natgillin/translations-raw huggingface dataset:
• Possible side effects (the most likely ones, how to recognise them and when to alert physicians)
• Možni neželeni učinki (najbolj verjetni, kako jih prepoznati in kdaj obvestiti zdravnika)
Sometimes, your doctor may tell you to place the tablet under your tongue instead.
Morda vam bo zdravnik naročil, da namesto tega tableto vstavite pod jezik.
Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Vaš zdravnik bo ocenil, ali potrebujete zdravilo za zmanjšanje ali izničenje odtegnitvenih simptomov
This product should only be used by patients already taking other opioids.
Zdravilo lahko uporabljajo samo bolniki, ki že jemljejo druge opioide.
• How to use EFFENTORA (how to take it, how to reach the effective dose during the titration process)?
• Kako uporabljati zdravilo EFFENTORA (kako ga jemati, kako med postopkom titriranja doseči učinkoviti odmerek)?
The differences observed were not clinically significant.
Opažene razlike niso bile statistično značilne.
<1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
neznana (ni mogoče oceniti iz razpoložljivih podatkov); v vsaki skupini pogostnosti so neželeni učinki predstavljeni v padajočem vrstnem redu po resnosti:
Dosage increase should be done with caution.
Odmerek je treba povečati previdno.
• The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
• Tveganje neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi ali antipsihotiki.
A Q&A document, providing answers to potential questions on the following topics:
Dokument z vprašanji in odgovori, kjer so odgovori na možna vprašanja na naslednje teme:
Doses above 800 micrograms were not evaluated in clinical studies.
Odmerkov nad 800 mikrogramov v kliničnih študijah niso ocenjevali.
• Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
• Bolniki brez vzdrževalne opioidne terapije, saj obstaja povišano tveganje respiratorne depresije.
The plasma protein binding of fentanyl is 80% to 85%.
Vezava fentanila na plazemske beljakovine je 80 % do 85 %.
The main pharmacokinetic parameters are shown in the following table.
Glavni farmakokinetični parametri so prikazani v spodnji tabeli.
• lack of sex hormones (androgen deficiency)
• pomanjkanje spolnih hormoneov (pomanjkanje androgena)
• Educational material for the patients
• Izobraževalno gradivo za bolnike
• What is Breakthrough pain?
• Kaj je prebijajoča bolečina?
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder or call the following number:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom ali pokličite naslednjo številko:
Physicians should keep in mind the potential of abuse of fentanyl.
Zdravniki morajo upoštevati možnost zlorabe fentanila.
In the further course of treatment your requirement for analgesic therapy may change.
V nadaljevanju zdravljenja se lahko vaše zahteve po analgetičnem zdravljenju spremenijo.
• Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
• Zdravila, imenovana zaviralci monamin-oksidaze (MAO) (uporabljajo se za hudo depresijo), če ste jih jemali v prejšnjih 2 tednih.
Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to
Neželeni učinki so našteti spodaj po sistemu MedDRA glede na organske sisteme in pogostnost (pogostnost je opredeljena kot: zelo pogosti ≥1/10, pogosti ≥1/100 do <1/10, občasni ≥1/1.000 do <1/100, redki (≥1/10.000 do <1/1.000),
If you have not been using these medicines you must not use Effentora, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Če niste uporabljali teh zdravil, ne smete uporabljati zdravila Effentora, saj lahko poviša tveganje, da postane dihanje nevarno počasno in/ali plitko ali se celo ustavi.
Aluminium laminated blister of PVC/Al foil/Polyamide/PVC with paper/polyester lidding.
Plastificiran aluminijev pretisni omot PVC/Al folija/poliamid/PVC s pokrovom iz papirja/poliestra.
Following the intravenous administration of fentanyl, less than 7% of the administered dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the faeces.
Po intravenski aplikaciji fentanila se manj kot 7 % apliciranega odmerka nespremenjenega izloči v urinu in samo približno 1 % se izloči nespremenjenega v blatu.
You must let your doctor know immediately if you are using Effentora more than four times per day, as a change may be required to your treatment regimen.
