FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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.
Danish: 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.
English: 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).
Danish: 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.
English: • Blister, pain of the hands or soles of the feet, rash or redness of the skin, dry skin
Danish: • Blister, smerter i hænderne eller fodsålerne, udslæt på eller rødmen af huden, tør hud
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Danish: Hos rotter medførte cabozantinib postimplantationstab, føtalt ødem, hareskår/ganespalte, dermal aplasi og knækket eller rudimentær hale.
English: 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%.
Danish: 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 %.
English: • Haemorrhoids
Danish: • Ansigtsmerter
English: • Tear or hole or bleeding in your stomach or intestine, inflammation or tear of anus, , bleeding in lungs or trachea (airway)
Danish: • Rift eller hul eller blødning i din mave eller tarmene, inflammation eller rift i endetarmsåbningen, blødninger i lungerne eller luftrøret
English: The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80 mg orange capsule and three 20 mg grey capsules.
Danish: Den anbefalede dosis COMETRIQ er 140 mg én gang daglig, taget som én 80 mg orange kapsel og tre 20 mg grå kapsler.
English: • Swelling, pain in your hands and feet, or shortness of breath.
Danish: • Hævelse, smerter i dine hænder og fødder, eller kortåndethed.
English: Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Danish: Administration af MRP2-hæmmere kan resultere i øget cabozantinib-plasmakoncentration.
English: What you need to know before you take COMETRIQ
Danish: Det skal du vide, før du begynder at tage COMETRIQ
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu hjemmeside og på Lægemiddelstyrelsens hjemmeside www.dkma.dk.
English: Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Danish: Samtidig administration af cabozantinib med den stærke CYP3A4-inducer rifampicin resulterede i et fald i cabozantinib plasmaeksponering.
English: Black iron oxide (E172) Propylene glycol
Danish: Sort jernoxid (E172) Propylenglycol
English: • 100 mg (1 orange 80 mg capsule and 1 grey 20 mg capsule)
Danish: • 100 mg (1 orange 80 mg kapsel og 1 grå 20 mg kapsel)
English: Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Danish: Samtidige administreret lægemidler der er potente hæmmere af CYP3A4, bør anvendes med forsigtighed, og kronisk administration af lægemidler, der er potente induktorer af CYP3A4, bør undgås (se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Dispensing instructions
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Dispenseringsinstruktioner
English: Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Danish: Administration af MRP2-hæmmere kan derfor resultere i øget cabozantinib-plasmakoncentration.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Danish: Palmoplantar erytrodysæstesi-syndrom (PPES) er blevet observeret med cabozantinib.
English: Events of venous thromboembolism and events of arterial thromboembolism have been observed with cabozantinib.
Danish: Bivirkninger i form af venøs thromboemboli og arteriel thromboemboli er blevet observeret med cabozantinib.
English: 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.
Danish: Kronisk co-administration af potente CYP3A4inducere (f.eks. phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler indeholdende perikon [Hypericum perforatum]) med cabozantinib bør derfor undgås.
English: Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
Danish: Cabozantinib anbefales ikke til patienter med svært nedsat leverfunktion, da sikkerheden og virkningen ikke er blevet fastslået hos denne population.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 mennesker)
English: Other medicines and COMETRIQ
Danish: Brug af anden medicin sammen med COMETRIQ
English: - Capsule contents: microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, silica colloidal anhydrous, and stearic acid
Danish: - Kapsel indhold: mikrokrystallinsk cellulose, croscarmellosenatrium, natriumstivelsesglycolat, kolloid vandfri silica og stearinsyre.
English: Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Danish: Samtidig administration af cabozantinib med den stærke CYP3A4-hæmmer ketoconazol resulterede i en øgning i cabozantinib plasmaeksponering.
English: • Inflammation of the lips and corners of the mouth
Danish: • Inflammation af læberne eller mundvigene
English: Titanium dioxide (E171)
Danish: Sort jernoxid (E172) Titandioxid (E171)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside og på Lægemiddelstyrelsens hjemmeside www.dkma.dk.
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Danish: 5.2), kan plasmaprotein fortrænges, som en mulig interaktion med warfarin.
English: 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%.
Danish: Administration af den potente CYP3A4-inducer rifampicin (600 mg daglig i 31 dage) til raske frivillige øgede cabozantinib-clearance (4,3 gange) og reducerede eksponeringen af cabozantinib i plasma (AUC) efter en enkelt dosis med 77 %.
