natgillin/translations-raw huggingface dataset:
(cannot be estimated from the available data)
(ni mogoče oceniti iz razpoložljivih podatkov)
Date of first authorisation: 28 May 2015
Datum prve odobritve: 28. maj 2015.
This is because it may seriously harm your baby.
To bi namreč lahko resno škodovalo vašemu otroku.
Urgent intervention is indicated.
Indicirana je urgentna intervencija.
The results of subgroup analyses should be interpreted with caution.
Rezultate analize podskupin je treba razlagati previdno.
• Take the capsules at about the same time each day.
• Kapsule vzemite vsak dan približno ob istem času.
Then take the next dose at the normal time.
Nato vzemite naslednji odmerek ob normalnem času.
Effects in humans are unknown.
Učinki pri ljudeh niso znani.
Frequencies are defined as:
Pogostnosti so opredeljene kot:
Urine protein should be monitored regularly.
Beljakovine v urinu je treba redno spremljati.
Includes cases with a fatal outcome.
Vključuje primere s smrtnim izidom.
Results are based on confirmed and unconfirmed responses.
c Rezultati temeljijo na potrjenih in nepotrjenih odzivih.
+ = censored observations.
+ = cenzurirani podatki.
• Median age: 62 years
• mediana starost: 62 let,
• are over 75 years
• ste starejši od 75 let;
• Male: 84%
• moški: 84 %,
The following terms have been combined: a:
Naslednji izrazi so bili združeni: a:
CI, confidence interval; NE, not estimable.
IZ, interval zaupanja; NE, ni mogoče oceniti.
Paediatric patients have not been studied.
Pediatričnih bolnikov niso proučevali.
The mechanism of action for hypothyroidism is not fully elucidated.
Mehanizem delovanja za hipotiroidizem ni popolnoma pojasnjen.
These findings were reversible at the end of a 4-week recovery period.
Te ugotovitve so bile reverzibilne ob koncu 4-tedenskega obdobja okrevanja.
• You can take the capsules with or without food.
• Kapsule lahko jemljete s hrano ali brez nje.
The effects of LENVIMA in people younger than 18 years old are not known.
Učinki zdravila LENVIMA pri ljudeh, mlajših od 18 let, niso znani.
Your doctor will help you decide whether the treatment should be continued.
Zdravnik vam bo pomagal pri odločitvi, ali naj se zdravljenje nadaljuje.
Independent radiologic review.
Neodvisen radiološki pregled.
Food does not affect the extent of absorption, but slows the rate of absorption.
Hrana ne vpliva na obseg absorpcije, a upočasni hitrost absorpcije.
The capsules should be taken at about the same time each day, with or without food (see section 5.2).
Kapsule je treba jemati vsak dan približno ob istem času, bodisi s hrano bodisi brez nje (glejte poglavje 5.2).
• belong to an ethnic group other than White or Asian
• pripadate etnični skupini, ki ni niti bela niti azijska;
ORRc, f, g (mRECIST)
ORRc, f, g (mRECIST) NA
• painful infection or irritation near the anus
• boleča okužba ali razdraženost blizu anusa,
Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggest that it is in the order of 85%.
Absolutne biološke uporabnosti pri ljudeh niso določili, vendar podatki iz študije masnega ravnovesja kažejo, da je približno 85 %.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Zdravljenje naj se nadaljuje, dokler je vidna klinična korist ali dokler se ne pojavi nesprejemljiva toksičnost.
• Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vsakem pretisnem omotu poleg oznake »EXP«.
If the submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
Secondary efficacy outcome measures included overall response rate and overall survival.
Sekundarna merila izida učinkovitosti so vključevala celotno odzivnost in celotno preživetje.
What to do if you forget to take your dose depends on how long it is until your next dose.
Kaj storiti, če pozabite vzeti odmerek, je odvisno od tega, koliko še manjka do naslednjega odmerka.
• weigh less than 60 kg
• tehtate manj od 60 kg
If you forget to take LENVIMA Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo LENVIMA Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), da bi nadomestili pozabljeni odmerek.
Lenvatinib was not genotoxic.
Lenvatinib ni bil genotoksičen.
The adverse reaction frequency category represents the most conservative estimate of frequency from the two individual populations.
Kategorija pogostnosti neželenih učinkov je najbolj konzervativna ocena pogostnosti v dveh posameznih populacijah.
Juvenile animal toxicity studies
Študije toksičnosti na mladih živalih
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Nemudoma povejte zdravniku, če opazite katerega od naslednjih neželenih učinkov - mogoče boste potrebovali nujno medicinsko zdravljenje:
Eight healthy, demographically matched subjects served as controls and received a 10-mg dose.
Osem zdravih, demografsko podobnih preiskovancev je služilo za kontrole in prejelo 10-miligramski odmerek.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Data cut-off date = 13 Nov 2016.
Presečni datum zajema podatkov = 13. november 2016.
How long to take LENVIMA You will usually carry on taking this medicine as long as you are getting benefit.
Kako dolgo jemljite zdravilo LENVIMA Navadno boste jemali to zdravilo tako dolgo, kolikor vam bo koristilo.
Age, sex, weight, race
Starost, spol, telesna masa, rasa
Symptoms depend on where the fistula is located.
Simptomi so odvisni od lokacije fistule.
• Body weight: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
• telesna masa: < 60 kg - 31 %, 60-80 kg - 50 %, > 80 kg - 19 %,
Contraception, pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Kontracepcija, nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Estimated with Cox proportional hazard model.
Ocenjeno s Coxovim modelom proporcionalnih tveganj.
Lenvatinib is a substrate for P-gp and BCRP.
Lenvatinib je substrat za P-gp in BCRP.
Clinical data are not available in this population (see section 4.2).
Za to populacijo klinični podatki niso na voljo (glejte poglavje 4.2).
This is because the medicine passes into breast milk and may seriously harm your breastfed baby.
Zdravilo namreč prehaja v materino mleko in bi lahko resno škodovalo vašemu dojenemu otroku.
• you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na lenvatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Baseline demographics and disease characteristics were well balanced for both treatment groups.
Izhodiščni demografski podatki in značilnosti bolezni so bili za obe zdravljeni skupini dobro uravnoteženi.
The median time to first dose reduction was 2.8 months.
Mediani čas do prvega zmanjšanja odmerka je bil 2,8 meseca.
• decrease in the number of white blood cells
• zmanjšanje števila belih krvnih celic,
• White: 29%, Asian: 69%, Black or African American: 1.4%
• bela rasa: 29 %, azijska: 69 %, črna ali afroameriška: 1,4 %,
A treatment decision should be made based upon an assessment of the individual patient's benefit/risk.
Odločitev o zdravljenju je treba sprejeti na podlagi ocene razmerja med koristmi in tveganji pri posameznem bolniku.
Therefore, mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Zato lahko smrtnost pripišemo zapletom, povezanim s primarnimi duodenalnimi lezijami, z možnim prispevkom dodatnih toksičnosti v nezrelih ciljnih organih.
• loss of body fluids (dehydration)
• izguba telesnih tekočin (dehidracija),
Dose proportionality and accumulation
Proporcionalnost odmerku in akumulacija
• The recommended dose of LENVIMA depends on your body weight when you first start treatment.
• Priporočeni odmerek zdravila LENVIMA je odvisen od vaše telesne mase, ko prvič začnete zdravljenje.
Patients who experience these symptoms should use caution when driving or operating machines.
Bolniki, ki opazijo te simptome, naj bodo pri vožnji in upravljanju s stroji previdni.
System Organ Class (MedDRA terminology*)
Organski sistem (terminologija MedDRA*)
• headache and back pain
• glavobol in bolečina v hrbtu,
See section 4.8 Description of selected adverse reactions for further characterisation.
Glejte poglavje 4.8 Opis izbranih neželenih učinkov za nadaljnjo karakterizacijo.
Within each frequency category, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
This leaflet was last revised in 09/2019
Navodilo je bilo nazadnje revidirano septembra 2019.
• have high blood pressure
• imate visok krvni tlak;
Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances.
Sočasna uporaba lenvatiniba, karboplatina in paklitaksela ni značilno vplivala na farmakokinetiko katere koli od teh treh snovi.
Lung metastases may also increase the risk of pneumothorax.
Pljučne metastaze lahko prav tako zvečujejo tveganje pnevmotoraksa.
Lenvatinib should not be used in children younger than 2 years of age because of safety concerns identified in animal studies (see section 5.3).
Lenvatinib se ne sme uporabljati pri otrocih, mlajših od 2 let, zaradi pomislekov glede varnosti, ugotovljenih v študijah na živalih (glejte poglavje 5.3).
The median cumulative RAI activity administered prior to study entry was 350 mCi (12.95 GBq).
Mediana kumulativna aktivnost RAI, dana pred vključitvijo v študijo, je bila 350 mCi (12,95 GBq).
The capsules should be swallowed whole with water.
Kapsule je treba pogoltniti cele z nekaj vode.
There are no data on the use of lenvatinib immediately following sorafenib or other anticancer treatments and there may be a potential risk for additive toxicities unless there is an adequate washout period between treatments.
Ni podatkov o uporabi lenvatiniba takoj po sorafenibu ali drugih zdravilih proti raku in lahko obstaja možno tveganje aditivnih toksičnosti, če med terapijami ni ustreznega obdobja spiranja.
Each carton contains 30 ,60,or 90 hard capsules.
Ena kartonska škatla vsebuje 30, 60 ali 90 trdih kapsul.
Life-threatening toxicities (Grade 4): Discontinuee a.
Življenjsko nevarne toksičnosti (stopnje 4): ukinitee a.
Median (95% CI) e Lenvatinib (N= 478)
Mediana (95-odstotni IZ) e lenvatinib (N= 478)
What LENVIMA is and what it is used for
Kaj je zdravilo LENVIMA in za kaj ga uporabljamo
Life-threatening consequences (malignant hypertension, neurological deficit, or hypertensive crisis)
življenjsko nevarne posledice (maligna hipertenzija, nevrološki deficit ali hipertenzivna kriza)
• high or low blood pressure
• visok ali nizek krvni tlak,
The safety and efficacy of lenvatinib in children aged 2 to <18 years have not yet been established (see section 5.1).
Varnost in učinkovitost lenvatiniba pri otrocih, starih od 2 do < 18 let, še nista bili dokazani (glejte poglavje 5.1).
• Barcelona Clinic Liver Cancer (BCLC) stage B: 20%; BCLC stage C: 80%
• stadij raka BCLC (Barcelona Clinic Liver Cancer) B: 20 %; stadij BCLC C: 80 %,
These in vivo metabolic routes align with the data provided in the in vitro studies using human biomaterials.
Te presnovne poti in vivo se ujemajo s podatki, ki so jih dale študije in vitro s človeškimi biomateriali.
Resolves to Grade 0, 1 or See detailed guidance in Table 4 in section 4.4.
Izboljša se na stopnjo 0, 1 ali 2 Glejte podrobne smernice v preglednici 4 v poglavju 4.4
Similarly, no induction of P-gp mRNA expression was observed .
Prav tako niso opazili nikakršne indukcije ekspresije mRNA P-gp.
This includes herbal preparations and medicines without a prescription.
To vključuje zdravila rastlinskega izvora in zdravila brez recepta.
• Aetiology: Hepatitis B (50%), Hepatitis C (23%), alcohol (6%)
• etiologija: hepatitis B (50 %), hepatitis C (23 %), alkohol (6 %),
Dose adjustments are based only on toxicities observed and not on body weight changes during treatment.
Prilagoditve odmerkov opravimo le po opaženih toksičnostih in ne zaradi spremembe telesne mase med zdravljenjem.
The minimal washout period in clinical trials was 4 weeks.
Najkrajše obdobje spiranja v kliničnih preskušanjih je bilo obdobje 4 tednov.
• Your doctor may reduce your dose if you have problems with side effects.
• Zdravnik vam lahko zmanjša odmerek, če imate težave z neželenimi učinki.
Refer also to section 4.8, Other special populations.
Glejte tudi poglavje 4.8, Druge posebne skupine bolnikov.
The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Zgodnje odkrivanje in učinkovito zdravljenje hipertenzije sta pomembna, da se kar najbolj zmanjša potreba po prekinitvah in zmanjševanjih odmerjanja lenvatiniba.
The mean terminal exponential halflife of lenvatinib is approximately 28 hours.
Povprečna končna eksponencialna razpolovna doba lenvatiniba je približno 28 ur.
Before initiating lenvatinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo lenvatiniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
See section 4.2 for dosing recommendation.
Glejte poglavje 4.2 za priporočila za odmerjanje.
If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Če bolnik pozabi vzeti odmerek, ki ga ne more vzeti v naslednjih 12 urah, naj tisti odmerek preskoči in ob običajnem času uporabe vzame naslednji odmerek.
Serious complications of poorly controlled hypertension, including aortic dissection, have been reported.
Poročali so o resnih zapletih slabo nadzorovane hipertenzije, vključno z disekcijo aorte.
Lenvatinib use has been associated with cases of fistulae including reactions resulting in death.
Uporaba lenvatiniba je povezana s primeri fistul, vključno z reakcijami, ki so se končale s smrtjo.
In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy.
Pri večini primerov so gastrointestinalna perforacija in fistule nastale pri bolnikih z dejavniki tveganja, na primer predhodno operacijo ali radioterapijo.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Your doctor will discuss the results of these tests with you and decide whether you can be given LENVIMA.
Zdravnik se bo pogovoril z vami o rezultatih teh preiskav in se odločil, ali vam lahko da zdravilo LENVIMA.
Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification
Vztrajne in nevzdržne toksičnosti stopnje 2 ali 3a Neželeni učinek Prilagoditev
Differentiated Thyroid Cancer (DTC)
Diferencirani karcinom ščitnice (DTC)
Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Bolniki so lahko sodelovali, če so imeli status jetrne funkcije razreda A po lestvici Child-Pugh in stanje zmogljivosti po lestvici ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0 ali 1.
• Do not take LENVIMA if you are planning to become pregnant during your treatment.
• Ne jemljite zdravila LENVIMA, če načrtujete zanositev med zdravljenjem.
• Demographic and baseline disease characteristics were similar between the lenvatinib and the sorafenib groups and are shown below for all 954 randomised patients:
• Demografske značilnosti in bolezni v izhodišču so bile podobne med skupinama, ki sta prejemali lenvatinib, in skupino, ki je prejemala sorafenib, in so prikazane v nadaljevanju za vseh 954 randomiziranih bolnikov:
Number of capsules
Število kapsul
• Underlying cirrhosis (by independent imaging review): 75%
• osnovna ciroza (z neodvisnim pregledom slike): 75 %,
When necessary, manage hypertension as recommended in Table 4.
Po potrebi zdravite hipertenzijo po priporočilih v preglednici 4.
Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Lenvatinib naj se med nosečnostjo ne uporablja, če to ni nujno potrebno in le po skrbni presoji nujnosti zdravljenja za mater in tveganja za plod.
Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Druga možnost je, da kapsule lenvatiniba dodamo, ne da bi jih prelomili ali zdrobili, v jedilno žlico vode ali jabolčnega soka v majhnem kozarcu, da nastane suspenzija.
Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
Nadaljnja zmanjševanja odmerka se presojajo za vsakega bolnika posebej, ker je za odmerke, manjše od 10 mg, na voljo malo podatkov.
The daily dose is to be modified as needed according to the dose/toxicity management plan.
Dnevni odmerek naj se spreminja po potrebi v skladu z načrtom za obvladovanje odmerka/toksičnosti.
The percentage of the dose of lenvatinib excreted in urine was low in all cohorts (<2.16% across treatment cohorts).
Odstotni delež v urinu izločenega odmerka lenvatiniba je bil v vseh kohortah majhen (< 2,16 % v zdravljenih kohortah).
The Efron method was used for ties.
Za izenačenja je bila uporabljena metoda Efron.
• Swallow the capsules whole with water or dissolved.
• Kapsule pogoltnite cele z vodo ali raztopljene.
Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications.
Poročila o fistulah, ki so zajele druge telesne dele, ne želodca ali črevesja, so opazili pri različnih indikacijah.
Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Na podlagi AUC(0-inf) je lenvatinib predstavljal 60 % oziroma 64 % celotne radioaktivnosti v plazmi oziroma krvi.
The safety profile of lenvatinib is based on data from 452 DTC patients and 496 HCC patients; allowing characterisation only of common adverse drug reactions in DTC and HCC patients.
Varnostni profil lenvatiniba temelji na podatkih 452 bolnikov z DTC in 496 bolnikov s HCC, kar omogoča samo opis pogostih neželenih učinkov zdravila pri bolnikih z DTC in HCC.
The adverse reactions presented in this section are based on safety data of both DTC and HCC patients (see section 5.1).
Neželeni učinki, predstavljeni v tem poglavju, temeljijo na podatkih o varnosti pri bolnikih z DTC in bolnikih z HCC (glejte poglavje 5.1).
HR was estimated from the Cox proportional hazard model with treatment as independent variable and stratified by IxRS stratification factors.
Vrednost HR je bila ocenjena s Coxovim modelom proporcionalnih tveganj z zdravljenjem kot neodvisno spremenljivko in stratifikacijo po faktorjih stratifikacije IxRS.
Pancreatitis includes: pancreatitis and acute pancreatitis.
Pankreatitis vključuje: pankreatitis in akutni pankreatitis.
• increase in lipase and amylase (enzymes involved in digestion)
• zvišanje lipaze in amilaze (encimov, ki sta vpletena v prebavo).
The following side effects may happen with this medicine.
Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki.
• Absence of macroscopic portal vein invasion (MPVI): 79%
• odsotnost makroskopske invazije portalne vene (MPVI - macroscopic portal vein invasion):
• If it is 12 hours or more until your next dose: take the missed dose as soon as you remember.
• Če do naslednjega odmerka manjka 12 ur ali več: vzemite pozabljeni odmerek, takoj ko se spomnite nanj.
Talk to your doctor if you experience any new or unsual symptoms such as coughing when swallowing.
Posvetujte se z zdravnikom, če imate kakšne nove ali nenavadne simptome, na primer kašljanje med požiranjem.
In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%.
V vzorcih plazme, odvzetih do 24 ur po dajanju zdravila, je lenvatinib predstavljal 97 % radioaktivnosti v radiokromatogramih plazme, presnovek M2 pa je predstavljal še dodatna 2,5 %.
Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy.
Bolnike s HCC je treba spremljati glede poslabšanja delovanja jeter, vključno z jetrno encefalopatijo.
If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Če imajo bolniki hudo okvaro ledvic, je treba prilagoditi začetni odmerek lenvatiniba (glejte poglavji 4.2 in 5.2).
Patients with body weight <60 kg
Bolniki s telesno maso < 60 kg
These proteins can be present in high amounts in cancer cells, and by blocking their action LENVIMA may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Te beljakovine so lahko prisotne v velikih količinah v rakastih celicah, z zaviranjem njihovega delovanja pa zdravilo LENVIMA lahko upočasni hitrost razmnoževanja rakavih celic in rast tumorja in pomaga prekiniti preskrbo s krvjo, ki jo rak potrebuje.
There are no data on the use of lenvatinib in pregnant women.
Podatkov o uporabi lenvatiniba pri nosečnicah ni na voljo.
The additional liquid must be swallowed.
Dodatno tekočino moramo spiti.
Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with median latency of about 3 months.
O reakcijah so poročali ob različnih časovnih točkah med zdravljenjem, od dveh tednov do več kot enega leta po uvedbi lenvatiniba, mediana latenca je bila okrog 3 mesece.
>500 ms
> 500 ms prekinite
These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent.
Te ugotovitve kažejo, da ima lenvatinib teratogen potencial, ki je verjetno povezan s farmakološko aktivnostjo lenvatiniba kot antiangiogenega sredstva.
The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day.
Največja odmerka lenvatiniba, ki so ju klinično proučevali, sta bila 32 mg in 40 mg na dan.
No adjustment of starting dose is required on the basis of race (see section 5.2).
Na podlagi rase prilagoditev začetnega odmerka ni potrebna (glejte poglavje 5.2).
Effect of lenvatinib on other medicinal products
Učinek lenvatiniba na druga zdravila
The majority of patients had an ECOG performance status of 0; 42.1% had a status of 1; 3.9% had a status above 1.
Večina bolnikov je imela stanje zmogljivosti 0 po ECOG; 42,1 % jih je imelo stanje 1; 3,9 % je imelo stanje, večje od 1.