FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 LIFMIOR-treated psoriatic arthritis patients.
Slovenian: V kliničnih študijah z zdravilom LIFMIOR, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).
Slovenian: 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).
English: If you or the child in your care have Wegener's granulomatosis, talk to your doctor.
Slovenian: Povejte zdravniku, če imate vi ali otrok, za katerega skrbite, Wegenerjevo granulomatozo.
English: If the doctor has not given this instruction, please contact him/her.
Slovenian: Posvetujte se z zdravnikom, če od njega takih navodil niste dobili.
English: LIFMIOR 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.
Slovenian: 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 zdravilom LIFMIOR skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
English: • The doctor or his/her assistant should have instructed you on the proper amount of solution to be withdrawn from the vial.
Slovenian: dravnik ali medicinska sestra vam morata natančno pojasniti koliko raztopine morate izvleči iz viale.
English: Patients received LIFMIOR 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Slovenian: Bolniki so 12 tednov enkrat na teden prejemali zdravilo LIFMIOR v odmerku 0,8 mg/kg (do 50 mg) ali placebo.
English: LIFMIORa
Slovenian: zdravilo LIFMIOR
English: CARTON TEXT (For paediatric use) - EU/1/16/1165/001
Slovenian: BESEDILO NA ŠKATLI - (za uporabo pri otrocih) - EU/1/16/1165/001
English: Among patients with plaque psoriasis who received LIFMIOR, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Slovenian: Med bolniki s psoriazo v plakih, ki so dobivali zdravilo LIFMIOR, je bil pomemben odziv v primerjavi s placebom opazen na prvem pregledu (po 2 tednih) in se je ohranil skozi 24 tednov zdravljenja.
English: Paediatric patients with plaque psoriasis
Slovenian: Pediatrični bolniki s psoriazo v plakih
English: Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Slovenian: Zdravljenje artritisa, povezanega z entezitisom, pri mladostnikih, starih 12 let ali več, ki so se nezadostno odzvali na konvencionalno zdravljenje ali ga niso prenašali.
English: Serious and fatal infections have been reported during use of LIFMIOR; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Slovenian: Med povzročitelji, o katerih so poročali, so bile bakterije, mikobakterije (vključno s tuberkulozo), virusi in glivice.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Slovenian: Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom LIFMIOR priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila LIFMIOR bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
English: Using the MYCLIC pre-filled pen to inject LIFMIOR
Slovenian: Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR
English: INFORMATION IN BRAILLE LIFMIOR 10 mg
Slovenian: LIFMIOR 10 mg
English: OTHER MYCLIC Pre-filled pen
Slovenian: Napolnjeni peresnik MYCLIC
English: • Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using LIFMIOR.
Slovenian: Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom LIFMIOR izpostavljeni noricam.
English: At week 12, more patients randomised to LIFMIOR had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
Slovenian: V 12. tednu je imelo pozitivne odzive glede učinkovitosti (npr. PASI 75) več bolnikov v skupini z zdravilom LIFMIOR kot v skupini s placebom.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including LIFMIOR.
Slovenian: Pri bolnikih, zdravljenih z antagonisti TNF, vključno z zdravilom LIFMIOR, so poročali o melanomu in nemelanomskem kožnem raku (NMSC- Non-Melanoma Skin Cancer).
English: Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
Slovenian: Uporabljeno iglo in brizgo odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
English: No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
Slovenian: V študijah z metotreksatom, digoksinom ali varfarinom klinično pomembnih farmakokinetičnih interakcij med zdravili niso opazili.
English: Nervous system disorders
Slovenian: Bolezni živčevja demielinizirajoči pojavi
English: Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
Slovenian: Uporabljeno iglo in brizgi odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
English: LIFMIOR should not be used if all the powder in the vial is not dissolved within 10 minutes.
Slovenian: Zdravila LIFMIOR ne smete uporabiti, če se ves prašek v viali ne raztopi v 10 minutah; v tem primeru to vialo zavrzite in vzemite novo.
