FrancophonIA/ELRC3.0 huggingface dataset:
English: Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months.
Croatian: Također je primijećena značajna prednost etanercepta u kombinaciji s metotreksatom u usporedbi s etanerceptom kao monoterapijom i metotreksatom kao monoterapijom nakon 24 mjeseca.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, ”Instructions for use”.
Croatian: Iscrpne upute za primjenu dane su u uputi o lijeku, u dijelu 7, “Upute za primjenu".
English: Keep the pre-filled syringes or pens in the outer carton in order to protect from light.
Croatian: Napunjene štrcaljke i brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: However, your doctor may determine an alternative frequency at which to inject Benepali.
Croatian: Međutim, liječnik može odrediti drukčiju učestalost primjene Benepalija.
English: Baseline Week 52
Croatian: Početna ocjena 52. tjedan
English: Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of
Croatian: Bolesnici koji su u tom trenutku primali metotreksat (stabilni ≥ 2mjeseca) mogli su nastaviti s njegovom primjenom u stalnoj dozi od ≤ 25 mg tjedno.
English: Etanercept 0.8 mg/kg Once Weekly (N = 106)
Croatian: Ishodi plak psorijaze dječje dobi nakon 12 tjedana Etanercept 0,8 mg/kg jednom tjedno (N = 106)
English: In study 1, the etanercept-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001).
Croatian: U ispitivanju 1 skupina liječena etanerceptom imala je nakon 12 tjedana značajno veći udio bolesnika s odgovorom PASI 75 (30%) u usporedbi sa skupinom koja je primala placebo (2%) (p < 0,0001).
English: Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept.
Croatian: U bolesnika liječenih etanerceptom opisani su slučajevi aktivne tuberkuloze, uključujući milijarnu tuberkulozu i tuberkulozu na ekstrapulmonalnim lokacijama.
English: Step 2:
Croatian: Korak 2:
English: Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Croatian: Bolesnicima tjelesne težine od 62,5 kg ili veće može se dati fiksna doza iz napunjene štrcaljke ili napunjene brizgalice.
English: Step 4:
Croatian: Korak 4:
English: Dispose of the empty pen in an approved sharps container.
Croatian: Praznu brizgalicu odložite u spremnik za odlaganje oštrih predmeta.
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Water for injections
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari saharoza natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat voda za injekcije
English: Remissionc
Croatian: Remisijac
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study.
Croatian: Djelotvornost etanercepta ispitivana je u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 50 mg/1 ml
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon); opportunistic infections (infections that occur because of a weakened immune system); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Croatian: Ozbiljne alergijske reakcije (uključujući izraženo lokalizirano oticanje kože i piskanje pri disanju); limfomi (vrsta raka krvi); leukemija (rak koji zahvaća krv i koštanu srž); melanom (vrsta raka kože); istovremeno smanjenje broja krvnih pločica, crvenih i bijeli krvnih stanica; poremećaji živčanog sustava (s jakom mišićnom slabošću i znakovima i simptomima sličnim onima u multiploj sklerozi ili upala vidnog živca ili leđne moždine); tuberkuloza; novi nastupi kongestivno zatajenje srca; napadaji; lupus ili sindrom sličan lupusu (simptomi mogu uključivati osip produženog trajanja, vrućicu, bol u zglobovima i umor); osip kože koji može dovesti do teške pojave mjehura i ljuštenja kože; upala jetre izazvana reakcijom vlastitog imunološkog sustava (autoimuni hepatitis; u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost je manje česta); poremećaji imunološkog sustava koji mogu zahvatiti pluća, kožu i limfne čvorove (sarkoidoza); upala ili ožiljkasto zacjeljivanje pluća (u bolesnika koji ujedno primaju i terapiju metotreksatom učestalost upale ili ožiljkastog zacjeljivanja pluća je manje česta); oportunističke infekcije (infekcije koje nastaju zbog oslabljenog imunološkog sustava); Lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici.
English: There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with etanercept 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 etanerceptom, uključujući i vrlo mali broj slučajeva ponovnog javljanja nuspojave nakon ponovne primjene lijeka (vidjeti dio 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS OF 8 AND 24 (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE OD 8 ILI 24 (S PLAVIM OKVIROM)
English: Rotate the site for each injection.
