natgillin/translations-raw huggingface dataset:
Et fase 1-dosiseskaleringsstudie med oral sunitinib blev udført hos 35 patienter, herunder 30 pædiatriske patienter (i alderen 3-17 år) og 5 unge voksne patienter (i alderen 18-21 år) med refraktære solide tumorer, hvoraf de fleste blev inkluderet med en hjernetumor som primær diagnose.
A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric patients (aged 3 years to 17 years) and 5 young adult patients (aged: 18 years to 21 years), with refractory solid tumours, the majority of whom were enrolled with a primary diagnosis of brain tumour.
Der er set gastroduodenale karcinomer, øget forekomst af baggrunds-hæmangiosarkomer og/eller hyperplasi af ventrikelslimhinden efter 1 eller 6 måneders behandling med doser på >25 mg/kg/dag (>7,3 gange AUC hos patienter behandlet med de anbefalede daglige doser [ADD]).
Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD).
De alvorligeste bivirkninger forbundet med sunitinib (hvoraf nogle har været letale) er nyresvigt, hjertesvigt, lungeemboli, gastrointestinal perforation og blødninger (f.eks. blødninger i luftvejene, gastrointestinale blødninger, tumorblødninger, blødninger i urinvejene og hjerneblødning).
The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages (e.g., respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages).
Der er begrænset viden om fortsat sunitinibbehandling af patienter med fistler (se pkt.
Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8).
Primært TTP (uger) Interim 27,3 (16,0-32,1) 6,4 (4,4-10,0) 0,329 (0,233-0,466) <0,001 Slut Sekundært PFS (uger) Interim 24,1 (11,1-28,3) 6,0 (4,4-9,9) 0,333 (0,238-0,467) <0,001 Slut ORR (%) Interim 6,8 (3,7-11,1)
Primary TTP (weeks) Interim 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001 Final
I et studie hos 24 patienter, i alderen 20-87 år med avanceret malign sygdom, er forlængelse af QTcintervallet undersøgt.
QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies.
Patienter, som havde haft hjertehændelser inden for 12 måneder før sunitinib-behandling, som f.eks. myokardieinfarkt (inklusive alvorlig/ustabil angina), koronar/perifer arterie bypass operation,
Patients who presented with cardiac events within 12 months prior to sunitinib administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischaemic attack, or pulmonary embolism were excluded from all sunitinib clinical studies.
Sutent 12,5 mg hårde kapsler Sutent 25 mg hårde kapsler Sutent 37,5 mg hårde kapsler Sutent 50 mg hårde kapsler sunitinib
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules sunitinib
Fortæl det til lægen, hvis du får hoste, smerter i brystet, pludseligt åndedrætsbesvær eller hoster blod op.
Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood.
Du må ikke amme, når du tager Sutent.
You should not breast-feed during treatment with Sutent.
Pulmonal blødning Respirationssvigt
Pulmonary haemorrhage* Respiratory failure*
Stomatitis Abdominalsmerter Opkastning Diarré
Stomatitiso Abdominal painp
Akut myokardieinfarkt, myokardieinfarkt og tavst myokardieinfarkt Orofaryngeale og faryngolaryngeale smerter
m Acute myocardial infarction, myocardial infarction, and silent myocardial infarction.
Kronisk venstresidig hjerteinsufficiens Myokardieinfarkt m,*
Cardiac failure congestive Myocardial infarctionm,* Cardiac failure* Cardiomyopathy*
• Unormale blodprøveresultater fx for bugspytkirtel- og leverenzymer.
• Abnormal blood tests including pancreatic and liver enzymes.
Fortæl det til lægen, hvis dit vandladningsmønster ændrer sig eller vandladningen ophører, det kan være symptomer på nyresvigt.
Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
Thyroideadysfunktion skal behandles efter gældende medicinsk praksis.
Patients who develop thyroid dysfunction should be treated as per standard medical practice.
I nogle tilfælde var bivirkningerne i overenstemmelse med sunitinibs kendte sikkerhedsprofil.
Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Der er rapporteret tilfælde af gangrænøs pyoderma , der generelt var reversibel efter seponering af behandlingen (se også pkt.
Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported (see also section 4.4).
Sutent bør ikke tages sammen med grapefrugtjuice.
You should avoid drinking grapefruit juice while on treatment with Sutent.
Der sås ikke hypertyreose hos patienter i behandling med sunitinib, men 1 (1,0%) patient i standardbehandling fik hypertyreose.
Hyperthyroidism was reported in no sunitinib-treated patients and 1 (1.0%) patient receiving standard of care.
Bisfosfonater er medicin til forebyggelse af knogleskørhed.
Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
- Hvis du har eller har haft sygdomme i blodet, blødningstendens eller tendens til blå mærker.
- If you have or have had blood disease, bleeding problems, or bruising.
Et ublindet fase 2-studie blev udført hos 29 patienter, herunder 27 pædiatriske patienter (i alderen 3 til 16 år) og 2 unge voksne patienter (i alderen 18 til 19 år) med gliom af høj grad eller ependymom.
A Phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 16 years) and 2 young adult patients (aged 18 years to 19 years) with HGG or ependymoma.
Der er set alvorlige inf ektioner, med eller uden neutropeni, inklusive letale tilfælde.
Serious infections, with or without neutropenia, including some with a fatal outcome, have been reported.
Trykkeblæk: shellac, propylenglycol, kaliumhydroxid, sort jernoxid (E172).
- Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Lægen vil tage blodprøver før og under behandlingen med Sutent, og hvis det ellers er nødvendigt.
Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.
4.8 nedenfor og som betragtes mulig relateret til sunitinib, omfatter multiorgansvigt, dissemineret intravaskulær koagulation, peritoneal blødning, adrenal insufficiens, pneumothorax, shock og pludselig død af ukendt årsag.
Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death.
I rotter med plasmakoncentrationer 5,5 gange højere end human eksponering medfører sunitinib-behandling ved >5 mg/kg/dag under organogenesen en forøget forekomst af skeletforandringer hos fostrene, fortrinsvis forsinket ossifikation af bryst- og lændehvirvlerne.
Sunitinib treatment in rats during organogenesis resulted in developmental effects at  5 mg/kg/day consisting of increased incidence of foetal skeletal malformations, predominantly characterised as retarded ossification of thoracic/lumbar vertebrae and occurred at plasma exposure levels 5.5 times the systemic exposure in humans.
Sutent kan give forstyrrelser i hjerterytmen.
Sutent can cause abnormality of your heart rhythm.
Ikke almindelige: forekommer hos op til 1 ud af 100 personer
Uncommon: may affect up to 1 in 100 people
Fortæl det til din læge, hvis du ammer.
Check with your doctor if you are not sure.
OS (uger) Interim Slut
Interim Final
I fase 3-studiet hos behandlingsnaive mRCC-patienter oplevede 0,6% af patienterne i IFN-α-armen og 0% af patienterne i sunitinib-armen letale hjertehændelser.
In a Phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the Phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN- arm and 0% of patients on the sunitinib arm experienced fatal cardiac events.
Samtidig anvendelse af sunitinib og potente CYP3A4-induktorer, som f.eks. rifampin bør undgås (se pkt.
Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see sections 4.4 and 4.5).
• Voldsom reaktion på allergifremkaldende stoffer, herunder høfeber, hududslæt, kløende hud,
• Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
Brunnerkirtelkarcinom i duodenum sås ved >1 mg/kg/dag hos hunrotter, ved 3 mg/kg/dag hos hanrotter og slimhindehyperplasi var tydelig i maveslimhinden ved 3 mg/kg/dag hos hanrotter, ved henholdsvis >0,9, 7,8 og 7,8 gange AUC hos patienter behandlet med ADD. Human relevans af neoplastiske fund set i mus (rasH2 transgene) og karcinogenicitetsstudier i rotter efter behandling med sunitinib er uklar.
Brunner's glands carcinoma occurred in the duodenum at ≥ 1 mg/kg/day in females and at 3 mg/kg/day in males, and mucous cell hyperplasia was evident in the glandular stomach at 3 mg/kg/day in males, which occurred at ≥ 0.9, 7.8, and 7.8 times the AUC in patients administered the RDD, respectively.
