FrancophonIA/ELRC3.0 huggingface dataset:
English: You must drink the suspension immediately after preparing it.
Slovenian: Suspenzijo morate zaužiti takoj po pripravi.
English: 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Slovenian: 30 x 1 disperzibilna tableta 100 x 1 disperzibilna tableta
English: Estimated progression-free rates at 6 months were 98.4% for the everolimus arm and 83.4% for the placebo arm. At the final analysis, median time to angiomyolipoma progression was not reached.
Slovenian: Ocenjeni delež bolnikov brez napredovanja bolezni po 6 mesecih je pri skupini, ki je prejemala everolimus, znašal 98,4 %, pri skupini, ki je prejemala placebo, pa 83,4 %.
English: Starting dose with co-administration of CYP3A4/PgP inducer
Slovenian: Začetni odmerek pri sočasni uporabi induktorja CYP3A4/PgP
English: Refractory seizures associated with tuberous sclerosis complex (TSC)
Slovenian: Ledvični angiomiolipom v povezavi s tuberozno sklerozo (TSC)
English: Butylated hydroxytoluene (E321) Magnesium stearate Lactose monohydrate Hypromellose
Slovenian: 6.1 Seznam pomožnih snovi butilhidroksitoluen (E321) magnezijev stearat laktoza monohidrat hipromeloza krospovidon (tipa A) brezvodna laktoza
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg or 2.5 mg daily may be considered.
Slovenian: Za bolnike z ledvičnim angiomiolipomom v povezavi s TSC: Če bolnik potrebuje sočasno uporabo zmernega zaviralca CYP3A4 ali P-glikoproteina, je treba razmisliti o znižanju odmerka na 5 mg ali 2,5 mg na dan.
English: The primary efficacy endpoint was SEGA response rate based on independent central radiology review.
Slovenian: Primarni cilj opazovanja učinkovitosti je bil delež bolnikov z odzivom subependimskega gigantoceličnega astrocitoma po presoji neodvisnega centralnega pregledovalca radioloških izvidov.
English: Consider re-initiating Votubia at approximately 50% lower than the daily dose previously administered.
Slovenian: Razmislite o ponovni uvedbi zdravila Votubia s približno 50 % nižjim odmerkom od predhodno zaužitega dnevnega odmerka.
English: Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena disperzibilna tableta vsebuje 0,98 mg laktoze.
English: Votubia 1 mg dispersible tablets are available in packs containing 30 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Slovenian: Zdravilo Votubia 1 mg disperzibilne tablete je na voljo v pakiranjih, ki vsebujejo 30 disperzibilnih tablet v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
English: If you do not drink it within 30 minutes when using an oral syringe or within 60 minutes when using a small glass, throw it away and prepare a new suspension.
Slovenian: Če je ne zaužijete v 30 minutah po pripravi, kadar uporabljate brizgo za peroralno dajanje, ali v 60 minutah po pripravi, kadar uporabljate majhen kozarec, jo zavrzite in pripravite novo suspenzijo.
English: Votubia tablets and Votubia dispersible tablets are not to be used interchangeably.
Slovenian: Tablet in disperzibilnih tablet zdravila Votubia se ne sme uporabljati izmenoma ali v kombinaciji za sestavljanje izbranega odmerka.
English: Discontinue Votubia.
Slovenian: Stopnja 4 Prenehajte z uporabo zdravila Votubia.
English: Recommendations concerning co-administration
Slovenian: Priporočila pri sočasnem odmerjanju
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered.
Slovenian: Zdravilo Votubia je mogoče ponovno uvesti v dnevnem odmerku, ki je za približno 50 % nižji od odmerka pred prekinitvijo.
English: Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 2,5 mg tablete vsebuje 2,5 mg everolimusa.
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
Slovenian: Pakiranja vsebujejo 10 x 1, 30 x 1 ali 100 x 1 tableto.
English: Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena disperzibilna tableta vsebuje 4,90 mg laktoze.
English: Mean CL/F of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Slovenian: Pri bolnikih z napredovalim trdim tumorjem je bil povprečni CL/F everolimusa po jemanju odmerka 10 mg na dan 24,5 l/h.
English: The two treatment arms were generally well balanced with respect to demographic and baseline disease characteristics and history of prior anti-SEGA therapies.
Slovenian: Demografske značilnosti bolnikov, izhodiščne karakteristike bolezni in anamneza predhodnih zdravil za zdravljenje SEGA so bile v obeh skupinah večinoma podobne.
