FrancophonIA/ELRC3.0 huggingface dataset:
English: In healthy subjects, high fat meals reduced systemic exposure to everolimus 10 mg (as measured by AUC) by 22% and the peak plasma concentration Cmax by 54%.
Slovenian: Pri zdravih osebah je uživanje obrokov z visoko vsebnostjo maščob zmanjšalo sistemsko izpostavljenost everolimusu v odmerku 10 mg (merjeno z AUC) za 22 %, najvišjo koncentracijo v plazmi Cmax pa za 54 %.
English: Table 3 presents the frequency category of adverse reactions reported in the pooled analysis considered for the safety pooling.
Slovenian: V preglednici 3 so prikazane kategorije pogostnosti neželenih učinkov, o katerih so poročali na podlagi združene analize podatkov za skupno oceno varnosti zdravila.
English: Afinitor was superior to placebo for the primary endpoint of progression-free survival, with a statistically significant 67% reduction in the risk of progression or death (see Table 7 and Figure 6).
Slovenian: Zdravilo Afinitor je bilo boljše od placeba glede primarnega cilja opazovanja, to je preživetja brez napredovanja bolezni, in sicer s statistično značilnim 67-odstotnim zmanjšanjem tveganja za napredovanje bolezni ali smrt (glejte preglednico 7 in sliko 6).
English: Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Slovenian: Everolimus zmanjša oskrbo tumorja s krvjo in upočasni rast ter širjenje rakastih celic.
English: Food, however, had no apparent effect on the post absorption phase concentration-time profile.
Slovenian: Vendar pa hrana ni opazno vplivala na spreminjanje koncentracije everolimusa po fazi absorpcije.
English: The safety profile is based on pooled data from 2,879 patients treated with Afinitor in eleven clinical studies, consisting of five randomised, double-blind, placebo controlled phase III studies and six open-label phase I and phase II studies, related to the approved indications.
Slovenian: Varnostne lastnosti zdravila izhajajo iz združenih podatkov 2.879 bolnikov, ki so prejemali zdravilo Afinitor v enajstih kliničnih študijah, med katerimi je bilo pet randomiziranih, dvojno slepih, s placebom kontroliranih študij faze III in šest z odobrenimi indikacijami povezanih odprtih študij faze I in faze II.
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased plasma concentrations of everolimus (see section 4.5).
Slovenian: Sočasno zdravljenje z močnimi zaviralci CYP3A4 povzroča izrazito zvišanje koncentracije everolimusa (glejte poglavje 4.5).
English: Prior therapy with bevacizumab and interferon-α was also permitted.
Slovenian: Dovoljeno je bilo tudi predhodno zdravljenje z bevacizumabom in interferonom alfa.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Afinitor in all subsets of the paediatric population in neuroendocrine tumours of pancreatic origin, thoracic neuroendocrine tumours and in renal cell carcinoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Afinitor za vse podskupine pediatrične populacije z nevroendokrinimi tumorji pankreatičnega izvora, torakalnimi nevroendokrinimi tumorji oziroma s karcinomom ledvičnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste neobičajno utrujeni (utrujenost je zelo pogost neželeni učinek), bodite pri vožnji in upravljanju s stroji posebno pozorni.
English: • Abnormal results of liver blood tests (increased alanine and aspartate aminotransferase)
Slovenian: • nenormalni izvidi jetrnih krvnih testov (zvišana vrednost alanin-aminotransferaze in aspartat-aminotransferaze)
English: The median PFS was 8.4 months (90% CI: 6.6, 9.7) and 6.8 months (90% CI: 5.5, 7.2), respectively.
Slovenian: Mediana trajanja preživetja brez napredovanja bolezni je bila 8,4 meseca (90-odstotni IZ: 6,6, 9,7) oziroma 6,8 meseca (90-odstotni IZ: 5,5, 7,2).
