FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with tivozanib in all subsets of the paediatric population in advanced renal cell carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med tivozanib i alle undergrupper af den pædiatriske population med avanceret renal cellecarcinom (se pkt.
English: After a single 1340 microgram dose, mean Cmax was 10.2 to 25.2 ng/mL across healthy subject and patient studies.
Danish: Efter en enkelt dosis på 1340 mikrogram var middel Cmax 10,2 til 25,2 ng/ml på tværs af studier med sunde frivillige og patienter.
English: No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Ingen dosisjustering er påkrævet hos patienter med mild eller moderat nedsat nyrefunktion (se pkt.
English: Progression-Free Survival, No prior treatment for Metastatic RCC Subgroup [median, months (95% CI)]
Danish: Progressionsfri overlevelse, Undergruppe uden tidligere behandling for metastatisk RCC [median, måneder (95% CI)]
English: However, if your blood pressure remains too high, your doctor may decide to interrupt or to stop treatment with Fotivda.
Danish: Hvis dit blodtryk bliver ved med at være for højt, kan din læge dog beslutte at afbryde eller standse behandlingen med Fotivda.
English: Printing ink (blue)
Danish: Blæk (blå)
English: • if you suffer or have suffered from any of these symptoms or are treated for heart failure: o Shortness of breath (dyspnoea) when you exert yourself or when you lie down o Feeling weak and tired o Swelling (oedema) in your legs, ankles and feet o Reduced ability to exercise o Persistent cough or wheezing with white or pink blood-tinged phlegm Signs and symptoms of heart failure will be monitored whilst you are taking your medicine.
Danish: • Hvis du lider af eller har lidt af et af disse symptomer eller er behandlet for hjertesvigt: o Åndenød (dyspnø) når du anstrenger dig eller når du ligger ned o Føler at du er svag og træt o Hævelse (ødem) i dine ben, ankler og fødder o Nedsat evne til at dyrke motion o Vedvarende hoste eller hvæsende lyd med hvidt eller lyserødt blodigt slim Tegn og symptomer på hjertesvigt vil blive overvåget, mens du tager din medicin.
English: When tivozanib was evaluated in a food effect study in healthy subjects, a high fat meal decreased the peak serum concentrations (Cmax) by 23.4% compared to the fasted state.
Danish: Tivozanib er blevet evalueret i et studie af mad-effekt hos sunde frivillige, som har vist, at et måltid med et højt fedtindhold reducerer maksimale serumkoncentrationer (Cmax) med 23,4% sammenlignet med fastende tilstand.
English: Endocrine disorders
Danish: Endokrine forstyrrelser
English: Progression-Free Survival, One Prior Therapy for Metastatic Disease Subgroup [median, months (95% CI)]
Danish: Progressionsfri overlevelse, Undergruppe med en tidligere terapi for metastatisk sygdom [median, måneder (95% CI)]
English: • if you have problems with your thyroid gland or use medicines to treat thyroid disease.
Danish: • Hvis du har problemer med din skjoldbruskkirtel eller tager medicin for at behandle en sygdom i skjoldbruskkirtlen.
English: Risk factors for VTEs include major surgery, multiple trauma, prior VTEs, advanced age, obesity, cardiac or respiratory failure, and prolonged immobility.
Danish: Risikofaktorer for VTE omfatter større operation, flere traumer, tidligere VTE, høj alder, obesitet, hjertesvigt eller respiratorisk svigt og langvarig immobilitet.
English: There were no deaths due to arterial thromboembolic adverse reactions in those receiving tivozanib as initial therapy but a myocardial infarction in a patient receiving second-line tivozanib had a fatal outcome.
Danish: Der var ingen dødsfald på grund af arterielle tromboemboliske hændelser hos patienter, som modtog tivozanib som oprindelig terapi, men et myokardieinfarkt med et fatalt udfald hos en patient, der modtog tivozanib som anden linje-behandling.
