natgillin/translations-raw huggingface dataset:
Zinbryta has no or negligible influence on the ability to drive and use machines. 
Zdravilo Zinbryta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
As an IgG1 monoclonal antibody, daclizumab is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG. 
Kot monoklonsko protitelo IgG1 se pričakuje, da se daklizumab katabolično presnovi na peptide in aminokisline na enak način kot endogeni IgG.
These symptoms vary from patient to patient but usually involve problems such as difficulty with walking, vision and balance. 
Ti simptomi se med bolniki razlikujejo, vendar običajno vključujejo težave s hojo,
Hold the Zinbryta pre-filled syringe at a 45°-90° angle to the injection site (see Figure I). 
Zdravilo Zinbryta napolnjena injekcijska brizga držite pod kotom 45° do 90° na mesto injiciranja (glejte sliko I).
Mean change in MSIS-29 physical score 
Povprečno zmanjšanje fizičnega seštevka MSIS-29
• The recommendation not to initiate Zinbryta in patients with ALT or AST ≥ 2 times the ULN, and to discontinue treatment in patients with ALT or AST > 3 times the ULN; 
• priporočilu, naj se zdravilo Zinbryta ne uvaja pri bolnikih, ki imajo ALT ali AST ≥ 2-krat višjo od ULN, in naj se zdravljenje prekine pri bolnikih z AST ali ALT, ki je > 3-krat višja od ULN;
Treatment initiation is not recommended in patients with ALT or AST ≥ 2 times the upper limit of normal (ULN) and is contraindicated in patients with pre-existing hepatic impairment (see section 4.3). 
Uvedba zdravljenja ni priporočljiva pri bolnikih z ALT ali AST, ki je ≥ 2-krat višja od zgornje meje normalnih vrednosti (ULN - upper limit of normal), in je kontraindicirana pri bolnikih z obstoječo okvaro jeter (glejte poglavje 4.3).
The majority of the treatment-emergent anti-drug antibodies responses were transient (12% [110/913]) and the remaining minority (7% [65/913]) were persistent. 
Pri večini so bili odzivi s protitelesi proti zdravilu zaradi zdravljenja prehodni (12 % [110/913]), pri preostali manjšini (7 % [65/913]) pa so bili obstojni.
Carcinogenicity studies with daclizumab have not been conducted. 
Študij kancerogenosti z daklizumabom niso izvajali.
Pull the pen cap straight off and set it aside (See Figure E). 
Povlecite pokrovček naravnost s peresnika in ga položite na stran (glejte sliko E).
If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), it is recommended to promptly measure serum transaminases, discontinue treatment with Zinbryta, as appropriate, and promptly refer the patient to a hepatologist. 
Če se pri bolniku razvijejo klinični znaki ali simptomi, ki kažejo na motnje delovanja jeter (npr. nepojasnjena navzea, bruhanje, bolečina v trebuhu, utrujenost, anoreksija ali zlatenica in/ali temen urin), se priporoča takojšnje merjenje serumskih transaminaz; zdravljenje z zdravilom Zinbryta pa prekinite, kot je ustrezno, in nemudoma napotite bolnika k hepatologu.
Your pen is now ready to inject. 
Zdaj je vaš napolnjen injekcijski peresnik pripravljen za injiciranje.
Zinbryta 150 mg p-value 
Zinbryta 150 mg Vrednost p
Percentage of relapse-free patients 
Odstotek bolnikov brez recidiva
Microglial aggregates in monkeys did not increase in incidence or severity with increased duration of dosing and were not associated with neuronal damage or neurobehavioral effects. 
Incidenca ali resnost agregatov celic mikroglije pri opicah se niso povečali s podaljšanim trajanjem odmerjanja in niso bili povezani z nevronskimi poškodbami ali nevro-vedenjskimi učinki.
If Zinbryta has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, it should be discarded. 