English: Each vial contains 10 mg of etanercept.
Slovenian: Ena viala vsebuje 10 mg etanercepta.
English: The LIFMIOR pre-filled pen is available in a 50 mg strength.
Slovenian: Napolnjeni injekcijski peresnik LIFMIOR je na voljo v jakosti 50 mg.
English: Diagram 4
Slovenian: Slika 4
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. LIFMIOR was significantly better than placebo in all components of the
Slovenian: Odziv na 10 mg odmerek je bil po vrednosti med odzivoma na placebom in 25 mg odmerek.
English: If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
Slovenian: Če imate glede shranjevanja kakršnokoli vprašanje, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Do not shake the pre-filled syringe of LIFMIOR.
Slovenian: Napolnjenih injekcijskih brizg zdravila LIFMIOR ne smete tresti.
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of LIFMIOR in adult patients with rheumatoid arthritis, and the majority were mild.
Slovenian: Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih zdravila LIFMIOR pri odraslih bolnikih z revmatoidnim artritisom.
English: In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
Slovenian: V dvojno slepih obdobjih nadzorovanih kliničnih preskušanj etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) neželenih učinkov zvečanih vrednosti jetrnih encimov pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,54 % (pogostnost: občasni).
English: Diagram 6
Slovenian: Slika 6
English: 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Slovenian: 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
English: LIFMIOR was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Slovenian: Zdravilo LIFMIOR so dobivali 6 mesecev zapored v odmerkih 25 mg enkrat na teden, 25 mg dvakrat na teden ali 50 mg dvakrat na teden.
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
Slovenian: V nadzorovanih kliničnih preskušanjih, v katerih je bilo dovoljeno sočasno zdravljenje z etanerceptom in metotreksatom, je bila pogostnost (delež pojavnosti) avtoimunskega hepatitisa 0,24 % (pogostnost: občasni).
English: Solution for injection in pre-filled syringe
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Dispose of the used pen as instructed by your doctor, nurse or pharmacist.
Slovenian: Rabljeni peresnik odstranjujte v skladu z navodili zdravnika, medicinske sestre ali farmacevta.
English: Increased etanercept concentrations were not observed in patients with acute hepatic failure.
Slovenian: Pri bolnikih z akutno odpovedjo jeter niso opazili povečanih koncentracij etanercepta.
English: 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Slovenian: 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
English: Diagram 14
Slovenian: Slika 14
English: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe (vključno s prehladi, sinuzitisom, bronhitisom, okužbami sečil in okužbami kože); reakcije na mestu injiciranja (vključno s krvavitvami, podplutbami, rdečino, srbenjem, bolečino in oteklino).
English: 2 MYCLIC pre-filled pens 2 alcohol swabs
Slovenian: 2 napolnjena injekcijska peresnika MYCLIC 2 alkoholni blazinici
English: Refer to package leaflet for alternative storage details.
Slovenian: Za podrobnosti o pogojih shranjevanja glejte navodilo za uporabo.
English: 4 pre-filled syringes 4 alcohol swabs
Slovenian: 4 napolnjene injekcijske brizge 4 alkoholne blazinice
English: Thrombocytopenia, anaemia, leukopenia, neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija*
English: Treatment with LIFMIOR may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Slovenian: B, lahko zdravljenje z zdravilom LIFMIOR povzroči ponoven zagon hepatitisa B. V takem primeru morate zdravilo LIFMIOR prenehati uporabljati.
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: Pridobljen je z rekombinantno DNK tehnologijo v sesalskem ekspresijskem sistemu, in sicer v ovarijskih celicah kitajskega hrčka (CHO - Chinese Hamster Ovary).
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon).
Slovenian: V nadzorovanih kliničnih preskušanjih, v katerih je bilo dovoljeno sočasno zdravljenje z etanerceptom in metotreksatom, je bila pogostnost (delež pojavnosti) intersticijske bolezni pljuč 0,47 % (pogostnost: občasni).
