natgillin/translations-raw huggingface dataset:
If the drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the foetus.
Če zdravilo uporabimo med nosečnostjo ali če bolnica med zdravljenjem s tem zdravilom zanosi, jo moramo seznaniti z možnimi nevarnostmi za plod.
7 Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with SUTENT.
Ženskam v rodni dobi moramo povedati, naj med zdravljenjem s SUTENTOM ne zanosijo.
Based on non-clinical findings, male and female fertility may be compromised by treatment with SUTENT (see section 5.3).
Neklinični izsledki kažejo, da lahko zdravljenje s SUTENTOM poslabša plodnost samcev in samic (glejte poglavje 5. 3).
Lactation Sunitinib and/ or its metabolites are excreted in rat milk.
Dojenje Sunitinib in/ ali njegovi presnovki se pri podganah izločajo v mleko.
It is not known whether sunitinib or its primary active metabolite are excreted in human milk.
Ni znano, ali se sunitinib ali njegov primarni aktivni presnovek izločata v materinem mleku.
Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should not breast feed while taking SUTENT.
Ker se zdravila pogosto izločajo v materinem mleku in ker obstaja možnost resnih neželenih reakcij pri dojenih otrocih, ženske, ki jemljejo SUTENT, ne smejo dojiti.
No studies on the effects on the ability to drive or operate machinery have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Patients should be advised that they may experience dizziness during treatment with SUTENT.
Bolnikom je treba povedati, da jih med zdravljenjem s SUTENTOM lahko obide omotica.
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%).
Najpogostejši z zdravljenjem povezani resni neželeni učinki, ki so spremljali uporabo SUTENTA pri bolnikih s čvrstimi tumorji, so bili pljučna embolija (1%), trombocitopenija (1%), krvavitev tumorja (0, 9%), febrilna nevtropenija (0, 4%) in hipertenzija (0, 4%).
The most common treatment-related adverse events (experienced by at least 20% of the patients) of any grade included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; dysgeusia and anorexia.
Med najpogostejšimi z zdravljenjem povezanimi neželenimi učinki (ki so se pojavili pri vsaj 20% bolnikov) so ne glede na stopnjo bili: utrujenost; prebavne motnje, npr. diareja, navzea, stomatitis, dispepsija in bruhanje; obarvanje kože; disgevzija in anoreksija.
Fatigue, hypertension and neutropoenia were the most common treatment-related adverse events of Grade 3 maximum severity and increased lipase was the most frequently occurring treatment-related adverse event of Grade 4 maximum severity in patients with solid tumours.
Pri bolnikih s čvrstimi tumorji so bili najpogostejši z zdravljenjem povezani neželeni učinki, ki so dosegli 3. stopnjo izraženosti, utrujenost, hipertenzija in nevtropenija; najpogostejši z zdravljenjem povezani neželeni učinek, ki je dosegel 4. stopnjo izraženosti, pa je bilo zvišanje ravni lipaze.
Hepatitis and hepatic failure occurred in < 1% of patients and prolonged QT interval in < 0.1% (see section 4.4).
Hepatitis in odpoved jeter sta se pojavila pri manj kot 1% bolnikov, podaljšanje intervala QT pa pri manj kot 0, 1% bolnikov.
Fatal events other than those listed in section 4.4 above or section 4.8 below that were considered possibly related to SUTENT included multi-system organ failure, disseminated intravascular coagulation, peritonoeal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
Med dogodki s smrtnim izidom, (razen naštetih v poglavju 4. 4 zgoraj ali poglavju 4. 8 spodaj), ki so jih ocenili kot morda povezane s SUTENTOM so bili: odpoved več organov, diseminirana intravaskularna koagulacija, peritonealna krvavitev, rabdomioliza, cerebrovaskularni inzult, dehidracija, adrenalna insuficienca, odpoved ledvic, respiratorna insuficienca, plevralni izliv, pnevmotoraks, šok in nenadna smrt.