Zdravnika morate nemudoma obvestiti, če uporabljate zdravilo Effentora več kot štirikrat na dan, saj bo morda potrebna sprememba pri vašem režimu zdraviljenja.
** Data for Tmax presented as median (range).
** Podatki za Tmax, predstavljeni kot mediana (razpon).
• You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor.
• Imate bolečino ali zvečano občutljivost za bolečino (hiperalgezijo), ki se ne odziva na večje odmerke zdravila, ki vam jih predpiše zdravnik.
A document explaining the titration process and the dosing recommendations after treatment initiation
Dokument z razlago postopka titriranja in priporočil za odmerjanje po uvedbi zdravljenja
Your doctor will decide if your dose needs to be changed.
Zdravnik se bo odločil, ali je treba odmerek spremeniti.
The educational material for healthcare professionals shall consist of four items: • Opioid prescribing guide
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje štiri postavke: • Vodnika za predpisovanje opioidov
• disturbance in thinking, movements disturbance
• motnje v razmišljanju, motnje v gibanju
Pharmacotherapeutic group: analgesics; opioids; ATC code N02AB03.
Farmakoterapevtska skupina: analgetiki; opioidi; oznaka ATC N02AB03.
Any used or unused but no longer required medicinal product or waste material should be disposed of in accordance with local requirements.
Vso uporabljeno ali neuporabljeno zdravilo ali odpadni material, ki ga ne uporabljate več, zavrzite v skladu z lokalnimi predpisi.
The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Glavna vezna beljakovina je alfa-1 kisli glikoprotein, do neke mere pa sodelujeta tudi albumin in lipoproteini.
As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Kot z vsemi opioidi obstaja tveganje klinično pomembne respiratorne depresije, povezane z uporabo fentanila.
OTFC (normalized to 400 mcg)
OTFC (normalizirano na 400 mcg)
Effentora with food, drink and alcohol
Zdravilo Effentora skupaj s hrano, pijačo in alkoholom
This can occur if your dose of Effentora is too high or if you take too much Effentora.
To se lahko pojavi, če je vaš odmerek zdravila Effentora previsok ali če ste vzeli preveč zdravila Effentora.
Sixty-seven percent of the patients were able to be titrated to an effective dose.
Sedeminšestdeset odstotkov bolnikov je bilo možno titrirati na učinkovit odmerek.
• Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
• Nekateri mišični relaksanti, kot sta baklofen in diazepam (glejte tudi poglavje »Opozorila in previdnostni ukrepi«).
There are no adequate data from the use of fentanyl in pregnant women.
Ni ustreznih podatkov za uporabo fentanila pri nosečnicah.
• You have liver or kidney problems, as these organs have an effect on the way in which your system breaks down the medicine.
• Imate težave z jetri ali ledvicami, saj ti organi vplivajo na način, na katerega vaš organizem razgrajuje zdravilo.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
IZDELOVALEC (IZDELOVALCI), ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
Patients who identified an effective dose entered the double-blind phase of the study.
Bolniki, pri katerih je bil učinkovit odmerek ugotovljen, so bili uvrščeni v dvojno slepo fazo študije.
Patients receiving Effentora concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Bolnike, ki prejemajo zdravilo Effentora hkrati z zmernimi ali močnimi zaviralci CYP3A4, je treba daljše časovno obdobje skrbno nadzirati.
Your doctor will tell you whether Effentora is suitable for you.
Vaš zdravnik vam bo povedal, ali je zdravilo Effentora za vas primerno.
Your doctor may change the treatment for your persistent pain; when your persistent pain is controlled, your doctor may need to change the dose of Effentora.
Zdravnik bo morda spremenil vaše zdravilo za zdravljenje stalne bolečine; ko je vaša stalna bolečina pod nadzorom, bo morda zdravnik moral še enkrat spremeniti odmerek zdravila Effentora.
Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child.
Bolnike in njihove skrbnike je treba opozoriti, da vsebuje zdravilo Effentora učinkovino v količini, ki je lahko smrtna, posebej za otroke.
It may harm them,
bolečina dlesni,
The dose and duration of concomitant use should be limited (see section 4.4).
Odmerek in trajanje sočasne uporabe je treba omejiti (glejte poglavje 4.4).
