FrancophonIA/ELRC3.0 huggingface dataset:
English: Subgroup analyses of the SELECT and DECIDE studies demonstrated a consistent effect of Zinbryta compared to placebo and interferon beta-1a (intramuscular) across subgroups defined by demographic and MS disease characteristics.
Slovenian: Analiza podskupin študij SELECT in DECIDE je pokazala dosleden učinek zdravila Zinbryta v primerjavi s placebom in interferonom beta-1a (intramuskularno) za podskupine, opredeljene z demografskimi značilnostmi in značilnostmi multiple skleroze.
English: Step 5: Gently pinch your injection site Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge.
Slovenian: 5. korak: Nežno uščipnite mesto injiciranja Kožo okoli očiščenega mesta injiciranja nežno uščipnite s palcem in kazalcem, da nastane rahla izboklina.
English: You could get a needle injury.
Slovenian: Obstaja možnost, da se poškodujete.
English: It is essentially ‘sodium-free' and can be used by patients on a sodium-restricted diet.
Slovenian: V bistvu je »brez natrija« in se sme uporabljati pri bolnikih, ki so na dieti z omejenim vnosom natrija.
English: In addition, an increase in CD56bright NK cells and a decrease in regulatory T-cells (defined as CD4+CD127lowFoxP3+ T-cells) was observed within 2 weeks after the first dose, with a sustained 5-fold increase in CD56bright NK cells above baseline and an approximately 60% decrease in regulatory T-cells in the treatment phase, with a return to baseline levels approximately 20-24 weeks after the last dose.
Slovenian: Poleg tega so v 2 tednih po prvem odmerku opazili povečanje ravni naravnih celic ubijalk CD56bright in zmanjšanje ravni regulatornih celic T (opredeljenih kot celice T CD4+CD127lowFoxP3+), s trajnim 5-kratnim povečanjem ravni naravnih celic ubijalk CD56bright nad izhodišče in približno 60% zmanjšanjem ravni regulatornih celic T v fazi zdravljenja; ravni so se na izhodiščne vrnile približno 20 do 24 tednov po zadnjem odmerku.
English: Let your injection site dry on its own before injecting your dose.
Slovenian: Pustite, da se mesto injiciranja samo od sebe posuši, preden si injicirate odmerek.
English: Lung infections:
Slovenian: Okužbe pljuč:
English: • the pen has been dropped or is visibly damaged.
Slovenian: • je injekcijski peresnik padel na tla ali je vidno poškodovan.
English: • The need to provide the patient with the Patient Card and the Acknowledgment Form, discuss their content before starting Zinbryta treatment, informing patients of the risk of hepatic injury, the need for periodic monitoring and the signs or symptoms suggestive of hepatic dysfunction.
Slovenian: • potrebi, da zdravstveni delavec bolniku posreduje opozorilno kartico za bolnika in potrditveni obrazec, da se pred začetkom zdravljenja z zdravilom Zinbryta pogovori z bolnikom o njuni vsebini, da obvesti bolnike o tveganju za poškodbe jeter, potrebi po rednem spremljanju in znakih ali simptomih, ki kažejo na moteno delovanje jeter.
English: At week 96, Zinbryta demonstrated a statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions.
Slovenian: V 96. tednu je zdravilo Zinbryta pokazalo statistično značilno zmanjšanje števila novih in na novo povečanih hiperintenzivnih lezij T2, števila novih lezij T1, vidnih z gadolinijem, in povprečnega števila novih hipointenzivnih lezij T1.
English: Patients on Zinbryta may receive non-live vaccines.
Slovenian: Bolniki, ki se zdravijo z zdravilom Zinbryta, lahko prejmejo neživa cepiva.
English: What Zinbryta is and what it is used for What you need to know before you use Zinbryta How to use Zinbryta
Slovenian: Kaj je zdravilo Zinbryta in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta Kako uporabljati zdravilo Zinbryta Možni neželeni učinki
English: Be sure that this hand is not pushing on the Finger Flange.