English: AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
Slovenian: Cmax ↑2,3-krat (od 1,3 do 3,8) peroralni ciklosporin AUC ↑2,7-krat (od 1,5 do 4,7)
English: TSC with angiomyolipoma of the kidney in adults who do not require immediate surgery.
Slovenian: Tablete Votubia uporabljamo za zdravljenje: - tuberozne skleroze z angiomiolipomom ledvice pri odraslih, pri katerih ni potreben takojšen kirurški poseg.
English: In rats, everolimus caused embryo/foetotoxicity at systemic exposure below the therapeutic level.
Slovenian: Pri podganah je bil everolimus pri sistemski izpostavljenosti pod terapevtsko ravnijo toksičen za zarodek in plod, kar se je pokazalo s smrtjo in z zmanjšano telesno maso ploda.
English: How to store Votubia
Slovenian: Shranjevanje zdravila Votubia
English: Votubia 5 mg tablets everolimus
Slovenian: Votubia 5 mg tablete everolimus
English: Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
Slovenian: Pri bolnikih, ki so se zdravili z everolimusom, so poročali o pojavu pljučnice, povzročene s Pneumocystis jiroveci (carinii) (PJP, PCP), ki se je pri nekaj bolnikih končala s smrtjo.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets
Slovenian: Votubia 1 mg disperzibilne tablete Votubia 2 mg disperzibilne tablete Votubia 3 mg disperzibilne tablete Votubia 5 mg disperzibilne tablete
English: Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena disperzibilna tableta vsebuje 2,94 mg laktoze.
English: Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Slovenian: Vključuje izpuščaj (zelo pogost) in eritematozni izpuščaj (pogost) ter generaliziran izpuščaj, eritem, makulopapulozni izpuščaj in makularni izpuščaj (občasni).
English: Different strengths of Votubia tablets can be combined to attain the desired dose.
Slovenian: Za izbrani odmerek je mogoče kombinirati različne jakosti tablet zdravila Votubia.
English: Each tablet contains 10 mg everolimus.
Slovenian: Ena tableta vsebuje 10 mg everolimusa.
English: Talk to your doctor if you wish to have children.
Slovenian: Če načrtujete otroka, se posvetujte z zdravnikom.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Slovenian: Votubia 1 mg disperzibilne tablete Votubia 2 mg disperzibilne tablete Votubia 3 mg disperzibilne tablete Votubia 5 mg disperzibilne tablete everolimus
English: Each Votubia 10 mg tablet contains 10 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 10 mg tablete vsebuje 10 mg everolimusa.
English: Blood lactate dehydrogenase increased, blood luteinising hormone increased, weight decreased
Slovenian: Preiskave pogosti zvišana koncentracija laktat dehidrogenaze v krvi, zvišana koncentracija lutropina (LH) v krvi, zmanjšanje telesne mase občasni zvišana koncentracija folikulotropina (FSH) v krvi a
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported in patients taking Votubia.
Slovenian: Pri bolnikih, ki so jemali zdravilo Votubia, so poročali o dislipidemiji (vključno s hiperholesterolemijo in hipertrigliceridemijo).
English: They are engraved with “5” on one side and “NVR” on the other.
Slovenian: Na eni strani imajo vtisnjeno oznako “5”, na drugi pa “NVR”.
English: higher starting dose of 7 mg/m is recommended for patients 1 to less than 3 years of age based on pharmacokinetic simulations (see section 5.2).
Slovenian: Na osnovi simulacije farmakokinetičnih podatkov je za bolnike, ki so stari od 1 leta do manj kot 3 leta, priporočen višji začetni odmerek 7 mg/m
English: Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Slovenian: Tablete Votubia 10 mg so podolgovate tablete, bele do nekoliko rumenkaste barve.
English: Consistent treatment effects on angiomyolipoma response rate were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex, age and race) at the primary efficacy analysis.
Slovenian: V primarni analizi učinkovitosti so pri vseh ocenjevanih podskupinah (na primer uporaba antiepileptikov, ki inducirajo encime v primerjavi brez uporabe antiepileptikov, ki inducirajo encime, spol, starost in rasa) opažali skladne učinke zdravljenja na delež odziva angiomiolipoma.
English: Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 1 mg disperzibilne tablete vsebuje 1 mg everolimusa.
English: Interrupt Votubia until symptoms resolve to Grade 1.
Slovenian: Stopnja 3 Prekinite z uporabo zdravila Votubia, dokler se simptomi ne popravijo na raven stopnje 1.