• drug dependence (addiction)
• odvisnost od zdravil (zasvojenost)
Transient pH changes accompanying the effervescent reaction may optimise dissolution (at a lower pH) and membrane permeation (at a higher pH).
Prehodne spremembe v pH, ki spremljajo efervescentno reakcijo, lahko optimirajo raztapljanje (ob nižjem pH) in prepustnost membrane (pri višjem pH).
Its primary therapeutic actions are analgesia and sedation.
Njegova primarna terapevtska učinka sta analgetični in pomirjevalni.
You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
To upoštevajte, če ste na dieti z nadzorovanim vnosom natrija, in prosite zdravnika za nasvet.
A condition in which the adrenal glands do not produce enough hormones.
To je stanje, pri katerem nadledvične žleze ne ustvarijo dovolj hormonov.
Please tell your doctor about all sedative medicines you are taking (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions (antihistamines), or tranquillisers) and follow your doctor's dose recommendation closely.
Zdravniku povejte za vsa sedativna zdravila, ki jih jemljete (kot so uspavalne tablete, zdravila za zdravljenje anksioznosti, nekatera zdravila za zdravljenje alergijskih reakcij (antihistaminiki) ali pomirjevala) in natančno upoštevajte zdravnikova priporočila za odmerek.
Absolute bioavailability Fraction absorbed transmucosally Tmax (minute) ** Cmax (ng/ml)
Absolutna biološka razpoložljivost Frakcije, absorbirane transmukozno Tmax (minuta) ** Cmax (ng/ml)
If this occurs, please seek immediate medical assistance.
V takem primeru nemudoma poiščite zdravniško pomoč.
If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away.
Če ste zelo omotični ali zelo zaspani, preden se tableta povsem razkroji, sperite usta z vodo in preostanke takoj izpljunite v umivalnik ali stranišče.
Patients with xerostomia
Bolniki s kserostomijo
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Za zmanjšanje tveganja neželenih učinkov, povezanih z jemanjem opioidov, in za opredelitev učinkovitega odmerka je nujno, da bolnike med postopkom titriranja skrbno nadzira zdravstveni delavec.
When you place a tablet in your mouth, it dissolves and the medicine is absorbed through the lining of your mouth, into the blood system.
Ko tableto vstavite v usta, se raztopi in zdravilo se preko ustne sluznice absorbira v krvni sistem.
Patients assessed pain intensity on a 11-point scale.
Intenzivnost bolečine pri bolnikih so ocenjevali na 11-točkovni lestvici.
Therefore it is not possible to definitively separate the effects of Effentora alone.
Zato ni možno natančno opredeliti samo učinkov zdravila Effentora.
• You have a history of alcoholism or any drug abuse or dependence.
• Če imate anamnezo alkoholizma ali kakršne koli druge zasvojenosti ali odvisnosti od zdravil.
• Do not use this medicine after the expiry/use before date which is stated on the blister package label and the carton.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki pretisnega omota in na škatli.
Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating.
Ne vozite in ne upravljajte strojev, če ste zaspani ali omotični, imate zamegljen ali dvojni vid ali imate težave s koncentracijo.
Approximately 50% of the total dose administered is rapidly absorbed transmucosally and becomes systemically available.
Približno 50 % celotnega apliciranega odmerka se hitro absorbira transmukozno in postane sistemsko razpoložljivo.
The treatment for the persistent background pain should be kept as prescribed.
Zdravljenje trajne bolečine v ozadju naj se nadaljuje kot je predpisano.
Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Opioidi lahko zakrijejo klinični potek bolnika s poškodbo glave, zato naj se uporabljajo samo, če je to klinično potrebno.
Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Bolniki, ki prejemajo vzdrževalno opioidno terapijo so tisti, ki prejemajo vsaj 60 mg morfija peroralno dnevno, vsaj 25 mikrogramov transdermalnega fentanila na uro, vsaj 30 mg oksikodona dnevno, vsaj 8 mg peroralnega hidromorfona dnevno ali ekvivalenten analgetični odmerek drugega opioida en teden ali dlje.
• Open the blister only when you are ready to use the tablet.
• Odprite pretisni omot, ko ste pripravljeni vzeti tableto.
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001).
V drugi osrednji študiji (študija 2) je bila primarna končna točka SPID30, kar je bilo prav tako statistično značilno v primerjavi s placebom (p < 0,0001).
Because of these risks, concomitant prescribing of opioids and benzodiazepines or related drugs should be made only in patients for whom alternative treatment options are inadequate.
Zaradi teh tveganj se lahko opioidi in benzodiazepini ali povezana zdravila sočasno predpisujejo le pri bolnikih, za katere alternativne možnosti zdravljenja niso primerne.
If you become very sleepy or have slow and/or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Če postanete zelo zaspani ali opazite počasno in/ali plitko dihanje, morate o tem sami ali prek negovalca nemudoma obvestiti zdravnika in poklicati urgentno pomoč.
Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Nadaljnji izsledki pri odmerkih, toksičnih za mater pri mladičih F1 so bili zapoznel fizični razvoj, senzorične funkcije, refleksi in vedenje.
• Safe use, storage and disposal of EFFENTORA.
• Varna uporaba, shranjevanje in odstranjevanje zdravila EFFENTORA.
Cmax and AUC0-8 were 1% and 25% higher in patients with mucositis compared to those without mucositis, respectively.
Cmax je bil za 1 % in AUC0-8 za 25 % višji pri bolnikih z mukozitisom v primerjavi z bolniki brez mukozitisa.
If a second tablet of Effentora was required for several consecutive times, the usual maintenance dose is to be readjusted (see below).
Če je večkrat zaporedoma potrebna še druga tableta zdravila Effentora, je treba običajni vzdrževalni odmerek prilagoditi (glejte spodaj).
No studies of the effects on the ability to drive and use machines have been performed.
Študij vpliva na sposobnost vožnje in upravljanja strojev niso izvajali.
* See section Description of selected adverse reactions
* Glejte poglavje Opis izbranih neželenih učinkov
If you think someone has accidentally taken Effentora please seek immediate medical assistance.
Če menite, da je nekdo pomotoma uporabil zdravilo Effentora, nemudoma poiščite zdravniško pomoč.
Alternatively, the tablet could be placed sublingually (see section 5.2).
Druga možnost je, da se tableta vstavi pod jezik (glejte poglavje 5.2).
If you are not sure about the right dose, or if you have questions about taking this medicine, you should contact your doctor.
Če niste prepričani o pravem odmerku ali če imate vprašanja v zvezi z jemanjem tega zdravila, se posvetujte z zdravnikom.
Pharmacokinetic Parameters* in Adult Subjects Receiving Effentora
Farmakokinetični parametri* pri odraslih, ki so dobivali zdravilo Effentora
However, in these patients, a starting dose higher than 100 micrograms may be considered.
Vendar pa je lahko pri teh bolnikih začetni odmerek višji od 100 mikrogramov.
• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na fentanil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Trajanje respiratorne depresije po prevelikem odmerku je lahko daljše kot učinek delovanja opioidnega antagonista (npr. razpolovna doba naloksona niha med 30 in 81 minutami), zato ga bo morda treba ponovno aplicirati.
• Your other opioid pain medicine taken for your persistent (around-the-clock) cancer pain is not stabilised yet.
• Vaše drugo opioidno zdravilo, ki ga jemljete za lajšanje stalne (24-urne) bolečine zaradi karcinoma, še ni stabilizirano.
Fentanyl concentrations obtained in serum were higher than in plasma: Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
Koncentracije fentanila v serumu so bile višje kot v plazmi: AUC v serumu je bil približno 20 % višji in Cmax v serumu približno 30 % višji, kot sta AUC in Cmax v plazmi.
Time after Dose Administration (hours)
Čas po apliciranju odmerka (ure)
The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
V nekaterih primerih je morda potrebna razsodna uporaba naloksona ali drugih opioidnih antagonistov, vendar je povezana s tveganjem, da povzroči akutni odtegnitveni sindrom.
The risk of respiratory depression is less in patients receiving chronic opioid therapy as these patients will develop tolerance to respiratory depressant effects.
