FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean number of new T1 hypointense lesions
Slovenian: Povprečno število novih hipointenzivnih lezij T1
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema limfadenopatija†
English: Although the effect on disability progression was mainly seen in patients with baseline EDSS < 3.5, evidence of efficacy was shown in patients with relapsing secondary progressive MS (SPMS) as defined by baseline EDSS ≥ 3.5 and at least one of the three: confirmed 24 week worsening of EDSS, or ≥ 20% decline on Timed 25-foot Walk (T25FW), or, ≥ 20% decline on 9-Hole Peg Test (9HPT).
Slovenian: so bili dokazi o učinkovitosti opazni tudi pri bolnikih z recidivno sekundarno progresivno multiplo sklerozo (SPMS), kot to opredeljuje izhodiščni EDSS ≥ 3,5 in vsaj eden od treh: 24-tedensko potrjeno poslabšanje EDSS ali ≥ 20 % upad pri časovno omejeni hoji na 25 čevljev (=7,62 m) (T25FW
English: If a patient develops severe depression, and/or suicidal ideation, discontinuation of Zinbryta should be considered (see section 4.8).
Slovenian: Če se pri bolniku razvijejo huda depresija in/ali samomorilne misli, je treba razmisliti o prekinitvi uporabe zdravila Zinbryta (glejte poglavje 4.8).
English: No impact on male or female fertility as assessed by fertility indices was detected in animal studies (see section 5.3).
Slovenian: V študijah na živalih niso opazili vpliva na plodnost pri samcih ali samicah, ocenjeno z indeksom plodnosti (glejte poglavje 5.3).
English: Zinbryta significantly reduced the ARR and the risk of relapse, compared to interferon beta-1a (intramuscular)-treated patients.
Slovenian: Zdravilo Zinbryta je značilno zmanjšalo ARR in tveganje za recidiv v primerjavi z bolniki, zdravljenimi z interferonom beta-1a (intramuskularno).
English: Zinbryta is for subcutaneous use.
Slovenian: Zdravilo Zinbryta se uporablja subkutano.
English: Throw away any Zinbryta that is accidentally frozen.
Slovenian: Zdravilo Zinbryta, ki je bilo pomotoma zamrznjeno, zavrzite.
English: Try to do your injection on the same day each month, to help you remember it. For example, inject on the first day of each month.
Slovenian: Na primer, injicirajte si ga prvi dan vsakega meseca.
English: This can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Slovenian: To lahko pomaga pri zmanjšanju števila recidivov, ki jih imate, in upočasni onesposabljajoče učinke MS. Zdravljenje z zdravilom Zinbryta lahko pomaga preprečiti slabšanje bolezni, vendar MS ne ozdravi.
English: Re-capping could cause the pen to lock.
Slovenian: Ponovno pokrivanje s pokrovčkom bi lahko napolnjen injekcijski peresnik zaklenilo.
English: • skin infection (folliculitis, acne)
Slovenian: • okužba kože (folikulitis, akne)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1107/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1107/001
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Zinbryta 150 mg injekcija daklizumab s.c.
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.24 [95% CI: 0.09, 0.63].
Slovenian: Poleg tega je bil pri bolnikih, zdravljenih z zdravilom Zinbryta, statistično značilen učinek na 24-tedensko potrjeno napredovanje bolezni z razmerjem ogroženosti 0,24 [95 % IZ: 0,09, 0,63].
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.73 [95% CI: 0.55, 0.98].
Slovenian: Poleg tega je bil pri bolnikih, zdravljenih z zdravilom Zinbryta, statistično značilen učinek na 24-tedensko potrjeno napredovanje bolezni z razmerjem ogroženosti 0,73 [95 % IZ: 0,55, 0,98].
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI SKUPNO NOTRANJE PAKIRANJE (brez podatkov za t.i. modro okno)
English: Treatment initiation is not recommended in patients with history of concurrent autoimmune conditions other than multiple sclerosis.
Slovenian: Uvedba zdravljenja ni priporočljiva pri bolnikih, ki imajo poleg multiple skleroze tudi anamnezo drugih sočasnih avtoimunskih bolezni.
