FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to response was 6 weeks (range: 6 weeks to 36 weeks) after the first dose of avelumab.
Slovenian: Mediana časa do odziva je bila 6 tednov (razpon: 6 tednov do 36 tednov) po prvem odmerku avelumaba.
English: The recommended dose of avelumab is 800 mg every 2 weeks.
Slovenian: Priporočeni odmerek avelumaba je 800 mg vsaka 2 tedna.
English: The median duration of response was not estimable (95% CI: 4 months, not estimable) with a minimum of 1.2 months to a maximum of 8.3 months duration.
Slovenian: Mediane trajanja odziva ni bilo mogoče oceniti (95-% IZ: 4 meseci, ni mogoče oceniti) s trajanjem najmanj 1,2 meseca do največ 8,3 meseca.
English: Avelumab plus axitinib
Slovenian: Avelumab plus aksitinib
English: The observed hazard ratio (HR) for OS was 0.80 (95% CI: 0.616, 1.027) for avelumab in combination with axitinib compared to sunitinib.
Slovenian: Opazovano razmerje ogroženosti (HR, hazard ratio) za OS je bilo 0,80 (95 % IZ: 0,616; 1,027) za avelumab v kombinaciji z aksitinibom v primerjavi s sunitinibom.
English: Weight decreased
Slovenian: nižjo hitrostjo
English: • problems due to inflammation of your lungs (pneumonitis);
Slovenian: • težave zaradi vnetja pljuč (pnevmonitisa),
English: Part A was a single-arm, multi-centre study conducted in patients with histologically confirmed metastatic MCC, whose disease had progressed on or after chemotherapy administered for distant metastatic disease, with a life expectancy of more than 3 months.
Slovenian: Del A je bila multicentrična študija z enim krakom, izvedena pri bolnikih s histološko potrjenim metastatskim KMC z napredovalo boleznijo ali po kemoterapiji zaradi bolezni z oddaljenimi zasevki s pričakovano življenjsko dobo več kot 3 mesece.
English: Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Slovenian: Okvaro jeter so opredelili po kriterijih Nacionalnega inštituta za raka (NCI, National Cancer Institute) za motnje delovanja jeter.
English: The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
Slovenian: Učinkovitost in varnost avelumaba v kombinaciji z aksitinibom sta bili prikazani v študij B9991003, randomizirani, multicentrični, odprti študiji avelumaba v kombinaciji z aksitinibom pri 886 bolnikih z nezdravljenim napredovalnim ali metastatskim KLC s svetlocelično komponento.
English: Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
Slovenian: Avelumaba niso preučili pri bolnikih s hudo okvaro ledvic (GFR 15 do 29 ml/min).
English: Forty-seven (53%) of the patients had visceral metastases.
Slovenian: Sedeminštirideset (53 %) bolnikov je imelo visceralne zasevke.
English: It is very important for you to keep all your appointments to receive Bavencio.
Slovenian: Zelo pomembno je, da pridete na vse dogovorjene termine, kjer boste prejeli zdravilo Bavencio.
English: Patients should be monitored for elevated serum creatinine prior to and periodically during treatment.
Slovenian: Bolnike je treba spremljati zaradi pojava zvišane vrednosti kreatinina v serumu pred zdravljenjem in periodično med zdravljenjem.
English: Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
Slovenian: Zdravljenje z avelumabom in aksitinibom se je nadaljevalo do napredovanja bolezni, opredeljenega v RECIST v1.1 in ocenjenega s slepim neodvisnim centralnim pregledom (BICR, Blinded Independent Central Review), ali nesprejemljive toksičnosti.
English: Assessment of tumour status was performed at baseline, after randomisation at 6 weeks, then every 6 weeks thereafter up to 18 months after randomisation, and every 12 weeks thereafter until documented confirmed disease progression by BICR.
Slovenian: Oceno tumorskega statusa so opravili na začetku, po randomizaciji v 6. tednu, nato na vsakih 6 tednov še do 18 mesecev po randomizaciji, pozneje pa na vsakih 12 tednov do potrjenega napredovanja bolezni, dokumentiranega z BICR.