Sutent 37,5 mg hårde kapsler
Sutent 37.5 mg hard capsules
Disse kan omfatte unormale leverfunktionstest, hepatitis eller leversvigt (se pkt.
Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4).
• Hæmorider, smerter i endetarmen, blødende tandkød, synkebesvær.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
Hos patienter behandlet med sunitinib er der set kardiovaskulære hændelser, inklusive hjertesvigt, kardiomyopati, fald i venstre ventrikels ejektionsfraktion til under den nedre referenceværdi, myokarditis,og myokardieiskæmi og myokardieinfarkt; disse hændelser var i nogle tilfælde letale.
Cardiovascular events, including heart failure, cardiomyopathy, left ventricular ejection fraction decline to below the lower limit of normal, myocarditis, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported in patients treated with sunitinib.
Der er set letale tilfælde af lungeemboli efter markedsaføring.
Cases of pulmonary embolism with fatal outcome have been observed in postmarketing surveillance.
Tabel 3 - Sammenfatning af effekt-endepunkter for behandlingsnaiv mRCC (ITT-populationen) Sammenfatning af progression-fri overlevelse
Treatment-naïve mRCC summary of efficacy endpoints (ITT population)
Det er set, at virkningerne af TMA reverseres efter behandlingsophør (se pkt.
Reversal of the effects of TMA has been observed after treatment discontinuation (see section 4.8).
- Hvis du for nylig har haft problemer med blodpropper, inklusive slagtilfælde og hjertetilfælde.
- If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Hjertesvigt Kardiomyopati Perikardieeffusion Forlænget QTinterval i ekg
Pericardial effusion Electrocardiogram QT prolonged
Derudover var legemsoverfladeareal (BSA), ved baseline en signifikant kovariant på den tilsyneladende clearance af sunitinib og dets aktive metabolit, hvilket var baseret på en integreret farmakokinetisk populationsanalyse af samlede data fra 3 pædiatriske studier (2 pædiatriske studier med solide tumorer og 1 pædiatrisk GIST studie; alder: 6-11 år og 12-17 år).
Furthermore, based on an integrated population PK analysis of pooled data from the 3 paediatric studies (2 paediatric solid tumour studies and 1 paediatric GIST study; ages: 6 years to 11 years and 12 years to 17 years), baseline body surface area (BSA) was a significant covariate on apparent clearance of sunitinib and its active metabolite.
BLISTER - 37,5 MG KAPSLER
BLISTER - 37.5 MG CAPSULES
Muskuloskeletale smerter
Muscular weakness
Hud- og vævslidelser
Skin and tissue disorders
Sutent 12,5 mg hårde kapsler
Sutent 12.5 mg hard capsules
BLISTER - 12,5 MG KAPSLER
BLISTER - 12.5 MG CAPSULES
- Hvis du har eller har haft problemer med bugspytkirtlen eller galdeblæren.
- If you have or have had pancreatic or gallbladder disorders.
Du skal omgående kontakte din læge, hvis du får symptomer på infektion omkring en hudskade, herunder feber, smerter, rødme, hævelse eller sivning af pus eller blod.Dette forsvinder sædvanligvis, når behandlingen ophører.
Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood.
Der sås forhøjet TSH i blodet hos 1 (0,9%) patient på sunitinib, men ikke hos patienter i standardbehandling.
Blood TSH increase was reported in 1 (0.9%) patient on sunitinib and no patients on standard of care.
Sutent 50 mg hårde kapsler
Sutent 50 mg hard capsules
Ansigtsødem, ødem og perifert ødem Amylase og forhøjet amylase
z Amylase and amylase increased.
Ved den afsluttende analyse var ORR 46% (95% CI: 41%-51%) i sunitinib-armen og 12% (95% CI: 9%16%) i IFN-α-armen (p<0,001), baseret på investigators vurderinger.
Core radiology assessment was discontinued after the primary endpoint had been met. At the final analysis, the ORR as determined by the investigator's assessment was 46% (95% CI: 41%, 51%) for the sunitinib arm and 12.0% (95% CI: 9%, 16%) for the IFN-α arm (p<0.001).
