FrancophonIA/ELRC3.0 huggingface dataset:
English: Wait for 3 minutes - until the dispersible tablets have completely broken apart.
Croatian: Pričekajte 3 minute - dok se tablete za oralnu suspenziju u potpunosti ne rastope.
English: If patients require co-administration of a potent CYP3A4 inducer, a Votubia dose increase from 10 mg daily up to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer.
Croatian: Ako je u bolesnika potrebna istodobna primjena potentnog CYP3A4 induktora, mora se razmotriti povećanje doze Votubie s 10 mg dnevno do najviše 20 mg dnevno s povišenjima od po 5 mg ili manje primijenjenima na 4. i 8. dan nakon početka primjene induktora.
English: High level of lipids (fats) in the blood (hypercholesterolaemia) Decreased appetite
Croatian: Povišena razina lipida (masnoća) u krvi (hiperkolesterolemija) Smanjenje apetita
English: Do not take a double dose to make up for the forgotten dispersible tablets.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljene tablete za oralnu suspenziju.
English: Excess amount of gas in the bowels (flatulence)
Croatian: Povećana količina plinova u crijevima (flatulencija) Zatvor
English: Draw up about 5 ml of water by slowly pulling the plunger out until it is at the 5 ml mark on the syringe.
Croatian: Uvucite otprilike 5 ml vode polaganim izvlačenjem klipa štrcaljke sve dok klip ne dođe do oznake od 5 ml na štrcaljki.
English: If the total prescribed dose is more than 10 mg or has to be prepared using more than 5 dispersible tablets, repeat steps 2 to 10 to finish taking the dose.
Croatian: Ako je ukupna propisana doza veća od 10 mg ili mora biti pripremljena korištenjem više od 5 tableta za oralnu suspenziju, ponovite korake 2 do 10 da biste završili uzimanje doze.
English: Consider interruption of therapy until symptoms improve to Grade 1.
Croatian: Stupanj 2 Razmotriti prekid terapije dok se simptomi ne poboljšaju do stupnja 1.
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Croatian: Bolesnici koji istodobno uzimaju terapiju ACE inhibitorima (npr. ramipril) mogu imati povećan rizik od angioedema (npr. oticanje dišnih puteva ili jezika, sa ili bez respiratornog oštećenja) (vidjeti dio 4.5).
English: The safety and efficacy of Votubia in children aged 0 to 18 years with renal angiomyolipoma associated with TSC in the absence of SEGA have not been established.
Croatian: Sigurnost i djelotvornost Votubie u djece starosti od 0 do 18 godina oboljele od angiomiolipoma bubrega povezanog s KTS-om u odsutnosti SEGA-e nisu ustanovljene.
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (everolimus, 10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Croatian: U ispitivanju s jednom skupinom ispitanika, provedenom nakon stavljanja lijeka u promet u postmenopauzalnih žena s uznapredovalim rakom dojke (N=92), topikalno liječenje bezalkoholnom oralnom otopinom deksametazona 0,5 mg/5 ml primijenjeno je kao otopina za ispiranje usta (4 puta dnevno tijekom prvih 8 tjedana liječenja) bolesnicama u vrijeme započinjanja liječenja Afinitorom (everolimus, 10 mg/dan) uz eksemestan (25 mg/dan), radi smanjenja incidencije i težine stomatitisa.
English: Sustained reductions were evident at week 24, 41.9% (31/74) of patients had ≥50% reductions and 78.4% (58/74) of patients had ≥30% reductions in SEGA volume.
Croatian: Održana smanjenja uočena su u 24. tjednu, 41,9% (31/74) bolesnika imalo je smanjenja od ≥50%, a 78,4% (58/74) bolesnika imalo je smanjenja volumena SEGA-e od ≥30%.
English: There was evidence of reversibility.
Croatian: Nađeni su dokazi da su opisane promjene reverzibilne.
English: The first symptoms may include fever, skin rash, joint pain and inflammation.
Croatian: Prvi simptomi mogu uključivati vrućicu, osip na koži, bol i upalu u zglobovima.
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: Caregivers should try to avoid skin contact with the oral suspension.