English: Hypertension was reported as an adverse reaction in 47.6% of patients receiving tivozanib as initial therapy; in 23.0% the hypertension was CTC ≥Grade 3.
Danish: Hypertension blev rapporteret som en bivirkning hos 47,6% af patienter, som havde modtaget tivozanib som oprindelig terapi; hos 23,0% var hypertensionen CTC ≥ Grad 3.
English: Monitoring for proteinuria before initiation of, and periodically throughout treatment is recommended.
Danish: Det anbefales at monitorere proteinuri før initieringen af og med jævne mellemrum under hele behandlingen.
English: Venous thromboembolism11
Danish: Venøs tromboembolisme11
English: The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy (see section 4.4).
Danish: Forekomsten af bivirkninger kan kræve en midlertidig afbrydelse og/eller en dosisreduktion af tivozanib-terapien (se pkt.
English: • St. John's Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety) as this herbal remedy should not be used at the same time as Fotivda.
Danish: • perikon (også kendt som Hypericum perforatum, et naturlægemiddel, der bruges til behandling af depression og uro), da dette naturlægemiddel ikke bør bruges sammen med Fotivda.
English: • Rashes with pus; fungal infections.
Danish: • Udslæt med pus; svampeinfektioner.
English: In vitro studies have shown that tivozanib is neither a substrate nor an inhibitor of the multidrug efflux pump, P-glycoprotein.
Danish: In vitro studier har vist, at tivozanib hverken er et substrat eller en hæmmer af multilægemiddel-efflukspumpen, P-glycoprotein.
English: Treatment decision, especially in patients who are at risk for VTEs, should be based on individual patient benefit/risk assessment.
Danish: Behandlingsbeslutningen bør være baseret på en benefit-risk-vurdering for den enkelte patient, især hos patienter med risiko for VTE.
English: In vitro studies have shown that tivozanib is neither a substrate nor inhibitor of the transporter proteins MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 and BSEP.
Danish: In vitro studier har vist, at tivozanib hverken er et substrat eller en hæmmer af transportørproteinerne MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 og BSEP.
English: There was no unchanged tivozanib recovered in the urine indicating that tivozanib does not undergo renal excretion.
Danish: Der blev ikke fundet uændret tivozanib i urin, hvilket angiver, at tivozanib ikke undergår renal udskillelse.
English: Symptoms include cough, chest pain, sudden shortness of breath or coughing up blood.
Danish: Symptomer omfatter hoste, brystsmerter, pludselig åndenød eller ophostning af blod.
English: If a patient is already taking St John's wort, this should be stopped before starting tivozanib treatment.
Danish: Hvis en patient allerede tager perikon, skal denne indtagelse standses, før tivozanib-behandlingen startes.
English: • if you have symptoms of gastrointestinal perforation or fistula formation (developing a hole in the stomach or intestine or abnormal passages forming between parts of the intestine) such as severe stomach pain, chills, fever, nausea, vomiting or painful bowel obstruction, diarrhoea or rectal bleeding.
Danish: • Hvis du har symptomer på gastrointestinal perforation eller fisteldannelse (udvikling af et hul i maven eller tarmen eller unormale passager mellem tarmens dele) som f.eks. svære mavesmerter, kuldegysninger, feber, kvalme, opkastning eller smertefuld tarmobstruktion, diarré eller blødning fra endetarmsåbning.
English: Cross-over to the tivozanib arm was permitted upon Response Evaluation Criteria In Solid Tumours (RECIST)-defined progression on sorafenib according to the protocol of a separate extension study.
Danish: Skift til tivozanib-armen var tilladt tilfælde af en progression defineret ved RECIST-kriterier (Response Evaluation Criteria In Solid Tumours) med sorafenib iht.
English: One Fotivda 890 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken.
Danish: En Fotivda 890 mikrogram kapsel, taget én gang om dagen i 21 dage (3 uger), efterfulgt af en periode på 7 dage (1 uge), hvor der ingen kapsler tages.
English: • Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stomach; swollen and painful tongue; inflamed painful and/or bleeding gums.
Danish: • Flatulens; halsbrand; vanskelig og smertefuld synkning; ondt i halsen; oppustet mave; opsvulmet og smertefuld tunge; betændte smertefulde og/eller blødende gummer.
English: • Underactive thyroid gland which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, weight gain.
Danish: • Underaktiv skjoldbruskkirtel, som kan give symptomer som f.eks. træthed, sløvhed, muskelsvaghed, lav hjertefrekvens, vægtforøgelse.
English: • Posterior reversible encephalopathy syndrome (PRES).
Danish: • Posterior reversibelt encefalopati-syndrom (PRES).
English: In nonclinical studies assessing mating and fertility parameters in male rats, doses > 2-fold higher than the recommended clinical dose, produced increased epididymis and testis weights associated with infertility.
Danish: I non-kliniske studier med vurdering af parrings- og fertilitetsparametre hos hanrotter, har doser > 2 gange højere end den anbefalede kliniske dosis produceret øget bitestikel- og testikelvægt forbundet med infertilitet.
English: Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of tivozanib therapy, plus treatment of potential underlying causes of cardiac failure e.g. hypertension.
Danish: Varetagelse af hændelser med hjertesvigt kan kræve midlertidig afbrydelse eller permanent standsning og/eller dosisreduktion af tivozanib-terapien, plus behandling af potentielt underliggende årsager til hjertesvigt som f.eks. hypertension.
English: Fotivda 890 microgram
Danish: Fotivda 890 mikrogram
English: Herbal preparations containing St. John's wort (Hypericum perforatum) are contraindicated.
Danish: Urtepræparater, som indeholder perikon (Hypericum perforatum), er kontraindicerede.
English: • Tiredness; unusual weakness; pain (including in the mouth, bone, extremities, side of the body,
Danish: • Træthed; usædvanlig svaghed; smerter (herunder i mund, knogler, ekstremiteter, på siden af kroppen, lyske, tumor).
English: Pooled data of 674 patients with advanced RCC who continued to receive tivozanib as their initial on trial therapy in the five core RCC monotherapy studies have been evaluated in the overall assessment of safety and tolerability of tivozanib.
Danish: Poolede data fra 674 patienter med avanceret RCC, som fortsatte med at modtage tivozanib som deres oprindelige forsøgsterapi i de fem vigtigste RCC-monoterapi-studier, er blevet evalueret i den globale vurdering af tivozanibs sikkerhed og tolerabilitet.
English: The most frequent adverse reactions leading to tivozanib dose reduction/ interruption were hypertension (4.7%), diarrhoea (3.1%), fatigue
Danish: De hyppigste bivirkninger, som førte til dosisreduktion/afbrydelse af tivozanib, var hypertension (4,7%), diarré (3,1%), træthed (1,8%).
English: • Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
Danish: • Svimmelhed; ringen for ørerne; svimmelhed og en fornemmelse af at alt kører rundt (vertigo).
English: Other medicines and Fotivda
Danish: Brug af anden medicin sammen med Fotivda
English: The printing ink used on the Fotivda 890 microgram capsule contains tartrazine (E102), which may cause allergic reactions.
Danish: Det anvendte blæk på Fotivda 890 mikrogram kapsler indeholder tartrazin (E102), som kan fremkalde allergiske reaktioner.
English: Tivozanib exposure was increased in patients with severe hepatic impairment (mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment (mean AUC0-∞ by 2.6-fold).
Danish: Eksponeringen for tivozanib var øget hos patienter med svær nedsat leverfunktion (gennemsnitlig AUC0-∞ med 4,0 gange) og hos patienter med moderat nedsat leverfunktion (gennemsnitlig AUC0-∞ med 2,6 gange).
English: Fotivda 1340 microgram
Danish: Fotivda 1340 mikrogram
English: The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7-day rest period to comprise one complete treatment cycle of 4 weeks.
