natgillin/translations-raw huggingface dataset:
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.
Oboseala, hipertensiunea şi neutropenia au fost cele mai frecvente evenimente adverse legate de tratament având gradul de severitate maxim 3, iar creşterea lipazei a fost cel mai frecvent eveniment advers cu grad de severitate
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.
4. 8 mai jos şi care au fost considerate ca fiind posibil legate de administrarea SUTENT, au inclus insuficienţa multiplă sistemică de organ, coagularea intravasculară diseminată, hemoragia peritoneală, rabdomioliza, accidentul cerebrovascular, deshidratarea, insuficienţa suprarenaliană, insuficienţa renală, insuficienţa respiratorie, efuziunea pleurală, pneumotoraxul, şocul şi moartea subită.
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.
Reacţiile adverse legate de tratament care s- au raportat la > 2% dintre pacienţii cu tumori solide sunt enumerate mai jos, în funcţie de sistemul implicat, frecvenţă şi grad de severitate.
Frequencies are defined as:
Frecvenţa apariţiei este definită după cum urmează:
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).
Foarte frecvente (≥ 1/ 10), frecvente (≥ 1/ 100 şi < 1/ 10), mai puţin frecvente (≥ 1/ 1000 şi < 1/ 100), rare (≥ 1/ 10 000 şi > 1/ 1000), foarte rare (< 1/ 10000).
Treatment-Related Adverse Reactions reported in GIST studies
Reacţii adverse legate de tratament, raportate în studiile GIST
System Organ Class
Aparate Organe şi Sisteme
All Grades n (%)
Toate gradele de severitate n (%)
Grade 3 n (%)
Gradul 3 de severitate n (%)
Grade 4 n (%)
Gradul 4 de severitate n (%)
Very common Very common Very common Common Common
Foarte frecvente Foarte frecvente Foarte frecvente Frecvente Frecvente
Anaemia Neutropoenia Thrombocytopoenia Leukopoenia Lymphopoenia
Anemie Neutropenie Trombocitopenie Leucopenie Limfopenie
24 (5.5%) 39 (8.9%) 19 (4.3%) 9 (2.0%) 3 (0.7%)
24 (5, 5%) 39( 8, 9%) 19 (4, 3%) 9 (2, 0%) 3 (0, 7%)
3 (0.7%) 5 (1.1%) 6 (1.4%) 1 (0.2%) 1 (0.2%)
3 (0, 7%) 5( 1, 1%) 6 (1, 4%) 1 (0, 2%) 1 (0, 2%)
Hypothyroidism
Hipotiroidism Scăderea apetituluia
Decreased appetite a
Foarte frecvente
Very common
Tulburări ale
Taste disturbance b
Foarte frecvente
105 (23.9%)
105
8
nervos
System Organ Class
Tulburări vasculare
Adverse Reactions
Hipertensiune arterială
All Grades n (%)
101 (23, 0%)
Grade 3 n (%)
43 (9, 8%)
Nervous system disorders
Tulburări respiratorii, toracice şi mediastinale,
Very common Common Common Common Common
Frecvente Frecvente
Headache Paraesthesia Dizziness Neuropathy peripheral Hypoaesthesia
Epistaxis Dispnee
76 (17.3%) 27 (6.1%) 18 (4.1%) 11 (2.5%) 10 (2.3%)
28 (6, 4%) 16 (3, 6%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
1 (0, 2%) 2 (0, 5%)
Hypertension
Cromaturie
101 (23.0%)
18 (4, 1%)
43 (9.8%)
0 (0, 0%)
Epistaxis Dyspnoea
Diaree
28 (6.4%) 16 (3.6%)
187 (42, 5%)
1 (0.2%) 2 (0.5%)
24 (5, 5%)
Renal and urinary disorders
Foarte frecvente
Common
Greaţă
Chromaturia
161 (36, 6%)
18 (4.1%)
15 (3, 4%)
Gastrointestinal disorders
Gradul 4 de severitate n (%)
Very common Very common Very common Very common Very common Very common
Foarte frecvente Foarte frecvente
Diarrhoea Nausea Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
Dispepsie Dureri/ distensie abdominalec
187 (42.5%) 161 (36.6%) 98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
