natgillin/translations-raw huggingface dataset:
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach,
• bolečine/draženje v ustih, rane/vnetje v ustih/suha usta, motnje okušanja, težave z želodcem,
Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the 2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the IFN- arm in the treatment-naïve MRCC study.
V dveh študijah MRCC, odpornega proti citokinom, so o hipotiroidizmu kot o neželenem učinku poročali pri 7 bolnikih (4 %), ki so prejemali sunitinib; v študiji še nezdravljenega MRCC pa pri 61 bolnikih (16 %) v skupini s sunitinibom in pri 3 bolnikih (< 1 %) v skupini z IFN-.
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 to 21 years), with refractory solid tumours, the majority of whom had a primary diagnosis of brain tumour.
Študija s povečevanjem odmerka peroralnega sunitiniba 1. faze je potekala pri 35 bolnikih, od katerih je bilo 30 pediatričnih bolnikov (starih od 3 let do 17 let) in 5 mlajših odraslih bolnikov (starih od 18 let do 21 let) z neodzivnimi čvrstimi tumorji, med katerimi je imela večina primarno diagnozo možganskega tumorja.
The majority of cases were reported in patients who had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Pri bolnikih, ki so se zdravili z zdravilom Sutent, so poročali o primerih osteonekroze čeljustnic; večina teh bolnikov je bila predhodno ali sočasno zdravljena z intravenskimi bisfosfonati, za katere je osteonekroza čeljustnic znano tveganje.
Decreased absolute neutrophil counts of Grade 3 and 4 severities, respectively, were reported in 10% and 1.7% of patients on the Phase 3 GIST study, in 16% and 1.6% of patients on the Phase 3 MRCC study, and in 13% and 2.4% of patients on the Phase 3 pNET study.
V študiji 3. faze pri GIST so o zmanjšanju absolutnega števila nevtrofilcev 3. stopnje poročali pri 10 % bolnikov, 4. stopnje pa pri 1,7 % bolnikov; v študiji 3. faze pri MRCC o zmanjšanju 3. stopnje pri 16 % bolnikov in 4. stopnje pri 1,6 % bolnikov, in v študiji 3. faze pri pNET pri 13 % oziroma 2,4 % bolnikov.
nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
slabost s siljenjem na bruhanje, bruhanje, driska, zaprtje, bolečine/otekanje v trebuhu, izguba ali zmanjšanje teka
• Blood clots in the blood vessels.
• krvni strdki v žilah
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules sunitinib
Sutent 12,5 mg trde kapsule Sutent 25 mg trde kapsule Sutent 37,5 mg trde kapsule Sutent 50 mg trde kapsule sunitinib
Cases of fistula formation, sometimes associated with tumour necrosis and regression, in some cases with fatal outcomes, have been reported (see section 4.4).
Poročali so o primerih nastanka fistule, ki so bili včasih povezani z nekrozo in regresijo tumorja, v nekaterih primerih s smrtnim izidom (glejte poglavje 4.4).
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.
Študija s povečevanjem odmerka peroralnega sunitiniba 1. faze je potekala pri 35 bolnikih, od katerih je bilo 30 pediatričnih bolnikov (starih od 3 let do 17 let) in 5 mlajših odraslih bolnikov (starih od 18 let do 21 let) z neodzivnimi čvrstimi tumorji, med katerimi je imela večina ob vključitvi v študijo primarno diagnozo možganskega tumorja.
Gastrointestinal stromal tumour (GIST)
Gastrointestinalni stromalni tumorji (GIST)
- If you have or have had pancreatic or gallbladder disorders.
- Če imate ali ste imeli bolezni trebušne slinavke ali žolčnika.
Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported.
Poročali so o primerih gangrenozne pioderme, ki običajno izgine po prekinitvi zdravljenja s sunitinibom.
Hyperthyroidism was reported in no sunitinib-treated patients and 1 (1.0%) patient receiving standard of care.
O hipertiroidizmu pri bolnicah, ki so prejemale sunitinib, niso poročali, so pa o njem poročali pri 1 bolnici (1,0 %), ki je prejemala standardno zdravljenje.
A pivotal Phase 3, multi-centre, international, randomised, double-blind, placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET.
Pri bolnikih z neizrezljivim pNET so opravili ključno, multicentrično, mednarodno, randomizirano, dvojno slepo, s placebom nadzorovano študijo 3. faze.
Combination with CYP3A4 inhibitors should therefore be avoided, or the selection of an alternate concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.
Kombinaciji z zaviralci CYP3A4 se je torej treba izogibati ali pa izbrati drugo sočasno zdravljenje z minimalnim potencialom za zaviranje CYP3A4 ali brez takšnega potenciala.
Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8).
Podatki o nadaljnji uporabi sunitiniba pri bolnikih s fistulo so omejeni (glejte poglavje 4.8).
In the treatment-naïve MRCC study, 27% of patients on sunitinib and 15% of patients on IFN- had an LVEF value below the lower limit of normal.
V študiji še nezdravljenega MRCC je imelo LVEF pod spodnjo mejo normale 27 % bolnikov, ki so prejemali sunitinib, in 15 % bolnikov, ki so prejemali IFN-.
Stepwise covariate modelling analyses were performed to evaluate the effect of age and body size (total body weight or body surface area) as well as other covariates on important PK parameters for sunitinib and its active metabolite.
Za ovrednotenje vpliva starosti in velikosti telesa (skupne telesne mase ali telesne površine), kot tudi drugih sospremenljivk, na pomembne FK parametre sunitiniba in njegovega aktivnega presnovka so izvedli analize postopnega modeliranja sočasnih spremenljivk.
Pyoderma gangrenosum Toxic epidermal necrolysis*
Stevens-Johnsonov sindrom gangrenozna pioderma toksična epidermalna nekroliza
There were no serious adverse events (SAEs) or Grade 5 adverse drug reactions reported in this study.
V tej študiji niso poročali o resnih neželenih učinkih ali neželenih učinkih 5. stopnje.
A 6-month, oral gavage carcinogenicity study (0, 8, 25, 75 [reduced to 50] mg/kg/day), with daily dosing was conducted in rasH2 transgenic mice.
Pri rasH2 transgenskih miših so izvedli 6-mesečno študijo rakotvornosti ob uporabi gastrične sonde z dnevnim odmerjanjem (0, 8, 25, 75 [zmanjšano na 50] mg/kg/dan).
A Phase 1/2 single-arm, study was conducted in 6 paediatric patients (aged 13 years to 16 years) with advanced unresectable GIST.
faze je potekala pri 6 pediatričnih bolnikih (starih od 13 let do 16 let) z napredovalim neizrezljivim GIST.
If you get any side effects, talk to your doctor.
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom.
- If you have abnormal heart rhythm changes.
- Če imate motnje v srčnem ritmu.
Patients who presented with pulmonary embolism within the previous 12 months were excluded from sunitinib clinical studies.
V klinične študije s sunitinibom niso vključili bolnikov, ki so imeli pljučno embolijo v zadnjih 12 mesecih.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Razmisliti je treba o izbiri drugega sočasnega zdravila, ki nima potenciala za indukcijo ali zaviranje CYP3A4 oz. je njegov potencial v tem pogledu minimalen.
Uncommon cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see section 4.8).
Poročali so o občasnih primerih nekrotizirajočega fasciitisa, vključno s prizadetostjo presredka, ki so bili včasih smrtni (glejte poglavje 4.8).
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 times the systemic exposure in humans.
Pri kuncih so učinki na razvoj obsegali večjo incidenco heiloshize (ob plazemski izpostavljenosti, ki je bila približno enaka kot med klinično uporabo) ter heilognatoshize (ob plazemski izpostavljenosti, ki je bila približno 2,7-krat večja od sistemske izpostavljenosti pri ljudeh).
• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
• bolečina v trebuhu zaradi vnetja trebušne slinavke
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
• bolečine v ustih, zobeh in/ali čeljusti, otekline ali ranice v ustih, odrevenelost ali občutek teže v čeljusti ali majav zob; to bi lahko bili znaki in simptomi poškodbe kosti v čeljusti (osteonekroza),
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.
Podobno je med bolniki razmerje ogroženosti za PFS znašalo 0,456 (95 % IZ: 0,264, 0,787), p = 0,0036, in sicer med 57 bolniki v skupini, ki je prejemala sunitinib (vključno z 28, ki so bili deležni enega predhodnega sistemskega zdravljenja, in 29, ki so bili deležni dveh ali več predhodnih sistemskih zdravljenj) in 61 bolniki v skupini, ki je prejemala placebo (vključno s 25, ki so bili deležni enega predhodnega sistemskega zdravljenja, in 36, ki so bili deležni dveh ali več predhodnih sistemskih zdravljenj).
Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported (see also section 4.4).
Poročali so o primerih nekrotizirajočega fasciitisa, vključno s prizadetostjo presredka, včasih s smrtnim izidom (glejte tudi poglavje 4.4).
Cytokine-refractory metastatic renal cell carcinoma A Phase 2 study of sunitinib was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or IFN-.
Proti citokinom odporni metastatski karcinom ledvičnih celic (MRCC) Pri bolnikih, odpornih proti prejšnjemu citokinskemu zdravljenju z interlevkinom-2 ali IFN-, so opravili študijo 2. faze s sunitinibom.
Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patients receiving placebo.
V študiji 3. faze pri GIST so o pojavih krvavitev poročali pri 18 % bolnikov, ki so prejemali sunitinib, in pri 17 % bolnikov, ki so prejemali placebo.
• 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.
• porumenela koža/obarvanje kože, čezmerna pigmentacija kože, sprememba barve las in dlak,
However, in repeated-dose toxicity studies performed in rats and monkeys, effects on female fertility were observed in the form of follicular atresia, degeneration of corpora lutea, endometrial changes in the uterus, and decreased uterine and ovarian weights at clinically relevant systemic exposure levels.
So pa v študijah toksičnosti ponavljajočih se odmerkov pri podganah in opicah, ob klinično pomembni sistemski izpostavljenosti, ugotovili učinke na plodnost samic, ki so se kazali kot atrezija foliklov, degeneracija rumenih telesc, spremembe endometrija v maternici in zmanjšanje mase maternice in jajčnikov.
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.
Pri bolnikih, zdravljenih s sunitinibom, so poročali o srčno-žilnih dogodkih, vključno s srčnim popuščanjem, kardiomiopatijo, zmanjšanjem iztisnega deleža levega prekata pod spodnjo mejo normale, miokarditisom, miokardno ishemijo in miokardnim infarktom, v nekaterih primerih s smrtnim izidom.
Cases of pulmonary embolism with fatal outcome have been observed in postmarketing surveillance.
Med nadzorom v obdobju trženja zdravila so zabeležili primere pljučne embolije s smrtnim izidom.
Weight, performance status
Telesna masa in stanje zmogljivosti
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.
Do 14. dneva je kombinirana koncentracija sunitiniba in njegovega aktivnega presnovka v plazmi 62,9-101 ng/ml.
Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood.
Obvestite zdravnika, če se pojavijo kašelj, bolečina v prsnem košu, nenadna zasoplost ali izkašljevanje krvi.
Blood TSH increase was reported in 12 (5.0%) patients on sunitinib and no patients on capecitabine.
O zvišanju ravni TSH v krvi so poročali pri 12 bolnicah (5,0 %), ki so prejemale sunitinib, pri bolnicah, ki so prejemale kapecitabin, pa tovrstnih poročil ni bilo.
Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see sections 4.4 and 4.5).
Izogibati se je treba sočasni uporabi sunitiniba z močnimi induktorji CYP3A4, npr. z rifampicinom (glejte poglavji 4.4 in 4.5).
Blood TSH increase was reported in 1 (0.9%) patient on sunitinib and no patients on standard of care.
O zvišanju ravni TSH v krvi so poročali pri 1 bolnici (0,9 %), ki je prejemala sunitinib, pri bolnicah, ki so prejemale standardno zdravljenje, pa tovrstnih poročil ni bilo.
- Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
- Črnilo za tisk: šelak, propilenglikol, kalijev hidroksid, črni železov oksid (E172).
Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Obvestite zdravnika, če imate hude bolečine v trebuhu, vročino, slabost s siljenjem na bruhanje, bruhanje, kri v blatu ali spremembe v izločanju blata.
Hypertension was reported in 26.5% of patients receiving sunitinib in a Phase 3 pNET study, compared to 4.9% of patients receiving placebo.
V študiji 3. faze pri pNET so o hipertenziji poročali pri 26,5 % bolnikov, ki so prejemali sunitinib, in pri 4,9 % bolnikov, ki so prejemali placebo.
Cases of myopathy and/or rhabdomyolysis, some with acute renal failure, have been reported.
Bolezni mišično-skeletnega sistema in vezivnega tkiva Poročali so o primerih miopatije in/ali rabdomiolize, v nekaterih primerih z akutno odpovedjo ledvic.