Treatment-related adverse reactions that were reported in > 2% of solid tumour patients are listed below, by system organ class, frequency and grade of severity.
8 Z zdravljenjem povezani neželeni učinki, opisani pri > 2% bolnikov s čvrstimi tumorji, so našteti spodaj, po organskih sistemih, pogostnosti in stopnji izraženosti.
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Pogostnosti so opredeljene na naslednji način: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do > 1/ 1. 000); zelo redki (< 1/ 10. 000).
Treatment-Related Adverse Reactions reported in GIST studies
Z zdravljenjem povezani neželeni učinki, o katerih so poročali v študijah GIST
Adverse Reactions
Neželeni učinek
Very common Very common Very common Common Common
zelo pogosti zelo pogosti zelo pogosti pogosti pogosti
Anaemia Neutropoenia Thrombocytopoenia Leukopoenia Lymphopoenia
Anemija nevtropenija trombocitopenija levkopenija limfopenija
Hypothyroidism
hipotiroidizem zmanjšanje teka a
Taste disturbance b
motnje okušanja b
105 (23.9%)
117 (26, 6%)
Frequency
Bolezni živčevja
Adverse Reactions
zelo pogosti zelo pogosti
All Grades n (%)
Glavobol
Grade 3 n (%)
105 (23, 9%) 76 (17, 3%)
Grade 4 n (%)
1 (0, 2%) 5 (1, 1%)
Nervous system disorders
0 (0, 0%) 0 (0, 0%)
Very common Common Common Common Common
pogosti pogosti pogosti
Headache Paraesthesia Dizziness Neuropathy peripheral Hypoaesthesia
parestezije omotica periferna nevropatija
76 (17.3%) 27 (6.1%) 18 (4.1%) 11 (2.5%) 10 (2.3%)
27 (6, 1%) 18 (4, 1%) 11 (2, 5%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
1 (0, 2%) 1 (0, 2%) 0 (0, 0%)
Hypertension
hipestezija
101 (23.0%)
10 (2, 3%)
Common Common
zelo pogosti pogosti pogosti
Epistaxis Dyspnoea
hipertenzija epistaksa dispneja
28 (6.4%) 16 (3.6%)
101 (23, 0%) 28 (6, 4%) 16 (3, 6%)
1 (0.2%) 2 (0.5%)
43 (9, 8%) 1 (0, 2%) 2 (0, 5%)
Renal and urinary disorders
Bolezni sečil Bolezni prebavil
Common
pogosti zelo pogosti zelo pogosti zelo pogosti zelo pogosti zelo pogosti
Chromaturia
kromaturija diareja navzea bruhanje stomatitis dispepsija bolečina v trebuhu c
18 (4.1%)
18 (4, 1%) 187 (42, 5%) 161 (36, 6%) 98 (22, 2%) 90 (20, 5%) 80 (18, 2%)
0 (0.0%)
0 (0, 0%) 24 (5, 5%) 15 (3, 4%) 7 (1, 6%) 7 (1, 6%) 4 (0, 9%)
Gastrointestinal disorders
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Very common Very common Very common Very common Very common Very common
zelo pogosti
Diarrhoea Nausea Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
/ napihnjenost
187 (42.5%) 161 (36.6%) 98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
77 (17, 5%)
24 (5.5%) 15 (3.4%) 7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
15 (3, 4%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
2 (0, 5%)
Very common Very common Common Common Common Common
zelo pogosti zelo pogosti pogosti pogosti pogosti pogosti
Flatulence Oral pain Constipation Glossodynia Dry mouth Gastro-oesophageal reflux disease
flatulenca bolečine v ustih zaprtje glosodinija suha usta gastroezofagealna refluksna bolezen
Mouth ulceration Oral discomfort
razjede v ustih nelagodje v ustih
Yellow skin/ Skin discolouration
porumenela koža/ obarvanje kože
tissue disorders
Vse stopnje n (%)
Palmar-plantar erythrodysaesthesia syndrome
sindrom palmarno- plantarne eritrodizestezije
Very common Very common Common Common Common Common Common Common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti pogosti pogosti pogosti pogosti
