FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Pričakujte, da je treba pri večini bolnikov, zdravljenih z zdravilom COMETRIQ, zaradi toksičnosti odmerek prilagoditi enkrat ali večkrat (zmanjšanje in/ali prekinitev).
English: • A wound that does not heal.
Slovenian: • rana, ki se ne celi.
English: Swallow the capsules one at a time with water.
Slovenian: Kapsule pogoltnite eno za drugo z vodo.
English: • Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
Slovenian: • spremembe rezultatov krvnih preiskav, ki se uporabljajo za nadziranje splošnega zdravja in jeter, nizke ravni elektrolitov (kot so magnezij, kalcij ali kalij)
English: Patients should be advised regarding oral hygiene practice.
Slovenian: Bolnikom je treba svetovati glede vzdrževanja higiene ustne votline.
English: What COMETRIQ is and what it is used for 2.
Slovenian: Kaj je zdravilo COMETRIQ in za kaj ga uporabljamo 2.
English: Before initiating cabozantinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo kabozantiniba je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: 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).
Slovenian: 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).
English: Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Slovenian: Študije na živalih so pokazale učinke na zarodek/plod in teratogene učinke (glejte poglavje 5.3).
English: • Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
Slovenian: • bruhanje ali izkašljevanje krvi, ki je lahko svetlo rdeča ali ima videz mlete kave.
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Slovenian: 65 quai Georges Gorse 92100 Boulogne-Billancourt Francija
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Slovenian: Profili plazemske koncentracije glede na čas kažejo drugi vrh absorpcije približno 24 ur po dajanju, kar kaže, da je lahko kabozantinib predmet enterohepatične recirkulacije.
English: Duration of Response; Median (95% CI)
Slovenian: Trajanje odziva; mediana (95-% IZ)
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Slovenian: Če lahko vi ali vaša partnerica zanosite, morate med zdravljenjem in še vsaj 4 mesece po koncu uporabljati ustrezno kontracepcijo.
English: No cabozantinib-treated subjects had a QTcF >500 ms.
Slovenian: Osebe, ki niso bile zdravljene s kabozantinibom, so imele QTcF > 500 ms.
English: 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).
Slovenian: 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).
English: If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Slovenian: Če bolnik odmerek izpusti, naj pozabljenega odmerka ne vzame, če je do naslednjega odmerka manj kot 12 ur.
English: Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Slovenian: Zdravljenje je treba nadaljevati tako dolgo, dokler bolnik nima več kliničnih koristi od terapije ali do pojava nesprejemljive toksičnosti.
English: Cabozantinib has a minor influence on the ability to drive and use machines.
Slovenian: Kabozantinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Slovenian: Odločitev o nadaljevanju zdravljenja s kabozantinibom po kirurškem posegu mora temeljiti na klinični presoji ustreznega celjenja rane.
English: COMETRIQ should be taken once a day.
Slovenian: Zdravilo COMETRIQ jemljite enkrat na dan.
English: Table 2: Summary of key efficacy findings
Slovenian: Preglednica 2: Povzetek ključnih izsledkov o učinkovitosti Kabozantinib
English: Adverse reactions associated with overdose are to be treated symptomatically.
Slovenian: Neželene učinke, povezane s prevelikim odmerjanjem, je treba zdraviti simptomatsko.
English: 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.
Slovenian: 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.
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Slovenian: Kabozantinib se in vitro v človeški plazmi močno veže na beljakovine (≥ 99,7 %).
English: Uncommon (1/1,000 to
Slovenian: Občasni (1/1.000 do
English: • Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
Slovenian: • izguba pozornosti, izguba zavesti, spremembe govora, delirij, nenormalne sanje
English: Patients should therefore be closely monitored during the first eight weeks of therapy (see section 4.4).
Slovenian: Bolnike je treba zato prvih osem tednov zdravljenja skrbno opazovati (glejte poglavje 4.4).
English: Figure 2: Kaplan-Meier curve of overall survival
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja
English: • Loss of coordination in your muscles, damage to skeletal muscles
Slovenian: • izguba koordinacije mišic, poškodovanje skeletnih mišic
English: Each 28 day pack contains enough medicine for 28 days.
