FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Sigurnosni profil temelji se na objedinjenim podacima od 2879 bolesnika liječenih Afinitorom u jedanaest kliničkih ispitivanja, od kojih su pet bila randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III, a šest su bila otvorena ispitivanja faze I i faze II, vezana uz odobrene indikacije.
English: 10 tablets 30 tablets 90 tablets
Croatian: 10 tableta 30 tableta 90 tableta
English: (2.8 to 4.1)
Croatian: (2,8 do 4,1)
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).
Croatian: Ispitivanje interakcije u zdravih ispitanika pokazalo je da je istodobna primjena oralne doze midazolama, osjetljivog CYP3A4 supstrata, s everolimusom rezultirala 25%-tnim povećanjem Cmax midazolama i 30%-tnim povećanjem AUC(0-inf) midazolama.
English: • Acne
Croatian: • Akne
English: Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4EBP-1) that regulate proteins involved in the cell cycle, angiogenesis and glycolysis.
Croatian: Inhibicija mTORC1 signalnog puta interferira s translacijom i sintezom proteina tako da smanjuje aktivnost S6 ribosomske protein kinaze (S6K1) i proteina koji veže eukariotski faktor elongacije 4E (4EBP-1; engl.
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).
Croatian: Ako se Afinitor uzima s peroralno primijenjenim CYP3A4 supstratima s uskom terapijskom širinom (npr. pimozid, terfenadin, astemizol, cisaprid, kinidin ili derivati ergot alkaloida), bolesnike je potrebno pratiti kako bi se uočile nuspojave opisane u informacijama o lijeku peroralno primijenjenih supstrata CYP3A4 (vidjeti dio 4.5).
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.
Croatian: Prelazak na otvoreno liječenje Afinitorom nakon progresije bolesti za bolesnike koji su prethodno primali placebo onemogućilo je otkrivanje bilo kakve razlike vezane uz liječenje u ukupnom preživljenju.
English: The key secondary objective was to estimate the HR of PFS for everolimus + exemestane versus capecitabine.
Croatian: Ključni sekundarni cilj bio je procijeniti HR PFS-a za everolimus i eksemestan u odnosu na kapecitabin.
English: (0.5 to 4.2)
Croatian: (0,5 do 4,2)
English: Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Croatian: Umjereno oštećenje funkcije jetre (Child-Pugh B) - preporučena doza je 5 mg dnevno.
English: (0.31 to 0.48)
Croatian: (0,31 do 0,48)
English: • Pain in the mouth
Croatian: • Bol u ustima
English: Therefore, you may be at risk of getting an infection while you are taking Afinitor.
Croatian: Zbog toga možete biti u opasnosti od infekcije dok uzimate Afinitor. utjecati na funkciju bubrega.
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Croatian: Najčešći ciljni organi su bili muški i ženski reproduktivni sustavi (testikularna tubularna degeneracija, smanjen sadržaj sperme u epididimusu i atrofija uterusa) u nekoliko vrsta; pluća (povećani broj alveolarnih makrofaga) u štakora i miševa; gušterača (degranulacija i vakuolizacija egzokrinih stanica u majmuna odnosno u patuljastih svinja te degeneracija stanica otočića u majmuna) te oči samo u štakora (zamućenje prednje linije leće).
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
Croatian: • Oticanje lica, područja oko očiju, usnica, unutrašnjosti usta i/ili vrata, kao i jezika, te otežano disanje ili gutanje (također poznato kao angioedem), mogu biti znakovi alergijske reakcije
English: What Afinitor contains The active substance is everolimus.
Croatian: Što Afinitor sadrži Djelatna tvar je everolimus.
English: Afinitor with food and drink Avoid grapefruit and grapefruit juice while you are on Afinitor.
Croatian: Afinitor s hranom i pićem Tijekom liječenja Afinitorom izbjegavajte konzumaciju grejpa i soka od grejpa.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava i kategoriji učestalosti.
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.