However, the discontinuation rates due to adverse events were 20% for sunitinib and 23% for IFN-α.
Vendar so zaradi neželenih učinkov zdravljenje prekinili pri 20 % bolnikov, ki so prejemali sunitinib, in pri 23 % bolnikov, ki so prejemali IFN-.
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.
Če to ni mogoče, bo morda potrebno zvečevanje odmerka sunitiniba po 12,5 mg (do 87,5 mg na dan pri GIST in MRCC, oziroma 62,5 mg na dan pri pNET), pri čemer moramo stalno spremljati bolnikovo prenašanje.
Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management.
Pri bolnikih s hudo hipertenzijo, ki je ni mogoče urediti z zdravili, je priporočljivo začasno prenehanje zdravljenja.
Co-administration with medicinal products that are BCRP inhibitors In vitro, sunitinib is a substrate of the efflux transporter BCRP.
Sunitinib je in vitro substrat izločevalnega prenašalca BCRP.
Hazard Ratio (95% CI)
Razmerje ogroženosti (95% IZ)
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.
Pri bolnikih z GIST, pri katerih je bilo zdravljenje z imatinibom zaradi odpornosti ali neprenašanja neuspešno (mediana največjega dnevnega odmerka 800 mg), so opravili uvodno, odprto študijo s povečevanjem odmerka.
Acquired hypothyroidism was noted in 6.2% of GIST patients on sunitinib versus 1% on placebo.
Hipotiroidizem so opazili pri 6,2 % bolnikov z GIST, ki so prejemali sunitinib, in pri 1 % bolnikov, ki so prejemali placebo.
Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabine.
O hipertiroidizmu so poročali pri 4 bolnicah (1,7 %), ki so prejemale sunitinib, pri bolnicah, ki so prejemale kapecitabin, pa tovrstnih poročil ni bilo.
Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine's dosage needs to be adjusted to minimise the risk of low blood sugar.
Tako zdravnik oceni, ali je treba odmerek zdravila za sladkorno bolezen prilagoditi, da se zmanjša tveganje za nizke ravni sladkorja v krvi.
Decreased absolute neutrophil counts and decreased platelet counts were reported in association with sunitinib (see section 4.8).
V povezavi s sunitinibom so poročali o zmanjšanju absolutnega števila nevtrofilcev in zmanjšanju števila trombocitov (glejte poglavje 4.8).
- If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, tell your doctor and dentist immediately.
- Nemudoma obvestite zdravnika ali zobozdravnika, če imate ali ste imeli bolečine v ustih, zobeh in/ali čeljusti, otekline ali rane v ustih, odrevenelost ali občutek teže v čeljusti ali če se vam je razmajal zob.
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
• razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij)
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.
Pri bolnikih s še nezdravljenim MRCC so opravili randomizirano, multicentrično mednarodno študijo 3. faze za oceno učinkovitosti in varnosti sunitiniba v primerjavi z interferonom IFN-.
If you are breast-feeding, tell your doctor.
Če dojite, morate to povedati zdravniku.
- If you have or have had seizures.
- Če imate ali ste imeli težave z ledvicami.
• Nasal dryness, congested nose.
• suha nosna sluznica, zamašen nos
- Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
- Ovojnica kapsule: želatina, rdeči železov oksid (E172) in titanov dioksid (E171).
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.
Če to ni mogoče, bo morda potrebno zmanjšanje odmerka sunitiniba na ne manj kot 37,5 mg na dan pri GIST in MRCC, oziroma 25 mg na dan pri pNET, pri čemer moramo stalno spremljati bolnikovo prenašanje.
Sutent 37.5 mg hard capsules
Sutent 37,5 mg trde kapsule
The PK of gefitinib (250 mg daily) and sunitinib (37.5 mg [Cohort 1, n=4] or 50 mg [Cohort 2, n=7] daily on a 4-weeks on followed by 2 weeks-off schedule) when co-administered was evaluated as a secondary study objective.
faze, v kateri so preučevali varnost/prenašanje, največji odmerek, ki ga bolniki še prenašajo, in protitumorsko delovanje sunitiniba v kombinaciji z gefitinibom pri preskušancih z MRCC. FK sočasno uporabljenih gefitiniba (250 mg na dan) in sunitiniba (37,5 mg [kohorta 1, n = 4] ali 50 mg [kohorta 2, n = 7] na dan po shemi 4-tedenskega jemanja zdravila, čemur sledi 2-tedenski premor) so ocenjevali kot sekundarni cilj študije.