English: Renal angiomyolipoma associated with TSC
Slovenian: Ledvični angiomiolipom v povezavi s TSC
English: Response was defined as: ≥50% reduction in the sum of SEGA volume relative to baseline, plus no unequivocal worsening of non-target SEGA lesions, plus absence of new SEGA ≥1 cm in longest diameter, plus no new or worsening hydrocephalus Primary analysis for double blind period Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.9 weeks
Slovenian: Odziv je bil opredeljen kot najmanj 50-odstotno zmanjšanje skupnega volumna lezij SEGA v primerjavi z njihovim izhodiščnim volumnom, odsotnost nedvomnega poslabšanja lezij SEGA, ki niso bile ciljne, odsotnost novih lezij SEGA z najdaljšim premerom najmanj 1 cm in odsotnost razvoja hidrocefalusa oziroma poslabšanja hidrocefalusa.
English: Prophylaxis for PJP/PCP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required.
Slovenian: Kadar je potrebno sočasno zdravljenje s kortikosteroidi ali drugimi imunosupresivnimi zdravili, je treba razmisliti o profilaksi PJP/PCP.
English: When switching pharmaceutical forms, the dose should be adjusted to the closest milligram strength of the new pharmaceutical form and the everolimus trough concentration should be assessed at least 1 week later (see section “Therapeutic drug monitoring” above).
Slovenian: Najnižjo koncentracijo everolimusa pred naslednjim odmerjanjem je treba izmeriti najmanj 1 teden po prehodu (glejte zgoraj pod naslovom “Terapevtsko spremljanje uporabe zdravila”).
English: 100 x 1 dispersible tablets
Slovenian: 100 x 1 disperzibilna tableta
English: Votubia 3 mg and Votubia 5 mg dispersible tablets are available in packs containing 30 x 1 or 100 x1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Slovenian: Zdravili Votubia 3 mg in Votubia 5 mg disperzibilne tablete sta na voljo v pakiranjih, ki vsebujejo 30 x 1 ali 100 x 1 disperzibilno tableto v perforiranih enoodmernih pretisnih omotih po 10 x 1 tableto.
English: 30 x 1 dispersible tablets
Slovenian: 30 x 1 disperzibilna tableta
English: Votubia 1 mg dispersible tablets
Slovenian: Votubia 1 mg disperzibilne tablete
English: Serious cases of haemorrhage, some with a fatal outcome, have been reported in patients treated with everolimus in the oncology setting.
Slovenian: Pri bolnikih, ki so prejemali everolimus v okviru onkološkega zdravljenja, so poročali o resnih primerih krvavitev, v nekaterih primerih s smrtnim izidom.
English: Following oral administration, everolimus is the main circulating component in human blood.
Slovenian: Everolimus je glavna od oblik, ki so pri človeku prisotne v krvnem obtoku po peroralnem vnosu.
English: 10 x 1 dispersible tablets
Slovenian: 10 x 1 disperzibilna tableta
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Slovenian: Do najvišje koncentracije pride v 1 do 2 urah po odmerjanju (tmax).
English: Monitoring of complete blood count is recommended prior to the start of Votubia therapy and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Votubia in periodično med zdravljenjem je priporočeno spremljanje celotne krvne slike.
English: Caregivers should try to avoid skin contact with the oral suspension.
Slovenian: Negovalci naj pazijo, da peroralna suspenzija ne pride v stik s kožo.
English: Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Slovenian: Če se uporabi zdravila Votubia v kombinaciji z zmernimi zaviralci CYP3A4 ali P-glikoproteina ne da izogniti, je potrebna previdnost.
English: Each Votubia 3 mg dispersible tablet contains 3 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 3 mg disperzibilne tablete vsebuje 3 mg everolimusa.
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets.
Slovenian: Pakiranja vsebujejo 10 x 1, 30 x 1 ali 100 x 1 disperzibilno tableto.
English: The dose may be increased to attain a higher trough concentration within the target range to obtain optimal efficacy, subject to tolerability.
Slovenian: Za doseganje optimalne učinkovitosti je mogoče odmerek zvišati tako, da najnižja koncentracija pred naslednjim odmerjanjem doseže višjo vrednost v okviru ciljnih vrednosti glede na to, kako bolnik prenaša določen odmerek.
English: Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Slovenian: Tablete Votubia 5 mg so podolgovate tablete, bele do nekoliko rumenkaste barve.
English: Re-initiate Votubia at approximately 50% lower than the daily dose previously administered.
Slovenian: Ponovno začnite zdravljenje z zdravilom Votubia s približno 50 % nižjim odmerkom od predhodno zaužitega dnevnega odmerka.
English: Response rates were 34.6% (95% CI: 24.2, 46.2) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (Table 6).