English: After Part B was fully enrolled, a subsequent interim analysis was conducted with 116 patients who received at least one dose of avelumab and with at least 7 months of follow-up at the time of the data cut-off (cut-off date 14 September 2018).
Slovenian: Potem ko je bil del B v celoti vključen, je bila naslednja vmesna analiza izvedena na 116 bolnikih, ki so prejeli najmanj en odmerek avelumaba z najmanj 7-mesečnim spremljanjem v času zbiranja presečnih podatkov (datum zbiranja presečnih podatkov 14. september 2018).
English: One vial of 10 mL contains 200 mg of avelumab.
Slovenian: Ena viala z 10 ml vsebuje 200 mg avelumaba.
English: Table 1: Guidelines for withholding or discontinuation of Bavencio Treatment-related adverse reaction
Slovenian: Preglednica 1: Smernice za odložitev ali prekinitev uporabe zdravila Bavencio Neželeni učinki zaradi zdravljenja
English: Patients were included irrespective of prognostic risk groups or tumour PD-L1 expression and had to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 that was not been previously irradiated.
Slovenian: Bolniki so bili vključeni neodvisno od prognostičnih skupin tveganja ali izraženosti PD-L1 tumorja in so morali imeti najmanj eno merljivo lezijo po merilih za oceno odgovora na zdravljenje pri čvrstih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumors), različica 1.1, ki predhodno ni bila obsevana.
English: • Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
Slovenian: • sladkorna bolezen tipa 1, vključno s kislino v krvi zaradi sladkorne bolezni (diabetična ketoacidoza),
English: These reactions are presented by system organ class and frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
English: The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Slovenian: Potrebno količino zdravila Bavencio izvlecite iz vial(e) in prenesite v vrečo za infundiranje.
English: If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
Slovenian: Če je raztopina motna, spremenjene barve ali vsebuje delce, morate vialo zavreči.
English: • Decrease in the number of red blood cells
Slovenian: • zmanjšano število rdečih krvnih celic
English: Figure 2 presents the Kaplan-Meier curve for PFS from the subsequent interim analysis with 116 patients enrolled into Part B with a minimum follow-up of 7 months.
Slovenian: Slika 2 predstavlja Kaplan-Meierjevo krivuljo PFS naslednje vmesne analize za 116 bolnikov, vključenih v del B, z najkrajšim spremljanjem 7 mesecev.
English: What Bavencio is and what it is used for
Slovenian: Kaj je zdravilo Bavencio in za kaj ga uporabljamo
English: 10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Slovenian: 10 ml koncentrat v viali (steklo vrste I) s halobutilnim gumijastim zamaškom in aluminijastim tesnilom z odstranljivo plastično zaporko.
English: PD-L1 expression at cut-off of 5%
Slovenian: Izraženost PD-L1 ob prekinitvi 5 %
English: For at least the first 4 treatments, you will receive paracetamol and an antihistamine before being given Bavencio, to help to prevent possible side effects related to the infusion.
Slovenian: Preden boste prejeli zdravilo Bavencio, boste vsaj prve 4 cikle zdravljenja prejeli paracetamol in antihistaminik, ki bosta pomagala preprečiti možne neželene učinke, povezane z infuzijo.
English: If you are a woman who could become pregnant, you must use effective contraceptives while you are being treated with Bavencio and for at least 1 month after your last dose.
Slovenian: Če ste ženska, ki lahko zanosi, morate med zdravljenjem z zdravilom Bavencio in še vsaj 1 mesec po zadnjem odmerku uporabljati učinkovito kontracepcijo.
English: The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Slovenian: Najpogostejši neželeni učinki stopnje ≥ 3 so bili anemija (6,0 %), dispneja (3,9 %) in bolečine v trebuhu (3,0 %).
English: It must not be administered as an intravenous push or bolus injection.
Slovenian: Ni ga dovoljeno dati v obliki hitre intravenske ali bolusne injekcije.
English: 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 < 1/1,000); very rare (< 1/10,000).
Slovenian: Pogostnosti so opredeljene 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); zelo redki (<1/10.000).
English: The patient educational material should contain
Slovenian: Izobraževalno gradivo za bolnike mora vsebovati:
English: Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Slovenian: Ženskam, ki dojijo, je treba svetovati, naj med zdravljenjem in še vsaj 1 mesec po zadnjem odmerku ne dojijo zaradi možnih resnih neželenih učinkov pri dojenih otrocih.
English: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN
Slovenian: Vrednosti aspartat-aminotransferaze (AST) ali alanin-aminotransferaze (ALT), ki so več kot 3- in do 5-krat večje od zgornje meje normalne ravni (ULN, upper limit of normal) ali vrednost cekolupnega bilirubina, ki je več kot 1,5- in do 3-krat večja od ULN
English: Renal cell carcinoma (study B9991003)
Slovenian: Karcinom ledvičnih celic (študija B9991003)
English: The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Slovenian: Ključni sekundarni izidi PFS so temeljili na oceni BICR z uporabo kriterijev RECIST v.1.1 in OS neodvisno od izraženosti PD-L1.
English: Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy could continue treatment.
Slovenian: Z zdravljenjem so lahko nadaljevali bolniki z radiološko potrjenim napredovanjem bolezni, ki ni bilo povezano s pomembnim kliničnim poslabšanjem, opredeljenim z odsotnostjo novih simptomov ali poslabšanjem simptomov, ohranitvijo statusa zmogljivosti dlje kot dva tedna in odsotnostjo potrebe po rešilnem zdravljenju.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6.3.
English: Permanently discontinue
Slovenian: Zdravljenje trajno ukinite
English: Pregnancy There are no or limited data from the use of avelumab in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi avelumaba pri nosečnicah ni oziroma so omejeni.
English: Patient distribution by Memorial Sloan-Kettering Cancer Center (MSKCC) risk groups was 22% favourable, 65% intermediate, and 11% poor.
Slovenian: Porazdelitev bolnikov glede na skupine tveganja po napovednem modelu Memorial Sloan-Kettering Cancer Center (MSKCC, Memorial Sloan-Kettering Cancer Center) je bila 22 % ugodna, 65 % srednje ugodna in 11 % slaba.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of avelumab (see “Description of selected adverse reactions” below).
Slovenian: Večina neželenih učinkov, vključno s hudimi, je po uvedbi ustreznega zdravljenja z zdravili ali prenehanju dajanja avelumaba izzvenela (glejte razdelek "Opis izbranih neželenih učinkov" v nadaljevanju).
English: Pneumonitis
Slovenian: Pnevmonitis
English: • Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
Slovenian: • Trdovratni imunsko pogojeni neželeni učinki 2. ali 3. stopnje, ki trajajo 12 tednov ali dlje
English: Confirmed objective response rate (ORR)
Slovenian: Potrjena stopnja objektivnega odziva (ORR)
English: The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Slovenian: Druge sestavine so manitol, koncentrirana ocetna kislina, polisorbat 20, natrijev hidroksid, voda za injekcije (glejte poglavje 2 "Zdravilo Bavencio ima majhno vsebnost natrija").
English: • Merkel cell carcinoma (MCC), a rare type of skin cancer, when it is metastatic (has spread to other parts of the body).
Slovenian: • karcinoma Merklovih celic (KMC), kar je redka vrsta kožnega raka, kadar gre za metastatsko obliko (razširjeno tudi na druge dele telesa).
English: Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 1.
Slovenian: Na podlagi individualne varnosti in prenašanja bo morda treba z odmerkom počakati ali odmerjanje prekiniti; glejte preglednico 1.
English: Table 3: Adverse reactions in patients treated with avelumab in combination with axitinib in clinical studies B9991002 and B9991003
Slovenian: Preglednica 3: Neželeni učinki pri bolnikih, zdravljenih z avelumabom v kombinaciji z aksitinibom v kliničnih študijah B9991002 in B9991003 Pogostnost
English: Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Slovenian: Če se vam pojavi vnetje v katerem koli delu vašega telesa ali če imate katerega od naslednjih znakov ali simptomov ali se le-ti poslabšajo, poiščite nujno zdravniško pomoč.
