natgillin/translations-raw huggingface dataset:
Erelzi is supplied as a pre-filled syringe containing a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection).
Erelzi je dostupan kao napunjena štrcaljka koja sadrži bistru ili blago opalescentnu, bezbojnu do blijedožutu otopinu za injekciju (injekciju).
Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Poremećaji kože i potkožnog tkiva), nastanak autoprotutijela
The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Djelotvornost etanercepta u bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza (nrAxSpa, engl. non-radiographic axial spondyloarthritis) procijenjena je u randomiziranom, 12tjednom, dvostruko slijepom, placebom kontroliranom ispitivanju.
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).
U ispitivanju 1 skupina liječena etanerceptom imala je nakon 12 tjedana značajno veći udio bolesnika s odgovorom PASI 75 (30%) u usporedbi sa skupinom na placebu (2%) (p< 0,0001).
• Reminder to record brand name and batch number of the medication
• podsjetnik kako treba evidentirati zaštićeni naziv i broj serije lijeka
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
koji je obuhvaćao ocjenu nesposobnosti, vitalnosti, mentalnog zdravlja, općeg zdravstvenog stanja kao i potpitanja za ocjenu zdravstvenog stanja u bolesnika s artritisom.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarna mjera ishoda djelotvornosti u sva četiri ispitivanja bila je udio bolesnika u svakoj ispitivanoj skupini koji su postigli PASI 75 (tj. najmanje 75% poboljšanja u
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi.
• Upalna bolest crijeva: prijavljeni su slučajevi upalne bolesti crijeva u bolesnika s juvenilnim idiopatskim artritisom liječenih Erelzijem.
The other ingredients are: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Drugi sastojci su: bezvodna citratna kiselina, natrijev citrat dihidrat, natrijev klorid, saharoza, L-lizinklorid, natrijev hidroksid, kloridna kiselina i voda za injekcije.
There have been post-marketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Nakon stavljanja lijeka u promet zabilježeni su slučajevi pancitopenije i aplastične anemije, od kojih neki sa smrtnim ishodom (vidjeti dio 4.4).
Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Liječenje etanerceptom dovelo je do poboljšanja fizičke funkcije tijekom dvostruko slijepog razdoblja,
Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Alergijske reakcije, vrućica, osip, svrbež, nastanak protutijela na vlastito tkivo (autoprotutijela).
• Do not shake the pen.
• Ne tresite brizgalicu.
Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen.
Pedijatrijskim bolesnicima tjelesne težine 62,5 kg ili više može se davati doza od 25 mg dva puta tjedno ili 50 mg jednom tjedno pomoću napunjene štrcaljke s fiksnom dozom ili napunjene brizgalice s fiksnom dozom.
The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Prosječne najniže koncentracije u serumu u stanju dinamičke ravnoteže kretale su se od 1,6 do 2,1 μg/ml u 12., 24. i 48. tjednu.
If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).
smijete izravno ubrizgati u povišena, zadebljala, crvena ili ljuskama prekrivena područja kože ili lezije („psorijatične kožne lezije“).
Radiographic progression: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration (12 month results)
Radiološka progresija: usporedba etanercepta prema metotreksatu i prema etanerceptu u kombinaciji s metotreksatom u bolesnika s RA u trajanju od 6 mjeseci do 20 godina (rezultati nakon 12 mjeseci)
Responses of patients with psoriatic arthritis in a placebo-controlled trial Percent of Patients
Odgovori bolesnika s psorijatičnim artritisom u placebom kontroliranom ispitivanju Postotak bolesnika
The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
18 do 49 godina), koji su definirani kao oni bolesnici koji ispunjavaju kriterije ASAS klasifikacije aksijalnog spondiloartritisa, ali nisu ispunili modificirane New York kriterije za AS.
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.
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-om.
Uncommon ≥ 1/1,000 to
≥ 1/1000 i
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Erelzi.
• Vodene kozice: obavijestite svog liječnika ako ste Vi ili dijete bili izloženi vodenim kozicama za vrijeme primjene Erelzija.
Your Erelzi SensoReady pen:
Vaša Erelzi SensoReady brizgalica:
There were no differences in rates of infection among patients treated with etanercept and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Kod liječenja plak psorijaze nisu zabilježene razlike u stopi infekcija između bolesnika liječenih etanerceptom i onih koji su primali placebo u placebom kontroliranim ispitivanjima u trajanju do
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Štrcaljka se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili naljepnici na štrcaljki iza oznake „EXP“.
EU/1/17/1195/008 12 pre-filled syringes
EU/1/17/1195/008 12 napunjenih štrcaljki
Read ALL the way through these instructions before injecting.
Pročitajte ove upute DO KRAJA prije primjene injekcije.