Slovenian: V skupini z zdravilom Votubia je znašal delež bolnikov z odzivom 34,6 % (95-odstotni IZ: 24,2; 46,2), v skupini s placebom pa 0 % (95-odstotni IZ: 0,0; 9,0) (preglednica 6).
English: Temporary dose interruption until recovery to Grade 1.
Slovenian: Stopnja 2 Začasna prekinitev zdravljenja, dokler ne pride do izboljšanja na raven stopnje 1.
English: Tell your doctor immediately if you experience these symptoms.
Slovenian: Če pride do teh simptomov, takoj povejte zdravniku.
English: Votubia is not recommended for patients <18 years of age with SEGA or refractory seizures and hepatic impairment.
Slovenian: Za bolnike, ki so stari manj kot 18 let in imajo SEGA ali neodzivno epilepsijo ter okvaro jeter, uporaba zdravila Votubia ni priporočena.
English: Packs containing 30 x 1 or 100 x 1 tablets.
Slovenian: Pakiranja vsebujejo 30 x 1 ali 100 x 1 tableto.
English: Children and adolescents Votubia can be used in children and adolescents with SEGA associated with TSC.
Slovenian: Zdravilo Votubia se lahko uporablja pri otrocih in mladostnikih, ki imajo subependimski gigantocelični astrocitom v povezavi s tuberozno sklerozo.
English: Each Votubia 2 mg dispersible tablet contains 2 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 2 mg disperzibilne tablete vsebuje 2 mg everolimusa.
English: Each tablet contains 5 mg everolimus.
Slovenian: Ena tableta vsebuje 5 mg everolimusa.
English: Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis Skin and subcutaneous tissue disorders Very common Rash c, acne
Slovenian: Bolezni prebavil zelo pogosti stomatitis b, diareja, bruhanje pogosti obstipacija, navzea, bolečine v trebuhu, flatulenca, bolečine v ustih, gastritis Bolezni kože in podkožja zelo pogosti izpuščaj c, akne pogosti suha koža, akneiformni dermatitis, pruritus, alopecija občasni angioedem
English: Each Votubia 5 mg dispersible tablet contains 5 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 5 mg disperzibilne tablete vsebuje 5 mg everolimusa.
English: They are engraved with “UHE” on one side and “NVR” on the other.
Slovenian: Na eni strani imajo vtisnjeno oznako “UHE”, na drugi pa “NVR”.
English: It is essential to assess everolimus blood levels in cases of suspected overdose.
Slovenian: V primeru suma na preveliko odmerjanje je določanje koncentracije everolimusa v krvi bistvenega pomena.
English: Response rates were 34.6% (95% CI: 24.2, 46.2) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (Table 7).
Slovenian: V skupini z zdravilom Votubia je znašal delež bolnikov z odzivom 34,6 % (95-odstotni IZ: 24,2; 46,2), v skupini s placebom pa 0 % (95-odstotni IZ: 0,0; 9,0) (preglednica 7).
English: Each dispersible tablet contains 1 mg everolimus.
Slovenian: Ena disperzibilna tableta vsebuje 1 mg everolimusa.
English: Different strengths of Votubia dispersible tablets can be combined to attain the desired dose.
Slovenian: Za izbrani odmerek je mogoče kombinirati različne jakosti disperzibilnih tablet zdravila Votubia.
English: If the moderate inhibitor is discontinued, consider a washout period of at least 2
Slovenian: Pri ukinitvi zmernega zaviralca je treba upoštevati, da se zaviralec izloča iz imatinib
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.
Slovenian: Priporočeni začetni odmerki zdravila Votubia za zdravljenje bolnikov z epileptičnimi napadi so navedeni v preglednici 1.
English: • Spoon for stirring
Slovenian: • žličko za mešanje
English: Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Slovenian: Infekcijske in parazitske bolezni zelo pogosti nazofaringitis, okužbe zgornjih dihal, pljučnica a, sinusitis, okužba sečil, faringitis pogosti vnetje srednjega ušesa, flegmona, streptokokni faringitis, virusni gastroenteritis, gingivitis občasni herpes zoster, sepsa, virusni bronhitis Bolezni krvi in limfatičnega sistema pogosti anemija, nevtropenija, levkopenija, trombocitopenija, limfopenija Bolezni imunskega sistema pogosti preobčutljivost
English: cause shortness of breath, cough and fever (see section 4 ‘Possible side effects').
Slovenian: vpliva na delovanje ledvic, zato bo zdravnik v času, ko jemljete zdravilo Votubia, spremljal delovanje vaših ledvic, povzroča zadihanost, kašelj in zvišano telesno temperaturo (glejte poglavje 4 “Možni neželeni učinki”).
