FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Rezultati za etanercept so bili statistično pomembno boljši od placeba po vseh kriterijih ACR, prav tako pa tudi po tistih merilih aktivnosti revmatoidnega artritisa, ki v kriterije odziva po ACR niso vključeni, na primer jutranja okorelost.
English: Remove one pre-filled pen from the carton that is stored in the refrigerator and leave at room temperature for at least 30 minutes before injecting.
Slovenian: Iz zunanje ovojnine odstranite en napolnjen injekcijski peresnik, shranjen v hladilniku, in ga pustite na sobni temperaturi vsaj 30 minut pred injiciranjem.
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Slovenian: starih od 2 do 18 let, so bile na splošno blage do zmerne in skladne s tistimi, ki jih pogosto vidimo pri skupinah ambulantnih pediatričnih bolnikov.
English: Methotrexate (n = 228)
Slovenian: (n = 228)
English: Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash); Listeria (a bacterial infection).
Slovenian: • Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): Karcinom Merklovih celic (vrsta kožnega raka); čezmerna aktivacija belih krvničk, povezanih z vnetjem (sindrom aktivacije makrofagov); ponovitev hepatitisa B (vnetje jeter); poslabšanje stanja, imenovanega dermatomiozitis (vnetje mišic in mišična oslabelost, ki ju spremlja kožni izpuščaj); listerija (bakterijska okužba).
English: Common to < 1/10
Slovenian: Pogosti ≥ 1/100 do < 1/10
English: • moderate or severe psoriasis.
Slovenian: • zmerno ali hudo luskavico.
English: Step 7:
Slovenian: 7. korak:
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Slovenian: Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B (HBV) in so se zdravili z antagonisti TNF, vključno z etanerceptom, so poročali o reaktivaciji hepatitisa B. Poročila vključujejo tudi reaktivacijo hepatitisa B pri anti-HBc pozitivnih, vendar HBsAg negativnih bolnikih.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week.
Slovenian: Običajni odmerek za zdravljenje poliartritisa ali razširjenega oligoartritisa pri bolnikih, starejših od 2 let in s telesno maso 62,5 kg ali več, in za zdravljenje artritisa, povezanega z entezitisom, ali psoriatičnega artritisa pri bolnikih, starejših od 12 let s telesno maso 62,5 kg ali več, je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: 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)
Slovenian: Radiografsko napredovanje: primerjava med etanerceptom, metotreksatom in kombinacijo etanercepta in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let (rezultati pri 12 mesecih)
English: • Do not twist or bend the needle cap while removing it, as this may damage the needle.
Slovenian: • Ne zvijajte in ne upogibajte pokrova igle, medtem ko ga odstranjujete, da ne poškodujete igle.
English: The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Slovenian: Povprečne najnižje serumske koncentracije v stanju dinamičnega ravnovesja so se v 12., 24. in 48. tednu gibale med 1,6 in 2,1 µg/ml.
English: 25 m g
Slovenian: 25 mg
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg × hr/l vs. 316 mg × hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively.
Slovenian: Pri bolnikih z revmatoidnim artritisom so bile povprečne koncentracije v serumu v stanju dinamičnega ravnovesja naslednje: pri zdravljenju z etanerceptom v odmerku 50 mg enkrat na teden (n = 21) je vrednost Cmax znašala 2,4 mg/l, vrednost Cmin 1,2 mg/l, delna AUC pa 297 mg × h/l, pri zdravljenju z etanerceptom v odmerku 25 mg dvakrat na teden (n = 16) pa je vrednost Cmax znašala 2,6 mg/l, vrednost Cmin 1,4 mg/l, delna AUC pa 316 mg × h/l.
English: Reintroduction of treatment with etanercept after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received etanercept without interruption of therapy based on results of open-label studies.
Slovenian: Po podatkih iz odprtih študij so bile velikosti odziva po ponovni uvedbi zdravljenja z etanerceptom po prekinitvah, ki so trajale do 24 mesecev, enake kot pri bolnikih, ki so prejemali etanercept brez prekinitve zdravljenja.
English: Benepali is supplied as a pre-filled syringe containing a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Slovenian: Zdravilo Benepali je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro do rahlo opalescentno, brezbarvno do bledorumeno raztopino za injiciranje (injekcija).
English: Etanercept 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: Etanercept so dobivali 6 mesecev zapored v odmerkih 25 mg enkrat na teden, 25 mg dvakrat na teden ali 50 mg dvakrat na teden.
English: • Do not touch this area again before giving the injection.
Slovenian: • Tega predela se do injiciranja več ne dotikajte.
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Slovenian: Infekcijske in parazitske bolezni okužba(vključno z okužbo zgornjih dihal, bronhitisom, cistitisom in okužbo kože)*
English: At week 12, more patients randomised to etanercept 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 etanerceptom kot v skupini s placebom.
English: With a quick, dart-like motion, insert the needle fully into the skin.
Slovenian: S hitrim gibom, podobnim metanju pikada podobnim metu sulice, zabodite iglo do konca v kožo.
English: Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Slovenian: Klinični odzivi pri bolnikih z nr-AxSpa, ki so prejemali etanercept, so bili vidni ob prvem obisku (po 2 tednih) in so se vzdrževali med celotnim 2-letnim zdravljenjem.
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 50 mg etanercept administered once weekly.
Slovenian: Psoriatični artritis, ankilozirajoči spondilitis in radiografsko nezaznavni aksialni spondilartritis Priporočeni odmerek je 25 mg etanercepta dvakrat na teden ali 50 mg enkrat na teden.
English: Step 2:
Slovenian: 2. korak:
English: The safety and efficacy profiles of the 50 mg once-weekly and 25 mg twice-weekly regimens were similar.
Slovenian: Profil varnosti in učinkovitosti je bil pri režimu dajanja 50 mg enkrat na teden podoben kot pri režimu dajanja 25 mg dvakrat na teden.
English: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept.
Slovenian: Pri bolnikih, zdravljenih z etanerceptom, so v obdobju trženja poročali o zelo redkih primerih karcinoma Merklovih celic.
English: The dose should be 50 mg once weekly.
Slovenian: Odmerek je 50 mg enkrat na teden.
English: Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
Slovenian: Bolnikom, ki tehtajo 62,5 kg ali več, lahko dajemo odmerke zdravila z napolnjeno injekcijsko brizgo ali napolnjenim injekcijskim peresnikom kot fiksni odmerek.
English: SC
Slovenian: PC
English: 50 mg/1 ml
Slovenian: 50 mg 1x/
English: The pen contains a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Slovenian: Injekcijski peresnik vsebuje bistro do rahlo opalescentno, brezbarvno do bledorumeno raztopino za injiciranje (injekcija).
English: Patients should be tested for HBV infection before initiating treatment with Benepali.
Slovenian: Pred uvedbo zdravljenja z zdravilom Benepali je treba bolnike testirati na okužbo s HBV.
English: There is insufficient evidence of the efficacy of etanercept in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Slovenian: Zaradi majhnega števila proučevanih bolnikov ni zadostnih dokazov glede učinkovitosti etanercepta pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in z artritisom mutilansom.
English: Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Slovenian: Zdravljenje psoriatičnega artritisa pri mladostnikih, starih 12 let in več, ki so se nezadostno odzvali na zdravljenje z metotreksatom ali ga niso prenašali.
English: 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 openlabel extension therapy.
Slovenian: 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 enteraceptom v času študije (prvi del, odprta) pojavila okužba.
English: Remissionc
Slovenian: Remisijac
English: No treatment was given for the majority of injection site reactions in the etanercept treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Slovenian: Večina bolnikov, pri katerih je zdravljenje le bilo potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide, ali peroralne antihistaminike.
English: Components inside the pre-filled pen may be broken.
Slovenian: Deli v napolnjenem injekcijskem peresniku so se morda zlomili.
English: These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Slovenian: Takšne bolnike je treba ves čas zdravljenja in še več tednov po prekinitvi zdravljenja spremljati glede znakov in simptomov aktivne okužbe s HBV. O sočasnem protivirusnem zdravljenju in zdravljenju z antagonisti TNF pri bolnikih, okuženih s HBV, ni zadostnih podatkov.
English: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Benepali, 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 Benepali in nemudoma obvestite zdravnika.
English: Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Slovenian: Po 12 mesecih zdravljenja je bilo radiografsko napredovanje pri bolnikih, ki so jih zdravili z etanerceptom, statistično pomembno počasnejše kot pri bolnikih, ki so jih zdravili z metotreksatom; kombinacija obeh zdravil pa je radiografsko napredovanje upočasnila statistično pomembno učinkoviteje kot eno samo zdravilo (glejte spodnjo sliko).
English: Etanercept (n = 223)
Slovenian: (n = 223)
English: Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Slovenian: Podobno so po 24 mesecih ugotovili tudi pomembne prednosti monoterapije z etanerceptom pred monoterapijo z metotreksatom.
English: For rheumatoid arthritis, Benepali is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Slovenian: Pri zdravljenju revmatoidnega artritisa se zdravilo Benepali običajno uporablja skupaj z metotreksatom.
English: Benepali should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Slovenian: Pri otrocih s poliartritisom ali z razširjenim oligoartritisom, mlajših od 2 let ali s telesno maso manj kot 62,5 kg, otrocih z artritisom, povezanim z entezitisom, ali s psoriatičnim artritisom, mlajših od 12 let ali s telesno maso manj kot 62,5 kg, in otrocih s psoriazo, mlajših od 6 let ali s telesno maso manj kot 62,5 kg, se zdravila Benepali običajno ne sme uporabljati.
English: Month 6
Slovenian: 6. mesec
English: Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva kožni eritematozni lupus, subakutni kožni eritematozni lupus, lupusu podoben sindrom
English: Thus, the combined use of Benepali and anakinra is not recommended (see sections 4.5 and 4.8).
Slovenian: Ta kombinacija ni pokazala povečane klinične koristi, zato uporaba zdravila Benepali skupaj z anakinro ni priporočljiva (glejte poglavji 4.5 in 4.8).
English: Benepali is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Slovenian: Zdravilo Benepali ni indicirano za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg.
English: • Do not remove the needle cap until you are ready to inject.
Slovenian: • Z igle ne odstranite pokrovčka, dokler niste pripravljeni na injiciranje.
English: Dispose of the entire syringe in an approved sharps container.
Slovenian: Celo prazno iglo odstranite v odobren vsebnik za ostre odpadke.
English: • Do not use the pre-filled pen if it has been dropped onto a hard surface.
Slovenian: • Ne uporabljajte napolnjenega injekcijskega peresnika, če je padel na trdo površino.
English: The Benepali pre-filled syringe is for a subcutaneous injection.
Slovenian: Napolnjen injekcijski peresnik z zdravilom Benepali je za subkutano injiciranje.
English: Τηλ: + 30 211 176 8555
Slovenian: Genesis Pharma S.A. Τηλ: + 30 211 176 8555
English: 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).
Slovenian: V študiji 1 je bil v 12. tednu delež bolnikov z odzivom PASI 75 pomembno večji v skupini, zdravljeni z etanerceptom (30 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
English: Step 4:
Slovenian: 4. korak:
English: Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.
Slovenian: saharoza, natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, voda za injekcije.
English: PC SN NN
Slovenian: SN NN
English: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Slovenian: Bolezni dihal, prsnega koša in mediastinalne ga prostora intersticijska bolezen pljuč (vključno s pnevmonitisom in pljučno fibrozo)*
English: • Very common (may affect more than 1 in 10 people):
Slovenian: • Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Patients received etanercept 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Slovenian: Bolniki so 12 tednov enkrat na teden prejemali etanercept v odmerku 0,8 mg/kg (do 50 mg) ali placebo.
English: CNS demyelinating cases 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
Slovenian: Bolezni živčevja demielinizirajoči primeri 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 Guillain
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Slovenian: (sindrom aktivacije makrofagov) *
English: After taking a syringe or a pen from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe or the pen to reach room temperature.
Slovenian: Ko napolnjeno injekcijsko brizgo ali peresnik vzamete iz hladilnika, počakajte približno 30 minut, da se raztopina zdravila Benepali v brizgi ali peresniku segreje na sobno temperaturo.
English: Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept.
Slovenian: Pri bolnikih, ki so bili zdravljeni z etanerceptom, so poročali o redkih primerih pancitopenije in zelo redkih primerih aplastične anemije, tudi s smrtnim izidom.
English: Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Slovenian: Študija 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki,
English: Inflammatory bowel disease
Slovenian: Bolezni prebavil vnetna črevesna bolezen
English: Placebo (n = 104)
Slovenian: (n = 104)
English: Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Slovenian: Med bolniki s psoriatičnim artritisom, ki so prejemali etanercept, so bili klinični odzivi vidni že pri prvem obisku (po 4 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks containing 8 (2 packs of 4) pre-filled syringes and multipacks containing 24 (6 packs of 4) pre-filled syringes.
Slovenian: Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, večodmerno pakiranje, ki vsebuje 8 (2 pakiranji po 4) napolnjenih injekcijskih brizg in večodmerno pakiranje, ki vsebuje 24 (6 pakiranj po 4) napolnjenih injekcijskih brizg.
English: • Rare (may affect up to 1 in 1,000 people):
Slovenian: • Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Inspect the solution: Look at the medicine through the viewing window.
Slovenian: Zdravilo preglejte skozi okence za pregledovanje.
English: Allergic reactions associated with etanercept administration have been reported commonly.
Slovenian: V povezavi z uporabo etanercepta so pogosto poročali o alergijskih reakcijah.
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 PASI 75 med
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received etanercept without interruption.
Slovenian: Dolgotrajna odzivnost na neprekinjeno zdravljenje z etanerceptom je bila v odprtih podaljšanih kliničnih preskušanjih potrjena za obdobja do 10 let.
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 napolnjenem injekcijskem peresniku Ena napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
English: • Very rare (may affect up to 1 in 10,000 people):
Slovenian: • Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: Psoriatic Arthritis Response
Slovenian: Odziv psoriatičnega artritisa
English: 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).
Slovenian: 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).
English: In part 2, patients with a clinical response at day 90 were randomised to remain on etanercept or receive placebo for four months and assessed for disease flare.
Slovenian: V drugem delu študije pa so bolnike s kliničnim odzivom na etanercept na 90. dan randomizirali v dve podskupini: ena je nadaljevala zdravljenje z etanerceptom, druga pa je nadaljnje štiri mesece prejemala placebo - pri obeh so ocenjevali ponoven izbruh bolezni.
English: Placebo (N = 105)
Slovenian: (n = 105)
English: Step 3:
Slovenian: 3. korak:
English: Allow the medicine to reach room temperature: Remove one pre-filled syringe from the refrigerator and leave at room temperature for at least 30 minutes before injecting.
Slovenian: Iz hladilnika vzemite eno napolnjeno injekcijsko brizgo in jo pustite na sobni temperaturi vsaj 30 minut pred injiciranjem.
English: • Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Benepali.
Slovenian: • Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom Benepali izpostavljeni noricam.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 mg/1 ml
English: Name and address of the manufacturer responsible for batch release Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød
English: Step 6:
Slovenian: 6. korak:
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 zdravljenja z etanerceptom, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
English: Solution for injection Multipack: 12 (3 packs of 4) pre-filled syringes
Slovenian: Večodmerno pakiranje: 12 (3 pakiranja s 4) napolnjenimi injekcijskimi peresniki
English: Solution for injection 4 pre-filled syringes
Slovenian: raztopina za injiciranje 4 napolnjene injekcijske brizge
English: Baseline Week 52
Slovenian: 52. teden
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Benepali 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 Benepali skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.