English: If you have taken too much Afinitor, or if someone else accidentally takes your tablets, see a doctor or go to a hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Afinitor, kot bi smeli Če ste vzeli preveč zdravila Afinitor ali je nekdo drug pomotoma vzel vaše tablete, pojdite takoj k vašemu zdravniku ali v bolnišnico.
English: At the time of the final OS analysis, the median duration of everolimus treatment was 24.0 weeks (range 1.0-199.1 weeks).
Slovenian: V času končne analize celotnega preživetja je bila mediana trajanja zdravljenja z everolimusom 24,0 tedna (v razponu od 1,0 do 199,1 tedna).
English: RADIANT-3 involved patients with well- and moderately-differentiated advanced pNET whose disease had progressed within the prior 12 months.
Slovenian: V študijo RADIANT-3 so bili vključeni bolniki z dobro in zmerno diferenciranimi napredovalimi nevroendokrinimi tumorji pankreatičnega izvora, pri katerih je bolezen napredovala v 12 mesecih pred vključitvijo.
English: Concomitant treatment of Afinitor and potent inhibitors is not recommended.
Slovenian: Sočasna uporaba zdravila Afinitor in močnih zaviralcev ni priporočena.
English: Those randomised to placebo were then able to receive open-label Afinitor.
Slovenian: Bolniki, ki so do tedaj prejemali placebo, so nato lahko odprto prejemali zdravilo Afinitor.
English: The potential for everolimus to cause infertility in male and female patients is unknown, however amenorrhoea (secondary amenorrhoea and other menstrual irregularities) and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients.
Slovenian: Možnost everolimusa, da povzroči neplodnost pri bolnikih moškega in ženskega spola, ni znana, vendar pa so pri bolnicah opažali amenorejo (sekundarno amenorejo in druge menstrualne motnje) in hkrati prisotno neuravnoteženost razmerja luteinizirajoči hormon (LH)/folikle stimulirajoči hormon (FSH).
English: If you stop taking Afinitor Do not stop taking Afinitor unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Afinitor Ne prekinite jemanja zdravila Afinitor, če vam tega ni naročil zdravnik.
English: (2.8 to 4.1)
Slovenian: (2,8 do 4,1)
English: • Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in your lungs become blocked)
Slovenian: • nenadno pomanjkanje sape, bolečina v prsnem košu ali izkašljevanje krvi (možni znaki pljučne embolije, to je stanja, do katerega pride, če se zamaši ena ali več arterij v pljučih)
English: Co-administration of everolimus and depot octreotide increased octreotide Cmin with a geometric mean ratio (everolimus/placebo) of 1.47.
Slovenian: Sočasna uporaba everolimusa in depo oblike oktreotida je zvišala Cmin oktreotida z razmerjem geometričnih sredin (everolimus/placebo) 1,47.
English: (0.5 to 4.2)
Slovenian: (0,5 do 4,2)
English: No difference in the time to definitive deterioration of WHO PS (≥1 point) and time to definitive deterioration in quality of life (FACT-G total score ≥7 points) was observed between the two arms.
Slovenian: Med obema skupinama niso opažali razlike glede časa do definitivnega poslabšanja stanja zmogljivosti po lestvici WHO (za ≥1 točko) in časa do definitivnega poslabšanja kakovosti življenja (znižanje skupne ocene po vprašalniku FACT-G za ≥7 točk).
English: advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas.
Slovenian: napredovalimi tumorji, ki se imenujejo nevroendokrini tumorji in izvirajo iz želodca, črevesja, pljuč ali trebušne slinavke.
English: (0.31 to 0.48)
Slovenian: (0,31 do 0,48)
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Slovenian: Glede na ugotovitve nekliničnih študij lahko zdravljenje z everolimusom ogroža moško in žensko plodnost (glejte poglavje 5.3).
English: Do not use this medicine if any pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali da je bilo že odprto.
English: Re-initiate treatment at 5 mg daily.
Slovenian: Ponovno začnite zdravljenje z odmerkom 5 mg dnevno.