Hair colour changes Rash Dry skin Alopecia Dermatitis Periorbital oedema Skin Reaction Erythema Eczema Pruritus Skin hyperpigmentation
izpuščaji suha koža alopecija dermatitis periorbitalni edem kožne reakcije eritem ekcem srbenje hiperpigmentiranos t kože
Skin exfoliation Blister Skin lesion
eksfoliacija kože mehur kožne lezije
Muscoloskeletal, connective tissue
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Very Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti
Pain in extremity/ limb Arthralgia
bolečine v udih artralgija mialgija spazem mišic bolečine v hrbtu mišična oslabelost
54 (12.3%) 39 (8.9%)
54 (12, 3%) 39 (8, 9%) 29 (6, 6%) 21 (4, 8%) 11 (2, 5%) 10 (2, 3%)
5 (1.1%) 3 (0.7%)
5 (1, 1%) 3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 2 (0, 5%) 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%)
9
Splošne težave in spremembe na mestu aplikacije
System Organ Class
zelo pogosti zelo pogosti
Frequency
287 (65, 2%) 70 (15, 9%)
Adverse Reactions
64 (14, 5%) 6 (1, 4%)
All Grades n (%)
0 (0, 0%) 0 (0, 0%)
Grade 3 n (%)
59 (13, 4%)
Grade 4 n (%)
1 (0, 2%)
and bone disorders
0 (0, 0%)
Common Common Common Common
pogosti
Myalgia Muscle spasm Back pain Muscular weakness
pireksija
29 (6.6%) 21 (4.8%) 11 (2.5%) 10 (2.3%)
26 (5, 9%)
General disorders and administration site conditions Psychiatric disorders
Psihiatrične motnje
Very common Very common Very common Common Common
pogosti
Fatigue/ Asthenia Mucosal inflammation Oedema d Pyrexia Insomnia
nespečnost
Lipase increase White blood cell count decreased e
zmanjšanje števila belih krvnih celic e
Haemoglobin decreased
znižanje ravni hemoglobina
Platelet count decrease
zmanjšanje števila trombocitov
Weight decreased Blood creatinine phosphokinase increased
zmanjšanje telesne mase
23 (5.2%) 22 (5.0%)
23 (5, 2%)
Amylase increased Aspartate aminotransferase increased
zvišanje amilaze zvišanje aspartat - aminotransferaze
Alanine aminotransferase increased
zvišanje alanin - aminotransferaze
Any adverse event
Združeni so naslednji a
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
anoreksije in zmanjšanje teka b Dizgevzija, asgevzija in motnje okušanja c Bolečine v trebuhu in bolečine v zgornjem delu trebuha d Edemi, periferni edemi in edem obraza e Zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev in zmanjšanje števila levkocitov
Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Z zdravljenjem povezani neželeni učinki, o katerih so poročali v študijah MRCC, odpornega proti citokinom, ter še nezdravljenega MRCC
Very common Very common
zelo pogosti zelo pogosti zelo pogosti pogosti pogosti
Neutropoenia Thrombocytopoenia
nevtropenija trombocitopenija anemija levkopenija limfopenija
3 (0.6%) 0 (0%) 1 (0.2%)
5 (0, 9%) 5 (0, 9%) 3 (0, 6%) 0 (0, 0%) 1 (0, 2%)
Endocrine
Bolezni endokrinega sistema
System Organ Class disorders
Očesne bolezni Presnovne in
Frequency
pogosti pogosti
Adverse Reactions
močnejše solzenje edem vek
All Grades n (%)
39 (7, 2%)) 12 (2, 2%)
Grade 3 n (%)
0 (0%) 0 (0%)
Eye disorders
prehranske
Lacrimation increased
zmanjšanje teka a
0 (0%)
motnje
0 (0%)
(1, 7%)
Very Common Common
pogosti
Decreased appetite Dehydration
dehidracija motnje okušanja b
205 (37.7%) 33 (6.1%)
33 (6, 1%)
9 (1.7%) 7 (1.3%)
7
0 (0%) 1 (0.2%)
1
Nervous system disorders
(0, 2%)
