FrancophonIA/ELRC3.0 huggingface dataset:
English: • Side effect due to an injection
Croatian: • nuspojava kao posljedica injekcije
English: Remsima 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: Remsima 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: If you are not sure, talk to your doctor before you are given Remsima.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego što primite lijek Remsima.
English: 2 Number of patients evaluated for ALT. 3 Median follow-up is based on patients treated.
Croatian: 3 Medijan praćenja temelji se na broju liječenih bolesnika.
English: Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SDc)
Croatian: Ukupan broj bodovad (van der Heijdeova modifikacija Sharpove bodovne skale)
English: In the RA patients, the mean (± standard deviation) clearance of Remsima 120 mg subcutaneously was 18.8 ± 8.3 mL/hr at steady state.
Croatian: U bolesnika s reumatoidnim artritisom, srednja vrijednost (± standardno odstupanje) klirensa lijeka Remsima od 120 mg primijenjenog supkutano bio je 18,8 ± 8,3 ml/sat u stanju dinamičke ravnoteže.
English: In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Croatian: U skupini u kojoj su bili bolesnici koji nisu odgovorili na liječenje na odgovarajući način (skupina 2, n = 329) bilo je dozvoljeno postupno povećavati dozu s 3 mg/kg na najviše 9 mg/kg u koracima od 1,5 mg/kg.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU S AUTOMATSKIM ŠTITNIKOM IGLE
English: Studies with infliximab have not been performed in patients with liver or renal disease.
Croatian: Ispitivanja infliksimaba na bolesnicima s bolestima bubrega ili jetre nisu provedena.
English: Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2 and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Croatian: 5 mg/kg ili placeba u 0., 2. i 6. tjednu, nakon čega je slijedila terapija održavanja svakih 8 tjedana koja je trajala do 22. tjedna u placebo skupini, odnosno do 46. tjedna u skupini koja je primala infliksimab.
English: Keep the medicinal product in its outer carton in order to protect from light.
Croatian: Lijek čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
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: 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: If these medicines do not work well enough, you will be given Remsima to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete lijek Remsima kako bi se:
English: Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Croatian: Remsima 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: Infliximab has been associated with systemic injection reactions, anaphylactic shock and delayed hypersensitivity reactions (see section 4.8).
Croatian: Primjena infliksimaba povezana je sa sistemskim reakcijama na injekciju, anafilaktičkim šokom te reakcijama kasne preosjetljivosti (vidjeti dio 4.8).
English: (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Croatian: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko ≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.
Croatian: Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki (staklo tip I) za jednokratnu primjenu s čepom klipa (elastomer presvučen flurotekom) i iglom s čvrstim štitnikom igle.
English: • Children should receive recommended vaccinations before starting Remsima treatment.
Croatian: • Prije započinjanja liječenja lijekom Remsima djeca trebaju primiti preporučena cjepiva.
English: Crohn's disease2
Croatian: Crohnova bolest2
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial (C0168T72) and adult ulcerative colitis (ACT 1 and ACT 2) studies were generally consistent.
Croatian: (C0168T72) i odraslih (ACT 1 i ACT 2) općenito su bile konzistentne.
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Croatian: Sigurnost i djelotvornost infliksimaba nisu ispitivani u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remsima therapy.
Croatian: Preporučuje se da, ako je to moguće, prije početka liječenja lijekom Remsima bolesnici prime sva cjepiva u skladu s važećim smjernicama za cijepljenje.
English: PGA of cleared (0) or minimal (1)
Croatian: Poboljšanje ≥ 50% PGA čist (0) ili minimalan (1)
English: Table 2 Proportion of patients with increased ALT activity in clinical studies using intravenous infliximab
Croatian: Udio bolesnika s povišenom aktivnošću ALT-a u kliničkim ispitivanjima s intravenskim imfliksimabom
English: e
Croatian: I
English: Name doctor:
Croatian: Ime bolesnika: Ime liječnika:
English: Signs include shortness of breath or swelling of your feet.
Croatian: Znakovi obuhvaćaju nedostatak zraka ili oticanje stopala.
English: 1 pre-filled syringe with 2 alcohol pads 1 pre-filled syringe with needle guard with 2 alcohol pads 2 pre-filled syringes with 2 alcohol pads 2 pre-filled syringes with needle guard with 2 alcohol pads 4 pre-filled syringes with 4 alcohol pads 4 pre-filled syringes with needle guard with 4 alcohol pads
Croatian: 1 napunjena štrcaljka s 2 jastučića natopljena alkoholom 1 napunjena štrcaljka sa štitnikom igle s 2 jastučića natopljena alkoholom 2 napunjene štrcaljke s 2 jastučića natopljena alkoholom 2 napunjene štrcaljke sa štitnikom igle s 2 jastučića natopljena alkoholom 4 napunjene štrcaljke s 4 jastučića natopljena alkoholom 4 napunjene štrcaljke sa štitnikom igle s 4 jastučića natopljena alkoholom
English: 1 hour.
