natgillin/translations-raw huggingface dataset:
*Some patients did not provide complete data for each endpoint **ASAS = Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0.001, b:< 0.01 and c:< 0.05, respectively between etanercept and placebo 
*** Indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa a: p < 0,001, b: < 0,01 oziroma c: < 0,05 med etanerceptom in placebom
A new and unused Erelzi SensoReady pen. 
V škatli najdete: nov in neuporabljen injekcijski peresnik SensoReady z zdravilom Erelzi.
Antibodies to etanercept have been detected in the sera of some subjects treated with etanercept. 
Protitelesa proti etanerceptu V serumu nekaterih bolnikov, zdravljenih z etanerceptom, so odkrili protitelesa proti etanerceptu.
EU/1/17/1195/009 1 pre-filled SensoReady pen EU/1/17/1195/010 2 pre-filled SensoReady pens EU/1/17/1195/011 4 pre-filled SensoReady pens 
EU/1/17/1195/009 1 napolnjen injekcijski peresnik SensoReady EU/1/17/1195/010 2 napolnjena injekcijska peresnika SensoReady EU/1/17/1195/011 4 napolnjeni injekcijski peresniki SensoReady
Dispose of the used syringe in a sharps container (closable, puncture-resistant container). 
Uporabljeno injekcijsko brizgo odvrzite v zbiralnik za ostre predmete (ki ga je mogoče zapreti in je narejen iz materiala, ki ga ni mogoče prebosti).
• Instruction to immediately seek for medical attention after detection of symptoms suggestive for infection 
• navedba, da zdravljenje z zdravilom Erelzi ni primerno za bolnike z okužbami; • napotek, da je treba ob simptomih, ki nakazujejo na okužbo, takoj poiskati zdravniško pomoč;
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). 
• Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih); poslabšanje kongestivnega srčnega popuščanja; nizko število rdečih krvnih celic, nizko število belih krvnih celic, nizko število nevtrofilcev (vrste belih krvnih celic); nizko število krvnih ploščic; kožni rak (razen melanoma); lokalizirano otekanje kože (angioedem); koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo); očesno vnetje; luskavica (na novo nastala ali poslabšanje obstoječe); vnetje krvnih žil, ki negativno vpliva na več organov; zvečane vrednosti jetrnih encimov pri krvnih preiskavah (pri bolnikih, ki sočasno prejemajo metotreksat, so zvečane vrednosti jetrnih encimov pri krvnih preiskavah pogoste); krči in bolečinav trebuhu, driska, izguba telesne mase ali kri v blatu (znaki težav s črevesjem).
• Sharps disposal container 
• zbiralnik za ostre predmete
What you need for your injection: Included in the carton: 
Kaj potrebujete pri injiciranju:
The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established. 
(DMARD - Disease-Modifying AntiRheumatic Drugs) ni bila ugotovljena.
Take the syringe out of the blister. 
Injekcijsko brizgo vzemite iz pretisnega omota.
Baseline scoreb Week 52 scoreb 
ocena v izhodiščub ocena po 52 tednihb
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. 
Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom Erelzi priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Erelzi bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
Erelzi 25 mg solution for injection in pre-filled syringe EU/1/17/1195/001 
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/17/1195/001
Important safety checks before you inject: 
Kaj je treba preveriti pred injiciranjem:
Erelzi 50 mg solution for injection in pre-filled syringe EU/1/17/1195/005 
Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/17/1195/005
Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, 
Hudi neželeni učinki, o katerih so poročali, so bili: norice z znaki in simptomi aseptičnega meningitisa, ki je izzvenel brez posledic (glejte tudi poglavje 4.4),
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. 
Med bolniki z ankilozirajočim spondilitisom, ki so prejemali etanercept, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev zdravljenja.
• Request to keep the Patient Alert Card during and after treatment 
• napotek, naj bolnik med zdravljenjem in po njem hrani opozorilno kartico za bolnika pri sebi;
Some patients receiving Erelzi have developed skin cancers. 
Pri nekaterih bolnikih, ki so prejemali zdravilo Erelzi, se je pojavil kožni rak. Povejte zdravniku,
Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady pen). 
