FrancophonIA/ELRC3.0 huggingface dataset:
English: Ribociclib exhibits high solubility at or below pH 4.5 and in bio-relevant media (at pH 5.0 and 6.5).
Slovenian: Ribociklib je dobro topen pri vrednosti pH 4,5 ali manj in v biološko ustreznih medijih (pri vrednostih pH 5,0 in 6,5).
English: It is not known if ribociclib is present in human milk.
Slovenian: Ni znano, ali je ribociklib prisoten v materinem mleku.
English: Of all patients who received Kisqali in studies MONALEESA-2 and MONALEESA-3, representative proportions of patients were ≥65 years and ≥75 years of age (see section 5.1).
Slovenian: Izmed vseh bolnikov, ki so prejemali zdravilo Kisqali v študijah MONALEESA-2 in MONALEESA-3, je bil delež bolnikov star 65 let ali več oziroma 75 let ali več reprezentativen (glejte poglavje 5.1).
English: Patients in MONALEESA-7 had not received prior endocrine treatment in the advanced breast cancer setting.
Slovenian: Bolnice v študiji MONALEESA-7 pred tem niso prejemale hormonskega zdravljenja zaradi napredovalega raka dojke.
English: Effect of ribociclib on cytochrome P450 enzymes
Slovenian: Vpliv ribocikliba na encime citokroma P450
English: Following oral administration of a single 600 mg dose of [
Slovenian: Po peroralnem dajanju enkratnega odmerka 600 mg s [
English: The concomitant use of moderate CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for impaired efficacy, in particular in patients treated with ribociclib at 400 mg or 200 mg once daily.
Slovenian: Sočasna uporaba zmernega induktorja CYP3A4 lahko privede do zmanjšane izpostavljenost ribociklibu, to pa lahko predstavlja tveganje za manjšo učinkovitost, še posebej pri bolnikih, ki se zdravijo z ribociklibom v odmerku 400 mg ali 200 mg enkrat dnevno.
English: If necessary, your doctor may reduce your dose of Kisqali or temporarily stop it to allow your liver, blood cells, electrolyte levels or heart activity to recover.
Slovenian: Če bo potrebno, vam bo zdravnik zmanjšal odmerek zdravila Kisqali ali začasno prekinil zdravljenje, da si bodo vaša jetra in krvne celice opomogle oziroma da se bodo popravile vrednosti elektrolitov ali delovanje srca.
English: Do not take a double dose to make up for a missed dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti odmerek.
English: In vitro, ribociclib decreased pRb phosphorylation, leading to arrest in the G1 phase of the cell cycle, and reduced cell proliferation in breast cancer cell lines.
Slovenian: In vitro je ribociklib zmanjšal obseg fosforilacije retinoblastomskega proteina, kar je ustavilo celični ciklus v fazi G1 in zavrlo proliferacijo celic v celičnih linijah raka dojke.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE42
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE42
English: If the patient vomits after taking the dose or misses a dose, an additional dose should not be taken that day.
Slovenian: Če bolnik po zaužitju odmerka bruha ali pozabi vzeti odmerek, na ta dan ne sme vzeti dodatnega odmerka.
English: The primary efficacy results were supported by PFS results based on blinded independent central radiological assessment.
Slovenian: Primarne rezultate glede učinkovitosti so dopolnili tudi rezultati preživetja brez napredovanja bolezni na osnovi slepe neodvisne radiološke ocene centralnih ocenjevalcev.
English: LEQ803 Cmax increased 1.7-fold and AUCinf decreased by 27%, respectively.
Slovenian: Cmax presnovka LEQ803 se je zvišala za 1,7-krat, njegova AUCinf pa se je zmanjšala za 27 %.
English: Continue Kisqali treatment for as long as your doctor tells you to.
Slovenian: Zdravljenje z zdravilom Kisqali nadaljujte tako dolgo, kot vam naroči zdravnik.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO S PODATKI V MODREM OKENCU)
English: Patients should be instructed to report any fever promptly.
Slovenian: Bolnikom je treba naročiti, naj takoj obvestijo zdravnika, če pride do zvišanja telesne temperature.
English: Combined elevations in AST and/or ALT together with total bilirubin increase, in the absence of cholestasis
Slovenian: Kombinacija zvišanja vrednosti AST in/ali ALT z zvišanjem vrednosti celokupnega bilirubina brez prisotne holestaze
English: Adverse drug reactions from the phase III clinical studies (Table 6) are listed by MedDRA system organ class.
Slovenian: Neželeni učinki iz kliničnih študij faze III (preglednica 6) so navedeni po organskih sistemih v skladu s klasifikacijo MedDRA.
English: Ribociclib is a substrate for P-gp in vitro, but based on mass balance data inhibition of P-gp or BCRP is unlikely to affect ribociclib exposure at therapeutic doses.
Slovenian: Ribociklib je substrat P-gp in vitro, vendar na osnovi podatkov o ravnotežju mas, zaviranje P-gp ali BCRP po vsej verjetnosti ne vpliva na izpostavljenost ribociklibu pri terapevtskih odmerkih.
English: 40.7 (37.4, NE)
Slovenian: 40,7 (37,4; NO)
English: What you need to know before you take Kisqali
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Kisqali
English: Due to inter-patient variability, the recommended dose adjustments may not be optimal in all patients, therefore close monitoring of signs of toxicity is recommended.
Slovenian: Zaradi interindividualne variabilnosti priporočeno prilagajanje odmerjanja morda ni najboljše za vse bolnike, zato je priporočeno skrbno spremljanje bolnikov glede znakov toksičnega delovanja.
English: A pharmacokinetic-pharmacodynamic analysis included a total of 997 patients treated with ribociclib at doses ranging from 50 to 1200 mg.
Slovenian: V farmakokinetično-farmakodinamično analizo so vključili skupno 997 bolnikov, ki so prejemali ribociklib v odmerkih od 50 mg do 1200 mg.
English: • Medicines like intravenous ondansetron, used to prevent nausea and vomiting caused by chemotherapy (treatment with cancer medicines).
Slovenian: • zdravila, kot je intravenski ondansetron, ki jih uporabljamo za preprečevanje slabosti in bruhanja zaradi kemoterapije (zdravljenja s protitumorskimi zdravili).
English: Medicinal products that elevate gastric pH
Slovenian: Zdravila, ki zvišujejo pH v želodcu
English: • Antimalarials such as chloroquine.
Slovenian: • antimalariki, kot je klorokin,
English: Table 3 Dose modification and management - Hepatobiliary toxicity
Slovenian: Preglednica 3 Prilagajanje odmerka in drugi ukrepi - hepatobiliarna toksičnost
English: Do not exceed the recommended dose prescribed by your doctor.
Slovenian: Priporočenega odmerka, ki vam ga je predpisal vaš zdravnik, ne smete prekoračiti.
English: Your heart activity will also be monitored before and during treatment with Kisqali with a test called an electrocardiogram (ECG).
Slovenian: Pred začetkom zdravljenja in med zdravljenjem z zdravilom Kisqali bodo spremljali tudi aktivnost vašega srca s preiskavo, ki jo imenujemo elektrokardiografija (snemanje EKG).
English: Grade 1 or 2**
Slovenian: Stopnja 1 ali 2**
English: The effect of a moderate CYP3A4 inducer on ribociclib exposure has not been studied.
Slovenian: Učinka zmernega induktorja CYP3A4 na izpostavljenost ribociklibu niso proučevali.
English: General supportive care should be initiated in all cases of overdosage as necessary.
Slovenian: V vseh primerih prevelikega odmerjanja je treba uvesti ustrezno splošno podporno oskrbo.
English: 46.7% of patients were of age 65 years and older, including 13.8% patients of age 75 years and older.
Slovenian: 46,7 % bolnic je bilo starih 65 let ali več, kar vključuje 13,8 % bolnic, ki so bili stari 75 let ali več.
English: Contains soya lecithin.
Slovenian: Vsebuje sojin lecitin.
English: There is only limited experience with reported cases of overdosage with Kisqali.
Slovenian: Izkušenj s poročanimi primeri prevelikega odmerjanja zdravila Kisqali je malo.
English: Additionally, in vivo antitumour activity of ribociclib in combination with fulvestrant was assessed in immune-deficient mice bearing the ZR751 ER+ human breast cancer xenografts and the combination with fulvestrant resulted in complete tumour growth inhibition.
Slovenian: In vivo protitumorsko aktivnost ribocikliba v kombinaciji s fulvestrantom so poleg tega ocenjevali na miših z imunsko pomanjkljivostjo in s humanimi ksenografti ZR751 ER+ raka dojk in kombinacija s fulvestrantom je v celoti zavrla rast tumorja.
English: Patients should be advised to be cautious when driving or using machines in case they experience fatigue, dizziness or vertigo during treatment with Kisqali (see section 4.8).
Slovenian: Bolnike je treba opozoriti, naj bodo pri vožnji in upravljanju strojev previdni, če imajo v času zdravljenja z zdravilom Kisqali težave z utrujenostjo, omotičnostjo ali vrtoglavico (glejte poglavje 4.8).
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Grade 3 neutropenia with a single fever >38.3°C (or above 38°C for more than one hour and/or concurrent infection)
Slovenian: * opredelitev stopenj neželenih dogodkov po verziji 4.03 CTCAE (Skupni terminološki kriteriji za neželene dogodke, angl. Common Terminology Criteria for Adverse Events) ** nevtropenija stopnje 3 z enkratnim zvišanjem telesne temperature > 38,3 °C (ali več kot 38 °C, ki traja več kot eno uro in/ali sočasna okužba)
English: a p-value is obtained from the one-sided stratified log-rank test.
Slovenian: a vrednost p na osnovi enostranskega stratificiranega log-rank testa
English: What Kisqali looks like and contents of the pack Kisqali is supplied as film-coated tablets in aluminum blisters.
Slovenian: Izgled zdravila Kisqali in vsebina pakiranja Zdravilo Kisqali je na voljo v obliki filmsko obloženih tablet v pretisnih omotih iz aluminija.
English: The major circulating metabolites included metabolite M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), and M1 (secondary glucuronide).
Slovenian: Najpomembnejši presnovki v krvnem obtoku so bili M13 (CCI284, nastane z N-hidroksilacijo), M4 (LEQ803, nastane z N-demetilacijo) in M1 (sekundarni glukuronid).
English: Other medicines and Kisqali
Slovenian: Druga zdravila in zdravilo Kisqali
English: In the second OS analysis the study met its key secondary endpoint demonstrating a statistically significant improvement in OS.
Slovenian: Pri drugi analizi celokupnega preživetja je bil dosežen ključni sekundarni cilj študije z rezultati, ki so pokazali statistično značilno izboljšanje celokupnega preživetja.
English: • Antipsychotics such as pimozide or quetiapine.
Slovenian: • antipsihotiki, kot sta pimozid ali kvetiapin,
English: Ribociclib was equally distributed between red blood cells and plasma with a mean in vivo blood-to-plasma ratio of 1.04.
Slovenian: Ribociklib se je enakovredno porazdelil med eritrociti in plazmo s povprečnim in vivo razmerjem koncentracij v krvi in plazmi 1,04.
English: If any of the following apply to you, tell your doctor or pharmacist before taking Kisqali:
Slovenian: Če opažate katero koli od spodnjih težav, obvestite zdravnika ali farmacevta, preden začnete jemati zdravilo Kisqali:
English: Updated analysis (30 November 2018 cut-off)
Slovenian: Dopolnjena analiza (do presečnega datuma 30. novembra
English: Pregnancy and women of childbearing potential
Slovenian: Nosečnost in ženske v rodni dobi
English: Ribociclib and its metabolites readily passed into the milk of lactating rats.
Slovenian: Ribociklib in njegovi presnovki z lahkoto prehajajo v mleko doječih podgan.
English: Dose interruptions and/or adjustments due to hepatobiliary toxicity events were reported in 10.4% of Kisqali plus any combination treated patients, primarily due to ALT increased (6.9%) and/or AST increased (6.1%).
Slovenian: O prekinitvi jemanja in/ali prilagajanju odmerka zaradi epizod hepatobiliarne toksičnosti so poročali pri 10,4 % bolnikov, ki so prejemali zdravilo Kisqali v kateri koli kombinaciji, in sicer predvsem zaradi zvišanih vrednosti ALT (6,9 %) in/ali zvišanih vrednosti AST (6,1 %).
English: In rabbits, there were adverse effects on embryo-foetal development as evidenced by increased incidences of foetal abnormalities (malformations and external, visceral and skeletal variants) and foetal growth (lower foetal weights).
Slovenian: Pri kuncih je prišlo do neželenih učinkov na embriofetalni razvoj, kar se je pokazalo kot povečana pogostnost nepravilnosti pri plodu (malformacij in pojavljanja zunanjih, visceralnih in skeletnih različic) in motenj rasti ploda (zmanjšana telesna masa ploda).
English: The use of Kisqali should be avoided in patients who already have or who are at significant risk of developing QTc prolongation.
Slovenian: Uporabi zdravila Kisqali se je treba izogibati pri bolnikih s prisotnim podaljšanjem intervala QTc ali s povečanim tveganjem za podaljšanje intervala QTc.
English: 40.9 (37.8, NE)
Slovenian: 40,9 (37,8; NO)
English: Patients with prior (neo)adjuvant therapy with anastrozole or letrozole must have completed this therapy at least 12 months before study randomisation.
Slovenian: Bolnice, ki so predhodno prejemale neoadjuvantno ali adjuvantno zdravljenje z anastrozolom ali letrozolom, so morale s tem zdravljenjem zaključiti najmanj 12 mesecev pred randomizacijo v tej študiji.
English: • St. John's Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
Slovenian: • šentjanževka (znana tudi kot Hypericum perforatum) - zdravilo rastlinskega izvora, ki ga uporabljamo za zdravljenje depresije in drugih motenj,
English: Healthy subjects received single oral doses ranging from 400 mg to 600 mg or repeated daily doses (8 days) at 400 mg.
Slovenian: Zdravi preiskovanci so prejeli enkratne peroralne odmerke od 400 mg do 600 mg ali večkratne (8 dni) dnevne odmerke po 400 mg. Absorpcija
English: Ribociclib+Fulvestrant: 210, Placebo+Fulvestrant: 151 Hazard Ratio = 0.593
Slovenian: št. dogodkov ribociklib + fulvestrant: 210, placebo + fulvestrant: 151 razmerje ogroženosti = 0,593
English: The analysis suggested that ribociclib causes concentration-dependent increases in the QTc interval.
Slovenian: Rezultati analize so pokazali, da ribociklib povzroča od koncentracije odvisno podaljšanje intervala QTc.
English: Other toxicities
Slovenian: Druge vrste toksičnosti
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment (see section 4.4).
Slovenian: Načrt zdravljenja v primeru neželenih učinkov naj po svoji presoji pripravi lečeči zdravnik na osnovi ocene koristi in tveganj pri posameznem bolniku (glejte poglavje 4.4).
English: When Kisqali is used in combination with an aromatase inhibitor, the aromatase inhibitor should be taken orally once daily continuously throughout the 28-day cycle.
Slovenian: Pri uporabi zdravila Kisqali v kombinaciji z zaviralcem aromataze je treba zaviralec aromataze jemati peroralno enkrat na dan neprekinjeno vseh 28 dni ciklusa.
English: Stopping your treatment with Kisqali may cause your condition to get worse.
Slovenian: Če prenehate jemati zdravilo Kisqali, se lahko vaša bolezen poslabša.
English: In rats, reduced foetal weights accompanied by skeletal changes considered to be transitory and/or related to the lower foetal weights were noted.
Slovenian: Pri podganah so opažali zmanjšanje telesne mase ploda skupaj s skeletnimi spremembami, ki so verjetno prehodne in/ali povezane z nižjo plodovo telesno maso.
English: • Medicines used to prevent the rejection of an organ transplant such as tacrolimus, sirolimus and ciclosporin (also used to treat inflammation in rheumatoid arthritis and psoriasis).
Slovenian: • zdravila za preprečevanje zavrnitve organa po presaditvi, kot so takrolimus, sirolimus in ciklosporin (uporabljamo ga tudi za zmanjševanje vnetja pri revmatoidnem artritisu in psoriazi),
English: • Medicines used to treat pulmonary arterial hypertension and erectile dysfunction such as sildenafil.
Slovenian: • zdravila za zdravljenje pljučne arterijske hipertenzije in erektilne disfunkcije, kot je sildenafil,
English: It is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies.
Slovenian: Zdravilo uporabljamo v kombinaciji z zaviralcem aromataze ali fulvestrantom, ki ju uporabljamo kot hormonski protitumorski zdravili.
English: • Abnormal kidney blood test result (high level of creatinine in the blood)
Slovenian: • nenormalni izvidi krvnih preiskav delovanja ledvic (zvišana vrednost kreatinina v krvi),
English: You will have regular blood tests before and during treatment with Kisqali to check your liver function and the amount of blood cells (white blood cells, red blood cells and platelets) and electrolytes (blood salts including potassium, calcium, magnesium and phosphate) in your body.
Slovenian: Spremljanje v času zdravljenja z zdravilom Kisqali Pred začetkom zdravljenja in med zdravljenjem z zdravilom Kisqali boste morali opravljati redne krvne preiskave zaradi preverjanja delovanja jeter, števila krvnih celic (bele krvne celice, rdeče krvne celice in krvne ploščice) in vrednosti elektrolitov (mineralnih soli v krvi, med drugim vrednosti kalija, kalcija, magnezija in fosfatov) v telesu.
English: First and second line patients were enrolled in this study (of whom 19.1% had de novo metastatic disease).
Slovenian: V študijo so bile vključene bolnice, ki so študijska zdravila prejemale kot zdravljenje prve ali druge linije (med njimi jih je 19,1 % imelo metastaze že ob odkritju bolezni).
English: • The recommended starting dose of Kisqali is 600 mg (3 tablets of 200 mg) once daily.
Slovenian: • Priporočeni začetni odmerek zdravila Kisqali je 600 mg (tri 200-miligramske tablete) enkrat na dan.
English: Serial, triplicate ECGs were collected following a single dose and at steady state to evaluate the effect of ribociclib on the QTc interval in patients with advanced cancer.
Slovenian: Bolnikom so zaporedno trikrat posneli EKG po prejemu enkratnega odmerka in v stanju dinamičnega ravnovesja, da bi ovrednotili učinek ribocikliba na interval QTc pri bolnikih z napredovalim rakom.
English: If QTcF interval prolongation to greater than 500 msec or greater than 60 msec change from baseline occurs in combination with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue Kisqali.
Slovenian: Če pride do podaljšanja intervala QTcF na več kot 500 ms ali za več kot 60 ms od izhodiščne vrednosti v kombinaciji s prisotno aritmijo torsade de pointes ali polimorfno ventrikularno tahikardijo ali z znaki/simptomi resne aritmije, je treba zdravilo Kisqali ukiniti.
English: nelfinavir, telaprevir and efavirenz.
Slovenian: indinavir, lopinavir, nelfinavir, telaprevir in efavirenz,
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of ribociclib.
Slovenian: Iz tega razloga lahko zdravila, ki vplivajo na encimsko aktivnost CYP3A4, vplivajo tudi na farmakokinetiko ribocikliba.
English: Elderly No dose adjustment is required in patients over 65 years of age (see section 5.2).
Slovenian: Starostniki Pri bolnikih, ki so stari več kot 65 let, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: congestive heart failure, unstable angina and bradyarrhythmias;
Slovenian: kongestivno popuščanje srca, nestabilno angino pektoris in bradiaritmije,
English: Amongst the patients who had QTcF prolongation >480 msec, the median time to onset was 15 days regardless of the combination and these changes were reversible with dose interruption and/or dose reduction (see sections 4.2, 4.4 and 5.2).
Slovenian: Pri bolnikih s podaljšanjem intervala QTcF na > 480 ms je bil mediani čas do nastopa tega podaljšanja 15 dni ne glede na kombinacijo, navedene spremembe pa so po prekinitvi jemanja zdravila oziroma prilagoditvi odmerka izzvenele (glejte poglavja 4.2, 4.4 in 5.2).
English: • with long QT syndrome;
Slovenian: • s sindromom podaljšanega intervala QT,
English: Tables 2, 3, 4 and 5 summarise recommendations for dose interruption, reduction or discontinuation of Kisqali in the management of specific ADRs.
Slovenian: V preglednicah 2, 3, 4 in 5 so podana priporočila za prekinitev jemanja zdravila, zmanjšanje odmerka ali ukinitev zdravljenja z zdravilom Kisqali v primerih, ko je to potrebno za obvladovanje določenih neželenih učinkov zdravila.
English: Patients enrolled in this study had a median age of 62 years (range 23 to 91).
Slovenian: Mediana starost bolnic, ki so bile vključene v to študijo, je bila 62 let (v razponu od 23 do 91 let).
English: Grade 4**
Slovenian: Stopnja 4**
English: Patients enrolled in this study had a median age of 63 years (range 31 to 89).
Slovenian: Mediana starost bolnic, ki so bile vključene v to študijo, je bila 63 let (od 31 do 89 let).
English: The film-coated tablets are light greyish violet in colour, unscored, round, debossed with “RIC” on one side and “NVR” on the other side.
Slovenian: Filmsko obložene tablete so svetlo sivkasto vijolične barve, brez razdelilne zareze, okrogle oblike in z vtisnjeno oznako “RIC” na eni strani in “NVR” na drugi.
English: Women of childbearing potential who are receiving Kisqali should use effective contraception (e.g. double-barrier contraception) during therapy and for at least 21 days after stopping treatment with Kisqali.
Slovenian: Ženske v rodni dobi, ki prejemajo zdravilo Kisqali, morajo uporabljati učinkovito kontracepcijo (na primer dvojna pregradna kontracepcija) med zdravljenjem in še najmanj 21 dni po prekinitvi zdravljenja z zdravilom Kisqali.
English: Simulations using physiologically-based pharmacokinetic models suggested that Kisqali given at the clinically relevant dose of 600 mg is expected to increase the midazolam AUC by 5.2-fold.
Slovenian: Po podatkih simulacij s farmakokinetičnimi modeli na fiziološki osnovi je mogoče pričakovati, da odmerjanje zdravila Kisqali v klinično ustreznem odmerku 600 mg poveča AUC midazolama za 5,2-krat.
English: • Skin reddening (erythema)
Slovenian: • rdečina kože (eritem),
English: Based on findings in animals, ribociclib can cause foetal harm when administered to a pregnant woman (see section 5.3).
Slovenian: Glede na ugotovitve pri živalih lahko ribociklib škoduje plodu, če ga ženska prejema v času nosečnosti (glejte poglavje 5.3).
English: • Tiredness, pale skin (potential sign of a low level of red blood cells, anaemia)
Slovenian: • utrujenost, bledica (možni znaki znižanega števila rdečih krvnih celic oziroma anemije),
English: Cmax and AUClast for LEQ803 (a prominent metabolite of ribociclib accounting for less than 10% of parent exposure) decreased by 96% and 98%, respectively.
Slovenian: Cmax presnovka LEQ803 (ki je pomemben presnovek ribocikliba in predstavlja nekaj manj kot 10 % izpostavljenosti matični učinkovini) se je znižala za 96 %, njegova AUClast pa se je zmanjšala za 98 %.
English: There are no data on the effects of ribociclib on the breast-fed infant or the effects of ribociclib on milk production.
Slovenian: O učinkih ribocikliba na dojenega otroka oziroma o vplivu ribocikliba na nastajanje mleka ni podatkov.
English: If you vomit after taking the dose or forget a dose, skip the missed dose that day.
Slovenian: Če po zaužitju odmerka bruhate ali če pozabite vzeti odmerek, tega dne ne vzemite izpuščenega odmerka.
English: The median time to resolution (to normalisation or grade ≤2) was 22 days in the Kisqali plus any combination arms.
Slovenian: Mediani čas do izboljšanja (do normalnih vrednosti ali do izboljšanja do stopnje ≤ 2) je bil v skupinah z zdravilom Kisqali skupaj s katero koli kombinacijo 22 dni.
English: A starting dose of 400 mg is recommended in patients with severe renal impairment (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic je priporočen začetni odmerek 400 mg (glejte poglavje 5.2).
English: • Medicines used to improve blood fat levels such as simvastatin or lovastatin, pitavastatin,
Slovenian: • zdravila za izboljševanje ravni maščob v krvi, kot so simvastatin, lovastatin, pitavastatin,