FrancophonIA/ELRC3.0 huggingface dataset:
English: Seven hundred and fifty patients were randomised 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter, on 3 nonconsecutive days each week.
Slovenian: Zdravljenje z IFN-α je potekalo s subkutanim injiciranjem 3 milijonov enot (ME) prvi teden, 6 ME drugi teden, 9 ME tretji teden, potem pa vsak teden na 3 nezaporedne dni.
English: Hyperthyroidism Thyroiditis
Slovenian: Bolezni endokrinega sistema hipotiroidizem hipertiroidizem tiroiditis
English: 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Slovenian: 37,5 mg trde kapsule Ena kapsula vsebuje 37,5 mg sunitiniba (v obliki sunitinibijevega malata).
English: Interim Final
Slovenian: Končni ni ustrezno
English: A Phase 3, randomised, double-blind, placebo-controlled study of sunitinib 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).
Slovenian: Pri bolnikih z GIST, ki so bili odporni proti imatinibu ali jim je bolezen med zdravljenjem ali po zdravljenju z njim napredovala (mediana največjega dnevnega odmerka 800 mg), so opravili randomizirano, dvojno slepo, s placebom nadzorovano študijo 3. faze s sunitinibom.
English: Sutent 37.5 mg hard capsules sunitinib
Slovenian: Sutent 37,5 mg trde kapsule sunitinib
English: No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis.
Slovenian: Kadar dajemo sunitinib bolnikom z ledvično okvaro (blago do hudo) ali končno ledvično odpovedjo (ESRD - end-stage renal disease), ki potrebujejo hemodializo, prilagajanje začetnega odmerka ni potrebno.
English: Periorbital oedema Eyelid oedema Lacrimation increased
Slovenian: Očesne bolezni periorbitalni edem edem vek močnejše solzenje
English: Skin exfoliation Skin reactionv
Slovenian: pankreatitis analna fistula kolitis
English: Overall survival [5 years follow-up] [median, months (95% CI)]
Slovenian: Preživetje brez napredovanja bolezni [mediana, meseci (95% IZ)] pri slepem, neodvisnem, centralnem pregledu ocenjevanja tumorja Celokupno preživetje (5-letno spremljanje) [mediana, meseci (95 % IZ)] Objektivni odziv na zdravljenje [%, (95 % IZ)]
English: Sutent 12.5 mg hard capsules sunitinib
Slovenian: Sutent 12,5 mg trde kapsule sunitinib
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Slovenian: - Ovojnica kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172).
English: 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Slovenian: 12,5 mg trde kapsule Ena kapsula vsebuje 12,5 mg sunitiniba (v obliki sunitinibijevega malata).
English: Sunitinib was not clastogenic in rat bone marrow in vivo.
Slovenian: Sunitinib v podganjem kostnem mozgu in vivo ni bil klastogen.
English: - If you have thyroid glands problems.
Slovenian: - Če imate težave s ščitnico.
English: Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood.
Slovenian: Če se vam okoli poškodbe na koži pojavijo simptomi okužbe, vključno z vročino, bolečino, pordelostjo, oteklino ali izcejanjem gnoja ali krvi, se takoj obrnite na zdravnika.
English: Skin discolourationt
Slovenian: Nestratificirana analiza
English: Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5).
Slovenian: Sočasni uporabi z močnimi induktorji CYP3A4 se je treba izogibati, ker lahko zmanjša koncentracijo sunitiniba v plazmi (glejte poglavji 4.2 in 4.5).
English: Sutent 50 mg hard capsules sunitinib
Slovenian: Sutent 50 mg trde kapsule sunitinib
English: • Chest pain.
