FrancophonIA/ELRC3.0 huggingface dataset:
English: By Day 14, combined plasma concentrations of sunitinib and its active metabolite are 62.9-101 ng/ml, which are target concentrations predicted from preclinical data to inhibit receptor phosphorylation in vitro and result in tumour stasis/growth reduction in vivo.
Danish: På dag 14 er den kombinerede plasmakoncentration af sunitinib og dets aktive hovemetabolit 62,9-101 ng/ml.
English: • Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
Danish: • Unormal berøringsfølelse i huden, kløende, skallende og betændt hud, blærer, bumser,
English: Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported.
Danish: Der er set tilfælde af gangrænøs pyoderma, der normalt var reversibelt efter behandlingsophør.
English: BLISTER OUTER CARTON - 12.5 MG CAPSULES
Danish: BLISTER YDRE KARTON - 12,5 mg KAPSLER
English: Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patients receiving placebo.
Danish: I et fase 3 GIST-studie forekom blødningshændelser hos 18% af patienterne, der fik sunitinib, sammenlignet med 17% af patienterne, der fik placebo.
English: If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg steps (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET) based on careful monitoring of tolerability.
Danish: Hvis dette ikke er muligt, kan det være nødvendigt at øge dosis af sunitinib med en dosistilvækst på 12,5 mg ad gangen (op til 87,5 mg dagligt ved GIST og mRCC eller 62,5 mg dagligt ved pNET) med omhyggelig monitorering af tolerabilitet.
English: T3 increase was reported in 1 (0.8%) patient on sunitinib and no patients on capecitabine.
Danish: Der sås forhøjet T3 hos 1 (0,8%) patient på sunitinib, men ikke hos patienter i behandling med capecitabin.
English: 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Danish: 37,5 mg hårde kapsler Hver kapsel indeholder sunitinibmalat, svarende til 37,5 mg sunitinib.
English: Sutent 37.5 mg hard capsules sunitinib
Danish: Sutent 37,5 mg hårde kapsler sunitinib
English: g Abdominal abscess, abdominal sepsis, diverticulitis, and osteomyelitis.
Danish: Abdominal absces, abdominal sepsis, divertikulitis og osteomyelitis Trombotisk mikroangiopati, trombotisk trombocytopenisk purpura og hæmolytisk uræmisk syndrom Nedsat appetit og appetitløshed
English: BLISTER OUTER CARTON - 37.5 MG CAPSULES
Danish: BLISTER YDRE KARTON - 37,5 MG KAPSLER
English: Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment Schedule 4 weeks on /2 weeks off (“Schedule 4/2”).
Danish: 55 patienter fik 50 mg sunitinib og den anbefalede behandlingscyklus på 4 på hinanden følgende uger og 2 uger uden behandling (doseringsskema 4/2).
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: forekommer hos optil 1 ud af 10 personer
English: Skin hyperpigmentation Skin lesion Hyperkeratosis Dermatitis Nail disorderw
Danish: Hudlæsioner Hyperkeratose Dermatitis Neglesygdomme
English: Thirteen patients (3%) receiving sunitinib in the Phase 3 treatment-naïve MRCC study and 4 patients (2%) on the 2 cytokine-refractory MRCC studies had venous thromboembolic events reported.
Danish: Venøse tromboemboliske hændelser blev rapporteret hos 13 af patienterne (3%), der fik sunitinib i det behandlingsnaive fase 3 mRCC-studie og hos 4 af patienterne (2%) i de 2 cytokin-refraktære mRCCstudier.
English: If this is not possible, the dose of Sutent may need to be increased in 12.5 mg increments (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET), based on careful monitoring of tolerability (see section 4.2).
Danish: Hvis dette ikke er muligt, bør dosis af Sutent øges med 12,5 mg ad gangen (op til 87,5 mg dagligt ved GIST og mRCC eller 62,5 mg dagligt ved pNET) med omhyggelig monitorering af tolerabilitet (se pkt.
