natgillin/translations-raw huggingface dataset:
Der er observeret embryo- føtal mortalitet hos rotter, hvor der ved plasmakoncentrationer 5, 5 gange højere end observeret i klinikken 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-fold higher than is observed in clinic.
Hos kaniner er der konstateret nedsat vægt af den drægtige livmoder, et nedsat antal levende fostre som følge af forøget antal resorptioner, forøget postimplantationstab og tab af hele kuldet hos 4/ 6 drægtige hunner ved plasmakoncentrationer, der er 3 gange højere end dem der observeres i klinikken.
In rabbits, reductions in gravid uterine weights and number of live foetuses were due to increases in the number of resorptions, increases in post-implantation loss and complete litter loss in 4 of 6 pregnant females at plasma exposure levels 3-fold higher than is observed in clinic.
I rotter med plasmakoncentrationer 6 gange højere end i klinikken medfører sunitinib- behandling 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 characterized as retarded ossification of thoracic/ lumbar vertebrae and occurred at plasma exposure levels 6-fold higher than is observed in clinic.
Hos kaninfostre ses udviklingsforstyrrelser i form af hareskår ved plasmakoncentrationer på omtrent samme niveau som i klinikken og i form af hareskår og ganespalte ved plasmakoncentrationer, der er 2, 7 gange højere end der ses i klinikken.
In rabbits, developmental effects consisted of increased incidence of cleft lip at plasma exposure levels approximately equal to that observed in clinic, and cleft lip and cleft palate at plasma exposure levels 2.7-fold higher than is observed in clinic.
Mannitol Croscarmellosenatrium Povidon Magnesiumstearat
Capsule content Mannitol Croscarmellose Sodium Povidone Magnesium Stearate
Gelatine Rød jernoxid (E172) Titandioxid (E171)
17 Capsule Shell Gelatin Red Iron Oxide (E172) Titanium dioxide (E171)
Shellac Propylenglycol Natriumhydroxid Povidon Titandioxid (E171).
Printing ink Shellac Propylene glycol Sodium hydroxide Povidone Titanium dioxide (E171)
High- density polyethylen (HDPE) beholder med et polypropylenlåg, indeholdende 30 kapsler.
High-density polyethylene (HDPE) bottles with a polypropylene closure, containing 30 capsules.
Gennemsigtigt blister (aclar/ PVC) med aluminiumsfolie belagt med varmeforseglet lak, der indeholder 28 (4 x 7) hårde kapsler.
Aclar/ PVC transparent blister with aluminium foil coated with heat seal lacquer containing 28 (4 x 7) hard capsules Not all pack sizes may be marketed.
6. 6 Regler for destruktion og håndtering
6.6 Special precautions for disposal
19. juli 2006
July 19, 2006
Sutent 25 mg hårde kapsler
SUTENT 25 mg hard capsules
Hjælpestof:
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib Excipient(s):
39, 663 mg mannitol.
39.663 mg of mannitol.
Hårde kapsler Gelatinekapsler med karamelfarvet overdel og orange underdel, der med hvidt blæk er mærket ” Pfizer ” på overdelen, ” STN 25 mg ” på underdelen, og som indeholder gule til orange granulater.
Hard capsules Gelatin capsules with caramel cap and orange body, printed with white ink “ Pfizer” on the cap and “ STN 25 mg” on the body and containing yellow to orange granules.
20 Børn:
19 Paediatric use:
SUTENT bør ikke anvendes til børn, før yderligere data er tilgængelige.
SUTENT should not be used in paediatric population until further data become available.
21 får IFN- α.
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
26% af patienterne, der får sunitinibmalat til behandling af cytokin- refraktær mRCC, oplever blødning.
20 refractory MRCC, 26% experienced bleeding.
Gastrointestinale system Alvorlige, og til tider fatale gastrointestinale komplikationer, herunder gastrointestinal perforation ses sjældent hos patienter med intraabdominal malignitet behandlet med SUTENT.
Gastro-intestinal tract Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT.
Hæmatologisk Nedsat absolut neutrofiltal af sværhedsgrad 3 og 4 er rapporteret hos henholdsvis 10% og 1, 7% af patienterne i fase 3 GIST- studiet og hos henholdsvis 16% og 1, 6% af patienterne i fase 3 mRCC - studiet.