Danish: Den anbefalede dosis af tivozanib er 1340 mikrogram én gang om dagen i 21 dage, efterfulgt af en hvileperiode på 7 dage for at udgøre en komplet behandlingscyklus på 4 uger.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Undersøgelser med dyr har vist forplantningstoksicitet (se pkt.
English: Most events in the five renal cell carcinoma monotherapy studies were CTC Grade 1 or 2 (≥ CTC Grade 3 was observed in < 2% of patients treated with tivozanib) and there were no serious events (see section 4.8).
Danish: De fleste hændelser i de fem monoterapi-studier med renalcellecarcinom var CTC grad 1 eller 2 (≥ CTC grad 3 blev observeret hos < 2% af patienter behandlet med tivozanib) og der var ingen alvorlige hændelser (se pkt.
English: • Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals,
Danish: • Blødning, f.eks. i hjernen, fra mund, gummer, lunger, mave, tarmsår, kvindelige kønsorganer, endetarmsåbning, binyre.
English: In vitro studies with tivozanib indicate that it is not a CYP enzyme inducer.
Danish: In vitro studier med tivozanib angiver, at det ikke er en CYP-enzyminduktor.
English: Tivozanib has not been studied in patients who had an ATE within the preceding 6 months of clinical study initiation.
Danish: Tivozanib er ikke blevet undersøgt hos patienter, som havde haft en ATE inden for de 6 forudgående måneder før det kliniske studies initiering.
English: If you develop high blood pressure, your doctor may prescribe a medicine to treat your high blood pressure, lower your dose of Fotivda, or stop your treatment with Fotivda.
Danish: Hvis du udvikler højt blodtryk, vil din læge måske ordinere en medicin for at behandle højt blodtryk, sænke din dosis af Fotivda eller standse din behandling med Fotivda.
English: • Fever; chest pain; swelling of feet and legs; chills and low body temperature.
Danish: • Feber; brystsmerter; hævede fødder og ben; kuldegysninger og lav kropstemperatur.
English: In the five core RCC monotherapy studies tivozanib was discontinued in a total of 20 patients (3%) owing to adverse reactions, most commonly due to hypertension (0.4%), persistent severe hypertension (0.3%), or acute myocardial infarction (0.3%).
Danish: I de fem kerne-RCC-monoterapi-studier blev tivozanib standset hos i alt 20 patienter (3%) på grund af bivirkninger, som regel på grund af hypertension (0,4%), vedvarende svær hypertension (0,3%) eller akut myokardieinfarkt (0,3%).
English: Serious side effects
Danish: Alvorlige bivirkning
English: In a clinical study in healthy volunteers, co-administration of tivozanib with a potent CYP3A4 inhibitor, ketoconazole (400 mg once daily), had no influence on tivozanib serum concentrations (Cmax or AUC); therefore, tivozanib exposure is unlikely to be altered by CYP3A4 inhibitors.
Danish: Samtidig administration af tivozanib og en potent CYP3A4-hæmmer, ketoconazol (400 mg én gang/dag), i en klinisk undersøgelse med sunde frivillige, havde ingen indflydelse på serumkoncentrationer af tivozanib (Cmax eller AUC); det er derfor ikke sandsynligt, at tivozanib-eksponeringen ændres af CYP3A4-hæmmere.
English: Talk to your doctor, pharmacist or nurse before taking Fotivda:
Danish: Kontakt lægen, eller apotekspersonalet eller sundhedspersonalet, før du tager Fotivda:
English: Arterial thromboembolic adverse reactions in the patients receiving tivozanib as initial therapy were ischaemic stroke (1.0%), myocardial infarction (0.7%), transient ischaemic attack (0.7%) and acute myocardial infarction (0.4%), the majority of which were at least CTC Grade 3, plus iliac artery thrombosis (0.1%).
