natgillin/translations-raw huggingface dataset:
Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR).
Dodatni sekundarni izidi so vključevali objektivni odziv (OR, objective response), čas do odziva (TTR, time to response) in trajanje odziva (DOR, duration of response).
Blood tests and weight checks:
Krvne preiskave in preverjanje telesne mase:
Although there was no clear dose-response relationship, it cannot be excluded that this finding was related to avelumab treatment.
Čeprav ni bilo očitnega razmerja med odzivom in odmerkom, ni mogoče izključiti dejstva, da je to odkritje povezano z zdravljenjem z avelumabom.
Confirmed pancreatitis
Potrjeni pankreatitis
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).
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).
PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body's natural defences).
PD-L1 najdemo na površini določenih tumorskih celic in jih ščiti pred imunskim sistemom (naravno obrambo telesa).
You must not use Bavencio if you are pregnant unless your doctor specifically recommends it.
Zdravila Bavencio ne smete uporabljati, če ste noseči, razen če tako izrecno priporoča zdravnik.
The management guidelines for these adverse reactions are described in section 4.4.
Smernice za obravnavo teh neželenih učinkov so opisane v poglavju 4.4.
• 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.
• 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.
The elimination half-life (t½) at the recommended dose is 6.1 days based on the population PK analysis.
Razpolovni čas izločanja (t½) pri priporočenem odmerku je 6,1 dni na podlagi populacijske farmakokinetične analize.
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.
Več opičjih samcev, uporabljenih v tej študiji, je bilo spolno nezrelih, kar ne dopušča eksplicitnega sklepanja glede učinkov na moške spolne organe.
Patients were randomised (1:1) to one of the following treatment arms:
Bolniki so bili randomizirani (1:1) v enega od naslednjih krakov zdravljenja:
Store in a refrigerator (2°C to 8°C).
Shranjujte v hladilniku (2 °C do 8 °C).
All 5 patients with Type 1 diabetes mellitus were treated with insulin.
Vseh 5 bolnikov s sladkorno boleznijo tipa 1 je bilo zdravljenih z inzulinom.
Avelumab ORR (95% CI)
Avelumab ORR (95 % IZ)
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.
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.
Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors.
Avelumab veže PD-L1 in blokira medsebojno delovanje med PD-L1 in receptorji programirane smrti 1 (PD-1) in B7.1.
If you have any questions about axitinib, ask your doctor.
Če imate vprašanja glede aksitiniba, se posvetujte z zdravnikom.
Pack size of 1 vial.
Velikost pakiranja 1 viala.
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.
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.
Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Pri dvaindvajsetih od 29 (76 %) bolnikov z odzivom se je odziv pojavil v 7 tednih po prvem odmerku avelumaba.
It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Uporabe avelumaba med nosečnostjo se ne priporoča, razen če klinično stanje nosečnice zahteva zdravljenje z avelumabom.
Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity.
Dajanje zdravila Bavencio naj se nadaljuje v skladu s priporočenim načrtom do napredovanja bolezni ali nesprejemljive toksičnosti.
Avelumab has negligible influence on the ability to drive and use machines.
Avelumab ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja strojev.
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.
• 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.
• The solution should be inspected to ensure it is clear, colourless, and free of visible particles.
• Raztopino preglejte, da se prepričate, da je bistra, brezbarvna in brez vidnih delcev.
This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
To prekine supresivne učinke PD-L1 na citotoksične celice T CD8+, kar povzroči obnovo antitumorskega odziva celic T.
Fertility The effect of avelumab on male and female fertility is unknown.
Učinek avelumaba na plodnost pri moških in ženskah ni znan.
Median, months (range)
Mediana, meseci (razpon)
Patients received avelumab at a dose of 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Bolniki so avelumab prejemali v odmerku 10 mg/kg vsaka 2 tedna do napredovanja bolezni ali nesprejemljive toksičnosti.
Based on a population pharmacokinetic analysis from 1,629 patients, the value of total systemic clearance (CL) is 0.59 L/day.
Izločanje Na podlagi populacijske farmakokinetične analize pri 1.629 bolnikih je vrednost skupnega sistemskega očistka 0,59 l/dan.
From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
Z mikrobiološkega vidika je treba odprto zdravilo takoj razredčiti in infundirati.
It is unknown if Bavencio passes into your breast milk.
Ni znano, ali zdravilo Bavencio prehaja v materino mleko.
