natgillin/translations-raw huggingface dataset:
Bivirkninger, der generelt ses tidligt, omfatter hypokalcæmi, hypokaliæmi, trombocytopeni, hypertension, palmoplantar erytrodysæstesisyndrom (PPES), proteinuri og gastrointestinale bivirkninger (abdominalsmerter, slimhindeinflammation, obstipation, diarré, opkastninger).
Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Samlet overlevelse (OS) Median OS (95% CI), måneder HR (95 % CI)1,2 p-værdi1
Overall Survival Median OS (95% CI), months HR (95% CI)1,2 p-value1
Patienter skal advares ved indtagelse af et P-gp-substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatranetexilat, 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.
Administration af den potente CYP3A4-induktor rifampicin (600 mg dagligt i 31 dage) til raske frivillige øgede cabozantinib-clearance (4,3 gange) og sænkede cabozantinibs plasmaeksponering (AUC) (efter en enkeltdosis) med 77 %.
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%.
I HCC-studiet (CELESTIAL) blev diarré rapporteret hos 54 % af de cabozantinib-behandlede patienter (251/467), grad 3-4-hændelser hos 9,9 %.
In the HCC study (CELESTIAL), diarrhoea was reported in 54% of cabozantinib-treated patients (251/467);Grade 3- 4 events in 9.9%.
Langvarig samtidig administration af cabozantinib og potente CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler, der indeholder perikon [Hypericum perforatum]) bør derfor undgås.
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.
Mediantiden til opståen var 5,9 uger.
Median time to onset was 5.9 weeks.
Mediantiden til opståen var 9,1 uger.
Median time to onset was 9.1 weeks.
Ved behandlingsnaivt nyrecellekarcinom forekom dosisreduktioner og dosisafbrydelser hos henholdsvis 46 % og 73 % af de cabozantinib-behandlede patienter i det kliniske forsøg (CABOSUN).
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).
• Stigning af mængden af amylase i blodet
• Increase in amylase levels in the blood
Figur 1: Kaplan-Meier-kurver for progressionsfri overlevelse bedømt radiologisk af en uafhængig komité, hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling (første 375 randomiserede patienter) (METEOR)
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)
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 mennesker)
Common side effects (may affect up to 1 in 10 people)
Venetrombose, arteriel trombose
Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Cabozantinib skal anvendes med forsigtighed hos patienter med en anamnese med eller risikofaktorer for disse hændelser.
Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Det skal du vide, før du begynder at tage CABOMETYX
What you need to know before you take CABOMETYX Do not take CABOMETYX
Kaukasisk: 56 %, asiatisk: 34 % ECOG performance status (PS) 0: 53 % eller ECOG PS 1: 47 % Child Pugh A: 99 %, Child Pugh B: 1 %
ECOG performance status (PS) 0: 53% or ECOG PS 1: 47%.
Figur 2: Kaplan-Meier-kurver for samlet overlevelse hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling (METEOR)
Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
I HCC-studiet (CELESTIAL) var forekomsten af alvorlige hæmoragiske hændelser (grad ≥ 3) 7,3 % hos cabozantinib-behandlede patienter (34/467).
In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
I det behandlingsnaive RCC-studie (CABOSUN) blev diarré rapporteret hos 73 % af de cabozantinibbehandlede patienter (57/78), grad 3-4-hændelser hos 10 %.
In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
Hepatisk encefalopati
Hepatic encephalopathy
Patienter skal advares ved indtagelse af et P-gp-substrat (f.eks. fexofenadin, aliskiren, ambrisentan, dabigatranetexilat, digoxin, colchicin, maraviroc, posaconazol, ranolazin, saxagliptin, sitagliptin, talinolol, tolvaptan), mens de får cabozantinib (se pkt.
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).
Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 mennesker)
Uncommon side effects (may affect 1 in 100 people)
Bemærk: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Middel-PFS (95 % CI), måneder HR (95 % CI), p-værdi1
Median PFS (95% CI), months HR (95% CI), p-value1
I studiet af RCC efter forudgående VEGF-målrettet behandling (METEOR) blev diarré rapporteret hos 74 % af de cabozantinib-behandlede RCC-patienter (245/331); Grad 3-4-hændelser hos 11 %.
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%.