Slovenian: S to roko ne pritiskajte na držalo za prste.
English: • Hepatic Risk Management Guide for Physicians;
Slovenian: • vodnik za zdravnike pri obvladovanju tveganj za jetra;
English: You may be tested for TB before starting Zinbryta and monitored during treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Zinbryta vas lahko testirajo za TB in spremljajo med zdravljenjem.
English: Use caution when removing the needle cover to avoid getting a needle injury.
Slovenian: Pri odstranjevanju pokrovčka igle bodite previdni, da se z iglo ne poškodujete.
English: The clinical relevance of microglial aggregates is unknown, however no deleterious neurologic effects attributed to the microscopic change have been observed in monkeys.
Slovenian: Klinični pomen agregatov celic mikroglije ni znan, vendar pri opicah niso opazili škodljivih nevroloških vplivov, ki bi jih lahko pripisali mikroskopskim spremembam.
English: Read the instructions before you start using Zinbryta and each time you get a refill of your prescription.
Slovenian: Preden začnete uporabljati zdravilo Zinbryta in vsakič, ko dobite novo pakiranje, preberite navodilo za uporabo.
English: Pre-existing hepatic disease or hepatic impairment (see section 4.4).
Slovenian: Predhodna bolezen jeter ali okvara jeter (glejte poglavje 4.4).
English: Percentage of patients with clinically meaningful worsening in MSIS-29
Slovenian: Odstotek bolnikov s klinično pomembnim poslabšanjem s fizičnim seštevkom MSIS-29 (≥ 7,5 točk)
English: Elimination As an IgG1 monoclonal antibody, daclizumab is not expected to undergo renal elimination.
Slovenian: Izločanje Kot monoklonsko protitelo IgG1 se ne pričakuje, da bi se daklizumab izločal skozi ledvice.
English: Step 4: Firmly remove the needle cover
Slovenian: 4. korak: Čvrsto povlecite za pokrovček igle
English: Step 4: Choose and clean your injection site a.
Slovenian: 4. korak: Izberite in očistite mesto injiciranja a.
English: Before you prepare your injection, take the syringe out of the fridge and let it warm to room temperature.
Slovenian: Preden pripravite injekcijo, vzemite napolnjeno injekcijsko brizgo iz hladilnika in počakajte, da se ogreje na sobno temperaturo.
English: Step 1: Remove the pen from the fridge a. Remove the pen from the carton in the fridge 30 minutes before giving your injection to allow it to warm to room temperature.
Slovenian: Priprava na injiciranje 1. korak: Vzemite napolnjen injekcijski peresnik iz hladilnika a. Vzemite napolnjen injekcijski peresnik iz škatle v hladilniku 30 minut pred injiciranjem, da se bo ogrel na sobno temperaturo.
English: If you forget to take Zinbryta
Slovenian: Če ste pozabili uporabiti zdravilo Zinbryta
English: Hold the pen over your injection site.
Slovenian: Držite napolnjeni injekcijski peresnik nad mestom injiciranja.
English: • However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your next dose on your usual day.
Slovenian: • Če od izpuščenega odmerka mineta več kot 2 tedna, pozabljeni odmerek izpustite in si dajte naslednji odmerek na vaš običajni dan.
English: A multipack of three packs of one syringe/pen is also available.
Slovenian: Na voljo je tudi skupno pakiranje s tremi pakiranji z eno injekcijsko brizgo/enim injekcijskim peresnikom.
English: The majority of patients had skin reactions that were mild or moderate in severity.
Slovenian: Večina bolnikov je imela blage do zmerne kožne reakcije.
English: Treatment-emergent anti-drug antibodies and neutralising antibodies were observed in 19% (175/913) and 8% (71/913) of study patients, respectively.
Slovenian: Protitelesa proti zdravilu zaradi zdravljenja so opazili pri 19 % (175/913) in nevtralizirajoča protitelesa zaradi zdravljenja pri 8 % (71/913) bolnikov v študiji.
English: Do not touch, clean or manipulate the needle cover.
Slovenian: Ne dotikajte se, ne čistite pokrovčka igle in ne rokujte z njim.
English: INFORMATION IN BRAILLE Zinbryta
Slovenian: PODATKI V BRAILLOVI PISAVI Zinbryta
English: • Prescriber name, signature and date.
Slovenian: • ime in podpis zdravnika, ki predpisuje zdravilo, in datum.
English: If you have injected more than your usual dose, and you notice any side effects, or are concerned, speak with your doctor or nurse.
Slovenian: Če ste uporabili večji odmerek zdravila Zinbryta, kot bi smeli Če ste si injicirali odmerek, večji od običajnega, in opazite neželene učinke ali ste zaskrbljeni, se posvetujte z zdravnikom ali medicinsko sestro.
English: Step 8: Check to make sure you have received your full dose of Zinbryta (see Figure J).
Slovenian: 8. korak: Preverite, ali ste prejeli polni odmerek zdravila Zinbryta (glejte sliko J) a.
English: The usual sites for subcutaneous injection include the thigh, abdomen, and back of the upper arm.
Slovenian: Običajna mesta za subkutano injiciranje vključujejo stegno, trebuh in hrbtni del nadlakti.
English: • Before you use the pen for the first time, your doctor or nurse should show you or your carer how to prepare and inject the pen.
Slovenian: • Pred prvo uporabo napolnjenega injekcijskega peresnika mora zdravnik ali medicinska sestra vam ali vašemu negovalcu pokazati, kako pravilno pripravite in injicirate napolnjen injekcijski peresnik.
English: Caution!
Slovenian: Pozor!
English: It is not known whether Zinbryta passes into breast milk.
Slovenian: Ni znano, ali se zdravilo Zinbryta izloča v materino mleko.
English: Store in a refrigerator (2oC-8oC).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: In addition, Zinbryta reduced clinically meaningful worsening in the patient reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29
Slovenian: Poleg tega je zdravilo Zinbryta zmanjšalo klinično pomembno poslabšanje fizičnega vpliva multiple skleroze, o katerem poročajo bolniki, (poslabšanja za ≥ 7,5 točk od izhodišča do 96. tedna v fizičnem seštevku MSIS-29) v primerjavi z interferonom beta-1a (intramuskularno).
English: There are limited data from the use of Zinbryta in pregnant women.
Slovenian: Podatki o uporabi zdravila Zinbryta pri nosečnicah so omejeni.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C for up to 30 days.
Slovenian: • Po potrebi lahko zdravilo Zinbryta do 30 dni shranjujete v zaprti originalni škatli zunaj hladilnika pri temperaturi do 30 °C.
English: Marketing Authorisation Holder Biogen Idec Ltd.
Slovenian: Imetnik dovoljenja za promet z zdravilom Biogen Idec Ltd.
English: Zinbryta has not been studied in patients with immunodeficiency syndromes.
Slovenian: Zdravila Zinbryta niso preučevali pri bolnikih s sindromi imunske pomanjkljivosti.
English: Following subcutaneous administration of daclizumab 150 mg every 4 weeks, steady-state serum daclizumab concentrations were achieved by the 4th dose and daclizumab accumulated to a level approximately 2.5-fold compared to a single dose.
Slovenian: Po subkutani uporabi daklizumaba 150 mg vsake 4 tedne je bilo stanje dinamičnega ravnovesja koncentracij daklizumaba v serumu doseženo do 4. odmerka; daklizumab se je akumuliral do ravni, ki je bila približno 2,5-kratnik v primerjavi z enkratnim odmerkom.
English: Using one hand, hold the syringe by the glass barrel.
Slovenian: Z eno roko držite injekcijsko brizgo za stekleno telo.
English: Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija)
English: If a dose is missed and it is more than 2 weeks from the missed dose, patients should skip the missed dose, wait until their next scheduled dose, and then remain on their original monthly dosing schedule.
Slovenian: Če sta od izpuščenega odmerka pretekla več kot 2 tedna, naj bolnik izpuščeni odmerek preskoči, počaka na naslednji načrtovani odmerek, nato pa nadaljuje s prvotnim mesečnim urnikom odmerjanja.
English: Note: Do not rest the pen on the injection site until you are ready to inject.
Slovenian: Opomba: Ne položite napolnjenega injekcijskega peresnika na mesto injiciranja, dokler niste pripravljeni injicirati.
English: Autoimmune haemolytic anaemia
Slovenian: Avtoimunska hemolitična anemija
English: o Make sure Zinbryta is out of the refrigerator for no longer than 30 days.
Slovenian: o Zdravilo Zinbryta ne sme biti zunaj hladilnika dlje kot 30 dni.
English: • unexplained nausea (feeling sick)
Slovenian: • nepojasnjena navzea (siljenje na bruhanje)
English: • the solution is cloudy or you can see particles floating in it.
Slovenian: • je raztopina motna ali v njej opazite plavajoče delce.
English: Zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable (see section 4.4).
Slovenian: Zdravilo Zinbryta je indicirano za zdravljenje odraslih bolnikov z recidivnimi oblikami multiple skleroze (RMS), ki so imeli nezadosten odziv na vsaj dve terapiji z zdravilom, ki spreminja potek bolezen (DMT - disease modifying therapy) in pri katerih je zdravljenje s katerim koli drugim DMT
English: • Zinbryta pre-filled syringe is for injecting the medicine under the skin only (subcutaneous).
Slovenian: • Zdravilo Zinbryta napolnjena injekcijska brizga je samo za injiciranje zdravila pod kožo (subkutano).
English: • Each Zinbryta pre-filled syringe can be used once only.
Slovenian: • Eno zdravilo Zinbryta napolnjena injekcijska brizga lahko uporabite samo enkrat.
English: Do not take the Zinbryta pre-filled syringe out of the injection site until you have pushed the plunger all the way down.
Slovenian: Zdravila Zinbryta napolnjena injekcijska brizga ne odstranjujte iz mesta injiciranja, dokler bata ne potisnete do konca navzdol.
English: In clinical studies, serum transaminase elevations occurred at any time during treatment and up to 6 months after the last dose of Zinbryta.
Slovenian: V kliničnih študijah so se kadar koli med zdravljenjem in še do 6 mesecev po zadnjem odmerku zdravila Zinbryta pojavila povišanja serumskih transaminaz.
English: Your doctor will evaluate if any medicines or supplements you are taking have liver side effects and whether you should continue these medicines while receiving Zinbryta.
Slovenian: 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.
English: Can be stored at room temperature (up to 30°C) for a single period up of to 30 days.
Slovenian: Lahko shranite pri sobni temperaturi (do 30 °C) za enkratno obdobje do 30 dni.
English: In patients with severe active infection, a delay in initiation of Zinbryta therapy should be considered (see section 4.8).
Slovenian: Pri bolnikih s hudo aktivno okužbo je treba razmisliti o preložitvi uvedbe zdravljenja z zdravilom Zinbryta (glejte poglavje 4.8).
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Slovenian: Ključni učinek te modulacije poti IL-2, ki je morda povezan s terapevtskimi učinki daklizumaba pri multipli sklerozi, vključuje selektivni antagonizem odzivov aktiviranih celic T in ekspanzijo imunoregulacijskih naravnih celic ubijalk CD56bright, za katere se je pokazalo, da selektivno zmanjšujejo aktivirane celice T. Ti imunomodulirajoči učinki daklizumaba skupaj naj bi zmanjševali patologijo osrednjega živčnega sistema pri multipli sklerozi in s tem zmanjševali pojavnost recidivov in napredovanje bolezni.
English: Zinbryta is injected under the skin (subcutaneously) into your thigh, stomach or back of your upper arm.
Slovenian: Zdravilo Zinbryta se injicira pod kožo (subkutano) v stegno, trebuh ali hrbtni del nadlahti.
English: In case a dose is missed and it is within 2 weeks of the missed dose, patients should be instructed to inject without delay their missed dose and then remain on their original monthly dosing schedule.
Slovenian: Pri izpuščenem odmerku, kjer še nista pretekla 2 tedna, je treba bolniku naročiti, naj si izpuščeni odmerek injicira nemudoma, nato pa nadaljuje s prvotnim mesečnim urnikom odmerjanja.
English: The active substance in Zinbryta is daclizumab.
Slovenian: Učinkovina zdravila Zinbryta je daklizumab.
English: Low level of a type of white blood cells (called lymphocytes): Zinbryta could reduce your level of these white blood cells so you will have a blood test every 3 months.
Slovenian: Zdravilo Zinbryta lahko zmanjša raven belih krvnih celic, zato boste vsake 3 mesece opravljali krvne preiskave.
English: In clinical trials, an increased incidence of elevations of ALT or AST was reported more frequently in Zinbryta-treated patients compared to placebo or interferon beta1a (intramuscular).
Slovenian: V kliničnih preskušanjih so pogosteje poročali o povečani incidenci povišanja vrednosti ALT ali AST pri bolnikih, zdravljenih z zdravilom Zinbryta, v primerjavi s placebom ali interferonom beta-1a (intramuskularno).
English: Treatment discontinuation should be considered if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring.
Slovenian: Če ni bil dosežen zadosten odziv ali če bolnik ne izpolnjuje zahtev glede načrtovanega spremljanja jetrnih testov, je treba razmisliti o prekinitvi zdravljenja.
English: 1.0 point improvement p=0.0008
Slovenian: poslabšanje za 3,0 točke izboljšanje za 1,0 točko p=0,0008
English: Do not inject into an area of the body where the skin is irritated, tender, red, bruised, tattooed, infected or scarred.
Slovenian: Ne injicirajte v predel telesa, kjer je koža razdražena, občutljiva, pordela ali so na njej modrice, tetovaže, okužbe ali brazgotine.
English: The active substance is daclizumab.
Slovenian: Učinkovina je daklizumab.
English: Green Stripes Visible
Slovenian: Vidne zelene črte
English: Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali za zdravilo Zinbryta 150 mg Organski sistem
English: In the placebo-controlled study (the SELECT study), 417 patients received Zinbryta (150 mg, n=208; 300 mg, n=209; every 4 weeks) for up to 1 year.
Slovenian: V s placebo nadzorovani študiji (študija SELECT) je 417 bolnikov do 1 leto prejemalo zdravilo Zinbryta (150 mg, n = 208; 300 mg, n = 209; vsake 4 tedne).
English: Seborrhoeic dermatitis†
Slovenian: pogosti psoriaza pogosti seboroični dermatitis†
English: No studies were conducted to evaluate daclizumab pharmacokinetics in patients with renal or hepatic impairment.
Slovenian: Študij za ovrednotenje farmakokinetike daklizumaba pri bolnikih z ledvično ali jetrno okvaro niso izvedli.
English: After your injection After Use - Parts of your Zinbryta Pen (see Figure K):
Slovenian: Po injiciranju Po uporabi - sestavni deli vašega zdravila Zinbryta napolnjen injekcijski peresnik (glejte sliko K):
English: Patient serum transaminase and total bilirubin levels should be monitored at least monthly and as close as possible before each administration, and more frequently as clinically indicated during treatment and up to 6 months after the last dose of Zinbryta.
Slovenian: Bolnikove ravni serumskih transaminaz in celotnega bilirubina je treba spremljati vsaj mesečno in kolikor mogoče neposredno pred vsakim dajanjem zdravila in še pogosteje, če je klinično indicirano,
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Order Class by frequency and incidence.
Slovenian: Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na organske sisteme po MedDRA po pogostnosti in incidenci.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij:
English: Daclizumab is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Slovenian: Ne pričakuje se, da bi se daklizumab presnavljal z jetrnimi encimi, kot so izoencimi CYP (glejte poglavje 4.5).