Hypersensitivity Angioedema
Bolezni imunskega sistema preobčutljivost angioedem
Use sunitinib with caution in patients who are at risk for, or who have a history of, these events (see section 4.8).
Pri bolnikih s tveganjem za ali z anamnezo teh dogodkov, je treba sunitinib uporabljati previdno (glejte poglavje 4.8).
• Excessive tear flow.
• prekomerno solzenje
Concomitant administration of sunitinib with potent CYP3A4 inhibitors should be limited because of the possible increase in sunitinib plasma concentrations (see sections 4.2, 4.5 and 4.8).
Sočasna uporaba sunitiniba z močnimi zaviralci CYP3A4 mora biti omejena zaradi možnega zvečanja koncentracije sunitiniba v plazmi (glejte poglavja 4.2, 4.5 in 4.8).
Sutent 25 mg hard capsules
Sutent 25 mg trde kapsule
Sutent 50 mg hard capsules
Sutent 50 mg trde kapsule
If this is not possible, the dose of Sutent may need to be increased in 12.5 mg increments (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET), based on careful monitoring of tolerability (see section 4.2).
Če to ni mogoče, bo morda potrebno zvečevanje odmerka zdravila Sutent po 12,5 mg (do 87,5 mg na dan pri GIST in MRCC, oziroma 62,5 mg na dan pri pNET), pri čemer moramo bolnikovo prenašanje stalno spremljati (glejte poglavje 4.2).
No pulmonary embolism was reported for patients with pNET who received sunitinib in the Phase 3 study.
Pri bolnikih s pNET, ki so v študiji 3. faze prejemali sunitinib, niso poročali o pljučni emboliji.
In the pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Z zdravljenjem povezani učinki na srce s smrtnim izidom so se v ključni študiji 3. faze pri GIST (n = 312) v obeh skupinah (tj. skupini s sunitinibom in skupini s placebom) pojavili pri 1 % bolnikov.
Blood TSH decrease was reported in 3 (1.3%) patients on sunitinib and no patients on capecitabine.
O znižanju ravni TSH v krvi so poročali pri 3 bolnicah (1,3 %), ki so prejemale sunitinib, pri bolnicah, ki so prejemale kapecitabin, pa tovrstnih poročil ni bilo.
Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Izogibati se je treba sočasni uporabi sunitiniba z močnimi zaviralci CYP3A4, npr. s ketokonazolom (glejte poglavji 4.4 in 4.5).
Sutent 12.5 mg hard capsules
Sutent 12,5 mg trde kapsule
Temporary interruption of sunitinib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Iz previdnostnih razlogov je pri bolnikih, pri katerih naj bi bil opravljen večji kirurški poseg, priporočljiva začasna prekinitev zdravljenja s sunitinibom.
The administration of sunitinib should be interrupted and/or the dose reduced in patients without clinical evidence of CHF but with an ejection fraction < 50% and > 20% below baseline.
Pri bolnikih brez kliničnih znakov kongestivnega srčnega popuščanja, vendar z iztisnim deležem < 50 % in > 20 % pod izhodiščno vrednostjo, je treba jemanje sunitiniba prekiniti in/ali odmerek zmanjšati.
Propylene glycol Potassium hydroxide Black iron oxide (E172)
črnilo šelak propilenglikol natrijev hidroksid črni železov oksid (E172)
Haemorrhage and tumour bleeding
Krvavitev in krvavitev tumorja
A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Pri vseh podskupinah, pri katerih so bile ovrednotene izhodiščne značilnosti, vključno z analizo števila predhodnih sistemskih zdravljenj, so opažali razmerje ogroženosti v prid zdravilu sunitinib.
Thirteen patients (3%) receiving sunitinib in the Phase 3 treatment-naïve MRCC study and 4 patients (2%) on the 2 cytokine-refractory MRCC studies had venous thromboembolic events reported.
O venskih trombemboličnih dogodkih so poročali pri 13 bolnikih (3 %), ki so sunitinib prejemali v 3. fazi študije pri še nezdravljenem MRCC, in pri 4 bolnikih (2 %) v 2 študijah MRCC, odpornega proti citokinom.