natgillin/translations-raw huggingface dataset:
SUTENT and placebo arms).
Z zdravljenjem povezani smrtni srčni dogodki so se v študiji 3. faze pri GIST (n = 312) v obeh krakih (tj. kraku s SUTENTOM in kraku s placebom) pojavili pri 1% bolnikov.
In a phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN-α arm and 0 patients on the
V študiji 2. faze pri bolnikih z MRCC, odpornim proti citokinom, je imelo z zdravljenjem povezan smrten miokardni infarkt 0, 9% bolnikov.
4 SUTENT arm experienced fatal cardiac events.
V študiji 3. faze pri še nezdravljenih bolnikih z MRCC pa so se smrtni srčni dogodki pojavili pri 0, 6% bolnikov v kraku z IFN- α ter pri nobenem bolniku v kraku s SUTENTOM.
The relationship, if any, between receptor tyrosine kinase (RTK) inhibition and cardiac function remains unclear.
Povezanost med zaviranjem receptorjev tirozin- kinaze (RTK) in delovanjem srca ostaja nejasna, v kolikor sploh obstaja.
Patients who presented with cardiac events within 12 months prior to SUTENT administration, such as myocardial infarction (including severe/ unstable angina), coronary/ peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism were excluded from SUTENT clinical studies.
Klinične študije SUTENTA so izključile bolnike, ki so imeli v 12 mesecih pred aplikacijo SUTENTA kakšen srčni dogodek, npr. miokardni infarkt (vključno s hudo/ nestabilno angino pektoris), obvodno operacijo koronarne ali periferne arterije, simptomatsko kongestivno srčno popuščanje, cerebrovaskularni insult ali tranzitorno ishemično atako, ali pljučno embolijo.
Close monitoring for clinical signs and symptoms of CHF should be performed, especially in patients with cardiac risk factors and/ or history of coronary artery disease.
Bolnike morate natančno nadzirati glede kliničnih znakov in simptomov kongestivnega srčnega popuščanja, zlasti bolnike s srčnimi dejavniki tveganja in/ ali anamnezo koronarne bolezni.
Physicians are advised to weigh this risk against the potential benefits of the drug.
Zdravnik mora to tveganje pretehtati v primerjavi z možnimi koristmi zdravila.
These patients should be carefully monitored for clinical signs and symptoms of CHF while receiving SUTENT.
Takšne bolnike je treba med zdravljenjem s SUTENTOM natančno nadzirati glede kliničnih znakov in simptomov kongestivnega srčnega popuščanja.
Baseline and periodic evaluations of LVEF should also be considered while the patient is receiving SUTENT.
Med zdravljenjem s SUTENTOM je treba razmisliti tudi o določitvi vrednosti LVEF na začetku zdravljenja in to občasno ponoviti.
In the presence of clinical manifestations of CHF, discontinuation of SUTENT is recommended.
Če se pojavijo klinični znaki kongestivnega srčnega popuščanja, je priporočljivo prekiniti zdravljenje s SUTENTOM.
The dose of SUTENT should be interrupted and/ or 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, a z iztisnim deležem < 50% in > 20% pod izhodiščnim, je treba jemanje SUTENTA prekiniti oz. odmerek zmanjšati.
QT Interval prolongation Data 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).
Podaljšanje intervala QT Podatki iz nekliničnih študij (in vitro in in vivo) z odmerki, večjimi od priporočenega odmerka za človeka, kažejo, da lahko sunitinib zavre repolarizacijsko fazo srčnega akcijskega potenciala (npr. podaljšanje intervala QT).
Increases in the QTc interval to over 500 msec occurred in 0.5% and changes from baseline in excess of 60 msec occurred in 1.1% of the 450 solid tumours patients; both these parameters are recognized as potentially significant changes.