No studies on the effects on the ability to drive and use machines have been performed.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima nisu provedena.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA)
Upalne bolesti crijeva i uveitis u bolesnika s juvenilnim idiopatskim artritisom (JIA)
In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
U jednom drugom otvorenom ispitivanju na jednoj skupini 60 bolesnika s oligoartritisom produljenog trajanja (15 bolesnika u dobi od 2 do 4 godine, 23 bolesnika u dobi od 5 do 11 godina i 22 bolesnika u dobi od 12 do 17 godina), 38 bolesnika s artritisom povezanim s entezitisom (u dobi od 12 do
Solution for injection (injection)
OBLIK Otopina za injekciju (injekcija).
Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
(uključujući hipersenzitivni vaskulitis), erythema multiforme, lihenoidne reakcije
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• Znakovi poremećaja krvi, kao što su krvarenje, modrice ili bljedilo.
Check the green indicator fills the window:
Provjerite je li zeleni indikator ispunio prozorčić: • To znači da je lijek ubrizgan.
The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
Preporučena doza je 0,8 mg/kg (do maksimalno 50 mg po dozi) jednom tjedno u trajanju do 24 tjedna.
Multipack: 12 (3 packs of 4) pre-filled SensoReady pens.
Višestruko pakiranje: 12 (3 pakiranja po 4) SensoReady napunjenih brizgalica.
At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
56% bolesnika u skupini liječenoj etanerceptom postiglo je PASI 75 u usporedbi s 5% u skupini na placebu.
This medicinal product contains less than 1 mmol sodium (23 mg) per 25mg or 50 mg, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 25 mg ili 50 mg, odnosno zanemarive količine natrija.
The other ingredients are citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections.
Drugi sastojci su bezvodna citratna kiselina, natrijev citrat dihidrat, natrijev klorid, saharoza, Llizinklorid, natrijev hidroksid, kloridna kiselina i voda za injekcije.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the post-marketing period (see section 4.4).
Razne zloćudne bolesti (uključujući karcinom dojke i pluća te limfom) zabilježene su, također, i u razdoblju nakon stavljanja etanercepta u promet (vidjeti dio 4.4).
QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
KVALITATIVNI I KVANTITATIVNI SASTAV Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 25 mg etanercepta (etanerceptum).
Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Supkutano su davane doze od 25 mg etanercepta (na temelju ispitivanja o određivanju doze u bolesnika s reumatoidnim artritisom) odnosno placebo dva puta tjedno tijekom 6 mjeseci u 138 bolesnika.
Discard the needle cap. You may see a drop of liquid at the end of the needle.
Možda ćete vidjeti kapljicu tekućine na vrhu igle.
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
(uključujuć i krvarenje, modrice, eritem, svrbež, bol, oticanje)*
Contents of the pack and other information Instructions for Use of the Erelzi SensoReady pen
Sadržaj pakiranja i druge informacije Upute za primjenu Erelzi SensoReady napunjene brizgalice
The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Profili djelotvornosti i sigurnosti dva režima liječenja etanerceptom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA.
Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Istodobno liječenje anakinrom Istodobno davanje etanercepta i anakinre povezano je s povećanim rizikom od ozbiljnih infekcija i neutropenije u usporedbi s monoterapijom etanerceptom.
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).
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 u krvi je česta); grčevi i bol u trbuhu, proljev, gubitak težine ili krv u stolici (znakovi problema s crijevima).
Paediatric population Vaccinations
Pedijatrijska populacija Cijepljenje
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.
Alternativno, 50 mg može biti primjenjivano dva puta tjedno 12 tjedana iza čega slijedi 25 mg dva puta tjedno ili 50 mg jednom tjedno.
The SensoReady pen contains a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection).
SensoReady brizgalica sadrži bistru ili blago opalescentnu, bezbojnu ili blago žućkastu otopinu za injekciju (injekciju).
Preparing the Erelzi pre-filled syringe
Priprema Erelzi napunjene štrcaljke
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Etanercept 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.
Etanercept se pokazao značajno 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.
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature.
Nakon što izvadite štrcaljku iz hladnjaka, pričekajte približno 15-30 minuta kako bi otopina Erelzija u štrcaljki postigla sobnu temperaturu.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
U svih bolesnika, a pogotovo u onih koji su pod povećanim rizikom od raka kože,
Paediatric plaque psoriasis outcomes at 12 weeks Etanercept 0.8 mg/kg Once Weekly (N = 106)
Etanercept 0,8 mg/kg jednom tjedno (N = 106)
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
U bolesnika s psorijatičnim artritisom liječenih etanerceptom rezultat indeksa nesposobnosti je bio značajno bolji u svim vremenskim točkama određivanja u odnosu na placebo (p<0,001).
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
• Znakovi lupusa ili sindroma nalik lupusu, kao što su promjene tjelesne težine, uporan kašalj,
Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months.
Također je primijećena značajna prednost za etanercept u kombinaciji s metotreksatom u usporedbi s etanerceptom kao monoterapijom i s metotreksatom kao monoterapijom nakon 24 mjeseca.
