natgillin/translations-raw huggingface dataset:
A significant improvement in OS was observed in the subgroup of RET M918T mutation positive patients (n=81/219 cabozantinib arm): 44.3 months in the cabozantinib arm vs. 18.9 months in the placebo arm (HR = 0.60, p = 0.0255).
Značilno izboljšanje OS so opazili za podskupino RET M918T pri bolnikih s pozitivnimi mutacijami (n = 81/219 krak s kabozantinibom): 44,3 meseca v kraku s kabozantinibom oz. 18,9 meseca v kraku s placebom ((HR = 0,60; p = 0,0255).
Concomitant treatment with strong CYP3A4 inhibitors, which may increase cabozantinib plasma concentrations, should be used with caution.
Pri sočasnem zdravljenju z močnimi zaviralci CYP3A4, ki lahko povečajo koncentracije kabozantiniba v plazmi, je potrebna previdnost.
Cardiac disorders atrial fibrillation angina pectoris, supraventricular tachycardia myocardial infarction
Srčne bolezni atrijska fibrilacija angina pektoris, supraventrikularna tahikardija miokardni infarkt
Probability amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Verjetnost manjša od < 1 % ciljne učinkovitosti izhodiščnega kabozantiniba, vsak predstavljata < 10 % skupne z zdravilom povezane izpostavljenosti v plazmi.
Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Kabozantinib je treba pri bolnikih, pri katerih obstaja tveganje ali imajo te dogodke v anamnezi, uporabljati previdno.
Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westboughton, Bolton, Lancashire, BL5 3XX, United Kingdom
Ime in naslov izdelovalca, odgovornega za sproščanje serij Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton,
Taking COMETRIQ with food
Zdravilo COMETRIQ skupaj s hrano
Therefore, cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Zato kabozantinib morda lahko poveča koncentracije sočasno uporabljenih substratov P-gp v plazmi.
Results from a study in patients with hepatic impairment indicate that exposure (AUC0-inf) increased by 81% and 63% in subjects with mild and moderate hepatic impairment, respectively (90% CI for AUC0-inf: 121.44% to 270.34% for mild and 107.37% to 246.67% for moderate).
Rezultati študije pri bolnikih z okvaro jeter kažejo, da se je izpostavljenost (AUC0-inf) povečala za 81 % oz. 63 % pri osebah z blago oz. zmerno jetrno okvaro (90-% IZ za AUC0-inf: 121,44 % do 270,34 % za blago in 107,37 % do 246,67 % za zmerno).
Therefore chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Zato se je treba kronični sočasni uporabi kabozantiniba in učinkovin, ki so močni induktorji CYP3A4, izogniti (glejte poglavji 4.2 in 4.5).
There are no studies in pregnant women using cabozantinib.
Študij pri nosečnicah, ki bi uporabljale kabozantinib, niso izvedli.
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, ki jemljejo kabozantinib, je treba opozoriti na uporabo substratov P-gp (npr. feksofenadina, aliskirena, ambrisentana, dabigatran eteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana).
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Razmisliti je treba o sočasni uporabi alternativnih zdravil, ki CYP3A4 ne inducirajo in ne zavirajo ali pa inducirajo in zavirajo le neznatno.
In case of hypertensive crisis, cabozantinib should be discontinued.
V primeru hipertenzijske krize je treba zdravljenje s kabozantinibom prekiniti.
Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
Uporaba kabozantiniba se ne priporoča pri bolnikih s hudo ledvično okvaro, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
• Inflammation of the lips and corners of the mouth
• vnetje ustnic in ustnih kotičkov
Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Sočasno dajanje zaviralca protonske črpalke esomeprazola (40 mg na dan za 6 dni), z enkratnim odmerkom 100 mg kabozantiniba, zdravim prostovoljcem ni povzročila klinično značilnih učinkov na izpostavljenost kabozantinibu v plazmi (AUC).
In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
V primeru suma na prevelik odmerek je treba zdravljenje s kabozantinibom ustaviti in uvesti podporno zdravljenje.
Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Dajanje močnega zaviralca CYP3A4 ketokonazola (400 mg na dan 27 dni) zdravim prostovoljcem je povzročila zmanjšan očistek kabozantiniba (za 29 %) in povečano izpostavljenost kabozantinibu v plazmi po enem odmerku (AUC) za 38 %.
The result of the PFS analysis, based on the central review RECIST assessment, demonstrated a statistically significant difference in the duration of PFS with cabozantinib versus placebo: the median duration was 11.2 months for subjects in the cabozantinib arm versus 4.0 months for subjects in the placebo arm (stratified Hazard Ratio [HR] = 0.28; 95% CI: 0.19, 0.40; p<0.0001; Figure 1).
Rezultat analize PFS na podlagi ocene centralnega pregleda RECIST je pokazal statistično značilno razliko v trajanju PFS s kabozantinibom v primerjavi s placebom: mediana trajanja je bila 11,2 meseca za osebe v kraku s kabozantinibom v primerjavi s 4,0 meseci za osebe v kraku s placebom (stratificirano razmerje tveganj [HR, hazard ratio] = 0,28; 95-% IZ: 0,19; 0,40; p < 0,0001; slika 1).
• Inflammation in the eye, cataracts
• vnetje očesa, katarakte
• Fatigue, weakness, headache, dizziness
• utrujenost, šibkost, glavobol, omotičnost
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of COMETRIQ therapy.
Pri obravnavanju suma na neželene reakcije na zdravilo bo morda treba zdravljenje z zdravilom COMETRIQ začasno prekiniti in/ali zmanjšati odmerek.
You should not eat anything for at least 2 hours before taking COMETRIQ and for 1 hour after taking the medicine.
Vsaj 2 uri, preden vzamete odmerek zdravila COMETRIQ, in 1 uro po uporabi tega zdravila ne smete ničesar jesti.
The most frequent adverse reactions of any grade (experienced by at least 20% of patients) included diarrhoea, PPES, weight decreased, decreased appetite, nausea, fatigue, dysgeusia, hair colour changes, hypertension, stomatitis, constipation, vomiting, mucosal inflammation, asthenia, and dysphonia.
Najpogostejši neželeni učinki katere koli stopnje (pojavili so se pri vsaj 20 % bolnikov) vključujejo drisko, PPES, zmanjšanje telesne mase, zmanjšanje apetita, navzeo, utrujenost, disgevzijo, spremembe v barvi las, hipertenzijo, stomatitis, konstipacijo, bruhanje, vnetje sluznice, astenijo in disfonijo.
- have had surgery within the last month (or if surgical procedures are planned), including dental procedures - have had radiotherapy in the last 3 months - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis or diverticulitis) - have been told that your cancer has spread to your airway or oesophagus - have a recent history of blood clot in the leg, stroke, or heart attack - are taking medicines to control your heart rhythm, have a slow heart rate, have problems with your heart or have problems with the levels of calcium, potassium or magnesium in your blood - have severe liver or kidney disease.
- ste bili v zadnjih 3 mesecih obsevani, - imate vnetno bolezen črevesja (na primer Crohnovo bolezen ali ulcerozni kolitis ali divertikulitis), - so vam povedali, da se je vaš rak razširil na dihala ali požiralnik, - ste pred kratkim imeli krvni strdek v nogi, možgansko kap ali srčni infarkt, - jemljete zdravila za nadzor srčnega ritma, imate počasen srčni utrip, težave s srcem ali težave z ravnmi kalcija, kalija ali magnezija v krvi, - imate hudo jetrno ali ledvično bolezen.
• Skin ulcers, cysts, red spots on the face or thighs
• kožne razjede, ciste, rdeče pike na obrazu ali stegnih
However, a trend in increased rate of SAEs has been observed in subjects aged 75 years and older.
Vendar pa so pri osebah, starih 75 let in več, opazili težnjo k večji pogostnosti resnih neželenih učinkov.
Cabozantinib exhibited dose-related tumour growth inhibition, tumor regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Kabozantinib kaže od odmerka odvisno zaviranje rasti tumorja, regresijo tumorja in/ali zaviranje metastaz v številnih predkliničnih tumorskih modelih.