Zdravilo Erelzi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Erelzi je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo, vloženi v peresnik trikotne oblike s prozornim okencem in nalepko (injekcijski peresnik SensoReady).
Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. 
Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta (etanerceptum).
At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n = 153) and 1.40 the spine (n = 154). 
znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
By looking through the viewing window, the solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein. 
Ko pogledate skozi pregledno okence, mora biti raztopina bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta in lahko vsebuje majhne prosojne ali bele delce beljakovine.
• 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 Erelzi. 
• Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
Instructions for use of the Erelzi pre-filled syringe Read ALL the way through these instructions before injecting. 
Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga Pred injiciranjem preberite ta navodila V CELOTI: Te informacije so na voljo tudi na www.erelzi.eu in s spodnjo kodo.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients. 
V kliničnih študijah z etanerceptom, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o skupno 2 primerih malignega obolenja.
In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients. 
Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom Na splošno so bili neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom po vrsti in pogostnosti podobni tistim pri odraslih.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. 
Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor.
Women using Erelzi should not breast-feed, since Erelzi passes into human breast milk. 
Zdravilo Erelzi prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom Erelzi ne smejo dojiti.
25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. 
Odmerki 10 mg ali 25 mg etanercepta so bili dani subkutano (s.c.) 2-krat tedensko do 24 mesecev.
Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Erelzi in patients who have congestive heart failure (CHF). 
Zdravniki morajo biti previdni, kadar predpišejo zdravilo Erelzi bolnikom s kongestivnim srčnim popuščanjem (KSP).
2.3 †, ϕ 
-0,23 †,φ
After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the pen to reach room temperature. 
Ko napolnjen injekcijski peresnik vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Erelzi v peresniku segreje na sobno temperaturo.
There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis. 
Etanercept se običajno ne uporablja za zdravljenje juvenilnega idiopatskega artritisa pri otrocih,
In adults (aged 18 and over), Erelzi can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you. 
Pri odraslih (starih 18 let in več) se zdravilo Erelzi lahko uporablja pri zdravljenju zmernega ali hudega revmatoidnega artritisa, psoriatičnega artritisa, hudega aksialnega spondilartritisa,
EU/1/17/1195/013 8 pre-filled syringes EU/1/17/1195/004 12 pre-filled syringes EU/1/17/1195/014 24 pre-filled syringes 
EU/1/17/1195/013 8 napolnjenih injekcijskih brizg EU/1/17/1195/004 12 napolnjenih injekcijskih brizg EU/1/17/1195/014 24 napolnjenih injekcijskih brizg
• 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. 
• Bolezni krvi: Če se pri vas ali otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
Erelzi 50 mg solution for injection in pre-filled pen EU/1/17/1195/009 
Erelzi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/17/1195/009
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 non-steroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum). 
Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients). 
merjeno z radioimunskimi testi (15 % pri etanerceptu in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri etanerceptu in 0 % pri placebu).
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi. 
• Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom
Erelzi should be used with caution in patients with a history of hepatitis C. 
Pri bolnikih z anamnezo hepatitisa C morate zdravilo Erelzi uporabljati previdno.
The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly. 
Priporočeni odmerek je 25 mg etanercepta dvakrat na teden ali 50 mg enkrat na teden.
The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever. 
Neželeni učinki, o katerih so poročali najpogosteje, so: reakcije na mestu injiciranja (kot so bolečina, oteklina, srbenje, rdečina in krvavitev na mestu vboda), okužbe (kot so okužbe zgornjih dihal,
Talk to your doctor before taking Erelzi. 
Pred začetkom uporabe zdravila Erelzi se posvetujte z zdravnikom.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Erelzi needs to be used with caution under these circumstances. 
• Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate. 
mediani odmerek 20 mg) ali z etanerceptom in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediano trajanje 5 let) in pri katerih je bil odziv na najmanj eno od imunomodulirajočih antirevmatičnih zdravil (DMARD), razen metotreksata, manj kot zadovoljiv.
Elevated liver enzymes* 
žolčnika in žolčevodov zvečane vrednosti jetrnih encimov*
Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard. 
raztopina za injiciranje Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih brizg z zapiralom igle
INFORMATION IN BRAILLE Erelzi 25 mg 
etanercept 25 mg
Erelzi is available as 25 mg strength and 50 mg strength. 