Croatian: Sa svakom injekcijom mijenjajte mjesto injekcije.
English: Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept.
Croatian: U bolesnika liječenih etanerceptom prijavljeni su rijetki slučajevi pancitopenije i vrlo rijetki slučajevi aplastične anemije, ponekad sa smrtnim ishodom.
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (see section 4.8).
Croatian: Pri primjeni etanercepta primijećeni su slučajevi teških infekcija, sepse, tuberkuloze i oportunističkih infekcija, uključujući i invazivne gljivične infekcije, listeriozu i legionelozu (vidjeti dio 4.8).
English: The dose should be 25 mg twice weekly or 50 mg once weekly.
Croatian: Primijenjena doza mora biti 25 mg dvaput tjedno ili 50 mg jednom tjedno.
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.
Croatian: Općenito, štetni događaji u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom po učestalosti i obliku bili su slični onima zabilježenim u odraslih bolesnika.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg × hr/l vs. 316 mg × hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively.
Croatian: Profili srednje vrijednosti koncentracije u serumu u stanju dinamičke ravnoteže u bolesnika liječenih zbog RA kod primjene etanercepta u dozi od 50 mg jednom tjedno (n = 21) naspram primjene etanercepta u dozi od 25 mg dva puta tjedno (n = 16) iznosili su Cmax od 2,4 mg/l naspram 2,6 mg/l, Cmin od 1,2 mg/l naspram 1,4 mg/l, a djelomični AUC od 297 mg × h/l naspram 316 mg × h/l.
English: Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Croatian: Zabilježeni patogeni mikroorganizmi uključuju bakterije, mikobakterije (uključujući tuberkulozu), viruse i gljivice.
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks containing 8 (2 packs of 4) pre-filled syringes and multipacks containing 24 (6 packs of 4) pre-filled syringes.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene štrcaljke, višestrukom pakiranju koje sadrži 8 (2 pakiranja od 4) napunjenih štrcaljki i višestrukom pakiranju koje sadrži 24 (6 pakiranja od 4) napunjene štrcaljke.
English: Check the expiry date on the pre-filled syringe label.
Croatian: Pregledajte napunjenu brizgalicu: Provjerite datum roka valjanosti na naljepnici napunjene brizgalice.
English: • Material to remind healthcare professionals that Benepali is not for use in children and adolescents who weigh less than 62.5 kg
Croatian: • Podsjetnik za zdravstvenog djelatnika da Benepali nije namijenjen za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg.
English: JSN
Croatian: SN
English: (Scoreb) Baseline (Scoreb) Week 52
Croatian: (Rezultatb) Početni bodovi (Rezultatb) 52.
English: Inflammatory bowel disease
Croatian: Upalne bolesti crijeva
English: • Do not throw the sharps container in household bin.
Croatian: • Spremnik za odlaganje oštrih predmeta nemojte zbrinjavati s kućnim otpadom.
English: Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months.
Croatian: Primjenjivale su se doze od 10 mg ili 25 mg etanercepta, supkutano, dva puta tjedno tijekom najduže 24 mjeseca.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept.
Croatian: U razdoblju nakon stavljanja lijeka u promet u bolesnika liječenih etanerceptom vrlo su rijetko prijavljeni slučajevi pojave karcinoma Merkelovih stanica.
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 etanercept (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 etanerceptom (vidjeti dio 4.8).
English: The pen contains a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Croatian: Brizgalica sadrži bistru do blago opalescentnu, bezbojnu ili svijetložutu otopinu za injekciju
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Croatian: Djelotvornost etanercepta ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
English: Pre-filled pen containing a pre-filled syringe of Benepali.
Croatian: Napunjena brizgalica sadrži napunjenu štrcaljku lijeka Benepali.
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
Croatian: • Hepatitis B: Obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
English: Among patients with ankylosing spondylitis who received etanercept, 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 etanercept, klinički odgovor bio je očit u trenutku prvog kontrolnog pregleda (nakon 2 tjedna), a zadržan je i tijekom trajanja terapije od 6 mjeseci.
