FrancophonIA/ELRC3.0 huggingface dataset:
English: Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady pen).
Slovenian: 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).
English: Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Slovenian: Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta (etanerceptum).
English: 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).
Slovenian: znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
English: 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.
Slovenian: 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.
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 Erelzi.
Slovenian: • Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
English: Instructions for use of the Erelzi pre-filled syringe Read ALL the way through these instructions before injecting.
Slovenian: 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.
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
Slovenian: 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.
English: In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Slovenian: 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.
English: 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.
Slovenian: Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor.
English: Women using Erelzi should not breast-feed, since Erelzi passes into human breast milk.
Slovenian: Zdravilo Erelzi prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom Erelzi ne smejo dojiti.
English: 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months.
Slovenian: Odmerki 10 mg ali 25 mg etanercepta so bili dani subkutano (s.c.) 2-krat tedensko do 24 mesecev.
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Erelzi in patients who have congestive heart failure (CHF).
Slovenian: Zdravniki morajo biti previdni, kadar predpišejo zdravilo Erelzi bolnikom s kongestivnim srčnim popuščanjem (KSP).
English: 2.3 †, ϕ
Slovenian: -0,23 †,φ
English: 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.
Slovenian: Ko napolnjen injekcijski peresnik vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Erelzi v peresniku segreje na sobno temperaturo.
English: There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
Slovenian: Etanercept se običajno ne uporablja za zdravljenje juvenilnega idiopatskega artritisa pri otrocih,
English: 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.
Slovenian: Pri odraslih (starih 18 let in več) se zdravilo Erelzi lahko uporablja pri zdravljenju zmernega ali hudega revmatoidnega artritisa, psoriatičnega artritisa, hudega aksialnega spondilartritisa,
English: 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
Slovenian: 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
English: • Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Slovenian: • 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.
English: Erelzi 50 mg solution for injection in pre-filled pen EU/1/17/1195/009
Slovenian: Erelzi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/17/1195/009
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 non-steroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Slovenian: Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
English: 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).
Slovenian: merjeno z radioimunskimi testi (15 % pri etanerceptu in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri etanerceptu in 0 % pri placebu).
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi.
Slovenian: • Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom
English: Erelzi should be used with caution in patients with a history of hepatitis C.
Slovenian: Pri bolnikih z anamnezo hepatitisa C morate zdravilo Erelzi uporabljati previdno.
English: The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
Slovenian: Priporočeni odmerek je 25 mg etanercepta dvakrat na teden ali 50 mg enkrat na teden.
English: 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.
Slovenian: 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,
English: Talk to your doctor before taking Erelzi.
Slovenian: Pred začetkom uporabe zdravila Erelzi se posvetujte z zdravnikom.
English: • 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.
Slovenian: • Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
English: 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.
Slovenian: 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.
English: Elevated liver enzymes*
Slovenian: žolčnika in žolčevodov zvečane vrednosti jetrnih encimov*
English: 50 mg BIW
Slovenian: Erelzi 50 mg
English: 25 mg BIW
Slovenian: Erelzi 25 mg
English: Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.
Slovenian: raztopina za injiciranje Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih brizg z zapiralom igle
English: INFORMATION IN BRAILLE Erelzi 25 mg
Slovenian: etanercept 25 mg
English: Erelzi is available as 25 mg strength and 50 mg strength.
Slovenian: Zdravilo Erelzi je na voljo v jakosti 25 mg in 50 mg.
English: • Do not use the pen if it has been dropped with the cap removed.
Slovenian: • Ko pokrovček odstranite, ga zavrzite.
English: Each pre-filled syringe contains 25 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
English: 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.
Slovenian: Med obdobjem randomiziranega prekinjanja zdravljenja se je recidiv bolezni (izguba odziva PASI 75)
English: Do not shake the syringe.
Slovenian: Injekcijske brizge ne stresajte.
English: 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.
Slovenian: psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
English: 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.
Slovenian: Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo
English: 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.
Slovenian: juvenilnim idiopatskim artritisom, psoriazo v plakih in otroško psoriazo v plakih, so za bolnike, ki prejemajo zdravilo Erelzi, prejeli opozorilno kartico za bolnika.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
Slovenian: Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom,
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe".
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga".
English: Storage of the Erelzi pre-filled syringe
Slovenian: Shranjevanje zdravila Erelzi
English: Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi SensoReady pen”.
Slovenian: Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjen injekcijski peresnik SensoReady”.
English: Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%).
Slovenian: pojavnost reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
English: The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Slovenian: Tekočina mora biti bistra ali rahlo opalescentna, brezbarvna do nekoliko rumenkasta ter lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
English: Erelzi 25 mg solution for injection in pre-filled syringe etanercept
Slovenian: Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
English: Discard the needle cap. You may see a drop of liquid at the end of the needle.
Slovenian: Na konici igle lahko opazite kapljico, kar je normalno.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 25 MG PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: 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).
