FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of infections and serious infections did not increase over time.
Slovenian: Stopnja okužb in resnih okužb se sčasoma ni povečala.
English: For additional information on storage at room temperature, see section 6.3.
Slovenian: Za dodatne informacije o shranjevanju pri sobni temperaturi glejte poglavje 6.3.
English: • Be designed to enable physicians to present patient-friendly information;
Slovenian: • biti oblikovana tako, da omogoči zdravnikom predstavitev informacij na bolniku prijazen način;
English: • Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
Slovenian: • zelo redki (<1/10.000) • neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: • Acknowledgment Form.
Slovenian: • potrditveni obrazec.
English: This is a type of medicine called a monoclonal antibody.
Slovenian: To je vrsta zdravila, ki se imenuje monoklonsko protitelo.
English: • changes in your blood (anaemia) which may make you feel weak
Slovenian: • spremembe na krvi (anemija), zaradi česar ste lahko šibki
English: This loss of myelin is called demyelination.
Slovenian: Izguba mielina se imenuje demielinizacija.
English: In the absence of compatibility studies, this medicinal product should not be mixed with other products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: • thoughts of hurting yourself or suicide
Slovenian: • misli o samopoškodovanju ali samomoru
English: Do not use this medicine if you notice that:
Slovenian: Ne uporabljajte tega zdravila, če opazite, da:
English: Percent ≥ 2 relapses in the year prior to study
Slovenian: Odstotek ≥ 2 recidivov v letu pred študijo
English: Do not freeze or expose to high temperatures.
Slovenian: Ne zamrzujte in ne izpostavljajte visokim temperaturam.
English: Table 5 and Figures 1-2 show the results for the DECIDE study.
Slovenian: Preglednica 5 in sliki 1-2 prikazujeta rezultate študije DECIDE.
English: It is very important that you do not miss this blood test.
Slovenian: Pomembno je, da te krvne preiskave ne izpustite.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 July 2016
Slovenian: Datum prve odobritve: 01. julij 2016
English: Reported experience with overdose is limited.
Slovenian: Poročane izkušnje s prevelikim odmerjanjem so omejene.
English: Daclizumab 150 mg (N=1943)
Slovenian: Daklizumab 150 mg (N=1943)
English: This medicinal product should not be used if:
Slovenian: Tega zdravila se ne sme uporabiti, če:
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Slovenian: Te informacije ne morejo nadomestiti pogovora z zdravnikom ali medicinsko sestro o vašem zdravstvenem stanju ali zdravljenju.
English: Try to keep to a set day for it each month.
Slovenian: Poskušajte si določiti dan za to vsak mesec.
English: Percent prior DMT use (%)
Slovenian: Odstotek pred uporabo DMT (%)
English: Do not make changes unless your doctor tells you to.
Slovenian: Ne spreminjajte ničesar, če vam tako ne naroči zdravnik.
English: You should then contact your doctor, nurse or pharmacist.
Slovenian: Potem morate stopiti v stik z zdravnikom, medicinsko sestro ali farmacevtom.
English: However, Zinbryta's effect on other vaccines (live vaccines) is not known.
Slovenian: Vendar pa učinek zdravila Zinbryta na druga cepiva (živa cepiva) ni znan.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake »EXP«.
English: Although human IgG is secreted into human milk, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
Slovenian: Čeprav se humani IgG izloča v materino mleko, objavljeni podatki kažejo, da protitelesa v materinem mleku ne vstopajo v obtok pri novorojencu in dojenčku v znatnih količinah.
English: Disease history
Slovenian: Zgodovina bolezni
English: Additional supplies which are not included in the pack (See Figure B):
Slovenian: Dodatni pripomočki, ki niso priloženi pakiranju (glejte sliko B):
English: Symptoms may disappear completely after the relapse is over but, over time, some problems may remain between relapses and interfere with daily activities.
Slovenian: Simptomi lahko po recidivu povsem izginejo, toda sčasoma nekatere težave med recidivi ostanejo in ovirajo vsakodnevne dejavnosti.
English: It is very important that you have these regular blood tests.
Slovenian: Redno izvajanje teh krvnih preiskav je zelo pomembno.
English: Component of a multipack, cannot be sold separately.
Slovenian: Sestavni del skupnega pakiranja, ni za posamično prodajo.
English: • Patient details, signature and date;
Slovenian: • bolnikovi podatki, podpis in datum;
English: In case of overdose, patients may require medical attention and appropriate supportive treatment should be given.