Zdravilo Erelzi je na voljo v jakosti 25 mg in 50 mg.
• Do not use the pen if it has been dropped with the cap removed. 
• Ko pokrovček odstranite, ga zavrzite.
Each pre-filled syringe contains 25 mg etanercept. 
Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to etanercept. 
Med obdobjem randomiziranega prekinjanja zdravljenja se je recidiv bolezni (izguba odziva PASI 75)
Do not shake the syringe. 
Injekcijske brizge ne stresajte.
Erelzi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis. 
psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately. 
Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo
All healthcare professionals (HCPs) who are most likely to prescribe Erelzi for patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis, juvenile idiopathic arthritis, plaque psoriasis and paediatric plaque psoriasis are provided with a Patient Alert Card for distribution to patients receiving Erelzi. 
juvenilnim idiopatskim artritisom, psoriazo v plakih in otroško psoriazo v plakih, so za bolnike, ki prejemajo zdravilo Erelzi, prejeli opozorilno kartico za bolnika.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001). 
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom,
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe". 
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga".
Storage of the Erelzi pre-filled syringe 
Shranjevanje zdravila Erelzi
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi SensoReady pen”. 
Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjen injekcijski peresnik SensoReady”.
Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%). 
pojavnost reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. 
Tekočina mora biti bistra ali rahlo opalescentna, brezbarvna do nekoliko rumenkasta ter lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
Erelzi 25 mg solution for injection in pre-filled syringe etanercept 
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
Discard the needle cap. You may see a drop of liquid at the end of the needle. 
Na konici igle lahko opazite kapljico, kar je normalno.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 25 MG PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001). 
(sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z etanerceptom kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light. 
Napolnjene injekcijske brizge in napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Erelzi treatment. 
Erelzi ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
What Erelzi contains 
Kaj vsebuje navodilo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 25 MG PRE-FILLED SYRINGE 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
Serious allergic reactions are rare. 
resne alergijske/
EU/1/17/1195/005 1 pre-filled syringe EU/1/17/1195/006 2 pre-filled syringes EU/1/17/1195/007 4 pre-filled syringes 
EU/1/17/1195/005 1 napolnjena injekcijska brizga EU/1/17/1195/006 2 napolnjeni injekcijski brizgi EU/1/17/1195/007 4 napolnjene injekcijske brizge
Elderly 
vaskulitis
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen". 
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo zdravila Erelzi SensoReady injekcijski peresnik".
Erelzi 50 mg solution for injection in pre-filled syringe etanercept 
Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch) 
• občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ali občutek toplote; • hud izpuščaj, srbenje ali koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 50 MG PRE-FILLED PEN 
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 50 MG
Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias. 
zdravljenih z zdravilom Erelzi, ki imajo krvno diskrazijo v anamnezi.
Do not use the pen if the expiry date has passed. 
Injekcijskega peresnika ne uporabljajte, če mu je potekel rok uporabnosti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept. 
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta (etanerceptum).
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36. 
Pri bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je odziv
Keep the pre-filled SensoReady pens in the outer carton in order to protect from light. 
Napolnjene injekcijske peresnike SensoReady shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 25 MG PRE-FILLED SYRINGE 
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 25 MG
Your Erelzi SensoReady pen: 
Injekcijski peresnik SensoReady z zdravilom Erelzi:
Thrombocytopenia, anaemia, leukopenia, neutropenia 
Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija* aplastična anemija*
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 50 MG PRE-FILLED SYRINGE 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
EU/1/17/1195/001 1 pre-filled syringe EU/1/17/1195/002 2 pre-filled syringes EU/1/17/1195/003 4 pre-filled syringes 
EU/1/17/1195/001 1 napolnjena injekcijska brizga EU/1/17/1195/002 2 napolnjeni injekcijski brizgi EU/1/17/1195/003 4 napolnjene injekcijske brizge
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. 
Raztopina mora biti bistra ali rahlo opalescentna, brezbarvna do rahlo rumenkasta in lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein. 
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi pre-filled syringe”. 
Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga”.