Croatian: Njegovatelji bi trebali izbjegavati kontakt kože s oralnom suspenzijom.
English: Table 4 Adverse reactions reported in TSC studies
Croatian: Tablica 4 Nuspojave zabilježene u ispitivanjima KTS-a
English: If you stop taking Votubia Do not stop taking Votubia tablets unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Votubia tablete sve dok Vam to ne kaže Vaš liječnik.
English: Non-infectious pneumonitis (including interstitial lung disease) was described very commonly in patients taking everolimus in the advanced renal cell carcinoma (RCC) setting (see section 4.8).
Croatian: Neinfektivni pneumonitis (uključujući intersticijsku bolest pluća) vrlo je učestalo opisivan u oboljelih od uznapredovaloga raka bubrežnih stanica liječenih everolimusom (vidjeti dio 4.8).
English: Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-based medicinal products.
Croatian: Preporučuje se praćenje zbog moguće pojave gljivične infekcije te njezino liječenje, osobito u bolesnika koji se liječe steroidnim lijekovima.
English: Of the enrolled patients, 83.1% had angiomyolipomas ≥4 cm (28.8% ≥8 cm), 78.0% had bilateral angiomyolipomas, and 39.0% had undergone prior renal embolisation/nephrectomy; 96.6% had skin lesions at baseline and 44.1% had target SEGAs (at least one SEGA ≥1 cm in longest diameter).
Croatian: Od uključenih bolesnika, 83,1% imalo je angiomiolipome veličine ≥4 cm (28,8% ≥8 cm), 78,0% imalo je obostrane angiomiolipome, a 39,0% ranije je bilo podvrgnuto embolizaciji bubrega/nefrektomiji; 96,6% imalo je kožne lezije na početku, a 44,1% imalo je ciljane SEGA-e (najmanje jedna SEGA ≥1 cm u najduljem promjeru).
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 3 below.
Croatian: Poznate i teoretske interakcije s izabranim inhibitorima i induktorima CYP3A4 i PgP-a navedene su niže u Tablici 3.
English: Aggression
Croatian: Agresivnost
English: Increased exposure expected.
Croatian: Očekuje se povećana izloženost.
English: Swallow the tablet(s) whole with a glass of water.
Croatian: Tabletu(e) progutajte s čašom vode.
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 2 below.
Croatian: Poznate i teoretske interakcije s izabranim inhibitorima i induktorima CYP3A4 i PgP-a navedene su niže u Tablici 2.
English: How to take Votubia
Croatian: Kako uzimati Votubiu
English: The most frequent grade 3-4 adverse reactions (incidence ≥1%) were pneumonia, stomatitis, amenorrhoea, neutropenia, pyrexia, menstruation irregular, hypophosphataemia, diarrhoea, and cellulitis.
Croatian: Najučestalije nuspojave stupnja 3-4 (incidencija ≥1%) bile su pneumonija, stomatitis, amenoreja, neutropenija, pireksija, neredovita menstruacija, hipofosfatemija, proljev i celulitis.
English: Dose adjustments due to adverse reactions
Croatian: Prilagođavanje doze zbog nuspojava
English: If the total prescribed dose is more than 10 mg or has to be prepared using more than 5 dispersible tablets, repeat steps 2 to 17 to finish giving the dose.
Croatian: Ako je ukupna propisana doza veća od 10 mg ili mora biti pripremljena korištenjem više od 5 tableta za oralnu suspenziju, ponovite korake 2 do 17 da biste završili davanje doze.
English: Presence of at least one SEGA lesion ≥1.0 cm in longest diameter using MRI (based on local radiology assessment) was required for entry.
Croatian: Za uključenje je bila potrebna prisutnost barem jedne SEGA lezije od ≥1,0 cm u najduljem promjeru zabilježene MR-om (na temelju lokalne radiološke procjene).
English: • Moderate hepatic impairment (Child-Pugh B): 50% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Croatian: • Umjereno oštećenje funkcije jetre (Child-Pugh B): 50% preporučene početne doze izračunate na temelju PT-a (zaokruženo na najbližu jačinu)
English: Starting dose and target trough concentrations in TSC with refractory seizures The recommended starting dose for Votubia for the treatment of patients with seizures is shown in Table 1.