Very common Very common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti
Taste disturbance b Headache Dizziness Paraesthesia Neuropathy peripheral
glavobol omotica parestezije periferna nevropatija hipestezija hiperestezija
1 (0.2%) 3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
(0, 6%) (0, 4%) (0%) (0, 2%) (0%) (0%)
Common Common
Žilne bolezni
Hypoaesthesia Hyperaesthesia
zelo pogosti
20 (3.7%) 17 (3.1%)
hipertenzija
0 (0%) 0 (0%)
143 (26, 3%)
0 (0%) 0 (0%)
55 (10, 1%)
Vascular disorders
0 (0%)
Very common Common Common
pogosti pogosti
Hypertension Flushing Hot flush
zardevanje valovi vročine
143 (26.3%) 17 (3.1%) 12 (2.2%)
17 (3, 1%) 12 (2, 2%)
55 (10.1%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
mediastinal
mediastinalnega
45 (8.3%)
45 (8, 3%)
6 (1.1%)
6 (1, 1%)
disorders
prostora
Pharyngolaryngeal pain
faringolaringealna bolečina
29 (5.3%)
29 (5, 3%)
Common Common Common Common Common Common
pogosti pogosti pogosti
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
kašelj disfonija suhost nosu
23 (4.2%) 16 (2.9%) 14 (2.6%) 12 (2.2%) 12 (2.2%) 12 (2.2%)
23 (4, 2%) 16 (2, 9%) 14 (2, 6%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (0.6%)
0 (0%) 0 (0%) 0 (0%)
Gastrointestinal disorders
Vse stopnje n (%)
Very common Very common Very common Very common Very common Very common
pogosti pogosti
Diarrhoea Nausea Dyspepsia Stomatitis Vomiting Abdominal pain c / distension
zamašenost nosu plevralen izliv
326 (59.9%) 290 (53.3%) 189 (34.7%) 185 (34.0%) 178 (32.7%) 106 (19.5%)
12 (2, 2%) 12 (2, 2%)
38 (7.0%) 19 (3.5%) 8 (1.5%) 13 (2.4%) 17 (3.1%) 10 (1.8%)
0 (0%) 3 (0, 6%)
Very common Very common Very common Very common Very common Common
zelo pogosti
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
navzea
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
290 (53, 3%)
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
189 (34, 7%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
8 (1, 5%)
Common Common Common Common Common Common Common Common
zelo pogosti
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
bruhanje bolečina v trebuhu c
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
17 (3, 1%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
106 (19, 5%)
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%)
10 (1, 8%)
11
83 (15, 3%) 63 (11, 6%) 60 (11%)
System Organ Class
1 (0, 2%) 0 (0%)
Frequency
0 (0%) 0 (0%)
Adverse Reactions
60 (11, 0%) 60 (11, 0%) 56 (10, 3%) 50 (9, 2%)
All Grades n (%)
0 (0%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
Grade 3 n (%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Grade 4 n (%)
2 (0, 4%) 1 (0, 2%) 0 (0%) 0 (0%) 1 (0, 2%) 0 (0%) 0 (0%) 0 (0%)
Palmar-plantar erythrodysaesthesia syndrome
sindrom palmarno - plantarne eritrodizestezije
Yellow discolouration/ Skin discolouration
rumeno obarvanje kože
Very common Very common Very common Very common Common Common Common Common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti pogosti pogosti
Rash Dry skin Hair colour changes Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
alopecija eritem eksfoliacija kože srbenje periorbitalni edem dermatitis kožne lezije
121 (22.2%) 108 (19.9%) 103 (18.9%) 64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
64 (11, 8%) 51 (9, 4%) 47 (8, 6%) 40 (7, 4%) 31 (5, 7%) 27 (5, 0%) 26 (4, 8%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