Progressionsfri overlevelse (PFS) pr. Investigator Median PFS i måneder (95% CI) HR (95% CI); stratificeret b,c Tosidet stratificeret log-rank p-værdi b p=0,0042
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
Lægemidler til modificering af gastrisk pH
Gastric pH modifying agents
Cabozantinib er et CYP3A4-substrat.
CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Der er blevet observeret sårkomplikationer med cabozantinib.
Wound complications have been observed with cabozantinib.
I studiet af RCC efter tidligere VEGF-målrettet behandling (METEOR) blev der rapporteret GI-perforation hos 0,9 % (3/331) af de cabozantinib-behandlede RCC-patienter.
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.
Mediantiden til opståen var 4,9 uger.
Median time to onset was 4.9 weeks.
• Gener fra maven, herunder diarré, kvalme, opkastning, forstoppelse, fordøjelsesbesvær og mavesmerter
• Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
• Stigning af triglyceridniveauet i blodet
• Increase in blood triglyceride levels in the blood
Regelmæssig monitorering af ekg og elektrolytter (serumcalcium, -kalium og -magnesium) under behandlingen med cabozantinib skal overvejes.
When using cabozantinib, periodic monitoring with ontreatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
• Stigning af mængden af lipase i blodet
• Increase in lipase levels in the blood
Cabometyx indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Advarsler relateret til hjælpestof
Excipient related warnings
Progressionsfri overlevelse (PFS) pr. IRCa Median PFS i måneder (95% CI) HR (95% CI); stratificeret b,c Tosidet stratificeret log-rank p-værdi b p=0,0005
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
• Anæmi (blodmangel)
• Anaemia (low levels of red blood cells)
• Stigning af mængden af kolesterol i blodet
• Increase in cholesterol levels in the blood
• Sårkomplikationer.
• Wound complications
I studiet af behandlingsnaivt RCC (CABOSUN) var forekomsten af alvorlige blødningshændelse (grad ≥ 3) 5,1 % (4/78) hos cabozantinib-behandlede RCC patienter.
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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Derfor skal der udvises forsigtighed ved samtidig administration af cabozantinib og potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice).
Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
• Nedsat mængde galde, der udtømmes fra leveren
• Decrease in bile flow from the liver
- Tabletindhold: mikrokrystallinsk cellulose, vandfri lactose, hypromellose, croscarmellosenatrium, kolloid vandfri silica og magnesiumstearat.
The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion.
In patients with mild hepatic impairment no dose adjustment is required.
De hyppigste bivirkninger af en hvilken som helst grad (set hos mindst 25 % af patienterne) i HCCpopulationen omfattede diarré, palmoplantar erytrodysætesisyndrom, træthed, nedsat appetit, hypertension og kvalme.
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.
CABOMETYX 20 mg filmovertrukne tabletter CABOMETYX 40 mg filmovertrukne tabletter CABOMETYX 60 mg filmovertrukne tabletter cabozantinib
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
Afbryd behandlingen, indtil bivirkningerne er reduceret til grad Tilføj understøttende behandling som indiceret.
Interrupt treatment until the adverse reaction resolves to Grade ≤1.
Cabozantinib er substrat for CYP3A4-metabolisme in vitro, eftersom et neutraliserende antistof mod CYP3A4 hæmmede dannelsen af metabolitten XL184 N-oxid med >80 % i en NADPH-katalyseret inkubation med humane levermikrosomer (HLM).
Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Kolestatisk hepatitis
Hepatic encephalopathy hepatitis cholestatic
Fistler
Fistulas
CABOMETYX 20 mg filmovertrukne tabletter CABOMETYX 40 mg filmovertrukne tabletter CABOMETYX 60 mg filmovertrukne tabletter
CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
- leverkræft hos voksne, der tidligere har været behandlet med en specifik kræftmedicin (sorafenib).
It is used to treat: - advanced stages of a type of kidney cancer called renal cell carcinoma - liver cancer in adults who have been previously treated with a specific anticancer medicine (sorafenib).
- Lægemidler til behandling af svampeinfektioner, såsom itraconazol, ketoconazol og posaconazol.
- Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin,
• Smerter i maven, kvalme, opkastning, forstoppelse eller feber.
• Symptoms including pain in the abdomen, nausea (feeling sick), vomiting, constipation, or fever.