Danish: Arterielle tromboemboliske bivirkninger hos patienter, som modtog tivozanib som oprindelig terapi var iskæmisk slagtilfælde (1,0%), myokardieinfarkt (0,7%), transitorisk iskæmisk attak (0,7%) og akut myokardieinfarkt (0,4%), hvoraf de fleste var mindst CTC Grad 3, plus trombose i arteria iliaca
English: Posterior reversible encephalopathy syndrome
Danish: Posterior reversibelt encefalopati-syndrom
English: No dose adjustment is required when administering tivozanib to patients with mild hepatic impairment.
Danish: Ingen dosisjustering er påkrævet, når tivozanib administreres til patienter med mild nedsat leverfunktion.
English: Your doctor will regularly monitor how well your thyroid gland is working before and during treatment with Fotivda (e.g. with blood tests).
Danish: Din læge vil jævnligt overvåge, hvor godt din skjoldbruskkirtel fungerer før og i løbet af behandlingen med Fotivda (f.eks. med blodprøver).
English: Based on the population pharmacokinetic analysis, there is no clinically relevant effect of age, gender or race on the pharmacokinetics of tivozanib.
Danish: Der findes ingen klinisk relevant effekt af alder, køn eller race på baggrund af en farmakokinetisk populationanalyse af tivozanib.
English: In vitro studies suggest that tivozanib is an inhibitor of intestinal BCRP.
Danish: In vitro studier tyder på, at tivozanib er en hæmmer af intestinal BCRP.
English: • Bruising easily, bleeding into the skin.
Danish: • Huden får nemt blå mærker, blødning i huden.
English: Abdominal pain15 Nausea Diarrhoea Stomatitis16
Danish: Mave-tarmkanalen Abdominalsmerter Kvalme Diarré Stomatitis16
English: Tivozanib has not been studied in patients who had a VTE within the preceding 6 months of clinical study initiation.
Danish: Tivozanib er ikke blevet undersøgt hos patienter, som havde haft en VTE inden for de 6 forudgående måneder før det kliniske studies initiering.
English: In patients receiving tivozanib as initial therapy, there were three adverse reactions with outcome death; one was uncontrolled hypertension in the setting of a suspected overdose (see section 4.9) and two were reported simply as death.
Danish: Hos patienter, som modtog tivozanib som oprindelig terapi, var der tre bivirkninger som resulterede i dødsfald; en var ukontrolleret hypertension inden for rammerne af en mistænkt overdosering (se pkt.
English: • Difficult breathing; shortness of breath during exercise; coughing.
Danish: • Åndedrætsbesvær; åndenød under anstrengelser; hoste.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Danish: PRES er en neurologisk forstyrrelse, som kan manifestere sig med hovedpine, anfald, letargi, konfusion, blindhed og andre visuelle og neurologiske forstyrrelser.
English: Haemorrhage adverse reactions were reported in the core monotherapy studies during initial treatment (see section 4.4).
Danish: Der er rapporteret om hæmoragi-bivirkninger i kerne monoterapistudierne i løbet af den oprindelige behandling (se pkt.
English: Chest pain28 Chills29 Pyrexia Peripheral oedema
Danish: Brystsmerter28 Kulderystelser29 Pyreksi Perifert ødem
English: Hypothyroidism Hyperthyroidism Goitre1
Danish: Hypothyroidisme Hyperthyroidisme Struma1
English: In a clinical study in healthy volunteers, co-administration of a single 1340 microgram dose of tivozanib with a strong CYP3A4 inducer at steady-state (rifampin 600 mg once daily) decreased the average half-life of tivozanib from 121 to 54 hours which was associated with a decrease in the single dose AUC0-∞ of 48% compared with AUC0-∞ in the absence of rifampin.
Danish: Samtidig administration af en enkelt dosis på 1340 mikrogram tivozanib og en potent CYP3A4-induktor ved steady-state (rifampin 600 mg én gang/dag), i en klinisk undersøgelse med sunde frivillige, mindskede tivozanibs gennemsnitlige halveringstid fra 121 til 54 timer, hvilket var kombineret med en mindskning af enkeltdosis AUC0-∞ på 48% sammenlignet med AUC0-∞ uden rifampin.
English: • Coughing up blood; vomiting up blood.
Danish: • Ophostning af blod; opkastning af blod.
English: The recommended dose is one Fotivda 1340 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken.
Danish: Den anbefalede dosis er en Fotivda 1340 mikrogram kapsel, taget én gang om dagen i 21 dage (3 uger), efterfulgt af en periode på 7 dage (1 uge), hvor du ingen kapsler tager.
English: Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 5.2).
Danish: Patienter med moderat nedsat leverfunktion bør kun behandles med en tivozanib kapsel på 1340 mikrogram hver anden dag, da disse patienter kan have en øget risiko for bivirkninger på grund af øget eksponering med en dosis på 1340 mikrogram hver dag (se pkt.
English: Dose modification
Danish: Ændring af dosis
English: Tartrazine Fotivda 890 microgram hard capsules contain tartrazine (E102) which may cause allergic reactions.
Danish: Fotivda 890 mikrogram hårde kapsler indeholder tartrazin (E102), som kan fremkalde allergiske reaktioner.
English: QT prolongation was reported in two patients (CTC Grade 2 and Grade 3) in the tivozanib cardiac safety study, neither reaction was considered serious (see section 4.4 and section 5.1).
Danish: Der blev rapporteret om forlængelse af QT-interval hos to patienter (CTC Grad 2 og Grad 3) i tivozanib-studiet for hjertesikkerhed, ingen af reaktionerne blev anset for at være alvorlige (se pkt.
English: • Heart failure.
Danish: • Hjertesvigt.
English: Contents of the pack and other information What Fotivda contains
Danish: Pakningsstørrelser og yderligere oplysninger Fotivda indeholder:
English: Symptoms include shortness of breath or ankle swelling.
Danish: Symptomer omfatter åndenød eller hævede ankler.
English: • Unable to sleep.
Danish: • Søvnløshed.
English: Talk to your doctor, pharmacist or nurse while taking Fotivda:
Danish: Kontakt lægen, eller apotekspersonalet eller sundhedspersonalet, mens du tager Fotivda:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET PÅ BEHOLDER
English: In female rats, an increase in non-viable foetuses was noted at a dose 0.7-fold the recommended clinical dose, while dose levels ≥ 2 fold the recommended clinical dose produced infertility.
Danish: Hos hunrotter blev der noteret en stigning af ikke levedygtige fostre ved en dosis, der var 0,7 gange højere end den anbefalede kliniske dosis, mens dosisniveauer ≥ 2 gange den anbefalede kliniske dosis fremkaldte infertilitet.
English: • Red, swollen and sore skin; blistering skin; excessive sweating; hives.
Danish: • Rød, opsvulmet og smertefuld hud; hud med vabler; overdreven sveden; nældefeber.
English: Arterial thromboembolism10
Danish: Arteriel tromboembolisme10
English: Treatment with Fotivda may increase the risk of bleeding.
Danish: • Hvis du har haft problemer med blødning Behandlingen med Fotivda kan øge risikoen for blødning.
English: For patients who develop Grade 2 (> 1.0-3.4 g/24 hours) or Grade 3 (≥ 3.5 g/24 hours) proteinuria (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), the dose of tivozanib has to be reduced or the treatment temporarily interrupted.
Danish: Dosis af tivozanib skal reducers eller behandlingen skal afbrydes midlertidigt hos patienter, som udvikler en grad 2 (> 1,0-3,4 g/24 timer) eller grad 3 (≥ 3,5 g/24 timer) proteinuri (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]).
English: Myocardial infarction (acute) / ischaemia7 Angina pectoris Tachycardia8
Danish: Myokardieinfarkt (akut) / iskæmi7
English: Tivozanib is not recommended in patients with severe hepatic impairment.
Danish: Tivozanib anbefales ikke hos patienter med svær nedsat leverfunktion.