English: Each Votubia 5 mg tablet contains 5 mg of everolimus.
Slovenian: Ena tableta zdravila Votubia 5 mg tablete vsebuje 5 mg everolimusa.
English: Votubia 2 mg dispersible tablets everolimus
Slovenian: Votubia 2 mg disperzibilne tablete everolimus
English: Votubia 1 mg dispersible tablets everolimus
Slovenian: Votubia 1 mg disperzibilne tablete everolimus
English: Votubia 3 mg dispersible tablets
Slovenian: Votubia 3 mg disperzibilne tablete
English: Symptoms of heart failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
Slovenian: simptomi srčnega popuščanja kot na primer zasoplost, težave pri dihanju v ležečem položaju, otekanje stopal ali nog blokada ali obstrukcija krvne žile (vene) v nogi (globoka venska tromboza).
English: - Keep this leaflet.
Slovenian: glejte spodnjo sliko
English: High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides) Low level of phosphate in the blood (hypophosphataemia) High level of sugar in the blood (hyperglycaemia) Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, also known as anaemia)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vnetje srednjega ušesa občutljive, krvaveče dlesni (znaki vnetja dlesni, ki ga imenujemo gingivitis) vnetje kože (flegmona) visoka raven lipidov (maščob) v krvi (hiperlipidemija, zvišana raven trigliceridov) nizka raven fosfatov v krvi (hipofosfatemija) visoka raven sladkorja v krvi (hiperglikemija) utrujenost, zadihanost, omotičnost, bleda koža (znaki nizke ravni rdečih krvnih celic, kar imenujemo anemija) zvišana telesna temperatura, vnetje grla oziroma žrela ali ustne razjede zaradi okužbe (znaki nizke ravni belih krvnih celic, kar imenujemo levkopenija, limfopenija ali nevtropenija) glavobol in omotičnost sta znaka visokega krvnega tlaka (hipertenzija)
English: Cellulose microcrystalline Silica colloidal anhydrous
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni rabdomioliza
English: Votubia 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Slovenian: Votubia 5 mg disperzibilne tablete so okrogle ploščate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze.
English: Everolimus had no impact on pre-dose concentrations of antiepileptics that are substrates of CYP3A4 (clonazepam, diazepam, felbamate and zonisamide).
Slovenian: Pri antiepileptikih, ki so substrati CYP3A4 (klonazepam, diazepam, felbamat in zonisamid), everolimus ni vplival na njihove koncentracije pred naslednjim odmerjanjem.
English: Each dispersible tablet contains 3 mg everolimus.
Slovenian: Ena disperzibilna tableta vsebuje 3 mg everolimusa.
English: Each dispersible tablet contains 2 mg everolimus.
Slovenian: Ena disperzibilna tableta vsebuje 2 mg everolimusa.
English: Ask your pharmacist how to throw away the oral syringe.
Slovenian: O načinu odstranjevanja brizge za peroralno dajanje se posvetujte s farmacevtom.
English: White to slightly yellow, elongated tablets of approximately 10.1 x 4.1 mm, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
Slovenian: Podolgovate tablete, velikosti približno 10,1 x 4,1 mm, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “LCL” na eni strani in “NVR” na drugi.
English: Votubia 3 mg dispersible tablets everolimus
Slovenian: Votubia 3 mg disperzibilne tablete everolimus
English: Votubia 2 mg dispersible tablets
Slovenian: Votubia 2 mg disperzibilne tablete
English: Preparations containing St John's Wort should not be used during treatment with everolimus
Slovenian: V času zdravljenja z everolimusom se ne sme jemati pripravkov, ki vsebujejo šentjanževko.
English: Votubia 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Slovenian: Votubia 2 mg disperzibilne tablete so okrogle ploščate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze.
English: Packs containing 30 x 1 or 100 x 1 dispersible tablets
Slovenian: Pakiranja vsebujejo 30 x 1 ali 100 x 1 disperzibilno tableto.
English: They are engraved with “D5” on one side and “NVR” on the other.
Slovenian: Na eni strani imajo vtisnjeno oznako “D5”, na drugi pa “NVR”.
English: Each dispersible tablet contains 5 mg everolimus.
Slovenian: Ena disperzibilna tableta vsebuje 5 mg everolimusa.
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered depending on the individual clinical circumstances.
Slovenian: Zdravilo Votubia je glede na klinično stanje posameznika mogoče ponovno uvesti v dnevnem odmerku, ki je za približno 50 % nižji od odmerka pred prekinitvijo.