FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term studies have not been performed to evaluate the carcinogenic potential of anakinra.
Slovenian: Dolgoročnih študij za ovrednotenje kancerogenega potenciala anakinre niso opravili.
English: In observations up to 3 years, the serious infection rate remained stable over time.
Slovenian: V opazovanjih, ki so trajala do 3 leta, je bil delež resnih okužb ves čas stalen.
English: The risk may be increased in patients with Down's syndrome (trisomy 21).
Slovenian: Tveganje je lahko večje pri bolnikih z Downovim sindromom (trisomijo 21).
English: These study data are insufficient to demonstrate efficacy and, therefore, Kineret is not recommended for paediatric use in JIA.
Slovenian: Podatki iz te študije ne zadoščajo za dokaz učinkovitosti in zato se zdravilo Kineret ne priporoča za pediatrično uporabo pri JIA.
English: Check the expiry date on the pre-filled syringe label (EXP).
Slovenian: Preverite datum izteka roka uporabnosti na nalepki napolnjene injekcijske brizge („EXP“).
English: - if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6; - if you are allergic to other products that are produced by DNA technology using the micro organism E. coli; - if you have neutropenia (low white blood cell count) determined after a blood test.
Slovenian: če ste alergični na anakinro ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če ste alergični na druga zdravila, izdelana s tehnologijo DNA z uporabo mikroorganizma E. coli; če imate nevtropenijo (nizko število belih krvnih celic), ugotovljeno po preiskavi krvi.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must either be used within 12 hours or disposed of.
Slovenian: Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (do 25 °C), jo morate v 12 urah bodisi porabiti ali zavreči.
English: In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
Slovenian: Pri otrocih z nezadostnim odzivom se odmerek lahko poviša na 4 mg/kg/dan.
English: Less than 2.5% of the administered dose of Kineret was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
Slovenian: Manj kot 2,5 % danega odmerka zdravila Kineret je bilo odstranjenega s hemodializo ali stalno ambulantno peritonealno dializo.
English: If you are not able to set the correct dose, dispose of the syringe and use a new one.
Slovenian: Če ne morete nastaviti pravilnega odmerka, odvrzite injekcijsko brizgo in uporabite novo.
English: However, after adjusting for creatinine clearance and body weight, gender and age were not significant factors for mean plasma clearance.
Slovenian: Vendar po prilagoditvi na očistek kreatinina in telesno maso spol in starost nista bila pomembna dejavnika za srednji plazemski očistek.
English: • If you had a dose lower than 100 mg you will have been told to eject liquid from the syringe onto a gauze or tissue.
Slovenian: • Če imate odmerek, manjši od 100 mg, vam je bilo naročeno, da izbrizgate tekočino iz brizge v gazo ali robček.
English: For instructions on how to inject yourself or your child with Kineret, please read the “Instructions for preparing and giving an injection of Kineret” section at the end of this leaflet.
Slovenian: Glede navodil, kako zdravilo Kineret injicirate sebi ali svojemu otroku, preberite poglavje „Navodila za pripravo in dajanje injekcije zdravila Kineret“ na koncu tega navodila.
English: None of the syringe or needle shield components are made with natural rubber latex.
Slovenian: Nobena izmed komponent brizge ali ščita igle ni izdelana iz lateksa iz naravne gume.
English: Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Slovenian: Normalno vaše telo izdeluje beljakovino, ki blokira škodljive učinke interlevkina-1.
English: Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Slovenian: Interakcij med zdravilom Kineret in drugimi zdravili niso raziskovali v uradnih študijah.
English: If you forget to use Kineret
Slovenian: Če ste pozabili uporabiti zdravilo Kineret
English: Dose increases may become necessary within 1-2 months based on therapeutic response.
Slovenian: Na podlagi terapevtskega odziva bo morda v 1-2 mesecih treba povečati odmerek.
English: Response to treatment should be evaluated after 1 month: In case of persistent systemic manifestations dose may be adjusted in children or continued treatment with Kineret should be reconsidered by the treating physician.
Slovenian: Odziv na zdravljenje je treba oceniti po 1 mesecu: V primeru vztrajnih sistemskih manifestacij je odmerek pri otrocih mogoče prilagoditi oziroma lahko lečeči zdravnik ponovno razmisli o nadaljevanju zdravljenja z zdravilom Kineret.
English: - Elevated levels of liver enzymes determined after a blood test.
Slovenian: - zvišane vrednosti jetrnih encimov, ugotovljene po preiskavi krvi.
English: How to prepare a 100 mg dose
Slovenian: Kako pripraviti odmerek 100 mg
English: Immunogenicity See section 4.8.
Slovenian: Imunogenost Glejte poglavje 4.8.
English: What Kineret is and what it is used for What you need to know before you use Kineret How to use Kineret
Slovenian: Kaj je zdravilo Kineret in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Kineret Kako uporabljati zdravilo Kineret
English: Before you inject Kineret you must do the following:
Slovenian: Pred injiciranjem zdravila Kineret morate narediti naslednje:
English: The safety of Kineret in individuals with latent tuberculosis is unknown.
Slovenian: Varnost zdravila Kineret pri posameznikih z latentno tuberkulozo ni znana.
English: At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
Slovenian: Po koncu hranjenja izven hladilnika se zdravila ne sme ponovno shraniti v hladilnik, ampak ga je treba zavreči.
English: The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Slovenian: Profil neželenih učinkov iz teh študij v celoti gledano ne kaže razlik od tistega, ki so ga ugotovili v študijah revmatoidnega artritisa.
English: These symptoms are generally mild to moderate and are more common at the start of your treatment.
Slovenian: Ti učinki so v splošnem blagi do zmerni in pogostejši na začetku zdravljenja;
English: Kineret was temporarily stopped in one patient, all other patients continued Kineret treatment during the infections.
Slovenian: Zdravilo Kineret je bilo začasno ustavljeno pri enem bolniku, vsi drugi bolniki so med okužbami nadaljevali zdravljenje z zdravilom Kineret.
English: The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.
Slovenian: Običajni vzdrževalni odmerek pri težkih oblikah CAPS je 3-4 mg/kg/dan in se lahko prilagodi do največ 8 mg/kg/dan.
English: At 1 year follow-up, 18 of 20 patients showed at least an adapted ACRpedi 70 response, and 17 of 20 patients reached an adapted ACRpedi 90 response as well as inactive disease.
Slovenian: Ob kontroli po 1 letu se je pri 18 od 20 bolnikov pokazal vsaj prilagojeni odziv ACRpedi 70, 17 od 20 bolnikov pa je doseglo tako prilagojeni odziv ACRpedi 90, kot tudi neaktivno bolezen.
English: The majority of CAPS patients in Study 03-AR-0298 developed anakinra anti-drug antibodies.
Slovenian: Pri večini bolnikov s CAPS v študiji 03-AR-0298 so se razvila protitelesa proti zdravilu anakinra.
English: The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Slovenian: Pojav protiteles je bil praviloma prehoden in ni bil povezan s kliničnimi neželenimi učinki ali manjšo učinkovitostjo.
English: The MAH shall ensure that in each Member State where Kineret is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe or use Kineret have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, v kateri se zdravilo Kineret trži, zagotoviti, da vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Kineret, prejmejo naslednji paket izobraževalnih gradiv:
English: Routine testing of hepatic enzymes during the first month should be considered, especially if the patient has pre-disposing factors or develops symptoms indicating liver dysfunction.
Slovenian: Treba je razmisliti o rutinskem testiranju jetrnih encimov v prvem mesecu, zlasti če ima bolnik predispozicijske dejavnike ali se pri njem razvijejo simptomi, ki kažejo na motnje v delovanju jeter.
English: You should try to have the injection at the same time each day.
Slovenian: Poskusite si dati injekcijo vsak dan ob istem času.
English: Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Slovenian: Tako je mogoče pričakovati, da se bo pri antagonistih receptorjev IL-1, kot je anakinra, nastajanje encimov CYP450 med zdravljenjem lahko normaliziralo.
English: Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.
Slovenian: Zdravila, imenovana zaviralci tumorje nekrotizirajočega faktorja (TNF-α), kot npr. etanercept, se ne smejo uporabljati z zdravilom Kineret, ker lahko to poveča tveganje za okužbo.
English: Eleven serious events in 4 (9.3%) patients were considered related to Kineret.
Slovenian: Enajst resnih dogodkov pri 4 (9,3 %) bolnikih je bilo povezanih z zdravilom Kineret.
English: It is important that you do not try to give yourself or your child the injection unless you have received training from a doctor, nurse or pharmacist.
Slovenian: Pomembno je, da ne poskušate dajati injekcij sebi ali svojemu otroku, dokler vas tega ne nauči zdravnik, medicinska sestra ali farmacevt.
English: If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.
Slovenian: Če ste si pozabili vbrizgati odmerek zdravila Kineret, se posvetujte z zdravnikom glede tega, kdaj si boste injicirali naslednji odmerek.
English: During an open-label extension phase, switching or add-on treatment with the comparator drug was possible if improvement did not occur within 24 weeks.
Slovenian: Med odprto podaljšano fazo je bilo mogoče preiti na primerjalno zdravilo ali ga uvesti kot dodatno zdravilo, če v 24 tednih ni prišlo do izboljšanja.
English: Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.
Slovenian: Zdravilo Kineret je namenjeno bolnikom, katerih odziv na metotreksat sam ni dovolj dober, da bi obvladal revmatoidni artritis.
English: • The early signs indicative of MAS
Slovenian: • zgodnje znake, ki so značilni za MAS,
English: Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Slovenian: Poleg tega se celotna incidenca malignomov v 3 letih izpostavljenosti zdravilu Kineret ni povečala.
English: The recommended dose is either 20 to 90 mg or 100 mg.
Slovenian: Priporočeni odmerek je bodisi od 20 do 90 mg bodisi 100 mg.
English: INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF KINERET
Slovenian: NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA KINERET
English: Take your Kineret pre-filled syringe out of the refrigerator.
Slovenian: Vzemite napolnjeno injekcijsko brizgo zdravila Kineret iz hladilnika.
English: A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Slovenian: Uradna študija o toksikoloških in toksikokinetičnih interakcijah pri podganah ni razkrila dokazov, da zdravilo Kineret spreminja toksikološki ali farmakokinetični profil metotreksata.
English: Maximal clinical response was generally seen within 12 weeks after starting treatment.
Slovenian: Največji klinični odziv je bil običajno viden v obdobju prvih 12 tednov po začetku zdravljenja.
English: • Information on macrophage activation syndrome (MAS) in patients receiving the product for the treatment of Still's disease
Slovenian: • podatke o sindromu aktivacije makrofagov (MAS) pri bolnikih, ki zdravilo prejemajo za zdravljenje Stillove bolezni,
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC03
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkina, oznaka ATC: L04AC03
English: If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated.
Slovenian: Če se pojavi huda alergijska reakcija, je treba prekiniti uporabo zdravila Kineret in uvesti ustrezno zdravljenje.
English: For more information on neutropenia see section 4.8.
Slovenian: Za več informacij o nevtropeniji glejte poglavje 4.8.
English: The majority of these reactions were maculopapular or urticarial rashes.
Slovenian: Večina teh reakcij je bila makulopapuloznih ali urtikarijskih izpuščajev.
English: Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Slovenian: Anakinra nevtralizira biološko aktivnost interlevkina-1α IL-1α in interlevkina-1β IL-1β s kompetitivno inhibicijo njune vezave na receptor za interlevkin-1 tipa I (IL-1RI).
English: A similar pattern was seen after 24 weeks Kineret treatment.
Slovenian: Podoben vzorec je bilo opaziti 24 tednov po zdravljenju z zdravilom Kineret.
English: In clinical studies transient elevations of liver enzymes have been seen.
Slovenian: V kliničnih študijah so opazili prehodna zvišanja vrednosti jetrnih encimov.
English: There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens.
Slovenian: Poročali so o tuberkulozi pri bolnikih, ki so bili deležni različnih bioloških protivnetnih programov zdravljenja.
English: • Patient identification
Slovenian: • identifikacijo bolnika,
English: When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.
Slovenian: Ko je bolezen pri bolnikih klinično dobro urejena, se lahko spremljanje CŽS in oftalmološki pregledi izvajajo enkrat letno.
English: In a standard battery of tests designed to identify hazards with respect to DNA, anakinra did not induce bacterial or mammalian cell gene mutations.
Slovenian: V standardni testni bateriji, namenjeni identifikaciji nevarnosti glede DNA, anakinra ni povzročila genskih mutacij v bakterijskih ali sesalskih celicah.
English: The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies.
Slovenian: Vloga IL-1 v patogenezi Stillove bolezni je bila dokazana s študijami ex vivo in študijami genske ekspresije.