Slovenian: V primeru prevelikega odmerka bo morda treba bolnike zdravniško oskrbeti in jim nuditi ustrezno podporno zdravljenje.
English: Keep this Card with you during treatment and for 6 months afterwards.
Slovenian: Kartico shranite med zdravljenjem in še 6 mesecev potem.
English: The magnitude of the immune response to the seasonal influenza vaccine, and proportion of patients with seroconversion and seroprotection were consistent with those observed in healthy volunteer populations.
Slovenian: Velikost imunskega odziva na sezonsko cepivo proti gripi in delež bolnikov s serokonverzijo in serozaščito je bil skladen s tistim pri populaciji zdravih prostovoljcev.
English: In either case, do not use two injections to make up for a missed dose.
Slovenian: V nobenem primeru ne uporabite dveh injekcij odmerka, da bi nadomestili izpuščeni odmerek.
English: • feeling unusually sad, hopeless or bad about yourself
Slovenian: • neobičajen občutek žalosti, brezupa ali nezadovoljstva s seboj
English: Doses up to this level were well tolerated with no evidence of acute toxicity.
Slovenian: Odmerke do te ravni so bolniki dobro prenašali brez dokazov akutne toksičnosti.
English: If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection.
Slovenian: Če ne slišite zvokov klikanja ali če ne vidite zelenih kljukic v oknu za stanje injiciranja, potem ko ste poskusili injicirati, se je napolnjeni injekcijski peresnik mogoče zaklenil in injekcije mogoče niste prejeli.
English: Clinical trial data from the DECIDE study demonstrated consistent treatment effects in the highly active disease subgroup.
Slovenian: Podatki kliničnih preskušanj za študijo DECIDE so dokazali skladne učinke zdravljenja v podskupini z zelo aktivno boleznijo.
English: People with relapsing MS have repeated attacks (relapses) of symptoms caused by their nerves not working properly.
Slovenian: Ljudje z recidivno MS imajo ponavljajoče napade (recidive) simptomov, ki jih povzročajo nepravilno delujoči živci.
English: Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose.
Slovenian: Izpostavljenosti (AUC) v teh študijah so bile v razponu od 55- do 140-krat večje od opaženih pri kliničnih odmerkih.
English: Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Slovenian: Celotna izpostavljenost (osebe-leta) 7011 ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
English: Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids.
Slovenian: Kožne reakcije so običajno izzvenele s standardno oskrbo, vključno z zdravljenjem z lokalnimi ali sistemskimi steroidi.
English: Even if you have had no previous liver problems, your doctor will carry out blood tests to test your liver function.
Slovenian: Tudi če prej še niste imeli težav z jetri, bo vaš zdravnik opravil krvne preiskave, da testira delovanje vaših jeter.
English: Results for the SELECT study are shown in Table 4.
Slovenian: Rezultati za študijo SELECT so prikazani v preglednici 4.
English: - if you have liver problems.
Slovenian: - če imate težave z jetri.
English: Contact your doctor immediately if you get any serious side effects.
Slovenian: Takoj se obrnite na zdravnika, če se pojavi kateri koli resen neželeni učinek.
English: In patients who have had tuberculosis or who live in endemic areas of the disease, screening for active tuberculosis should be performed before starting treatment, and patients should be monitored during treatment.
Slovenian: Pri bolnikih, ki so že imeli tuberkulozo ali ki živijo na endemičnih področjih te bolezni, so pred začetkom zdravljenja potrebne preiskave za aktivno tuberkulozo, bolnike pa je treba med zdravljenjem spremljati.
English: Race No pharmacokinetic differences were observed between Japanese and Caucasian healthy volunteers.
Slovenian: Rasa Razlik v farmakokinetiki med zdravimi japonskimi in belskimi prostovoljci niso opazili.
English: Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors, ATC code: L04AC01
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC01
English: Daclizumab pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Slovenian: Farmakokinetika daklizumaba je dobro opisana v dvoprostornem modelu z absorpcijo in izločanjem prvega reda.
English: Interferon beta-1a (intramuscular) 30 micrograms
Slovenian: Interferon beta-1a (intramuskularno) 30 mikrogramov
English: b. Wash your hands with soap and water.
Slovenian: b. Umijte si roke z milom in vodo.
English: The Acknowledgment Form aims at providing information on the risk of serious hepatic injury to patients.
Slovenian: Potrditveni obrazec ima namen zagotavljanja informacij bolnikom o tveganju za resne poškodbe jeter.
English: There was no effect on foetal development and no evidence of teratogenicity.