Slovenian: (sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z etanerceptom kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
English: Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light.
Slovenian: Napolnjene injekcijske brizge in napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: 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.
Slovenian: Erelzi ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
English: What Erelzi contains
Slovenian: Kaj vsebuje navodilo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 25 MG PRE-FILLED SYRINGE
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: Serious allergic reactions are rare.
Slovenian: resne alergijske/
English: 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
Slovenian: 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
English: Elderly
Slovenian: vaskulitis
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen".
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo zdravila Erelzi SensoReady injekcijski peresnik".
English: Erelzi 50 mg solution for injection in pre-filled syringe etanercept
Slovenian: Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
English: • Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Slovenian: • 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).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 50 MG PRE-FILLED PEN
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 50 MG
English: Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias.
Slovenian: zdravljenih z zdravilom Erelzi, ki imajo krvno diskrazijo v anamnezi.
English: Do not use the pen if the expiry date has passed.
Slovenian: Injekcijskega peresnika ne uporabljajte, če mu je potekel rok uporabnosti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Slovenian: Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta (etanerceptum).
English: For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Slovenian: Pri bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je odziv
English: Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.
Slovenian: Napolnjene injekcijske peresnike SensoReady shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 25 MG PRE-FILLED SYRINGE
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 25 MG
English: Your Erelzi SensoReady pen:
Slovenian: Injekcijski peresnik SensoReady z zdravilom Erelzi:
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija* aplastična anemija*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 50 MG PRE-FILLED SYRINGE
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: 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
Slovenian: 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
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Slovenian: Raztopina mora biti bistra ali rahlo opalescentna, brezbarvna do rahlo rumenkasta in lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
English: The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Slovenian: Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi pre-filled syringe”.
Slovenian: Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga”.
English: 2 pre-filled SensoReady pens
Slovenian: 1 napolnjen injekcijski peresnik SensoReady 2 napolnjena injekcijska peresnika SensoReady 4 napolnjeni injekcijski peresniki SensoReady
English: Erelzi 50 mg solution for injection in pre-filled syringe.
Slovenian: Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Each pre-filled syringe contains 50 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
English: Erelzi solution for injection in pre-filled syringe
Slovenian: Priprava napolnjene injekcijske brizge z zdravilom Erelzi na injiciranje
English: In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Slovenian: V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja etanercepta v odmerku 50 mg enkrat na teden
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 50 MG NAPOLNJEN INJEKCIJSKI PERESNIK
English: Erelzi 25 mg solution for injection in pre-filled syringe.
Slovenian: Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Erelzi 25 mg injection etanercept SC
Slovenian: Erelzi 25 mg injekcija etanercept (etanerceptum) s.c.
English: n = 166 n =
Slovenian: 50 mg 1x/teden n = 166 n =
English: • Swelling of the face, throat, hands, or feet
Slovenian: • težave pri požiranju ali dihanju; • otekanje obraza, žrela, rok ali nog;
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 25 MG PRE-FILLED SYRINGE
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: Do not use if the safety seal has been broken.
Slovenian: Zdravila ne uporabljajte, če injekcijski peresnik ni originalno zaprt.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the post-marketing period (see section 4.8).
Slovenian: Čvrste in hematopoetične maligne bolezni (razen kožnega raka) V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 4.8).
English: These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;
Slovenian: Med temi so bili abscesi (na različnih mestih), bakteriemija,
English: Antibodies to etanercept
Slovenian: etanercept etanercept + metotreksat
English: In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) etanercept subcutaneously twice weekly.
Slovenian: V prvem delu študije so vsi bolniki 2-krat tedensko prejemali po 0,4 mg/kg
English: 1 pre-filled SensoReady pen
Slovenian: Prikaz injekcijskega peresnika SensoReady z zdravilom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 50 MG PRE-FILLED SYRINGE
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: Keep the pre-filled SensoReady pen in the outer carton in order to protect from light.
Slovenian: Napolnjen injekcijski peresnik SensoReady shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Pancytopenia* Aplastic anaemia*
Slovenian: bakterijo Legionella)*
English: • Do not shake the pen.
Slovenian: • Ne stresajte injekcijskega peresnika.
English: The solution is clear or slightly opalescent, colourless to slightly yellowish.
Slovenian: raztopina za injiciranje (injekcija) Raztopina je bistra ali rahlo opalescentna, brezbarvna do rahlo rumenkasta.
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: kortikosteroide, ali peroralne antihistaminike.
English: Paediatric plaque psoriasis outcomes at 12 weeks Etanercept 0.8 mg/kg Once Weekly (N = 106)
Slovenian: 0,8 mg/kg enkrat na teden (n = 106)
English: NAME OF THE MEDICINAL PRODUCT Erelzi 25 mg injection etanercept
Slovenian: Erelzi 25 mg injekcija etanercept