Pruritus, alopecia, tør hud, acneiform dermatitis, ændret hårfarve
Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
CABOMETYX 40 mg filmovertrukne tabletter er gule og trekantede, uden delekærv og præget med "XL" på den ene side og "40" på den anden side.
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.
I studiet af RCC efter tidligere VEGF-målrettet behandling (METEOR) blev der rapporteret fistler hos 1,2 % (4/331) af de cabozantinib-behandlede patienter, herunder analfistler hos 0,6 % (2/331).
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.
Der er blevet observeret proteinuri med cabozantinib.
Proteinuria has been observed with cabozantinib.
Patienter (N=157) med tidligere ubehandlet, lokal fremskreden eller metastatisk RCC med en klar cellekomponent blev randomiseret (1:1) til behandling
Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78).
Der er set dødelige perforationstilfælde i det kliniske cabozantinib-program.
Fatal perforations have occurred in the cabozantinib clinical program.
• Vabler, smerter i hænder eller fodsåler, udslæt på huden eller hudrødme
• Blisters, pain of the hands or soles of the feet, rash or redness of the skin
Sådan skal du tage CABOMETYX
How to take CABOMETYX
investigator ITT-population
ORR per Investigator Review Intent-To-Treat Population
Der er blevet observeret alvorlige gastrointestinale perforationer og fistler med cabozantinib, inklusive tilfælde med dødelig udgang.
Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Gastrointestinal perforation, fistler, gastroøsofageal reflukssygdom, hæmorider, smerter i mundhulen, mundtørhed
Gastrointestinal disorders diarrhoea, nausea, vomiting, stomatitis, constipation, abdominal pain, dyspepsia, upper abdominal pain gastrointestinal perforation, fistula, gastroesophageal reflux disease, haemorrhoids, oral pain, dry mouth pancreatitis, glossodynia
CABOMETYX 60 mg filmovertrukne tabletter er gule og ovale, uden delekærv og præget med "XL" på den ene side og "60" på den anden side.
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.
I studiet af RCC efter tidligere VEGF-målrettet behandling (METEOR) var forekomsten af alvorlige blødningshændelser (grad ≥3) 2,1 % (7/331) hos cabozantinib-behandlede RCC-patienter.
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.
Mediantiden til opståen var 4,1 uger.
Median time to onset of all events was 4.1 weeks.
Hver filmovertrukne tablet indeholder 46,61 mg lactose.
Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
herunder indgreb i mund/tænder - har en betændelseslignende (inflammatorisk) tarmsygdom (for eksempel Crohns sygdom, blødende tyktarmsbetændelse, udposninger på tyktarmen eller blindtarmsbetændelse) - for nyligt har haft en blodprop i benet, et slagtilfælde eller et hjerteanfald - hvis du har en lever- eller nyresygdom.
diverticulitis, or appendicitis) - have a recent history of blood clot in the leg, stroke, or heart attack - have liver or kidney disease.
Tabletterne er gule og runde uden delekærv og præget med "XL" på den ene side og "20" på den anden side af tabletten.
The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
Tabel 3: Oversigt over PFS, bedømt radiologisk af en uafhængig komité hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling (METEOR) Population ved den primære PFS-analyse
Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
CABOMETYX 20 mg filmovertrukne tabletter
CABOMETYX 20 mg film-coated tablets
Cabozantinib er blevet forbundet med bivirkninger som træthed og svaghed.
Adverse reactions such as fatigue and weakness have been associated with cabozantinib.
Hvis du har taget for mange CABOMETYX
If you take more CABOMETYX than you should
Derfor bør langvarig administration af cabozantinib og lægemidler, der er potente CYP3A4-induktorer, undgås (se pkt.
Therefore, chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Der var dødelige tilfælde i det kliniske cabozantinib-program.
Fatal haemorrhages have occurred in the cabozantinib clinical program.
I HCC-studiet (CELESTIAL) blev hepatisk encefalopati rapporteret hyppigere i cabozantinib- end i placeboarmen.
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.
LÆGEMIDLETS NAVN CABOMETYX 20 mg filmovertrukne tabletter cabozantinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder cabozantinib (S)-malat svarende til 20 mg cabozantinib.
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.
Hver filmovertrukne tablet indeholder cabozantinib (S)-malat svarende til 40 mg cabozantinib.