80 (18, 2%) 77 (17, 5%)
24 (5.5%) 15 (3.4%) 7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
4 (0, 9%) 15 (3, 4%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
0 (0, 0%) 2 (0, 5%)
Very common Very common Common Common Common Common
Foarte frecvente Foarte frecvente Frecvente Frecvente Frecvente Frecvente
Flatulence Oral pain Constipation Glossodynia Dry mouth Gastro-oesophageal reflux disease
Flatulenţă Dureri la nivel bucal Constipaţie Glosodinie Xerostomie Boală de reflux gastro- esofagian
Mouth ulceration Oral discomfort
Ulceraţii bucale Discomfort oral
Yellow skin/ Skin discolouration
Depigmentări ale pielii/ Îngălbenirea pielii
0 (0.0%)
27 (6, 1%)
tissue disorders
subcutanat
Palmar-plantar erythrodysaesthesia syndrome
Eritrodisestezie palmo- plantară
Very common Very common Common Common Common Common Common Common Common Common Common
Foarte frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente
Hair colour changes Rash Dry skin Alopecia Dermatitis Periorbital oedema Skin Reaction Erythema Eczema Pruritus Skin hyperpigmentation
Erupţie cutanată *** Piele uscată Alopecie Dermatită Edem periorbital Reacţii cutanate Eritem Eczemă Prurit Hiperpigmentare cutanată
67 (15.2%) 64 (14.5%) 41 (9.3%) 33 (7.5%) 29 (6.6%) 20 (4.5%) 20 (4.5%) 18 (4.1%) 16 (3.6%) 16 (3.6%) 15 (3.4%)
64 (14, 5%) 41 (9, 3%) 33 (7, 5%) 29 (6, 6%) 20 (4, 5%) 20 (4, 5%) 18 (4, 1%) 16 (3, 6%) 16 (3, 6%) 15 (3, 4%)
0 (0.0%) 3 (0.7%) 0 (0.0%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 3 (0.7%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
3 (0, 7%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 3 (0, 7%) 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%) 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 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Skin exfoliation Blister Skin lesion
Exfoliere cutanată Vezicule Leziuni cutanate
Muscoloskeletal, connective tissue
Tulburări musculo - scheletice, ale
Pain in extremity/ limb Arthralgia
Dureri la nivelul extremităţilor/ membr elor
9
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
System Organ Class
Tulburări generale şi la
Adverse Reactions
Oboseală/ Astenie
All Grades n (%)
287 (65, 2%)
Grade 3 n (%)
64 (14, 5%)
Grade 4 n (%)
5 (1, 1%)
and bone disorders
nivelul locului
Common Common Common Common
Foarte frecvente Frecvente
Myalgia Muscle spasm Back pain Muscular weakness
Pirexie
29 (6.6%) 21 (4.8%) 11 (2.5%) 10 (2.3%)
59 (13, 4%) 26 (5, 9%)
0 (0.0%) 1 (0.2%) 2 (0.5%) 1 (0.2%)
1 (0, 2%) 2 (0, 5%)
General disorders and administration site conditions Psychiatric disorders
Tulburări psihice
Very common Very common Very common Common Common
Frecvente
Fatigue/ Asthenia Mucosal inflammation Oedema d Pyrexia Insomnia
Insomnie
287 (65.2%) 70 (15.9%) 59 (13.4%) 26 (5.9%) 14 (3.2%)
14 (3, 2%)
64 (14.5%) 6 (1.4%) 1 (0.2%) 2 (0.5%) 0 (0.0%)
0 (0, 0%)
5 (1.1%) 1 (0.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0, 0%)
Lipase increase White blood cell count decreased e
Creşterea lipazei Scăderea numărului
35 (8.0%) 33 (7.5%)
35 (8, 0%) 33 (7, 5%)
12 (2.7%) 15 (3.4%)
12 (2, 7%) 15 (3, 4%)
7 (1.6%) 0 (0.0%)
7 (1, 6%) 0 (0, 0%)
Ejection fraction decreased
Scăderea fracţiei de ejecţie
Haemoglobin decreased
Reducerea hemoglobinei
Platelet count decrease
Reducerea numărului de trombocite
Common Common
Frecvente Frecvent