Podaljšanje intervala QTc prek 500 milisekund se je pojavilo pri 0, 5%, spremembe od izhodišča, večje od 60 milisekund, pa pri 1, 1% od 450 bolnikov s čvrstimi tumorji; oba parametra veljata za potencialno pomembni spremembi.
At approximately twice therapeutic concentrations, SUTENT has been shown to prolong the QTcF Inteval (Frederica’ s Correction).
Dokazano je, da SUTENT v približno dvakratni terapevtski koncentraciji podaljša interval QTcF (Fredericova korekcija).
QT interval prolongation was investigated in a trial in 24 patients, aged 20-87 years, with advanced malignancies.
Podaljšanje intervala QT so preučevali v študiji na 24 bolnikih z napredovalim rakom v starosti od 20 do 87 let.
The results of this study demonstrated that sunitinib had an effect on QTc (defined as a mean placebo-adjusted change of > 10 msec with a 90% CI upper limit > 15 msec) at therapeutic concentration (day 3) using the within-day baseline correction method, and at greater than therapeutic concentration (Day 9) using both baseline correction methods.
Rezultati te študije so pokazali, da sunitinib vpliva na QTc (to je bilo opredeljeno kot povprečna, glede na placebo korigirana sprememba za > 10 milisekund in z zgornjo mejo 90% intervala zaupanja > 15 milisekund); vpliv se je izkazal pri terapevtski koncentraciji (3. dan) z uporabo znotrajdnevnega postopka korekcije glede na izhodišče ter v več kot terapevtski koncentraciji (9. dan) z uporabo obeh postopkov korekcije glede na izhodišče.
No patients had a QTc value > 500 msec.
Noben bolnik ni imel vrednosti QTc > 500 milisekund.
Although an effect on QTcF was observed on Day 3 at 24 hours post-dose (i. e. at therapeutic plasma concentration expected after the recommended starting dose of 50 mg) with the within-day baseline correction method, the clinical significance of this finding is unclear.
Tretji dan so 24 ur po odmerku (tj. pri terapevtski plazemski koncentraciji, ki je pričakovana po priporočenem začetnem odmerku 50 mg) ugotovili učinek na QTcF z uporabo znotrajdnevnega postopka korekcije glede na izhodišče, vendar klinični pomen te ugotovitve ni jasen.
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable or ITT populations were observed to develop QTc prolongation considered as “ severe” (i. e. equal to or greater than Grade 3 by CTCAE version 3.0).
Med tem ovrednotenjem pri nobenem bolniku v ocenljivi populaciji ali populaciji z- namenom- zdravljenja niso opazili podaljšanja QTc, ki bi veljalo za "hudo" (tj. enako ali večje stopnji 3 po CTCAE, verzija 3. 0).
At therapeutic plasma concentrations, the maximum QTcF (Frederica’ s correction) mean change from baseline was 9.6 msec (90% CI 15.1msec).
Pri terapevtski koncentraciji v plazmi je bila največja povprečna sprememba QTcF (Fredericova korekcija) od izhodišča 9, 6 milisekunde (90% interval zaupanja 15, 1 milisekunde).
At approximately twice therapeutic concentrations, the maximum QTcF change from baseline was 15.4 msec (90% CI 22.4 msec).
Pri približno dvakratni terapevtski koncentraciji je bila največja sprememba QTcF od izhodišča 15, 4 milisekunde (90% interval zaupanja 22, 4 milisekunde).
Moxifloxacin (400 mg) used as a positive control showed a 5.6 msec maximum mean QTcF change from baseline.
Pri
No subjects experienced an effect on the QTc inteval greater than Grade 2 (CTCAE version 3.0).
5 nobenem preiskovancu niso ugotovili učinka na interval QTc, ki bi bil večji od stopnje 2 (CTCAE, verzija 3. 0).
No patient presented with a cardiac arrhythmia.
Noben bolnik ni imel motnje srčnega ritma.
Torsade de pointes has been observed in < 0.1% of SUTENT-exposed patients.