English: If this is not possible, the dose of Sutent may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability (see section 4.2).
Danish: Hvis dette ikke er muligt, bør dosis af Sutent nedsættes til minimum 37,5 mg dagligt ved GIST og mRCC eller 25 mg dagligt ved pNET med omhyggelig monitorering af tolerabilitet (se pkt.
English: For pNET, dose modification in 12.5 mg steps may be applied based on individual safety and tolerability.
Danish: På baggrund af individuel sikkerhed og tolerabilitet kan dosis justeres med en dosisøgning på 12,5 mg ad gangen ved pNET.
English: Concomitant administration of sunitinib with potent CYP3A4 inhibitors should be limited because of the possible increase in sunitinib plasma concentrations (see sections 4.2, 4.5 and 4.8).
Danish: Samtidig administration af sunitinib og potente CYP3A4-hæmmere, bør begrænses på grund af den mulige øgning af sunitinibs plasmakoncentration (se pkt.
English: Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Danish: Alvorlige hudreaktioner (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og erythema multiforme) er rapporteret ved anvendelse af sunitinib.
English: Temporary suspension of sunitinib is recommended; following resolution, treatment may be resumed at the discretion of the treating physician (see section 4.8).
Danish: Efter resolution kan behandlingen genoptages efter den behandlende læges skøn (se pkt.
English: However, in repeated-dose toxicity studies performed in rats and monkeys, effects on female fertility were observed in the form of follicular atresia, degeneration of corpora lutea, endometrial changes in the uterus, and decreased uterine and ovarian weights at clinically relevant systemic exposure levels.
Danish: Derimod er der i kroniske studier i rotter og aber forandringer i hunkønsorganerne i form af follikulær atresi, degeneration af corpora lutea, endometrielæsioner og nedsat vægt af uterus og ovarier, som viser sig ved klinisk relevant systemisk eksponering, og i hankønsorganerne hos rotter i form af tubulær testikelatrofi, nedsat forekomst af sædceller i bitestiklerne og nedsat forekomst af kolloid i prostata og sædblærer ved plasmakoncentrationer, der var 25 gange højere end human eksponering.
English: Hyperthyroidism Thyroiditis
Danish: Artralgi Rygsmerter
English: Cerebral haemorrhage* Cerebrovascular accident*
Danish: Cerebral blødning Cerebrovaskulær hændelse
English: Sutent 50 mg hard capsules sunitinib
Danish: Sutent 50 mg hårde kapsler sunitinib
English: Sutent 37.5 mg is supplied as hard gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, containing yellow to orange granules.
Danish: Sutent 37,5 mg er hårde gelatinekapsler med gul overdel og gul underdel, der med sort blæk er mærket ”Pfizer” på overdelen, ”STN 37,5 mg” på underdelen, indeholdende et gult til orange granulat.
English: Sutent 25 mg hard capsules sunitinib
Danish: Sutent 25 mg hårde kapsler sunitinib
English: Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5).
Danish: Samtidig anvendelse af potente CYP3A4-induktorer bør undgås, da det kan nedsætte plasmakoncentrationen af sunitinib (se pkt.
English: - Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide
Danish: Trykkeblæk: shellac, propylenglycol, natriumhydroxid, povidon og titandioxid (E171).
English: The long-term safety of sunitinib in patients with MRCC was analysed across 9 completed clinical studies conducted in the first-line, bevacizumab-refractory, and cytokine-refractory treatment settings in 5,739 patients, of whom 807 (14%) were treated for ≥ 2 years up to 6 years.
Danish: Sunitinibs langtidssikkerhed hos patienter med mRCC er analyseret på tværs af 9 afsluttede kliniske studier udført i 1. linie, bevacizumab-refraktære og cytokin-refraktære behandlingsforløb.