Haematological Decreased absolute neutrophil counts of grade 3 and 4 severity were reported in 10% and 1.7% of patients on the phase 3 GIST study, respectively and in 16% and 1.6% of patients on the phase 3 MRCC study, respectively.
Nedsat trombocyttal af sværhedsgrad 3 og 4 er rappporteret hos henholdsvis 3, 7% og 0, 4% af patienterne i fase 3- GIST studiet og hos henholdsvis 8, 2% og 1, 1% af patienterne i fase 3 mRCC - studiet.
Decreased platelet counts of grade 3 and 4 severity were reported in 3.7% and 0.4% of patients on the phase 3 GIST study, respectively, and in 8.2% and 1.1% of patients on the phase 3 MRCC study, respectively.
I fase 3- undersøgelsen hos behandlingsnaive mRCC- patienter oplevede 0, 6% af patienterne i IFN- α- gruppen og 0% af patienterne SUTENT- gruppen fatale hjertehændelser.
21 SUTENT arm experienced fatal cardiac events.
Forlængelse af QT- interval Data fra non- kliniske forsøg (in vivo og in vitro) med doser, der var højere end de anbefalede humane doser tyder på, at sunitinib potentielt kan hæmme hjertets repolarisationsproces (f. eks forlængelse af QT- intervallet).
QT Interval prolongationData from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that sunitinib has the potential to inhibit the cardiac action potential repolarization process (e. g. prolongation of QT interval).
5 ud af 7 var grad 3 dyb venetrombose (DVT), og 2 var grad 1 eller 2.
22 Seven patients (3%) on SUTENT and none on placebo in a phase 3 GIST study experienced venous thromboembolic events; five of the seven were Grade 3 deep venous thrombosis (DVT) and two were Grade 1 or 2.
Respiratoriske hændelser Patienter, som havde haft lungeemboli indenfor de seneste 12 måneder, blev ekskluderet fra de kliniske undersøgelser med SUTENT.
Respiratory Events Patients who presented with pulmonary embolism within the previous 12 months were excluded from SUTENT clinical studies.
Sjældne fatale tilfælde blev rapporteret.
In patients who received SUTENT in Phase 3 registrational studies, treatment- related pulmonary events (i. e. dyspnoea, pleural effusion, pulmonary embolism or pulmonary oedema) were reported in approximately 5% of patients with GIST and in approximately 14% of patients with MRCC.
8% af patienterne med solide tumorer, herunder GIST og mRCC, som blev behandlet med SUTENT i kliniske undersøgelser.
Rare cases with fatal outcome were reported Approximately 8% of patients with solid tumours, including GIST and MRCC, who received Sutent in clinical trials experienced treatment-related pulmonary events.
Alle patienter, der er i sunitinibbehandling, bør observeres tæt for tegn og symptomer på skjoldbruskkirteldysfunktion.
All patients should be observed closely for signs and symptoms of thyroid dysfunction on sunitinib treatment.
24 Der er rapporteret om alvorlige tilfælde af pankreatitis, nogle fatale. Ved symptomer på pankreatitis, bør behandling med SUTENT seponeres, og patienterne bør have relevant medicinsk behandling.
Cases of serious pancreatic events, some with fatal outcome, have been reported.
Leverfunktion Der er rapporteret om alvorlige tilfælde af SUTENT- relaterede lever - og galdehændelser er rapporteret hos patienter med solide tumorer.
If symptoms of pancreatitis are present, patients should have SUTENT discontinued and be provided with appropriate supportive care.
Nyrefunktion Der er ikke foretaget sikkerhedsvurdering ved fortsat behandling med SUTENT hos patienter med moderat til alvorlig proteinuri.
23 Renal function The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Kramper I kliniske undersøgelser af SUTENT og fra erfaringer efter markedsføring, er der set kramper hos forsøgspersoner med eller uden radiologisk evidens på metastaser i hjernen.
Seizures In clinical studies of SUTENT and from post-marketing experience, seizures have been observed in subjects with or without radiological evidence of brain metastases.
Lægemidler, som kan øge plasmakoncentrationen af sunitinib:
Drugs that may increase sunitinib plasma concentrations:.
Graviditet Der foreligger ikke data ovedrørende anvendelsen af SUTENT hos gravide kvinder.
Pregnancy There are no studies in pregnant women using SUTENT.
SUTENT bør ikke anvendes under graviditet, eller hos kvinder, der ikke anvender sikker antikonception, medmindre den potentielle fordel opvejer den potentielle risiko for fostret.
SUTENT should not be used during pregnancy or in any woman not employing adequate contraception unless the potential benefit justifies the potential risk to the foetus.
Kvinder i den fødedygtige alder bør rådes til ikke at blive gravide under behandling med SUTENT.
24 Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
Der er ikke foretaget undersøgelser af virkningenpå evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive or operate machinery have been performed.
De vigtigste alvorlige behandlingsrelaterede bivirkninger, der er forbundet med behandling med SUTENT hos patienter med solide tumorer er lungeemboli (1%), trombocytopeni (1%), tumorblødning (0, 9%), febril neutropeni (0, 4%) og hypertension (0, 4%).
The most important treatment-related serious adverse events associated with SUTENT treatment of patients with solid tumours were pulmonary embolism (1%), thrombocytopoenia (1%), tumour haemorrhage (0.9%), febrile neutropoenia (0.4%), and hypertension (0.4%).
4. 8 nedenfor og som betragtes mulig relateret til SUTENT, omfatter multiorgansvigt, dissemineret intravaskulær koagulation, peritoneal blødning, rhabdomyolyse, cerebrovaskulær hændelse, dehydrering, adrenal insufficiens, nyresvigt, pleuraeffusion, pneumothorax, shock og pludselig død af ukendt årsag.
Fatal events other than those listed in section 4.4 above or section 4.8 below that were considered possibly related to SUTENT drug included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
26 Behandlingsrelaterede bivirkninger rapporteret i GIST- undersøgelserne
Treatment-Related Adverse Reactions reported in GIST studies
Meget almindelig Meget almindelig
Very common Very common Very common Common Common
Anæmi Neutropeni
Anaemia Neutropoenia Thrombocytopoenia Leukopoenia Lymphopoenia
86 (19, 5) 81 (18, 4%)
86 (19.5%) 81 (18.4%) 67 (15.2%) 26 (5.9%) 10 (2.3%)
24 (5, 5%) 39 (8, 9%)
24 (5.5%) 39 (8.9%) 19 (4.3%) 9 (2.0%) 3 (0.7%)
67 (15, 2%) 26 (5, 9%) 10 (2, 3%)
3 (0.7%) 5 (1.1%) 6 (1.4%) 1 (0.2%) 1 (0.2%)
Nervesystemet
Adverse Reactions
Meget almindelig
All Grades n (%)
Smagsforstyrrelser b
Taste disturbance b
Meget almindelig Almindelig Almindelig Almindelig Almindelig
Very common Common Common Common
Hovedpine Paræstesi Svimmelhed Perifer neuropati Hypæstesi
Headache Paraesthesia Dizziness Neuropathy peripheral
76 (17, 3%) 27 (6, 1%) 18 (4, 1%) 11 (2, 5%) 10 (2, 3%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%)
5 (1, 1%) 1 (0, 2%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Common
Vaskulære sygdomme
Hypoaesthesia
Luftveje, thorax og mediastinum Nyrer og urinveje Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders
Almindelig Almindelig Almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig
Common Common
Epistaxis Dyspnø Kromaturi Diarré Kvalme Opkastning Stomatitis Dyspepsi Abdominal - smerter c / distension
Epistaxis Dyspnoea
28 (6, 4%) 16 (3, 6%) 18 (4, 1%) 187 (42, 5%) 161 (36, 6%) 98 (22, 2%) 90 (20, 5%) 80 (18, 2%) 77 (17, 5%)
28 (6.4%) 16 (3.6%)
1 (0, 2%) 2 (0, 5%) 0 (0, 0%) 24 (5, 5%) 15 (3, 4%) 7 (1, 6%) 7 (1, 6%) 4 (0, 9%) 15 (4, 3%)
0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 2 (0, 5%)
Renal and urinary disorders
Meget almindelig Meget almindelig Almindelig Almindelig Almindelig Almindelig
Chromaturia
Flatulens Oral smerte Obstipation Glossalgi Mundtørhed Gastro- øsofageal refluks
18 (4.1%)
46 (10, 5%) 44 (10, 0%) 37 (8, 4%) 37 (8, 4%) 31 (7, 0%) 12 (2, 7%)
0 (0.0%)
0 (0, 0%) 2 (0, 5%) 2 (0, 5%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Gastrointestinal disorders
Sår i munden
Diarrhoea
Ubehag i munden
Nausea
11 (2, 5%)
161 (36.6%)
0 (0, 0%)
15 (3.4%)
Hud og subkutane væv
0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
Gulfarvning af hud/ misfarvning af huden
46 (10.5%) 44 (10.0%) 37 (8.4%) 37 (8.4%) 31 (7.0%) 12 (2.7%)
146 (33, 2%)
0 (0.0%) 2 (0.5%) 2 (0.5%) 0 (0.0%) 0 (0.0%) 1 (0.2%)
0 (0, 0%)
Common Common
Meget almindelig
Mouth ulceration Oral discomfort
Palmar- plantar erythrodysaesthe - sia syndrom
11 (2.5%) 11 (2.5%)
106 (24, 1%)
0 (0.0%) 0 (0.0%)
0 (0, 0%)
Skin and subcutaneous
Ændringer i hårfarve
Yellow skin/ Skin discolouration
67 (15, 2%)
146 (33.2%)
27
0 (0.0%)
Ekstremitets - smerter/ halten
Pain in extremity/ limb
5 (1, 5%)
5 (1.1%)
bindevæv
and bone disorders
Artralgi Myalgi Muskelkrampe Rygsmerter Muskelsvaghed
Arthralgia Myalgia Muscle spasm Back pain Muscular weakness
39 (8, 9%) 29 (6, 6%) 21 (4, 8%) 11 (2, 5%) 10 (2, 3%)
39 (8.9%) 29 (6.6%) 21 (4.8%) 11 (2.5%) 10 (2.3%)
3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 2 (0, 5%) 1 (0, 2%)
3 (0.7%) 0 (0.0%) 1 (0.2%) 2 (0.5%) 1 (0.2%)
Almene symptomer og reaktioner på administrationssted
General disorders and
Træthed/ asteni Mucosa inflammation
Fatigue/ Asthenia
et
1 (0.2%)
Ødem d Pyreksi
Oedema d Pyrexia
Nedsat uddrivningsfraktio n
Ejection fraction decrease
Nedsat antal trombocytter
Platelet count decrease
Vægttab Forhøjet blod - kreatinin - fosfokinase
Weight decreased Blood creatinine phosphokinase increase
Stigning i amylase Aspartat - aminotransferase stigning
Amylase increased Aspartate aminotransferase increased
28 Følgende betegnelser er kombineret: a Anoreksi og nedsat appetit b Dysgeusi, ageusi og smagsforstyrrelser c Abdominalsmerter og smerter i øvre abdomen d Ødem, perifert ødem og ødem i ansigt e Fald i antal hvide blodlegemer, fald i neutrofiler og leukocytter
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Blod - og lymfesystem
System Organ Class
Neutropeni
Adverse Reactions
89 (16, 4%)
All Grades n (%)
46 (8, 5%)
Grade 3 n (%)
5 (0, 9%)
Grade 4 n (%)
Meget almindelig
Very common Very common Very common Common Common
Trombocytopeni
Neutropoenia Thrombocytopoenia Anaemia Leukopoenia Lymphopenia
86 (15, 8%)
89 (16.4%) 86 (15.8%) 67 (12.3%) 45 (8.3%) 21 (3.9%)
Meget almindelig
46 (8.5%) 37 (6.8%) 20 (3.7%) 16 (2.9%) 12 (2.2%)
67 (12, 3%)
5 (0.9%) 5 (0.9%) 3 (0.6%) 0 (0%) 1 (0.2%)
20 (3, 7% 9
Endocrine disorders
3 (0, 6%)
Very common
Almindelig Almindelig
Hypothyroidism
35 (6%) 21 (3, 9%)
67 (12.3%)
11 (2%) 12 (2, 2%)
7 (1.3%)
Det endokrine system
Eye disorders
Meget Almindelig
Common
Hypotyreose
Lacrimation increased
67 (12, 3%)
39 (7.2%)
7 (1, 3%)
0 (0%)
Almindelig Almindelig
Eyelid oedema
Øget tåreflåd Hævede øjenlåg
a
39 (7, 2%) 12 (2, 2%)
12 (2.2%)
Meget Almindelig
Very Common
Nedsat appetit a
Decreased appetite
Nervesystemet
disorders Nervous system disorders
Meget almindelig
Common Very common
Smagsforstyrrelser b
Dehydration Taste disturbance b
Hovedpine
Headache Dizziness Paraesthesia Neuropathy peripheral
82 (15, 1%)
82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
3 (0, 6%)
3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
Almindelig Almindelig Almindelig Almindelig Almindelig
Common Common
Svimmelhed Paræstesi Perifer neuropati Hypæstesi Hyperæstesi
Hypoaesthesia Hyperaesthesia
38 (7, 0%) 36 (5, 9%) 33 (6, 1%) 20 (3, 7%) 17 (3, 1%)
20 (3.7%) 17 (3.1%)
2 (0, 4%) 0 (0%) 1 (0, 2%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
Rødmen Hedeture
Flushing Hot flush
Dyspnø Faryngolaryngeal smerte
Dyspnoea Pharyngolaryngeal pain
29
45 (8.3%) 29 (5.3%)
Organklasse
6 (1.1%) 2 (0.4%)
Bivirkning
0 (0%) 0 (0%)
Alle Grader n (%)
Common Common Common Common Common Common
Grad 3 n (%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (0.6%)
Grad 4 n (%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
290 (53, 3%)
290 (53.3%)
189 (34, 7%)
189 (34.7%)
185 (34, 0%)
185 (34.0%)
13 (2, 4%)
13 (2.4%)
178 (32, 7%)
178 (32.7%)
17 (3, 1%)
17 (3.1%)
Abdominalsmerterc / distension
Abdominal pain c / distension 28
106 (19, 5%)
106 (19.5%)
10 (1, 8%)
10 (1.8%)
83 (15, 3%)
Frequency
Glossalgi
All Grades n (%)
63 (11, 6%)
Grade 3 n (%)
Mundtørhed
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
56 (10, 3%)
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
Almindelig
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
Gastro- øsofageal refluks
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
Common Common Common Common Common Common Common Common Very common
Dysfagi Keilitis Gingival blødning Hæmorroider Proktalgi Sår i munden Ubehag i maven Rektalblødning
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage Palmar-plantar erythrodysaesthesia syndrome
1 (0, 2%) 1 (0, 2%) 0 (0%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%) 0 (0%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 46 (8.5%)
Hud og subkutane væv
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
Palmar- plantar erythrodysaesthesia syndrom
Yellow discolouration/ Skin discolouration
Meget almindelig
Skin and subcutaneous
144 (26, 5%)
Very common
0 (0%)
Rash
121 (22, 2%)
121 (22.2%)
1 (< 1%)
1 (0.2%)
Meget almindelig
tissue disorders
108 (19, 9%)
108 (19.9%)
Ændringer i hårfarve
Hair colour changes
103 (18, 9%)
103 (18.9%)
Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig
Very common Common Common Common Common Common Common Common
Erytem Hudeksfoliation Kløe Periorbitalt ødem Dermatitis Hudlæsioner
Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
51 (9, 4%) 47 (8, 6%) 40 (7, 4%) 31 (5, 7%) 27 (5, 0%) 26 (4, 8%)
64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
2 0, 4%) 4 (0, 7%) 1 (0, 2%) 1 (0, 2%) 4 0, 7%) 1 (0, 2%)
0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Blærer Hudreaktioner Hyperkeratose Acne
Blister Skin reaction Hyperkeratosis Acne
bindevæv
Musculoskeletal and connective tissue disorders
Artralgi Myalgi Muskelkramper Rygsmerter
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
Træthed/ asteni
Fatigue/ asthenia
reaktioner på administrationss
administration site conditions
Mucosa inflammation
Mucosal inflammation
tedet
0 (0%)
Ødem d
Oedema d Pyrexia Chills
99 (18, 2%)
99 (18.2%) 37 (6.8%) 35 (6.4%)
5 (0, 9%)
5 (0.9%) 3 (0.6%) 2 (0.4%)
0 (0%)
29
Almindelig Almindelig Almindelig Almindelig
System Organ Class
Pyreksi Kuldegysninger Smerter Brystsmerter
Frequency
37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%)
Adverse Reactions
3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
All Grades n (%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Grade 3 n (%)
Psykiske forstyrrelser Undersøgelser
Grade 4 n (%)
Almindelig Almindelig Meget almindelig
Common Common
Insomni Depression Nedsat uddrivningsfraktion
Pain Chest pain
Vægttab
Insomnia Depression Ejection fraction decrease
Nedsat antal trombocytter
Weight decrease Platelet count decrease
Nedsat antal hvide blodlegemer e
White blood cell count decreased e
Forhøjet lipase Nedsat hæmoglobin
Lipase increase Haemoglobin decreased
Forhøjet blod - kreatinin - fosfokinase
Blood creatine phosphokinase increased
Aspartat - aminotransferase stigning
Aspartate aminotransferase increased
Stigning i amylase
Blood amylase increased
Forhøjet blod - kreatinin
Blood creatinine increased
Blodtryksstigning Alanin - aminotransferase stigning
Blood pressure increased
0 (0%) 2 (0, 4%)
Common
Enhver bivirkning
Alanine aminotransferase increased
524 (96, 3%)
14 (2.6%)
296 (54, 4%)
7 (1.3%)
57 (10, 5%)
2 (0.4%)
Følgende betegnelser a
Any adverse event
er kombineret:
524 (96.3%)
Anoreksi og nedsat
296 (54.4%)
appetit
57 (10.5%)
Dysgeusi, ageusi og smagsforstyrrelser c Abdominalsmerter og smerter i øvre abdomen d Ødem, perifert ødem og ødem i ansigt e Fald i antal hvide blodlegemer, fald i neutrofiler og leukocytter
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Infektioner og parasitære sygdomme Hyppighed ikke kendt:
Infections and Infestations Not known:
Luftveje, thorax og Hyppighed ikke kendt
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
Hyppighed ikke kendt
Not known:
Der er ikke foretaget sikkerhedsvurdering ved fortsat behandling med
The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
4. 4).
Discontinue SUTENT in patients with nephrotic syndrome (see also section 4.4)
Sunitinib er identificeret som en hæmmer af receptorerne for trombocytafledte vækstfaktorer (PDGFRα og PDGFβ), vaskulære endotel - vækstfaktorer (VEGFR1, VEGFR2 og VEGF3), stamcellefaktor (KIT), Fms- lignende tyrosinkinase- 3 (FLT3), kolonistimulerende faktor (CSF- 1R) og gliacelleafledt neurotrof faktor (RET).
Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
KLINISKE UNDERSØGELSER Den kliniske sikkerhed og effekt af SUTENT er undersøgt hos patienter med malign gastrointestinal stromal tumor (GIST).
CLINICAL STUDIES The clinical safety and efficacy of SUTENT has been studied in the treatment of patients with malignant gastrointestinal stromal tumour (GIST) who were resistant to imatinib (i. e. those who experienced disease
Ligeledes er den kliniske sikkerhed og effekt af SUTENT undersøgt for behandling af patienter med metastaserende renalcellecarcinom (mRCC) Effekten er baseret på tidspunktet for tumorprogression og stigning i overlevelse med GIST samt på henholdsvis progressions- fri overlevelse og objektiv responsrate for for behandlingsnaiv og cytokin - refraktær mRCC.
31 progression during or following treatment with imatinib) or intolerant to imatinib (i. e. those who experienced significant toxicity during treatment with imatinib that precluded further treatment) and the treatment of patients with metastatic renal cell carcinoma (MRCC) Efficacy is based on time to tumour progression and an increase in survival in GIST and on progression free survival and objective response rates for treatment-naïve and cytokine-refractory MRCC respectively.