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Luftveje, thorax og mediastinum
Ear and labyrinth disorders tinnitus
CABOMETYX 60 mg filmovertrukne tabletter: Hver tablet indeholder cabozantinib (S)-malat svarende til 60 mg cabozantinib.
CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.
De forsøgspersoner, der fik disse behandlinger, var nødt til at seponere studiebehandlingen.
CABOMETYX Placebo these therapies had to discontinue study treatment.
Sådan virker CABOMETYX
How CABOMETYX works
Tabletterne er gule og trekantede uden delekærv og præget med "XL" på den ene side og "40" på den anden side af tabletten.
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.
Tabletterne er gule og ovale uden delekærv og præget med "XL" på den ene side og "60" på den anden side af tabletten.
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.
CABOMETYX 40 mg filmovertrukne tabletter
CABOMETYX 40 mg film-coated tablets
Hver filmovertrukne tablet indeholder cabozantinib (S)-malat svarende til 60 mg cabozantinib.
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
LÆGEMIDLETS NAVN CABOMETYX 20 mg filmovertrukne tabletter cabozantinib NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma UDLØBSDATO
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
CABOMETYX 40 mg filmovertrukne tabletter: Hver tablet indeholder cabozantinib (S)-malat svarende til 40 mg cabozantinib.
CABOMETYX 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.
LÆGEMIDLETS NAVN CABOMETYX 60 mg filmovertrukne tabletter cabozantinib NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma UDLØBSDATO
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 60 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
CABOMETYX 60 mg filmovertrukne tabletter
CABOMETYX 60 mg film-coated tablets
• Kramper
• Stroke
LÆGEMIDLETS NAVN CABOMETYX 40 mg filmovertrukne tabletter cabozantinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder cabozantinib (S)-malat svarende til 40 mg cabozantinib.
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.
CABOMETYX 20 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder cabozantinib (S)-malat svarende til 20 mg cabozantinib.
CABOMETYX 20 mg film-coated tablets Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
LÆGEMIDLETS NAVN CABOMETYX 40 mg filmovertrukne tabletter cabozantinib NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma UDLØBSDATO
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER NAME OF THE MEDICINAL PRODUCT CABOMETYX 40 mg film-coated tablets cabozantinib NAME OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma EXPIRY DATE
CABOMETYX 20 mg filmovertrukne tabletter: Hver tablet indeholder cabozantinib (S)-malat svarende til 20 mg cabozantinib.
CABOMETYX 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Dysfoni, dyspnø, hoste
Respiratory, thoracic, and mediastinal disorders dysphonia, dyspnoea, cough pulmonary embolism
1 2-sidet stratificeret log-rank test med sygdommens ætiologi (HBV [med eller uden HCV], HCV [uden HBV] eller andet), geografisk region (Asien, andre regioner) og tilstedeværelse af ekstrahepatisk spredning af sygdom og/eller makrovaskulær invasion (Ja/Nej) som stratifikationsfaktorer (pr. IVRS-data)
HBV], or Other), geographic region (Asia, Other Regions), and presence of extrahepatic spread of disease and/or macrovascular invasion (Yes, No) as stratification factors (per IVRS data) 2 estimated using the Cox proportional-hazard model 3 as assessed by investigator per RECIST 1.1
en uafhængig radiologisk komité (IRC) og investigator, hos RCC patienter efter tidligere vaskulær endothelvækstfaktor (VEGF) målrettet behandling Primæranalyse ORR ITT-population (IRC)
Primary Analysis ORR IntentTo-Treat Population (IRC)
• Hæmorider
Haemorrhage
Cabozantinib har været associeret med diarré, opkastning, nedsat appetit og elektrolytabnormiteter.
Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Ekstremitetssmerter Muskelspasmer, artralgi
Musculoskeletal and connective tissue disorders pain in extremity muscle spasms, arthralgia osteonecrosis of the jaw
Hepatiske virkninger
Patients with hepatic impairment
• Kortåndethed
• Shortness of breath
Cabozantinib skal seponeres i tilfælde af hypertensiv krise.
In case of hypertensive crisis, cabozantinib should be discontinued.
Svangerskabsforbyggende piller
Oral contraceptives
Påbegynd relevant behandling.
Institute appropriate medical care.