Slovenian: • bolečina v prsnem košu
English: Aspartate aminotransferase increased Alanine aminotransferase increased Blood creatinine increased Blood pressure increased Blood uric acid increased
Slovenian: Preiskave zmanjšanje telesne mase zmanjšanje števila belih krvnih celic zvišanje ravni lipaze zmanjšanje števila trombocitov znižanje ravni hemoglobina zvišanje ravni amilaze zvišanje ravni aspartat-aminotransferaze zvišanje ravni alanin-aminotransferaze zvišanje ravni kreatinina v krvi zvišanje krvnega tlaka zvišanje ravni sečne kisline v krvi zvišanje ravni kreatin-kinaze v krvi zvišanje ravni ščitnico stimulirajočega hormona v krvi vključno s smrtnimi primeri.
English: Sutent 12.5 mg hard capsules EU/1/06/347/001
Slovenian: Sutent 12,5 mg trde kapsule EU/1/06/347/001
English: − GIST or MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.
Slovenian: Če se zdravite zaradi: - gastrointestinalnega stromalnega tumorja (GIST) ali raka ledvic (MRCC): običajni odmerek znaša 50 mg enkrat na dan, 28 dni (4 tedne), čemur sledi 14 dni (2 tedna) premora (brez zdravila), tako da celotni cikel traja 6 tednov; - nevroendokrinega tumorja trebušne slinavke (pNET): običajni odmerek znaša 37,5 mg enkrat na dan brez obdobja premora.
English: No starting dose adjustment is recommended when administering sunitinib to patients with mild or moderate (Child-Pugh class A and B) hepatic impairment.
Slovenian: Kadar dajemo sunitinib bolnikom z blago ali zmerno jetrno okvaro (razred A in B po Child-Pughu), prilagajanje odmerka ni potrebno.
English: Viral infectionsa
Slovenian: Žilne bolezni
English: Anaemia has been observed to occur early as well as late during treatment with sunitinib.
Slovenian: V zgodnjem in tudi v poznejšem obdobju zdravljenja s sunitinibom so opažali pojav anemije.
English: Sutent 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, containing yellow to orange granules.
Slovenian: Zdravilo Sutent 12,5 mg je na voljo v obliki trdih želatinskih kapsul z oranžnim pokrovčkom in telesom kapsule, ki imajo na pokrovčku z belim črnilom natisnjeno “Pfizer”, na telesu pa “STN 12.5 mg”.
English: • Fluid around the heart (pericardial effusion).
Slovenian: • tekočina okrog srca (izliv v srčno mreno)
English: Red iron oxide (E172) Titanium dioxide (E171)
Slovenian: črnilo šelak propilenglikol natrijev hidroksid povidon titanov dioksid (E171)
English: Sutent 37.5 mg hard capsules EU/1/06/347/007
Slovenian: Sutent 37,5 mg trde kapsule EU/1/06/347/007
English: Sutent 25 mg hard capsules sunitinib
Slovenian: Sutent 25 mg trde kapsule sunitinib
English: 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Slovenian: 50 mg trde kapsule Ena kapsula vsebuje 50 mg sunitiniba (v obliki sunitinibijevega malata).
English: Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received sunitinib.
Slovenian: Pri bolnikih z različnimi čvrstimi tumorji, ki so prejemali sunitinib, so opazili zvečanje aktivnosti serumske lipaze in amilaze.
English: Seventeen (4.5%) patients on sunitinib versus 5 (1.7%) patients on IFN-α experienced Grade 3 or greater bleeding events.
Slovenian: Krvavitve 3. ali višje stopnje so se pojavile pri 17 bolnikih (4,5 %), ki so prejemali sunitinib, in pri 5 bolnikih (1,7 %), ki so prejemali IFN-α.
English: Co-administration of sunitinib with potent CYP3A4 inducers or inhibitors should be avoided because the plasma levels of sunitinib may be altered (see sections 4.4 and 4.5).
Slovenian: Sočasni uporabi sunitiniba z močnimi induktorji ali zaviralci CYP3A4 se moramo izogibati, ker se lahko koncentracija sunitiniba v plazmi spremeni (glejte poglavji 4.4 in 4.5).