Tveganje respiratorne depresije je manjše pri bolnikih, ki prejemajo kronično opioidno terapijo, saj se pri teh bolnikih razvije toleranca na učinke respiratorne depresije.
Effentora should be individually titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions.
Zdravilo Effentora je treba titrirati individualno do ‘učinkovitega' odmerka, ki daje ustrezne analgetične rezultate in zmanjšuje neželene reakcije na najmanjšo možno mero.
A Daily Pain Journal to record daily pain levels, providing patients and physicians with a follow-up tool for daily symptoms and treatment efficacy.
Dnevnik bolečine v katero bolnik beleži raven dnevne bolečine, ki bolniku in zdravniku omogoča spremljanje dnevnih simptomov in učinkovitosti zdravljenja.
• Educational material for the healthcare professionals
• Izobraževalno gradivo za zdravstvene delavce.
Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).
Bolnike je treba natančno spremljati zaradi znakov in simptomov respiratorne depresije in sedacije (glejte poglavje 4.5).
Norfentanyl is not pharmacologically active in animal studies.
V študijah na živalih norfentanil ni farmakološko aktiven.
The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Pediatrična populacija Varnost in učinkovitost zdravila Effentora pri otrocih, starih 0 do 18 let, nista bili dokazani.
It is recommended that two tablets should be placed in each side of the mouth.
Priporoča se, da bolnik vstavi ti dve tableti na vsako stran ust.
• You have low amount of fluid in the circulation or low blood pressure.
• Imate malo tekočine v obtoku ali nizek krvni tlak.
Patients and carers must be advised to dispose of any unopened tablets remaining from a prescription as soon as they are no longer needed.
Bolnike in negovalce je treba poučiti, da vse zaprte tablete, ki jih niso porabili, odstranijo takoj, ko jih več ne potrebujejo.
Dosage and frequency
Odmerjanje in pogostost
OTFC data was dose adjusted (800 mcg to 400 mcg)
OTFC podatki so bili prilagojeni (800 mcg do 400 mcg)
• A serious side effect of Effentora is slow and/or shallow breathing.
• Resen neželeni učinek zdravila Effentora je počasno in/ali plitko dihanje.
During determination of your right dose, your doctor may instruct you to take more than one tablet per episode.
Med določanjem pravilnega odmerka vam lahko zdravnik naroči, da vzamete več kot eno tableto na epizodo.
Effentora should not be used during pregnancy unless you have discussed this with your doctor.
Nosečnost Zdravila Effentora ne smete uporabljati med nosečnostjo, razen če ste se tako dogovorili s svojim zdravnikom.
• The most serious side effects are shallow breathing, low blood pressure and shock.
• Najresnejši neželeni učinki so plitko dihanje, nizek krvni tlak in šok.
B. CONDITIONS OR RESTRICTION(S) REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
The analgesic effects of fentanyl are related to its plasma level.
Analgetični učinki fentanila so povezani s plazemsko ravnjo.
The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h.
Skupni plazemski očistek fentanila po intravenski aplikaciji je približno 42 L/h.
Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines.
Prebijajoča bolečina je dodatna, nenadna bolečina, ki se pojavi kljub temu, da jemljete običajno opioidno zdravilo za lajšanje bolečine.
The remaining half of the total dose is swallowed and slowly absorbed from the gastrointestinal tract.
Preostala polovica skupnega odmerka se pogoltne in počasi absorbira iz prebavnega trakta.
If you experience withdrawal symptoms or if you are concerned about your pain relief, you should contact your doctor.
Če se pojavijo odtegnitveni simptomi ali če ste zaskrbljeni glede lajšanja bolečin, se posvetujte z zdravnikom.
• blisters in the mouth, dry lips, collection of pus under the skin in the mouth
• mehurčki v ustih, suhe ustnice, nabiranje gnoja pod kožo v ustih
In each Member State where EFFENTORA is marketed the Marketing Authorisation Holder (MAH) shall agree an updated educational programme with the National Competent Authority.
V vseh državah članicah, kjer je zdravilo EFFENTORA v prometu, se bo imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoril za posodobljen izobraževalni program.