Croatian: Početna doza i ciljane najniže koncentracije kod KTS-a s refraktornim napadajima Preporučena početna doza Votubie za liječenje bolesnika s napadajima prikazana je u Tablici 1.
English: Wait for 3 minutes until the dispersible tablets have completely broken apart.
Croatian: Pričekajte 3 minute dok se tablete za oralnu suspenziju u potpunosti ne rastope.
English: In an exploratory analysis of patients with TSC with angiomyolipoma who also had SEGA, the SEGA response rate (proportion of patients with ≥50% reduction from baseline in target lesion volumes in the absence of progression) was 10.3% in the everolimus arm in the primary analysis (versus no responses reported in the 13 patients randomised to placebo with a SEGA lesion at baseline) and increased to 48.0% in the final analysis.
Croatian: U eksploratornoj analizi bolesnika s KTS-om s angiomiolipomom koji su također imali SEGA-u, stopa odgovora SEGA-e (udio bolesnika sa smanjenjem ≥50% od početne vrijednosti u ciljanim volumenima lezije u odsutnosti progresije) bila je 10,3% u everolimus skupini u primarnoj analizi (u odnosu na odsustvo odgovora prijavljeno u 13 bolesnika sa SEGA lezijama na početku koji su randomizirani na placebo) te se povećala na 48,0% u završnoj analizi.
English: Presence of at least one angiomyolipoma ≥3 cm in longest diameter using CT/MRI (based on local radiology assessment) was required for entry.
Croatian: Za uključenje je bila potrebna prisutnost barem jednog angiomiolipoma veličine ≥3 cm u najduljem promjeru zabilježenog CT-om/MR-om (na temelju lokalne radiološke procjene).
English: Minor kidney changes were seen in the rat (exacerbation of age-related lipofuscin in tubular epithelium, increases in hydronephrosis) and mouse (exacerbation of background lesions).
Croatian: Manje promjene bubrega zabilježene su u štakora (egzacerbacija lipofuscina vezanog uz dob u epitelu tubula, povećanje hidronefroze) i miševa (egzacerbacija postojećih lezija).
English: Blood glucose
Croatian: Glukoza u krvi
English: LT target of 3-7 ng/ml
Croatian: DN ciljana vrijednost od 3-7 ng/ml
English: Table 3 Adverse reactions reported in TSC studies
Croatian: Tablica 3 Nuspojave zabilježene u ispitivanjima KTS-a
English: Severe pain in the lower abdomen and pelvic area that may be sharp, with menstrual irregularities (ovarian cyst)
Croatian: Teška bol u području donjeg dijela trbuha i zdjelice koja može biti oštra, uz menstrualne nepravilnosti (ciste na jajnicima)
English: Add the dispersible tablets into the water.
Croatian: Dodajte tablete za oralnu suspenziju u vodu.
English: Mixing the medicine
Croatian: Miješanje lijeka
English: Votubia dose adjustment
Croatian: Prilagođavanje doze Votubie
English: An inflammatory condition of the skin characterised by redness, itching, and oozing liquidfilled cysts which become scaly, crusted, or hardened (dermatitis acneiform) Loss of hair (alopecia)
Croatian: Upalno stanje kože karakterizirano crvenilom, svrbežom, cistama punjenim tekućinom iz kojih curi iscjedak i koje postaju ljuskave, krastave ili stvrdnute (akneiformni dermatitis) Gubitak kose (alopecija)
English: Very common side effects (may affect more than 1 in 10 people) Fever, cough, difficulty breathing, wheezing (signs of inflammation of the lung due to infection, also known as pneumonia)
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba) Vrućica, kašalj, otežano disanje, zviždanje pri disanju (znakovi upale pluća uzrokovane infekcijom, poznate i pod nazivom pneumonija)
English: x H
Croatian: x V
English: Discontinue Votubia.
Croatian: Stupanj 4 Prekinuti primjenu Votubie.
English: Estimated progression-free rates at 6 months were 100% for the Votubia arm and 85.7% for the placebo arm.
Croatian: Procijenjene stope bez progresije nakon 6 mjeseci bile su 100% za skupinu koja je primala Votubiu i 85,7% za skupinu koja je primala placebo.
English: With the tip of the oral syringe pointing upwards, swirl the water around to collect any medicine that is left inside.
Croatian: Držite štrcaljku za usta s vrhom okrenutim prema gore i kružnim pokretima promiješajte tako da s vodom pokupite ostatke lijeka koji su ostali unutra.
English: Phase II study in patients with SEGA
Croatian: Ispitivanje faze II u bolesnika oboljelih od SEGA-e
English: The most frequent adverse reactions (incidence ≥1/10) from the pooled safety data are (in decreasing order): stomatitis, pyrexia, nasopharyngitis, diarrhoea, upper respiratory tract infection, vomiting, cough, rash, headache, amenorrhoea, acne, pneumonia, urinary tract infection, sinusitis, menstruation irregular, pharyngitis, decreased appetite, fatigue, hypercholesterolaemia, and hypertension.
Croatian: Najčešće nuspojave (incidencija ≥1/10) iz objedinjenih sigurnosnih podataka su (prema padajućem redoslijedu): stomatitis, pireksija, nazofaringitis, proljev, infekcije gornjeg dijela dišnog sustava, povraćanje, kašalj, osip, glavobolja, amenoreja, akne, pneumonija, infekcija mokraćnog sustava, sinusitis, neredovita menstruacija, faringitis, smanjeni apetit, umor, hiperkolesterolemija i hipertenzija.
English: Very common side effects (may affect more than 1 in 10 people) Upper respiratory tract infection
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba) Infekcija gornjeg dijela dišnog sustava
English: Co-administration with inhibitors and inducers of CYP3A4 and/or the multidrug efflux pump P-glycoprotein (PgP) should be avoided.
Croatian: Mora se izbjegavati istodobna primjena s inhibitorima i induktorima CYP3A4 i/ili pumpe za izbacivanje mnogih lijekova P-glikoproteinom (PgP).
English: Impaired wound healing is a class effect of rapamycin derivatives, including Votubia.
Croatian: Odgođeno cijeljenje rane je učinak povezan sa skupinom derivata rapamicina, uključujući Votubiu.
English: AUC ↑ 3.7-fold Cmax ↑ 2.2-fold
Croatian: AUC ↑3,7-puta Cmax ↑2,2-puta
English: • Mild hepatic impairment (Child-Pugh A): The recommended dose is 7.5 mg daily.
Croatian: • Blago oštećenje funkcije jetre (Child-Pugh A): preporučena doza je 7,5 mg dnevno.
English: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Votubia (see section 4.8).
Croatian: Slučajevi zatajenja bubrega (uključujući akutno zatajenje bubrega), od kojih neki sa smrtnim ishodom, su primjećeni u bolesnika liječenih Votubiom (vidjeti dio 4.8).
English: Patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve the same exposure as patients not taking potent inducers.
Croatian: U bolesnika koji istodobno uzimaju potentne induktore CYP3A4 može se ukazati potreba za povišenjem doze Votubie u cilju postizanja iste izloženosti kao i u bolesnika koji ne uzimaju potentne induktore.
English: Everolimus is a substrate of CYP3A4 and PgP.
Croatian: Everolimus je supstrat CYP3A4 i PgP-a.
English: TSC with angiomyolipoma of the kidney in adults who do not require immediate surgery.
Croatian: KTS-a s angiomiolipomom bubrega u odraslih osoba kojima nije potrebno hitno kirurško liječenje.
English: Caregivers are advised to avoid contact with suspensions of Votubia tablets.
Croatian: Njegovateljima se savjetuje da izbjegavaju kontakt sa suspenzijom Votubia tableta.
English: Monitoring of blood cholesterol and triglycerides prior to the start of Votubia therapy and periodically thereafter, as well as management with appropriate medical therapy, is also recommended.
