati kako bi se utvrdile eventualne infekcije i poduzele odgovarajuće mjere.
English: • The other ingredients are sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate and disodium phosphate dihydrate.
Croatian: • Pomoćne tvari su saharoza, polisorbat 80, natrijev dihidrogenfosfat hidrat i natrijev hidrogenfosfat dihidrat.
English: If these medicines do not work well enough, you will be given Inflectra to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete lijek Inflectra kako bi se:
English: The following side effects have been observed with Inflectra:
Croatian: Sljedeće nuspojave su opažene kod primjene lijeka Inflectra:
English: • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Croatian: • U slučaju ponovne aktivacije hepatitisa B liječnik će možda morati prekinuti liječenje i dati
English: Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: Inflectra je indicirana za liječenje umjerenog do teškog, aktivnog ulceroznog kolitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), odnosno koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p<0.001; and 20.2% vs. 6.6%, p<0.001, respectively).
Croatian: Udio bolesnika s održanim terapijskim odgovorom i održanom remisijom u 54. tjednu bio je veći u skupinama liječenima infliksimabom (zbirni podaci) nego u skupini koja je primala placebo (37,9% naspram 14,0%, p < 0,001; odnosno 20,2% naspram 6,6%, p < 0,001).
English: This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Croatian: Guillain-Barréov sindrom, epileptičke napadaje ili dijagnozu "optičkog neuritisa".
English: Inflectra should be administered intravenously.
Croatian: Inflectra se primjenjuje intravenski.
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents including infliximab.
Croatian: Nakon stavljanja u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica (engl. hepatospenic T-cell lymphoma, HSTCL) u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p <0.001).
Croatian: Četvrtog tjedna nakon primjene jednokratne doze ispitivanog lijeka klinički su odgovor postigla 22 od 27 (81%) bolesnika liječenih infliksimabom u dozi od 5 mg/kg naspram 4 od 25 (16%) bolesnika koji su primili placebo (p < 0,001).
English: At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p<0.01).
Croatian: U 12. tjednu, klinički odgovor BASDAI 50 imalo je 3 od 35 (9%) bolesnika u skupini koja je primala placebo i 20 od 35 (57%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,01).
English: • Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Inflectra.
Croatian: • Odmah obavijestite svog liječnika ako dobijete nove simptome zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Inflectra.
English: ≥ 50% improvement PGA of cleared (0) or minimal (1)
Croatian: PGA čist (0) ili minimalan (1)
English: How to store Inflectra
Croatian: Kako primjenjivati lijek Inflectra
English: If these medicines do not work well enough, you will be given Inflectra to treat your disease.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, za liječenje bolesti dobit ćete lijek Inflectra.
English: • Fungal infections such as yeast infection or fungal infection of the nails
Croatian: • gljivične infekcije kao što su infekcije uzrokovane kvascima ili gljivična infekcija noktiju
English: and headache.
Croatian: • glavobolja
English: Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Croatian: Nakon 0. tjedna bilo je dozvoljeno prekinuti primjenu imunomodulatora i postupno smanjivati dozu kortikosteroida.
English: Foaming of the solution on reconstitution may occur.
Croatian: Otopina se može zapjeniti tijekom rekonstitucije.
English: • Bruising, hot flush or nosebleed, warm, red skin (flushing)
Croatian: • modrice, napadaji vrućine ili krvarenje iz nosa, crvenilo kože (crvenilo praćeno osjećajem užarenosti)
English: Neutropenia, leukopenia, anaemia, lymphadenopathy.
Croatian: neutropenija, leukopenija, anemija, limfadenopatija
English: Please make sure you also have a list of all other medicines that you are using with you at any visit to a healthcare professional.
Croatian: Prilikom svakog posjeta liječniku obavezno ponesite popis svih drugih lijekova koje uzimate
English: Week 54 Fistula Response (%)
Croatian: Odgovor fistula (%)
English: Sustained remission(in remission at both week 8 and week 30)
Croatian: 8. i u 30. tjednu)
English: Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Croatian: Inflectra je indicirana za liječenje teškog oblika aktivnog ulceroznog kolitisa u djece i adolescenata u dobi između 6 i 17 godina koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-MP ili AZA, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Croatian: Nakon stavljanja u promet, u bolesnika koji su primali infliksimab prijavljeni su slučajevi žutice i hepatitisa, koji je u nekim slučajevima imao obilježja autoimunog hepatitisa (vidjeti dio 4.4).
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Croatian: anafilaktički šok, vaskulitis, reakcija nalik na sarkoidozu Psihijatrijski poremećaji Često:
English: It is recommended that live vaccines not be given concurrently with infliximab.
Croatian: Ne preporučuje se istodobna primjena živih cjepiva s infliksimabom.
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blocking agents including infliximab.
Croatian: Nakon stavljanja u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
English: How much Inflectra is given
Croatian: Koliko lijeka Inflectra ćete primiti
English: • Tell your doctor before you are given Inflectra if you have an infection, even if it is a very minor one.