Če je bilo zdravilo Zinbryta zunaj hladilnika skupaj več kot 30 dni ali če niste prepričani, kako dolgo je zdravilo Zinbryta stalo pri sobni temperaturi, ga zavrzite.
These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and sub-acute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe. 
Ti izsledki (suhe, rdeče izbočene kožne zaplate, v primerjavi s kontrolo, kar mikroskopsko korelira z akantozo/hiperkeratozo in subakutnim do kroničnim vnetjem) so bili opisani pretežno kot blagi do zmerni, en primer pa je bil ocenjen kot resen.
Based on the cross-study population pharmacokinetic analysis, body weight accounted for less than 40% of the inter-patient variability in daclizumab clearance. 
Na podlagi medštudijske analize populacijske farmakokinetike je bila telesna masa vzrok za manj kot 40 % variabilnost med bolniki pri očistku daklizumaba.
Daclizumab did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively). 
Daklizumab ni vplival na sposobnost razmnoževanja pri samicah in samcih opic vrste cynomolgus (AUC pri samicah in samcih do 85- oz. 100-krat večji, kot je izpostavljenost pri kliničnih odmerkih).
The most common adverse reactions reported for Zinbryta were rash, increased alanine aminotransferase (ALT), depression, nasopharyngitis, upper respiratory tract infection, influenza, oropharyngeal pain, and lymphadenopathy. 
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Zinbryta, so bili izpuščaj, povišanje alanin-aminotransferaze (ALT), depresija, nazofaringitis, okužba zgornjih dihal, gripa, orofaringealna bolečina in limfadenopatija.
Do not remove the cap until you are ready to inject. 
Ne odstranite pokrovčka, dokler niste pripravljeni na injiciranje.
Zinbryta is not expected to affect your ability to drive and use machines. 
Ne pričakuje se, da bi zdravilo Zinbryta vplivalo na sposobnost vožnje in upravljanja strojev.
Do not lift your pen off your injection site until the clicking sounds stop and you see green ticks in the injection status window. 
Ne dvignite napolnjenega peresnika za injiciranje z mesta injiciranja, dokler zvok klikanja ne preneha in v oknu za stanje injiciranja ne zagledate zelenih kljukic.
Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients). 
Na podlagi medštudijske analize populacijske farmakokinetike je volumen porazdelitve v stanju dinamičnega ravnovesja daklizumaba 6,34 l pri bolniku s telesno maso 68 kg (približno mediana ocenjenih bolnikov).
The most common skin reactions were rash, dermatitis, and eczema. 
Najpogostejše kožne reakcije so bile izpuščaj, dermatitis in ekcem.
• If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster. 
• Če na mestu injiciranja vidite kri, jo obrišite z gazo in namestite lepljiv povoj ali obliž.
After the clicking sound has stopped, lift the pen from your injection site. 
Potem ko zvok klikanja preneha, dvignite napolnjeni injekcijski peresnik z mesta injiciranja.
Among the evaluable patients, the majority of treatment-emergent neutralising antibody responses were transient (6% [56 of 913]) and 2% of patients (15 of 913) had persistent responses. 
Med bolniki, ki jih je bilo možno oceniti, je bil pri večini odziv z nevtralizirajočimi protitelesi zaradi zdravljenja prehoden (6 % [56 od 913]), 2 % bolnikov (15 od 913) pa sta imela obstojen odziv.
In two 9 month studies conducted in cynomolgus monkeys daclizumab was subcutaneously administered at bi-weekly doses of 10-200 mg/kg. 
V dveh 9-mesečnih študijah, izvedenih na opicah vrste cynomolgus, so daklizumab subkutano dajali dvakrat tedensko v odmerkih od 10 do 200 mg/kg.
Compared with interferon beta-1a intramuscular (n=440), Zinbryta (n=404) led to reductions on ARR (rate ratio 0.52 [95% CI: 0.42, 0.64], p<0.0001), number of new or newly enlarging T2 hyperintense lesions (lesion mean ratio 0.46 [95% CI: 0.37, 0.57], p<0.0001), and 24 weeks confirmed disability progression (hazard ratio 0.60 [95% CI: 0.40, 0.89], p=0.012). 
