natgillin/translations-raw huggingface dataset:
Hos rotte og hund i gentaget-dosis toksicitetsstudier op til 6 måneders varighed, var målorganer for toksicitet mave-tarmkanalen, lymfevæv, nyre-, binyre- og reproduktionsvejs-væv.
In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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.
Sort jernoxid (E172) (kun 20 mg kapsler) Rød jernoxid (E172) (kun 80 mg kapsler) Titandioxid (E171)
Black iron oxide (E172) (20 mg capsules only) Red iron oxide (E172) (80 mg capsules only) Titanium dioxide (E171)
Proteinbindingen var ikke ændret hos forsøgspersoner med let til moderat nedsat nyre- eller leverfunktion.
Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Juvenile rotter (sammenlignelig med en >2 år gammel pædiatrisk population), der fik cabozantinib, udviste øgede WBC-parametre, nedsat hæmatopoiese, pubertetsalder/umodent kvindeligt reproduktionssystem (uden forsinket vaginal åbning), abnormaliteter af tænderne, reduceret mineralindhold og densitet af knoglerne, leverpigmentering og hyperplasi af galdeveje.
Juvenile rats (comparable to a >2 year old pediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and bile duct hyperplasia.
• Hudsår, cyster, røde pletter i ansigtet eller på lårene
• Skin ulcers, cysts, red spots on the face or thighs
Derfor skal samtidig anvendelse af MRP2-hæmmere (f.eks. ciclosporin, efavirenz, emtricitabin) ske med forsigtighed.
Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution.
• Nedsat appetit, vægttab, ændret smagsans
• Decreased appetite, weight loss, altered sense of taste
Cabozantinib udviste dosis-relateret hæmning af tumorvækst, tumor regression og/eller hæmmede metastase i en lang række præ-kliniske tumormodeller.
Cabozantinib exhibited dose-related tumour growth inhibition, tumor regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
cabozantinib hos raske frivillige, blev cirka 81 % af den totalt administrerede radioaktivitet genfundet med 54 % i fæces og 27 % i urin.
Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
11,2 måneder
11.2 months
• Blodpropper i venerne og i lungerne
• Blood clots in the veins and the lungs
Cabozantinib bør seponeres hos patienter, der udvikler nefrotisk syndrom.
Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Sådan skal du tage COMETRIQ 4.
How to take COMETRIQ 4.
• Infektion og inflammation i lungen, kollaps af lunge
• Infection and inflammation in the lung, collapse of lung
Cabozantinib bør ikke gives til patienter med alvorlig hæmoragi eller nylig hæmoptyse.
Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis.
Samtidig behandling med potente CYP3A4-hæmmere, der kan øge plasmakoncentrationerne af cabozantinib, bør anvendes med forsigtighed.
Concomitant treatment with strong CYP3A4 inhibitors, which may increase cabozantinib plasma concentrations, should be used with caution.
Patienter bør advares mod at tage et P-gp substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatran etexilat, digoxin, colchicin, maraviroc, posaconazol, ranolazin, saxagliptin, sitagliptin, talinolol, tolvaptan), mens de får cabozantinib.
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.
Et måltid med højt fedtindhold øgede moderat Cmax - og AUC-værdier (henholdsvis 41 % og 57 %) relativt til fastende tilstande hos raske frivillige, der fik en enkelt 140 mg oral cabozantinib dosis.
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.
Cabozantinib bør seponeres hos patienter med sårhelingskomplikationer, der kræver medicinsk intervention.
Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
COMETRIQ er indiceret til behandling af voksne patienter med progressiv, inoperable, lokal fremskreden eller metastatisk thyroideacarcinom.
COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
Resultatet af PFS-analysen, baseret på den centrale gennemgang RECIST vurdering, påviste en statistisk signifikant forskel i varigheden af PFS med cabozantinib versus placebo: Median varigheden var 11,2 måneder for forsøgspersoner i cabozantinib-armen versus 4,0 måneder for forsøgspersoner i placebo-armen (stratifieret fareratio [HR] = 0,28; 95 % CI: 0,19, 0,40; p<0,0001; Figur 1).
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).
COMETRIQ bør ikke tages sammen med mad.
COMETRIQ should not be taken with food.
Patienter med svært nedsat leverfunktion er ikke blevet undersøgt.
Patients with severe renal impairment have not been studied.
Ved invasive dentale indgreb bør behandling med cabozantinib om muligt stoppes mindst 28 dage forud for den planlagte operation.
For invasive dental procedures, cabozantinib treatment should be held at least 28 days prior to scheduled surgery, if possible.
• Inflammation af abdomen eller bugspytkirtlen
• Inflammation of the abdomen or pancreas
Øre og labyrint ørepine, tinnitus hypoacusis
Ear and labyrinth disorders ear pain, tinnitus hypoacusis
En signifikant forbedring i OS blev observeret i undergruppen af RET-M918T-mutationspositive patienter (n=81/219 i cabozantinib-armen): 44,3 måneder i cabozantinib-armen vs. 18,9 måneder i placebo-armen (HR = 0,60; p = 0,0255).
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).
NOAEL for embryo-føtal toksicitet og teratogene fund var under humane kliniske eksponeringsniveauer ved den tilsigtede terapeutiske dosis.
NOAEL for embryo-foetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
14,6 måneder
14.6 months
Aktivt stof: cabozantinib (S)-malat.
The active substance is cabozantinib (S)-malate.
Patienter med nedsat hjertefunktion
Patients with cardiac impairment
Niveauet uden observerede bivirkninger (NOAEL) for disse fund var under humane kliniske eksponeringsniveauer ved den tilsigtede terapeutiske dosis.
The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Dosisjustering er ikke nødvendig, når midler til modificering af gastrisk pH (dvs. PPI'er, H2-receptorantagonister og antacida) administreres sammen med cabozantinib.
No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
26,6 måneder
26.6 months
Cabozantinib bør anvendes med forsigtighed hos patienter med risiko for, eller som har en anamnese, for disse bivirkninger.
Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Patienter, som for nylig har fået strålebehandling, har inflammatorisk tarmsygdom (f.eks. Crohn's sygdom, ulcerativ colitis, peritonitis eller diverticulitis), har tumorinfiltration af trachea, bronkierne eller øsofagus, har komplikationer fra tidligere GI-kirurgi (især i forbindelse med forsinket eller ufuldstændig opheling) eller har komplikationer fra tidligere strålebehandling af thorakshulen (inklusive mediastinum), bør omhyggeligt evalueres inden indledning af behandling med cabozantinib, og de bør efterfølgende monitoreres tæt for symptomer på perforationer og fistler.
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.
Der var fire metaboliter tilstede i plasma ved eksponeringer (AUC) større end 10 % af moderstoffet: XL184-N-oxid, XL184 amid spaltningsprodukt, XL184 monohydroxysulfat og 6-desmethylamid spaltningsprodukt sulfat.
Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
• Brystsmerter, som skyldes blokeringer i arterierne, hurtig hjertefrekvens
• Chest pain due to blockage in arteries, rapid heartbeat
• Krampeanfald, hovedpiner, konfusion eller problemer med at koncentrere sig.
• Seizures, headaches, confusion, or finding it difficult to concentrate.
Den endelige analyse af OS blev gennemført, efter at 218 hændelser (dødsfald) var forekommet og viser en tendens til en øgning i median overlevelse på 5,5 måneder i cabozantinib-armen: Median (måneder) 26,6 for cabozantinib vs. 21,1 for placebo (HR = 0,85 [95 % CI: 0,64-1,12], p = 0,2409).
The final analysis of OS was conducted after 218 events (deaths) occurred and shows a trend for an increase in median survival of 5.5 months in the cabozantinib arm: median (months) 26.6 cabozantinib vs. 21.1 placebo (HR = 0.85 [95% CI: 0.64, 1.12], p = 0.2409).
Dette kunne være tegn på knoglebeskadigelse af kæben (osteonekrose).
These could be signs of bone damage in the jaw (osteonecrosis).
Infektioner og parasitære sygdomme absces (inklusive visceral, hud, tand), pneumoni, folliculitis, svampeinfektion (inklusive hud, oral, genital)
Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
hovedpine, konfusion, eller besvær med at koncentrere sig
confusion, or finding it difficult to concentrate
Cabozantinib bør anvendes med forsigtighed hos patienter med let eller moderat nedsat nyrefunktion.
Cabozantinib should be used with caution in patients with mild or moderate renal impairment.
Ydermere blev der observeret hypospermatogenese hos hanhunde ved eksponeringsniveauer under det kliniske eksponeringsniveau ved den tilsigtede terapeutiske dosis til mennesker.
Further, hypospermatogenesis was observe in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Behandling med cabozantinib bør seponeres hos patienter med RPLS.
Cabozantinib treatment should be discontinued in patients with RPLS.