Croatian: tjedna.
English: If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered (see section 4.8).
Croatian: Ako se pojave ozbiljne reakcije, mora se primijeniti simptomatska terapija i više se ne smije davati infliksimab (vidjeti dio 4.8).
English: • Tell your doctor straight away if you develop symptoms of lupus during treatment with Remsima.
Croatian: • Odmah obavijestite Vašeg liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Remsima.
English: Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and in the case of intravenously administered infliximab, a reduction in the frequency of infusion reactions.
Croatian: Istodobna primjena imunomodulatora povezana je s nižom incidencijom protutijela na infliksimab i kod slučajeva intravenske primjene infliksimaba, smanjenom učestalošću reakcija vezanih uz infuziju.
English: Remsima 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: Remsima 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: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Croatian: Do sada dostupni podaci opisani su u dijelu 5.2, ali ne mogu se dati preporuke za doziranje.
English: Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions when administered by intravenous infusion.
Croatian: Mogu se razviti protutijela na infliksimab koja su povezana s povećanom učestalošću reakcija vezanih uz infuziju kad se infuzija daje intravenski.
English: Clinical Responsea
Croatian: Klinički odgovora Klinička remisija
English: Although subcutaneous administration is not indicated for children under age of 18 years, it should be noted that malignancies, some fatal, have been reported among children, adolescents and young adults
Croatian: Iako supkutana primjena nije indicirana u djece mlađe od 18 godina, potrebno je imati na umu da su zloćudne bolesti, neke sa smrtnim ishodom, prijavljene u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
English: Consult your healthcare provider if you have questions about using the Remsima syringe.
Croatian: Obratite se svom liječniku ako imate pitanja u vezi primjene Remsima štrcaljke.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors,
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Imunosupresivi, inhibitori faktora nekroze tumora alfa (TNFα), ATK
English: Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Croatian: Znakovi obuhvaćaju ustrajan kašalj, gubitak tjelesne težine, umor, vrućicu, noćno znojenje.
English: Tel.: + 48 22 417 9200 recepcja@egis.pl
Croatian: EGIS Polska Dystrybucja Sp. z o.o. Tel.: + 48 22 417 9200 recepcja@egis.pl
English: Rheumatoid arthritis1 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Croatian: Reumatoid ni artritis1 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
English: In rheumatoid arthritis patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Croatian: Ima naznaka da istodobna primjena metotreksata i drugih imunomodulatora u bolesnika s reumatoidnim artritisom, smanjuje stvaranje protutijela protiv infliksimaba i povećava koncentraciju infliksimaba u plazmi.
English: Cyanosis, pericardial effusion
Croatian: cijanoza, perikardijalni izljev
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%
English: At week 16, 47 placebo patients with <10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Croatian: 47 bolesnika koji su primali placebo i u odnosu na početno stanje imali < 10% poboljšanja s obzirom na broj otečenih i bolnih zglobova prebačeno na uvodnu terapiju infliksimabom (rani bijeg).
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte s Vašim liječnikom, ljekarnikom ili medicinskom sestrom prije nego primite lijek Remsima.
English: a. Select an injection site.
Croatian: Izaberite mjesto primjene injekcije.
English: If these medicines do not work well enough, you will be given Remsima to treat your disease.
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, za liječenje bolesti dobit ćete lijek Remsima.
English: Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Croatian: Liječenje lijekom Remsima uvodi se i provodi pod nadzorom liječnika specijaliste s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, upalnih bolesti crijeva, ankilozantnog spondilitisa,
English: Patients with a PGA score ≥3 were eligible to receive an additional infusion of the same treatment at week 26.
Croatian: Physician Global Assessment, PGA) imali ≥ 3 boda, zadovoljili su kriterije da još jednom prime istu infuziju u 26. tjednu.
English: Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment.
Croatian: Lokalizirane reakcije na mjestu injekcije su pretežno blagog do umjerenog oblika, uključujući sljedeće reakcije ograničene na mjesto injekcije: eritem, bol, svrbež, oticanje, induracija, hematom, edem, modrice, osjećaj hladnoće, nadraženost, parestezija, čir, urtikarija, krvarenje, osip i krasta prijavljeni su kao povezani sa supkutanim liječenjem infliksimabom.
English: Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Croatian: Dopuštala se istodobna primjena ustaljenih doza peroralnih kortikosteroida (≤ 10 mg/dan) i/ili nesteroidnih protuupalnih lijekova, a davala se i nadomjesna terapija folatima.
English: In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Croatian: Crohnova bolest u pedijatrijskih bolesnika (6 do 17 godina) U kliničkom ispitivanju REACH, 112 bolesnika (raspon dobi: 6-17 godina, medijan 13 godina) s umjerenom do teškom, aktivnom Crohnovom bolešću (srednji pedijatrijski CDAI bio je 40) i neodgovarajućim odgovorom na konvencionalnu terapiju primilo je infliksimab u dozi od 5 mg/kg u
English: Percentage ACR improvement
Croatian: Broj randomiziranih ispitanika Postotak poboljšanja ACR odgovora
English: b. Remove the syringe from the carton stored in your refrigerator by holding the middle of the syringe body.