English: Child
Slovenian: Otrok
English: In RA patients, no unexpected accumulation of anakinra was observed after daily subcutaneous doses for up to 24 weeks.
Slovenian: Pri bolnikih z RA niso opazili nikakršnega nepričakovanega kopičenja anakinre po dnevnih subkutanih odmerkih do 24 tednov.
English: Significant improvements are seen in the pain, tender joint count, physical function (HAQ score), acute phase reactants and in the patient's and physician's global assessment.
Slovenian: Pomembno izboljšanje vidimo pri bolečini, številu občutljivih sklepov, telesnem funkcioniranju (lestvica HAQ), reaktantih akutne faze in globalni oceni tako bolnika kot zdravnika.
English: A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra.
Slovenian: Klinični odziv na anakinro se je običajno pojavil v 2 tednih po uvedbi zdravljenja in se je s stalnim dajanjem anakinre vzdrževal.
English: In RA, CAPS and in Still's disease, your body produces too much of a cytokine called interleukin-1.
Slovenian: Pri RA, CAPS in Stillovi bolezni vaše telo izdeluje preveč citokina, imenovanega interlevkin-1.
English: For a more comfortable injection, leave at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Slovenian: Da injiciranje ne bo neprijetno, pustite napolnjeno injekcijsko brizgo približno 30 minut na sobni temperaturi ali jo previdno nekaj minut držite v roki.
English: Hearing and visual acuity did not deteriorate further during anakinra treatment.
Slovenian: Ostrina sluha in vida se ni poslabšala ob nadaljnjem zdravljenju z anakinro.
English: (Your doctor will have told you what dose you need to use.)
Slovenian: kateri odmerek morate uporabljati.)
English: Symptoms of lung disease can be e.g. shortness of breath during light exercise, morning cough, and difficulties breathing.
Slovenian: Simptomi pljučne bolezni so lahko npr. oteženo dihanje med lažjo vadbo, jutranji kašelj in težave z dihanjem.
English: You can now use the pre-filled syringe as described in the “Where should you give your injection?” section and “How do you give your injection?” section.
Slovenian: Zdaj lahko uporabite napolnjeno injekcijsko brizgo, kot je opisano v poglavjih „Kam naj si daste injekcijo?“ in „Kako si daste injekcijo?“ Kam naj si daste injekcijo?
English: Kineret must be injected under your skin (subcutaneous) daily.
Slovenian: Zdravilo Kineret je treba vsak dan injicirati pod kožo (subkutano).
English: Inject the liquid slowly and evenly, always keeping the skin pinched as in Figure E.
Slovenian: Tekočino injicirajte počasi in enakomerno; kožo medtem držite med prstoma, kot je prikazano na sliki E.
English: Contents of the pack and other information What Kineret contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kineret
English: The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Slovenian: Absolutna biološka uporabnost anakinre po subkutani bolusni injekciji 70 mg pri zdravih osebah (n = 11) je 95 %.
English: • Contact details of their physician
Slovenian: • kontaktne podatke njegovega zdravnika,
English: * Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
Slovenian: * Antagonist humanega receptorja za interlevkin-1 (r-metHuIL-1ra), ki ga izdelujejo v celicah Escherichie coli s tehnologijo rekombinantne DNA.
English: After injecting the liquid, remove the needle and let go of the skin.
Slovenian: Ko ste tekočino vbrizgali, iglo izvlecite in spustite kožo.
English: Place a sterile gauze or tissue on a flat surface and hold the syringe above it with the needle pointing towards the gauze or tissue, as shown in Figure C. Make sure the needle does not touch the gauze or tissue.
Slovenian: Položite sterilno gazo ali robček na ravno površino in držite brizgo nad njo tako, da je igla usmerjena proti gazi ali robčku, kot je prikazano na sliki C. Pazite, da se z iglo ne boste dotaknili gaze ali robčka.
English: Any unused medicine must be discarded.
Slovenian: Neuporabljeno zdravilo je treba zavreči.
English: • If your doctor has prescribed a lower dose you should continue to the “How to prepare a 20 to 90 mg dose” section.
Slovenian: • Če vam je zdravnik predpisal manjši odmerek, preberite poglavje „Kako pripraviti odmerek od 20 do 90 mg“.
