natgillin/translations-raw huggingface dataset:
Some vaccines, such as oral polio vaccine, should not be given while using Erelzi.
Med zdravljenjem z zdravilom Erelzi nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
The SensoReady pen contains a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection).
Napolnjen injekcijski peresnik SensoReady vsebuje bistro do rahlo opalescentno, brezbarvno do rahlo rumenkasto raztopino za injiciranje (injekcijo).
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study.
Učinkovitost etanercepta je bila ugotovljena v randomizirani, dvojno slepi klinični študiji, nadzorovani s placebom.
Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept.
Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta ali 50 mg etanercepta.
Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Pri bolnikih, ki so prejemali etanercept v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score)
• This medicine has been prescribed for you or a child in your care.
• Zdravilo je bilo predpisano vam ali otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
Your injection:
Injiciranje:
4 pre-filled syringes with a needle guard.
4 napolnjene injekcijske brizge z zapiralom igle.
• Keep holding the pen firmly against your skin.
• Injekcijski peresnik še naprej močno pritiskajte v kožo.
• Signs of serious infections such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
• znaki resnih okužb, npr. visoka vročina, ki jo lahko spremljajo kašelj, kratka sapa, mrzlica,
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving etanercept 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 open-label extension therapy.
V eni študiji pri otrocih z juvenilnim idiopatskim artritisom, starih od 4 do 17 let, se je pri 43 od 69 otrok (62 %) med trimesečnim zdravljenjem z etanerceptom v času študije (prvi del,
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• znaki rakavih obolenj: rak• znaki avtoimunskih reakcij (reakcije, pri katerih se tvorijo protitelesa, ki lahko poškodujejo normalna telesna tkiva), kot so bolečina, srbenje, oslabelost,
A 25 mg strength of Erelzi is available for doses of 25 mg.
Zdravilo Erelzi je na voljo v jakosti 25 mg za odmerke 25 mg.
Serious infections experienced by etanercept-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received etanercept.
V združeni zbirki podatkov iz kliničnih preskušanj je bila celokupna pojavnost oportunističnih okužb pri 15.402
Holding your pen: • Hold the pen at 90 degrees to the cleaned injection site.
• Injekcijski peresnik držite pravokotno nad očiščenim mestom injiciranja (pod kotom 90 stopinj).
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Erelzi.
• Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom Erelzi izpostavljeni noricam.
Instructions for use of the Erelzi SensoReady pen
Navodila za uporabo injekcijskega peresnika SensoReady z zdravilom Erelzi
Your Erelzi pre-filled syringe with needle guard and add-on finger flange
Vaše zdravilo Erelzi napolnjena injekcijska brizga z zapiralom igle in držalom za prste
Erelzi is available in strengths of 25 mg and 50 mg.
Zdravilo Erelzi je na voljo v jakostih 25 mg in 50 mg.
This combination has not demonstrated increased clinical benefit.
Ta kombinacija ni pokazala povečane klinične koristi, zato njena uporaba ni priporočljiva
There have been reports of IBD and uveitis in JIA patients being treated with etanercept (see section 4.8).
Pri bolnikih z JIA, ki so se zdravili z etanerceptom, so poročali o KVČB in uveitisu (glejte poglavje 4.8).
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; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike whitegrey lines on mucous membranes); 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).
melanom (vrsta kožnega raka); kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic; motnje živčevja (s hudo mišično oslabelostjo ter z znaki in simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače); tuberkuloza; nastanek kongestivnega srčnega popuščanja; epileptični napadi; lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost); kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože; lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah); vnetje jeter, ki je posledica delovanja imunskega sistema proti tkivu lastnega telesa (avtoimunski hepatitis; pri bolnikih, ki sočasno prejemajo metotreksat, je občasen); imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza); vnetje ali brazgotinjenje pljuč (pri bolnikih, ki sočasno prejemajo metotreksat, je vnetje ali brazgotinjenje pljuč občasno).
After your injection:
Po injiciranju:
Contact your doctor if the green indicator is not visible.
Če zelenega indikatorja ni videti, obvestite zdravnika.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe” or “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 napolnjena injekcijska brizga" ali "Navodila za uporabo zdravila Erelzi SensoReady injekcijski peresnik".
Mean (SE) annualized change from baseline in total sharp score
Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature.
Ko brizgo vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Erelzi v brizgi segreje na sobno temperaturo.
The usual dose is 25 mg twice a week or 50 mg once a week.
Odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including etanercept.
Pri bolnikih, zdravljenih z antagonisti TNF, vključno z etanerceptom, so poročali o melanomu in nemelanomskem kožnem raku (NMSC - Non-Melanoma Skin Cancer).
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.
Če je treba, je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Pri zdravljenju revmatoidnega artritisa se zdravilo Erelzi običajno uporablja skupaj z metotreksatom.
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 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
TSS ≤ 0,5) je bil po 24 mesecih večji v skupini, ki je dobivala etanercept v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali etanercept ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
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 Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Bolezni živčevja demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo, ali lokalizirana demielinizirajoča stanja, kot sta optični nevritis in transverzni mielitis (glejte poglavje 4.4), demielinizacija perifernega živčevja, vključno z
Leave it to dry before injecting.
Pred injiciranjem naj se koža posuši.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA)
Kronična vnetna črevesna bolezen (KVČB) in uveitis pri bolnikih z juvenilnim idiopatskim artritisom
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months.
faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z etanerceptom ali placebom zaradi zmernega do hudega alkoholnega hepatitisa,
How to use the Erelzi pre-filled syringe
Kako uporabljati napolnjeno injekcijsko brizgo z zdravilom Erelzi
In study 4, the etanercept-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z etanerceptom (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild.
Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih etanercepta pri odraslih bolnikih z revmatoidnim artritisom.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Erelzi.
• Rak: Preden boste prejeli zdravilo Erelzi, povejte zdravniku, če imate ali ste kdaj imeli limfom
The other ingredients are: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Druge sestavine so: brezvodna citronska kislina, natrijev citrat dihidrat, natrijev klorid, saharoza, L-lizinijev klorid, natrijev hidroksid (za uravnavanje pH- vrednosti), solna kislina (za uravnavanje pHvrednosti) in voda za injekcije.
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Erelzi to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Pri bolnikih z demielinizirajočimi obolenji, ki so obstajala že prej ali so nastopila pred kratkim, ali pri tistih, ki imajo povečano tveganje za razvoj demielinizirajoče bolezni, je treba pred zdravljenjem z z zdravilom Erelzi skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
From the start of part 2, the median time to flare was ≥ 116 days for patients who received etanercept and 28 days for patients who received placebo.
≥ 116 dni pri bolnikih na etanerceptu in 28 dni pri bolnikih na placebu.
*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