Croatian: Štrcaljku izvadite iz kutije držeći za sredinu tijela štrcaljke.
English: The required volume of the reconstituted Remsima solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Croatian: Potrebni volumen rekonstituirane otopine lijeka Remsima trebate razrijediti s otopinom natrijevog klorida od 9 mg/ml (0,9%) za infuziju do ukupnog volumena od 250 ml.
English: No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation.
Croatian: U kliničkim ispitivanjima s intravenskim formulacijama infliksimaba nisu opažene veće dobno uvjetovane razlike u klirensu i volumenu distribucije lijeka, a isto se očekuje i za supkutane formulacije.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12).
Croatian: Psoriasis Area and Severity Index [PASI] ≥ 12).
English: Start the injection (see Figure F).
Croatian: Započnite ubrizgavanje (vidjeti Sliku F).
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 Remsima.
Croatian: Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Remsima.
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: 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: Package leaflet: Information for the user Remsima 100 mg powder for concentrate for solution for infusion infliximab
Croatian: Uputa o lijeku: Informacije za korisnika Remsima 100 mg prašak za koncentrat za otopinu za infuziju
English: Do not use the pen if:
Croatian: Nemojte primijeniti brizgalicu:
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: 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: Powder for concentrate for solution for infusion (powder for concentrate) The powder is white.
Croatian: Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
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 (HSTCL, engl. hepatosplenic T-cell lymphoma) u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
English: Infliximab (Week 54)
Croatian: Infliksima b (54. tjedan
English: Clinical Remission
Croatian: KLINIČKI PODACI
English: • Cancer
Croatian: • rak
English: Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab on the skin of the injection site.
Croatian: Znakovi lokalne reakcije na mjestu injekcije mogu uključiti crvenilo, bol, svrbež, oticanje, otvrdnuće, krvarenje, modrice, osjećaj hladnoće, nadraženost, trnce, čir, koprivnjaču, osip i krastu na koži na mjestu injekcije.
English: EU/1/13/853/006 1 pre-filled syringe EU/1/13/853/009 1 pre-filled syringe with automatic needle guard EU/1/13/853/007 2 pre-filled syringes EU/1/13/853/010 2 pre-filled syringes with automatic needle guard EU/1/13/853/008 4 pre-filled syringes EU/1/13/853/011 4 pre-filled syringes with automatic needle guard
Croatian: EU/1/13/853/006 1 napunjena štrcaljka EU/1/13/853/009 1 napunjena štrcaljka s automatskim štitnikom igle EU/1/13/853/007 2 napunjene štrcaljke EU/1/13/853/010 2 napunjene štrcaljke s automatskim štitnikom igle EU/1/13/853/008 4 napunjene štrcaljke EU/1/13/853/011 4 napunjene štrcaljke s automatskim štitnikom igle
English: Tel: + 421 2 3240 9422 info@egis.sk
Croatian: Egis Slovakia spol.s r.o. Tel: + 421 2 3240 9422 info@egis.sk
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: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Croatian: (primarno palmarnu i plantarnu), urtikarija, osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis, ekcem, alopecija
English: Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Croatian: Staklena bočica (staklo tip 1) s gumenim čepom i aluminijskim prstenom zaštićenim plastičnim zatvaračem.
English: Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only.
Croatian: Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki ili napunjenoj brizgalici primjenjuju se samo kao supkutane injekcije.
English: • Signs of an immune system disorder called lupus 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, nedostatak zraka, vrućica ili kožni osip
English: The pharmacokinetics of infliximab injected via subcutaneous route in elderly patients has not been studied.
Croatian: Farmakokinetika infliksimaba injektiranog supkutano u starijih bolesnika nije ispitivana.
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: ACCENT II, primili su inicijalnu dozu infliksimaba od 5 mg/kg na početku ispitivanja, dok su u fazi održavanja primali placebo.
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
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Croatian: Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50. tjednu, EXPRESS
English: How much Remsima is given
Croatian: Koliko lijeka Remsima ćete primiti
English: • Some patients receiving infliximab have developed serious liver problems.
Croatian: • U nekih bolesnika koji primaju infliksimab razvile su se ozbilljne jetrene tegobe.
English: Infliximab Placebo 5 mg/kg 10 mg/kg Combined
Croatian: Placebo + MTX 3 mg/kg 6 mg/kg Kombinirano
English: a. Clean the injection site with an alcohol swab.
Croatian: Očistite mjesto primjene jastučićem natopljenom alkoholom.
English: When starting a new card, please keep this card as a reference for 4 months after your last dose of Remsima.
Croatian: Kada dobijete novu karticu, nastavite čuvati ovu karticu za potrebe provjere još 4 mjeseca nakon posljednje doze lijeka Remsima.
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima.
Croatian: Odmah obavijestite svog liječnika ako dobijete nove znakove zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Remsima.