Croatian: Također se preporučuje praćenje kolesterola i triglicerida u krvi prije početka terapije Votubiom i redovito nakon toga, kao i liječenje odgovarajućom terapijom.
English: Headache, pressure in the eyes, nose or cheek area (signs of inflammation of the sinuses and nasal passages, also known as sinusitis)
Croatian: Glavobolja, tlak u području očiju, nosa ili obraza (znakovi upale sinusa i nosnih puteva, poznate i pod nazivom sinusitis)
English: If dose reduction is required, the recommended dose is approximately 50% lower than the daily dose previously administered.
Croatian: Ako je potrebno smanjenje doze, preporučuje se doza koja je otprilike 50% niža od prethodno primjenjivane dnevne doze.
English: Take Votubia dispersible tablets as an oral suspension only Do not chew or crush the dispersible tablets.
Croatian: Uzimajte Votubia tablete za oralnu suspenziju samo kao oralnu suspenziju Nemojte žvakati ili drobiti tablete za oralnu suspenziju.
English: Votubia contains lactose
Croatian: Votubia sadrži laktozu
English: Potent and moderate CYP3A4 inducers Rifampicin
Croatian: Potentni i umjereni induktori CYP3A4 Rifampicin
English: Women who could potentially become pregnant must use highly effective contraception during treatment, and for up to 8 weeks after ending treatment.
Croatian: Tijekom liječenja te do 8 tjedana po završetku liječenja, žene koje bi mogle zatrudnjeti moraju provoditi visoko učinkovitu kontracepciju.
English: You will have blood tests during treatment with Votubia.
Croatian: Tijekom liječenja Votubiom obavljat ćete krvne pretrage.
English: After administration of everolimus in patients with advanced solid tumours, steady-state AUC0-τ was dose-proportional over the range of 5 to 10 mg daily dose.
Croatian: Nakon primjene everolimusa u bolesnika s uznapredovalim solidnim tumorima AUC0-τ u stanju dinamičke ravnoteže bio je razmjeran dozi u rasponu dnevnih doza od 5 do 10 mg.
English: Median age was 31 years (range: 18 to 61 years; 46.6% were <30 years at enrolment), 33.9% were male, and 89.0% were Caucasian.
Croatian: Medijan dobi bio je 31 godina (raspon: 18 do 61 godine; 46,6% bilo je mlađe od 30 godina kod uključenja), 33,9% bilo je muškoga spola, a 89,0% bjelaca.
English: Your doctor will determine the dose of Votubia you need to take depending on: your age your body size the health of your liver other medicines you are taking.
Croatian: Dozu Votubie koju morate uzimati odredit će Vaš liječnik na temelju: Vaše dobi veličine Vašega tijela zdravlja
English: • Mild hepatic impairment (Child-Pugh A): 75% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Croatian: • Blago oštećenje funkcije jetre (Child-Pugh A): 75% preporučene početne doze izračunate na temelju PT-a (zaokruženo na najbližu jačinu)
English: The safety, efficacy and pharmacokinetic profile of Votubia in children below the age of 1 year with TSC who have SEGA have not been established.
Croatian: Sigurnost, djelotvornost i farmakokinetički profil Votubie u djece mlađe od 1 godine s KTS-om koji imaju SEGA-u nisu ustanovljene.
English: If you receive Votubia for the treatment of SEGA associated with TSC, regular blood tests are also necessary to measure how much Votubia is in your blood since this will help your doctor decide how much Votubia you need to take.
Croatian: Ako primate Votubiu za liječenje SEGA-e povezane s KTS-om, redovite krvne pretrage nužne su i zato da bi se izmjerila količina Votubie u Vašoj krvi, što će Vašem liječniku pomoći da odluči koliko Votubie trebate uzimati.
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Votubia may be required (see section 4.5).
Croatian: Ako se ne može izbjeći istodobna primjena umjerenog inhibitora ili induktora CYP3A4 i/ili PgP, potrebno je razmotriti prilagodbu doze Votubie (vidjeti dio 4.5).
English: The safety, efficacy and pharmacokinetic profile of Votubia in children below the age of 2 years with TSC and refractory seizures have not been established.