Torsade de pointes so opazili pri manj kot 0, 1% bolnikov, ki so jemali SUTENT.
SUTENT should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Pri bolnikih z znano anamnezo podaljšanja intervala QT, tistih, ki jemljejo antiaritmike, in tistih z relevantno, že obstoječo srčno boleznijo, bradikardijo ali elektrolitskimi motnjami je treba SUTENT uporabljati previdno.
Concomitant treatment with potent CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and the dose of SUTENT reduced (see Section 4.2 and 4.5).
K sočasnemu zdravljenju z močnimi zaviralci CYP3A4, ki utegnejo zvečati koncentracijo sunitiniba v plazmi, je treba pristopiti previdno, odmerek SUTENTA pa zmanjšati (glejte poglavji 4. 2 in 4. 5).
Venous Thromboembolic Events Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received SUTENT on clinical trials, including GIST and MRCC.
Venski trombembolični dogodki Z zdravljenjem povezane venske trombembolične dogodke so zabeležili pri približno 1, 0% bolnikov s čvrstimi tumorji, ki so dobivali SUTENT med kliničnimi preskušanji, vključno z GIST in MRCC.
5 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.
2. stopnje.
Seven patients (1.9%) receiving SUTENT in the phase 3 treatment-naïve MRCC study and four patients (2%) on the two cytokine-refractory MRCC studies had treatment-related venous thromboembolic events reported.
O venskih trombemboličnih dogodkih, ki so povezani z zdravljenjem, so poročali pri sedmih bolnikih (1, 9%), ki so SUTENT dobivali v 3. fazi študije pri še nezdravljeni MRCC, in pri štirih bolnikih (2%) v dveh študijah MRCC, odpornega proti citokinom.
Six of these patients had pulmonary embolisms, one was Grade 3 and five were Grade 4, and five of these patients had DVT, one each with Grade 1 and 2, and three with Grade 3.
Pet od teh bolnikov pa je imelo globoko vensko trombozo: po eden 1. in 2. stopnje ter trije 3. stopnje.
In treatment-naïve MRCC patients receiving IFN-α, six (2%) venous thromboembolic events occurred; one patient (< 1%) experienced a Grade 3 DVT and five patients (1%) had pulmonary embolisms, one with Grade 1 and four with Grade 4.
Med bolniki s še nezdravljenim MRCC, ki so dobivali IFN- α, se je pojavilo šest (2%) venskih trombemboličnih dogodkov; pri enem bolniku (< 1%) je šlo za globoko vensko trombozo 3. stopnje, pet bolnikov (1%) pa je imelo pljučne embolije, in sicer eden 1. stopnje in štirje 4. stopnje.
No cases with fatal outcome were reported in GIST and MRCC registrational studies.
V registracijskih študijah GIST in MRCC ni bilo opisanih smrtnih izidov.
Cases with fatal out- come had been observed in post-marketing setting (see respiratory events and section 4.8).
Smrtne izide so zabeležili v postmarketinškem obdobju (glejte Dogodki na dihalih in poglavje 4. 8).
Respiratory events Patients who presented with pulmonary embolism within the previous 12 months were excluded from SUTENT clinical studies.
Dogodki na dihalih V klinične študije zdravila SUTENT niso bili vključeni bolniki, ki so imeli pljučno embolijo v zadnjih 12 mesecih.
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.
Pri bolnikih, ki so dobivali SUTENT v registracijskih študijah 3. faze, so z zdravljenjem povezane plučne dogodke (tj. dispnejo, plevralni izliv, pljučno embolijo ali pljučni edem) zabeležili pri približno 5% bolnikov z GIST in približno 14% bolnikov z MRCC.
Rare cases with fatal outcome were reported.
Opisani so bili redki primeri smrtnih izidov.
Approximately 8% of patients with solid tumours, including GIST and MRCC, who received SUTENT in clinical trials experienced treatment-related pulmonary events.