Administration af protonpumpe-hæmmeren (PPI) esomeprazol (40 mg daglig i 6 dage) sammen med en enkelt dosis 100 mg cabozantinib til raske frivillige resulterede ikke i nogen klinisk signifikant effekt på cabozantinibs plasmaeksponering (AUC).
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).
COMETRIQ 80 mg kapsler er orange og har “XL184 80mg” trykt på den ene side.
COMETRIQ 80 mg capsules are orange and have “XL184 80mg” printed on one side.
Brug af COMETRIQ sammen med mad
Taking COMETRIQ with food
INFORMATION I BRAILLESKRIFT COMETRIQ 20 mg
INFORMATION IN BRAILLE COMETRIQ 20 mg
Metabolisme og ernæring nedsat appetit, hypokalcæmi, hypofosfatæmi, hyperbilirubinæmi, hypokaliæmi, hypomagnesiæmi dehydrering, hypoalbuminæni
Metabolism and nutrition disorders decreased appetite, hypocalcaemia, hypophosphataemia, hyperbilirubinemia, hypokalaemia, hypomagnesaemia dehydration, hypoalbuminaemia
HR: 0,85 (0,64-1,12) p = 0,2409
21.1 months HR: 0.85 (0.64, 1.12) p = 0.2409
Cabozantinib var en hæmmer (IC50 = 7,0 μM), men ikke et substrat, af P-gp transportaktiviteter i et torettet assay-system, der anvender MDCK-MDR1 celler.
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.
De mest almindelige laboratorieabnormaliteter var øget aspartat aminotransferase (ASAT), øget alanin aminotransferase (ALAT), øget alkalisk fosfatase (ALP), lymfopeni, hypokalcæmi, neutropeni, thrombocytopeni, hypofosfatæmi, hyperbililirubinæmi, hypomagnesiæmi og hypokaliæmi.
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.
PFSresultaterne var konsistente på tværs af alle evaluerede baseline og demografiske undergrupper, inklusive forudgående behandling med tyrosinkinase-hæmmere (der kan have bestået af midler målrettet mod veje forbundet med anti-angiogenese), RET-mutationsstatus (inklusive forsøgspersoner dokumenteret ikke at have RET-mutationer), forudgående anticancer- eller strålebehandlingsstatus eller eksistensen af knogle-metastaser.
The PFS results were consistent across all baseline and demographic subgroups evaluated, including prior therapy with tyrosine kinase inhibitors (which may have consisted of agents targeting pathways associated with anti-angiogenesis), RET mutational status (including subjects documented not to have RET mutations), prior anticancer or radiotherapy status, or the existence of bone metastases.
De hyppigste bivirkninger af en hvilken som helst grad (oplevet af mindst 20 % af patienterne) omfatter diaré, PPES, vægttab, nedsat appetit, kvalme, træthed, dysgeusi, ændringer i hårfarve, hypertension, stomatitis, konstipation, opkastning, slimhindeinflammation, asteni og dysphoni.
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.
Når dosisreduktion er nødvendig, anbefales det at reducere til 100 mg daglig, administreret som én 80 mg orange kapsel og én 20 mg grå kapsel, og derefter til 60 mg daglig, administreret som tre 20 mg grå kapsler.
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.
én orange 80 mg + én grå 20 mg
one orange 80 mg + one grey 20 mg
Du må ikke tage COMETRIQ sammen med mad.
You should not take COMETRIQ with food.
Derfor bør co-administration af potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice) med cabozantinib foretages med forsigtighed.
Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 mennesker)
Very common side effects (may affect more than 1 in 10 people)
• Generaliserede smerter, bryst- eller muskelsmerter, ørepine, ringen for ørerne
• Generalised pain, chest or muscle pain, ear pain, ringing in ears
Cabozantinib var en hæmmer (IC50 = 7,0 μM), men ikke et substrat, af P-glykoprotein (P-gp) transportaktiviteter i et to-rettet assay-system, der anvender MDCK-MDR1 celler.
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.
Resultater fra et studie med patienter med nedsat leverfunktion indikerer, at eksponeringen (AUC0-inf) øgedes med henholdsvis 81 % og 63 % hos forsøgspersoner med let og moderat nedsat leverfunktion (90 % CI for AUC0-inf: 121,44 % til 270,34 % ved let og 107,37 % til 246,67 % ved moderat nedsat leverfunktion).
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).
De hårde kapsler er grå med “XL184 20mg” trykt i sort på kapslens krop.
The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule.
• Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, manglende følelse i eller en følelse af tyngde i kæben eller løsnen af en tand.
• 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.
- Gem indlægsedlen.
- Keep this leaflet.
(XL184-N-oxid og XL184 amid spaltningsprodukt), der besidder <1 % af on-target kinasehæmningspotentialet af moderstoffet cabozantinib, hver repræsenterende <10 % af total lægemiddelrelateret plasmaeksponering.
Two non-conjugated metabolites (XL184-N-oxide and XL184 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.
tre grå 20 mg
three grey 20 mg
Patienter med svært nedsat nyrefunktion er ikke blevet undersøgt.
Patients with severe hepatic impairment have not been studied.
Midler til modificering af gastrisk pH
Gastric pH modifying agents
De mest almindelige alvorlige bivirkninger forbundet med cabozantinib er pneumoni, slimhinde inflammation, hypokalcæmi, dysfagi, dehydrering, lungeemboli og hypertension.
The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension.
Der kræves forsigtighed ved administration af cabozantinib med midler, der er stærke CYP3A4-hæmmere.
Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
• Træthed, svaghed, hovedpine, svimmelhed
• Fatigue, weakness, headache, dizziness
De hårde kapsler er orange med ”XL184 80mg” trykt i sort på kapslens krop.
The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Resultater fra et studie hos patienter med nedsat nyrefunktion indikerer, at ratioerne af middelværdierne beregnet ved mindste kvadraters metode for plasme-cabozantinib, Cmax og AUC0-inf var 19 % og 30 % højere hos forsøgspersoner med let nedsat nyrefunktion (90 % CI for Cmax 91,60 % til 155,51 %; AUC0-inf 98,79 % til 171,26 %) og 2 % og 6-7 % højere (90 % CI for Cmax 78,64 % til 133,52 %; AUC0-inf 79,61 % til 140,11 %) hos forsøgspersoner med moderat nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
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.
Kapslens indhold Mikrokrystallinsk cellulose Croscarmellosenatrium Natriumstivelsesglycolat Kolloid vandfri silica Stearinsyre
Capsule content Microcrystalline cellulose Croscarmellose sodium Sodium starch glycolate Silica colloidal anhydrous Stearic acid
Indlægsseddel er inden i posen.
Package leaflet inside pouch.
• Symptomer omfattende smerter i maven, kvalme, opkastning, forstoppelse eller feber.
• Symptoms including pain in the abdomen, nausea, vomiting, constipation, or fever.
• 140 mg (1 orange 80 mg kapsel og 3 grå 20 mg kapsler)
• 140 mg (1 orange 80 mg capsule and 3 grey 20 mg capsules)
har for højt blodtryk har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg har diaré har en nylig baggrund med at hoste blod op eller væsentlig blødning har gennemgået operation inden for den sidste måned (eller hvis et kirurgisk indgreb er planlagt), inklusive dentale indgreb har fået strålebehandling inden for de sidste 3 måneder har inflammatorisk tarmsygdom (for eksempel Crohn's sygdom eller ulcerativ colitis eller diverticulitis) har fået at vide, at din cancer har spredt sig til dine luftveje eller spiserøret har en nylig baggrund med blodprop i benet, hjerneblødning eller hjerteanfald tager lægemidler for at kontrollere din hjerterytme, har en langsom hjertefrekvens, har problemer med dit hjerte eller har problemer med niveauerne af calcium, kalium eller magnesium i dit blod har svær lever- eller nyresygdom.
- 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.
Bivirkninger, der generelt opstår tidligt, omfatter hypokalcæmi, hypokaliæmi, thrombocytopeni, hypertension, palmoplantar erythrodysæsthesi-syndrom (PPES), og gastrointestinale (GI) bivirkninger (abdominal- og mundsmerter, slimhindeinflammation, konstipation, diaré, opkastning.
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).
• Blister, smerter i hænderne eller fodsålerne, udslæt på eller rødmen af huden, tør hud
• Blister, pain of the hands or soles of the feet, rash or redness of the skin, dry skin
Hos rotter medførte cabozantinib postimplantationstab, føtalt ødem, hareskår/ganespalte, dermal aplasi og knækket eller rudimentær hale.
In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Administration af den potente CYP3A4-hæmmer ketoconazol (400 mg daglig i 27 dage) til raske frivillige sænkede cabozantinib clearance (med 29 %) og øgede enkeltdosis plasma cabozantinib eksponering (AUC) med 38 %.
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%.
• Ansigtsmerter
• Haemorrhoids