natgillin/translations-raw huggingface dataset:
In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
U ispitivanju prethodno neliječenog RCC-a (CABOSUN), GI perforacije zabilježene su u 2,6 % (2/78) bolesnika liječenih kabozantinibom.
• Increase in cholesterol levels in the blood
• Povišene razine kolesterola u krvi
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).
U liječenju hepatocelularnog karcinoma nakon prethodne sistemske terapije, doza je bila smanjena u 62 %, a doziranje prekinuto u 84 % bolesnika liječenih kabozantinibom u kliničkom ispitivanju (CELESTIAL).
• Symptoms including pain in the abdomen, nausea (feeling sick), vomiting, constipation, or fever.
• Simptomi koji uključuju bol u trbuhu, mučninu, povraćanje, zatvor ili vrućicu.
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.
Ispitanike je potrebno upozoriti u vezi uzimanja supstrata P-gp-a (npr. feksofenadina, aliskirena, ambrisentana, dabigatraneteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) za vrijeme primjene kabozantiniba.
• Decrease in bile flow from the liver
• Smanjeno istjecanje žuči iz jetre
Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Istodobna primjena kabozantiniba s jakim induktorom CYP3A4 rifampicinom dovela je do smanjenja plazmatske izloženosti kabozantinibu.
Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Klinički podaci za karcinom bubrežnih stanica nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF)
Stable disease Progressive Disease
Stabilna bolest
In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
U ispitivanju HCC-a (CELESTIAL), incidencija teških događaja krvarenja (stupnja ≥ 3) bila je 7,3 % u bolesnika liječenih kabozantinibom (34/467).
Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Prilikom primjene kabozantiniba zabilježeni su, ponekad smrtonosni, događaji venske tromboembolije, uključujući plućnu emboliju, te arterijsku tromboemboliju.
• Blisters, pain of the hands or soles of the feet, rash or redness of the skin
• Mjehuri, bolne šake ili tabani, osip ili crvenilo na koži
Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Prilikom primjene kabozantiniba zabilježen je sindrom palmarno-plantarne eritrodizestezije (PPES).
Probability of Progression-Free Survival
Vjerojatnost preživljenja bez progresije bolesti
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.
Najčešće nuspojave bilo kojeg stupnja (pojavile su se u najmanje 25 % bolesnika) u populaciji bolesnika s karcinomom bubrežnih stanica uključivale su proljev, sindrom palmarno-plantarne eritrodizestezije, umor, smanjen apetit, hipertenziju i mučninu.
Median time to onset was 4.9 weeks.
Medijan vremena do pojave bio je 4,9 tjedana.
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.
U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR) fistule su zabilježene u 1,2 % (4/331) bolesnika liječenih kabozantinibom i uključivale su analne fistule u 0,6 % (2/331) bolesnika liječenih kabozantinibom.
In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
U ispitivanju prethodno neliječenog RCC-a (CABOSUN), proljev je zabilježen u 73 % bolesnika liječenih kabozantinibom (57/78); događaji od 3. do 4. stupnja u 10 %.
How to take CABOMETYX
Kako uzimati CABOMETYX
Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant thromboembolic complication.
U bolesnika koji razviju akutni infarkt miokarda ili bilo koju drugu klinički značajnu tromboembolijsku komplikaciju, primjena kabozantiniba mora se prekinuti.
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-Meierova krivulja preživljenja bez progresije bolesti u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (prvih 375 randomiziranih ispitanika) (METEOR)
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%.
U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), proljev je zabilježen u 74 % bolesnika s RCC-om liječenih kabozantinibom (245/331); događaji od 3. do 4. stupnja u 11 %.
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.
U bolesnika liječenih kabozantinibom često su opažene abnormalnosti testova funkcije jetre (povećanja alanin aminotransferaze [ALT], aspartat aminotransferaze [AST] i bilirubina).
• Increase in blood triglyceride levels in the blood
• Povišenje razina triglicerida u krvi
Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
Tablica 5: Rezultati djelotvornosti u prethodno neliječenih ispitanika s RCC-om (ITT populacija, ispitivanje CABOSUN)
2D barcode carrying the unique identifier included.
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Ako je hipertenzija teška i perzistira unatoč primjeni antihipertenzivne terapije i smanjenju doze kabozantiniba, primjena kabozantiniba se mora prekinuti.
Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Slika 2: Kaplan-Meierova krivulja ukupnog preživljenja u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) (METEOR)
Al. Jana Pawła II 29 Selise 26-11,
Selise 26-11,
Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Krvožilni poremećaji hipertenzija, krvarenje venska tromboza, arterijska tromboza aneurizme i disekcije arterije
Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Prilikom primjene kabozantiniba zabilježene su ozbiljne, u nekim slučajevima i smrtonosne, gastrointestinalne (GI) perforacije i fistule.
Cabozantinib should not be administered to patients that have or are at risk for severe haemorrhage.
Kabozantinib se ne smije primjenjivati u bolesnika s teškim krvarenjem ili s rizikom od teškog krvarenja.
In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
U ispitivanju HCC-a (CELESTIAL), smrtonosno krvarenje prijavljeno je u višoj incidenciji u skupini koja je primala kabozantinib nego u skupini koja je primala placebo.
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).
U prethodno neliječenih bolesnika s karcinomom bubrežnih stanica, doza je bila smanjena u 46 %, a doziranje prekinuto u 73 % bolesnika liječenih kabozantinibom u kliničkom ispitivanju (CABOSUN).
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.
U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), GI perforacije zabilježene su u 0,9 % (3/331) bolesnika s RCC-om liječenih kabozantinibom.
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
CABOMETYX 20 mg filmom obložene tablete CABOMETYX 40 mg filmom obložene tablete CABOMETYX 60 mg filmom obložene tablete kabozantinib
Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
Jedna filmom obložena tableta sadrži 46,61 mg laktoze.
Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
pruritus, alopecija, suha koža, akneiformni dermatitis, promjena boje kose
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.
U ispitivanju RCC-a nakon prethodne terapije usmjerene na VEGF (METEOR), incidencija teških hemoragijskih događaja (≥ 3. stupanj) bila je 2,1 % (7/331) u bolesnika s RCC-om liječenih kabozantinibom.
Median time to onset of all events was 4.1 weeks.
Medijan vremena do pojave bio je 4,1 tjedan.
Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Objective Response Rate, ORR), koje procjenjuje ispitivač prema kriteriju RECIST (engl.
What CABOMETYX is
Što CABOMETYX sadrži
Patients with cardiac impairment
Bolesnici s oštećenjem funkcije srca
No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
U ispitivanjima RCC-a (METEOR i CABOSUN) nisu prijavljeni slučajevi hepatične encefalopatije.
• Changes in blood tests used to monitor general health and function of your organs (including the liver, and kidney), low levels of electrolytes (like magnesium, or potassium)
(uključujući jetru i bubrege), niske razine elektrolita (kao što su magnezij ili kalij)
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
CABOMETYX 20 mg filmom obložene tablete CABOMETYX 40 mg filmom obložene tablete CABOMETYX 60 mg filmom obložene tablete
Clinical data in treatment-naïve renal cell carcinoma
Klinički podaci za prethodno neliječeni karcinom bubrežnih stanica
Administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 31 days) to healthy volunteers increased cabozantinib clearance (4.3-fold) and decreased single-dose plasma cabozantinib exposure (AUC) by 77%.
Primjena jakog induktora CYP3A4 rifampicina (600 mg dnevno tijekom 31 dana) u zdravih dobrovoljaca izazvala je povećanje klirensa kabozantiniba (za 4,3 puta) te smanjenje plazmatske izloženosti kabozantinibu
The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
- Sadržaj tablete: mikrokristalična celuloza; bezvodna laktoza; hidroksipropilceluloza; umrežena karmelozanatrij; koloidni, bezvodni silicijev dioksid; magnezijev stearat (pogledajte dio 2 za sadržaj laktoze)
MARKETING AUTHORISATION NUMBER(S) Cabometyx 20 mg film-coated tablets
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CABOMETYX 20 mg filmom obložene tablete
CABOMETYX Placebo these therapies had to discontinue study treatment.
Ispitanici koji su primali te terapije morali su prekinuti liječenje.
You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished.
Za vrijeme uzimanja CABOMETYXA i najmanje 4 mjeseca nakon završetka liječenja trebate također koristiti i mehanička kontraceptivna sredstva (npr. kondom ili dijafragmu).
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.
CABOMETYX 40 mg filmom obložene tablete su žute, trokutastog oblika bez ureza, s oznakom “XL” s jedne strane i “40” s druge strane.