Weight decreased Blood creatinine phosphokinase increased
Scăderea greutăţii Creşterea creatinfosfokinazei sanguine
Amylase increased Aspartate aminotransferase increased
Creşterea amilazei Creşterea aspartat aminotransferazei
21 (4.8%) 18 (4.1%)
21 (4, 8%) 18 (4, 1%)
8 (1.8%) 2 (0.5%)
8 (1, 8%) 2 (0, 5%)
Alanine aminotransferase increased
Creşterea alanin aminotransferazei
0 (0.0%)
0 (0, 0% 0
Any adverse event
Toate reacţiile adverse
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
Anorexia şi scăderea apetitului b Disgeuzia, ageuzia şi tulburările gustului c Durere abdominală şi durere abdominală superioară d Edem, edem periferic şi edem facial e Scăderea numărului celulelor sanguine albe, scăderea numărului de neutrofile şi scăderea numărului de leucocite
Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Reacţii adverse legate de tratament, raportate în studiile MRCC la pacienţi netrataţi anterior şi refractari la citokine
System Organ Class
Sistemele organismului
Very common Very common
Foarte frecvente Foarte frecvente Foarte frecvente Frecvente Frecvente
Neutropoenia Thrombocytopoenia
Neutropenie Trombocitopenie Anemie Leucopenie Limfopenie
Endocrine
Afecţiuni endocrine
Eyelid oedema
Frecvente
a
Edemul pleoapei Scăderea apetitului a
Very Common Common
oculare
Decreased appetite Dehydration
Foarte frecvente
205 (37.7%) 33 (6.1%)
205 (37, 7%)
9 (1.7%) 7 (1.3%)
9 (1, 7%)
Very common Very common Common Common Common
Foarte frecvente
Taste disturbance b Headache Dizziness Paraesthesia Neuropathy peripheral
Tulburări ale gustului b
250 (46.0%) 82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
250
1 (0.2%) 3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
0 (0%)
Common Common
Frecvente Frecvente Frecvente Frecvente Frecvente
Hypoaesthesia Hyperaesthesia
Tulburări vasculare
20 (3.7%) 17 (3.1%)
143 (26, 3%)
0 (0%) 0 (0%)
0 (0, 0%) 0 (0, 0%)
Vascular disorders
0 (0%) 0 (0%) 0 (0%)
Very common Common Common
Frecvente Frecvente Frecvente
Hypertension Flushing Hot flush
Tuse Disfonie Uscăciunea mucoasei nazale
143 (26.3%) 17 (3.1%) 12 (2.2%)
23 (4, 2%) 16 (2, 9%) 14 (2, 6%)
55 (10.1%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%)
Respiratory, thoracic and
Dispnee de efort Congestie nazală Efuziune pleurală
mediastinal
intestinale
Dyspnoea
Greaţă
disorders
Foarte frecvente
Common
Dispepsie
Common Common Common Common Common Common
Foarte frecvente
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
Stomatită
23 (4.2%) 16 (2.9%) 14 (2.6%) 12 (2.2%) 12 (2.2%) 12 (2.2%)
185 (34, 0%)
Gastrointestinal disorders
Durere/ distensie abdominalăc
Very common Very common Very common Very common Very common Very common
Foarte frecvente Foarte frecvente Foarte frecvente Foarte frecvente
Diarrhoea Nausea Dyspepsia Stomatitis Vomiting Abdominal pain c / distension
Constipaţie Glosodinie Flatulenţă Dureri la nivelul cavităţii bucale
326 (59.9%) 290 (53.3%) 189 (34.7%) 185 (34.0%) 178 (32.7%) 106 (19.5%)
83 (15, 3%) 63 (11, 6%) 60 (11, 0%) 60 (11, 0%)
38 (7.0%) 19 (3.5%) 8 (1.5%) 13 (2.4%) 17 (3.1%) 10 (1.8%)
1 (0, 2%) 0 (0%) 0 (0%) 0 (0%)
Very common Very common Very common Very common Very common Common
Foarte frecvente Frecvente
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
Xerostomie Boală de reflux gastro- esofagian
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
56 (10, 3%) 50 (9, 2%)
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
0 (0%) 2 (0, 4%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
Common Common Common Common Common Common Common Common
Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
Disfagie Cheilită Sângerări gingivale Hemoroizi Proctalgii Ulceraţii ale cavităţii bucale
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
20 (3, 7%) 19 (3, 5%) 18 (3, 3%) 18 (3, 3%) 17 (3, 1%) 16 (2, 9%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
2 (0, 4%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%) 1( 0, 2%) 0 (0, 0%)
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%)
1 (0, 2%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
11
Disconfort gastric Hemoragii rectale
System Organ Class
15 (2, 8%) 13 (2, 4%)
Yellow discolouration/ Skin discolouration
Depigmentări ale pielii / Colorarea în galben
Very common Very common Very common Very common Common Common Common Common Common Common Common
Foarte frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente Frecvente
Rash Dry skin Hair colour changes Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
Alopecie Eritem Exfoliere cutanată Prurit Edem periorbital Dermatită Leziuni cutanate Afecţiuni ale unghiilor/ decolorare
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%) 25 (4, 6%)
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%) 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 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Blister Skin reaction Hyperkeratosis Acne
Vezicule Reacţii cutanate Hiperkeratoză Acnee
1 (0.2%) 6 (1.1%) 4 (0.7%) 0 (0%)
1 (0, 2%) 6 (1, 1%) 4 (0, 7%) 0 (0, 0%)
Musculoskeletal and connective tissue disorders
scheletice ale ţesutului conjunctiv şi ale tesutului osos Tulburări generale şi la
Very common Common Common Common Common
Frecvente Frecvente Frecvente Frecvente Foarte frecvente
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
Artralgii Mialgii Spasme musculare Dureri lombare Astenie/ Oboseală
96 (17.6%) 49 (9.0%) 48 (8.8%) 26 (4.8%) 17 (3.1%)
49 (9, 0%) 48 (8, 8%) 26 (4, 8%) 17 (3, 1%) 397 (73, 0%)
6 (1.1%) 1 (0.2%) 2 (0.4%) 0 (0%) 2 (0.4%)
1 (0, 2%) 2 (0, 4%) 0 (0, 0%) 2 (0, 4%) 95 (17, 5%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
General disorders and administration
nivelul locului administrare
Very common Very common
Foarte Frecvente
Fatigue/ asthenia Mucosal inflammation
Inflamaţia mucoasei Edem d
397 (73.0%) 127 (23.3%)
127 (23, 3%)
95 (17.5%) 8 (1.5%)
8 (1, 5%)
site conditions
Foarte frecvente
Very common Common Common Common Common
Frecvente Frecvente Frecvente Frecvente
Oedema d Pyrexia Chills Pain Chest pain
Pirexie Frisoane Durere Durere toracică
99 (18.2%) 37 (6.8%) 35 (6.4%) 20 (3.7%) 13 (2.4%)
37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%)
5 (0.9%) 3 (0.6%) 2 (0.4%) 0 (0%) 2 (0.4%)
3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
Psychiatric disorders Investigations
Tulburări psihice Investigaţii diagnostice
Common Common Very common
Frecvente Frecvente Foarte frecvente
Insomnia Depression Ejection fraction decreased
Insomnie Depresie Scăderea fracţiei de ejecţie
22 (4.0%) 15 (2.8%) 84 (15.4%)
22 (4, 0%) 15 (2, 8%) 84 (15, 4%)
0 (0%) 1 (0.2%) 16 (2.9%)
0 (0%) 1 (0, 2%) 16 (2, 9%)
Weight decreased Platelet count decreased
Scădere în greutate Reducerea numărului de trombocite
White blood cell count decreased e
Scăderea numărului de celule albee
Lipase increased Haemoglobin decreased
Creşterea lipazei sanguine
Common
13
Blood creatine phosphokinase increased
Sistemele organismului
19 (3.5%)
Frecvenţă
7 (1.3%)
Gradul 3 de severitate n (%)
2 (0.4%)
Gradul 4 de severitate n (%)
Aspartate aminotransferase
Scăderea hemoglobinei
12
7 (1, 3%)
System Organ Class
2 (0, 4%)
Adverse Reactions increased
Creşterea aspartataminotransfe razei
Blood amylase increased
Creşterea amilazei sanguine
Blood pressure increased
Creşterea presiunii sanguine
14 (2.6%)
14 (2, 6%)
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
Următorii termeni au fost combinaţi: a Anorexia şi scăderea apetitului b Disgeuzia, ageuzia şi tulburările gustului c Durere abdominală şi durere abdominală superioară d Edem, edem periferic şi edem facial e Scăderea numărului celulelor sanguine albe, scăderea numărului de neutrofile, şi scăderea numărului de leucocite
Adverse reactions from post-marketing experience
Reacţii adverse raportate în cadrul experienţei după punerea pe piaţă
The following adverse reactions have been identified during post-approval use of SUTENT.
Următoarele tipuri de reacţii au fost raportate după punerea pe piaţă, în cadrul experienţei cu SUTENT.
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.
Acestea includ cazuri raportate spontan precum şi reacţii adverse grave din studiile clinice în desfăşurare, programele de acces extins, studiile de farmacologie clinică şi studiile exploratorii în indicaţiile neaprobate.
Cardiac failure, cardiac failure congestive, left ventricular failure Prolonged QT interval, Torsade de pointes
Insuficienţă cardiacă, insuficienţă cardiacă congestivă, insuficienţă ventriculară stângă Interval QT prelungit, torsada vârfurilor
Pancreatitis Gastrointestinal perforation
Perforaţie gastro- intestinală
Investigations:
Insuficienţă hepatică
Hepatic failure
Investigaţii diagnostice:
Elevated thyroid stimulating hormone (TSH)
Creşterea concentraţiei hormonului stimulant tiroidian (TSH)
Infections and Infestations Non known:
Cu frecvenţă necunoscută
Muscoloskeletal and Not known:
Infecţii (cu sau fără neutropenie)
Pulmonary disorders
Tulburări musculo- scheletice şi ale ţesutului conjunctiv Cu frecvenţă
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
Miopatie şi/ sau rabdomioliză
Not known:
necunoscută
Not known:
14
Pleural effusion Pulmonary embolism and respiratory failure
Efuziune pleurală Embolie pulmonară şi insuficienţă respiratorie
Thromboembolic events:
Evenimente tromboembolice:
Cases of pulmonary embolism, in some cases with fatal outcome, have been reported.
Au fost raportate cazuri de embolie pulmonară, unele cu evoluţie letală.
Cases of serious infection (with or without neutropoenia), including pneumonia, have been reported.
Au fost raportate cazuri de infecţii grave (cu sau fără neutropenie), inclusiv pneumonie.
Few cases had a fatal outcome.
Unele cazuri au avut evoluţie letală.
Rare cases of myopathy and/ or rhabdomyolysis, some with acute renal failure, have been reported.
Au fost raportate cazuri de miopatie şi/ sau rabdomioliză, unele cu evoluţie spre insuficienţă renală acută.
13 Blood and lymphatic system disorders:
Tulburări hematologice şi limfatice:
Rare cases of thrombotic microangiopathy have been reported.
Au fost raportate cazuri rare de microangiopatie trombotică.
Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.
Se recomandă întreruperea temporară a tratamentului cu SUTENT; după remiterea simptomelor, tratamentul poate fi reluat la latitudinea medicului curant.
Endocrine Disorders:
Tulburări endocrine:
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience (See also section 4.4).
4. 4).
The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Nu a fost evaluată sistematic siguranţa continuării tratamentului cu SUTENT la pacienţii cu proteinurie moderată sau severă.
Discontinue SUTENT in patients with nephrotic syndrome (see also section 4.4).
Tratamentul cu SUTENT trebuie întrerupt la pacienţii cu sindrom nefrotic (vezi şi pct 4. 4.).
There is no experience of acute overdosage with SUTENT.
Nu există experienţă cu privire la supradozaj acut cu SUTENT.
There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures.
Nu există un antidot specific pentru supradozajul cu SUTENT, iar tratamentul supradozajului trebuie să cuprindă măsurile generale de îngrijire.
If indicated, elimination of unabsorbed drug may be achieved by emesis or gastric lavage.
Dacă există indicaţie, eliminarea medicamentului neabsorbit poate fi realizată prin emeză sau lavaj gastric.
Antineoplastic agents - Protein-tyrosine kinase inhibitor, ATC Code:
Agenţi antineoplazici – inhibitor de protein- tirozin kinază, Cod ATC:
Sunitinib malate inhibits multiple receptor tyrosine kinases (RTKs) that are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Sunitinib malat inhibă mai mulţi receptori de tip tirozin kinază (RTK - receptor tyrosine kinases) implicaţi în creşterea tumorală, angiogeneza patologică şi progresia metastatică a cancerului.
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).
Sunitinib a fost identificat ca fiind un inhibitor al receptorilor pentru factorul de creştere derivat din trombocite (PDGFRα şi PDGFRß), al receptorilor pentru factorul de creştere endotelial vascular (VEGFR1, VEGFR2 şi VEGFR3), al receptorului pentru factorul celulelor stem (KIT), al tirozin kinazei 3 Fms- like (FLT3), al receptorului pentru factorul de stimulare a coloniiilor (CSF- 1R) şi al receptorului pentru factorul neurotrofic derivat din linia celulară glială (RET).
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.
STUDII CLINICE Siguranţa şi eficacitatea clinică a SUTENT s- au studiat pentru tratamentul pacienţilor cu tumoră stromală gastro- intestinală malignă (GIST) cu rezistenţă la imatinib (şi anume aceia care au prezentat progresia bolii în timpul sau după tratamentul cu imatinib) sau cu intoleranţă la imatinib (şi anume cei
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.
Tumorile stromale gastro- intestinale S- a realizat un studiu iniţial, deschis, de creştere a dozei la pacienţii cu GIST după eşecul imatinibului (doza mediană zilnică maximă – 800 mg) datorită rezistenţei sau intoleranţei.
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”).
Au fost incluşi 97 de pacienţi cărora li s- auadministrat diferite doze şi scheme; 55 de pacienţi au fost trataţi cu 50 mg conform schemei de tratament recomandate, de 4 săptămâni cu 2 săptămâni libere („ schema 4/ 2 ”).
In this study the median Time To Progression (TTP) was 34.0 weeks (95% CI = 22.0 – 46.0 weeks).
În acest studiu, timpul median de progresie a fost de 34, 0 săptămâni (95% IC = 22, 0 – 46, 0 săptămâni).
A phase 3, randomized, double-blind, placebo-controlled study of SUTENT was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with, imatinib (Median maximum daily dose 800 mg).
S- a efectuat un studiu de fază 3 randomizat, dublu orb, controlat placebo, cu SUTENT la pacienţi cu GIST care au prezentat intoleranţă, sau progresia bolii în timpul sau după tratamentul cu imatinib (doza mediană zilnică maximă – 800 mg).