V primerjavi z interferonom beta-1a intramuskularno (n = 440), je zdravilo Zinbryta (n = 404) vodilo do zmanjšanja ARR (razmerje pogostnosti 0,52 [95 % IZ: 0,42, 0,64], p<0,0001), števila novih ali na novo povečanih hiperintenzivnih lezij T2 (povprečno razmerje lezij 0,46 [95 % IZ: 0,37, 0,57], p<0,0001), in 24-tedensko potrjenega napredovanja bolezni (razmerje ogroženosti 0,60 [95 % IZ: 0,40, 0,89], p=0,012).
Check the injection status window. 
Preverite okno za stanje injiciranja.
It is essentially ‘sodium-free' and can be used by people on a sodium-restricted diet. 
To pomeni, da je zdravilo v bistvu ‘brez natrija' in ga lahko uporabljajo ljudje na dieti z omejenim vnosom natrija.
Zinbryta is contraindicated in patients with pre-existing hepatic impairment (see sections 4.3 and 4.4). 
Zdravilo Zinbryta je kontraindicirano pri bolnikih z obstoječo okvaro jeter (glejte poglavji 4.3 in 4.4).
Step 6: Give the injection a. 
6. korak: Injicirajte a.
This medicinal product contains 0.14 mmol sodium per dose. 
To zdravilo vsebuje 0,14 mmol natrija na odmerek.
Pack sizes: Each pack contains one pre-filled glass syringe/pre-filled pen with an attached needle, ready to inject. 
Velikosti pakiranja: Eno pakiranje vsebuje eno stekleno napolnjeno injekcijsko brizgo/en steklen napolnjen injekcijski peresnik s pritrjeno iglo, pripravljeno/pripravljen na injiciranje.
The 300 mg dose did not provide additional benefit over the 150 mg dose. 
Odmerek 300 mg v primerjavi z odmerkom 150 mg ni prinesel dodatnih prednosti.
Hepatic Risk Management Guide for Physicians, Patient Card and Acknowledgment Form 
Vodnik za zdravnike pri obvladovanju tveganj za jetra, opozorilna kartica za bolnika in potrditveni obrazec
The physician should discuss the risk of hepatic injury with patients and provide them with a Patient Card. 
Zdravnik se mora o tveganju za poškodbe jeter pogovoriti z bolniki in jim priskrbeti Opozorilno kartico za bolnike.
In patients with neutralising antibodies, daclizumab clearance was increased on average by 19% (see section 5.2). 
Pri bolnikih z nevtralizirajočimi protitelesi se je očistek daklizumaba povprečno povečal za 19 % (glejte poglavje 5.2).
Your doctor will help you decide whether you should stop breast-feeding, or stop using Zinbryta. 
Zdravnik vam bo pomagal pri odločitvi, ali naj prenehate dojiti ali prenehate uporabljati zdravilo Zinbryta.
Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom 
Biogen Idec Ltd. Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Velika Britanija
The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established. 
Varnost in učinkovitost zdravila Zinbryta pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
Treatment-emergent anti-drug antibodies and neutralising antibodies responses predominantly occurred during the first year of treatment and their frequency declined with continued Zinbryta treatment. 
Odzivi s protitelesi proti zdravilu in nevtralizirajočimi protitelesi zaradi zdravljenja so se pretežno pojavili v prvem letu zdravljenja, njihova pogostnost pa se je z nadaljevanjem zdravljenja z zdravilom Zinbryta zmanjševala.
Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while taking Zinbryta - if you have depression or have had it in the past. 
Zdravnik bo ocenil, ali imajo katera od zdravil ali pripravkov, ki jih jemljete, neželene učinke na jetra in ali smete med jemanjem zdravila Zinbryta jemati ta zdravila še naprej; - če imate depresijo ali ste jo imeli v preteklosti.