Croatian: Sigurnost primjene, podnošljivost i farmakokinetika everolimusa ocjenjivane su u dva ispitivanja jednokratne peroralne doze tableta Afinitora provedena u 8 odnosno 34 ispitanika s oštećenom funkcijom jetre u odnosu na ispitanike s normalnom funkcijom jetre.
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.
Croatian: U analizi populacijske farmakokinetike u 170 bolesnika s uznapredovalim solidnim tumorima nije zabilježen značajni utjecaj klirensa kreatinina (25-178 ml/min) na CL/F everolimusa.
English: Table 1 Afinitor dose adjustment recommendations
Croatian: Tablica 1 Preporuke za prilagođavanje doze Afinitora
English: Caution should be exercised when Afinitor is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Croatian: Potreban je oprez pri uzimanju Afinitora u kombinaciji s oralno primijenjenim CYP3A4 supstratima s uskom terapijskom širinom zbog mogućih interakcija među lijekovima.
English: Co-administration of everolimus and depot octreotide increased octreotide Cmin with a geometric mean ratio (everolimus/placebo) of 1.47.
Croatian: Istodobna primjena everolimusa i depo preparata oktreotida povećala je Cmin oktreotida s geometrijskim srednjim omjerom (everolimus/placebo) od 1,47.
English: Time(months) Everolimus Placebo
Croatian: Vrijeme (mjeseci) Everolimus Placebo
English: While taking Afinitor, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Afinitor.
Croatian: Za vrijeme uzimanja Afinitora, potrebno je biti na oprezu zbog mogućnosti pojave simptoma i znakova infekcije; u slučaju potvrde dijagnoze infekcije, odmah je potrebno započeti odgovarajuće liječenje i razmotriti privremeni ili trajni prekid primjene Afinitora.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su navedene od najozbiljnjih prema manje ozbiljnima.
English: Clinical benefit rate c
Croatian: Stopa kliničke dobiti c
English: The most common adverse reactions leading to discontinuation were pneumonitis (including interstitial lung disease), stomatitis, fatigue and dyspnoea.
Croatian: Najčešće nuspojave koje su dovele do prekida primjene bile su pneumonitis (uključujući intersticijsku plućnu bolest), stomatitis, umor i dispneja.
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%.
Croatian: U zdravih ispitanika, obroci s visokim sadržajem masti smanjili su sistemsku izloženost everolimusu u dozi od 10 mg (mjerenu putem AUC-a) za 22%, a vršnu koncentraciju (Cmax) u plazmi za 54%.
English: Everolimus 10 mg + exemestane: 7.82 months Placebo + exemestane: 3.19 months
Croatian: Everolimus 10 mg + eksemestan: 7,82 mjeseci Placebo + eksemestan: 3,19 mjeseci
English: Censoring Times Everolimus (n/N = 155/277) Placebo (n/N = 111/139)
Croatian: Vrijeme cenzuriranja cenzuriranja Everolimus (n/N = 155/277) Placebo (n/N = 111/139)
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)
Croatian: • Oticanje i/ili bol u jednoj od nogu, obično u listu, crvenilo ili topla koža na zahvaćenom dijelu (znakovi blokade krvne žile (vene) u nogama izazvano zgrušavanjem krvi)
English: In this case, a dose of 2.5 mg daily must not be exceeded.
Croatian: U tom slučaju, doza ne smije biti veća od 2,5 mg dnevno.
English: (2.9 to 5.6)
Croatian: (2,9 do 5,6)
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported.
Croatian: Prijavljena je dislipidemija (uključujući hiperkolesterolemiju i hipertrigliceridemiju).
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 4).
Croatian: Rezultati djelotvornosti za mjeru primarnog ishoda dobiveni su iz završne analize PFS-a (vidjeti Tablicu 6 i Sliku 4).
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and tuberous sclerosis complex (TSC) settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Croatian: Ukupni sigurnosni profil u ovom ispitivanju bio je u skladu s profilom everolimusa za onkološke bolesnike i bolesnike s kompleksom tuberozne skleroze (KTS), uz iznimku blago povećane učestalosti oralne kandidijaze koja je bila zabilježena u 2,2% (n=2/92) bolesnika.
English: The pre-planned OS interim analysis after 101 deaths (out of 191 required for final analysis) and 33 months follow-up favoured the everolimus arm; however, no statistically significant difference in OS was noted (HR= 0.73 [95% CI: 0.48 to 1.11; p=0.071]).
Croatian: Unaprijed planirana interim analiza ukupnog preživljenja nakon 101 smrti (od 191 koliko je potrebno za završnu analizu) i 33 mjeseca praćenja išli su u prilog skupini koja je primala everolimus; međutim, nije opažena statistički značajna razlika u ukupnom preživljenju (omjer hazarda= 0,73 [95% CI: 0,48 do 1,11; p=0,071]).
English: Hence, concomitant treatment of Afinitor and potent inhibitors is not recommended.
Croatian: Dakle, istodobno liječenje Afinitorom i potentnim inhibitorima se ne preporučuje.
English: A single-arm study in postmenopausal breast cancer patients treated with Afinitor plus exemestane suggested that an alcohol-free corticosteroid oral solution, administered as a mouthwash during the initial 8 weeks of treatment, may decrease the incidence and severity of stomatitis (see section 5.1).
Croatian: Ispitivanje s jednom skupinom u postmenopauzalnih bolesnica s rakom dojke liječenih Afinitorom plus eksemestanom ukazalo je na to da bi bezalkoholna oralna otopina kortikosteroida, primijenjena kao otopina za ispiranje usta tijekom prvih 8 tjedana liječenja, mogla smanjiti incidenciju i težinu stomatitisa (vidjeti dio 5.1).
English: A diagnosis of non-infectious pneumonitis should be considered in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough or dyspnoea, and in whom infectious, neoplastic and other non-medicinal causes have been excluded by means of appropriate investigations.
Croatian: Dijagnozu neinfektivnog pneumonitisa mora se uzeti u obzir u bolesnika s nespecifičnim respiratornim znakovima i simptomima kao što su hipoksija, pleuralni izljev, kašalj ili dispneja, te u kojih su odgovarajućim pretragama isključeni infekcija, novotvorine i drugi nemedicinski uzroci.
English: advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas.
Croatian: uznapredovale tumore koji se nazivaju neuroendokrinim tumorima, a potječu iz trbuha, crijeva, pluća ili gušterače.
English: If toxicity recurs at Grade 3, consider discontinuation.
Croatian: Ako se vrati toksičnost stupnja 3, razmotriti prekid liječenja.
English: Common Aspartate aminotransferase increased, alanine aminotransferase increased Skin and subcutaneous tissue disorders
Croatian: Povišena aspartat aminotransferaza, povišena alanin aminotransferaza Poremećaji kože i potkožnog tkiva Vrlo često Osip, svrbež
English: Your doctor might need to interrupt or discontinue your treatment with Afinitor.
Croatian: Vaš Liječnik može privremeno ili trajno prekinuti Vaše liječenje Afinitorom.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Afinitor u svim podskupinama pedijatrijske populacije za neuroendokrine tumore s primarnim sijelom u gušterači, torakalne neuroendokrine tumore i za karcinom bubrežnih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Croatian: Učinak je vjerojatno posljedica inhibicije CYP3A4 u crijevima izazvane everolimusom.
English: It is given together with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal anticancer therapy.
Croatian: Afinitor se daje zajedno sa steroidnim inhibitorom aromataze koji se zove eksemestan, a koji se primjenjuje u hormonskom liječenju raka.
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.
Croatian: Nije poznato izaziva li everolimus u liječenih muških i ženskih bolesnika neplodnost, no u bolesnica je uočena amenoreja (sekundarna amenoreja i druge menstrualne nepravilnosti) i s njome povezana neravnoteža luteinizirajućeg hormona (LH) i hormona koji stimulira folikule (FSH).
English: How to take Afinitor
Croatian: Kako uzimati Afinitor
English: The result of the final PFS analysis with 154 PFS events observed based on local investigator assessment showed an estimated HR of 0.74 (90% CI: 0.57, 0.97) in favour of the everolimus + exemestane arm relative to everolimus arm.
Croatian: Rezultat konačne analize preživljenja bez progresije bolesti s 154 zabilježenih PFS događaja temeljeno na procjeni lokalnog ispitivača pokazao je procjenu omjera hazarda od 0,74 (90% CI: 0,57, 0,97) u prilog skupine koja je primala everolimus i eksemestan, u odnosu na skupinu koja je primala everolimus.
English: Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP/PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see “Infections” below).
Croatian: Pri diferencijalnoj dijagnozi neinfektivnog pneumonitisa potrebno je isključiti oportunističke infekcije kao što je pneumonija koju uzrokuje Pneumocystis jirovecii (carinii) (PJP/PCP) (vidjeti niže „Infekcije“).
English: Demographics were well balanced (pooled median age [61 years; range 27-85], 78% male, 88% Caucasian, number of prior VEGFR-TKI therapies [1-74%, 2-26%]).
Croatian: Skupine su bile dobro uravnotežene prema demografskim karakteristikama (zajednički medijan dobi [61 godina; raspon 27-85], 78% muškaraca, 88% bijelaca, broj prethodnih liječenja VEGFR-TK inhibitorom [1-74%, 2-26%]).
English: Those randomised to placebo were then able to receive open-label Afinitor.
Croatian: Oni koji su bili randomizirani u skupinu koja je primala placebo mogli su nakon toga primati Afinitor u otvorenom dijelu ispitivanja.
English: • Itching (pruritus)
Croatian: • Svrbež (pruritus)
English: Everolimus/Exemestane (n/N=80/104) Everolimus (n/N=74/103)
Croatian: Vrijeme cenzuriranja Everolimus/eksemestan (n/N=80/104) Everolimus (n/N=74/103)
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Afinitor (see sections 4.4 and 4.8).
Croatian: Stomatitis je najčešće prijavljena nuspojava u bolesnika liječenih Afinitorom (vidjeti dijelove 4.4 i 4.8).
English: n/a d e a
Croatian: n/p d e a
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg which caused a reduction in male fertility.
Croatian: U ispitivanjima učinaka lijeka na plodnost mužjaka štakora, morfologija testisa bila je promijenjena pri primjeni doza od 0,5 mg/kg i višim, a do smanjenja motiliteta spermija, broja glavica spermija i razine testosterona u plazmi došlo je pri primjeni doze od 5 mg/kg što je uzrokovalo smanjenje plodnosti mužjaka.
English: Includes all reactions within the ‘infections and infestations' system organ class including (common) pneumonia, urinary tract infection; (uncommon) bronchitis, herpes zoster, sepsis, abscess, and isolated cases of opportunistic infections [e.g. aspergillosis, candidiasis, PJP/PCP and hepatitis B (see also section 4.4)] and (rare) viral myocarditis b
Croatian: Uključuje sve reakcije unutar klasifikacije organskog sustava ‘infekcije i infestacije' uključujući (često) pneumoniju, infekciju mokraćnog sustava; (manje često) bronhitis, herpes zoster, sepsu, apsces i izolirane slučajeve oportunističkih infekcija [npr. aspergiloza, kandidijaza, PJP/PCP i hepatitis B (vidjeti također dio 4.4)] i (rijetko) virusni miokarditis b
English: (46.8 to 55.9)
Croatian: (46,8 do 55,9)
English: No. of patients still at risk Time (months) Afinitor
Croatian: Broj bolesnika koji su još pod rizikom Vrijeme (mjeseci)
English: Patients in the placebo arm did not cross-over to everolimus at the time of progression.
Croatian: Bolesnici u placebo skupini nisu prešli na everolimus u vrijeme progresije bolesti.
English: In a randomised, double-blind, multi-centre trial in patients with functional carcinoid tumours, Afinitor plus depot octreotide was compared to placebo plus depot octreotide.