English: Palmar-plantar erythrodysaesthesia syndrome Rashu
Danish: Palmoplantar erytrodysæstesisyndrom
English: Sutent 12.5 mg hard capsules sunitinib
Danish: Sutent 12,5 mg hårde kapsler sunitinib
English: c Abscess, abscess limb, anal abscess, gingival abscess, liver abscess, pancreatic abscess, perineal abscess, perirectal abscess, rectal abscess, subcutaneous abscess, and tooth abscess.
Danish: Bronkitis, nedre luftvejsinfektioner, pneumonitis og luftvejsinfektion Absces, abscesser i ekstremiteter, analabsces, tandkødsabsces, leverabsces, pancreas-absces, perineal absces, perirektal absces, rektal absces, subkutan absces og tandrodsabsces Øsofageal candidiasis og oral candidiasis
English: 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Danish: 50 mg hårde kapsler Hver kapsel indeholder sunitinibmalat, svarende til 50 mg sunitinib.
English: Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see also section 4.4).
Danish: Der er set tilfælde af nekrotiserende fasciitis, inklusive perineum, hvoraf nogle var letale (se også pkt.
English: 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Danish: 12,5 mg hårde kapsler Hver kapsel indeholder sunitinibmalat svarende til 12,5 mg sunitinib.
English: • Dehydration.
Danish: • Væskemangel (dehydrering).
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Black iron oxide (E172)
Danish: Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172) Sort jernoxid (E172)
English: BLISTER OUTER CARTON - 50 MG CAPSULES
Danish: BLISTER YDRE KARTON - 50 MG KAPSLER
English: 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Danish: 25 mg hårde kapsler Hver kapsel indeholder sunitinibmalat, svarende til 25 mg sunitinib.
English: Sutent 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, containing yellow to orange granules.
Danish: Sutent 12,5 mg er hårde gelatinekapsler med orange overdel og orange underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen, ”STN 12,5 mg” på underdelen, indeholdende et gult til orange granulat.
English: - If you have or have had kidney problems.
Danish: - Hvis du har eller har haft hudproblemer.
English: Blood TSH decrease was reported in 3 (1.3%) patients on sunitinib and no patients on capecitabine.
Danish: Der sås nedsat TSH i blodet hos 3 (1,3%) patienter i behandling med sunitinib, men ikke hos patienter i behandling med capecitabin.
English: BLISTER OUTER CARTON - 25 MG CAPSULES
Danish: BLISTER YDRE KARTON - 25 MG KAPSLER
English: Sutent 37.5 mg hard capsules EU/1/06/347/007
Danish: Sutent 37,5 mg hårde kapsler EU/1/06/347/007
English: Sutent 12.5 mg hard capsules EU/1/06/347/001
Danish: Sutent 12,5 mg hårde kapsler EU/1/06/347/001
English: - If you have or have had seizures.
Danish: - Hvis du har eller har haft problemer med nyrerne.
English: HDPE BOTTLE OUTER CARTON - 37.5 MG CAPSULES
Danish: HDPE-BEHOLDER YDRE KARTON - 37,5 MG KAPSLER
English: The PK of gefitinib (250 mg daily) and sunitinib (37.5 mg [Cohort 1, n=4] or 50 mg [Cohort 2, n=7] daily on a 4-weeks on followed by 2 weeks-off schedule) when co-administered was evaluated as a secondary study objective.
Danish: Dette studie var et multicenter, open-label, fase 1/2-studie til undersøgelse af sikkerhed/tolerabilitet, maksimalt tolereret dosis og sunitinibs antitumoraktivitet i kombination med gefitinib hos forsøgspersoner med mRCC. PK-værdien af gefitinib (250 mg dagligt) og sunitinib (37,5 mg [kohorte 1, n=4] eller 50 mg [kohorte 2, n=7] dagligt i 4 uger med 2 ugers pause) ved samtidig administration blev evalueret som et sekundært studieformål.
English: Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules.
Danish: Gelatinekapsler med gul overdel og gul underdel, der med sort blæk er mærket ”Pfizer” på overdelen og ”STN 37,5 mg” på underdelen, og som indeholder gule til orange granulater.