0 (0%) 2 (0, 4%) 4 (0, 7%) 1 (0, 2%) 1 (0, 2%) 4 (0, 7%) 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 (0%)
Blister Skin reaction Hyperkeratosis Acne
mehur kožne reakcije hiperkeratoza akne
Very common Common Common Common Common
zelo pogosti pogosti pogosti pogosti pogosti
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
bolečine v udih artralgija mialgija spazem mišic bolečine v hrbtu
Very common Very common
zelo pogosti
Fatigue/ asthenia Mucosal inflammation
utrujenost/ astenija
Very common Common Common Common Common
pogosti pogosti pogosti pogosti
Oedema d Pyrexia Chills Pain Chest pain
pireksija mrzlica bolečine bolečine v prsih
Psychiatric disorders Investigations
Psihiatrične motnje Preiskave
Common Common Very common
pogosti pogosti zelo pogosti
Insomnia Depression Ejection fraction decreased
nespečnost depresija zmanjšanje iztisnega deleža
Weight decreased Platelet count decreased
zmanjšanje števila trombocitov
White blood cell count decreased e
zmanjšanje števila belih krvnih celic e
Lipase increased Haemoglobin decreased
zvišanje ravni lipaze zmanjšanje hemoglobina
Blood creatine phosphokinase increased
zvišanje kreatin - fosfokinaze v krvi
Aspartate aminotransferase
zvišanje aspartat - aminotransferaze
Blood amylase increased
zvišanje amilaze v krvi
Blood pressure increased
zvišanje krvnega tlaka
Any adverse event
katerikoli neželeni učinek
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
Združeni so naslednji izrazi: a anoreksije in zmanjšanje teka b Dizgevzija, asgevzija in motnje okušanja c Bolečine v trebuhu in bolečine v zgornjem delu trebuha d Edemi, periferni edemi in edem obraza 13 e Zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev in zmanjšanje števila levkocitov
Adverse reactions from post-marketing experience
Neželeni učinki iz pomarketinškega obdobja Med pomarketinškim obdobjem uporabe zdravila SUTENT so zabeležili naslednje vrste učinkov.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Navedeni učinki obsegajo spontano prijavljene primere, resne neželene učinke v potekajočih študijah, programih razširjenega dostopa, kliničnih farmakoloških študijah in eksploracijskih študijah pri neodobrenih indikacijah.
Cardiac failure, cardiac failure congestive, left ventricular failure Prolonged QT interval, Torsade de pointes
srčno popuščanje, kongestivno srčno popuščanje, popuščanje levega prekata podaljšanje intervala QT, torsade de pointes
Pancreatitis Gastrointestinal perforation
pankreatitis perforacija prebavil
Hepatic failure
odpoved jeter
Elevated thyroid stimulating hormone (TSH)
zvišanje ravni tiroideo stimulirajočega hormona (TSH)
Infections and Infestations Non known:
Infekcijske in parazitske bolezni:
Muscoloskeletal and Not known:
Ni znano:
Pulmonary disorders
okužbe (z nevtropenijo ali brez nje)
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
Bolezni pljuč
Pleural effusion Pulmonary embolism and respiratory failure
plevralen izliv pljučna embolija in respiratorna insuficienca
Thromboembolic events:
Trombembolični pojavi:
Cases of pulmonary embolism, in some cases with fatal outcome, have been reported.
Opisani so bili primeri pljučne embolije, nekateri s smrtnim izidom.
Few cases had a fatal outcome.
Opisani so primeri hudih okužb (z nevtropenijo ali brez nje), vključno s pljučnico Nekateri primeri so imeli smrten izid.