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, and abdominal pain
Danish: • Uro i maven, inklusive diaré, kvalme, opkastning, forstoppelse, fordøjelsesbesvær og mavesmerter
English: Investigations weight decreased, serum ALT, AST, and ALP increased, blood LDH increased, blood TSH increased, lymphopenia, neutropenia, thrombocytopenia blood creatinine phosphokinase increased activated partial thromboplastin time shortened, eosinophil count increased, platelet count increased
Danish: Undersøgelser vægttab, ALAT, ASAT og alkalisk fosfatase i serum forhøjet, blod-LDH forhøjet, blod-TSH forhøjet, lymfopeni, neutropeni, trombocytopeni blodkreatinkinase forhøjet aktiveret partiel tromboplastintid forkortet, eosinofiltælling forhøjet, trombocyttælling forhøjet
English: Vascular disorders hypertension hypotension, venous thrombosis, pallor, peripheral coldness arterial thrombosis Aneurysms and artery dissections
Danish: Vaskulære sygdomme hypertension hypotension, venøs trombose, bleghed, perifer kølighed arteriel trombose Aneurismer og arterielle dissektioner
English: Cabozantinib should be discontinued in patients who experience ONJ.
Danish: Cabozantinib skal seponeres hos patienter, der oplever ONJ.
English: CYP3A4 inhibitors and inducers
Danish: CYP3A4-hæmmere og -inducere
English: Nervous system disorders dysgeusia, headache, dizziness cerebrovascular accident, peripheral neuropathy, paraesthesia, ageusia, tremor ataxia, disturbance in attention, hepatic encephalopathy, loss of consciousness, speech disorder, posterior reversible encephalopathy syndrome
Danish: Nervesystemet dysgeusi, hovedpine, svimmelhed cerebrovaskulær hændelse, perifer neuropati, paræstesi, ageusi, tremor ataksi, opmærksomhedsforstyrrelse, hepatisk encefalopati, bevidsthedstab, talebesvær, posterior reversibelt encefalopatisyndr om
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, hair colour changes, rash, dry skin, alopecia, erythema hyperkeratosis, acne, blister, hair growth abnormal, skin exfolation, skin hypopigmentation skin ulcer, telangiectasia
Danish: Hud og subkutane væv palmoplantar erytrodysæstesisyndrom, ændringer i hårfarve, udslæt, tør hud, alopeci, erytem hyperkeratose, akne, blister, unormal hårvækst, hudafskalning, hypopigmentation af huden hudsår, telangiectasi
English: • Redness, swelling or pain in the mouth or throat, difficulty in speaking, hoarseness
Danish: • Rødmen, hævelse eller smerter i munden eller svælget, taleproblemer, hæshed
English: Each daily dose is given in one row and contains three 20 mg capsules:
Danish: Hver daglig dosis gives i én række og indeholder tre 20 mg kapsler:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD, 100 mg dose
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BLISTERKORT, 100 mg dosis
English: 140 mg Dose
Danish: 140 mg dosis
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Catalent UK Packaging Limited
English: Events of osteonecrosis of the jaw (ONJ) have been observed with cabozantinib.
Danish: Bivirkninger med osteonekrose af kæben (ONJ) er blevet observeret med cabozantinib.
English: Reversible posterior leukoencephalopathy syndrome
Danish: Reversibelt posterior leukoencephalopatisyndrom
English: Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinu m, tracheooesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Danish: Luftveje, thorax og mediastinum dysfoni, orofaryngeale smerter ikkegastrointestinal fistel (inklusive trakeal, pneumomediastin um, trakeoøsofageal), lungeemboli, blødning i luftvejene (inklusive pulmonær, bronchial, trakeal), aspirationspneum oni atelektase, faryngealt ødem, pneumonitis
English: See also section 4 “Possible side effects”.
Danish: 4 “Bivirkninger”.
English: EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Danish: EU/1/13/890/002 7 x 20 mg og 7 x 80 mg kapsler (100 mg/dag dosis som forsyning til 7 dage) EU/1/13/890/003 21 x 20 mg og 7 x 80 mg kapsler (140 mg/dag dosis som forsyning til 7 dage) EU/1/13/890/005 56 kapsler (4 blisterkort med 7 x 20 mg og 7 x 80 mg) (100 mg/dag dosis som forsyning til 28 dage)
English: • Chills, tremors
Danish: • Kulderystelser, rysten
English: Uncommon side effects (may affect 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan påvirke 1 ud af 100 mennesker)
English: • Inflammation in the eye, cataracts
Danish: • Inflammation i øjnene, grå stær
English: What COMETRIQ looks like and contents of the pack COMETRIQ 20 mg capsules are grey and have “XL184 20mg” printed on one side.
Danish: COMETRIQ 20 mg kapsler er grå og har “XL184 20mg” trykt på den ene side.
English: Reproductive system and breast disorders amenorrhoea, vaginal haemorrhage
Danish: Graviditet, puerperium og den perinatale periode amenorré, vaginalblødning
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Danish: Denne indlægsseddel blev senest ændret Dette lægemiddel er godkendt under ”betingede omstændigheder”.
English: 100 mg Dose
Danish: 100 mg dosis
English: 60 mg Dose
Danish: 60 mg dosis
English: CYP3A4 inducers and inhibitors
Danish: CYP3A4-inducere og -hæmmere
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD 140 mg dose
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BLISTERKORT 140 mg dosis
English: • Abnormal connection of the tissue in your trachea (airway), oesophagus, or lungs
Danish: • Abnorm forbindelse af vævet i dit luftrør, spiserør eller lunger
English: • Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
Danish: • Nedsat aktivitet i skjoldbruskkirtlen; symptomer kan omfatte: træhed, vægtøgning,
English: Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Danish: Hver 140 mg daglig dosis består af en kombination af tre grå 20 mg kapsel og én orange 80 mg kapsel.
English: Pack for the 100 mg daily dose
Danish: Pakning til 100 mg daglig dosis
English: How to take COMETRIQ
Danish: Sådan skal du tage COMETRIQ
English: Pack for the 140 mg daily dose
Danish: Pakning til 140 mg daglig dosis
English: 140 mg/day dose
Danish: 140 mg/dag dosis
English: Hypertension has been observed with cabozantinib.
Danish: Hypertension er blevet observeret med cabozantinib.
English: Each 60 mg daily dose contains a combination of three grey 20 mg capsules.
Danish: Hver 60 mg daglig dosis består af tre grå 20 mg kapsler.
English: Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.
Danish: Hver 100 mg daglig dosis består af én grå 20 mg kapsel og én orange 80 mg kapsel.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Disse bivirkninger er ikke observeret i kliniske studier, men anses for at være klinisk relevante:
English: EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
Danish: EU/1/13/890/001 21 x 20 mg kapsler (60 mg/dag dosis som forsyning til 7 dage) EU/1/13/890/004 84 kapsler (4 blisterkort med 21 x 20 mg) (60 mg/dag dosis som forsyning til
English: Pack for the 60 mg daily dose 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) Each 60 mg daily dose contains three grey 20 mg capsules.
Danish: 21 x 20 mg kapsler (60 mg/dag dosis til forsyning i 7 dage) Hver 60 mg daglig dosis består af tre grå 20 mg kapsler.
English: 100 mg/day dose
Danish: 100 mg/dag dosis
English: The COMETRIQ 80 mg capsules contain cabozantinib (S)-malate equivalent to 80 mg of cabozantinib.
Danish: COMETRIQ 80 mg kapslerne indeholder cabozantinib (S)-malat svarende til 80 mg cabozantinib.
English: • Inflammation of the oesophagus; symptoms can include heartburn, chest pain, feeling sick, altered taste, bloating, belching and indigestion
Danish: • Inflammation af spiserøret; symptomer kan omfatte halsbrand, brystsmerter, følen sig syg,
English: The 100 mg daily dose blister card contains seven 80 mg capsules and seven 20 mg capsules as 7 daily doses in total.
Danish: Blisterkortet for 100 mg daglig dosis indeholder syv 80 mg kapsler og syv 20 mg kapsler som 7 daglige doser totalt.
English: Each daily dose is provided in one row and contains one 80 mg capsule and one 20 mg capsule:
Danish: Hver daglig dosis findes i én række og indeholder én 80 mg kapsel og én 20 mg kapsel:
English: Each daily dose is provided in one row and contains one 80 mg capsule and three 20 mg capsules:
Danish: Hver daglig dosis findes i én række og indeholder én 80 mg kapsel og tre 20 mg kapsler:
English: 60 mg/day dose
Danish: 60 mg/dag dosis
English: COMETRIQ 80 mg hard capsules
Danish: COMETRIQ 80 mg hårde kapsler
English: • Joint pain, muscle spasms
Danish: • Tab af smagsans
English: COMETRIQ 20 mg hard capsules
Danish: COMETRIQ 20 mg hårde kapsler
English: Wound complications have been observed with cabozantinib.
Danish: Sårkomplikationer er blevet observeret med cabozantinib.
English: The 60 mg daily dose blister card contains twenty-one 20 mg capsules as 7 daily doses in total.
Danish: Blisterkortet for 60 mg daglig dosis indeholder énogtyve 20 mg kapsler som 7 daglige doser totalt.
English: Renal and urinary disorders proteinuria, dysuria, haematuria renal failure acute
Danish: Nyrer og urinveje proteinuri, dysuri, hæmaturi akut nyreinsufficiens
English: 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
Danish: 7 x 20 mg og 7 x 80 mg kapsler (100 mg/dag dosis som forsyning til 7 dage) eller 21 x 20 mg og 7 x 80 mg kapsler (140 mg/dag dosis som forsyning til 7 dage)
English: The 140 mg daily dose blister card contains seven 80 mg capsules and twenty one 20 mg capsules as 7 doses in total.
Danish: Blisterkortet for 140 mg daglig dosis indeholder syv 80 mg kapsler og énogtyve 20 mg kapsler som 7 doser totalt.
English: The COMETRIQ 20 mg capsules contain cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Danish: COMETRIQ 20 mg kapslerne indeholder cabozantinib (S)-malat svarende til 20 mg cabozantinib.
English: 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for a 28 day supply) 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for a 28 day supply)
Danish: 56 kapsler (4 blisterkort med 7 x 20 mg og 7 x 80 mg) (100 mg/dag dosis som forsyning til 28 dage) 112 kapsler (4 blisterkort med 21 x 20 mg og 7 x 80 mg) (140 mg/dag dosis som forsyning til 28 dage)
English: PHARMACEUTICAL FORM AND CONTENTS 100 mg Dose 28 day pack: 56 capsules (4 blister cards of 7 x 20 mg capsules and 7 x 80 mg capsules) for the 100 mg daily dose for a 28 day supply.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 mg dosis 28-dages pakning: 56 kapsler (4 blisterkort med 7 x 20 mg kapsler og 7 x 80 mg kapsler) (100 mg/dag dosis til forsyning i 28 dage).
English: Therefore chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Danish: Derfor bør kronisk administration af midler, der er stærke CYP3A4-inducere, med cabozantinib undgås.
English: 21 x 20 mg capsules (60 mg/day dose for a 7-day supply).
Danish: 21 x 20 mg kapsler (60 mg/dag dosis til forsyning i 7 dage).
English: COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules
Danish: COMETRIQ 20 mg hårde kapsler COMETRIQ 80 mg hårde kapsler
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cabozantinib (S)-malat svarende til 20 mg cabozantinib.
English: 7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).
Danish: 7 x 20 mg kapsler og 7 x 80 mg kapsler (100 mg/dag dosis til forsyning i 7 dage).
English: Proteinuria has been observed with cabozantinib.
Danish: Proteinuri er blevet observeret med cabozantinib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/890/005 56 kapsler (4 blisterkort med 7 x 20 mg og 7 x 80 mg) (100 mg/dag dosis til forsyning i 28 dage)
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply).
Danish: 21 x 20 mg kapsler og 7 x 80 mg kapsler (140 mg/dag dosis til forsyning i 7 dage).
English: EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28
Danish: EU/1/13/890/006 112 kapsler (4 blisterkort med 21 x 20 mg og 7 x 80 mg) (140 mg/dag dosis som forsyning til 28 dage)
English: PHARMACEUTICAL FORM AND CONTENTS 60 mg Dose 28 day pack: 84 capsules (4 blister cards of 21 x 20 mg capsules) for the 60 mg daily dose for a 28 day supply.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 mg dosis 28-dages pakning: 84 kapsler (4 blisterkort med 21 x 20 mg kapsler) (60 mg/dag dosis til forsyning i 28 dage).
English: Hepatobiliary disorders cholelithiasis
Danish: Lever og galdeveje cholelithiasis
English: COMETRIQ 20 mg COMETRIQ 80 mg 100 mg/day dose
Danish: COMETRIQ 20 mg COMETRIQ 80 mg
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
Danish: Én hård kapsel indeholder cabozantinib (S)-malat svarende til 20 mg eller 80 mg cabozantinib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/890/002
English: Gastrointestinal disorders diarrhoea, nausea, stomatitis, constipation, vomiting, abdominal pain, dyspepsia, dysphagia, glossodynia gastrointestinal perforation, gastrointestinal haemorrhage, pancreatitis, haemorrhoids, anal fissure, anal inflammation, cheilitis gastrointestinal fistula, oesophagitis
Danish: Ikke kendt opkastning, abdominalsmerter, dyspepsi, dysfagi, glossodyni hæmoragi, pancreatitis, hæmorrider, analfissurer, analinflammation, cheilitis
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER(-NUMRE) EU/1/13/890/001
English: PHARMACEUTICAL FORM AND CONTENTS 140 mg Dose 28 day pack: 112 capsules (4 blister cards of 21 x 20 mg capsules and 7 x 80 mg capsules) for the 140 mg daily dose for a 28 day supply.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 140 mg dosis 28-dages pakning: 112 kapsler (4 blisterkort med 21 x 20 mg kapsler og 7 x 80 mg kapsler (140 mg/dag dosis til forsyning i 28 dage).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/890/003