English: The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular).
Slovenian: Incidenca prekinitev zdravljenja zaradi jetrnih boleznih, povezanih z zdravilom, je bila pri bolnikih, zdravljenih z zdravilom Zinbryta, 5 %, pri bolnikih, zdravljenih z interferonom beta-1a (intramuskularno), pa 4 %.
English: Do not use Zinbryta - if you have previously had a serious allergic reaction to daclizumab, or any of the other ingredients of this medicine listed in section 6.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zinbryta Ne uporabljajte zdravila Zinbryta - če ste že prej imeli resne alergijske reakcije na daklizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Slovenian: Avtoimunska hemolitična anemija O avtoimunski hemolitični anemiji so poročali pri < 1 % bolnikov, ki so jih v kliničnih študijah zdravili z zdravilom Zinbryta.
English: 150 mg Prefilled Syringe Figure A
Slovenian: 150 mg napolnjena injekcijska brizga Slika A
English: • If a refrigerator is not available, Zinbryta syringes/pens can be stored at room temperature (up to 30oC) in the original pack for up to 30 days.
Slovenian: • Če hladilnika ni na voljo, lahko zdravilo Zinbryta injekcijske brizge/injekcijske peresnike do 30 dni shranjujete pri sobni temperaturi (do 30 °C).
English: Events - CTCAE] Grade 2; at least one measurement) occurred in 4% of placebo-treated and 5% of Zinbryta-treated patients in the SELECT study, and 9% of the interferon beta-1a (intramuscular)-treated and 8% of Zinbryta-treated patients in the DECIDE study.
Slovenian: Skupno število limfocitov < 0,8 x 109 celic/l ([terminološko poenoteni kriteriji za neželene učinke (CTCAE - Common Terminology Criteria for Adverse Events)] 2. stopnje; vsaj ena meritev) se je pojavilo pri 4 % bolnikov, zdravljenih s placebom, in 5 % bolnikov, zdravljenih z zdravilom Zinbryta v študiji SELECT, in pri 9 % bolnikov, zdravljenih z interferonom beta-1a (intramuskularno), in pri 8 % bolnikov, zdravljenih z zdravilom Zinbryta v študiji DECIDE.
English: Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred.
Slovenian: Ne injicirajte v telesni predel, kjer je koža razdražena, pordela ali so na njej modrice, tetovaže, okužbe ali brazgotine.
English: The exact metabolic pathway for daclizumab has not been characterised.
Slovenian: Natančne poti presnavljanja daklizumaba niso opisali.
English: Autoimmune haemolytic anaemia has been reported in patients treated with Zinbryta which resolved with standard treatment and discontinuation of Zinbryta.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Zinbryta, so poročali o avtoimunski hemolitični anemiji, ki je izzvenela s standardnim zdravljenjem in ukinitvijo zdravila Zinbryta.
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to daclizumab or to any of the excipients (see section 6.1).
Slovenian: Zdravilo Zinbryta je kontraindicirano pri bolnikih s hudo preobčutljivostjo v anamnezi (npr. anafilaksija ali anafilaktične reakcije) za daklizumab ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: - 3 month multipack containing three 150 mg pre-filled syringes (3 boxes containing 1 syringe each).
Slovenian: - 3-mesečno skupno pakiranje, ki vsebuje tri 150-mg napolnjene injekcijske brizge (3 škatle, ki vsebujejo vsak po eno 1 injekcijsko brizgo).
English: There is limited data on concomitant use of Zinbryta with MS symptomatic therapies.
Slovenian: Podatkov o sočasni uporabi zdravila Zinbryta s simptomatskimi terapijami za multiplo sklerozo je malo.
English: Do not use external heat sources, such as hot water, to warm the pen.
Slovenian: Za ogrevanje napolnjenega injekcijskega peresnika ne uporabljajte zunanjih virov toplote, kot je topla voda.
English: Gauze Pad
Slovenian: Jetrna okvara