English: In clinical studies and during post-marketing use, rare cases of opportunistic infections have been observed and have included fungal, mycobacterial, bacterial, and viral pathogens.
Slovenian: V kliničnih študijah in med uporabo po začetku trženja so zabeležili redke primere oportunističnih okužb, ki so vključevale glivične, mikobakterijske, bakterijske in virusne patogene.
English: Pharmacokinetic data in children < 4 years are lacking, but clinical experience is available from 8 months of age, and when started at the recommended daily dose of 1-2 mg/kg, no safety concerns have been identified.
Slovenian: Podatki o farmakokinetiki pri otrocih do 4 let manjkajo, vendar so na voljo klinične izkušnje od starosti 8 mesecev dalje in ob začetku zdravljenja s priporočenim dnevnim odmerkom 1-2 mg/kg ni bilo pomislekov glede varnosti.
English: A rapid and sustained decrease in the levels of the inflammatory biomarkers; serum amyloid A (SAA), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a normalization of inflammatory hematological changes are seen.
Slovenian: Opaziti je hitro in trajajoče zmanjšanje ravni bioloških označevalcev vnetja, serumskega amiloida A (SAA), C-reaktivnega proteina (CRP) in sedimentacije eritrocitov (ESR) ter normalizacijo hematoloških sprememb vnetja.
English: Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after subcutaneous bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects < 65 years than in subjects ≥ 65 years.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je bila povprečna vrednost plazemskega očistka po subkutani aplikaciji bolusa približno 14 % večja pri moških kot pri ženskah in približno 10 % večja pri osebah, mlajših od 65 let, kot pri osebah, starih 65 let ali več.
English: The physician educational material should contain:
Slovenian: Izobraževalno gradivo za zdravnika mora vsebovati:
English: • Instructions on correct injection procedures and disposal of used syringes
Slovenian: • navodila za pravilne postopke injiciranja in odstranjevanja uporabljenih brizg,
English: Untreated CAPS patients are characterized by increased CRP, SAA and IL-6 relative to normal serum levels.
Slovenian: Za nezdravljene bolniki s CAPS so značilne povečane ravni CRP, SAA in IL-6 glede na normalne ravni seruma.
English: This treatment combination has not demonstrated increased clinical benefit.
Slovenian: Ta kombinacija zdravil se ni izkazala za klinično koristnejšo.
English: These data support that no dose adjustment is required for patients with hepatic dysfunction of Child-Pugh Class B. See section 4.2.
Slovenian: Ti podatki potrjujejo, da ni potrebna prilagoditev odmerka za bolnike z jetrno disfunkcijo razreda Child-Pugh B. Glejte poglavje 4.2.
English: With careful monitoring, Kineret treatment can be continued also during a serious infection.
Slovenian: Pod skrbnim spremljanjem se lahko zdravljenje z zdravilom Kineret nadaljuje tudi med resno okužbo.
English: Hypersensitivity to the active substance or to to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali za beljakovine, ki izvirajo iz E. coli.
English: Patients with Still's disease have an increased risk of spontaneous development of MAS.
Slovenian: Bolniki s Stillovo boleznijo imajo povišano tveganje za spontani razvoj MAS.
English: The ejected liquid will be absorbed by the gauze or tissue as shown in Figure C.
Slovenian: Izbrizgana tekočina se bo vpila v gazo ali robček, kot je prikazano na sliki C.
English: Glucocorticoid doses can in many cases be reduced after initiation of Kineret therapy.
Slovenian: Odmerke glukokortikoidov je možno po začetku zdravljenja z zdravilom Kineret zmanjšati v veliko primerih.
English: Clinical efficacy and safety in RA
Slovenian: Klinična učinkovitost in varnost pri RA
English: A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study.
Slovenian: Podskupina teh bolnikov je nadaljevala odprto zdravljenje z zdravilom Kineret še do enega leta v spremljevalni podaljšani študiji.
English: If Kineret treatment is continued during serious infections to reduce the risk for a disease flare, careful monitoring is required.
Slovenian: V primeru nadaljevanja zdravljenja z zdravilom Kineret med hudimi okužbami, z namenom zmanjšanja nevarnosti za zagon bolezni, je potrebno skrbno spremljanje.
English: • The importance of providing patients and/or caregivers with the educational material
Slovenian: • pomembnost zagotavljanja izobraževalnega gradiva bolnikom in/ali skrbnikom.