English: HDPE BOTTLE - 12.5 MG CAPSULES
Danish: HDPE-BEHOLDER - 12,5 MG KAPSLER
English: In clinical studies of sunitinib and from postmarketing surveillance, there have been few reports (< 1%), some fatal, of subjects presenting with seizures and radiological evidence of RPLS.
Danish: Der har været enkelte rapporter (<1%) fra kliniske studier og fra overvågning efter markedsføring om personer med kramper og radiologiske tegn på reversibelt posteriort leukoencefalopatisk syndrom (RPLS), heraf nogle med letalt udfald.
English: Co-administration with potent CYP3A4 inhibitors should be avoided because it may increase the plasma concentration of sunitinib (see sections 4.2 and 4.5).
Danish: Samtidig anvendelse af potente CYP3A4-hæmmere bør undgås, da det kan øge plasmakoncentrationen af sunitinib (se pkt.
English: Sutent may affect the way your wounds heal.
Danish: Sutent kan påvirke sårhelingen.
English: q Gastrointestinal perforation and intestinal perforation.
Danish: Gastrointestinal perforation q,*
English: Skin discolourationt
Danish: Misfarvning af huden
English: Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules.
Danish: Gelatinekapsler med orange overdel og orange underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen og ”STN 12.5 mg” på underdelen, og som indeholder gule til orange granulater.
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Danish: Kapselskal: gelatine, titandioxid (E171), gul jernoxid (E172).
English: Four out of 6 patients (66.7%) experienced Grade 3-4 treatment-related adverse events (Grade 3 hypophosphataemia, neutropenia, and thrombocytopenia in 1 patient each and a Grade 4 neutropenia in 1 patient).
Danish: De rapporterede bivirkninger af grad 3 var hypofosfatæmi, neutropeni og trombocytopeni hos 1 patient hver og en grad 4 bivirkning af neutropeni hos 1 patient.
English: HDPE BOTTLE - 25 MG CAPSULES
Danish: HDPE-BEHOLDER - 25 MG KAPSLER
English: Osteonecrosis of the jaw
Danish: Osteonekrose af kæben
English: Uncommon cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see section 4.8).
Danish: Der er ikke almindeligt rapporteret tilfælde af nekrotiserende fasciitis, inklusive i perineum, hvoraf nogle var letale (se pkt.
English: Sutent 50 mg hard capsules EU/1/06/347/003
Danish: Sutent 50 mg hårde kapsler EU/1/06/347/003
English: Sutent 25 mg hard capsules EU/1/06/347/002
Danish: Sutent 25 mg hårde kapsler EU/1/06/347/002
English: Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib.
Danish: Hver kapsel indeholder sunitinibmalat svarende til 12,5 mg sunitinib
English: HDPE BOTTLE - 37.5 MG CAPSULES
Danish: HDPE-BEHOLDER - 37,5 MG KAPSLER
English: HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES
Danish: HDPE-BEHOLER YDRE KARTON - 12,5 MG KAPSLER
English: Red iron oxide (E172) Titanium dioxide (E171) Yellow iron oxide (E172) Black iron oxide (E172)
Danish: Rød jernoxid (E172) Titandioxid (E171) Gul jernoxid (E172) Sort jernoxid (E172)
English: HDPE BOTTLE - 50 MG CAPSULES
Danish: HDPE-BEHOLDER - 50 MG KAPSLER
English: Vomiting Diarrhoea Dyspepsia Nausea Constipation
Danish: Lungeemboli Pleuraeffusion Hæmoptyse Dyspnø ved anstrengelse Orofaryngeal smerte
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Danish: Titandioxid (E171) Gul jernoxid (E172)
English: Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Danish: Hver kapsel indeholder sunitinibmalat svarende til 37,5 mg sunitinib.