Slovenian: Učinka na razvoj fetusa in dokazov o teratogenosti ni bilo.
English: Hold
Slovenian: Držite
English: Table 5: DECIDE study clinical and MRI results (96 to 144 weeks) (Values refer to results at 96 weeks, unless otherwise indicated.)
Slovenian: Preglednica 5: Klinični rezultati in rezultati MR slikanja v študiji DECIDE (96 do 144 tednov) (Vrednosti se nanašajo na rezultate pri 96 tednih, razen kjer je navedeno drugače.)
English: Vaccination with live vaccines is not advised during treatment and up to 4 months after discontinuation.
Slovenian: Cepljenje z živimi cepivi se med zdravljenjem in še do 4 mesece po prekinitvi zdravljenja odsvetuje.
English: If you experience any of the following, contact your doctor immediately:
Slovenian: Če opazite kar koli od naslednjega, takoj obvestite zdravnika:
English: This small volume of distribution indicates that daclizumab is primarily confined to the vascular and interstitial spaces.
Slovenian: Ta majhen volumen porazdelitve kaže, da je daklizumab primarno omejen na ožilje in intersticijski prostor.
English: • increases in body temperature (fever)
Slovenian: • zvišana telesna temperatura (vročina)
English: The most common types of infections were upper respiratory tract infections and viral infections.
Slovenian: Najpogostejše vrste okužb so bile okužbe zgornjih dihal in virusne okužbe.
English: AST or ALT ≥ 3 x ULN AND total bilirubin ≥ x 2 ULN
Slovenian: AST ali ALT ≥ 3 x ULN IN celotni bilirubin ≥ x 2 ULN
English: Daclizumab had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Slovenian: Daklizumab nima vpliva na perinatalni in postnatalni razvoj potomcev od rojstva do 6 mesecev starosti.
English: Patients have received double the recommended dose of Zinbryta with no serious extra side effects.
Slovenian: Bolniki so prejeli dvojni priporočeni odmerek zdravila Zinbryta brez resnih dodatnih neželenih učinkov.
English: Side effects may occur even after stopping treatment (see serious side effects in section 4).
Slovenian: Neželeni učinki se lahko pojavijo tudi po koncu zdravljenja (glejte resne neželene učinke v poglavju 4).
English: Warning!
Slovenian: Opozorilo!
English: Mutagenesis Genotoxicity studies have not been conducted.
Slovenian: Mutageneza Študij genotoksičnosti niso izvajali.
English: Table 3: Study design and baseline characteristics for SELECT study and DECIDE study Study name
Slovenian: Preglednica 3: Zasnova študije in izhodiščne značilnosti za študijo SELECT in študijo DECIDE Ime študije
English: When you have any medical treatment, even if it is not for your MS, show the Patient Card to the doctor, pharmacist or nurse.
Slovenian: Ko se kakor koli zdravite, tudi če ni zaradi MS, to Opozorilno kartico za bolnika pokažite zdravniku, farmacevtu ali medicinski sestri.
English: Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials
Slovenian: Kumulativne incidence največjih zvišanj ALT ali AST (na podlagi laboratorijskih podatkov), ki so jih ugotovili v kliničnih preskušanjih.
English: Quickly insert the needle straight into the skin fold until the needle is fully under the skin.
Slovenian: Iglo hitro vbodite naravnost v kožno gubo tako, da je igla povsem pod kožo.
English: Name and address of the manufacturer of the biological active substance:
Slovenian: Ime in naslov izdelovalca biološke učinkovine:
English: For DECIDE, at least 2 relapses (one of which was a clinical relapse) within the prior 3 years was also required
Slovenian: Za študijo DECIDE sta bila potrebna vsaj 2 recidiva (med katerim je bil en klinični recidiv) v predhodnih 3 letih.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Slovenian: • Zdravilo je priporočljivo shranjevati v nadzorovanem hladilniku med 2 °C in 8 °C v zaprti originalni škatli za zagotovitev zaščite pred svetlobo.
English: In MS, the body's immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord).
Slovenian: Pri MS telesni imunski sistem povzroča vnetje, ki poškoduje zaščitno ovojnico (imenovano mielin) okoli živcev v osrednjem živčnem sistemu (vključno z možgani in hrbtenjačo).
English: Check the medicine window.
Slovenian: Preverite okno za zdravilo.
English: This tells you that the injection is happening (see Figure G).
Slovenian: To vam bo povedalo, da je injiciranje v teku (glejte sliko G).