English: • Do not reuse the Benepali pre-filled syringe.
Croatian: • Benepali napunjene štrcaljke nemojte ponovno koristiti.
English: Step 7:
Croatian: Korak 7:
English: Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections and Legionella)*
Croatian: (uključujući invazivne gljivične, protozoalne,bakt erijske, atipične mikobakterijske, virusne infekcije i Legionellu)*
English: Remove one pre-filled pen from the carton that is stored in the refrigerator and leave at room temperature for at least 30 minutes before injecting.
Croatian: Omogućite da lijek postigne sobnu temperaturu: Izvadite jednu napunjenu brizgalicu iz kutije koja se čuva u hladnjaku i prije davanja injekcije ostavite je najmanje 30 minuta na sobnoj temperaturi.
English: • Uncommon (may affect up to 1 in 100 people):
Croatian: • Manje često (mogu se javiti u do 1 na 100 osoba):
English: The recommended dose of etanercept is 50 mg administered once weekly.
Croatian: Preporučena doza etanercepta je 50 mg primijenjeno jednom tjedno.
English: Step 3:
Croatian: Korak 3:
English: The Benepali pre-filled syringe is for a subcutaneous injection.
Croatian: Napunjena štrcaljka lijeka Benepali namijenjena je za potkožnu (supkutanu) injekciju.
English: distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis like ankylosis.
Croatian: Bolesnici su bili u dobi od 18 do 70 godina te su imali aktivni psorijatični artritis (≥ 3 otečena zgloba i ≥ 3 bolna zgloba) u najmanje jednom od sljedećih oblika: (1) zahvaćenost distalnih interfalangealnih prostora (DIP), (2) poliartikularni artritis (izostanak reumatoidnih čvorića te prisutnost psorijaze), (3) artritis mutilans, (4) asimetrični psorijatični artritis ili (5) spondilitisu slična ankiloza.
English: Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Croatian: Odgovori su bili slični kod bolesnika bez obzira na to jesu li na početku istodobno primali neku drugu terapiju.
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); Abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems.
Croatian: Ozbiljne infekcije (uključujući upalu pluća, infekciju dubokih slojeva kože, infekciju zglobova, infekciju krvi i infekcije na različitim mjestima); pogoršanje kongestivnog zatajenja srca; smanjenje broja crvenih krvnih stanica; smanjenje broja bijelih krvnih stanica; smanjen broj neutrofila (vrsta 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 je česta); grčevi i bol u trbuhu, proljev, gubitak težine ili krv u stolici (znakovi problema s crijevima).
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, and paleness) whilst on Benepali, they should seek immediate medical advice.
Croatian: Sve bolesnike i roditelje/staratelje treba savjetovati da hitno zatraže savjet liječnika ako u tijeku liječenja Benepalijem bolesnik razvije bilo kakve znakove i simptome koji upućuju na krvne diskrazije ili infekcije (npr. perzistirajuća povišena temperatura, upala grla, modrice, krvarenja i bljedilo).
English: Among patients with plaque psoriasis who received etanercept, 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 etanercept 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: Patients treated with Benepali should be given the Patient Alert Card. Benepali is available in strengths of 25 and 50 mg.
Croatian: Benepali je dostupan u jačinama od 25 i 50 mg.
English: Icepharma hf. Sími: + 354 800 9836
Croatian: Sími: + 354 800 9836
English: • A new Benepali pre-filled pen o Do not shake the pre-filled pen.
Croatian: • Novu napunjenu štrcaljku Benepalija o Napunjenu štrcaljku nemojte tresti.
English: Serious adverse reactions have also been reported for etanercept.
Croatian: Prilikom primjene etanercepta također su prijavljene i ozbiljne nuspojave.
English: Dispose of the entire syringe in an approved sharps container.
Croatian: Cijelu štrcaljku odložite u spremnik za odlaganje oštrih predmeta.
English: 50 mg/1 ml
Croatian: 50 mg 1 x tj.