English: Vomiting Diarrhoea Dyspepsia Nausea Constipation
Slovenian: Psihiatrične motnje nespečnost depresija
English: • Inflammation of the colon (colitis, colitis ischaemic).
Slovenian: • vnetje debelega črevesa (kolitis, ishemični kolitis)
English: Discontinue sunitinib in patients with nephrotic syndrome.
Slovenian: Pri bolnikih z nefrotskim sindromom je treba uporabo sunitiniba prekiniti.
English: Prolongation of QT interval and Torsade de pointes have been observed in sunitinib-exposed patients.
Slovenian: Pri bolnikih, ki so jemali sunitinib, so opazili podaljšanje intervala QT in Torsade de pointes.
English: Reversal of the effects of TMA has been observed after treatment discontinuation (see section 4.8).
Slovenian: Ugotovili so, da TMA po prekinitvi zdravljenja s sunitinibom izzveni (glejte poglavje 4.8).
English: Tumour destruction leading to hole in the intestine.
Slovenian: Predrtje črevesa zaradi razkroja tumorja.
English: Sutent 25 mg hard capsules EU/1/06/347/002
Slovenian: Sutent 25 mg trde kapsule EU/1/06/347/002
English: A Phase 4 multinational, multi-centre, single-arm, open-label study evaluating the efficacy and safety of sunitinib was conducted in patients with progressive, advanced/metastatic, well-differentiated, unresectable pNET.
Slovenian: Pri bolnikih s progresivnim, napredovalim/metastatskim, dobro diferenciranim, neizrezljivim pNET so opravili mednarodno, multicentrično, odprto študijo 4. faze z eno skupino za oceno učinkovitosti in varnosti sunitiniba.
English: 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Slovenian: 25 mg trde kapsule Ena kapsula vsebuje 25 mg sunitiniba (v obliki sunitinibijevega malata).
English: • Fever.
Slovenian: • vročina
English: Sutent 50 mg hard capsules EU/1/06/347/003
Slovenian: Sutent 50 mg trde kapsule EU/1/06/347/003
English: HDPE BOTTLE - 12.5 MG CAPSULES
Slovenian: PLASTENKA IZ HDPE - 12,5 mg KAPSULE
English: Hypothyroidism
Slovenian: Hipoglikemija
English: Shellac
Slovenian: • kašelj
English: Venous thromboembolic events were reported for 1 (1.2%) patient in the sunitinib arm and 5 (6.1%) patients in the placebo arm in the Phase 3 pNET study.
Slovenian: V študiji 3. faze pri pNET so o venskih trombemboličnih dogodkih poročali pri 1 bolniku (1,2 %), ki je prejemal sunitinib, in pri 5 bolnikih (6,1 %), ki so prejemali placebo.
English: BLISTER - 12.5 MG CAPSULES
Slovenian: PRETISNI OMOTI - 12,5 mg KAPSULE
English: - Printing ink: shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide
Slovenian: - Črnilo za tisk: šelak, propilenglikol, natrijev hidroksid, povidon in titanov dioksid (E171).
English: Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules.
Slovenian: Na pokrovčku je s črnim črnilom natisnjeno "Pfizer", na telesu pa "STN 37.5 mg".
English: Of patients receiving sunitinib for cytokine-refractory MRCC, 26% experienced bleeding.
Slovenian: Krvavitve so se pojavile pri 26 % bolnikov, ki so sunitinib prejemali za zdravljenje MRCC, odpornega proti citokinom.
English: Co-administration with potent CYP3A4 inhibitors should be avoided because it may increase the plasma concentration of sunitinib (see sections 4.2 and 4.5).
Slovenian: Sočasni uporabi z močnimi zaviralci CYP3A4 se je treba izogibati, ker lahko zveča koncentracijo sunitiniba v plazmi (glejte poglavji 4.2 in 4.5).
English: Sutent 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, containing yellow to orange granules.
Slovenian: Zdravilo Sutent 25 mg je na voljo v obliki trdih želatinskih kapsul s pokrovčkom karamelne barve in telesom kapsule oranžne barve, ki imajo na pokrovčku z belim črnilom natisnjeno “Pfizer”, na telesu pa “STN 25 mg”.
