FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors
Croatian: 4 napunjene štrcaljke s 1 ml otapala 4 igle od nehrđajućeg čelika za ubrizgavanje 4 nastavka za bočicu
English: Each vial of LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Croatian: Jedna bočica LIFMIORa 10 mg praška i otapala za otopinu za injekciju za pedijatrijsku primjenu sadrži 10 mg etanercepta.
English: Diagram 5
Croatian: Slika 5
English: Responses were measured using the ACR Pedi 30, defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Croatian: Odgovori su mjereni upotrebom ACR Pedi 30, definirano kao 30% poboljšanje u najmanje tri od šest i 30% pogoršanje u ne više od jednom od šest temeljnih JRA kriterija koji uključuju broj zahvaćenih zglobova, ograničenje pokreta, opću procjenu liječnika i bolesnika/roditelja, funkcionalnu procjenu i sedimentaciju eritrocita.
English: • Chickenpox: Tell your doctor if the child is exposed to chickenpox when using LIFMIOR.
Croatian: • Vodene kozice: obavijestite svojeg liječnika ako je dijete bilo izloženo vodenim kozicama za vrijeme primjene LIFMIORa.
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Croatian: Preporučena doza je 0,4 mg/kg (do najviše 25 mg po dozi) primijenjeno dva puta tjedno u obliku supkutane injekcije s razmakom između doza od 3 do 4 dana ili doza od 0,8 mg/kg (do najviše 50 mg po dozi) primijenjena jednom tjedno.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory
Croatian: Slučajevi demijelinizacije SŽS koji upućuju na multiplu sklerozu ili lokalizirana demijelinizirajuć a stanja, kao što su neuritis vidnog živca i transverzalni mijelitis (vidjeti dio 4.4), slučajevi periferne demijelinizacije, uključujući
English: Among patients with ankylosing spondylitis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Croatian: Među bolesnicima s ankilozantnim spondilitisom koji su primali LIFMIOR klinički odgovor bio je očit u trenutku prvog kontrolnog pregleda (nakon 2 tjedna), a zadržan je i tijekom trajanja terapije od 6 mjeseci.
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Croatian: sPGA “čist” ili “minimalan”, n (%) Kratice: sPGA-statička opća procjena liječnika p < 0,0001 u usporedbi s placebom
English: It is important that the vial adaptor spike completely penetrates the vial stopper.
Croatian: Važno je da šiljak nastavka za bočicu potpuno probije čep bočice.
English: The needle cover should not be removed while allowing the prefilled pen to reach room temperature.
Croatian: Pokrov za iglu se ne smije ukloniti prilikom čekanja da napunjena brizgalica dosegne sobnu temperaturu.
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).
Croatian: Ozbiljne infekcije (uključujući upalu pluća, infekciju dubokih slojeva kože, infekciju zglobova, infekciju krvi i infekcije na različitim mjestima); pogoršanje kongestivnog zatajenja srca; nizak broj crvenih krvnih stanica, nizak broj bijelih krvnih stanica, nizak broj neutrofila (vrste bijelih krvnih stanica); nizak broj krvnih pločica; rak kože (osim melanoma); ograničeno oticanje kože (angioedem); koprivnjača (izdignute mrlje crvene ili blijede kože koje često svrbe); upala oka; psorijaza (novonastala ili pogoršanje postojeće); upala krvnih žila koja zahvaća više organa; povišene vrijednosti jetrenih enzima u krvi (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost povišenih jetrenih enzima u krvi je česta).
English: Adult patients with psoriatic arthritis
Croatian: Odrasli bolesnici sa psorijatičnim artritisom
English: Study 3
Croatian: Ispitivanje 3
English: The pre-filled syringe is available in dose strengths of 25 mg and 50 mg.
Croatian: Napunjena štrcaljka dostupna je u jačinama od 25 mg i 50 mg.
English: Paediatric patients with juvenile idiopathic arthritis
Croatian: Pedijatrijski bolesnici s juvenilnim idiopatskim artritisom
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis
Croatian: Nuspojave u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom
English: Adult patients with plaque psoriasis
Croatian: Odrasli bolesnici s plak psorijazom
English: Allergic reactions associated with LIFMIOR administration have been reported commonly.
Croatian: Alergijske reakcije često su povezane s primjenom LIFMIORa.
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Croatian: LIFMIOR se pokazao znatno uspješnijim od placeba u svim pokazateljima odgovora prema kriterijima ACR kao i prema svim ostalim kriterijima aktivnosti reumatoidnog artritisa koji nisu obuhvaćeni kriterijima ACR, kao npr. jutarnja ukočenost.
English: Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Croatian: Odgovori bolesnika sa psorijatičnim artritisom u placebom kontroliranom ispitivanju Postotak bolesnika Placebo LIFMIOR
English: Immediate use is then recommended.
Croatian: Tada se preporučuje odmah primijeniti LIFMIOR.
English: Serious adverse reactions have also been reported for LIFMIOR.
Croatian: Prilikom primjene LIFMIORa također su prijavljene i ozbiljne nuspojave.
English: The safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Croatian: Sigurnost i djelotvornost 50 mg LIFMIORa (dvije s.c. injekcije od 25 mg) jednom tjedno ispitivane su u dvostruko slijepom, placebom kontroliranom ispitivanju s 420 bolesnika s aktivnim RA.
English: The MYCLIC pen contains a clear, colourless to pale yellow or pale brown, solution for injection.
Croatian: Napunjena brizgalica MYCLIC sadrži bistru, bezbojnu do blijedožutu ili blijedosmeđu otopinu za injekciju.
English: Responses of Patients with Ankylosing Spondylitis in a Placebo-Controlled Trial Percent of Patients
Croatian: Odgovori bolesnika s ankilozantnim spondilitisom u placebom kontroliranom ispitivanju Postotak bolesnika
English: Study 4
Croatian: Ispitivanje 4
English: There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with LIFMIOR from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi upalne bolesti crijeva i uveitisa u bolesnika s juvenilnim idiopatskim artritisom koji su liječeni LIFMIORom, uključujući i vrlo mali broj slučajeva ponovnog javljanja nuspojave nakon ponovne primjene lijeka (vidjeti dio 4.4).
English: Among patients with plaque psoriasis who received LIFMIOR, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Croatian: Među bolesnicima s plak psorijazom koji su primali LIFMIOR zabilježen je značajan odgovor u usporedbi s placebom već za vrijeme prvog posjeta (nakon 2 tjedna) koji se održao do kraja 24. tjedna terapije.
English: Solution for injection in pre-filled syringe
Croatian: Otopina za injekciju u napunjenoj štrcaljki
English: In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving LIFMIOR during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of openlabel extension therapy.
Croatian: U jednom ispitivanju u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom u dobi od 4 do 17 godina, 43 od 69 (62%) djece imalo je infekciju tijekom primanja LIFMIORa u toku tromjesečnog ispitivanja (prvi dio, otvoreno ispitivanje), a učestalost i težina infekcija bile su slične u 58 bolesnika koji su završili produljeno liječenje tijekom 12 mjeseci otvorenog ispitivanja.
English: • Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Croatian: • Poremećaji krvne slike: ako dijete ima bilo koji od sljedećih simptoma, odmah potražite liječnički savjet: stalno povišenu tjelesnu temperaturu, grlobolju, krvne podljeve, krvarenje ili bljedilo.
English: Radiographic Progression: Comparison of LIFMIOR vs Methotrexate in Patients with RA of <3 Years Duration
Croatian: Radiološka progresija: usporedba LIFMIORa s metotreksatom u bolesnika s RA u trajanju od <3 godine
English: 12 MYCLIC pre-filled pens 12 alcohol swabs
Croatian: 12 napunjenih brizgalica MYCLIC 12 jastučića natopljenih alkoholom
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Croatian: Djelotvornost LIFMIORa ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
English: Paediatric patients with plaque psoriasis
Croatian: Pedijatrijski bolesnici s plak psorijazom
English: • Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Croatian: • Poremećaji krvne slike: ako Vi ili dijete imate bilo koji od sljedećih simptoma, odmah potražite liječnički savjet: stalno povišenu tjelesnu temperaturu, grlobolju, krvne podljeve, krvarenje ili bljedilo.
English: Select a clean, well-lit, flat surface.
Croatian: Odaberite čistu, dobro osvijetljenu, ravnu površinu.
English: The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Croatian: Srednje vrijednosti najnižih koncentracija u serumu u stanju dinamičke ravnoteže kretale su se od 1,6 do 2,1 μg/ml u 12., 24. i 48. tjednu.
English: 4 MYCLIC pre-filled pens 4 alcohol swabs
Croatian: 4 napunjene brizgalice MYCLIC 4 jastučića natopljenih alkoholom
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section
Croatian: Upalne bolesti crijeva i uveitis u bolesnika s juvenilnim idiopatskim artritisom (JIA) Bilo je prijava pojave upalne bolesti crijeva i uveitisa u bolesnika s JIA liječenih LIFMIORom (vidjeti dio 4.8).
English: 50 mg solution for injection in pre-filled syringe EU/1/16/1165/008
Croatian: LIFMIOR 50 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1165/008
English: 48 alcohol swabs
Croatian: 48 jastučića natopljenih alkoholom
English: 25 mg solution for injection in pre-filled syringe EU/1/16/1165/005
Croatian: LIFMIOR 25 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1165/005
English: Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Croatian: Jedno pakiranje sadrži 4, 8, ili 24 jednodoznih bočica, 4, 8 ili 24 napunjenih štrcaljki koje sadrže vodu za injekcije, 4, 8 ili 24 igala, 4, 8 ili 24 nastavaka za bočicu i 8, 16 ili 48 jastučića natopljenih alkoholom.
English: In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Croatian: U četvrtom ispitivanju ocjenjivana je sigurnost primjene i djelotvornost LIFMIORa 50 mg (dvije s.c. injekcije od 25 mg) primijenjenog jednom tjedno naspram 25 mg LIFMIORa primijenjenog dva puta tjedno u dvostruko slijepom, placebom kontroliranom ispitivanju 356 bolesnika s aktivnim ankilozantnim spondilitisom.
English: DSGA b, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Croatian: Nisu rađene statističke usporedbe s placebom u 24. tjednu u ispitivanjima 2 i 4 budući da je izvorna placebo skupina počela primati LIFMIOR 25 mg dva puta tjedno ili 50 mg jednom tjedno od 13. do 24. tjedna.
English: Patients in this study received a dose of 25 mg or 50 mg LIFMIOR, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg LIFMIOR twice weekly for an additional 24 weeks.
Croatian: 2. Bolesnici su primali LIFMIOR u dozi od 25 mg ili 50 mg ili placebo dva puta tjedno kroz 12 tjedana, a nakon toga su svi bolesnici u otvorenom dijelu studije primali 25 mg LIFMIORa dva puta tjedno tijekom dodatna 24 tjedna.
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
Croatian: U kontroliranim kliničkim ispitivanjima koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) autoimunog hepatitisa bila je 0,24% (manje česta učestalost).
English: 2 MYCLIC pre-filled pens 2 alcohol swabs
Croatian: 2 napunjene brizgalice MYCLIC 2 jastučića natopljenih alkoholom
English: In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
Croatian: U dvostruko slijepim fazama kontroliranih kliničkih ispitivanja etanercepta u svim indikacijama, učestalost (kumulativna incidencija) štetnih događaja povišenih jetrenih enzima u bolesnika koji su primali etanercept bez istodobne primjene metotreksata bila je 0,54% (manje česta učestalost).
English: 4 vials of powder
Croatian: 4 bočice s praškom
English: Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Croatian: U upalnom procesu reumatoidnog artritisa dominantni citokin je čimbenik nekroze tumora (TNF).
English: 24a n = wk n = wk
Croatian: 24a n =
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Croatian: Injekciju nemojte davati na mjestu gdje je koža osjetljiva, ima modrice ili je otvrdnula.
English: 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Croatian: 50 mg otopine za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta.
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients (see below, Undesirable effects in adults).
Croatian: Općenito, štetni događaji u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom po učestalosti i obliku bili su slični onima zabilježenim u odraslih bolesnika (pogledati u nastavku Nuspojave u odraslih bolesnika).
English: *see Description of selected adverse reactions, below.
Croatian: * vidjeti niže navedeni
English: Clinical Efficacy Results at 12 Months: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration
Croatian: Rezultati kliničke djelotvornosti kroz 12 mjeseci: usporedba LIFMIORa prema metotreksatu i prema LIFMIORu u kombinaciji s metotreksatom u bolesnika s RA koji traje od 6 mjeseci do 20 godina
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with LIFMIOR.
Croatian: • Hepatitis B: obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
English: 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Croatian: 25 mg otopine za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
English: If the doctor has not given this instruction, please contact him/her.
Croatian: Obratite se liječniku ako Vam nije dao tu uputu.
English: LIFMIOR may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Croatian: LIFMIOR se može čuvati izvan hladnjaka na temperaturi do najviše 25C jednokratno do najdulje četiri tjedna poslije čega ga se ne smije staviti ponovo u hladnjak.
English: n = 90 wk 24a
Croatian: n = 90 tj.
English: Diagram 3.
Croatian: Slika 3.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with LIFMIOR.
Croatian: U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih LIFMIORom vrlo rijetko su prijavljeni slučajevi pojave karcinoma Merkelovih stanica.