The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Pot PD-1/PD-L1 naj bi ves čas nosečnosti sodelovala pri vzdrževanju tolerance za plod.
After preparation of infusion
Po pripravi infuzije
Do not store any unused portion of the concentrate or of the diluted infusion solution for reuse.
Neporabljenega dela koncentrata ali razredčene raztopine za infundiranje ne shranjujte za ponovno uporabo.
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).
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).
Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.
Zdravilo Bavencio se veže na PD-L1 in blokira ta zaščitni učinek, s čimer imunskemu sistemu omogoči, da napade tumorske celice.
Other medicines and Bavencio
Druga zdravila in zdravilo Bavencio
The diluted solution should be used immediately once prepared.
Razredčeno raztopino morate uporabiti takoj po pripravi.
For instructions on the preparation and administration of the medicinal product, see section 6.6.
Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Avelumab se primarno presnavlja po kataboličnih poteh, zato se ne pričakuje, da bi prišlo do farmakokinetičnega medsebojnega delovanja avelumaba z drugimi zdravili.
Progression-free survival (PFS)
Preživetje brez napredovanja (PFS)
The Patient Alert Card shall contain the following key messages:
Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki zdravila navedeni po padajoči resnosti.
It is important that you also read the package leaflet for the medicine containing axitinib.
Pomembno je, da preberete tudi navodilo za uporabo zdravila, ki vsebuje aksitinib.
In symptomatic patients, obtain gastroenterology consultation and laboratory investigations (including imaging) to ensure the initiation of appropriate measures at an early stage.
Pri simptomatskih bolnikih se posvetujte z gastroenterologom in opravite laboratorijske preiskave (vključno s slikanjem), da se že v zgodnji fazi zagotovi uvajanje ustreznih ukrepov.
In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
V 1-mesečnih in 3-mesečnih študijah toksičnosti pri ponavljajočih se odmerkih pri opicah ni bilo opaznih učinkov na ženske spolne organe.
The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Pediatrična populacija Varnost in učinkovitost zdravila Bavencio pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
For Part A, an efficacy analysis was conducted in all 88 patients after a minimum follow-up of 36 months.
Za del A so analizo učinkovitosti izvedli pri vseh 88 bolnikih po najmanj 36-mesečnem spremljanju.
* Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
* 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)
In patients, whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants may be considered.
Pri bolnikih, pri katerih imunsko pogojenih neželenih učinkov ni možno nadzorovati z uporabo kortikosteroidov, je treba razmisliti o uporabi drugih sistemskih imunosupresivov.
• Do not co-administer other medicinal products through the same intravenous line.
• Po isti intravenski liniji sočasno ne dajajte drugih zdravil.
In symptomatic patients, obtain cardiologic consultation and laboratory investigations to ensure the initiation of appropriate measures at an early stage.
Pri simptomatskih bolnikih se posvetujte s kardiologom in opravite laboratorijske preiskave, da se že v zgodnji fazi zagotovi uvajanje ustreznih ukrepov.
Inflammation may cause serious damage to your body and some inflammatory conditions may lead to death and need treatment or withdrawal of Bavencio.
Vnetje lahko resno poškoduje vaše telo, nekatera vnetna stanja pa lahko ogrožajo življenje, zato jih je treba zdraviti ali prekiniti uporabo zdravila Bavencio.
How much Bavencio you will receive
Koliko zdravila Bavencio boste prejeli
Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC31.
If no improvement within 24 hours on corticosteroids, additional immunosuppression (e.g., mycophenolate, infliximab, anti-thymocyte globulin) should be considered.
Če pri uporabi kortikosteroidov v roku 24 ur ni izboljšanja, je treba razmisliti o dodatni uporabi imunosupresivov (npr. mikofenolata, infliksimaba, antitimocitnega globulina).
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.
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.
For Bavencio in combination with axitinib, see below.
Za zdravilo Bavencio v kombinaciji z aksitinibom, glejte spodaj
Dry mouth
Pogosti suha usta
Contents of the pack and other information What Bavencio contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Bavencio
The Patient Information brochure shall contain the following key messages:
Brošura z informacijami za bolnika mora vsebovati naslednja ključna sporočila:
Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Pri starejših bolnikih odmerka ni treba prilagajati (starost ≥ 65 let) (glejte poglavji 5.1 in 5.2).
PD-L1 expression at cut-off of 1%
Izraženost PD-L1 ob prekinitvi 1 %
Bavencio is for intravenous infusion only.
Zdravilo Bavencio je samo za intravensko infundiranje.
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%).
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 %).
Avelumab is most frequently associated with immune-related adverse reactions.
Avelumab je najpogosteje povezan z imunsko pogojenimi neželenimi učinki.
• 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.
• 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.
The median time to response was 6 weeks (range: 6 weeks to 36 weeks) after the first dose of avelumab.
Mediana časa do odziva je bila 6 tednov (razpon: 6 tednov do 36 tednov) po prvem odmerku avelumaba.
The recommended dose of avelumab is 800 mg every 2 weeks.
Priporočeni odmerek avelumaba je 800 mg vsaka 2 tedna.
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.
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.
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.
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.
Weight decreased
nižjo hitrostjo
• problems due to inflammation of your lungs (pneumonitis);
• težave zaradi vnetja pljuč (pnevmonitisa),
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.
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.
Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Okvaro jeter so opredelili po kriterijih Nacionalnega inštituta za raka (NCI, National Cancer Institute) za motnje delovanja jeter.
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.
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.
Avelumab has not been studied in patients with severe renal impairment (GFR 15 to 29 mL/min).
Avelumaba niso preučili pri bolnikih s hudo okvaro ledvic (GFR 15 do 29 ml/min).
Forty-seven (53%) of the patients had visceral metastases.
Sedeminštirideset (53 %) bolnikov je imelo visceralne zasevke.
It is very important for you to keep all your appointments to receive Bavencio.
Zelo pomembno je, da pridete na vse dogovorjene termine, kjer boste prejeli zdravilo Bavencio.
Patients should be monitored for elevated serum creatinine prior to and periodically during treatment.
Bolnike je treba spremljati zaradi pojava zvišane vrednosti kreatinina v serumu pred zdravljenjem in periodično med zdravljenjem.
Treatment with avelumab and axitinib continued until RECIST v1.1-defined progression of disease by Blinded Independent Central Review (BICR) assessment or unacceptable toxicity.
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.
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.
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.
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).
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).
One vial of 10 mL contains 200 mg of avelumab.
Ena viala z 10 ml vsebuje 200 mg avelumaba.
Table 1: Guidelines for withholding or discontinuation of Bavencio Treatment-related adverse reaction
Preglednica 1: Smernice za odložitev ali prekinitev uporabe zdravila Bavencio Neželeni učinki zaradi zdravljenja
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.
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.
• Type 1 diabetes, including acid in the blood produced from diabetes (diabetic ketoacidosis);
• sladkorna bolezen tipa 1, vključno s kislino v krvi zaradi sladkorne bolezni (diabetična ketoacidoza),
These reactions are presented by system organ class and frequency.
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
The required volume of Bavencio should be withdrawn from the vial(s) and be transferred to the infusion bag.
Potrebno količino zdravila Bavencio izvlecite iz vial(e) in prenesite v vrečo za infundiranje.
If the solution is cloudy, discoloured, or contains particulate matters, the vial should be discarded.
Če je raztopina motna, spremenjene barve ali vsebuje delce, morate vialo zavreči.
• Decrease in the number of red blood cells
• zmanjšano število rdečih krvnih celic
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.
Slika 2 predstavlja Kaplan-Meierjevo krivuljo PFS naslednje vmesne analize za 116 bolnikov, vključenih v del B, z najkrajšim spremljanjem 7 mesecev.
What Bavencio is and what it is used for
Kaj je zdravilo Bavencio in za kaj ga uporabljamo
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.
10 ml koncentrat v viali (steklo vrste I) s halobutilnim gumijastim zamaškom in aluminijastim tesnilom z odstranljivo plastično zaporko.
PD-L1 expression at cut-off of 5%
Izraženost PD-L1 ob prekinitvi 5 %
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.
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.
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.
Če ste ženska, ki lahko zanosi, morate med zdravljenjem z zdravilom Bavencio in še vsaj 1 mesec po zadnjem odmerku uporabljati učinkovito kontracepcijo.
The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%).
Najpogostejši neželeni učinki stopnje ≥ 3 so bili anemija (6,0 %), dispneja (3,9 %) in bolečine v trebuhu (3,0 %).
It must not be administered as an intravenous push or bolus injection.
Ni ga dovoljeno dati v obliki hitre intravenske ali bolusne injekcije.
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).
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).
The patient educational material should contain
Izobraževalno gradivo za bolnike mora vsebovati:
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.
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.
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
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