Daclizumab clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity). 
Očistek daklizumaba pri bolnikih, pri katerih se razvijejo nevtralizirajoča protitelesa, je bil povprečno 19 % večji (glejte poglavje 4.8 Imunogenost).
Giving the Injection 
Dajanje injekcije
Detailed instructions for injecting Zinbryta are given in section 7, Instructions for injecting Zinbryta. 
Podrobna navodila za injiciranje zdravila Zinbryta so navedena v poglavju 7, Navodila za injiciranje zdravila Zinbryta.
The Hepatic Risk Management Guide for Physicians should inform HCPs about: 
Vodnik za zdravnike pri obvladovanju tveganj za jetra mora zdravstvene delavce obvestiti o:
If you do not not undergo your scheduled blood tests your doctor may decide to stop treatment with Zinbryta. 
Če ne boste šli na načrtovane preiskave krvi, lahko zdravnik odloči, da vas bo prenehal zdraviti z zdravilom Zinbryta.
• sore throat, tonsillitis (pharyngitis, laryngitis) 
• vneto žrelo, tonzilitis (faringitis, laringitis)
*Hazard ratio for the risk of relapse #MRI analyses used evaluable dataset for each endpoint; T1 Gd-enhancing: MRI intensive population 
*Razmerje ogroženosti za tveganje za recidiv #Pri analizah MR slikanja so uporabili ovrednotene nabore podatkov za vsak opazovani dogodek; T1, vidno z gadolinijem: intenzivna populacija z MR slikanjem
In clinical studies, the pharmacodynamic effects of Zinbryta 150 mg administered subcutaneously every 4 weeks were consistent with modulation of IL-2 signalling as evidenced by the rapid and sustained saturation of the target CD25 receptors on circulating T-cells and a sustained approximately 2-fold increase in serum IL-2 concentration. 
V kliničnih študijah so bili farmakodinamični učinki zdravila Zinbryta 150 mg, apliciranega subkutano vsake 4 tedne, skladni z modulacijo sporočanja IL-2, kar je bilo dokazano s hitrim in trajnim nasičenjem ciljnih receptorjev CD25 na cirkulirajočih celicah T in trajnem, približno 2-kratnem povišanjem serumske koncentracije IL-2.
• The importance of the liver function monitoring, at least monthly during treatment (or more frequently as clinically indicated), and for up to 6 months after the last dose; 
• pomembnost spremljanja delovanja jeter vsaj enkrat na mesec med zdravljenjem (ali pogosteje, če je to klinično indicirano) in še do 6 mesecev po zadnjem odmerku zdravila;
Choose an injection site in your thigh, abdomen, or the back of your upper arm (See highlighted areas in Figure D). 
Izberite mesto injiciranja na stegnu, trebuhu ali zadnji strani nadlahti (glejte poudarjene predele na sliki D).
The most commonly reported adverse reactions leading to discontinuation in patients treated with Zinbryta were hepatic reactions, including elevations of serum transaminases (5%), and cutaneous reactions (4%) (see section 4.4). 
Neželeni učinki, o katerih so najpogosteje poročali, da so pri bolnikih povzročili prekinitev zdravljenja z zdravilom Zinbryta, so bile jetrne reakcije, vključno s povečanjem serumskih transaminaz (5 %), in kožne reakcije (4 %) (glejte poglavje 4.4).