English: Rare cases with fatal outcome have been observed in the postmarketing surveillance.
Slovenian: Med nadzorom v obdobju trženja zdravila so opažali redke primere s smrtnim izidom.
English: HDPE BOTTLE - 25 MG CAPSULES
Slovenian: PLASTENKA IZ HDPE - 25 mg KAPSULE
English: Sutent 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, containing yellow to orange granules.
Slovenian: Zdravilo Sutent 50 mg je na voljo v obliki trdih želatinskih kapsul s pokrovčkom in telesom kapsule karamelne barve, ki imajo na pokrovčku z belim črnilom natisnjeno “Pfizer”, na telesu pa “STN 50 mg”.
English: Table 2.
Slovenian: glejte poglavje 2
English: Placebo cross-over group treatment b
Slovenian: Skupina, ki je prešla z zdravljenja s placebom
English: HDPE BOTTLE - 50 MG CAPSULES
Slovenian: PLASTENKA IZ HDPE - 50 mg KAPSULE
English: This event is generally reversible after sunitinib discontinuation.
Slovenian: Ti simptomi običajno izginejo, ko z zdravljenjem s sunitinibom prekinete.
English: HDPE BOTTLE - 37.5 MG CAPSULES
Slovenian: PLASTENKA IZ HDPE - 37,5 mg KAPSULE
English: BLISTER - 37.5 MG CAPSULES
Slovenian: PRETISNI OMOTI - 37,5 mg KAPSULE
English: BLISTER - 50 MG CAPSULES
Slovenian: PRETISNI OMOTI - 50 mg KAPSULE
English: Hypertension was a very common adverse reaction reported in clinical trials.
Slovenian: V kliničnih preskušanjih so o hipertenziji kot neželenem učinku poročali zelo pogosto.
English: Method of administration Sutent is for oral administration.
Slovenian: Način uporabe Zdravilo Sutent se uporablja peroralno.
English: • Hot flushes.
Slovenian: • vročinski oblivi
English: 37.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Slovenian: 37,5 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172)
English: Treatment-naïve metastatic renal cell carcinoma
Slovenian: Še nezdravljeni metastatski karcinom ledvičnih celic (MRCC)
English: Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Slovenian: Ena kapsula vsebuje 37,5 mg sunitiniba v obliki sunitinibijevega malata.
English: Abbreviations: CI=confidence interval; ITT=intent-to-treat; NA=not applicable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; TTP=time-to-tumour progression.
Slovenian: Okrajšave: IZ = interval zaupanja, ITT = populacija z-namenom-zdravljenja, ORR = objektivni odziv na zdravljenje, OS = celokupno preživetje, PFS = preživetje brez napredovanja bolezni, TTP = čas do napredovanja tumorja a Rezultati dvojno slepega zdravljenja so iz populacije ITT in z uporabo centralne radiološke meritve, kot je primerno.
English: Renal failure* Renal failure acute* Chromaturia Proteinuria
Slovenian: Bolezni sečil odpoved ledvic akutna odpoved ledvic kromaturija proteinurija krvavitev v sečilih nefrotski sindrom
English: Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib for GIST or MRCC. No treatment-related pancreatitis was reported in the Phase 3 pNET study (see section 4.4).
Slovenian: V študiji 3. faze pri pNET niso poročali o nobenem primeru pankreatitisa, ki bi bil povezan z zdravljenjem (glejte poglavje 4.4).
English: Effects on male fertility in rat were observed in the form of tubular atrophy in the testes, reduction of spermatozoa in epididymides, and colloid depletion in prostate and seminal vesicles at plasma exposure levels 25 times the systemic exposure in humans.