• Allergic reactions: 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.
• 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 Erelzi i odmah se obratite svom liječniku.
In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Ukupno 18 limfoma je zabilježeno u 7416 bolesnika liječenih etanerceptom u kliničkim ispitivanjima s bolesnicima oboljelim od reumatoidnog artritisa, psorijatičkog artritisa, ankilozantnog spondilitisa i psorijaze.
In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
dvostruko slijepim fazama kontroliranih kliničkih ispitivanja koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) štetnih događaja povišenih jetrenih enzima bila je 4,18% (česta učestalost).
The long-term safety and effectiveness of etanercept 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 2 years beyond the 48 week study discussed above.
Nakon gore spomenutih 48 tjedana ispitivanja dugotrajna sigurnost primjene i djelotvornost etanercepta 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.
Patients in this study received a dose of 25 mg or 50 mg etanercept, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg etanercept twice weekly for an additional 24 weeks.
Bolesnici su primali etanercept 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 ispitivanja primali 25 mg etanercepta dvaput tjedno tijekom dodatna 24 tjedna.
This medicinal product contains less than 1 mmol sodium (23 mg) per 50 mg, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 50 mg, odnosno zanemarive količine natrija.
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).
Pri uzimanju etanercepta primijećeni su slučajevi teških infekcija, sepse, tuberkuloze i oportunističkih infekcija, uključujući i invazivne gljivične infekcije, listeriozu i legionelozu (vidjeti dio 4.8).
There have been reports of IBD and uveitis in JIA patients being treated with etanercept (see section 4.8).
Bilo je prijava pojave upalne bolesti crijeva i uveitisa u bolesnika s JIA liječenih etanerceptom (vidjeti dio 4.8).
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.
crvenilo i krvarenje na mjestu uboda), infekcije (kao infekcije gornjih dišnih puteva, bronhitis, infekcije mokraćnog mjehura i kožne infekcije), alergijske reakcije, razvoj autoprotutijela, svrbež i vrućica.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
bakterijemiju, bronhitis, burzitis, celulitis, kolecistitis, proljev, divertikulitis, endokarditis (suspektni), gastroenteritis, hepatitis B, herpes zoster, ulkus noge, infekcije usne šupljine, osteomijelitis, otitis,
Erelzi 50 mg injection etanercept SC
Erelzi 50 mg injekcija etanercept SC
Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
U bolesnika tjelesne težine 62,5 kg ili više može se primjenjivati doza iz napunjene štrcaljke ili napunjene brizgalice koje sadrže fiksnu dozu.
Citric acid anhydrous Sodium citrate dihydrate Sodium chloride
6.1 Popis pomoćnih tvari citratna kiselina, bezvodna natrijev citrat dihidrat natrijev klorid saharoza
However, your doctor may determine an alternative frequency at which to inject Erelzi.
Međutim, liječnik može odrediti drukčiju učestalost primjene Erelzija.
After your injection:
Nakon injekcije:
Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept.
Jedna napunjena štrcaljka sadrži 25 mg etanercepta ili 50 mg etanercepta.
In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count ˂ 1,000/mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno etanercept i anakinru opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo etanerceptom, dok je 2% bolesnika (3/139)
Pairwise comparison p-values: † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
c: Remisija je definirana kao DAS < 1,6 p-vrijednosti za usporedbu parova: † = p<0,05 za usporedbu etanercept + metotreksat u odnosu na metotreksat te ϕ = p<0,05 za usporedbu etanercept + metotreksat u odnosu na etanercept.
Do not use the pen if the expiry date has passed.
Ne upotrebljavajte brizgalicu ako je istekao rok valjanosti.
Erelzi solution for injection in pre-filled syringe
Erelzi otopina za injekciju u napunjenoj štrcaljki
Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
etanercepta nije zabilježena toksičnost koja bi ograničavala dozu, kao ni toksičnost prema ciljnim organima prilikom primjene u cinomolgus majmuna u dozi od 15 mg/kg supkutano, dva puta tjedno, tijekom 4 ili 26 uzastopnih tjedana, a pri toj su dozi serumske koncentracije lijeka izmjerene na osnovi
• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Erelzi se propisuje i za liječenje sljedećih bolesti u djece i adolescenata: • Kod sljedećih oblika juvenilnog idiopatskog artritisa kad liječenje metotreksatom nije dovoljno dobro djelovalo ili nije bilo pogodno:
Before your injection:
Prije primjene injekcije:
Allergic reactions associated with etanercept administration have been reported commonly.
Alergijske reakcije Alergijske reakcije često su povezane s primjenom etanercepta.
• Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
• Znakovi poremećaja živaca, kao što su utrnulost ili bockanje, poremećaji vida, bol u oku,
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 napunjena SensoReady brizgalica EU/1/17/1195/010 2 napunjene SensoReady brizgalice EU/1/17/1195/011 4 napunjene SensoReady brizgalice