English: OTHER MYCLIC Pre-filled pen
Croatian: Napunjena brizgalica MYCLIC
English: Detailed instructions on how to inject LIFMIOR are provided in section 7, “Using the MYCLIC pre-filled pen to inject LIFMIOR”.
Croatian: Detaljne upute kako ubrizgati LIFMIOR nalaze se u dijelu 7„Uporaba napunjene brizgalice MYCLIC za ubrizgavanje LIFMIORa“.
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
Croatian: Alternativno, može se primijeniti 50 mg dva puta tjedno do najviše 12 tjedana, nakon čega slijedi, ako je potrebno, liječenje dozom od 25 mg primijenjeno dva puta tjedno ili 50 mg jednom tjedno.
English: Instructions for preparing and giving an injection of LIFMIOR (See overleaf)
Croatian: Sadržaj pakiranja i druge informacije Upute za pripremu i primjenu injekcija LIFMIOR (vidjeti na poleđini)
English: The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger.
Croatian: I s iglom od nehrđajućeg čelika od 27G, gumenim pokrovom za iglu i plastičnim klipom.
English: You will be instructed by the child's doctor or his/her assistant on the technique of giving an injection and on the amount to be given to the child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Croatian: Djetetov liječnik ili medicinska sestra pokazat će Vam pravilnu tehniku davanja injekcije i količinu koja će se davati djetetu.
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Croatian: Smatra se da etanercept djeluje mehanizmom kompetitivne inhibicije vezanja TNF-a za TNFR-e na površini stanice čime inaktivira biološko djelovanje TNF-a i tako sprječava stanični odgovor posredovan TNF
English: The long-term safety and effectiveness of LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to
Croatian: Nakon gore spomenutih 48 tjedana ispitivanja dugotrajna sigurnost primjene i djelotvornost LIFMIORa u dozi 0,8 mg/kg (do 50 mg) primijenjenog jednom tjedno procijenjena je u otvorenom produžetku ispitivanja do 2 godine u kojoj je sudjelovao 181 pedijatrijski bolesnik s plak psorijazom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for LIFMIOR
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Croatian: Jedna napunjena štrcaljka sadrži 1,0 ml otopine, koja osigurava 50 mg etanercepta.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Croatian: U kontroliranim kliničkim ispitivanjima etanercepta u svim indikacijama, učestalost (kumulativna incidencija) intersticijske plućne bolesti u bolesnika koji su primali etanercept bez istodobne primjene metotreksata bila je 0,06% (rijetka učestalost).
English: INFORMATION IN BRAILLE LIFMIOR 10 mg
Croatian: LIFMIOR 10 mg
English: Paediatric population See Summary of the safety profile, above.
Croatian: Pedijatrijska populacija Vidjeti gore
English: LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe
Croatian: LIFMIOR 25 mg otopina za injekciju u napunjenoj štrcaljki LIFMIOR 50 mg otopina za injekciju u napunjenoj štrcaljki etanercept
English: With experience, you will find the angle that is most comfortable for the child. Be careful not to push the needle into the skin too slowly, or with great force.
Croatian: Pripazite da ne gurate iglu kroz kožu presporo ili prevelikom snagom.
English: Diagram 6
Croatian: Slika 6
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Croatian: U djece i adolescenata liječenih antagonistima TNF-a ne može se isključiti rizik razvoja zloćudnih bolesti.
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Croatian: • Alergijske reakcije: ako Vi ili dijete osjetite simptome alergijske reakcije kao što su stezanje u prsištu, piskanje pri disanju, omaglica ili osip, nemojte više ubrizgavati LIFMIOR i odmah se obratite svom liječniku.
English: Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Croatian: Alternativno, može se davati 50 mg dva puta tjedno 12 tjedana, nakon čega slijedi 25 mg dva puta tjedno ili 50 mg jednom tjedno.
English: Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Croatian: Jedna napunjena štrcaljka sadrži 0,5 ml otopine, koja osigurava 25 mg etanercepta.
English: Leave the white needle cap in place and wait approximately 15-30 minutes to allow the LIFMIOR solution in the pen to reach room temperature.
Croatian: Nemojte skinuti bijeli zatvarač igle i pričekajte 15 do 30 minuta da otopina LIFMIORa u brizgalici dosegne sobnu temperaturu.
English: Diagram 14
Croatian: Slika 14
English: The other ingredients in LIFMIOR are: Powder: Mannitol, sucrose and trometamol.
Croatian: Prašak: manitol, saharoza, trometamol.