Slovenian: Vsako 28-dnevno pakiranje vsebuje dovolj zdravila za 28 dni.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: To so lahko znaki poškodovanja čeljustne kosti (osteonekroze).
English: There was no improvement in OS for the RET M918T negative and unknown subgroups.
Slovenian: Izboljšanja OS za podskupino negativno za RET M918T in neznano podskupino ni bilo.
English: 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.
Slovenian: 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.
English: Embryo-foetal development studies were performed in rats and rabbits.
Slovenian: Študije razvoja zarodka-plodu so opravili pri podganah in kuncih.
English: Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
Slovenian: Dvaindevetdeset odstotkov bolnikov v kraku s kabozantinibom je imelo predhodno tiroidektomijo in 89 % jih je pred prvim odmerkom jemalo ščitnične hormone.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ipsen Pharma
English: • Decrease in the levels of protein in your blood
Slovenian: • znižana raven beljakovin v krvi
English: • Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
Slovenian: • zvišanje ravni bilirubina v krvi (kar lahko povzroči zlatenico/porumenelost kože ali beločnic)
English: • Anxiety, depression, confusion
Slovenian: • tesnobnost, depresija, zmedenost
English: The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Fertility studies in rats have shown reduced male and female fertility.
Slovenian: Študije plodnosti pri podganah so pokazale zmanjšano plodnost pri samcih in samicah.
English: • 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
Slovenian: • 60 mg (3 sive 20 mg kapsule) Vaš zdravnik bo določil odmerek, ki je za vas pravilen.
English: • Decreased appetite, weight loss, altered sense of taste
Slovenian: • zmanjšan apetit, izguba telesne mase, spremenjen občutek za okus
English: Patients were treated until disease progression or unacceptable toxicity.
Slovenian: Bolniki so z zdravljenjem nadaljevali do napredovanja bolezni ali nesprejemljive toksičnosti.
English: Not Known (unknown frequency)
Slovenian: Neznana pogostnost
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with COMETRIQ.
Slovenian: Zdravniku povejte, če vi ali vaša partnerica zanosite ali načrtujete zanositev med zdravljenjem z zdravilom COMETRIQ.
English: Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Slovenian: Kabozantinib ni kazal mutagenega ali klastogenega potenciala v standardnemu nizu genotoksičnih testov.
English: Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom COMETRIQ mora uvesti zdravnik z izkušnjami v uporabi zdravil za zdravljenje raka.
English: Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Slovenian: Nadaljevanje zdravljenja s kabozantinibom naj se začne z nižjim odmerkom, ko se PPES umiri do 1. stopnje.
English: 4.0 months
Slovenian: 4,0 meseci
English: Palmar-plantar erythrodysaesthesia syndrome
Slovenian: Sindrom palmarno-plantarne eritrodisestezije
English: COMETRIQ may slow or stop the growth of medullary thyroid cancer.
Slovenian: Zdravilo COMETRIQ lahko upočasni ali ustavi rast medularnega raka ščitnice.
English: Each blister card has enough capsules to last for seven days (one week).
Slovenian: Vsaka pretisna zgibanka vsebuje dovolj kapsul za vsaj sedem dni (en teden).
English: Each day, take all the capsules across the row.
Slovenian: Vsak dan vzemite vse kapsule v eni vrsti.
English: Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Slovenian: Slika 3: Kaplan-Meierjeva analiza OS pri osebah z mutacijo RET M918T
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Slovenian: Podatki in vitro kažejo, da je kabozantinib substrat MRP2.
English: This could mean that your doctor needs to change the dose(s) that you take.
Slovenian: To pomeni, da bo morda zdravnik moral prilagoditi odmerek/odmerke, ki jih jemljete.
English: • Hypertension (increase in blood pressure)
Slovenian: • hipertenzija (zvišanje krvnega tlaka)
English: Effect of other medicinal products on cabozantinib
Slovenian: Učinek drugih zdravil na kabozantinib
English: The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Slovenian: Mediana trajanja objektivnega odgovora je bila 14,6 mesecev (95-% IZ: 11,1; 17,5) za osebe v kraku s kabozantinibom.
English: This is because COMETRIQ can affect the way some other medicines work.
Slovenian: To je pomembno, ker lahko zdravilo COMETRIQ vpliva na način delovanja nekaterih zdravil.
English: 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.
Slovenian: 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.
English: COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Slovenian: Zdravilo COMETRIQ je indicirano za zdravljenje odraslih bolnikov s progresivnim, neizrezljivim, lokalno napredovalim ali metastatskim medularnim karcinomom ščitnice.
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Slovenian: Kaže, da so izsledki v maternici/jajčnikih in zmanjšana hematopoeza prehodni, medtem ko učinki na kostne parametre in pigmentacijo jeter ostali.
English: Use caution when driving or using machines.
Slovenian: Med vožnjo ali uporabo strojev bodite previdni.
English: Overall Response Ratea (95% CI)
Slovenian: Splošna stopnja odzivaa (95-% IZ)
English: Cabozantinib is a CYP3A4 substrate.
Slovenian: Kabozantinib je substrat CYP3A4.
English: Close monitoring of patients is therefore recommended during the first eight weeks of therapy (see section 4.2).
Slovenian: Zato se v prvih osmih tednih zdravljenja priporoča skrbno opazovanje bolnikov (glejte poglavje 4.2).
English: Median Overall Survival
Slovenian: Mediano celokupno preživetje
English: Also, some medicines can affect the way COMETRIQ works.
Slovenian: Prav tako lahko tudi nekatera zdravila vplivajo na delovanje zdravila COMETRIQ.
English: You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Slovenian: Morda vas bo treba zdraviti ali pa se bo zdravnik odločil, da spremeni odmerek zdravila COMETRIQ ali zdravljenje ukine.
English: Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
Slovenian: S svojim zdravnikom se posvetujte o metodah kontracepcije, ki so ustrezne med uporabo zdravila COMETRIQ.
English: • Weakness or reduced sensation or tingling in the limbs
Slovenian: • šibkost ali zmanjšanje občutenja ali ščemenje v udih
English: No data are available to determine a difference in PK based on race.
Slovenian: Podatki, na podlagi katerih bi bilo mogoče ugotoviti razlike v farmakokinetiki na podlagi rase, niso na voljo.
English: Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Slovenian: Kabozantinib v mišjem modelu rasH2 ni bil kancerogen ob nekoliko večji izpostavljenosti, kot je nameravana terapevtska izpostavljenost pri ljudeh.
English: • Hypotension (decrease in blood pressure)
Slovenian: • hipotenzija (znižanje krvnega tlaka)
English: The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Slovenian: Pridobljene vzorce DNA bodo ocenili glede kakovosti v testu pomnoževanja na podlagi PCR in z določanjem zaporedja za RET M918T z metodo po Sangerju.
English: • Protein or blood in the urine, gallstones, painful urination
Slovenian: • beljakovine ali kri v urinu, žolčni kamni, boleče odvajanje urina
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Slovenian: Nevtralizirajoče protitelo za CYP2C9 je pokazalo minimalni učinek na nastanek presnovka kabozantiniba (tj. zmanjšanje za < 20 %).
English: Mean clearance (CL/F) at steady-state in cancer patients was estimated to be 4.4 L/hr in a population PK analysis.
Slovenian: Povprečni očistek (CL/F) v stanju dinamičnega ravnovesja pri bolnikih z rakom je bil v farmakokinetični analizi populacije ocenjen na 4,4 l/uro.
English: Disease Control Rate b (95% CI) Calcitonin Responsea
Slovenian: Stopnja nadzora bolezni b (95-% IZ) Odziv na kalcitonina
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinske kinaze, oznaka ATC: L01XE26
English: • Swelling in the face and in other parts of the body
Slovenian: • oteklost obraza in drugih delov telesa
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Slovenian: V primeru trdovratne hipertenzije kljub uporabi antihipertenzivov je treba odmerek kabozantiniba zmanjšati.
English: Tumor tissue samples initially will undergo histological evaluation, manual tumor enrichment, and DNA isolation.
Slovenian: Vzorci tumorskega tkiva se bodo najprej ocenili histološko, s pomočjo ročne obogatitve tumorja in izolacije DNA.
English: Effect of cabozantinib on other medicinal products
Slovenian: Učinek kabozantiniba na druga zdravila
English: Other medicines and COMETRIQ
Slovenian: Druga zdravila in zdravilo COMETRIQ
English: In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro je priporočeni odmerek kabozantiniba 60 mg enkrat na dan.
English: Each row of the blister card contains the daily dose.
Slovenian: Vsaka vrsta pretisne zgibanke vsebuje dnevni odmerek.
English: PK assessments will be required for all subjects (both dose groups).
Slovenian: Za vse osebe (v skupinah z obema odmerkoma) se bo ocenila FK.
English: • A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
Slovenian: • raztrganje ali nenormalne povezave tkiva v prebavilih; simptomi lahko vključujejo hude ali trdovratne bolečine v trebuhu
English: The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Slovenian: Objektivne stopnje odzivov, izmerjene v teh podskupinah, so bile na splošno konsistentne z rezultati PFS, pri čemer so bile stopnje odziva v podskupini s pozitivno mutacijo RET 32 %, v podskupini z negativno mutacijo RET 22 % in v podskupini z neznano mutacijo RET 25 %.
English: What you need to know before you take COMETRIQ 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo COMETRIQ 3.
English: Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
Slovenian: Bolnikom je treba naročiti, naj vsaj 2 uri pred uporabo zdravila COMETRIQ in 1 uro po tem ničesar ne jedo.
English: Avoid consuming grapefruit-containing products for as long as you are using this medicine, as it may increase the levels of COMETRIQ in your blood.
Slovenian: Dokler uporabljate zdravilo COMETRIQ, ne jejte živil, ki vsebujejo grenivko, saj lahko zviša ravni zdravila v krvi.
English: Repeat daily dosing of cabozantinib at 140 mg for 19 days resulted in an approximately a 4- to 5-fold mean cabozantinib accumulation (based on AUC) compared to a single dose administration; steady state is achieved by approximately Day 15.
Slovenian: Ponavljajoče se dnevno odmerjanje kabozantiniba v odmerku 140 mg za 19 dni je povzročilo približno 4- do 5-kratno povprečno kopičenje kabozantiniba (na podlagi AUC) v primerjavi z uporabo enega odmerka; stanje dinamičnega ravnovesja se doseže na približno 15. dan.
English: RPLS is uncommon (it affects less than 1 in 100 people).
Slovenian: RPLS je občasen neželeni učinek (prizadene manj kot 1 od 100 bolnikov).
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Slovenian: Z uporabo kabozantiniba je treba prenehati, če je hipertenzija resna ali trdovratna kljub zdravljenju z antihipertenzivi in zmanjšanjem odmerka kabozantiniba.
English: A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Slovenian: Študija primerjave odmerka (XL-184-401) (140 mg v primerjavi s 60 mg) pri 112 bolnikih z dednim ali sporadičnim medularnim rakom ščitnice.
English: Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
Slovenian: Kabozantiniba ne smete uporabljati med nosečnostjo, razen če zdravljenje s kabozantinibom ni nujno potrebno zaradi kliničnega stanja ženske.
English: Monitor for adverse events and adjust dose or use dosing interruption as needed (see section 4.2).
Slovenian: Spremljati je treba neželene učinke in odmerek po potrebi prilagajati ali dajanje prekiniti (glejte poglavje 4.2).
English: Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Slovenian: Prekinitev odmerka se priporoča pri obravnavi toksičnosti 3. ali višje stopnje po CTCAE (common terminology criteria for adverse events) ali nevzdržnih toksičnosti 2. stopnje.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: Your capsules are also available as a 28 day pack, which contains enough capsules to last for 28 days, in 4 blister cards with seven days of capsules on each card.
Slovenian: Kapsule so na voljo kot 28-dnevno pakiranje, ki vsebuje dovolj kapsul za 28 dni v 4 pretisnih zgibankah s kapsulami za sedem dni na vsaki zgibanki.
English: Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Slovenian: Odvzeti je treba sveže vzorce tumorjev za gensko analizo tumorjev na nazadnje nastalih mestih zasevkov pri bolnikih, vključenih v študijo primerjave odmerka.
English: Centralized, independent, blinded review of the imaging data was used in the assessment of PFS and ORR.
Slovenian: Pri oceni PFS in ORR so opravili centralizirane, neodvisne, slepe preglede slikovnih podatkov.