natgillin/translations-raw huggingface dataset:
Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules).
Vzemite vse kapsule v eni vrsti vsak dan, brez hrane (bolniki vsaj 2 uri, preden vzamejo kapsule, in 1 uro po tem ne smejo jesti).
The safety and efficacy of cabozantinib in children aged <18 years have not yet been established.
Varnost in učinkovitost zdravila kabozantiniba pri otrocih, starih < 18 let, še nista bili dokazani.
Component of a 28 day pack, can't be sold separately.
Sestavni del 28-dnevnega pakiranja, ni za posamično prodajo.
This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Ta učinek ni bil povezan s spremembo morfologije oblike zobcev srca ali novimi ritmi.
Patients with both sporadic and hereditary forms of MTC will be eligible for the study.
Bolniki s sporadično in dedno obliko MTC bodo primerni za študijo.
For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Za bolnike, pri katerih status mutacije prerazporeditve med transfekcijo (RET, Rearranged during Transfection) ni znan ali je negativen, je treba pred odločitvijo za zdravljenje posameznika upoštevati možnost manjše koristi (za pomembne informacije glejte poglavji 4.4 in 5.1).
COMETRIQ is not recommended for children or adolescents.
Uporaba zdravila COMETRIQ se ne priporoča za otroke in mladostnike.
The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Učinka kabozantiniba na farmakokinetiko kontraceptivnih steroidov niso preučili.
Samples will undergo thorough evaluation for RET and RAS mutations.
Vzorci se bodo natančno pregledali glede mutacij RET in RAS.
The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Rakotvorni potencial kabozantiniba se je ocenjeval pri dveh vrstah: transgenih miših rasH2 in podganah vrste Sprague-Dawley.
More information on the blister cards including how many capsules you will take and how many capsules there are in total in each blister card are described below in section 6.
Več informacij o pretisnih zgibankah, vključno s številom kapsul, ki jih morate vzeti in koliko je vseh kapsul v posamični pretisni zgibanki, je opisanih spodaj v poglavju 6.
Both men and women should be advised to seek advice and consider fertility preservation before treatment.
Tako ženskam kot moškim je treba svetovati, da se posvetujejo in pred zdravljenjem razmislijo o ukrepih za ohranitev plodnosti.
Your doctor may also prescribe other medicines to help control your side effects.
Vaš zdravnik vam bo morda predpisal tudi druga zdravila za obvladovanje neželenih učinkov.
These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Pri teh bolnikih (n = 16) se je pokazalo značilno podaljšanje PFS (HR 0,15) in objektivne stopnje odziva za 31 %.
Pharmacokinetics in special patient populations
Farmakokinetika pri posebnih skupinah bolnikov
• Changes in test results that measure blood clotting or blood cells
• spremenjeni rezultati preiskav, s katerimi merijo strjevanje krvi ali krvne celice
These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.
To so lahko znaki perforacije prebavil, luknje, ki se razvije v želodcu ali črevesju in je lahko življenjsko nevarna.
Results will be used to evaluate the exposure to cabozantinib at the 60 and 140 mg dose levels and to further characterize the population PK models and exposure response relationships of cabozantinib and possible metabolites in this population.
Rezultati bodo uporabljeni za oceno izpostavljenosti kabozantinibu pri odmerku 60 in 140 mg in za nadaljnjo določanje značilnosti populacijskih FK modelov in razmerje v odzivu na izpostavljenost kabozantinibu in možne presnovke pri tej populaciji.
There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
Specifičnega zdravljenja za prevelik odmerek kabozantiniba ni, možnih simptomov prevelikega odmerjanja pa niso določili.
Push capsule through foil
Kapsule potisnite skozi folijo
The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Končni razpolovni čas kabozantiniba v plazmi v študijah enega odmerka pri zdravih prostovoljcih je približno 120 ur.
Keep in mind that treatment with COMETRIQ may make you feel tired or weak.
Ne pozabite, da lahko zdravljenje z zdravilom COMETRIQ povzroči utrujenost ali šibkost.
If you take COMETRIQ whilst using oral contraceptives, the oral contraceptives may be ineffective.
Če jemljete zdravilo COMETRIQ med uporabo peroralnih kontraceptivov, so lahko peroralni kontraceptivi neučinkoviti.
COMETRIQ capsules are also available in 28 day packs:
Zdravilo COMETRIQ kapsule so na voljo tudi kot 28-dnevno pakiranje:
If you experience serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Če se pojavijo resni neželeni učinki, bo morda zdravnik spremenil odmerek ali zdravljenje ustavil prej, kot je bilo načrtovano.
The European Medicines Agency has deferred the obligation to submit the results of studies with cabozantinib in one or more subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kabozantinibom za eno ali več podskupin pediatrične populacije za zdravljenje malignih trdih tumorjev (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The occurrence of some serious adverse reactions (like GI fistula) might be dependent on the cumulative dose and might present in a later stage of treatment.
Pojav nekaterih resnih neželenih reakcij (kot je gastrointestinalna fistula) je lahko odvisen od kumulativnega odmerka in se lahko izrazi v kasnejši dobi zdravljenja.
All patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Vse bolnike je treba spremljati glede pojava hipertenzije in jih po potrebi zdraviti s standardnimi antihipertenzivi.
• Atrial fibrillation (a fast and erratic heartbeat)
• atrijska fibrilacija (hitro in neredno bitje srca)
In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
Vzorci bodo ocenjeni tudi za mutacije RAS na določenih mestih gena (hotspots) (geni HRAS, KRAS in NRAS).
Further genetic analysis showed that a small proportion of patients harboured somatic tumour mutations in HRAS, KRAS, or NRAS.
Nadaljnje genetske analize so pokazale, da je imel majhen delež bolnikov somatske mutacije tumorja v HRAS, KRAS ali NRAS.
It should be expected that a majority of patients treated with COMETRIQ will require one or more dose adjustments (reduction and/or interruption) due to toxicity.
Pričakujte, da je treba pri večini bolnikov, zdravljenih z zdravilom COMETRIQ, zaradi toksičnosti odmerek prilagoditi enkrat ali večkrat (zmanjšanje in/ali prekinitev).
• A wound that does not heal.
• rana, ki se ne celi.
Swallow the capsules one at a time with water.
Kapsule pogoltnite eno za drugo z vodo.
• Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
• spremembe rezultatov krvnih preiskav, ki se uporabljajo za nadziranje splošnega zdravja in jeter, nizke ravni elektrolitov (kot so magnezij, kalcij ali kalij)
Patients should be advised regarding oral hygiene practice.
Bolnikom je treba svetovati glede vzdrževanja higiene ustne votline.
What COMETRIQ is and what it is used for 2.
Kaj je zdravilo COMETRIQ in za kaj ga uporabljamo 2.
Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo kabozantiniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Because oral contraceptives might possibly not be considered as “effective methods of contraception,” they should be used together with another method, such as a barrier method (see section 4.5).
Ker se morda peroralni kontraceptivi ne obravnavajo kot „zanesljiv način kontracepcije“, jih je treba uporabiti skupaj s še eno metodo, na primer pregradno metodo (glejte poglavje 4.5).
Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Študije na živalih so pokazale učinke na zarodek/plod in teratogene učinke (glejte poglavje 5.3).
• Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
• bruhanje ali izkašljevanje krvi, ki je lahko svetlo rdeča ali ima videz mlete kave.
65 quai Georges Gorse 92100 Boulogne-Billancourt France
65 quai Georges Gorse 92100 Boulogne-Billancourt Francija
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Profili plazemske koncentracije glede na čas kažejo drugi vrh absorpcije približno 24 ur po dajanju, kar kaže, da je lahko kabozantinib predmet enterohepatične recirkulacije.
Duration of Response; Median (95% CI)
Trajanje odziva; mediana (95-% IZ)
If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Če lahko vi ali vaša partnerica zanosite, morate med zdravljenjem in še vsaj 4 mesece po koncu uporabljati ustrezno kontracepcijo.
No cabozantinib-treated subjects had a QTcF >500 ms.
Osebe, ki niso bile zdravljene s kabozantinibom, so imele QTcF > 500 ms.
Bile salt-sequestering agents such as cholestyramine and cholestagel may interact with cabozantinib and may impact absorption (or reabsorption) resulting in potentially decreased exposure (see section 5.2).
Snovi, ki sekvestirajo žolčne soli, kot sta holestiramin in holestagel, lahko medsebojno vplivajo s kabozantinibom in vplivajo na absorpcijo (ali reabsorpcijo), kar lahko zmanjša izpostavljenost (glejte poglavje 5.2).
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Če bolnik odmerek izpusti, naj pozabljenega odmerka ne vzame, če je do naslednjega odmerka manj kot 12 ur.
Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Zdravljenje je treba nadaljevati tako dolgo, dokler bolnik nima več kliničnih koristi od terapije ali do pojava nesprejemljive toksičnosti.
Cabozantinib has a minor influence on the ability to drive and use machines.
Kabozantinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Odločitev o nadaljevanju zdravljenja s kabozantinibom po kirurškem posegu mora temeljiti na klinični presoji ustreznega celjenja rane.
COMETRIQ should be taken once a day.
Zdravilo COMETRIQ jemljite enkrat na dan.
Table 2: Summary of key efficacy findings
Preglednica 2: Povzetek ključnih izsledkov o učinkovitosti Kabozantinib
Adverse reactions associated with overdose are to be treated symptomatically.
Neželene učinke, povezane s prevelikim odmerjanjem, je treba zdraviti simptomatsko.
Women taking COMETRIQ should not breast feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
Ženske, ki jemljejo zdravilo COMETRIQ, med zdravljenjem in še vsaj 4 mesece po koncu zdravljenja ne smejo dojiti, saj se lahko kabozantinib in/ali njegovi presnovki izločajo v materino mleko in škodujejo otroku.
Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Kabozantinib se in vitro v človeški plazmi močno veže na beljakovine (≥ 99,7 %).
Uncommon (1/1,000 to
Občasni (1/1.000 do
• Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
• izguba pozornosti, izguba zavesti, spremembe govora, delirij, nenormalne sanje
Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
Bolnike je treba zato prvih osem tednov zdravljenja skrbno opazovati (glejte poglavje 4.4).
Figure 2: Kaplan-Meier curve of overall survival
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja
• Loss of coordination in your muscles, damage to skeletal muscles
• izguba koordinacije mišic, poškodovanje skeletnih mišic
Each 28 day pack contains enough medicine for 28 days.
Vsako 28-dnevno pakiranje vsebuje dovolj zdravila za 28 dni.
These could be signs of bone damage in the jaw (osteonecrosis).
To so lahko znaki poškodovanja čeljustne kosti (osteonekroze).
There was no improvement in OS for the RET M918T negative and unknown subgroups.
Izboljšanja OS za podskupino negativno za RET M918T in neznano podskupino ni bilo.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Embryo-foetal development studies were performed in rats and rabbits.
Študije razvoja zarodka-plodu so opravili pri podganah in kuncih.
Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
Dvaindevetdeset odstotkov bolnikov v kraku s kabozantinibom je imelo predhodno tiroidektomijo in 89 % jih je pred prvim odmerkom jemalo ščitnične hormone.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma
• Decrease in the levels of protein in your blood
• znižana raven beljakovin v krvi
• Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
• zvišanje ravni bilirubina v krvi (kar lahko povzroči zlatenico/porumenelost kože ali beločnic)
• Anxiety, depression, confusion
• tesnobnost, depresija, zmedenost
The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
Primarna opazovana točka je bila primerjava preživetja brez napredovanja bolezni (PFS, progression-free survival) pri bolnikih, ki so dobivali kabozantinib, v primerjavi z bolniki, ki so dobivali placebo.
In addition, cabozantinib inhibits other tyrosine kinases including RET, the GAS6 receptor (AXL), the stem cell factor receptor (KIT), and Fms-like tyrosine kinase-3 (FLT3).
Poleg tega kabozantinib zavira druge tirozin-kinaze, vključno z RET, receptorjem GAS6 (AXL), receptorjem faktorja matičnih celic (KIT) in Fms-ju podobno tirozin-kinazo-3 (FLT3).
Fertility studies in rats have shown reduced male and female fertility.
Študije plodnosti pri podganah so pokazale zmanjšano plodnost pri samcih in samicah.
• 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
• 60 mg (3 sive 20 mg kapsule) Vaš zdravnik bo določil odmerek, ki je za vas pravilen.
• Decreased appetite, weight loss, altered sense of taste
• zmanjšan apetit, izguba telesne mase, spremenjen občutek za okus
Patients were treated until disease progression or unacceptable toxicity.
Bolniki so z zdravljenjem nadaljevali do napredovanja bolezni ali nesprejemljive toksičnosti.
Not Known (unknown frequency)
Neznana pogostnost
Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Zdravniku povejte, če vi ali vaša partnerica zanosite ali načrtujete zanositev med zdravljenjem z zdravilom COMETRIQ.
Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Kabozantinib ni kazal mutagenega ali klastogenega potenciala v standardnemu nizu genotoksičnih testov.
Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Zdravljenje z zdravilom COMETRIQ mora uvesti zdravnik z izkušnjami v uporabi zdravil za zdravljenje raka.
Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Nadaljevanje zdravljenja s kabozantinibom naj se začne z nižjim odmerkom, ko se PPES umiri do 1. stopnje.
4.0 months
4,0 meseci
Palmar-plantar erythrodysaesthesia syndrome
Sindrom palmarno-plantarne eritrodisestezije
COMETRIQ may slow or stop the growth of medullary thyroid cancer.
Zdravilo COMETRIQ lahko upočasni ali ustavi rast medularnega raka ščitnice.
Each blister card has enough capsules to last for seven days (one week).
Vsaka pretisna zgibanka vsebuje dovolj kapsul za vsaj sedem dni (en teden).
Each day, take all the capsules across the row.
Vsak dan vzemite vse kapsule v eni vrsti.
Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Slika 3: Kaplan-Meierjeva analiza OS pri osebah z mutacijo RET M918T
In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Podatki in vitro kažejo, da je kabozantinib substrat MRP2.
This could mean that your doctor needs to change the dose(s) that you take.
To pomeni, da bo morda zdravnik moral prilagoditi odmerek/odmerke, ki jih jemljete.
• Hypertension (increase in blood pressure)
• hipertenzija (zvišanje krvnega tlaka)
Effect of other medicinal products on cabozantinib
Učinek drugih zdravil na kabozantinib
The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Mediana trajanja objektivnega odgovora je bila 14,6 mesecev (95-% IZ: 11,1; 17,5) za osebe v kraku s kabozantinibom.
This is because COMETRIQ can affect the way some other medicines work.
To je pomembno, ker lahko zdravilo COMETRIQ vpliva na način delovanja nekaterih zdravil.
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, and metastatic progression of cancer.
Kabozantinib je majhna molekula, ki zavira več receptorskih tirozin-kinaz (RTK), ki so vpletene v rast tumorja in angiogenezo, patološko preoblikovanje kosti in metastatsko napredovanje raka.
COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Zdravilo COMETRIQ je indicirano za zdravljenje odraslih bolnikov s progresivnim, neizrezljivim, lokalno napredovalim ali metastatskim medularnim karcinomom ščitnice.
Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Kaže, da so izsledki v maternici/jajčnikih in zmanjšana hematopoeza prehodni, medtem ko učinki na kostne parametre in pigmentacijo jeter ostali.
Use caution when driving or using machines.
Med vožnjo ali uporabo strojev bodite previdni.
Overall Response Ratea (95% CI)
Splošna stopnja odzivaa (95-% IZ)
Cabozantinib is a CYP3A4 substrate.
Kabozantinib je substrat CYP3A4.
Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Zato se v prvih osmih tednih zdravljenja priporoča skrbno opazovanje bolnikov (glejte poglavje 4.2).
Median Overall Survival
Mediano celokupno preživetje
Also, some medicines can affect the way COMETRIQ works.
Prav tako lahko tudi nekatera zdravila vplivajo na delovanje zdravila COMETRIQ.
You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Morda vas bo treba zdraviti ali pa se bo zdravnik odločil, da spremeni odmerek zdravila COMETRIQ ali zdravljenje ukine.
Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
S svojim zdravnikom se posvetujte o metodah kontracepcije, ki so ustrezne med uporabo zdravila COMETRIQ.
• Weakness or reduced sensation or tingling in the limbs
• šibkost ali zmanjšanje občutenja ali ščemenje v udih
No data are available to determine a difference in PK based on race.
Podatki, na podlagi katerih bi bilo mogoče ugotoviti razlike v farmakokinetiki na podlagi rase, niso na voljo.
Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Kabozantinib v mišjem modelu rasH2 ni bil kancerogen ob nekoliko večji izpostavljenosti, kot je nameravana terapevtska izpostavljenost pri ljudeh.
• Hypotension (decrease in blood pressure)
• hipotenzija (znižanje krvnega tlaka)
The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Pridobljene vzorce DNA bodo ocenili glede kakovosti v testu pomnoževanja na podlagi PCR in z določanjem zaporedja za RET M918T z metodo po Sangerju.
• Protein or blood in the urine, gallstones, painful urination
• beljakovine ali kri v urinu, žolčni kamni, boleče odvajanje urina
A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Nevtralizirajoče protitelo za CYP2C9 je pokazalo minimalni učinek na nastanek presnovka kabozantiniba (tj. zmanjšanje za < 20 %).
Mean clearance (CL/F) at steady-state in cancer patients was estimated to be 4.4 L/hr in a population PK analysis.
Povprečni očistek (CL/F) v stanju dinamičnega ravnovesja pri bolnikih z rakom je bil v farmakokinetični analizi populacije ocenjen na 4,4 l/uro.
Disease Control Rate b (95% CI) Calcitonin Responsea
Stopnja nadzora bolezni b (95-% IZ) Odziv na kalcitonina
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze, oznaka ATC: L01XE26
• Swelling in the face and in other parts of the body
• oteklost obraza in drugih delov telesa
RET mutation negative patients with no evidence of RAS mutation (n=33) showed a decreased PFS benefit on cabozantinib (HR of 0.87) and a lower response rate of 18% compared to other mutational subgroups.
Bolniki, negativni za mutacijo RET, in brez znakov mutacije RAS (n = 33) so pokazali zmanjšano korist PFS pri uporabi kabozantiniba (HR 0,87) in z 18 % nižjo stopnjo odziva v primerjavi z drugimi mutacijskimi podskupinami.
If you have taken more COMETRIQ than you have been instructed to, talk to a doctor or go to the hospital with the capsules and this leaflet straight away.
Če ste vzeli večji odmerek zdravila COMETRIQ, kot bi smeli Če ste vzeli več zdravila COMETRIQ, kot vam je bilo naročeno, se pogovorite z zdravnikom ali takoj pojdite v bolnišnico s kapsulami in tem navodilom.
In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
V primeru trdovratne hipertenzije kljub uporabi antihipertenzivov je treba odmerek kabozantiniba zmanjšati.
Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
Vzorci tumorskega tkiva se bodo najprej ocenili histološko, s pomočjo ročne obogatitve tumorja in izolacije DNA.
Effect of cabozantinib on other medicinal products
Učinek kabozantiniba na druga zdravila
Other medicines and COMETRIQ
Druga zdravila in zdravilo COMETRIQ
In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
Pri bolnikih z blago ali zmerno jetrno okvaro je priporočeni odmerek kabozantiniba 60 mg enkrat na dan.
Each row of the blister card contains the daily dose.
Vsaka vrsta pretisne zgibanke vsebuje dnevni odmerek.
PK assessments will be required for all subjects (both dose groups).
Za vse osebe (v skupinah z obema odmerkoma) se bo ocenila FK.