English: ACR Responsesa
Croatian: ACR odgovoria ACR 20
English: Solution for injection Multipack: 12 (3 packs of 4) pre-filled pens
Croatian: Višestruko pakiranje: 12 (3 pakiranja po 4) napunjene brizgalice
English: Step 6:
Croatian: Korak 6:
English: Gently pinch a fold of skin at the cleaned injection site.
Croatian: Nježno uhvatite nabor očišćene kože na mjestu injekcije.
English: Tel.: + 48 22 116 86 94
Croatian: Biogen Poland Sp. z o.o. Tel.: + 48 22 116 86 94
English: Component of a multipack, cannot be sold separately.
Croatian: Ne može se prodavati odvojeno.
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal antiinflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Croatian: Bolesnici su ostali na stabilnoj dozi jednog nesteroidnog protuupalnog lijeka i/ili prednizona (< 0,2 mg/kg/na dan ili maksimalno 10 mg).
English: Doses of 10 mg or 25 mg etanercept or placebo were administered subcutaneously twice a week for 6 consecutive months.
Croatian: Supkutano su primijenjene doze etanercepta od 10 mg ili 25 mg ili placebo, dva puta tjedno, tijekom šest uzastopnih mjeseci.
English: 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Croatian: 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mg etanercepta.
English: Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 50 mg once a week.
Croatian: Alternativno, može se davati 50 mg dva puta tjedno do najviše 12 tjedana nakon čega slijedi 50 mg jednom tjedno.
English: PASI 50 14 58* 70 74* 77 9
Croatian: 24a PASI 50 14 58*
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 do najviše 12 tjedana nakon čega slijedi 25 mg dvaput tjedno ili 50 mg jednom tjedno.
English: By looking though the inspection window, the solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.
Croatian: Kad se pogleda kroz kontrolni prozorčić otopina treba biti bistra do blago opalescentna, bezbojna ili svijetložuta i može sadržavati male prozirne ili bijele čestice proteina.
English: 25 mg BIW 50 mg BIW
Croatian: 25 mg 2 x tj. 50 mg 2 x tj.
English: The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly.
Croatian: Preporučena doza etanercepta je 25 mg primijenjeno dvaput tjedno ili 50 mg primjenjeno jednom tjedno.
English: Caution should be exercised in patients being treated with Benepali who have a previous history of blood dyscrasias.
Croatian: Pri liječenju Benepalijem potreban je oprez u bolesnika u kojih u anamnezi postoji pojava krvnih diskrazija.
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
Croatian: EnzymeLinked Immunosorbent Assay) kojim se mogu otkriti i ishodišni spoj i razgradni produkti na koje je osjetljiv ELISA test.
English: • Benepali is not for use in children and adolescents who weigh less than 62.5 kg.
Croatian: • Benepali nije namijenjen za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg.
English: CNS demyelinating cases suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Croatian: Slučajevi demijelinizacije SŽS koji upućuju na multiplu sklerozu ili lokalizirana demijelinizirajuć a stanja kao što je neuritis vidnog živca i transverzni mijelitis (vidjeti dio 4.4), slučajevi periferne demijelinizacije, uključujući
English: 50 mg solution for injection in pre-filled pen Each pre-filled pen contains 50 mg of etanercept.
Croatian: 50 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica sadrži 50 mg etanercepta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED PENS) (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE OD 12 (3 PAKIRANJA PO 4 NAPUNJENE BRIZGALICE) (S PLAVIM OKVIROM)
English: Solution for injection Multipack: 12 (3 packs of 4) pre-filled syringes
Croatian: Višestruko pakiranje: 12 (3 pakiranja po 4) napunjenih štrcaljki
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 a dose of 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 dvaput tjedno ili dozom od 50 mg primijenjeno jednom tjedno.
English: Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Croatian: Klinički odgovori među bolesnicima s aksijalnom spondiloatrtitisom bez radiografskog dokaza koji su primali etanercept bili su uočljivi u vrijeme prvog posjeta (2 tjedna) i održani su kroz 2 godine liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED SYRINGES) (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUKUTIJA UNUTAR VIŠESTRUKOG PAKIRANJA (4 NAPUNJENE ŠTRCALJKE) (BEZ PLAVOG OKVIRA)