English: Bavencio is compatible with polyethylene, polypropylene, and ethylene vinyl acetate infusion bags, glass bottles, polyvinyl chloride infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 micrometre.
Slovenian: Zdravilo Bavencio je združljivo z infuzijskimi vrečami iz polietilena, polipropilena in etilenvinilacetata, steklenicami, infuzijskimi seti iz polivinilklorida in linijskimi filtri z membranami iz polietersulfona z velikostjo por 0,2 mikrometra.
English: The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Slovenian: Učinkovitost in varnost avelumaba je bila raziskana v študiji v dveh delih EMR100070-003.
English: Positive (n=46)
Slovenian: Pozitiven (n = 46)
English: A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Slovenian: Populacijska farmakokinetična analiza ne kaže na razlike v celokupnem sistemskem očistku avelumaba na podlagi starosti, spola, rase, statusa PD-L1, tumorskega bremena, okvare ledvic in blage do zmerne okvare jeter.
English: Of these patients, none experienced immune-related pneumonitis Grade ≥ 3.
Slovenian: Od teh noben bolnik ni imel imunsko pogojenega pnevmonitisa ≥ 3. stopnji.
English: The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
Slovenian: Izpostavljenost avelumabu se je povečevala v odvisnosti od odmerka v razponu odmerkov od 10 mg/kg do 20 mg/kg vsaka 2 tedna.
English: Prior to launch of Bavencio in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Bavencio na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa,
English: In the supplemental analysis, avelumab CL was found to decrease over time: the largest mean maximal reduction (% coefficient of variation [CV%]) from baseline value with different tumour types was approximately 32.1% (CV 36.2%).
Slovenian: V dopolnilni analizi so ugotovili zmanjšanje skupnega sistemskega očistka avelumaba v odvisnosti od časa: največje povprečno maksimalno zmanjšanje (% koeficient variacije [KV%]) od izhodiščne vrednosti pri različnih vrstah tumorjev je bilo približno 32,1 %
English: • Feeling cold
Slovenian: • občutek hladu
English: Severity*
Slovenian: Resnost*
English: It is unknown whether avelumab is excreted in human milk.
Slovenian: Ni znano, ali se avelumab izloča v materino mleko.
English: The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Slovenian: Stopnja objektivnega odziva je bila 62,1 % (95-% IZ: 42,3; 79,3), pri čemer so za 4 (14 %) bolnike poročali o popolnem odzivu in za 14 (48 %) o delnem odzivu.
English: Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Slovenian: Med 73 bolniki, pri katerih so ponovno uvedli avelumab (59 %) ali aksitinib (85 %) v monoterapiji ali zdravljenje z obema (55 %), se pri 66 % ALT ≥ 3-kratniku ULN ni ponovno pojavil.
English: The pack size is 1 glass vial per carton.
Slovenian: Velikost pakiranja je 1 steklena viala v škatli.
English: Treatment modification
Slovenian: Spreminjanje zdravljenja
English: Bavencio will be added to an infusion bag containing a sodium chloride solution before use.
Slovenian: Zdravilo Bavencio bo pred uporabo dodano v infuzijsko vrečo, ki vsebuje raztopino natrijevega klorida.
English: Data for immune-related adverse reactions for avelumab as a monotherapy are based on 1,650 patients in the phase I study EMR100070-001 in solid tumours and 88 patients in study EMR100070-003, and for avelumab in combination with axitinib are based on 489 patients in study B9991002 and B9991003 (see section 5.1).
Slovenian: Podatki o imunsko pogojenih neželenih učinkih za avelumab v monoterapiji temeljijo na 1.650 bolnikih v študiji faze I EMR100070-001 s čvrstimi tumorji in na 88 bolnikih v študiji EMR100070-003, za avelumab v kombinaciji z aksitinibom pa temeljijo na 489 bolnikih v študijah B9991002 in B9991003 (glejte poglavje 5.1).
English: • Renal cell carcinoma (RCC), a type of kidney cancer, when it is advanced (has spread beyond the kidney or to other parts of the body).
Slovenian: • karcinoma ledvičnih celic (KLC), kar je vrsta ledvičnega raka, kadar gre za napredovalo obliko (razširjeno izven ledvice ali tudi na druge dele telesa).
English: Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Slovenian: Osemindvajset (90,3 %) od 31 bolnikov je dobivalo visoke odmerke kortikosteroidov za mediano 2,4 tedna (razpon: 1 dan do 10,2 meseca).
English: In the remaining 1.4% (6/439) of patients, infusion-related reactions occurred after the first 4 infusions and all were of Grade 1 or Grade 2.
Slovenian: Pri preostalih 1,4 % (6/439) bolnikov pa so se neželeni učinki, povezani z infundiranjem, pojavili po prvih 4 infundiranjih, pri čemer so bili vsi 1. ali
English: Bavencio is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate).
Slovenian: Zdravilo Bavencio je bister in brezbarven do rahlo rumenkast koncentrat za raztopino za infundiranje (sterilni koncentrat).
English: Systemic inflammatory response syndrome*
Slovenian: Občasni sindrom sistemskega vnetnega odziva*
English: Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Slovenian: Ne prenehajte se zdraviti z zdravilom Bavencio, če se niste tako dogovorili z zdravnikom.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati zaradi pojava znakov in simptomov neželenih učinkov.
English: Initiate treatment with insulin for Type 1 diabetes mellitus.
Slovenian: Uvesti je treba zdravljenje z insulinom za sladkorno bolezen tipa 1.
English: Results (N=116)
Slovenian: Rezultati (N = 116)
English: Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
Slovenian: Skupaj je 52 (59 %) bolnikov imelo 1 predhodno onkološko zdravljenje KMC, 26 (30 %) bolnikov 2 predhodni zdravljenji in 10 (11 %) bolnikov 3 ali več predhodnih zdravljenj.
English: • Avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally (N=442).
Slovenian: • Avelumab 10 mg/kg v obliki intravenske infuzije vsaka 2 tedna v kombinaciji z aksitinibom v odmerku 5 mg dvakrat na dan peroralno (n = 442).
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Slovenian: Podrobne smernice za obravnavo imunsko pogojenih neželenih učinkov so opisane v poglavju 4.4.
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Slovenian: Namen izobraževalnega programa je povečati ozaveščenost in zagotoviti informacije v povezavi z znaki in simptomi določenih pomembnih ugotovljenih tveganj avelumaba, vključno z imunsko pogojenim pnevmonitisom, hepatitisom, kolitisom, pankreatitisom, miokarditisom, motnjami delovanja žleze ščitnice, insuficienco nadledvične žleze, sladkorno boleznijo tipa 1, nefritisom in motnjami delovanja ledvic, miozitisom, hipopituitarizmom, uveitisom, Guillain-Barréjevim sindromom in reakcijah, povezanim z infundiranjem, ter napotki kako obvladovati navedena tveganja.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • inflammation of your liver (hepatitis) or other liver problems;
Slovenian: • vnetje jeter (hepatitis) ali druge težave z jetri,
English: Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies with avelumab in combination with axitinib are presented in Table 3.
Slovenian: Neželeni učinki, o katerih so poročali pri 489 bolnikih z napredovalim KLC, zdravljenih v dveh kliničnih študijah z avelumabom v kombinaciji z aksitinibom, so predstavljeni v preglednici 3.
English: • Increases or decreases in blood pressure
Slovenian: • zmanjšan ali zvišan krvni tlak
English: Grade 2 pneumonitis
Slovenian: Pnevmonitis 2. stopnje
English: Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Slovenian: Po tem, ko dobite zdravilo Bavencio, ne vozite in ne upravljajte strojev, če se ne počutite dovolj dobro.
English: Bavencio has a low sodium content
Slovenian: Zdravilo Bavencio ima majhno vsebnost natrija
English: • Flu-like illness (includes feeling of fever, muscle aches)
Slovenian: • gripi podobna bolezen (vključno z občutkom povišane telesne temperature, bolečinami v mišicah)
English: Do not breast-feed while receiving Bavencio and for at least 1 month after your last dose.
Slovenian: Med prejemanjem zdravila Bavencio in še vsaj 1 mesec po zadnjem odmerku ne dojite.