English: Seven patients (3%) on sunitinib and none on placebo in a Phase 3 GIST study experienced venous thromboembolic events; 5 of the 7 were Grade 3 deep venous thrombosis (DVT) and 2 were Grade 1 or 2.
Danish: 5 ud af de 7 var grad 3 dyb venetrombose (DVT), og 2 var grad 1 eller 2.
English: • Nasal dryness, congested nose.
Danish: • Tørhed i næsen, tilstoppet næse.
English: Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Danish: Hver kapsel indeholder sunitinibmalat svarende til 50 mg sunitinib.
English: Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Danish: Hver kapsel indeholder sunitinibmalat svarende til 25 mg sunitinib.
English: • Acid heartburn.
Danish: • Halsbrand.
English: NA 0.004 10.1 (5.0,
Danish: 4.4 og 4.5).
English: Sutent 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, containing yellow to orange granules.
Danish: Sutent 25 mg er hårde gelatinekapsler med karamelfarvet overdel og orange underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen, ”STN 25 mg” på underdelen, indeholdende et gult til orange granulat.
English: (not to exceed the total dose of 50 mg/day) based on individual patient safety/tolerability.
Danish: 5.1), som hos pædiatriske patienter med GIST blev øget til 22,5 mg/m2 og efterfølgende til 30 mg/m 2 (måtte ikke overstige en totaldosis på 50 mg/dag) baseret på individuel sikkerhed og tolerabilitet.
English: Sutent 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, containing yellow to orange granules.
Danish: Sutent 50 mg er hårde gelatinekapsler med karamelfarvet overdel og karamelfarvet underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen, ”STN 50 mg” på underdelen, indeholdende et gult til orange granulat.
English: Hypothyroidism
Danish: Hypotyreose
English: Hepatic impairment
Danish: Hæmatologiske lidelser
English: Oedemay
Danish: Erytem
English: Dizziness Headache Taste disturbancej
Danish: Svimmelhed Hovedpine Smagsforstyrrelser
English: - If you have abnormal heart rhythm changes.
Danish: - Hvis du har forstyrrelser i hjerterytmen.
English: HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES
Danish: HDPE-BEHOLDER YDRE KARTON - 50 MG KAPSLER
English: HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES
Danish: HDPE-BEHOLDER YDRE KARTON - 25 MG KAPSLER
English: Tumour haemorrhage*
Danish: Nyrer og urinveje
English: In some cases of suspected EM, patients tolerated the reintroduction of sunitinib therapy at a lower dose after resolution of the reaction; some of these patients also received concomitant treatment with corticosteroids or antihistamines (see section 4.8).
Danish: Nogle af disse patienter blev også samtidigt behandlet med kortikosteroider eller antihistaminer (se pkt.
English: Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules.
Danish: Gelatinekapsler med karamelfarvet overdel og orange underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen og ”STN 25 mg” på underdelen, og som indeholder gule til orange granulater.
English: In the same study, 4 out of 6 patients (66.7%) experienced Grade 3-4 treatment-related adverse events (Grade 3 hypophosphataemia, neutropenia, and thrombocytopenia in 1 patient each and a Grade 4 neutropenia in 1 patient).
Danish: I det samme studie oplevede 4 ud af 6 patienter (66,7 %) bivirkninger af grad 3-4.
English: 37.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Danish: 37,5 mg hårde kapsler Kapselindhold Mannitol (E421) Croscarmellosenatrium Povidon (K-25) Magnesiumstearat
English: Fistula
Danish: Fistler
English: • Hot flushes.
Danish: • Rygsmerter, ledsmerter.
English: Interim 6.8 (3.7, 11.1)
Danish: 84,3 (72,9 til 95,1)
English: In case of symptomatic hypoglycaemia, sunitinib should be temporarily interrupted.
Danish: Der anbefales midlertidig afbrydelse af sunitinib.
English: Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules.
Danish: Gelatinekapsler med karamelfarvet overdel og karamelfarvet underdel, der med hvidt blæk er mærket ”Pfizer” på overdelen og ”STN 50 mg” på underdelen, og som indeholder gule til orange granulater.
English: 50 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Danish: 50 mg hårde kapsler Kapselindhold Mannitol (E421) Croscarmellosenatrium Povidon (K-25) Magnesiumstearat
English: Haemorrhage and tumour bleeding
Danish: Blødning og tumorblødning
English: Co-administration of sunitinib with potent CYP3A4 inducers or inhibitors should be avoided because the plasma levels of sunitinib may be altered (see sections 4.4 and 4.5).
Danish: Samtidig administration af sunitinib og den potente CYP3A4-induktor eller -hæmmer bør undgås, da dette kan påvirke plasmakoncentrationen af sunitinib.
English: 25 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Danish: 25 mg hårde kapsler Kapselindhold Mannitol (E421) Croscarmellosenatrium Povidon (K-25) Magnesiumstearat
English: PFS (weeks)
Danish: mg/dag).
English: Renal failure* Renal failure acute* Chromaturia Proteinuria
Danish: Nyresvigt Nyresvigt, akut Kromaturi Proteinuri
English: (based on the MTD identified in the Phase 1 dose-escalation study, see section 5.1), which in paediatric patients with GIST increased to 22.5 mg/m and subsequently to 30 mg/m
Danish: Startdosis i de pædiatriske studier var 15 mg/m 2 (baseret på maksimalt tolereret dosis i fase 1dosiseskaleringsstudiet, se pkt.
English: u Dermatitis psoriasiform, exfoliative rash, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, and rash pruritic.
Danish: Dermatitis psoriasiformis, eksfoliativt udslæt, udslæt, erytematøst udslæt, follikulært udslæt, generaliseret udslæt, makuløst udslæt, makulopapuløst udslæt, papuløst udslæt og kløende udslæt v
English: b Bronchitis, lower respiratory tract infection, pneumonia, and respiratory tract infection.
Danish: Abdominale smerter, nedre abdominalsmerter, øvre abdominalsmerter Gastrointestinal perforation og intestinal perforation Colitis og iskæmisk colitis
English: Sutent can cause thyroid gland problems.
Danish: Sutent kan give problemer med skjoldbruskkirtlen.
English: Cardiac disorders
Danish: Kardiovaskulære lidelser
English: Haemorrhage urinary tract
Danish: Hudafskalning Hudreaktioner Eksem
English: Nephrotic syndrome
Danish: Urinvejsblødning Nefrotisk syndrom
English: Lymphopoenia
Danish: Levertoksicitet
English: Printing ink
Danish: Muskelspasmer Myalgi
English: 12.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Danish: 12,5 mg hårde kapsler Kapselindhold Mannitol (E421) Croscarmellosenatrium Povidon (K-25) Magnesiumstearat
English: i
Danish: NA
English: Skin exfoliation Skin reactionv
Danish: Hyperpigmentering i huden
English: Hepatotoxicity
Danish: Hypertyreose
English: Viral infectionsa
Danish: Virusinfektioner Luftvejsinfektioner b
English: Gastrointestinal perforationq,* Pancreatitis Anal fistula Colitisr
Danish: Pankreatitis Analfistler Colitis
English: The primary efficacy endpoint was PFS. A planned interim analysis showed a statistically significant advantage for sunitinib over IFN-α, in this study, the median PFS for the sunitinib-treated group was 47.3 weeks, compared with 22.0 weeks for the IFN-α-treated group; the HR was 0.415 (95% CI: 0.320, 0.539; p-value < 0.001).
Danish: I dette studie var median-PFS for den sunitinib-behandlede gruppe 47,3 uger sammenlignet med 22,0 uger for den IFN-α-behandlede gruppe.
English: Hepatic failure* Cholecystitiss,* Hepatic function abnormal
Danish: Leversvigt Cholecystitis s,*
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
Danish: Kapselskal: gelatine, titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), sort jernoxid (E172).