FrancophonIA/ELRC3.0 huggingface dataset:
English: • you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
Slovenian: • imate okužbo z virusom humane imunske pomanjkljivosti (HIV) ali sindrom pridobljene imunske pomanjkljivosti (AIDS);
English: Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Slovenian: Ker je znano, da se lahko protitelesa izločajo v materino mleko, tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: Guillain-Barré Syndrome*
Slovenian: Guillain-Barréjev sindrom*
English: • Brief introduction to avelumab (indication and purpose of this tool)
Slovenian: • Kratka predstavitev avelumaba (indikacija in namen kartice)
English: Time to response (TTR)
Slovenian: Čas do odziva (TTR)
English: • Feeling tired or weak
Slovenian: • občutek utrujenosti ali šibkost
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: • Inflammatory reaction of the whole body (Systemic inflammatory response syndrome)
Slovenian: • vnetna reakcija celega telesa (sindrom sistemskega vnetnega odziva)
English: The efficacy endpoints were based on 29 patients with 13 weeks of follow-up.
Slovenian: Izidi učinkovitosti so temeljili na 29 bolnikih s 13-tedenskim spremljanjem.
English: Decreased appetite
Slovenian: Zelo pogosti zmanjšan apetit
English: If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines.
Slovenian: Če med uporabo zdravila Bavencio doživite katerega koli od teh simptomov, jih ne poskušajte sami zdraviti z drugimi zdravili.
English: What you need to know before you use Bavencio Do not use Bavencio if you are allergic to avelumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Bavencio Ne uporabljajte zdravila Bavencio če ste alergični na avelumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression.
Slovenian: Večina (n = 160, 71,4 %) bolnikov z napredovalo boleznijo je po napredovanju nadaljevala zdravljenje z obema zdraviloma.
English: Bavencio has not been studied in children and adolescents below 18 years of age.
Slovenian: Zdravila Bavencio niso preučili pri otrocih in mladostnikih, starih manj kot 18 let.
English: • you have an autoimmune disease (a condition where the body attacks its own cells);
Slovenian: • imate avtoimunsko bolezen (bolezen, pri kateri telo napada lastne celice);
English: Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space.
Slovenian: Pričakuje se, da se avelumab porazdeli v sistemski cirkulaciji, v manjši meri pa v zunajceličnem prostoru.
English: • you have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Slovenian: • ste kadar koli imeli kronično virusno okužbo jeter, vključno s hepatitisom B (HBV) ali hepatitisom C (HCV);
English: • Reminder to carry the Patient Alert Card at all times and to show it to all healthcare professionals that may treat them.
Slovenian: • Opomnik, da naj imajo opozorilno kartico za bolnika vedno s seboj in jo pokažejo vsem zdravstvenim delavcem, ki jih bodo morda zdravili.
English: • Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
Slovenian: • Življenje ogrožujoči ali neželeni učinki 4. stopnje (razen endokrinopatij, nadzorovanih z nadomestnim hormonskim zdravljenjem)
English: You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment.
Slovenian: Med zdravljenjem boste opravljali krvne preiskave in vaš zdravnik bo pred in med zdravljenjem preverjal vašo telesno maso.
English: Please note that in some cases symptoms may be delayed, and may develop after your last dose.
Slovenian: Vedeti morate, da se ti simptomi včasih pojavijo pozno in da se lahko razvijejo po vašem zadnjem odmerku.
English: As expected for an antibody, avelumab does not bind to plasma proteins in a specific manner.
Slovenian: Kot se za protitelesa pričakuje, se avelumab ne veže na plazemske proteine na specifičen način.
English: Patients should be advised to use caution when driving or operating machinery until they are certain that avelumab does not adversely affect them.
Slovenian: Bolnikom je treba svetovati, naj bodo pri vožnji ali upravljanju strojev previdni, dokler niso prepričani, da avelumab pri njih nima neželenih učinkov.
English: BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable.
Slovenian: BICR: slepi neodvisni centralni pregled; IZ: interval zaupanja; NE: ni mogoče oceniti; TTR (Time To Response).
English: The MAH shall ensure that in each Member State where Bavencio is marketed, all patients/carers who are expected to use Bavencio have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer bo zdravilo Bavencio na trgu, vsi bolniki/skrbniki, za katere se pričakuje, da bodo zdravilo Bavencio uporabljali, imeli dostop do/prejeli sledeča izobraževalna gradiva:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če zdravilo ni uporabljeno takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo.
English: Consistent with a limited extravascular distribution, the volume of distribution of avelumab at steady state is small.
Slovenian: Skladno z omejeno ekstravaskularno porazdelitvijo je volumen porazdelitve avelumaba v stanju dinamičnega ravnovesja majhen.
English: Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 20°C to 25°C and room light.
Slovenian: Dokazana je 24-urna kemična in fizikalna stabilnost razredčene raztopine med uporabo pri temperaturi od 20 °C do 25 °C pri sobni svetlobi.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Slovenian: Če termin zamudite, se posvetujte z zdravnikom za načrtovanje naslednjega odmerka.
English: The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Slovenian: Razpon pH-vrednosti raztopine je med 5,0 in 5,6, osmolalnost pa je med 270 in 330 mOsm/kg.
English: With a median OS follow-up of 19 months, OS data were immature with 27% deaths.
Slovenian: Mediana spremljanja OS je bila 19 mesecev, podatki OS s 27 % smrtnih primerov so bili še nezreli.
English: Suspected pneumonitis should be confirmed with radiographic imaging.
Slovenian: Sum na pnevmonitis je treba potrditi z rentgenskim slikanjem.
English: • Reminder of the importance to consult their doctor before any change of treatment or in case of side effect
Slovenian: • Opomnik o pomenu posvetovanja z zdravnikom pred spremembo zdravljenja ali v primeru pojava neželenih učinkov
English: Bavencio acts on your immune system and may cause inflammation in parts of your body (see section 2).
Slovenian: Zdravilo Bavencio učinkuje na vaš imunski sistem in lahko povzroči vnetje v posameznih delih vašega telesa (glejte poglavje 2).
English: Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR).
Slovenian: Dodatni sekundarni izidi so vključevali objektivni odziv (OR, objective response), čas do odziva (TTR, time to response) in trajanje odziva (DOR, duration of response).
English: Blood tests and weight checks:
Slovenian: Krvne preiskave in preverjanje telesne mase:
English: Although there was no clear dose-response relationship, it cannot be excluded that this finding was related to avelumab treatment.
Slovenian: Čeprav ni bilo očitnega razmerja med odzivom in odmerkom, ni mogoče izključiti dejstva, da je to odkritje povezano z zdravljenjem z avelumabom.
English: Confirmed pancreatitis
Slovenian: Potrjeni pankreatitis
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1) and region (United States vs. Canada/Western Europe vs. the rest of the world).
Slovenian: Randomizacija je bila stratificirana skladno s statusom zmogljivosti (PS, Performance Status) po Vzhodni kooperativni onkološki skupini (ECOG, Eastern Cooperative Oncology Group) (0 proti 1) in regiji (Združene države Amerike v primerjavi s Kanado/Zahodno Evropo v primerjavi z ostalim svetom).
English: PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body's natural defences).
Slovenian: PD-L1 najdemo na površini določenih tumorskih celic in jih ščiti pred imunskim sistemom (naravno obrambo telesa).
English: You must not use Bavencio if you are pregnant unless your doctor specifically recommends it.
Slovenian: Zdravila Bavencio ne smete uporabljati, če ste noseči, razen če tako izrecno priporoča zdravnik.
English: The management guidelines for these adverse reactions are described in section 4.4.
Slovenian: Smernice za obravnavo teh neželenih učinkov so opisane v poglavju 4.4.
English: • Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Slovenian: • Opozorilo za bolnike glede pomena takojšnjega posvetovanja z zdravnikom, če se razvije kateri koli od navedenih znakov in simptomov, in da je pomembno, da jih ne poskušajo zdraviti sami.
English: The elimination half-life (t½) at the recommended dose is 6.1 days based on the population PK analysis.
Slovenian: Razpolovni čas izločanja (t½) pri priporočenem odmerku je 6,1 dni na podlagi populacijske farmakokinetične analize.
English: Many of the male monkeys used in these studies were sexually immature and thus no explicit conclusions regarding effects on male reproductive organs can be made.
Slovenian: Več opičjih samcev, uporabljenih v tej študiji, je bilo spolno nezrelih, kar ne dopušča eksplicitnega sklepanja glede učinkov na moške spolne organe.
English: Patients were randomised (1:1) to one of the following treatment arms:
Slovenian: Bolniki so bili randomizirani (1:1) v enega od naslednjih krakov zdravljenja:
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (2 °C do 8 °C).
English: All 5 patients with Type 1 diabetes mellitus were treated with insulin.
Slovenian: Vseh 5 bolnikov s sladkorno boleznijo tipa 1 je bilo zdravljenih z inzulinom.
English: Avelumab ORR (95% CI)
Slovenian: Avelumab ORR (95 % IZ)
English: Most immune-related adverse reactions with avelumab were reversible and managed with temporary or permanent discontinuation of avelumab, administration of corticosteroids and/or supportive care.
Slovenian: Večina imunsko pogojenih neželenih učinkov z avelumabom je bilo reverzibilnih in obvladljivih z začasno ali trajno prekinitvijo dajanja avelumaba, dajanjem kortikosteroidov in/ali podporno oskrbo.
English: Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Slovenian: Avelumab veže PD-L1 in blokira medsebojno delovanje med PD-L1 in receptorji programirane smrti 1 (PD-1) in B7.1.
English: If you have any questions about axitinib, ask your doctor.
Slovenian: Če imate vprašanja glede aksitiniba, se posvetujte z zdravnikom.
English: Pack size of 1 vial.
Slovenian: Velikost pakiranja 1 viala.
English: Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders.
Slovenian: Bolnike je treba spremljati zaradi pojava sprememb delovanja žleze ščitnice (ob začetku zdravljenja, periodično med zdravljenjem in nato kot je določeno na podlagi klinične ocene) in za klinične znake in simptome motenj delovanja žleze ščitnice.
English: Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Slovenian: Pri dvaindvajsetih od 29 (76 %) bolnikov z odzivom se je odziv pojavil v 7 tednih po prvem odmerku avelumaba.
English: It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Slovenian: Uporabe avelumaba med nosečnostjo se ne priporoča, razen če klinično stanje nosečnice zahteva zdravljenje z avelumabom.
English: Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity.
Slovenian: Dajanje zdravila Bavencio naj se nadaljuje v skladu s priporočenim načrtom do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Avelumab has negligible influence on the ability to drive and use machines.
Slovenian: Avelumab ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja strojev.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • The solution should be inspected to ensure it is clear, colourless, and free of visible particles.
Slovenian: • Raztopino preglejte, da se prepričate, da je bistra, brezbarvna in brez vidnih delcev.
English: This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
Slovenian: To prekine supresivne učinke PD-L1 na citotoksične celice T CD8+, kar povzroči obnovo antitumorskega odziva celic T.
English: Fertility The effect of avelumab on male and female fertility is unknown.
Slovenian: Učinek avelumaba na plodnost pri moških in ženskah ni znan.
English: Median, months (range)
Slovenian: Mediana, meseci (razpon)
English: Patients received avelumab at a dose of 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Slovenian: Bolniki so avelumab prejemali v odmerku 10 mg/kg vsaka 2 tedna do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Based on a population pharmacokinetic analysis from 1,629 patients, the value of total systemic clearance (CL) is 0.59 L/day.
Slovenian: Izločanje Na podlagi populacijske farmakokinetične analize pri 1.629 bolnikih je vrednost skupnega sistemskega očistka 0,59 l/dan.
English: From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
Slovenian: Z mikrobiološkega vidika je treba odprto zdravilo takoj razredčiti in infundirati.
English: It is unknown if Bavencio passes into your breast milk.
Slovenian: Ni znano, ali zdravilo Bavencio prehaja v materino mleko.
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Slovenian: Pot PD-1/PD-L1 naj bi ves čas nosečnosti sodelovala pri vzdrževanju tolerance za plod.
English: After preparation of infusion
Slovenian: Po pripravi infuzije
English: Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
Slovenian: Neporabljenega dela koncentrata ali razredčene raztopine za infundiranje ne shranjujte za ponovno uporabo.
English: Although studies to evaluate the effect of avelumab on fertility have not been conducted, there were no notable effects in the female reproductive organs in monkeys based on 1-month and 3-month repeat-dose toxicity studies (see section 5.3).
Slovenian: Čeprav študij za oceno učinka avelumaba na plodnost niso izvedli, ni bilo opaznih učinkov na ženske spolne organe pri opicah na podlagi 1-mesečnih in 3-mesečnih študij toksičnosti pri ponavljajočih se odmerkih (glejte poglavje 5.3).
English: Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.
Slovenian: Zdravilo Bavencio se veže na PD-L1 in blokira ta zaščitni učinek, s čimer imunskemu sistemu omogoči, da napade tumorske celice.
English: Other medicines and Bavencio
Slovenian: Druga zdravila in zdravilo Bavencio
English: The diluted solution should be used immediately once prepared.
Slovenian: Razredčeno raztopino morate uporabiti takoj po pripravi.
English: For instructions on the preparation and administration of the medicinal product, see section 6.6.
Slovenian: Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
English: Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Slovenian: Avelumab se primarno presnavlja po kataboličnih poteh, zato se ne pričakuje, da bi prišlo do farmakokinetičnega medsebojnega delovanja avelumaba z drugimi zdravili.
English: Progression-free survival (PFS)
Slovenian: Preživetje brez napredovanja (PFS)
English: The Patient Alert Card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki zdravila navedeni po padajoči resnosti.
English: It is important that you also read the package leaflet for the medicine containing axitinib.
Slovenian: Pomembno je, da preberete tudi navodilo za uporabo zdravila, ki vsebuje aksitinib.
English: In symptomatic patients, obtain gastroenterology consultation and laboratory investigations (including imaging) to ensure the initiation of appropriate measures at an early stage.
Slovenian: Pri simptomatskih bolnikih se posvetujte z gastroenterologom in opravite laboratorijske preiskave (vključno s slikanjem), da se že v zgodnji fazi zagotovi uvajanje ustreznih ukrepov.
English: In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Slovenian: V 1-mesečnih in 3-mesečnih študijah toksičnosti pri ponavljajočih se odmerkih pri opicah ni bilo opaznih učinkov na ženske spolne organe.
English: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Bavencio pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
English: For Part A, an efficacy analysis was conducted in all 88 patients after a minimum follow-up of 36 months.
Slovenian: Za del A so analizo učinkovitosti izvedli pri vseh 88 bolnikih po najmanj 36-mesečnem spremljanju.
English: * Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
Slovenian: * Toksičnost je bila ocenjena v skladu s Poenotenimi kriteriji za neželene učinke Nacionalnega inštituta za raka, različica 4.0 (NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, v4.03)
English: In patients, whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants may be considered.
Slovenian: Pri bolnikih, pri katerih imunsko pogojenih neželenih učinkov ni možno nadzorovati z uporabo kortikosteroidov, je treba razmisliti o uporabi drugih sistemskih imunosupresivov.
English: • Do not co-administer other medicinal products through the same intravenous line.
Slovenian: • Po isti intravenski liniji sočasno ne dajajte drugih zdravil.
English: In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Slovenian: Pri simptomatskih bolnikih se posvetujte s kardiologom in opravite laboratorijske preiskave, da se že v zgodnji fazi zagotovi uvajanje ustreznih ukrepov.
English: Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of Bavencio.
Slovenian: Vnetje lahko resno poškoduje vaše telo, nekatera vnetna stanja pa lahko ogrožajo življenje, zato jih je treba zdraviti ali prekiniti uporabo zdravila Bavencio.
English: How much Bavencio you will receive
Slovenian: Koliko zdravila Bavencio boste prejeli
English: Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC31.
English: If no improvement within 24 hours on corticosteroids, additional immunosuppression (e.g., mycophenolate, infliximab, anti-thymocyte globulin) should be considered.
Slovenian: Če pri uporabi kortikosteroidov v roku 24 ur ni izboljšanja, je treba razmisliti o dodatni uporabi imunosupresivov (npr. mikofenolata, infliksimaba, antitimocitnega globulina).
English: Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Slovenian: Koncentracije avelumaba v stanju dinamičnega ravnovesja so bile dosežene po približno 4 do 6 tednih (2 do 3 ciklih) ponavljajočega odmerjanja z 10 mg/kg vsaka 2 tedna, sistemsko kopičenje pa je bilo približno 1,25-kratno.
English: For Bavencio in combination with axitinib, see below.
Slovenian: Za zdravilo Bavencio v kombinaciji z aksitinibom, glejte spodaj
English: Dry mouth
Slovenian: Pogosti suha usta
English: Contents of the pack and other information What Bavencio contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Bavencio
English: The Patient Information brochure shall contain the following key messages:
Slovenian: Brošura z informacijami za bolnika mora vsebovati naslednja ključna sporočila:
English: Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Slovenian: Pri starejših bolnikih odmerka ni treba prilagajati (starost ≥ 65 let) (glejte poglavji 5.1 in 5.2).
English: PD-L1 expression at cut-off of 1%
Slovenian: Izraženost PD-L1 ob prekinitvi 1 %
English: Bavencio is for intravenous infusion only.
Slovenian: Zdravilo Bavencio je samo za intravensko infundiranje.
English: The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Slovenian: Primarni izidi učinkovitosti so bili stopnja preživetja brez napredovanja bolezni (PFS), kot je bilo ocenjeno z BICR z uporabo RECIST v1.1 in celokupnega preživetja (OS, overall survival) v zdravljenju prve izbire pri bolnikih z napredovalim KLC, ki imajo tumorje s pozitivnim PD-L1 (raven izraženosti PD-L1 ≥ 1 %).
English: Avelumab is most frequently associated with immune-related adverse reactions.
Slovenian: Avelumab je najpogosteje povezan z imunsko pogojenimi neželenimi učinki.
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Bavencio.
Slovenian: • Na kartici je tudi prostor za vnos kontaktnih podatkov zdravnika in opozorilo, da bolnik uporablja zdravilo Bavencio, namenjeno zdravstvenim delavcem, ki bodo bolnika kadar koli zdravili, vključno z nujnimi primeri.