natgillin/translations-raw huggingface dataset:
and rifampicin - Allergy medicines such as fexofenadine and ranolazine - Medicines used to treat epilepsy or fits such as phenytoin, carbamazepine, and phenobarbital - Herbal preparations containing St. John's Wort (Hypericum perforatum), sometimes used for treating depression or depression-related conditions such as anxiety - Medicines used to thin the blood, such as warfarin - Medicines to treat high blood pressure or other heart conditions, such as aliskiren,
- zdravila za zdravljenje glivičnih okužb, kot so itrakonazol, ketokonazol in posakonazol - zdravila za zdravljenje bakterijskih okužb (antibiotiki), kot so eritromicin, klaritromicin in rifampicin - zdravila proti alergijam, kot so feksofenadin in ranolazin - zdravila za zdravljenje epilepsije ali epileptičnih napadov, kot so fenitoin, karbamazepin in fenobarbital - pripravki zeliščnega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), ki se včasih uporabljajo za zdravljenje depresije ali z depresijo povezanih stanj, kot je tesnobnost - zdravila, ki se uporabljajo za redčenje krvi, kot je varfarin - zdravila za zdravljenje visokega krvnega tlaka ali drugih bolezni srca, kot so aliskiren,
Cardiac disorders myocardial infarction
Srčne bolezni miokardni infarkt
Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Osebe je treba opozoriti na uporabo substratov P-gp (npr. feksofenadina, aliskirena, ambrisentana, dabigatran eteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) sočasno s kabozantinibom.
In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467).
V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), so o GI perforacijah poročali pri 0,9 % bolnikov, ki so se zdravili s kabozantinibom (4/467).
In the HCC study (CELESTIAL), diarrhoea was reported in 54% of cabozantinib-treated patients (251/467);Grade 3- 4 events in 9.9%.
V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), so o driski poročali pri 54 % bolnikov, ki so se zdravili s kabozantinibom (251/467); dogodki 3.-4. stopnje pri 9,9 % bolnikov.
Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili sindrom palmarno-plantarne eritrodisestezije (PPES).
Presence of macroscopic vascular invasion and/ or extra-hepatic tumour spread:78%, Alfa-fetoprotein (AFP) levels ≥400 μg/L: 41%.
Vrednosti alfa-fetoproteina (AFP) ≥ 400 μg/l: 41 %.
CABOMETYX contains lactose
Zdravilo CABOMETYX vsebuje laktozo
In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
V študiji HCK (CELESTIAL) so pri uporabi kabozantiniba poročali o trombozi portalne vene, vključno z enim smrtnim primerom.
In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Pri zdravljenju hepatocelularnega karcinoma po predhodnem sistemskem zdravljenju je bil odmerek zmanjšan pri 62 % bolnikov in odmerjanje prekinjeno pri 84 % bolnikov, ki so se zdravili s kabozantinibom v kliničnem preskušanju (CELESTIAL).
The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Najpogostejši resni neželeni učinki zdravila v populaciji bolnikov s HCK (pojavnost ≥ 1 %) so bili jetrna encefalopatija, sindrom palmarno-plantarne eritrodisestezije, astenija in driska.
In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), so o GI perforacijah poročali pri 2,6 % (2/78) bolnikov, ki so se zdravili s kabozantinibom.
The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Druge sestavine zdravila so: - Jedro tablete: mikrokristalna celuloza, brezvodna laktoza, hidroksipropilceluloza, premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat (glejte poglavje 2
• Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
• razdražen želodec, vključno z drisko, slabostjo, bruhanjem, zaprtjem, prebavnimi motnjami in bolečinami v trebuhu
Thirty-six percent (36%) of patients had bone metastases.
Zasevke v kosteh je imelo 36 % bolnikov.
Median PFS (95% CI), months HR (95% CI), p-value1
Mediana PFS (95-% IZ), meseci HR (95-% IZ), p-vrednost1
Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Zato je potrebna pri sočasni uporabi močnih zaviralcev CYP3A4 (npr. ritonavirja, itrakonazola, eritromicina, klaritromicina, soka grenivke) s kabozantinibom previdnost.
• Increase in cholesterol levels in the blood
• zvišanje ravni holesterola v krvi
Crossover from placebo to cabozantinib was not allowed during theblinded treatment phase.
Med zaslepljeno fazo zdravljenja prehod iz skupine s placebom v skupino s kabozantinibom ni bil dovoljen.
Clinical data in treatment-naïve renal cell carcinoma
Klinični podatki pri predhodno nezdravljenem karcinomu ledvičnih celic
The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Najpogostejši resni neželeni učinki zdravila v populaciji bolnikov s KLC (pojavnost ≥ 1 %) so bili driska, hipertenzija, dehidracija, hiponatriemija, navzea, zmanjšanje apetita, embolija, utrujenost, hipomagneziemija in sindrom palmarno-plantarne eritrodisestezije (PPES).
A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Za zdravilo CABOMETYX je bilo v primerjavi s placebom dokazano statistično pomembno izboljšanje celokupnega preživetja (OS) (preglednica 6 in slika 4).
Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib (see section 4.5).
Bolnike je treba opozoriti na uporabo substratov P-gp (npr. feksofenadina, aliskirena, ambrisentana, dabigatran eteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) sočasno s kabozantinibom (glejte poglavje 4.5).
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Common Terminology Criteria for Adverse Events), različica 4.0.
There is a possibility your fertility could be affected by treatment with CABOMETYX.
Obstaja možnost, da bo zdravilo CABOMETYX vplivalo na vašo plodnost.
Hepatic effects Abnormalities of liver function tests (increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with cabozantinib.
Pri bolnikih, ki so se zdravili s kabozantinibom, so pogosto opažali nenormalne izvide preiskav delovanja jeter (zvišanje vrednosti alanin-aminotransferaze [ALT], aspartat-aminotransferaze [AST] in bilirubina).
Median time to onset was 4.9 weeks.
Mediani čas do pojava je bil 4,9 tedna.
Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Preživetje brez napredovanja bolezni (PFS)3 Mediana PFS v mesecih (95-% IZ) HR (95-% IZ)1 p-vrednost1
Patients with a history of portal vein invasion appeared to be at higher risk of developing portal vein thrombosis.
Kaže, da obstaja večje tveganje za razvoj tromboze portalne vene pri bolnikih z invazijo portalne vene v anamnezi.
Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Slika 3: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni IRC pri predhodno nezdravljenih osebah s KLC
The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
Izhodiščne demografske značilnosti in značilnosti bolezni so bile v kraku z zdravilom CABOMETYX podobne tistim v kraku z everolimusom.
Infections and infestations abscess
Infekcijske in parazitske bolezni absces
- have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall - have diarrhoea - have a recent history of significant bleeding - have had surgery within the last month (or if surgical procedures are planned), including dental surgery - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis,
- imate drisko - imate znatno krvavitev v nedavni anamnezi - ste imeli v zadnjem mesecu kirurški poseg (ali ga načrtujete), vključno z zobozdravstvenimi posegi - imate vnetno bolezen črevesja (na primer Crohnovo bolezen ali ulcerozni kolitis, divertikulitis ali apendicitis) - imate v nedavni anamnezi krvni strdek v nogi, možgansko kap ali srčni infarkt - imate bolezen jeter ali ledvic
• Haemorrhoids (piles)
• epileptični krči (konvulzije)
Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (METEOR)
In the study in RCC following prior VEGF-targeted therapy (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinibtreated patients.
V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o fistulah poročali pri 1,2 % (4/331) bolnikov, zdravljenih s kabozantinibom, vključno z analnimi fistulami pri 0,6 % (2/331) bolnikov, zdravljenih s kabozantinibom.
Closer monitoring is advised in patients with mild or moderate hepatic impairment.
Pri bolnikih z blago ali zmerno okvaro jeter je priporočljivo skrbno spremljanje.
Patients had to have intermediate or poor risk disease as defined by the International Metastatic RCC Database Consortium (IMDC) risk group categories.
CABOMETYX everolimus kategorijami skupin tveganja za KLC po IMDC (International Metastatic RCC Database Consortium).
How to take CABOMETYX
Kako jemati zdravilo CABOMETYX
Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
Preglednica 5: Rezultati učinkovitosti pri predhodno nezdravljenih osebah s KLC (ITT, Intent-To-Treat populacija, CABOSUN)
The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Najpogostejši neželeni učinki katere koli stopnje (ki so se pojavili pri vsaj 25 % bolnikov) v populaciji bolnikov s KLC so bili driska, hipertenzija, utrujenost, zvišanje vrednosti AST, zvišanje vrednosti ALT, navzea, zmanjšanje apetita, sindrom palmarno-plantarne eritrodisestezije (PPES), paragevzija, zmanjšanje števila trombocitov, stomatitis, anemija, bruhanje, zmanjšanje telesne mase, dispepsija in konstipacija.
In treatment-naïve renal cell carcinoma, dose reductions and dose interruptions occurred in 46% and 73%, respectively, of cabozantinib-treated patients in the clinical trial (CABOSUN).
Pri zdravljenju predhodno nezdravljenega karcinoma ledvičnih celic je bil odmerek zmanjšan pri 46 % bolnikov in odmerjanje prekinjeno pri 73 % bolnikov, ki so se zdravili s kabozantinibom v kliničnem preskušanju (CABOSUN).
In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
V študiji HCK (CELESTIAL) so poročali o usodnih krvavitvah, katerih pojavnost je bila pri uporabi kabozantiniba večja kot pri uporabi placeba.
The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the HCC population included diarrhoea, palmar-plantar erythrodysaesthesia syndrome, fatigue, decreased appetite hypertension and nausea.
Najpogostejši neželeni učinki katere koli stopnje (ki so se pojavili pri vsaj 25 % bolnikov) v populaciji bolnikov s HCK so bili driska, sindrom palmarno-plantarne eritrodisestezije, utrujenost, zmanjšanje apetita, hipertenzija in navzea.
Figure 1: Kaplan Meier curve for progression-free survival by independent radiology review committee, in RCC subjects following prior vascular endothelial growth factor (VEGF)targeted therapy (first 375 subjects randomized) (METEOR)
Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni neodvisne radiološke komisije pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (prvih 375 randomiziranih oseb) (METEOR)
Musculoskeletal and connective tissue disorders pain in extremity muscle spasms, arthralgia osteonecrosis of the jaw
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v okončinah mišični krči, artralgija osteonekroza čeljusti
In the study in RCC following prior VEGF-targeted therapy (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients.
V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o GI perforacijah poročali pri 0,9 % (3/331) bolnikov, zdravljenih s kabozantinibom.
Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Nenormalni izvidi biokemijskih laboratorijskih preiskav Uporaba kabozantiniba je bila povezana z večjo pojavnostjo elektrolitskih nepravilnosti (vključno s hipokaliemijo, hiperkaliemijo, hipomagneziemijo, hipokalciemijo in hiponatriemijo).
CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
KLINIČNI PODATKI 4.1 Terapevtske indikacije Karcinom ledvičnih celic (KLC) Zdravilo CABOMETYX je indicirano za zdravljenje napredovalega karcinoma ledvičnih celic (KLC): - pri predhodno nezdravljenih odraslih bolnikih s srednje ugodnim ali slabim prognostičnim obetom (glejte poglavje 5.1).
In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), je pojavnost dogodkov hude krvavitve (≥ 3. stopnje) pri bolnikih, ki so se zdravili s kabozantinibom, znašala 7,3 % (34/467).
Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili resne gastrointestinalne perforacije in fistule, ki so bile včasih tudi usodne.
• Increase in blood triglyceride levels in the blood
• zvišanje ravni trigliceridov v krvi
Table 6: Efficacy results in HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
Preglednica 6: Rezultati učinkovitosti pri bolnikih s HCK (ITT, Intent-To-Treat populacija, CELESTIAL)
There is limited data in patients with moderate hepatic impairment (n=15) as per NCI-ODWG (National Cancer Institute - Organ Dysfunction working Group) criteria.
Pri bolnikih z zmerno okvaro jeter je v skladu s kriteriji NCI-ODWG (National
Table 4: Summary of ORR findings per independent radiology committee review (IRC) and investigator review, in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy
Preglednica 4: Povzetek izsledkov ORR po oceni neodvisnih radioloških komisij (IRC, independent radiology committee) in oceni raziskovalca, pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF)
• Blisters, pain of the hands or soles of the feet, rash or redness of the skin
• mehurji, bolečine v dlaneh ali podplatih, izpuščaj ali rdečina kože
In the study in RCC following prior VEGF-targeted therapy (METEOR), diarrhoea was reported in 74% of cabozantinib-treated RCC patients (245/331); Grade 3-4 events in 11%.
V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o driski poročali pri 74 % bolnikov s KLC, ki so se zdravili s kabozantinibom (245/331); dogodki 3.-4. stopnje pri 11 % bolnikov.
A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
Pri zdravljenju s kabozantinibom se je jetrna encefalopatija pojavila pri višjem relativnem deležu bolnikov z zmerno okvaro jeter (Child-Pugh B).
• Numbness, tingling, burning sensation or pain in the limbs
• odrevenelost, mravljinčenje, pekoč občutek ali bolečina v okončinah
Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Žilne bolezni hipertenzija, krvavitev venska tromboza, arterijska tromboza anevrizme in disekcije arterij
Based on the populationpharmacokinetic (PK) model, the volume of distribution of the central compartment (Vc/F) was estimated to be 212 L. Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Na podlagi farmakokinetičnega modela populacije je bil volumen porazdelitve v centralnem prostoru (Vc/F) ocenjen na 212 litrov.
PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
FARMACEVTSKA OBLIKA filmsko obložena tableta
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
CABOMETYX 20 mg filmsko obložene tablete CABOMETYX 40 mg filmsko obložene tablete CABOMETYX 60 mg filmsko obložene tablete kabozantinib
General disorders and administration site conditions fatigue, mucosal inflammation, asthenia, peripheral oedema
Splošne težave in spremembe na mestu aplikacije utrujenost, vnetje sluznice, astenija, periferni edem
• Decrease in bile flow from the liver
• zmanjšanje pretoka žolča iz jeter
Cabozantinib treatment should be discontinued in patients with RPLS.
Pri bolnikih z RPLS je treba zdravljenje s kabozantinibom prekiniti.
Hepatic encephalopathy
Jetrna encefalopatija
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
CABOMETYX 20 mg filmsko obložene tablete CABOMETYX 40 mg filmsko obložene tablete CABOMETYX 60 mg filmsko obložene tablete
No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Pri sočasni uporabi zdravil, ki spreminjajo vrednost pH v želodcu (tj. zaviralci protonske črpalke, antagonisti receptorjev H2 in antacidi), odmerka kabozantiniba ni treba prilagajati.
Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
Ena filmsko obložena tableta vsebuje 46,61 mg laktoze.
Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Med zdravljenjem in še vsaj 4 mesece po koncu zdravljenja morajo tako bolniki in bolnice kot tudi njihovi partnerji uporabljati zanesljiv način kontracepcije.
Use caution when driving or using machines.
Vpliv na sposobnost upravljanja vozil in strojev Med vožnjo ali uporabo strojev bodite previdni.
Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Postopki loko-regionalne transarterialne embolizacije ali kemoinfuzije: 44 %.
In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), so o driski poročali pri 73 % bolnikov, ki so se zdravili s kabozantinibom (57/78); dogodki 3.-4. stopnje pri 10 % bolnikov.
CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Kabozantinib je substrat za CYP3A4.
• Increase in amylase levels in the blood
• zvišanje ravni amilaze v krvi
Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Preglednica 3: Povzetek izsledkov PFS po oceni neodvisne radiološke komisije pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (METEOR)
CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with “XL” on one side and “40” on the other side.
Zdravilo CABOMETYX 40 mg filmsko obložene tablete so rumene, trikotne, brez razdelilne zareze, identificirane z "XL" na eni strani in "40" na drugi strani tablete.
The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Pri bolnikih s hudo okvaro jeter farmakokinetike kabozantiniba niso vrednotili.
How CABOMETYX works
Kako deluje zdravilo CABOMETYX
Probability of Progression-Free Survival
Verjetnost preživetja brez napredovanja
No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
V študijah, izvedenih pri bolnikih s KLC (METEOR in CABOSUN), o primerih jetrne encefalopatije niso poročali.
CABOMETYX 60 mg film-coated tablets are yellow, oval shaped with no score, and identified with “XL” on one side and “60” on the other side.
Zdravilo CABOMETYX 60 mg filmsko obložene tablete so rumene, ovalne, brez razdelilne zareze, identificirane z "XL" na eni strani in "60" na drugi strani tablete.
Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant abnormalities (see Table 1).
Če pomembne nepravilnosti vztrajajo ali se ponavljajo, je treba presoditi o prekinitvi odmerjanja, zmanjšanju odmerka ali trajni ukinitvi zdravljenja s kabozantinibom (glejte preglednico 1).
Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
V kontroliranih kliničnih študijah pri bolnikih z medularnim rakom ščitnice so opazili zvišanje od izhodišča pri intervalu QT, popravljenem po Fridericiju (QTcF), za 10-15 ms na 29. dan (vendar ne na
In the study in RCC following prior VEGF-targeted therapy (METEOR), the incidence of severe haemorrhagic events (Grade ≥ 3) was 2.1% (7/331) in cabozantinib-treated RCC patients.
V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), je pojavnost dogodkov hude krvavitve (≥ 3. stopnje) pri bolnikih s KLC, zdravljenih s kabozantinibom, znašala 2,1 % (7/331).
A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Obrok z visoko vsebnostjo maščob je pri zdravih prostovoljcih, ki so dobili en peroralni odmerek 140 mg kabozantiniba, zmerno zvišal vrednosti Cmax in AUC (41 % oz. 57 %) v primerjavi s stanjem na tešče.
CABOMETYX 20 mg film-coated tablets
CABOMETYX 20 mg filmsko obložene tablete
The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
Tablete so rumene, okrogle brez razdelilne zareze, z vtisom "XL" na eni strani in "20" na drugi strani tablete.
Wound complications
Ledvična okvara