Z zdravljenjem povezani pljučni dogodki so se pojavili pri približno 8% bolnikov s čvrstimi tumorji, vključno z GIST in MRCC, ki so dobivali SUTENT v kliničnih preskušanjih.
Cases of Pulmonary embolism were observed in approximately 1.3% of patients with GIST and in approximately 0.8% of patients with MRCC, who received Sutent in Phase 3 studies (see section 4.4 - Venous Thromboembolic Events).
Primere pljučne embolije so zabeležili pri približno 1, 3% bolnikov z GIST in približno 0, 8% bolnikov z MRCC, ki so dobivali Sutent v študijah 3. faze (glejte poglavje 4. 4 – Venski trombembolični dogodki).
Thyroid Dysfunction Baseline laboratory measurement of thyroid function is recommended, and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Bolnike s hipotiroidizmom ali hipertiroidizmom je treba zdraviti v skladu z običajno medicinsko prakso še pred začetkom zdravljenja s sunitinibom.
All patients should be observed closely for signs and symptoms of thyroid dysfunction on sunitinib treatment.
Vse bolnike je treba med zdravljenjem s sunitinibom natančno nadzirati glede znakov in simptomov motenega delovanja ščitnice.
Patients with signs and/ or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.
Če ima bolnik znake ali simptome, ki nakazujejo moteno delovanje ščitnice, je treba laboratorijsko kontrolirati delovanje ščitnice in terapevtsko ukrepati v skladu z običajno medicinsko prakso.
Hypothyroidism was reported as an adverse event in 7 patients (4%) across the two cytokine-refractory MRCC studies; in nine patients (2%) on SUTENT and one patient (< 1%) in the IFN-α arm in the treatment- naïve MRCC study.
V dveh študijah MRCC, odpornega proti citokinom, so hipotiroidizem kot neželen učinek opisali pri 7 bolnikih (4%); v študiji še nezdravljenega MRCC pa pri devetih bolnikih (2%) v kraku s SUTENTOM in pri enem bolniku (< 1%) v kraku z IFN- α.
Additionally, TSH elevations were reported in 4 cytokine-refractory MRCC patients (2%).
Poleg tega so pri 4 bolnikih (2%) z MRCC, odpornemu proti citokinom, zabeležili zvišanje TSH.
Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
V celoti je imelo 7% populacije z MRCC bodisi klinične bodisi laboratorijske znake hipotiroidizma zaradi zdravljenja.
Treatment-emergent acquired hypothyroidism was noted in 8 GIST patients (4%) on SUTENT versus 1 (1%) on placebo.
Hipotiroidizem zaradi zdravljenja so opazili pri 8 bolnikih z GIST (4%), ki so dobivali SUTENT, in pri 1 bolniku (1%), ki je dobival placebo.
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.
6 Med kliničnimi preskušanji in pomarketinškim obdobjem so bili opisani redki primeri hipertiroidizma, ki mu je včasih sledil hipotiroidizem.
Pancreatitis Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received SUTENT.
Pankreatitis Pri bolnikih z različnimi čvrstimi tumorji, ki so dobivali SUTENT, so opazili zvišanje serumske lipaze in amilaze.
Increases in lipase activities were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours.
Zvišanje lipaze je bilo prehodno in ga pri preiskovancih z različnimi čvrstimi tumorji praviloma niso spremljali znaki ali simptomi pankreatitisa.
Pancreatitis has been observed rarely (< 1%) in patients receiving SUTENT for GIST or MRCC.
Pankreatitis so opazili redko, pri manj kot 1% bolnikov, ki so prejemali SUTENT za GIST ali MRCC.
If symptoms of pancreatitis are present, patients should have SUTENT discontinued and be provided with appropriate supportive care.
Opisani so bili primeri resnih pankreatičnih pojavov, včasih s smrtnim izidom. Če se pri bolnikih pojavijo simptomi pankreatitisa, je treba zdravljenje s SUTENTOM prekiniti in jim nuditi ustrezno podporno oskrbo.