Croatian: U randomiziranom, dvostruko slijepom, multicentričnom ispitivanju u bolesnika s funkcionalnim karcinoidnim tumorima, Afinitor primijenjen zajedno s depo preparatom oktreotida bio je uspoređen s primjenom placeba i depo preparata oktreotida.
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).
Croatian: U suportivnim analizama uočen je pozitivan učinak liječenja u svim podskupinama uz iznimku podskupine bolesnika s ileumom kao primarnim sijelom tumora (ileum: omjer hazarda=1,22 [95% CI: 0,56 do 2,65]; ne-ileum: omjer hazarda=0,34 [95% CI: 0,22 do 0,54]; pluća: omjer hazarda=0,43 [95% CI: 0,24 do 0,79]) (vidjeti Sliku 5).
English: (0.38 to 0.54)
Croatian: (0,38 do 0,54)
English: Concomitant treatment of Afinitor and potent inhibitors is not recommended.
Croatian: Istodobna primjena Afinitora i potentnih inhibitora se ne preporučuje.
English: However, inhibition of CYP3A4 and PgP in the gut cannot be excluded.
Croatian: Međutim, ne može se isključiti inhibicija CYP3A4 i PgP-a u crijevima.
English: Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d
Croatian: Uključuje (vrlo često) pneumonitis, (često) intersticijsku plućnu bolest, infiltraciju pluća i (rijetko) plućno alveolarno krvarenje, plućnu toksičnost i alveolitis d
English: Re-initiate treatment at 5 mg daily.
Croatian: Ponovno započeti liječenje u dozi od 5 mg dnevno.
English: Everolimus 10 mg + exemestane (n/N = 310/485) Placebo + exemestane (n/N = 200/239)
Croatian: Everolimus 10 mg + eksemestan (n/N = 310/485) Placebo + eksemestan (n/N = 200/239)
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Afinitor therapy and periodically thereafter.
Croatian: Preporučuje se praćenje funkcije bubrega, uključujući mjerenje dušika iz ureje u krvi (BUN - engl. blood urea nitrogen), proteina u mokraći ili kreatinina u serumu, prije početka liječenja Afinitorom i periodično nakon toga.
English: Grade 2 No dose adjustment required.
Croatian: Stupanj 2 Nije potrebno prilagođavanje doze.
English: Renal impairment No dose adjustment is required (see section 5.2).
Croatian: Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: If treatment with the inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction), before the Afinitor dose is returned to the dose used prior to initiation of the co-administration.
Croatian: Ako se prekine liječenje induktorom, potrebno je uzeti u obzir period ispiranja organizma od najmanje 3 do 5 dana (prihvatljivo vrijeme za značajno smanjenje indukcije enzima) prije povratka doze Afinitora na dozu primjenjivanu prije početka istodobne primjene.
English: Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment (see also sections 4.4 and 5.2).
Croatian: Dozu se mora prilagoditi ako se bolesnikov jetreni status (prema Child-Pugh klasifikaciji) promijeni tijekom liječenja (također vidjeti dijelove 4.4 i 5.2).
English: Do not use this medicine if any pack is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili postoje vidljivi znakovi neovlaštenog otvaranja.
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)
Croatian: • Vrućica, osip na koži, bol i upala u zglobovima, kao i umor, gubitak apetita, mučnina, žutica (žutilo kože), bol u gornjem desnom dijelu trbuha, blijeda stolica, tamna mokraća (mogu biti znakovi reaktivacije hepatitisa B)
English: The recommended dose is 10 mg everolimus once daily.
Croatian: Preporučena doza je 10 mg everolimusa jednom dnevno.
English: Telithromycin, clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir
Croatian: Ritonavir, atazanavir, sakvinavir, darunavir, indinavir, nelfinavir
English: • Thirst, low urine output, dark urine, dry flushed skin, irritability (signs of dehydration)
Croatian: • Žeđ, smanjeno mokrenje, tamna mokraća, suha zarumenjena koža, razdražljivost (znakovi dehidracije)
English: Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Afinitor.
Croatian: Već postojeće infekcije potrebno je pravilno liječiti i potpuno izliječiti prije početka liječenja Afinitorom.