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Slovenian: V nadzorovanih kliničnih preskušanjih etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) intersticijske bolezni pljuč pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,06 % (pogostnost: redki).
English: n = 196 wk 12
Slovenian: teden n = 196
English: The following instructions explain how to prepare and inject LIFMIOR.
Slovenian: V tem navodilu sta opisana priprava in dajanje injekcij zdravila LIFMIOR.
English: Then continue to inject the medicine on the usual day(s).
Slovenian: V tem primeru pozabljeni odmerek preskočite, nato pa nadaljujte z injiciranjem zdravila na predvideni dan (dneve).
English: Each vial of LIFMIOR 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Slovenian: Ena viala z zdravilom LIFMIOR 10 mg je namenjena za enkratno uporabo pri enem bolniku.
English: Each vial contains 25 mg of etanercept.
Slovenian: Ena viala vsebuje 25 mg etanercepta.
English: Cartons contain 4, 8 or 24 vials of LIFMIOR with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Slovenian: Ena škatla vsebuje 4, 8 ali 24 vial zdravila LIFMIOR, 4, 8 ali 24 z vehiklom napolnjenih injekcijskih brizg, 4, 8 ali 24 igel, 4, 8 ali 24 adapterjev za viale in 8, 16 ali 48 alkoholnih blazinic.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for LIFMIOR
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Purple needle safety shield
Slovenian: Beli pokrovček igle vijolični varnostni ščit igle
English: Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine, ki vsebuje 25 mg etanercepta.
English: If the child in your care has Wegener's granulomatosis, talk to your doctor.
Slovenian: Povejte zdravniku, če ima otrok, za katerega skrbite, Wegenerjevo granulomatozo.
English: Each vial should be used for just one dose in one patient, and any remaining solution should be discarded.
Slovenian: Ena viala je namenjena samo za aplikacijo enega odmerka enemu bolniku.
English: • If the child has psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Slovenian: Če ima otrok luskavico, se morate izogibati neposrednemu injiciranju v vsa privzdignjena, zadebeljena, rdeča ali luskava območja na koži ('psoriatične kožne spremembe').
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.
Slovenian: Če je treba, je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: 1 LIFMIOR vial
Slovenian: Vehikel za LIFMIOR subkutana uporaba
English: Adult patients had serum samples tested for autoantibodies at multiple timepoints.
Slovenian: Med zdravljenjem so odraslim bolnikom večkrat odvzeli vzorec seruma in ga pregledali na pojav avtoprotiteles.
English: Adult patients with plaque psoriasis
Slovenian: Odrasli bolniki s psoriazo v plakih
English: • Keep this leaflet.
Slovenian: • S podstavka vzemite vso vsebino.
English: Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Slovenian: Zdravnik vam lahko predpiše tudi 50 mg dvakrat na teden za največ 12 tednov, čemur sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: h. Preparing the injection site and injecting the LIFMIOR solution
Slovenian: Priprava mesta injiciranja in injiciranje raztopine zdravila LIFMIOR
English: 24a n = 193 wk 12
Slovenian: teden n = 193
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): alergijske reakcije; vročina; izpuščaj; srbenje; protitelesa proti normalnemu tkivu (nastanek avtoprotiteles).
English: Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC pre-filled pen after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na napolnjenem injekcijskem peresniku MYCLIC poleg oznake ''EXP''.
English: By looking though the inspection window, the solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein.
Slovenian: Pri pogledu skozi okence za pregledovanje mora biti raztopina bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: 50b
Slovenian: 1050 Bruxelles
English: • With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti-clockwise (see Diagram 12).
Slovenian: Vialo še vedno držite zasukano na glavo in odvijte brizgo iz adapterja tako, da jo zavrtite v nasprotno smer urnega kazalca (glejte sliko 12).
English: Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 1,0 ml raztopine, ki vsebuje 50 mg etanercepta.
English: Each vial of LIFMIOR contains 10 mg etanercept.
Slovenian: Ena viala zdravila LIFMIOR vsebuje 10 mg etanercepta.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with LIFMIOR (see section
Slovenian: Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom LIFMIOR, so poročali o primerih KVČB.
English: 28b a: p<0.001, LIFMIOR vs. placebo b: p = 0.002, LIFMIOR vs. placebo
Slovenian: ASAS 70 2 tedna 3 meseci 6 mesecev b a: p < 0,001, zdravilo LIFMIOR proti placebu b: p = 0,002, zdravilo LIFMIOR proti placebu
English: INFORMATION IN BRAILLE LIFMIOR 50 mg
Slovenian: LIFMIOR 50 mg
English: 25 mg BIW
Slovenian: 25 mg/0,5 ml
English: 50 mg QW
Slovenian: 50 mg/1 ml
English: 12b
Slovenian: Uvod b.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake ''EXP''.
English: 12 pre-filled syringes 12 alcohol swabs
Slovenian: 12 napolnjenih injekcijskih brizg 12 alkoholnih blazinic
English: LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe
Slovenian: LIFMIOR 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi LIFMIOR 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using LIFMIOR in patients who have congestive heart failure (CHF).
Slovenian: Zdravniki morajo biti previdni, kadar predpišejo zdravilo LIFMIOR bolnikom s kongestivnim srčnim popuščanjem (KSP).
English: Diagram 2
Slovenian: Slika 2
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because LIFMIOR 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: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with LIFMIOR.
Slovenian: Pri bolnikih, zdravljenih z zdravilom LIFMIOR, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
English: • Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Slovenian: Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri otroku kdaj pojavilo kongestivno srčno popuščanje.
English: Placing the needle on the syringe
Slovenian: Namestitev igle na injekcijsko brizgo
English: Each pack contains 4, 8 or 24 pre-filled syringes and 4, 8 or 24 alcohol swabs.
Slovenian: Eno pakiranje vsebuje 4, 8 ali 24 napolnjenih injekcijskih brizg in 4, 8 ali 24 alkoholnih blazinic.
English: Each vial of LIFMIOR 25 mg contains 25 mg of etanercept.
Slovenian: Ena viala zdravila LIFMIOR 25 mg vsebuje 25 mg etanercepta.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
Slovenian: V nadzorovanih kliničnih preskušanjih etanercepta za vse indikacije je bila pogostnost (delež pojavnosti) avtoimunskega hepatitisa pri bolnikih, ki so prejemali etanercept brez sočasnega metotreksata, 0,02 % (pogostnost: redki).
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''EXP''.
English: g. Choosing an injection site
Slovenian: Izbira mesta injiciranja
English: CARTON TEXT - (25 mg Pre-filled Syringe) - EU/1/16/1165/005-007
Slovenian: BESEDILO NA ŠKATLI - (25 mg napolnjena injekcijska brizga) - EU/1/16/1165/005-007
English: MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Slovenian: Za oceno vnetja ob izhodišču in po 12 ter 104 tednih so uporabili magnetnoresonančno slikanje sakroiliakalnega sklepa in hrbtenice.
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Slovenian: Pri nekaterih bolnikih, ki so prejemali zdravilo LIFMIOR, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: A biexponential curve is required to describe the concentration time curve of etanercept.
Slovenian: Krivulja koncentracije zdravila v odvisnosti od časa je pri etanerceptu bieksponencialna.
English: Detailed instructions on how to inject LIFMIOR are provided in section 7, “Using the MYCLIC pre-filled pen to inject LIFMIOR”.
Slovenian: Podrobna navodila o injiciranju zdravila LIFMIOR so v poglavju 7 “Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR”.
English: Women using LIFMIOR should not breast-feed, since LIFMIOR passes into human breast milk.
Slovenian: Zdravilo LIFMIOR prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom LIFMIOR ne smejo dojiti.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Slovenian: Pri uporabi zdravila LIFMIOR so poročali o redkih primerih demielinizacije centralnega in zelo redkih primerih demielinizacije perifernega živčevja.
English: Diagram 3
Slovenian: Slika 3