English: Grade 2 If toxicity is tolerable, no dose adjustment required.
Slovenian: Stopnja 2 V primeru, da so škodljivi učinki sprejemljivi, prilagajanje odmerka ni potrebno.
English: Dose adjustment due to adverse reactions
Slovenian: Prilagajanje odmerkov zaradi neželenih učinkov
English: In a population pharmacokinetic analysis of 170 patients with advanced solid tumours, no significant influence of creatinine clearance (25-178 ml/min) was detected on CL/F of everolimus.
Slovenian: V analizi populacijske farmakokinetike 170 bolnikov z napredovalim trdim tumorjem niso ugotovili pomembenga vpliva očistka kreatinina (25-178 ml/min) na CL/F everolimusa.
English: Hyperglycaemia has been reported (see section 4.8).
Slovenian: Poročali so o hiperglikemiji (glejte poglavje 4.8).
English: Afinitor may increase blood sugar levels and worsen diabetes mellitus.
Slovenian: Zdravilo Afinitor lahko zviša raven sladkorja v krvi in povzroči poslabšanje sladkorne bolezni.
English: Afinitor is an anticancer medicine containing the active substance everolimus.
Slovenian: Afinitor je zdravilo proti raku, ki vsebuje zdravilno učinkovino everolimus.
English: The safety, tolerability and pharmacokinetics of everolimus were evaluated in two single oral dose studies of Afinitor tablets in 8 and 34 subjects with impaired hepatic function relative to subjects with normal hepatic function.
Slovenian: Varnost, prenosljivost in farmakokinetične lastnosti everolimusa so ocenjevali v dveh študijah tablet Afinitor z enkratnim peroralnim odmerkom pri 8 oziroma 34 osebah z okvaro jeter v primerjavi z osebami z normalnim delovanjem jeter.
English: If Afinitor is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate (see section 4.5).
Slovenian: Pri jemanju zdravila Afinitor skupaj s peroralnimi substrati CYP3A4 z nizkim terapevtskim indeksom (na primer s pimozidom, s terfenadinom, z astemizolom, s cisapridom, s kinidinom ali z derivati ergot alkaloidov) je treba bolnika spremljati glede neželenih učinkov, ki so navedeni v podatkih o zdravilu posameznega peroralnega substrata CYP3A4 (glejte poglavje 4.5).
English: Afinitor is only recommended for use in patients with severe hepatic impairment (Child-Pugh C) if the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Slovenian: Uporaba zdravila Afinitor se pri bolnikih s hudo okvaro jeter (razreda C po Child-Pughovi lestvici) priporoča samo, če možna korist odtehta tveganje (glejte poglavji 4.2 in 5.2).
English: Everolimus 10 mg + exemestane: 7.82 months Placebo + exemestane: 3.19 months
Slovenian: everolimus 10 mg + eksemestan: 7,82 meseca placebo + eksemestan: 3,19 meseca
English: (2.9 to 5.6)
Slovenian: (2,9 do 5,6)
English: If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Afinitor.
Slovenian: Če kljub zaščiti pred nosečnostjo mislite, da ste zanosili, se posvetujte z zdravnikom preden nadaljujete z jemanjem zdravila Afinitor.
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported (see section 4.8).
Slovenian: Poročali so o zvišanih vrednostih kreatinina v serumu, običajno v blagi obliki, in o proteinuriji (glejte poglavje 4.8).
English: Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Afinitor sme uvesti in voditi zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: Following documented radiological progression, patients could be unblinded by the investigator.
Slovenian: Po radiološko potrjenem napredovanju bolezni je raziskovalec lahko razkril, katero slepo zdravljenje je bolnik prejemal.
English: Serious side effects of Afinitor include:
Slovenian: Resni neželeni učinki zdravila Afinitor so lahko:
English: 10 tablets 30 tablets 90 tablets
Slovenian: 10 tablet 30 tablet 90 tablet
English: Afinitor contains lactose
Slovenian: Zdravilo Afinitor vsebuje laktozo
English: For all analysed subgroups (age, sensitivity to prior hormonal therapy, number of organs involved, status of bone-only lesions at baseline and presence of visceral metastasis, and across major demographic and prognostic subgroups) a positive treatment effect was seen with everolimus + exemestane with an estimated hazard ratio (HR) versus placebo + exemestane ranging from 0.25 to 0.60.
Slovenian: V vseh analiziranih podskupinah (glede na leta, občutljivost na predhodno hormonsko zdravljenje, število zajetih organov, izhodiščni status kostnih lezij in prisotnost visceralnih metastaz, pa tudi po podskupinah glede na glavne demografske značilnosti in prognostične dejavnike) so opažali pozitiven učinek zdravljenja s kombinacijo everolimusa in eksemestana, pri čemer je ocenjeno razmerje tveganj (HR) v primerjavi s skupino s placebom in eksemestanom znašalo od 0,25 do 0,60.
English: Six-month PFS rates were 36% for Afinitor therapy compared with 9% for placebo.
Slovenian: Delež bolnikov s 6-mesečnim preživetjem brez napredovanja bolezni je bil 36 % pri jemanju zdravila Afinitor v primerjavi z 9 % pri jemanju placeba.
English: It may be necessary to treat your infection before starting Afinitor.
Slovenian: Verjetno bo treba okužbo pozdraviti, preden začnete jemati zdravilo Afinitor.
English: Agents whose plasma concentration may be altered by everolimus Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Slovenian: Zdravila, pri katerih bi everolimus lahko vplival na njihovo koncentracijo v plazmi Glede na rezultate in vitro študij sistemska koncentracija, do katere pride po peroralnem odmerjanju 10 mg na dan, praktično ne more zavirati P-glikoproteina, CYP3A4 in CYP2D6.
English: Table 7 RECORD-1 - Progression-free survival results
Slovenian: Preglednica 7 Študija RECORD-1 - Rezultati za preživetje brez napredovanja bolezni
English: • Dry skin, skin exfoliation, skin lesions
Slovenian: • suha koža, luščenje kože, kožne spremembe
English: What Afinitor is and what it is used for What you need to know before you take Afinitor How to take Afinitor
Slovenian: Kaj je zdravilo Afinitor in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Afinitor Kako jemati zdravilo Afinitor Možni neželeni učinki
English: These medicines should be avoided during your treatment with Afinitor.
Slovenian: Tem zdravilom se morate izogibati med jemanjem zdravila Afinitor.
English: Afinitor could harm your breast-fed baby.
Slovenian: Zdravilo Afinitor lahko škoduje dojenemu otroku.
English: • Increased temperature, chills (signs of infection)
Slovenian: • zvišana telesna temperatura, mrazenje (znaki okužbe)
English: Efavirenz, nevirapine Not studied.
Slovenian: efavirenz, nevirapin
English: Table 1 Afinitor dose adjustment recommendations
Slovenian: Preglednica 1 Priporočila za prilagajanje odmerka zdravila Afinitor
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported (see section 4.8).
Slovenian: Poročali so o znižanih koncentracijah hemoglobina, limfocitov, nevtrofilcev in trombocitov (glejte poglavje 4.8).
English: • Swelling of the face, around the eyes, mouth, and inside the mouth and/or throat, as well as the tongue and difficulty breathing or swallowing (also known as angioedema), may be signs of an allergic reaction
Slovenian: • otekanje obraza, predela okrog oči in ust ter v ustih in/ali žrelu oziroma grlu z otekanjem jezika in oteženim dihanjem ali požiranjem (to imenujemo tudi angioedem), kar so lahko znaki alergijske reakcije
English: Non-infectious pneumonitis (including interstitial lung disease) has been frequently reported in patients taking Afinitor (see section 4.8).
Slovenian: O neinfekcijski pljučnici (vključno z intersticijsko boleznijo pljuč) so pogosto poročali pri bolnikih, ki so jemali zdravilo Afinitor (glejte poglavje 4.8).
English: In supportive analyses, positive treatment effect has been observed in all subgroups with the exception of the subgroup of patients with ileum as primary site of tumour origin (Ileum: HR=1.22 [95% CI: 0.56 to 2.65]; Non-ileum: HR=0.34 [95% CI: 0.22 to 0.54]; Lung: HR=0.43 [95% CI: 0.24 to 0.79]) (see Figure 5).
Slovenian: V okviru podporne analize so opažali pozitivne učinke zdravljenja v vseh podskupinah razen v podskupini bolnikov, pri katerih je bilo primarno mesto izvora tumorja ileum (ileum: razmerje tveganj HR=1,22 [95-odstotni IZ: 0,56 do 2,65]; izven ileuma: HR=0,34 [95-odstotni IZ: 0,22 do 0,54]; pljuča: HR=0,43 [95-odstotni IZ: 0,24 do 0,79]) (glejte sliko 5).
English: The median duration of blinded treatment was 40.4 weeks for patients receiving Afinitor and 19.6 weeks for those receiving placebo.
Slovenian: Mediana trajanja slepega zdravljenja v študiji je bila 40,4 tedna pri bolnikih, ki so prejemali zdravilo Afinitor, in 19,6 tedna pri tistih, ki so prejemali placebo.
English: Aluminium/polyamide/aluminium/PVC blister containing 10 tablets.
Slovenian: 6.5 Vrsta ovojnine in vsebina pretisni omot iz materialov: aluminij/poliamid/aluminij/PVC, ki vsebuje 10 tablet.
English: An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf).
Slovenian: Rezultati študije interakcij pri zdravih prostovoljcih so pokazali, da je sočasna uporaba everolimusa in peroralnega odmerka midazolama, ki je občutljiv predstavnik substratov CYP3A, povzročila zvišanje Cmax midazolama za 25 % in povečanje AUC(0-inf).midazolama za 30 %.
English: (46.8 to 55.9)
Slovenian: (46,8 do 55,9)
English: How to store Afinitor
Slovenian: Kako jemati zdravilo Afinitor
English: Grapefruit juice or other food affecting CYP3A4/PgP
Slovenian: sok grenivke ali druga živila, ki vplivajo na CYP3A4/P-glikoprotein
English: (0.38 to 0.54)
Slovenian: (0,38 do 0,54)
English: • Swelling and/or pain in one of the legs, usually in the calf, redness or warm skin in the affected area (signs of blockade of a blood vessel (vein) in the legs caused by blood clotting)
Slovenian: • otekanje in/ali bolečina ene noge, običajno v mečih, rdeča ali topla koža nad prizadetim predelom (znaki zapore krvne žile (vene) v nogi zaradi krvnega strdka)
English: Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Slovenian: Zdravilo Afinitor je indicirano za zdravljenje neresektabilnih ali metastatskih, dobro ali zmerno diferenciranih nevroendokrinih tumorjev pankreatičnega izvora pri odraslih z napredovalo boleznijo.
English: No clinical safety or efficacy data are currently available to support dose adjustment recommendations for the management of adverse reactions in patients with hepatic impairment.
Slovenian: Zaenkrat ni na voljo ustreznih kliničnih podatkov o varnosti in učinkovitosti uporabe zdravila, na podlagi katerih bi lahko priporočili prilagajanje odmerjanja za obvladovanje neželenih učinkov pri bolnikih z okvaro jeter.
English: Afinitor is used to treat adult patients with: hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control.
Slovenian: Zdravilo Afinitor uporabljamo za zdravljenje odraslih bolnikov z: napredovalim rakom dojke, ki je pozitiven na hormonske receptorje, pri ženskah v pomenopavzi, pri katerih druga zdravila (takoimenovani “nesteroidni zaviralci aromataze”) ne morejo več obvladovati bolezni.