Rare cases of myopathy and/ or rhabdomyolysis, some with acute renal failure, have been reported.
Opisani so redki primeri miopatije in/ ali rabdomiolize, v nekaterih primerih z akutno odpovedjo ledvic.
Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.
Bolnike z znaki ali simptomi toksičnih učinkov na mišice je treba obravnavati v skladu s standardno zdravstveno prakso.
13 Blood and lymphatic system disorders:
Bolezni krvi in limfatičnega sistema:
Rare cases of thrombotic microangiopathy have been reported.
Opisani so bili redki primeri trombotične mikroangiopatije.
Endocrine Disorders:
Bolezni endokrinega sistema:
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience (See also section 4.4).
Med kliničnimi preskušanji in pomarketinškim obdobjem so bili opisani redki primeri hipertiroidizma, ki mu je včasih sledil hipotiroidizem (glejte tudi poglavje 4. 4).
The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Varnost nadaljnjega zdravljenja s SUTENTOM pri bolnikih z zmerno do hudo proteinurijo ni bila sistematično ocenjena.
Discontinue SUTENT in patients with nephrotic syndrome (see also section 4.4).
Pri bolnikih z nefrotskim sindromom morate uporabo zdravila SUTENT prekiniti (glejte poglavje 4. 4).
There is no experience of acute overdosage with SUTENT.
Izkušenj z akutnim prevelikim odmerjanjem SUTENTA ni.
There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures.
Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe.
If indicated, elimination of unabsorbed drug may be achieved by emesis or gastric lavage.
Izločanje neabsorbiranega zdravila je mogoče doseči z emezo ali izpiranjem želodca, če je to indicirano.
Antineoplastic agents - Protein-tyrosine kinase inhibitor, ATC Code:
Oznaka ATC:
Sunitinib malate inhibits multiple receptor tyrosine kinases (RTKs) that are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Sunitinibijev malat zavira več receptorskih tirozin- kinaz (RTK), vpletenih v rast tumorja, patološko angiogenezo in metastatsko napredovanje raka.
Sunitinib was identified as 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).
Ugotovljeno je, da sunitinib zavira receptorja rastnega faktorja iz trombocitov (PDGFRα in PDGFRβ), receptorje žilnih endotelijskih rastnih faktorjev (VEGFR2, VEGFR3 in VEGFR3), receptor faktorja matičnih celic (KIT), Fms- ju podobno tirozin- kinazo- 3 (FLT3), receptor kolonijo stimulirajočega faktorja (CSF- 1R) in receptor nevrotrofičnega faktorja iz celic glije (RET).
The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
Primarni presnovek ima v biokemičnih in celičnih preskusih podobno moč kot sunitinib.
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 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.
Učinkovitost temelji na času do napredovanja tumorja in podaljšanju preživetja pri GIST, na preživetju brez napredovanja bolezni pri še nezdravljenem MRCC ter na objektivnem odzivu na zdravljenje pri MRCC, odpornemu proti citokinom.
Gastrointestinal Stromal Tumours An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (Median maximum daily dose 800 mg) due to resistance or intolerance.
Gastrointestinalni stromalni tumorji Pri bolnikih z GIST, pri katerih je bilo zdravljenje z imatinibom zaradi odpornosti ali neprenašanja neuspešno (mediana največjega dnevnega odmerka 800 mg), je bila opravljena uvodna, odprta študija s povečevanjem odmerka.
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”).
Vključenih je bilo 97 bolnikov z različnimi odmerki in shemami; 55 bolnikov je dobivalo 50 mg po priporočeni terapevtski shemi 4 tedne da/ 2 tedna ne ("shema 4/ 2").
In this study the median Time To Progression (TTP) was 34.0 weeks (95% CI = 22.0 – 46.0 weeks).
V tej študiji je bil mediani čas do napredovanja (TTP – time to progression) 34, 0 tednov (95% IZ: