FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have an inadequate response to AMGEVITA 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Če odziv na zdravilo AMGEVITA 40 mg vsak drugi teden ne bo zadosten, bo zdravnik odmerek lahko povečal na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: In monotherapy, some patients who experience a decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo AMGEVITA 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Slovenian: redki levkemija neznana pogostnost karcinom Merkelovih celic (nevroendokrini karcinom kože)
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I−V.
Slovenian: V študijah revmatoidnega artritisa I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
English: Adults with plaque psoriasis
Slovenian: Odrasli z luskavico (psoriazo) v plakih
English: The usual AMGEVITA dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later, then 40 mg every other week.
Slovenian: Običajen odmerek zdravila AMGEVITA pri odraslih z ulceroznim kolitisom je 160 mg na začetku (kot štiri 40 mg injekcije v enem dnevu ali po dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje, nato pa 40 mg vsak drugi teden.
English: EU/1/16/1164/009 - 6 (3x2) multipack
Slovenian: EU/1/16/1164/009 - 6 (3x2) peresnikov v skupnem pakiranju
English: AMGEVITA works by reducing this inflammation.
Slovenian: Zdravilo AMGEVITA deluje tako, da zmanjša tako vnetje.
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije na en dan ali kot dve 40 mg injekciji na dan dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
English: AMGEVITA 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba v 0,8 ml (50 mg/ml) raztopine.
English: Treatment with AMGEVITA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom AMGEVITA prekiniti.
English: • inflammations.
Slovenian: • cepljenja.
English: Liver failure1)
Slovenian: kožni vaskulitis lihenoidna reakcija kože1)
English: Sustained remission
Slovenian: Avtoimunska dogajanja
English: Low dose 20/10 mg eow N = 95
Slovenian: Majhen odmerek 20/10 mg vsak drugi teden N = 95
English: Week 104
Slovenian: 4. teden
English: AMGEVITA 40 mg solution for injection in pre-filled pen adalimumab
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila AMGEVITA med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: Label expiration date
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: Plunger rod
Slovenian: Valj brizge
English: Label and expiration date
Slovenian: Nalepka brizge in rok uporabnosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJEN INJEKCIJSKI PERESNIK (brez modrega okenca)
English: Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
Slovenian: pogosti karcinom kože, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom,) benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice), melanom**
English: Grab the syringe barrel to remove the syringe from the tray.
Slovenian: Da vzamete brizgo iz pretisnega omota, primite za valj brizge.
English: Some patients who experience decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo AMGEVITA 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila AMGEVITA na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila AMGEVITA pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciran v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciran v obliki dveh 40 mg injiciranj v enem dnevu).
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri 1 od 100 bolnikov)
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period.
Slovenian: Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
English: The recommended dose of AMGEVITA for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Slovenian: Priporočeno odmerjanje zdravila AMGEVITA za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: NA 9.5% 41.5%
Slovenian: Tednu 65,1 %.
English: The 40 mg pre-filled pen cannot be used for the 20 mg dose.
Slovenian: 40 mg napolnjeni injekcijski peresnik se ne more uporabljati za odmerek 20 mg. Za odmerek 20 mg je na voljo zdravilo AMGEVITA 20 mg v napolnjeni injekcijski brizgi.
English: ● Do not twist or bend the needle cap.
Slovenian: ● Ne sučite ali upogibajte pokrovčka igle.
English: The recommended dose of AMGEVITA for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Priporočeni začetni odmerek zdravila AMGEVITA za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION AMGEVITA 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z enim odmerkom vsebuje 20 mg adalimumaba v 0,4 ml (50 mg/ml) raztopine.
English: NA 24.0% 58.9%
Slovenian: 52. teden 62,6 % 54,4 % 104. teden 56,0 % 49,3 % ACR 50
English: AMGEVITA is administered via subcutaneous injection.
Slovenian: Zdravilo AMGEVITA se odmerja v obliki subkutane injekcije.
English: The recommended AMGEVITA dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Slovenian: Psoriaza v plakih pri pediatričnih bolnikih Priporočeni odmerek zdravila AMGEVITA pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: There is no relevant use of AMGEVITA in children aged less than 12 years in this indication.
Slovenian: Uporaba zdravila AMGEVITA pri otrocih, mlajših od 12 let, za to indikacijo ni primerna.
English: Paediatric plaque psoriasis efficacy results at 16 weeks
Slovenian: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg The recommended dose of AMGEVITA is 20 mg every other week.
Slovenian: Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg Običajni odmerek zdravila AMGEVITA je 20 mg vsak drugi teden z metotreksatom.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new onset lupus-like syndrome.
Slovenian: V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, zdravljenih z adalimumabom.
English: The usual dose for adults with plaque psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z luskavico (psoriazo) v plakih je 80 mg (kot dve 40 mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: • cancer;
Slovenian: • rak,
English: Week 12 Week 24
Slovenian: 2. teden 12. teden 24. teden ASAS 70
English: EU/1/16/1164/003 - 2 pack
Slovenian: EU/1/16/1164/003 - 2 brizgi
English: Maintenance Dose
Slovenian: Začetni odmerek
English: Week 2 Week 12 Week 24
Slovenian: 2. teden 12. teden 24. teden BASDAIb 50 2. teden 12. teden 24. teden
English: A. Remove one AMGEVITA pre-filled pen from the package.
Slovenian: A. Vzemite en napolnjen injekcijski peresnikzdravila AMGEVITA iz škatle.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with AMGEVITA cannot be excluded (see section 4.8).
Slovenian: Potrebno je upoštevati potencialno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila AMGEVITA.Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo AMGEVITA, ni mogoče izključiti (glejte poglavje
English: EU/1/16/1164/004 - 4 pack
Slovenian: EU/1/16/1164/004 - 4 brizge
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/002 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/002 1 brizga
English: EU/1/16/1164/007 - 2 pack
Slovenian: EU/1/16/1164/007 - 2 peresnika
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Slovenian: Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/005
English: 0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 20 mg adalimumaba v 0,4 ml raztopine ali 40 mg adalimumaba v 0,8 ml raztopine.
English: • eye inflammation;
Slovenian: • okužba očesa;
English: Induction of clinical remission and response (percent of patients)
Slovenian: Indukcija klinične remisije in odziva (odstotek bolnikov) Študija pri Crohnovi bolezni I:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/009
English: MTX
Slovenian: RTa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA NAPOLNJEN INJEKCIJSKI PERESNIK
English: Intestinal infections (including gastroenteritis viral), Skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), Ear infections,
Slovenian: Neželeni učinki pogosti sistemske okužbe (vključno s sepso, kandidiazo in gripo), črevesne okužbe (vključno z virusnim gastroenteritisom), okužbe kože in mehkih tkiv (vklučno z zanohtnico, celulitisom, impetigom, nekrotizirajočim fasciitisom in herpes zostrom), okužbe ušes, okužbe ustne votline (vključno s herpesom simpleksom, ustnim herpesom in okužbami zob), okužbe reproduktivnega trakta (vključno z vulvovaginalno mikotično okužbo), okužbe urinarnega trakta (vključno s pielonefritisom), glivične okužbe, okužbe sklepov občasni okužbe centralnega živčevja (vključno z virusnim meningitisom), oportunistične okužbe in tuberkuloza (vključno s kokidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium), bakterijske okužbe, okužbe oči, divertikulitis1)
English: Using your AMGEVITA pre-filled syringe
Slovenian: Uporaba napolnjene injekcijske brizge zdravila AMGEVITA
English: EU/1/16/1164/004 4 pack
Slovenian: EU/1/16/1164/004 4 brizge
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED SYRINGE (with blue box)
Slovenian: ŠKATLA ZA SKUPNO PAKIRANJE NAPOLNJENIH INJEKCIJSKIH PERESNIKOV (z modrim okencem)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 20 mg of adalimumab in 0.4 mL of solution.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 20 mg adalimumaba v 0,4 ml raztopine.
English: EU/1/16/1164/003 2 pack
Slovenian: EU/1/16/1164/003 2 brizgi
English: There is no relevant use of AMGEVITA in children aged less than 2 years in this indication.
Slovenian: Uporaba zdravila AMGEVITA pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
English: AMGEVITA 40 mg solution for injection in pre-filled syringe.
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: Erythema multiforme1), Stevens-Johnson syndrome1), Angioedema1), Cutaneous vasculitis1) Lichenoid skin reaction1)
Slovenian: srbenje občasni nočno potenje, brazgotinjenje redki multiformni eritem sindrom Stevens-Johnson1),
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/006 1 pack
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1164/006 1 peresnik
English: AMGEVITA single use pre-filled syringe For subcutaneous use
Slovenian: Zdravilo AMGEVITA napolnjena injekcijska brizga za enkratno uporabo Za subkutano uporabo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 40 mg of adalimumab in 0.8 mL of solution.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba v 0,8 ml raztopine.
English: Adalimumabb / MTXc n = 207
Slovenian: adalimumab b/ MTXc n = 207
English: NAME OF THE MEDICINAL PRODUCT AMGEVITA 20 mg solution for injection in pre-filled syringe adalimumab
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: Pulmonary fibrosis1)
Slovenian: redki pljučna fibroza
English: • rash;
Slovenian: • rak;
English: EU/1/16/1164/008 - 4 pack
Slovenian: EU/1/16/1164/008 - 4 peresniki
English: Very common Leukopenia (including neutropenia and agranulocytosis), Anaemia
Slovenian: zelo pogosti levkopenija (vključno z nevtropenijo in agranulocitozo), anemija pogosti levkocitoza, trombocitopenija občasni idiopatska trombocitopenična purpura redki pancitopenija
English: p-valuea p-valueb p-valuec
Slovenian: P vrednos t b
English: EU/1/16/1164/007 2 pack
Slovenian: EU/1/16/1164/007 2 peresnika
English: combined.
Slovenian: Sestavni deli
English: if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating AMGEVITA therapy.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom AMGEVITA opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
English: AMGEVITA Dose for Paediatric Patients with Uveitis Patient Weight
Slovenian: Odmerjanje zdravila AMGEVITA pri pediatričnih bolnikih z uveitisom Masa bolnika
English: ● Do not shake the pre-filled pen.
Slovenian: ● Ne stresajte napolnjenega injekcijskega peresnika.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.4 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Slovenian: * p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide
English: paleness.
Slovenian: • vnetja.
English: Adalimumab 0.8 mg/kg eow N = 38
Slovenian: adalimumab 0,8 mg/kg vsak drugi teden N = 38
English: Pinch method
Slovenian: Brez metotreksata
English: Induction Dose
Slovenian: Zaviranje vnetja
English: Room spinning sensation and vision disturbances may occur after taking AMGEVITA.
Slovenian: Po dajanju zdravila AMGEVITA se lahko pojavita vrtoglavica in poslabšanje vida.
English: PASI 75b
Slovenian: PASI ≥ 75
English: Syringe barrel
Slovenian: Zapora tankega črevesa
English: Gastroesophageal reflux disease, Sicca syndrome
Slovenian: Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv
English: In some cases, serious complications have occurred.
Slovenian: V nekaterih primerih je prišlo do resnih zapletov.
English: Patients subsequently entered an extension study for a further 96 weeks.
Slovenian: Bolniki so bili nato vključeni v podaljšano študijo za nadaljnjih 96 tednov.
English: These events were not life-threatening, but led to hospitalisation.
Slovenian: Ti dogodki niso bili življenjsko nevarni, vendar so povzročili hospitalizacijo.
English: Date of first authorisation: 30 January 2014 Date of latest renewal: 20 September 2018
Slovenian: Datum prve odobritve: 30. januar 2014 Datum zadnjega podaljšanja: 20. september 2018
English: Take this starting dose for the first 7 days, then take the regular dose.
Slovenian: Ta začetni odmerek jemljite prvih 7 dni, nato pa jemljite redni odmerek.
English: Sun as a symbol Moon as a symbol
Slovenian: Sonce za simbol Luna za simbol
English: Your doctor may reduce your dose.
Slovenian: Zdravnik lahko vaš odmerek zmanjša.
English: DK - 3400 Hillerød Denmark
Slovenian: DK - 3400 Hillerød Danska
English: This may also help to delay future worsening of your MS.
Slovenian: Pomaga lahko tudi pri zakasnitvi poslabšanja MS v prihodnje.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Slovenian: Zdravnik vam bo svetoval glede tega, ali morate prejeti druge vrste cepiv (neživa cepiva).
English: Blood/laboratory tests
Slovenian: Krvni/laboratorijski testi
English: Your doctor will test these periodically during treatment.
Slovenian: Zdravnik bo te preiskave opravljal periodično med zdravljenjem.
English: These symptoms may disappear completely when the relapse is over, but some problems may remain.
Slovenian: Ti simptomi lahko povsem izginejo, ko recidiv mine, vendar pa lahko nekatere težave ostanejo.
English: These events may occur at any time during treatment.
Slovenian: Ti dogodki se lahko pojavijo kadar koli med zdravljenjem.
English: There were no effects on fertility in the F1 offspring.
Slovenian: Učinkov na plodnost pri F1 potomcih ni bilo.
English: The need for further MRI scanning should be considered in accordance with national and local recommendations.
Slovenian: Potrebo po dodatnem slikanju z MR je treba pretehtati v skladu z nacionalnimi in lokalnimi priporočili.
English: Subjects with progressive forms of MS were not included in these studies.
Slovenian: Bolniki s progresivnimi oblikami MS v ti študiji niso bili vključeni.
English: Do not reduce your dose unless your doctor tells you to.
Slovenian: Ne zmanjšajte svojega odmerka, razen če vam je zdravnik tako naročil.
English: Swallow each capsule whole, with some water.
Slovenian: Vsako kapsulo pogoltnite celo z nekaj vode.
English: This leaflet was last revised in {MM YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
English: The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Slovenian: Pogostnosti hudih alergijskih reakcij ni mogoče oceniti iz razpoložljivih podatkov (neznana).
English: Reduced white blood cells could mean your body is less able to fight an infection.
Slovenian: Zmanjšano število belih krvnih celic lahko pomeni, da je vaše telo manj sposobno, da se bori proti okužbam.
English: Otherwise the patient should wait until the next scheduled dose.
Slovenian: V nasprotnem primeru mora bolnik počakati do naslednjega načrtovanega odmerka.
English: However, these changes did not affect fertility or the number of viable fetuses produced.
Slovenian: Vendar pa te spremembe niso vplivale na plodnost ali število zarodkov, ki so bili sposobni preživeti.
English: Lymphocyte counts should be followed until recovery.
Slovenian: Število limfocitov je treba spremljati do okrevanja.
English: The Tmax of monomethyl fumarate is 2 to 2.5 hours.
Slovenian: Absorpcija Tmax monometil fumarata je 2 do 2,5 ure.
English: - medicines that affect the body's immune system including other medicines used to treat
Slovenian: - zdravila, ki vplivajo na imunski sistem telesa, vključno z drugimi zdravili za zdravljenje
English: Mean values for both parameters remained within normal range.
Slovenian: Povprečne vrednosti obeh parametrov so ostale znotraj normalnih vrednosti.
English: PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
Slovenian: PML je oportunistična okužba, ki jo povzroča virus John-Cunningham (JC) in ki je lahko smrtna ali pa povzroči hudo prizadetost.
English: Herpes zoster1
Slovenian: neznana herpes zoster1