English: Zinbryta is not to be used in children and adolescents younger than 18 years old.
Slovenian: Zdravila Zinbryta ne smejo uporabljati otroci in mladostniki, mlajši od 18 let.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Slovenian: Napolnjenega injekcijskega peresnika ne delite z nikomer, da ne bi od koga dobili infekcije ali da ne bi kdo dobil infekcije od vas.
English: Most patients had mild elevations that were below or up to 3 x ULN and resolved spontaneously.
Slovenian: Pri večini bolnikov so bila povišanja blaga, pod ali do 3 x ULN, in so spontano izzvenela.
English: Some side effects may require your doctor to interrupt your treatment and refer you to a specialist.
Slovenian: Zaradi nekaterih neželenih učinkov bo zdravnik moral vaše zdravljenje prekiniti in vas napotiti k specialistu.
English: This has important safety information that you need to know before and during treatment with Zinbryta.
Slovenian: Vsebuje pomembne informacije o varnosti, ki jih morate vedeti pred zdravljenjem z zdravilom Zinbryta in med njim.
English: Chronic administration of daclizumab at all doses increased the incidence of skin findings (compared to those observed in control animals).
Slovenian: Kronično dajanje daklizumaba pri vseh odmerkih je povečalo incidenco izsledkov na koži (v primerjavi z opaženimi pri kontrolnih živalih).
English: • The recommendation not to initiate treatment in patients with autoimmune disorders (other than multiple sclerosis);
Slovenian: • priporočilu, naj se zdravljenje ne uvaja pri bolnikih z avtoimunskimi boleznimi (razen multiple skleroze);
English: Time on study (weeks) Number of patients at risk
Slovenian: Čas v študiji (tedni) Število bolnikov s tveganjem
English: Do not try to treat any side effects yourself.
Slovenian: Neželenih učinkov ne poskušajte zdraviti sami.
English: Time on study (weeks) Average number of patients at risk
Slovenian: Čas v študiji (tedni) Povprečno število bolnikov s tveganjem
English: Your doctor will decide whether Zinbryta is the right medicine for you.
Slovenian: Zdravnik bo odločil o tem, ali je zdravilo Zinbryta pravo zdravilo za vas.
English: If your doctor has told you to stop using your medicine, do not restart unless your doctor tells you to.
Slovenian: Če vam je zdravnik povedal, da naj zdravilo prenehate uporabljati, ga ne začnite uporabljati ponovno,
English: Study design Treatment
Slovenian: Zasnova študije Zdravljenje
English: Zinbryta has had very little testing in people older than 55 years old.
Slovenian: Z zdravilom Zinbryta so pri osebah, starejših od 55 let, opravili zelo malo testov.
English: • If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
Slovenian: o Če nekatere predele pretežko dosežete, prosite usposobljenega negovalca, naj vam pomaga.
English: Seasonal flu vaccines (inactive vaccine) have been shown to be effective when given to patients taking Zinbryta.
Slovenian: Pokazalo se je, da so sezonska cepiva proti gripi (inaktivirana cepiva) učinkovita, ko se dajejo bolnikom, ki uporabljajo zdravilo Zinbryta.
English: Possible liver problems
Slovenian: Možne težave z jetri
English: Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments.
Slovenian: Zdravilo Zinbryta se uporablja za zdravljenje recidivne oblike multiple skleroze (MS) pri odraslih, ki se niso odzvali na zdravljenje kljub zdravljenju z vsaj dvema zdraviloma za MS in ki ne morejo prejemati drugih zdravil.
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Slovenian: Raziskovalne študije in vitro kažejo, da agregati celic mikroglije ne nastajajo kot neposredni učinek daklizumaba na mikroglijske celice, temveč so verjetno posledica povečanja biološke uporabnosti lokalnega IL-2.
English: As renal excretion is not a major route of elimination, no dose adjustments are considered necessary (see section 5.2).
Slovenian: Ker ledvično izločanje ni glavna pot izločanja, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Slovenian: Tveganje za progresivno multifokalno levkoencefalopatijo (PML), povezano z zdravljenjem z zdravilom Zinbryta, ni bilo ugotovljeno.
English: • diarrhoea that does not go away
Slovenian: • driska, ki ne mine
English: Note: You might see air bubbles in the medicine window.
Slovenian: Opomba: V oknu za zdravilo mogoče vidite zračne mehurčke.
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab in milk (for details see section 5.3).
Slovenian: Razpoložljivi toksikološki podatki pri doječih opicah cynomolgus kažejo na izločanje daklizumaba v mleko (za podrobnosti glejte poglavje 5.3).
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab.
Slovenian: Izpostavljenost bolnikov, starih več kot 55 let, v kliničnih študijah z daklizumabom je bila omejena.
English: In a clinical study, patients (n=90) on long-term treatment with Zinbryta mounted appropriate immune responses to an inactivated trivalent seasonal influenza vaccine.
Slovenian: V klinični študiji so bolniki (n = 90), ki so se dolgotrajno zdravili z zdravilom Zinbryta, razvili ustrezne imunske odzive na inaktivirano trivalentno sezonsko cepivo proti gripi.
English: • The liquid is cloudy or contains floating particles.
Slovenian: • je tekočina motna ali vsebuje plavajoče delce.
English: Daclizumab was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Slovenian: Daklizumab so odkrili v mleku 11/14 opic v laktaciji v ravneh, ki so bile < 0,122 % ravni v serumu matere, brez neželenih učinkov pri potomcih.
English: Total lymphocyte counts returned to baseline levels approximately 8-12 weeks after the last dose of Zinbryta (150mg).
Slovenian: Skupno število limfocitov se je vrnilo na izhodiščne ravni približno 8 do 12 tednov po zadnjem odmerku zdravila Zinbryta (150 mg).
English: • your skin or the whites of the eyes turn yellow Increased tiredness, dark urine and skin or whites of the eyes turning yellow also may be symptoms of liver problems, see section above on liver problems.
Slovenian: • vaša koža ali očesne beločnice porumenijo Povečana utrujenost, temen urin in porumenitev kože ali očesnih beločnic so lahko tudi simptomi težav z jetri, glejte zgornje poglavje o težavah z jetri.
English: This is normal and the bubbles do not need to be expelled before your injection.
Slovenian: To je normalno; pred injiciranjem mehurčkov ni treba iztisniti.
English: In addition, the Card explains the need for monitoring of liver function and educates the patient on the importance of adherence to their monthly blood tests.
Slovenian: Na opozorilni kartici je poleg tega pojasnjena potreba po spremljanju delovanja jeter, bolnike pa izobražuje tudi o pomembnosti udeleževanja mesečnih krvnih preiskav.
English: Treatment should be initiated by a physician experienced in the management of multiple sclerosis.
Slovenian: Zdravljenje naj se začne pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
English: # Hazard ratio for the risk of relapse.
Slovenian: # Razmerje ogroženosti za tveganje za recidiv.
English: Zinbryta may cause serious liver problems that may be life-threatening or result in death.
Slovenian: Zdravilo Zinbryta lahko povzroči resne težave z jetri, ki so lahko življenjsko nevarne ali celo povzročijo smrt.
English: • Patient Card;
Slovenian: • opozorilno kartico za bolnika;
English: p<0.0001 * Rates and risk reductions/endpoints are calculated over the treatment period up to 144 weeks.
Slovenian: * Pogostnost in zmanjšanje tveganja/opazovani dogodki se izračunajo na obdobje do 144 tednov.
English: Stomach pain may also be a symptom of liver problems, see section above on liver problems.
Slovenian: Bolečina v trebuhu je lahko tudi simptom težav z jetri, glejte poglavje o težavah z jetri.
English: Patients treated with Zinbryta should be advised to report any symptoms of new or worsening depression, and/or suicidal ideation immediately to the prescribing physician.
Slovenian: Bolnike, ki se zdravijo z zdravilom Zinbryta, je treba opozoriti, da morajo takoj poročati o vseh novih ali poslabšanih simptomih depresije in/ali samomorilnih mislih zdravniku, ki je zdravilo predpisal.
English: If you are over 55 your doctor may still prescribe Zinbryta.
Slovenian: Če ste starejši od 55 let, vam lahko zdravnik kljub temu predpiše zdravilo Zinbryta.
English: As data on use of Zinbryta during pregnancy are limited, the risk to the baby and benefit to the mother should be taken into consideration.
Slovenian: Ker so podatki o uporabi zdravila Zinbryta med nosečnostjo omejeni, je treba upoštevati tveganje za dojenčka in koristi za mater.
English: The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated.
Slovenian: Varnosti odmerkov, večjih od 300 mg, apliciranih subkutano, in 400 mg, apliciranih intravensko, niso ovrednotili.
English: Keep the pack closed until you need to use a new syringe/pen.
Slovenian: Pakiranje naj bo zaprto, dokler ne potrebujete nove injekcijske brizge/novega injekcijskega peresnika.