Croatian: • Prije nego što primite lijek Inflectra, obavijestite svog liječnika ako imate neku infekciju, čak i ako je vrlo blaga.
English: N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Croatian: Poboljšanje ≥ 50%
English: Corticosteroid tapering was permitted after week 6.
Croatian: Nakon 6. tjedna bilo je dozvoljeno postupno smanjenje doze kortikosteroida.
English: Sixty-eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Croatian: Klinički odgovor postiglo je 68% bolesnika (21/31) liječenih infliksimabom u dozi od 5 mg/kg naspram 26% bolesnika (8/31) koji su primali placebo (p = 0,002).
English: Corticosteroid taper was permitted after week 8.
Croatian: Nakon 8. tjedna bilo je dozvoljeno postupno smanjenje doze kortikosteroida.
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhoea, wounds, dental problems, burning when urinating or ‘flu-like' signs.
Croatian: Ti znakovi uključuju vrućicu, umor, (uporan) kašalj, nedostatak zraka, gubitak tjelesne težine, noćno znojenje, proljev, rane, probleme sa zubima, žarenje pri mokrenju ili simptome nalik gripi.
English: Infliximab (Week 54)
Croatian: Infliksimab (54. tjedan)
English: Infliximab b
Croatian: Infliksimab
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Croatian: hipotenzija, hipertenzija, ekhimoza, navala vrućine, crvenilo praćeno osjećajem užarenosti
English: Infliximab (Week 24)
Croatian: Infliksimab (24. tjedan)
English: How Inflectra is given
Croatian: Kako se primjenjuje Inflectra
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Croatian: bol u prsištu, umor, vrućica, reakcije na mjestu injekcije, zimica, edem
English: In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab.
Croatian: Protutijela protiv infliksimaba razvila su se u 8% bolesnika s reumatoidnim artritisom koji su liječeni po preporučenom režimu ponovljene primjene s metotreksatom.
English: Infliximab (Week 16)
Croatian: Infliksimab (16. tjedan)
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate
Croatian: Pomoćne tvari: saharoza, polisorbat 80, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat.
English: After reconstitution one mL contains 10 mg of infliximab.
Croatian: Nakon rekonstitucije, jedan ml sadrži 10 mg infliksimaba.
English: a p <0.001, for each infliximab treatment group vs. control.
Croatian: 50. tjedan p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
English: Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Croatian: I s (butilnim) gumenim čepom i aluminijskim zatvaračem s plastičnom “flip-off” kapicom.
English: Patients received placebo, 3 mg/kg or 10 mg/kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter.
Croatian: Bolesnici su primali ili placebo ili infliksimab u dozi od 3 mg/kg, odnosno 10 mg/kg u 0., 2. i 6. tjednu ispitivanja, a zatim svakih 4 ili 8 tjedana.
English: Improvements in quality of life measures, a reduction in disease-related hospitalisations and corticosteroid use were seen in the infliximab maintenance groups compared with the placebo maintenance group at weeks 30 and 54.
Croatian: U odnosu na skupinu koja je primala placebo, u skupinama koje su primale infliksimab kao terapiju održavanja opaženo je poboljšanje u mjerilima kvalitete života, smanjenje hospitalizacija zbog bolesti te smanjenje primjene kortikosteroida u 30. i 54. tjednu ispitivanja.
English: Infliximab (Week 98)
Croatian: Infliksimab (98. tjedan)
English: • You may get infections more easily when you are being treated with Inflectra.
Croatian: • Tijekom liječenja lijekom Inflectra možete postati osjetljiviji na infekcije.
English: Reproductive system and breast disorders Uncommon:
Croatian: pijelonefritis Poremećaji reproduktivnog sustava i dojki Manje često:
English: Week 50
Croatian: 54. tjedan
English: (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD c)
Croatian: Heijdeova modifikacija Sharpove bodovne skale)
English: • A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
Croatian: • rijedak rak krvnih stanica koji se najčešće javlja u dječaka tinejdžera ili mlađih muškaraca
English: • Children should receive recommended vaccinations before starting Inflectra treatment.
Croatian: • Prije započinjanja liječenja lijekom Inflectra djeca trebaju primiti preporučena cjepiva.
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively).
Croatian: U skupinama liječenima infliksimabom (zbirni podaci) u 54. je tjednu zabilježen veći udio bolesnika u kliničkoj remisiji u odnosu na skupinu koja je primala placebo (34,6% naspram 16,5%, p < 0,001), kao i veći udio bolesnika u kojih je nastupilo cijeljenje sluznice (46,1% liječenih infliksimabom naspram 18,2% bolesnika koji su primali placebo, p < 0,001).
English: Patients treated with Inflectra should be given the package leaflet and the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Inflectra moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnike.
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Croatian: U djece i adolescenata koji se liječe TNF-blokatorima ne može se isključiti rizik razvoja zloćudnih bolesti.