Croatian: Sigurnost, djelotvornost i farmakokinetički profil Votubie u djece mlađe od 2 godine s KTS-om i refraktornim napadajima nisu ustanovljene.
English: Important information for caregivers
Croatian: Važne upute za njegovatelje
English: 75% resp. 75 to <100
Croatian: 75% osoba s odgovorom 75 do <100
English: Primary tumour volume Mean (standard deviation)
Croatian: Primarni volumen tumora Srednja vrijednost (standardno odstupanje)
English: Includes (very common) stomatitis, mouth ulceration, aphthous ulcer; (common) tongue ulceration, lip ulceration and (uncommon) gingival pain, glossitis c
Croatian: Uključuje (vrlo često) stomatitis, ulceracije u usnoj šupljini, aftozne ulceracije; (često) ulceracije na jeziku, ulceracije na usnicama i (manje često) bol u zubnom mesu, glositis c
English: Common side effects (may affect up to 1 in 10 people) Swelling, feeling of heaviness or tightness, pain, limited mobility of body parts (this could occur anywhere in the body and is a potential sign of an abnormal build-up of fluid in soft tissue due to a blockage in the lymphatic system, also known as lymphoedema) Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity) Fever, cough, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba) Oticanje, osjećaj težine ili zategnutosti, bol, ograničena pokretljivost dijelova tijela (to se može pojaviti bilo gdje u tijelu te je potencijalno znak nenormalnog nakupljanja tekućine u mekom tkivu zbog blokade limfnog sustava, također poznato pod nazivom limfedem) Osip, svrbež, koprivnjača, otežano disanje ili gutanje, omaglica (znakovi ozbiljne alergijske reakcije, poznate i pod nazivom preosjetljivost) Vrućica, kašalj, otežano disanje, zviždanje pri disanju (znakovi upale pluća, poznate i pod nazivom pneumonitis)
English: For patients with TSC who have SEGA, SEGA volume should be evaluated approximately 3 months after commencing Votubia therapy, with subsequent dose adjustments taking changes in SEGA volume, corresponding trough concentration, and tolerability into consideration.
Croatian: Za bolesnike s KTS-om koji imaju SEGA-u, volumen SEGA-e se treba procijeniti otprilike 3 mjeseca nakon početka liječenja Votubiom, te nakon toga prilagoditi dozu lijeka uzevši u obzir promjenu volumena SEGA-e, pripadajuće najniže koncentracije lijeka u krvi i podnošljivost lijeka.
English: The median baseline seizure frequency across the treatment arms was 35, 38, and 42 seizures per 28 days for the Votubia LT, Votubia HT, and placebo groups, respectively.
Croatian: Medijan učestalosti napadaja na početku u svim terapijskim skupinama bio je 35, 38 odnosno 42 napadaja u 28 dana u skupinama koje su primale Votubiu DN, Votubiu GN, odnosno placebo.
English: Grade 4 (<0.5x10
Croatian: Stupanj 4 (<0,5x10
English: Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Croatian: Metabolički događaji (npr. hiperglikemija, dislipidemija)
English: • CRAD001C2485: This was a prospective, open-label, single-arm phase II study of everolimus in patients with SEGA (n=28).
Croatian: • CRAD001C2485: Ovo je bilo prospektivno, otvoreno ispitivanje faze II s jednom skupinom za ispitivanje everolimusa u bolesnika sa SEGA-om (n=28).
English: The median duration of blinded study treatment was 52.2 weeks (range 24 to 89) for patients receiving Votubia and 46.6 weeks (range 14 to 88) for those receiving placebo.
Croatian: Medijan trajanja slijepog ispitivanja liječenja bio je 52,2 tjedna (raspon 24 do 89) za bolesnike koji su primali Votubiu i 46,6 tjedana (raspon 14 do 88) za one koji su primali placebo.
English: The tablets must not be chewed or crushed.
Croatian: Tablete se ne smiju žvakati niti drobiti.
English: Temporary dose interruption until recovery to Grade 1 (≥75x10
Croatian: Privremeni prekid primjene do oporavka do stupnja 1 (≥75x10