Rød jernoxid (E172) Titandioxid (E171)
Red iron oxide (E172) Titanium dioxide (E171)
Sutent 25 mg hårde kapsler
Sutent 25 mg hard capsules
Administration Sutent er til oral brug, og kan tages med eller uden mad.
It may be taken with or without food.
• Hjertet pumper mindre blod rundt i kroppen.
• Decreased in the amount of blood pumped by the heart.
Hvis du er i den fødedygtige alder, skal du bruge sikker prævention, mens du tager Sutent.
If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent.
• Gulfarvning af huden/misfarvning af huden, mørkfarvning af huden, ændring af hårfarve,
• Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin.
Der sås forhøjet TSH i blodet hos 12 (5,0%) patienter på sunitinib, men ikke hos patienter på capecitabin.
Blood TSH increase was reported in 12 (5.0%) patients on sunitinib and no patients on capecitabine.
OS-data var endnu ikke tilgængelige ved studiets afslutning [20,6 måneder (95% CI 20,6; NR (ikke nået)) i sunitinib-gruppen sammenlignet med NR (95% CI 15,5; NR) i placebo-gruppen, hazard ratio:
OS data were not mature at the time of the study closure [20.6 months (95% CI: 20.6, NR) for the sunitinib arm compared to NR (95% CI: 15.5, NR) for the placebo arm, hazard ratio: 0.409 (95% CI: 0.187, 0.894), p-value=0.0204].
Hvis du har taget for meget Sutent
If you take more Sutent than you should
Behandlingsnaiv metastaserende renalcellekarcinom Der er udført et fase 3 randomiseret, multicenter, international studie, der evaluerede effekt og sikkerhed af sunitinib sammenlignet med interferon IFN-α på behandlingsnaive mRCC-patienter.
A Phase 3, randomised, multi-centre, international study evaluating the efficacy and safety of sunitinib compared with IFN- in treatment-naïve MRCC patients was conducted.
Kapselindhold: mannitol (E421), croscarmellosenatrium, povidon (K-25) og magnesiumstearat.
The other ingredients are: - Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
Samtidig anvendelse af sunitinib og potente CYP3A4-hæmmere, som f.eks. ketoconazol, bør undgås (se pkt.
Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Fortæl det til lægen, hvis du har kraftige mavesmerter, feber, kvalme, opkastning, blod i afføringen eller ændrede afføringsvaner
Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Neutropeni Trombocytopeni Anæmi
Neutropoenia Thrombocytopoenia Anaemia
Cellulitis og hudinfektion
e Cellulitis and skin infection.
BLISTER - 25 MG KAPSLER
BLISTER - 25 MG CAPSULES
Sunitinib er et substrat for effluxtransporteren BCRP in vitro.
Co-administration with medicinal products that are BCRP inhibitors In vitro, sunitinib is a substrate of the efflux transporter BCRP.
Periorbitalt ødem Øjenlågsødem Øget tåresekretion
Periorbital oedema Eyelid oedema Lacrimation increased
Stomatitis og aftøs stomatitis p
o Stomatitis and aphtous stomatitis.
Dårlig sårheling Der er set tilfælde af dårlig sårheling under behandling med sunitinib.
Impaired wound healing Cases of impaired wound healing have been reported during sunitinib therapy.
BLISTER - 50 MG KAPSLER
BLISTER - 50 MG CAPSULES
Ligeledes var hazard ratio for PFS 0,456 (95% CI: 0,264 - 0,787), p = 0,0036 blandt 57 sunitinib-behandlede patienter (inklusive 28 med 1 forudgående systemisk behandling og 29 med 2 forudgående systemiske behandlinger) og 61 placebo-behandlede patienter (inklusive 25 med 1 forudgående systemisk behandling og 36 med 2 forudgående systemiske behandlinger).
Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior systemic therapy and 29 with 2 or more prior systemic therapies) and 61 patients in the placebo arm (including 25 with 1 prior systemic therapy and 36 with 2 or more prior systemic therapies), the hazard ratio for PFS was 0.456 (95% CI: 0.264, 0.787), p=0.0036.
Kapselskal: gelatine, rød jernoxid (E172) og titandioxid (E171).
- Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
Lægemidler, som kan nedsætte plasmakoncentrationen af sunitinib:
Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers
Dyb venetrombose Hedeture
Deep vein thrombosis Hot flush
Fortæl det til din læge, hvis du får feber, oplever udmattethed, træthed eller forvirring, får blå mærker eller blødning, hævelser, synstab eller kramper.
Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
Hvis dette ikke er muligt, kan det være nødvendigt at nedsætte dosis af sunitinib til minimum 37,5 mg dagligt ved GIST og mRCC eller 25 mg dagligt ved pNET med omhyggelig monitorering af tolerabilitet.
If this is not possible, the dose of sunitinib 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.
Lægemidler, som kan øge plasmakoncentrationen af sunitinib:
Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors
På baggrund af individuel sikkerhed og tolerabilitet kan dosis justeres med en dosisøgning på 12,5 mg ad gangen ved GIST og mRCC.
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability.
Der er observeret embryo-føtal mortalitet hos rotter, hvor der ved plasmakoncentrationer 5,5 gange højere end human eksponering ses signifikant fald i antal levende fostre, forøget antal resorptioner, forøget postimplantationstab og tab af hele kuldet hos 8/28 drægtige hunner.
In rats, embryo-foetal mortality was evident as significant reductions in the number of live foetuses, increased numbers of resorptions, increased postimplantation loss, and total litter loss in 8 of 28 pregnant females at plasma exposure levels 5.5 times the systemic exposure in humans.
Der sås hypertyreose hos 4 (1,7%) patienter i behandling med sunitinib, men ikke hos patienter i behandling med capecitabin.
Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabine.
Ved overvågning efter markedsføring er der rapporteret om sjældne letale hæmatologiske tilfælde, inklusive blødning i forbindelse med trombocytopeni og neutropeniske infektioner.
None of these events in the Phase 3 studies were fatal, but rare fatal haematological events, including haemorrhage associated with thrombocytopenia and neutropenic infections, have been reported during postmarketing surveillance.
Forskellen i den samlede overlevelse (OS) var statistisk til fordel for sunitinib (hazard ratio (HR): 0,491: 95% (CI: 0,290 - 0,831)).
The difference in overall survival (OS) was statistically in favour of sunitinib [hazard ratio (HR): 0.491; (95% CI: 0.290, 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the sunitinib arm.
• Vægttab.
• Dizziness.
Hos forsøgspersoner med mildt eller moderat nedsat leverfunktion (Child-Pugh klasse A og B) er systemisk eksponering efter en enkeltdosis sunitinib den samme som hos patienter med svært nedsat leverfunktion (Child-Pugh klasse A og B).
Systemic exposures after a single dose of sunitinib were similar in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment compared to subjects with normal hepatic function.
• En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
• Trombotisk mikroangiopati (TMA), en sygdom hvor der er beskadigelse på de mindste blodkar.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Der er set tilfælde af nedsat nyrefunktion, nyresvigt og/eller akut nyresvigt, der i nogle tilfælde var letale (se pkt.
Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported (see section 4.8).
På dag 14 er den kombinerede plasmakoncentration af sunitinib og dets aktive hovemetabolit 62,9-101 ng/ml.
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.
• Unormal berøringsfølelse i huden, kløende, skallende og betændt hud, blærer, bumser,
• Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
Der er set tilfælde af gangrænøs pyoderma, der normalt var reversibelt efter behandlingsophør.
Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported.
BLISTER YDRE KARTON - 12,5 mg KAPSLER
BLISTER OUTER CARTON - 12.5 MG CAPSULES
I et fase 3 GIST-studie forekom blødningshændelser hos 18% af patienterne, der fik sunitinib, sammenlignet med 17% af patienterne, der fik placebo.
Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patients receiving placebo.
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.
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.
Der sås forhøjet T3 hos 1 (0,8%) patient på sunitinib, men ikke hos patienter i behandling med capecitabin.
T3 increase was reported in 1 (0.8%) patient on sunitinib and no patients on capecitabine.
37,5 mg hårde kapsler Hver kapsel indeholder sunitinibmalat, svarende til 37,5 mg sunitinib.
37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Sutent 37,5 mg hårde kapsler sunitinib
Sutent 37.5 mg hard capsules sunitinib