In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients.
U ispitivanju prethodno neliječenog RCC-a (CABOSUN), incidencija teških hemoragijskih događaja (≥3 stupnja) u bolesnika s RCC-om liječenih kabozantinibom iznosila je 5,1 % (4/78).
CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Induktori i inhibitori CYP3A4
• Increase in amylase levels in the blood
• Povišene razine amilaze u krvi
Method of administration CABOMETYX is for oral use.
CABOMETYX je namijenjen za peroralnu primjenu.
This syndrome should be considered in any patient presenting with multiple symptoms, including seizures, headache, visual disturbances, confusion or altered mental function.
glavobolju, poremećaje vida, konfuziju i promjenu mentalne funkcije.
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.
CABOMETYX 60 mg filmom obložene tablete su žute, ovalnog oblika bez ureza, s oznakom “XL” s jedne strane i “60” s druge strane.
CABOMETYX 20 mg film-coated tablets
CABOMETYX 20 mg filmom obložene tablete
Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
U sustavu za ispitivanje prolaska u oba smjera na MDCK-MDR1 stanicama kabozantinib se pokazao kao inhibitor (IC50 = 7,0 μM), ali ne i supstrat transportnog djelovanja P-glikoproteina (P-gp).
Excipient related warnings
Upozorenja povezana s pomoćnim tvarima
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Nositelj odobrenja za stavljanje lijeka u promet
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 su žute boje, okrugle bez ureza, s utisnutim “XL” s jedne strane i “20” s druge strane tablete.
Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Slika 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti u prethodno neliječenih ispitanika s RCC-om prema odboru za neovisnu radiološku procjenu
Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Tablica 3: Prikaz rezultata PFS-a u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (METEOR)
General disorders and administration site conditions fatigue, mucosal inflammation, asthenia, peripheral oedema
Opći poremećaji i reakcije na mjestu primjene umor, upala sluznice, astenija, periferni edem
Subjects receiving
MATERIJALA KOJI POTJEČU
• Haemorrhoids (piles)
• Upala gušterače
Centralpharma Communications OÜ Ipsen Poland Sp. z o.o.
Ipsen Poland Sp. z o.o. Al. Jana Pawła II 29
How to take CABOMETYX 4.
3. Kako uzimati CABOMETYX
Cabozantinib treatment should be discontinued in patients with RPLS.
U bolesnika s RPLS-om liječenje kabozantinibom se mora prekinuti.
Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Preživljenje bez progresije bolesti (PFS)3 Medijan PFS-a u mjesecima (95 % CI) 5,2 (4,0; 5,5) HR (95 % CI) 1 p-vrijednost1
CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
CABOMETYX 60 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 60 mg kabozantiniba.
Closer monitoring is advised in patients with mild or moderate hepatic impairment.
Preporučuje se pažljivo praćenje bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
CABOMETYX 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
U sustavu za ispitivanje prolaska u oba smjera na MDCK-MDR1 stanicama kabozantinib se pokazao kao inhibitor (IC50 = 7,0 μM), ali ne i supstrat transportnog djelovanja P-gp-a.
CABOMETYX 60 mg film-coated tablets
CABOMETYX 60 mg filmom obložene tablete
CABOMETYX 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
CABOMETYX 40 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
The tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet.
Tablete su žute boje, ovalnog oblika bez ureza, s utisnutim “XL” s jedne strane i “60” s druge strane tablete.
Fatal perforations have occurred in the cabozantinib clinical program.
U kliničkom programu primjene kabozantiniba bilo je pojave smrtonosnih perforacija.
The tablets are yellow triangle shaped with no score, and debossed with “XL” on one side and “40” on the other side of the tablet.
Tablete su žute boje, trokutastog oblika bez ureza, s utisnutim “XL” s jedne strane i “40” s druge strane tablete.
CABOMETYX 40 mg film-coated tablets
CABOMETYX 40 mg filmom obložene tablete
CABOMETYX 60 mg
16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 60 mg
Fatal haemorrhages have occurred in the cabozantinib clinical program.
U kliničkom programu primjene kabozantiniba bilo je pojave smrtonosnih fistula.
In the HCC study (CELESTIAL), hepatic encephalopathy was reported more frequently in the cabozantinib than the placebo arm. Cabozantinib has been associated with diarrhoea, vomiting, decreased appetite and electrolyte abnormalities.
U ispitivanju HCC-a (CELESTIAL), hepatična encefalopatija prijavljena je češće u skupini koja je primala kabozantinib nego u skupini koja je primala placebo.
CABOMETYX 20 mg
16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 20 mg
NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
NAZIV LIJEKA CABOMETYX 20 mg filmom obložene tablete kabozantinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib
NAZIV LIJEKA CABOMETYX 20 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
• Increase in lipase levels in the blood
• Povišene razine lipaze u krvi
Film-coated tablet 28 film-coated tablets 30 film-coated tablets
OBLIK I SADRŽAJ Filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta
Bucureşti, 010623
Bucureşti, 010623 Tel: + 40 (021) 231 27 20
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
Jedna filmom obložena tableta sadrži kabozantinib (S)-malat u količini koja odgovara 60 mg kabozantiniba.
NAME OF THE MEDICINAL PRODUCT CABOMETYX 60 mg film-coated tablets cabozantinib
NAZIV LIJEKA CABOMETYX 60 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
CABOMETYX 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
CABOMETYX 20 mg filmom obložene tablete: jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
Overall Survival Median OS in months (95% CI)
Ukupno preživljenje (OS) Medijan OS-a (95% CI), mjeseci
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
Tablica 4: Prikaz rezultata ORR-a u ispitanika s RCC-om nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) prema odboru za neovisnu radiološku procjenu (engl.
Progression-free survival (PFS) by Investigator Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0042
Preživljenje bez progresije bolesti (PFS) prema ispitivaču Medijan PFS-a (95% CI), mjeseci HR (95% CI); stratificirani b,c
Progression-free survival (PFS) by IRC a Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0005
Preživljenje bez progresije bolesti (PFS) prema IRC-u a Medijan PFS-a (95% CI), mjeseci HR (95% CI); stratificiran b,c
NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib
NAZIV LIJEKA CABOMETYX 40 mg filmom obložene tablete kabozantinib NAZIV NOSITELJA
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
NAZIV LIJEKA CABOMETYX 40 mg filmom obložene tablete kabozantinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži kabozantinib (S)-malat u količini koja odgovara 40 mg kabozantiniba.
• Increase in level of potassium in the blood
• Povišena razina kalija u krvi
CABOMETYX 40 mg
16. PODACI NA BRAILLEOVOM PISMU CABOMETYX 40 mg
• Bone damage in the jaw
• Oštećenje kosti čeljusti
España
Francuska
CABOMETYX Placebo
CABOMETYX
• Swelling in your legs and arms
• Oticanje ruku i nogu
Hepatic encephalopathy hepatitis cholestatic
Poremećaji jetre i žuči hepatična encefalopatija kolestatski hepatitis
Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Kada se PPES povuče do 1. stupnja, primjena kabozantiniba mora se nastaviti sa smanjenom dozom.
Cabozantinib should be discontinued in patients who experience a GI perforation or a fistula that cannot be adequately managed.
U bolesnika u kojih se pojavi GI perforacija ili fistula koja se ne može odgovarajuće zbrinuti mora se prekinuti primjena kabozantiniba.
Endpoint
Placebo
Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
U bolesnika u kojih se razvije nefrotski sindrom primjena kabozantiniba se mora prekinuti.
STATEMENT OF ACTIVE SUBSTANCE(S)
Populacija s namjerom liječenja (ITT)
(see section 2 for lactose content) - Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172) What CABOMETYX looks like and contents of the pack CABOMETYX 20 mg film-coated tablets are yellow, round with no score, and identified with “XL” on one side and “20” on the other side.
- Film-ovojnica: hipromeloza; titanijev dioksid (E171); triacetin; željezov oksid, žuti (E172)
Member State EU/EEA
Država Članica EU/EEA
ATCvet code: QJ01MA90.
ATCvet kod: QJ01MA90.
The main areas of disharmony in the existing product information relate to:
Glavna područja neusuglašenosti u postojećim informacijama za proizvod su:
Bayer BV Energieweg 1
Nizozemska Bayer BV Energieweg 1
Discussion of data available
Razmatranje dostupnih podataka
Do not eat, drink or smoke whilst handling the product.
Ne jesti, piti ili pušiti tijekom rukovanja s VMP-om.
Do not use in cats less than 8 weeks of age.
Ne primjenjivati mačkama mlađim od 8 tjedana.