Hepatic Function Serious cases of SUTENT-related hepatobiliary events have been reported in patients with solid tumours; hepatic failure was observed in < 1% of these patients.
Delovanje jeter Pri bolnikih s čvrstimi tumorji so se pojavili resni hepatobiliarni učinki, povezani s SUTENTOM; odpoved jeter so zabeležili pri < 1% teh bolnikov.
Cases of hepatobiliary events, some with fatal outcome, have been reported.
Opisani so bili primeri hepatobiliranih pojavov, včasih s smrtnim izidom.
If signs or symptoms of hepatic failure are present, SUTENT should be discontinued and appropriate supportive care should be provided.
Če se pojavijo znaki ali simptomi odpovedi jeter, je treba uporabo SUTENTA prekiniti in zagotoviti ustrezno podporno oskrbo.
6 Renal function The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Delovanje ledvic Varnost nadaljnjega zdravljenja z zdravilom SUTENT pri bolnikih z zmerno do hudo proteinurijo ni bila sistematično ocenjena.
Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Opisani so bili primeri proteinurije in redki primeri nefrotskega sindroma.
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Izhodiščno je priporočljivo narediti analizo urina, bolnike pa je treba nadzorovati, da bi odkrili pojav ali poslabšanje proteinurije.
Discontinue SUTENT in patients with nephrotic syndrome.
Pri bolnikih z nefrotskim sindromom je treba uporabo zdravila SUTENT prekiniti.
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.
Konvulzije V kliničnih študijah SUTENTA in med pomarketinškim obdobjem so konvulzije opažali pri preiskovancih z radiološkimi znaki metastaz v možganih ali brez njih.
In addition, there have been rare (< 1%) reports of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS).
Poleg tega je bilo nekaj redkih (< 1%) poročil o preiskovancih s konvulzijami in radiološkimi znaki reverzibilnega posteriornega levkoencefalopatskega sindroma (RPLS)..
Patients with seizures and signs/ symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning and visual loss, including cortical blindness should be controlled with medical management including control of hypertension.
Bolniki s konvulzijami in znaki oz. simptomi, ki se skladajo z RPLS, npr. hipertenzijo, glavobolom, zmanjšano pozornostjo, duševnimi motnjami in prizadetostjo vida (vključno s kortikalno slepoto), potrebujejo medicinski nadzor, ki naj obsega tudi obvladovanje hipertenzije.
Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.
Priporočljiva je prehodna opustitev SUTENTA; po izboljšanju stanja je mogoče zdravljenje po presoji lečečega zdravnika znova uvesti.
Drugs that may increase sunitinib plasma concentrations:
Zdravila, ki lahko zvišajo koncentracijo sunitiniba v plazmi:
Concomitant administration of sunitinib malate with the potent CYP3A4 inhibitor, ketoconazole, resulted in a 49% and 51% increase of the complex [sunitinib + primary metabolite] Cmax and AUC0-∞ values, respectively, after a single dose of sunitinib malate in healthy volunteers.
Sočasna uporaba sunitinibijevega malata z močnim zaviralcem CYP3A4 ketokonazolom je pri zdravih prostovoljcih po posamičnem odmerku sunitinibijevega malata povzročila 49% - no povečanje sestavljene [sunitinib + primarni presnovek] Cmax in 51% - no povečanje sestavljene AUC0– ∞.
Administration of SUTENT with potent inhibitors of the CYP3A4 family (e. g. ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations Combination with inhibitors should therefore be avoided, or the selection of an alternate concomitant medication with no, or minimal potential to inhibit CYP3A4 should be considered.
Kombinaciji z zaviralci se je torej treba izogniti ali pa izbrati drugo sočasno terapijo z minimalnim potencialom za zaviranje CYP3A4 ali brez takšnega potenciala.
If this is not possible, the dosage of SUTENT may need to be reduced to a minimum of 37.5 mg daily, based on careful monitoring of the tolerability (see section 4.2).
Če to ni mogoče, bo morda potrebno zmanjšanje odmerka SUTENTA na ne manj kot 37, 5 mg na dan, pri čemer moramo bolnikovo prenašanje stalno spremljati (glejte poglavje 4. 2).
Drugs that may decrease sunitinib plasma concentrations:
Zdravila, ki lahko znižajo koncentracijo sunitiniba v plazmi:
Concomitant use of SUTENT with the CYP3A4 inducer, rifampin, resulted in a 23% and 46% reduction of the complex [sunitinib + primary metabolite] Cmax and AUC0-∞ values, respectively, after a single dose of SUTENT in healthy volunteers.
Sočasna uporaba SUTENTA z induktorjem CYP3A4 rifampinom je pri zdravih prostovoljcih po posamičnem odmerku SUTENTA zmanjšala sestavljeno [sunitinib + primarni presnovek] Cmax za 23% in sestavljeno AUC0– ∞ za 46%.
Administration of SUTENT with potent inducers of the CYP3A4 family (e. g., dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital or Hypericum perforatum known also as St.
Uporaba SUTENTA z močnimi induktorji družine CYP3A4 (npr. deksametazonom, fenitoinom, karbamazepinom, rifampinom, fenobarbitalom ali Hypericum perforatum, znano tudi kot
John’ s Wort) may decrease sunitinib concentrations.
7 šentjanževka) lahko zniža koncentracijo sunitiniba.
Combination with inducers should therefore be avoided, or selection of an alternate concomitant medication with no, or minimal potential to induce CYP3A4 should be considered.
Kombinacijam z induktorji se je torej treba izogniti ali pa je treba izbrati drugo sočasno zdravilo z minimalnim potencialom za indukcijo CYP3A4 ali brez takšnega potenciala.
If this is not possible, the dosage of SUTENT may need to be increased in 12.5 mg increments (up to 87,5 mg per day) based on careful monitoring of tolerability (see section 4.2).
Če to ni mogoče, bo morda potrebno povečevanje odmerka SUTENTA po 12, 5 mg (do 87, 5 mg na dan), pri čemer moramo bolnikovo prenašanje stalno spremljati (glejte poglavje 4. 2).
To maintain sunitinib target concentrations, selection of co-medications with less enzyme induction potential, should be considered.
Za vzdrževanje ciljnih koncentracij sunitiniba je treba razmisliti o izbiri sočasno uporabljenih zdravil, ki imajo manjši potencial za indukcijo encimov.
If this is not possible, dose-adjustments of SUTENT may be necessary (see section 4.2).
Če to ni mogoče, bo morda potrebno prilagajanje odmerka (glejte poglavje 4. 2).
Haemorrhage has been observed rarely in patients treated with SUTENT (see section 4.4).
Redko so pri bolnikih, ki so dobivali SUTENT, opažali krvavitev.
Patients receiving concomitant treatment with anti-coagulants (e. g. warfarin; acenocumarole) may be periodically monitored by complete blood counts (platelets), coagulation factors (PT/ INR), and physical examination.
Pri bolnikih, ki sočasno dobivajo antikoagulante (npr. varfarin; acenokumarol), je priporočljivo redno kontrolirati celotno krvno sliko (trombocite) in koagulacijske faktorje (PČ/ INR) ter bolnike klinično pregledati.
Pregnancy There are no studies in pregnant women using SUTENT.
Nosečnost Študij z uporabo SUTENTA pri nosečnicah ni.
Studies in animals have shown reproductive toxicity including foetal malformations (see section 5.3).
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja, vključno z malformacijami ploda (glejte poglavje 5. 3).
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.
SUTENTA ne smemo uporabljati med nosečnostjo in tudi ne pri ženskah, ki ne uporabljajo ustrezne kontracepcije, razen če možna korist odtehta možno tveganje za plod.