• The unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several months after the last dose; 
• nepredvidljivem tveganju za resne in potencialno smrtne poškodbe jeter kadar koli med zdravljenjem in še več mesecev po zadnjem odmerku;
• The importance of detecting signs and symptoms which might indicate hepatic injury, and if any of these occur, to promptly contact their physician; 
• pomembnost odkrivanja znakov in simptomov, ki bi lahko kazali na poškodbo jeter, in pomembnost takojšnjega posvetovanja z zdravnikom, če se kateri koli izmed njih pojavi;
• Inform patients about the unpredictable risk of serious and potentially fatal hepatic injury at any time during treatment and up to several month after treatment; 
• obvestiti bolnike o nepredvidljivem tveganju za resne in potencialno smrtne poškodbe jeter kadar koli med zdravljenjem in še več mesecev po zadnjem zdravljenju;
The majority of patients with infections continued on treatment with Zinbryta. 
Večina bolnikov z okužbami je nadaljevala zdravljenje z zdravilom Zinbryta.
You will also have a blood test to check your liver every month, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary. 
Vsak mesec boste imeli tudi krvne preiskave za preverjanje delovanja jeter kolikor je mogoče tik pred vsakim odmerkom zdravila Zinbryta, če zdravnik odloči, da je to potrebno, pa še pogosteje.
General disorders and administration site conditions Pyrexia* 
Splošne težave in spremembe na mestu aplikacije pireksija*
• Patients with 2 or more relapses in 1 year, and with 1 or more Gd-enhancing lesions on brain MRI, or 
• bolniki z 2 ali več recidivi v 1 letu in z 1 ali več lezij, vidno z gadolinijem, pri MR slikanju možganov ali
The Finger Flange will allow you to better grip the syringe and should remain attached. 
S pomočjo držala za prste boste injekcijsko brizgo lažje prijeli, zato naj ostane pritrjena.
Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection. 
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Zdravilo Zinbryta naj se po odstranitvi iz hladilnika in pred injiciranjem ogreje na sobno temperaturo (20 °C do 30 °C) (približno 30 minut).
Within the studied regimens of daclizumab 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN). 
Znotraj preučevanih režimov subkutanega odmerjanja daklizumaba 150 mg in 300 mg vsake 4 tedne pri bolnikih z multiplo sklerozo ni bilo jasnega razmerja med izpostavljenostjo daklizumabu in opazovanimi dogodki klinične učinkovitosti (ARR, lezije T2 in lezije, vidne z gadolinijem), ali izbranimi opazovanimi dogodki varnosti (resne okužbe, zmerni ali resni kožni neželeni učinki in vrednosti AST/ALT > 5-kratna ULN).
In clinical studies, Zinbryta increased the incidence of lymphadenopathy, with onset occurring throughout the treatment period. 
V kliničnih študijah je zdravilo Zinbryta povečalo incidenco limfadenopatije, pri čemer se je začela pojavljati ves čas obdobja zdravljenja.
Patients should be informed about the risk of hepatic injury, the need for periodic monitoring and warned about signs or symptoms suggestive of hepatic dysfunction. 
Bolnike je treba obvestiti o tveganju okvare jeter in potrebi po rednem spremljanju in jih opozoriti na znake ali simptome, ki kažejo na moteno delovanje jeter.
In the DECIDE study subgroup analysis, there was a statistically significant reduction observed compared to interferon beta-1a (intramuscular) on ARR and the number of new or newly enlarging T2 hyperintense lesions across subgroups (gender, age, prior MS DMT therapy, and disease activity levels). 
V analizi podskupin študije DECIDE so opazili statistično značilno zmanjšanje v primerjavi z interferonom beta-1a (intramuskularno) pri ARR in številu novih ali na novo povečanih hiperintenzivnih lezij T2 za podskupine (spol, starost, predhodna zdravljenja multiple skleroze z DMT in ravni aktivnosti bolezni).
The recommended dose of Zinbryta is 150 mg injected subcutaneously once a month. 
Priporočeni odmerek zdravila Zinbryta je 150 mg, injiciranih subkutano enkrat na mesec.
The dose of Zinbryta is 150 mg every month. 
Odmerek zdravila Zinbryta je 150 mg vsak mesec.
Do not use the pen if it has been dropped or is visibly damaged. 