English: • inflamed or enlarged lymph nodes (lymphadenopathy, lymphadenitis)
Slovenian: • vnete ali povečane bezgavke (limfadenopatija, limfadenitis)
English: Step 7: Remove the pre-filled syringe from your injection site
Slovenian: 7. korak: Napolnjeno injekcijsko brizgo odstranite z mesta injiciranja
English: Only one dose should be administered at a time to make up for a missed dose.
Slovenian: Za nadomestitev izpuščenega odmerka naj se aplicira le en odmerek.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1107/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1107/002
English: A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen.
Slovenian: Napolnjena injekcijska brizga zdravila Zinbryta je vgrajena v napolnjen injekcijski peresnik z vzmetjo, ki se imenuje napolnjen injekcijski peresnik Zinbryta.
English: • You do not see the green stripes in the injection status window.
Slovenian: • v oknu za stanje injiciranja ne vidite zelenih črt,
English: In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was <1% with Zinbryta.
Slovenian: V kliničnih študijah je zdravilo Zinbryta povečalo incidenco depresije [5 % v primerjavi z 1 % (placebo); 8 % v primerjavi s 6 % (interferon beta-1a (intramuskularno))]; incidenca resnih reakcij depresije z zdravilom Zinbryta je bila < 1 %.
English: Clinical endpoints Number of patients Annualised relapse rate Rate ratio [95% CI]
Slovenian: Klinični opazovani dogodki Število bolnikov Letna stopnja recidivov* Razmerje pogostnosti * [95 % IZ]
English: Total NK cell counts increased approximately 1.5-fold as a result of the change in CD56bright NK cells.
Slovenian: Skupno število naravnih celic ubijalk se je povečalo za približno 1,5-krat kot posledica spremembe pri naravnih celicah ubijalkah
English: Check the expiry date.
Slovenian: Preverite rok uporabnosti.
English: If a patient develops a diffuse or highly inflammatory rash, referral to a dermatologist and discontinuation of Zinbryta may be required (see section 4.8).
Slovenian: Če se pri bolniku razvije difuzni ali močni vnetni izpuščaj, je morda potrebna napotitev k dermatologu in prekinitev uporabe zdravila Zinbryta (glejte poglavje 4.8).
English: • Keep the Zinbryta pre-filled syringe/pen in its original package to protect from light.
Slovenian: • Napolnjeno injekcijsko brizgo/Napolnjen injekcijski peresnik shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: You should see green stripes.
Slovenian: Videti morate zelene črte.
English: Referring patients who develop symptoms of colitis (e.g. abdominal pain, fever, prolonged diarrhoea) to a specialist is advisable (see section 4.8).
Slovenian: Pri bolnikih, pri katerih se razvijejo simptomi kolitisa (npr. bolečina v trebuhu, zvišana telesna temperatura, dolgotrajna driska), se svetuje napotitev k specialistu (glejte poglavje 4.8).
English: • Uncommon (≥1/1,000 to <1/100)
Slovenian: • občasni (≥1/1.000 do <1/100)
English: When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3).
Slovenian: Limfopenija, ki so jo opazili med kliničnimi študijami z zdravilom Zinbryta je bila običajno blaga do zmerna (≥ 500/mm3).
English: The SELECT study was double-blind, randomised, placebo-controlled, with either Zinbryta 150 mg (n=208), or 300 mg (n=209) versus placebo (n=204) every 4 weeks for 52 weeks.
Slovenian: Študija SELECT je bila dvojno slepa, randomizirana, s placebom nadzorovana študija, v kateri so bolniki 52 tednov prejemali zdravilo Zinbryta 150 mg (n = 208) ali 300 mg (n = 209) oziroma placebo (n = 204) vsake 4 tedne.
English: Instructions for injecting Zinbryta
Slovenian: Navodila za injiciranje zdravila Zinbryta
English: • Rare (≥1/10, 000 to <1/1,000)
Slovenian: • redki (≥1/10.000 do <1/1.000)
English: • It is expired.
Slovenian: • je potekel rok uporabnosti,
English: (See Figure H.)
Slovenian: (Glejte sliko H.)
English: • Check the expiry date on the Zinbryta prefilled syringe (See Figure D).
Slovenian: • Preverite rok uporabnosti zdravila Zinbryta napolnjena injekcijska brizga (glejte sliko D).
English: In clinical studies, Zinbryta increased the incidence of infections [50% vs 44% (placebo) and 65% vs 57% (interferon beta-1a (intramuscular))] and serious infections [3% vs 0% (placebo); 4% vs 2% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
Slovenian: V kliničnih študijah je zdravilo Zinbryta povečalo incidenco okužb [50 % v primerjavi s 44 % (placebo); 65 % v primerjavi s 57 % (interferon beta-1a (intramuskularno))] in resnih okužb [3 % v primerjavi z 0 % (placebo); 4 % v primerjavi z 2 % (interferon beta-1a (intramuskularno))] v primerjavi s placebom in interferonom beta-1a (intramuskularno).
English: Very common side effects (These may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (Pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular)
Slovenian: †Opaženo z incidenco, ki je ≥ 2 % večja kot pri interferonu beta-1a (intramuskularno)
English: Zinbryta can be stored at room temperature (up to 30oC) in the original pack for 30 days.
Slovenian: Zdravilo Zinbryta lahko 30 dni shranjujete pri sobni temperaturi (do 30 °C) v originalni ovojnini.
English: Preparing for your injection
Slovenian: Priprava na injiciranje
English: • alcohol wipe
Slovenian: • alkoholni robček
English: Each dose of Zinbryta contains 0.14 mmol sodium.
Slovenian: Zdravilo Zinbryta vsebuje majhno količino natrija Vsak odmerek zdravila Zinbryta vsebuje 0,14 mmol natrija.
English: In clinical studies Zinbryta increased the incidence of skin reactions [18% vs 13% (placebo); 37% vs 19% (interferon beta-1a (intramuscular))] and serious skin reactions [<1% vs 0% (placebo); 2% vs <1% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
Slovenian: V kliničnih študijah je zdravilo Zinbryta povečalo incidenco kožnih reakcij [18 % v primerjavi s 13 % (placebo); 37 % v primerjavi s 19 % (interferon beta-1a (intramuskularno))] in resnih kožnih reakcij [< 1 % v primerjavi z 0 % (placebo); 2 % v primerjavi z < 1 % (interferon beta-1a (intramuskularno)] v primerjavi s placebom in interferonom beta-1a (intramuskularno).
English: You will need: - a blood test before starting treatment to check your liver function and if you have hepatitis B
Slovenian: Morali boste: - opraviti krvno preiskavo pred začetkom zdravljenja, s katero bodo preverili delovanje vaših jeter in se prepričali, ali imate hepatitis B ali C. Če bo vaša krvna preiskava pokazala, da imate kakšne težave z jetri, bo zdravnik odločil o tem, ali boste začeli prejemati zdravilo Zinbryta;
English: • Each pen can be used once only.
Slovenian: • En napolnjen injekcijski peresnik lahko uporabite samo enkrat.
English: The Patient Card should:
Slovenian: Opozorilna kartica za bolnika mora:
English: Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution.
Slovenian: Napolnjena injekcijska brizga iz stekla (tip I) z gumijastim zamaškom in termoplastičnim togim varovalom za iglo, ki vsebuje 1 ml raztopine.
English: (See Figure I.)
Slovenian: (Glejte sliko I.)
English: Skin reactions: (Common - may affect up to 1 in 10 people)
Slovenian: Reakcije na koži: (Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Zinbryta pre-filled syringe should be injected into the abdomen, thigh, or the back of the upper arm (see Figure F).
Slovenian: Zdravilo Zinbryta napolnjena injekcija brizga se injicira v trebuh, stegno ali hrbtno stran nadlahti (glejte sliko F).
English: Daclizumab is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Slovenian: Ne pričakuje se, da bi se daklizumab izločal skozi ledvice ali presnavljal z jetrnimi encimi (glejte poglavje 4.2).
English: Step 2: Check The Zinbryta Pre-filled Syringe
Slovenian: 2. korak: Preglejte zdravilo Zinbryta napolnjena injekcijska brizga
English: Your doctor will tell you how long you need to keep using Zinbryta.
Slovenian: Kako dolgo morate uporabljati zdravilo Zinbryta Vaš zdravnik vam bo povedal, kako dolgo boste morali uporabljati zdravilo Zinbryta.
English: Percentage with 12 weeks confirmed disability progression
Slovenian: Odstotek z 12-tedenskim potrjenim napredovanjem bolezni
English: Do not re-cap the pen.
Slovenian: Bata ne vlecite nazaj.
English: Multipack: 3 (3 packs of 1) pre-filled syringes.
Slovenian: Skupno pakiranje: 3 (3 pakiranja z 1) napolnjene injekcijske brizge Skupno pakiranje: 3 (3 pakiranja z 1) napolnjeni injekcijski peresniki
English: In the active-controlled study (the DECIDE study), 919 patients received Zinbryta (150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular, (30 microgram weekly) for a minimum of 2 years and up to 3 years.
Slovenian: V študiji, nadzorovani z učinkovino (študija DECIDE), je vsaj 2 leti in največ 3 leta 919 bolnikov prejemalo zdravilo Zinbryta (150 mg, vsake 4 tedne), 922 bolnikov pa je prejemalo interferon beta-1a intramuskularno (30 mikrogramov na teden).
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can. Then carry on as normal, sticking to your usual injection day.
Slovenian: • Če izpustite odmerek in sta od pozabljenega odmerka minila manj kot 2 tedna, si ga injicirajte takoj, ko lahko.
English: (See Figure J.)
Slovenian: (Glejte sliko J.)
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina†
English: If your MS does not respond to Zinbryta, your doctor may decide to stop your treatment with Zinbryta.
Slovenian: Če se vaša MS ne odziva na zdravilo Zinbryta, zdravnik lahko odloči,
English: • infections of the airways, such as coughs and colds (nasopharyngitis, upper respiratory tract infection)
Slovenian: • okužbe dihal, kot sta kašelj ali prehlad (nazofaringitis, okužba zgornjih dihal); • zvišanje jetrnih encimov v krvi (to pokažejo krvne preiskave).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON (with blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI SKUPNO ZUNANJE PAKIRANJE (s podatki za t.i. modro okno)
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Slovenian: Prepričajte se, da lahko vidite zelene črte v oknu za stanje injiciranja
English: At steady state, daclizumab mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentrationtime curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Slovenian: daklizumaba približno 30 mikrogramov/ml, 15 mikrogramov/ml in 640 dan*mikrogramov/ml, s približno 40-odstotno variabilnostjo med bolniki (% CV).
English: Talk to your doctor before using Zinbryta: - if you have any other autoimmune disorders in addition to MS - if you are taking, have recently taken or might take any other medicines and herbal supplements.
Slovenian: - če imate poleg MS še kakšne druge avtoimunske bolezni; - če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati kakšna druga zdravila in pripravke rastlinskega izvora.
English: Daclizumab has not been studied in patients with renal impairment.
Slovenian: Daklizumaba niso preučevali pri bolnikih z okvaro ledvic.
English: Depression: (Uncommon - may affect up to 1 in 100 people)
Slovenian: Depresija: (Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov)
English: • the solution is any other colour than colourless to slightly yellow.
Slovenian: • raztopina ni brezbarvna do rumenkasta, temveč drugačne barve.
English: The syringe inside the pen is a pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield, containing 1 mL of solution.
Slovenian: Injekcijska brizga v napolnjenem injekcijskem peresniku je iz stekla (tip I) z zamaškom iz gume in termoplastičnim togim varovalom za iglo, ki vsebuje 1 ml raztopine.
English: External heat sources such as hot water must not be used to warm Zinbryta.
Slovenian: Za ogrevanje zdravila Zinbryta ni dovoljeno uporabljati zunanjih virov toplote, na primer tople vode.
English: Do not use the Zinbryta pre-filled syringe if the liquid is cloudy, or has floating particles in it. o You might see air bubbles in the Zinbryta medicine.
Slovenian: Ne uporabljajte zdravila Zinbryta napolnjena injekcijska brizga, če je tekočina motna ali vsebuje plavajoče delce.
English: Contents of the pack and other information Instructions for injecting Zinbryta
Slovenian: Shranjevanje zdravila Zinbryta Vsebina pakiranja in dodatne informacije Navodila za injiciranje zdravila Zinbryta
English: † MRI analyses used evaluable dataset for each MRI endpoint.
Slovenian: † Pri analizah MR slikanja so uporabili ovrednotene nabore podatkov za vsak opazovani dogodek MR slikanja.
English: Try to keep to a particular day of the month to help remember your injection.
Slovenian: Injekcijo si dajte vsak mesec na isti dan, da se boste lažje spomnili.
English: How to inject Zinbryta
Slovenian: Kako injicirati zdravilo Zinbryta
English: Zinbryta will be prescribed to you by a doctor experienced in the treatment of MS.
Slovenian: Kako uporabljati zdravilo Zinbryta Zdravilo Zinbryta vam bo predpisal zdravnik z izkušnjami z zdravljenjem MS.
English: Serious reactions, including autoimmune hepatitis, hepatitis and jaundice, were observed in 1.7% of patients in clinical trials.
Slovenian: Pri 1,7 % bolnikov v kliničnih preskušanjih so opazili resne reakcije, vključno z avtoimunskim hepatitisom, hepatitisom in zlatenico.
English: A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.
Slovenian: Na injekcijsko brizgo je pritrjena 0,5-palčna igla velikosti 29 G.
English: Discontinuation of Zinbryta due to infections was <1%.
Slovenian: Do prekinitve zdravljenja z zdravilom Zinbryta zaradi okužb je prišlo pri < 1 %.
English: Step 3: Check the Zinbryta Pen (Figure C) a.
Slovenian: 3. korak: Preglejte zdravilo Zinbryta napolnjen injekcijski peresnik (slika C) a.
English: Caution is recommended when administering medicinal products of known hepatotoxic potential including non-prescription products and herbal supplements concomitantly with Zinbryta (see section 4.4).
Slovenian: Pri dajanju zdravil z znanim hepatotoksičnim potencialom, vključno z zdravili, ki so na voljo brez recepta, in pripravki rastlinskega izvora, sočasno z zdravilom Zinbryta je potrebna previdnost (glejte poglavje 4.4).
English: Step 7: Remove the Zinbryta Pen from your injection site a.
Slovenian: 7. korak: Zdravilo Zinbryta napolnjen injekcijski peresnik odstranite z mesta injiciranja a.
English: Do not share Zinbryta pre-filled syringe with anyone else.
Slovenian: Zdravila Zinbryta napolnjena injekcijska brizga ne delite z drugimi.
English: Discontinuation due to lymphadenopathy was <1% in Zinbryta-treated patients.
Slovenian: Zaradi limfadenopatije je zdravljenje prekinilo < 1 % bolnikov, zdravljenih z zdravilom Zinbryta.
English: During Zinbryta treatment, mean cell counts for the major immune subsets (T, B, and NK cells) remained within normal ranges; total lymphocyte, T
Slovenian: Med zdravljenjem z zdravilom Zinbryta je ostalo povprečno število celic glavnih imunskih podskupin (celice T, B in naravne celice ubijalke) znotraj normalnih razponov; skupno število limfocitov, celic T in B se je povprečno zmanjšalo za ≤ 10 % od izhodišča v prvem letu zdravljenja.
English: Step 1: Collect your supplies and wash your hands Use a well-lit, clean, flat surface to work on, like a table.
Slovenian: 1. korak: Priskrbite si pripomočke in si umijte roke Poiščite dobro osvetljeno, čisto, ravno površino, na primer mizo, in nanjo položite vse pripomočke, ki jih potrebujete za samoinjiciranje ali za injiciranje.
English: Skin reactions, some serious (e.g. exfoliative rash or dermatitis, toxic skin eruption), have been reported with Zinbryta.
Slovenian: Pri zdravilu Zinbryta so poročali o kožnih reakcijah, nekaterih resnih (npr. eksfoliativni izpuščaj ali dermatitis, toksični kožni izpuščaj).
English: • blood in your stools
Slovenian: • kri v blatu
English: Percentage with 24 weeks confirmed disability progression
Slovenian: Odstotek s 24-tedenskim potrjenim napredovanjem bolezni
English: Step 8: Disposing of the used Zinbryta Pre-filled Syringe
Slovenian: Po injiciranju 8. korak: Odstranjevanje uporabljenega zdravila Zinbryta napolnjena injekcijska brizga
English: Parts of the Zinbryta pre-filled syringe (See Figure C)
Slovenian: Deli zdravila Zinbryta napolnjena injekcijska brizga (glejte sliko C)
English: Zinbryta pre-filled syringe is for subcutaneous injection (injection into skin).
Slovenian: Zdravilo Zinbryta napolnjena injekcija brizga je za subkutano (podkožno) injiciranje.
English: Upper respiratory tract infection†
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal†
English: What Zinbryta contains
Slovenian: Kaj vsebuje zdravilo Zinbryta
English: Liver problems: (Common - may affect up to 1 in 10 people)
Slovenian: Težave z jetri: (Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov)
English: How Zinbryta works
Slovenian: Kako deluje zdravilo Zinbryta
English: Do not reuse the Zinbryta pre-filled syringe.
Slovenian: Zdravila Zinbryta napolnjena injekcijska brizga ne uporabite ponovno.
English: Hepatic injury
Slovenian: Poškodbe jeter
English: Baseline characteristics Mean age (years) Mean disease duration (years) Mean number of relapses within 12 months prior to study Median EDSS score Percent with EDSS ≥ 3.5
Slovenian: 12 mesecih pred študijo Mediana seštevka EDSS Odstotek z EDSS ≥ 3,5
English: This may cause the pen to accidentally lock.
Slovenian: To bi lahko povzročilo, da se napolnjeni injekcijski peresnik po nesreči zaklene.
English: Sodium succinate Succinic acid Sodium chloride Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi natrijev sukcinat sukcinska kislina natrijev klorid polisorbat 80 voda za injekcije
English: • severe wide-spread rash.
Slovenian: • resen razširjen izpuščaj
English: The DECIDE study was double-blind, randomised, parallel-group, active-controlled with Zinbryta 150 mg every 4 weeks (n=919) versus interferon beta-1a (intramuscular) 30 micrograms weekly (n=922), for a minimum of 2 to a maximum of 3 years (96 to 144 weeks).
Slovenian: 150 mg vsake 4 tedne (n = 919) v primerjavi z interferonom beta-1a (intramuskularno) 30 mikrogramov na teden (n = 922), ki je trajala vsaj 2 leti do največ 3 leta (96 do 144 tednov).
English: • If needed, apply the gauze pad, adhesive bandage or plaster to the injection site.
Slovenian: • Po potrebi na mesto injiciranja namestite gazo in lepljivi povoj ali obliž.
English: • Keep Zinbryta pre-filled syringe and all medicines out of reach and sight of children.
Slovenian: • Zdravilo Zinbryta napolnjen injekcijski peresnik in vsa zdravila shranjujte nedosegljiva otrokom.
English: MRI endpoints † Mean number of new or newly enlarging T2 hyperintense lesions
Slovenian: Opazovani dogodki na MR slikanju† Povprečno število novih ali na novo povečanih hiperintenzivnih lezij T2
English: Daclizumab has not been studied in patients with hepatic impairment.
Slovenian: Daklizumaba niso preučevali pri bolnikih z okvaro jeter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-Filled Pen Label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • stomach pain
Slovenian: • bolečina v trebuhu