English: Figure 5 RADIANT-4 - Progression free survival results by pre-specified patient subgroup (independent radiological review)
Slovenian: Slika 5 Študija RADIANT-4 - Rezultati preživetja brez napredovanja bolezni po vnaprej opredeljenih podskupinah bolnikov (po pregledu neodvisnih radiologov)
English: Demographics were well balanced (median age 58 years, 55% male, 78.5% Caucasian).
Slovenian: Demografske značilnosti so bile med skupinama enakovredno razporejene (mediana starost je bila 58 let, 55 % je bilo moških, 78,5 % belcev).
English: Talk to your doctor before taking Afinitor: if you have any problems with your liver or if you have ever had any disease which may have affected your liver.
Slovenian: Pred začetkom jemanja zdravila Afinitor se posvetujte z zdravnikom: če imate težave z jetri ali ste kdaj prej imeli kakršnokoli bolezen, ki bi lahko prizadela jetra: v tem primeru vam bo moral zdravnik morda predpisati drugačen odmerek zdravila Afinitor.
English: Crossover to open-label Afinitor following disease progression for patients allocated to placebo confounded the detection of any treatment-related difference in overall survival.
Slovenian: Prehod na odprto zdravljenje z zdravilom Afinitor po napredovanju bolezni pri bolnikih, ki so prej jemali placebo, je motil ugotavljanje razlike v celotnem preživetju.
English: The recommended dose is 10 mg everolimus once daily.
Slovenian: Priporočeni odmerek je 10 mg everolimusa enkrat dnevno.
English: • Fever, skin rash, joint pain and inflammation, as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)
Slovenian: • zvišana telesna temperatura, kožni izpuščaj, bolečine in vnetje v sklepih skupaj z utrujenostjo, izgubo apetita, slabostjo, zlatenico (porumenevanjem kože), bolečino v zgornjem desnem delu trebuha, blatom svetle barve in temnim urinom (to so lahko znaki reaktivacije hepatitisa B)
English: advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.
Slovenian: napredovalega ledvičnega raka (napredovali karcinom ledvičnih celic), kadar druga zdravila (zdravila, ki so usmerjena proti žilnemu endotelijskemu rastnemu dejavniku) niso pomagala pri ustavljanju bolezni.
English: Prognostic factors in neuroendocrine tumours of gastrointestinal or lung origin In patients with non-functional gastrointestinal or lung neuroendocrine tumours and good prognostic baseline factors, e.g. ileum as primary tumour origin and normal chromogranin A values or without bone involvement, an individual benefit-risk assessment should be performed prior to the start of Afinitor therapy.
Slovenian: Prognostični dejavniki pri nevroendokrinih tumorjih gastrointestinalnega ali pljučnega izvora Pri bolnikih z nefunkcionalnimi nevroendokrinimi tumorji gastrointestinalnega ali pljučnega izvora in dobrimi izhodiščnimi prognostičnimi dejavniki, kot so ileum kot primarno mesto izvora tumorja in normalne vrednosti kromogranina A ali bolniki brez zajetosti kosti, je treba pred začetkom zdravljenja z zdravilom Afinitor oceniti razmerje med koristmi in tveganji zdravljenja pri vsakem bolniku posamezno.
English: Demographics and disease characteristics were generally balanced (median age 63 years [range 22 to 86], 76% Caucasian, history of prior somatostatin analogue [SSA] use).
Slovenian: Demografske karakteristike in karakteristike bolezni so bile večinoma enakomerno razporejene (mediana starost 63 let [od 22 do 86], 76 % je bilo belcev, podoben delež bolnikov, ki so predhodno jemali analoge somatostatina).
English: Consider re-initiating treatment at 5 mg daily.
Slovenian: Razmislite o ponovni uvedbi zdravljenja z odmerkom 5 mg dnevno.
English: • Reddening of the skin (erythema)
Slovenian: • pordela koža (eritem)
English: Probability (%) of event
Slovenian: verjetnost dogodka (%)