Slovenian: Pri plazemski izpostavljenosti, ki je bila 25-krat večja od sistemske izpostavljenosti pri ljudeh, so ugotovili učinke na plodnost podganjih samcev, ki so se kazali kot atrofija tubulov v modih, manjše število semenčic v obmodkih ter koloidno izčrpanje prostate in seminalnih vezikul.
English: Abdominal distension Abdominal discomfort Rectal haemorrhage Gingival bleeding Mouth ulceration Proctalgia
Slovenian: Bolezni živčevja omotica glavobol motnje okušanja periferna nevropatija parestezija hipestezija hiperestezija krvavitev v možganih cerebrovaskularni insult prehodna možganska ishemija sindrom reverzibilne posteriorne encefalopatije
English: Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib.
Slovenian: Ena kapsula vsebuje 12,5 mg sunitiniba v obliki sunitinibijevega malata.
English: Transient ischaemic attack
Slovenian: Srčne bolezni miokardna ishemija k,*
English: • Weight loss.
Slovenian: • izguba telesne mase
English: • Back pain, joint pain.
Slovenian: • bolečine v hrbtu, bolečine v sklepih
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
Slovenian: - Ovojnica kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172) in črni železov oksid (E172).
English: The primary efficacy endpoint was PFS. A planned interim analysis showed a statistically significant advantage for sunitinib over IFN-α, in this study, the median PFS for the sunitinib-treated group was 47.3 weeks, compared with 22.0 weeks for the IFN-α-treated group; the HR was 0.415 (95% CI: 0.320, 0.539; p-value < 0.001).
Slovenian: Načrtovana vmesna analiza je pokazala statistično pomembno prednost sunitiniba v primerjavi z IFN-, v tej študiji je mediano PFS v skupini, zdravljeni s sunitinibom, znašalo 47,3 tedna in v skupini,
English: 12.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Slovenian: 12,5 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina rdeči železov oksid (E172) titanov dioksid (E171)
English: BLISTER - 25 MG CAPSULES
Slovenian: PRETISNI OMOTI - 25 mg KAPSULE
English: Patients who presented with cardiac events within 12 months prior to sunitinib administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischaemic attack, or pulmonary embolism were excluded from all sunitinib clinical studies.
Slovenian: V nobeno klinično študijo sunitiniba niso bili vključeni bolniki, ki so imeli v 12 mesecih pred aplikacijo sunitiniba kakšen srčni dogodek, npr. miokardni infarkt (vključno s hudo/nestabilno angino pektoris),
English: h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome.
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija anemija levkopenija limfopenija pancitopenija trombotična mikroangiopatija h,*
English: n Oropharyngeal and pharyngolaryngeal pain.
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules.
Slovenian: Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 12.5 mg".
English: Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD).
Slovenian: Pri odmerkih ≥ 25 mg/kg/dan, ki so jih dajali 1 mesec ali 6 mesecev (≥ 7,3-kratnik vrednosti AUC pri bolnikih, ki prejemajo priporočene dnevne odmerke RDD - recommended daily dose), so opažali karcinome na želodcu in dvanajstniku, povečano pogostnost pojavljanja hemangiosarkomov v ozadju in/ali hiperplazijo želodčne sluznice.
English: Metabolic interactions
Slovenian: Interakcije pri presnovi
English: Oedemay
Slovenian: • omotica
English: Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Slovenian: Ena kapsula vsebuje 25 mg sunitiniba v obliki sunitinibijevega malata.
English: Musculoskeletal pain Muscle spasms Myalgia
Slovenian: Bolezni mišično-skeletneg a sistema in vezivnega tkiva bolečine v udih artralgija bolečina v hrbtu mišično-skeletna bolečina mišični krči mialgija mišična šibkost osteonekroza čeljustnic fistula rabdomioliza miopatija
English: Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Slovenian: Ena kapsula vsebuje 50 mg sunitiniba v obliki sunitinibijevega malata.
English: Other endpoints included OS, ORR, PROs, and safety.
Slovenian: Drugi opazovani dogodki so vključevali celokupno preživetje (OS), objektivni odziv na zdravljenje (ORR), izide o katerih so poročali bolniki (PRO - patient-reported outcomes) in varnost.