What COMETRIQ looks like and contents of the pack COMETRIQ 20 mg capsules are grey and have “XL184 20mg” printed on one side.
Izgled zdravila COMETRIQ in vsebina pakiranja COMETRIQ 20 mg kapsule so sive in imajo na eni strani napis "XL184 20mg".
If there are still 12 hours or more before your next dose is due then take the missed dose as soon as you remember.
Če ste pozabili vzeti zdravilo COMETRIQ Če je do naslednjega odmerka še 12 ur ali več, vzemite izpuščeni odmerek takoj, ko se spomnite.
COMETRIQ 80 mg capsules are orange and have “XL184 80mg” printed on one side.
COMETRIQ 80 mg kapsule so oranžne in imajo na eni strani napis "XL184 80mg".
Results from a study in patients with renal impairment indicate that the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function.
Rezultati študij pri bolnikih z okvaro ledvic kažejo, da so razmerja geometričnega povprečja LS za kabozantinib v plazmi, Cmax in AUC0-inf, za 19 % oz. 30 % višje za osebe z blago okvaro ledvic (90-% IZ za Cmax 91,60 % do 155,51 %; AUC0-inf 98,79 % do 171,26 %) ter 2 % oz. 6 do 7 % višje (90-% IZ za Cmax 78,64 % do 133,52 %; AUC0-inf 79,61 % do 140,11 %), za osebe z zmerno okvaro ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
Blister cards containing either:
Pretisna zgibanka, ki vsebuje bodisi:
Further, hypospermatogenesis was observe in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Nadalje so pri pasjih samcih pri ravneh izpostavljenosti, nižjih, kot so ravni klinične izpostavljenosti pri človeki pri nameravanemu terapevtskemu odmerku, opazili hipospermatogenezo.
Patients who have had recent radiotherapy, have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, or diverticulitis), have tumour infiltration of trachea, bronchi, or oesophagus, have complications from prior GI surgery (particularly when associated with delayed or incomplete healing), or have complications from prior radiation therapy to the thoracic cavity (including mediastinum) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas.
Bolnike, ki so jih pred kratkim obsevali, imajo vnetno bolezen črevesja (npr. Crohnovo bolezen, ulcerozni kolitis, peritonitis ali divertikulitis), ki imajo tumorsko infiltracijo sapnika, sapnic ali požiralnika, ki so imeli pred gastrointestinalnim posegom zaplete (zlasti v povezavi s poznim ali nepopolnim celjenjem), ali ki imajo zaplete zaradi predhodnega obsevanja prsne votline (vključno z mediastinumom), je treba pred uvedbo zdravljenja s kabozantinibom skrbno oceniti, nato pa natančno spremljati glede pojava simptomov perforacij in fistul.
Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmarplantar erythrodysaesthesia syndrome (PPES), and gastrointestinal (GI) events (abdominal or mouth pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Dogodki, ki se običajno pojavijo zgodaj, vključujejo hipokalciemijo, hipokaliemijo, trombocitopenijo, hipertenzijo, sindrom palmarno-plantarne eritrodisestezije (PPES, palmar-plantar erythrodysaesthesia syndrome) in gastrointestinalni (GI) dogodki (bolečine v trebuhu ali ustih, vnetje sluznice, zaprtje, driska, bruhanje).
When dose reduction is necessary, it is recommended to reduce to 100 mg daily, taken as one 80 mg orange capsule and one 20 mg grey capsule, and then to 60 mg daily, taken as three 20 mg grey capsules.
Če je treba odmerek zmanjšati, se priporoča zmanjšanje na 100 mg na dan in jemanje ene 80 mg oranžne kapsule in ene 20 mg sive kapsule, nato pa 60 mg na dan, v obliki treh 20 mg sivih kapsul.
The most common laboratory abnormalities were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), lymphopenia, hypocalcaemia, neutropenia, thrombocytopenia, hypophosphataemia, hyperbilirubinemia, hypomagnesaemia, and hypokalaemia.
Najpogostejše laboratorijske nenormalnosti so bile zvišanje ravni aspartat-aminotransferaze (AST), zvišanje ravni alanin-aminotransferaze (ALT), zvišanje ravni alkalne fosfataze (ALP), limfopenija, hipokalciemija, nevtropenija, trombocitopenija, hipofosfatemija, hiperbilirubinemija, hipomagneziemija in hipokaliemija.
• Liver damage, kidney failure
• poškodovanje jeter, odpoved ledvic
dabigatran etexilate, digoxin, talinolol, and tolvaptan - Medicines for diabetes, such as saxagliptin and sitagliptin - Medicines used to treat gout, such as colchicine - Medicines used to treat HIV or AIDS, such as ritonavir, maraviroc and emtricitabine - Medicines used to treat viral infections such as efavirenz - Medicines used to prevent transplant rejection (cyclosporine) and cyclosporine-based regimens in rheumatoid arthritis and psoriasis
ambrisentan, dabigatran eteksilat, digoksin, talinolol in tolvaptan - Zdravila za zdravljenje sladkorne bolezni, kot sta saksagliptin in sitagliptin - Zdravila za zdravljenje protina, kot je kolhicin - Zdravila za zdravljenje okužbe z virusom HIV ali AIDS-a, kot so ritonavir, maravirok in emtricitabin - Zdravila za zdravljenje virusnih okužb, kot je efavirenz - Zdravila za preprečevanje zavrnitve presadka (ciklosporin) in režimi na osnovi ciklosporina pri revmatoidnem artritisu in luskavici
- Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin, and rifampicin - Allergy medicines such as fexofenadine and ranolazine - Steroids used to reduce inflammation or treat a number of different diseases of the immune system - 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, ambrisentan,
- 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 sta feksofenadin in ranolazin - Steroidi, ki se uporabljajo za zmanjšanje vnetja ali zdravljenje številnih različnih bolezni imunskega sistema - 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,
The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80 mg orange capsule and three 20 mg grey capsules.
Priporočeni odmerek zdravila COMETRIQ je 140 mg enkrat na dan, ki se jemlje kot ena 80 mg oranžna kapsula in tri 20 mg sive kapsule.
How to store COMETRIQ 6.
Shranjevanje zdravila COMETRIQ 6.
In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Pri podganah je kabozantinib povzročil izgubo po vsaditvi, edeme ploda, razcepljeno nebo/zajčjo ustnico, dermalno aplazijo in upognjen ali nerazvit rep.
An oral examination should be performed prior to initiation of cabozantinib and periodically during cabozantinib therapy.
Pred uvedbo kabozantiniba je treba opraviti pregled ustne votline, ki ga je treba v času zdravljenja s kabozantinibom periodično ponavljati.
Cabozantinib is not recommended for use in patients with severe hepatic impairment as safety and efficacy have not been established in this population.
Uporaba kabozantiniba se ne priporoča pri bolnikih s hudo jetrno okvaro, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
Serious GI perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib.
Pri uporabi kabozantiniba so opazili resne gastrointestinalne perforacije in fistule, ki so včasih bile smrtne, ter intraabdominalne abscese.
• Swelling, pain in your hands and feet, or shortness of breath.
• oteklina, bolečina v dlaneh in stopalih ali kratka sapa.
Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Z uporabo kabozantiniba so povezani neželeni učinki, kot sta utrujenost in šibkost.
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%.
Dajanje močnega induktorja CYP3A4 rifampicina (600 mg na dan 31 dni) zdravim prostovoljcem je povzročila povečan očistek kabozantiniba (za 4,3-krat) in zmanjšano izpostavljenost kabozantinibu v plazmi po enem odmerku (AUC) za 77 %.
Cabozantinib was metabolized in vivo.
Kabozantinib se in vivo presnavlja.
Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Zato je pri sočasni uporabi močnih zaviralcev CYP3A4 (npr. ritonavirja, itrakonazola, eritromicina, klaritromicina, soka grenivke) s kabozantinibom potrebna previdnost.
Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
Infekcijske in parazitske bolezni absces (vključno z visceralnim, kožnim, zobnim), pljučnica, folikulitis, glivična okužba (vključno s kožno, oralno, genitalno)
one orange 80 mg + one grey 20 mg
ena oranžna 80 mg + ena siva 20 mg
The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule.
Trde kapsule so sive s črnim napisom "XL184 20mg" na telesu kapsule.
• 140 mg (1 orange 80 mg capsule and 3 grey 20 mg capsules)
• 140 mg (1 oranžna 80 mg kapsula in 3 sive 20 mg kapsule)
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES) has been observed with cabozantinib.
Sindrom reverzibilne posteriorne levkoencefalopatije Pri uporabi kabozantiniba so opazili sindrom reverzibilne posteriorne levkoencefalopatije (RPLS, Reversible Posterior Leukoencephalopathy Syndrome), znan tudi kot sindrom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome).
• Abscess (collection of pus, with swelling and inflammation) in the abdomen or pelvis area or in your teeth/gums
• abscesi (kopičenje gnoja z oteklostjo in vnetjem) v trebuhu ali predelu medenice ali zobeh/dlesnih
Package leaflet inside pouch.
Navodilo za uporabo je znotraj zgibanke.
The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension.
Najbolj pogosti resni neželeni učinki, povezani s kabozantinibom, so pljučnica, vnetje sluznice, hipokalciemija, disfagija, dehidracija, pljučna embolija in hipertenzija.
• Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
• zmanjšana aktivnost ščitnice; simptomi lahko vključujejo: utrujenost, zvišanje telesne mase,
A replacement sample will be requested if an original sample fails during the PCR quality or the Sanger sequencing tests.
Če izvirni vzorec ne bo ustrezen za test kakovosti po PCR ali določanje zaporedja po Sangerju, bo pridobljen nadomestni vzorec.
Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Zato lahko dajanje zaviralcev MRP2 povzroči povečanje koncentracije kabozantiniba v plazmi.
Metabolism and nutrition disorders decreased appetite, hypocalcaemia, hypophosphataemia, hyperbilirubinemia, hypokalaemia, hypomagnesaemia dehydration, hypoalbuminaemia
Presnovne in prehranske motnje zmanjšan apetit, hipokalciemija, hipofosfatemija, hiperbilirubinemija, hipokaliemija, hipomagneziemija dehidracija, hipoalbuminemija
The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Trde kapsule so oranžne s črnim napisom "XL184 80mg" na telesu kapsule.
Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Dajanje zaviralcev MRP2 lahko povzroči povečanje koncentracij kabozantiniba v plazmi.
CYP3A4 inducers and inhibitors
Zaviralci in induktorji CYP3A4
Ear and labyrinth disorders ear pain, tinnitus hypoacusis
Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesih, tinitus hipoakuzija
• 100 mg (1 orange 80 mg capsule and 1 grey 20 mg capsule)
• 100 mg (1 oranžna 80 mg kapsula in 1 sive 20 mg kapsula)
Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Kronični sočasni uporabi močnih induktorjev CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, fenobarbitala ali pripravkov zeliščnega izvora iz šentjanževke [Hypericum perforatum]) s kabozantinibom se je treba zato izogniti.
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 cancer patients.
V kontroliranih kliničnih študijah pri bolnikih z rakom so opazili zvišanje glede na izhodišče popravljenega intervala QT z metodo po Fridericiju (QTcF) 10 -15 ms na 29. dan (vendar ne na 1. dan) po uvedbi zdravljenja s kabozantinibom (odmerek 140 mg enkrat na dan).
• Chills, tremors
• mrzlica, tresenje
There is a possibility your fertility could be affected by treatment with COMETRIQ.
Obstaja možnost, da bo zdravilo COMETRIQ vplivalo na vašo plodnost.
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
• bolečine v ustih, zobeh in/ali čeljustih, oteklost ali razjede v ustih, omrtvelost ali občutek teže v čeljustih ali zrahljanje zoba.