Ne uporabite napolnjenega injekcijskega peresnika, če je padel ali je vidno poškodovan.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7)
Cases of hepatic injury have occurred in patients taking Zinbryta with other hepatotoxic drugs, although the role of these medicinal products is uncertain. 
Pri bolnikih, ki so jemali zdravilo Zinbryta skupaj z drugimi hepatotoksičnimi zdravili, so nastopili primeri poškodb jeter, čeprav je vloga teh zdravil negotova.
• the syringe/pen is cracked or broken. 
• je injekcijska brizga/injekcijski peresnik počena/počen ali zlomljena/zlomljen.
Zinbryta works by stopping the body's immune system from damaging your brain and spinal cord. 
Zdravilo Zinbryta učinkuje tako, da telesnemu imunskemu sistemu preprečuje poškodovanje možganov in hrbtenjače.
• nervousness, anxiety 
• razdražljivost, nagla jeza
Daclizumab is produced in a mammalian cell line (NS0) by recombinant DNA technology. 
Daklizumab se pridobiva iz celične kulture sesalcev (NS0) s tehnologijo rekombinantne DNA.
What Zinbryta is and what it is used for 
Kaj je zdravilo Zinbryta in za kaj ga uporabljamo
Patients with RMS, at least 1 relapse (clinical and/or MRI) during the year prior to randomisation, and had an EDSS score between 0 to 5.0. 
Bolniki z recidivno multiplo sklerozo, z vsaj 1 recidivom (kliničnim in/ali na MR slikanju) v letu pred randomizacijo, ki so imeli seštevek EDSS med 0 in 5,0.
Mean number of new T1 Gdenhancing lesions between 8 and 24 weeks (on monthly MRI scans) 
Povprečno število novih lezij T1, vidnih z gadolinijem, med 8. in 24. tednom (pri mesečnih slikanjih z MR)
Step 3: Choose and clean your injection site 
3. korak: Izberite in očistite mesto injiciranja
The majority of patients with lymphadenopathy continued on treatment with Zinbryta, and the majority of cases resolved within 3 months. 
Večina bolnikov z limfadenopatijo je zdravljenje z zdravilom Zinbryta nadaljevala in pri večini primerov je ta izzvenela v 3 mesecih.
Continue to hold the pen firmly down on your injection site until the clicking sounds have stopped (see Figure H). 
Še naprej pritiskajte z napolnjenim injekcijskim peresnikom na mesto injiciranja, dokler zvok klikanja ne preneha (glejte sliko H).
The Card informs patients of the risk of serious hepatic injury, and its possible symptoms, so that they are aware of situations in which they should contact a healthcare professional in a timely manner. 
Opozorilna kartica bolnike obvešča o tveganju za resne poškodbe jeter in o možnih simptomih, z namenom, da spoznajo situacije, v katerih se morajo pravočasno obrniti na zdravstvenega delavca.
• You should hold the pen over your injection site at a 90o angle. 
• Napolnjeni injekcijski peresnik morate držati nad mestom injiciranja pod kotom 90o.
• Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or AST > 3 times the ULN; o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form; o Receipt of the Patient Card; 
o pogovora med zdravnikom in bolnikom o tveganju za resne in potencialno smrtne poškodbe jeter in nepredvidljivi naravi takih reakcij in možnosti zamenjave zdravila v primeru, ko je raven AST ali ALT >3-krat ULN; o da bolnik razume posredovane informacije o tveganju; o o prejemu kopije potrditvenega obrazca; o o prejemu opozorilne kartice za bolnika;
You could get a needle injury or the pen may lock. 
Lahko se poškodujete z iglo ali pa se napolnjeni injekcijski peresnik lahko zaklene.
Injection Status Window 
Okno za stanje injiciranja
• Store in a refrigerator (2oC to 8oC). 
• Shranjujte v hladilniku (2 °C - 8 °C).
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA subkutana uporaba
Other medicines and Zinbryta 
Druga zdravila in zdravilo Zinbryta