English: Gastrointestinal stromal tumours
Slovenian: levostransko srčno popuščanje Torsade de pointes
English: Kidney disorders.
Slovenian: Motnje v delovanju ledvic.
English: Tumour haemorrhage*
Slovenian: • vnetje žleze ščitnice
English: HDPE BOTTLE OUTER CARTON - 37.5 MG CAPSULES
Slovenian: ŠKATLA ZA PLASTENKO IZ HDPE - 37,5 mg KAPSULE
English: Summary of overall survival Subject not known to have died [n (%)] Subject observed to have died [n (%)] OS (weeks)
Slovenian: Povzetek pri celokupnem preživetju (populacija ITT) Preskušanec, za katerega ne vemo, da je umrl [n (%)] Preskušanec, za katerega vemo, da je umrl [n (%)] OS (tedni)
English: HDPE BOTTLE OUTER CARTON - 12.5 MG CAPSULES
Slovenian: ŠKATLA ZA PLASTENKO IZ HDPE - 12,5 mg KAPSULE
English: Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules.
Slovenian: Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 25 mg".
English: Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules.
Slovenian: Na pokrovčku je z belim črnilom natisnjeno "Pfizer", na telesu pa "STN 50 mg".
English: Cholecystitis and acalculous cholecystitis.
Slovenian: Bolezni jeter, žolčnika in žolčevodov odpoved delovanja jeter holecistitis s,*
English: Hepatic impairment
Slovenian: nenormalno delovanje jeter hepatitis
English: Rhabdomyolysis* Myopathy
Slovenian: • ketokonazol, itrakonazol - za zdravljenje glivičnih okužb
English: Gastro-oesophageal reflux disease Dysphagia Gastrointestinal haemorrhage* Oesophagitis*
Slovenian: Presnovne in prehranske motnje zmanjšanje teka dehidracija hipoglikemija sindrom lize tumorja*
English: Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib.
Slovenian: Pri bolnikih z intraabdominalnimi malignomi, ki so prejemali sunitinib, so poročali o resnih zapletih na prebavilih (včasih s smrtnim izidom), vključno z gastrointestinalno perforacijo.
English: Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions.
Slovenian: Med najpogostejšimi neželenimi učinki so hematološke motnje (npr. nevtropenija, trombocitopenija in anemija).
English: HDPE BOTTLE OUTER CARTON - 25 MG CAPSULES
Slovenian: ŠKATLA ZA PLASTENKO IZ HDPE - 25 mg KAPSULE
English: Red iron oxide (E172) Titanium dioxide (E171) Yellow iron oxide (E172) Black iron oxide (E172)
Slovenian: 25 mg trde kapsule vsebina kapsule manitol (E421) premreženi natrijev karmelozat povidon (K-25) magnezijev stearat ovojnica kapsule želatina rdeči železov oksid (E172) titanov dioksid (E171) rumeni železov oksid (E172) črni železov oksid (E172)
English: HDPE BOTTLE OUTER CARTON - 50 MG CAPSULES
Slovenian: ŠKATLA ZA PLASTENKO IZ HDPE - 50 mg KAPSULE
English: Table 1.
Slovenian: V študiji 1./2.
English: Skin hyperpigmentation Skin lesion Hyperkeratosis Dermatitis Nail disorderw
Slovenian: Bolezni kože in podkožja obarvanje kože sindrom palmarno-plantarne eritrodizestezije izpuščaj obarvanje las in dlak suha koža luščenje kože kožne reakcije ekcem mehurji eritem alopecija akne srbenje hiperpigmentacija kože kožne lezije hiperkeratoza dermatitis bolezen nohtov multiformni eritem
English: • Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
Slovenian: • pretiran imunski odgovor na alergen, vključno s senenim nahodom, kožnim izpuščajem, srbečico,
English: The CHMP considers that:
Slovenian: Odbor CHMP meni: