FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients initially treated with placebo were allowed to cross over to everolimus at the time of SEGA progression and upon recognition that treatment with everolimus was superior to treatment with placebo.
Slovenian: Bolniki, ki so se v začetku zdravili s placebom, so lahko ob napredovanju SEGA in po ugotovitvi, da je zdravljenje z everolimusom učinkovitejše od zdravljenja s placebom, prešli na zdravljenje z everolimusom.
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Slovenian: Pri bolnikih, ki so jemali zdravilo Votubia, so poročali o znižanih koncentracijah hemoglobina, limfocitov, nevtrofilcev in trombocitov (glejte poglavje 4.8).
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Slovenian: Druge sestavine zdravila so butilhidroksitoluen (E321), magnezijev stearat, laktoza monohidrat, hipromeloza, krospovidon tipa A in brezvodna laktoza.
English: Table 5 EXIST-3 - Seizure frequency response rate (primary endpoint)
Slovenian: Preglednica 5 Študija EXIST-3 - Delež bolnikov z odzivom glede na pogostnost epileptičnih napadov (primarni cilj opazovanja)
English: Votubia dose adjustment
Slovenian: Sprememba odmerka zdravila Votubia
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)
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) otekanje, občutek teže ali zategovanja, bolečine in omejena gibljivost delov telesa (do česar lahko pride na kateremkoli delu telesa in lahko pomeni nenormalno zastajanje tekočine v mehkih tkivih zaradi zapore limfnega sistema, kar imenujemo limfedem) izpuščaj, srbenje, koprivnica, oteženo dihanje ali požiranje, omotičnost (znaki resne alergijske reakcije, ki jo imenujemo preobčutljivost) zvišana telesna temperatura, kašelj, oteženo dihanje, piskajoče dihanje (znaki vnetja v pljučih, ki ga imenujemo pljučnica)
English: Starting dose without co-administration of CYP3A4/PgP inducer
Slovenian: Začetni odmerek brez sočasne uporabe induktorja CYP3A4/PgP
English: If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before the Votubia dose is returned to the dose used prior to initiation of the coadministration.
Slovenian: Pri ukinitvi zmernega zaviralca je treba upoštevati, da se zaviralec izloča iz telesa vsaj 2 do 3 dni (povprečen čas izločanja najpogosteje uporabljanih zmernih zaviralcev) in po tem času vrniti odmerek zdravila Votubia na odmerek pred začetkom sočasne uporabe.
English: However, inhibition of CYP3A4 and PgP in the gut cannot be excluded.
Slovenian: Ni pa mogoče povsem izključiti zaviranja CYP3A4 in P-glikoproteina v črevesu.
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.
Slovenian: Varnost, učinkovitost in farmakokinetične lastnosti zdravila Votubia pri otrocih, ki so stari manj kot 2 leti in imajo tuberozno sklerozo in neodzivno epilepsijo, niso bile dokazane.
English: Kidney disorders: altered frequency or absence of urination may be symptoms of kidney failure and have been observed in some patients receiving everolimus.
Slovenian: Pri bolnikih, ki so everolimus jemali za zdravljenje drugih obolenj in ne tuberozne skleroze, so poročali o naslednjih neželenih učinkih: motnje v delovanju ledvic: spremenjena pogostnost ali odsotnost uriniranja sta lahko simptoma odpovedi ledvic in so ju opažali pri nekaterih bolnikih, ki so prejemali everolimus.
English: There was no indication of kidney toxicity in monkeys or minipigs.
Slovenian: Pri opicah in prašičkih ni bilo znakov toksičnih učinkov na ledvice.
English: For example, a patient's current dose based on BSA is 4 mg with a steady-state concentration of 4 ng/ml.
Slovenian: Na primer, bolnikov trenutni odmerek glede na telesno površino je 4 mg, koncentracija everolimusa v stanju dinamičnega ravnovesja pa 4 ng/ml.
English: • EXIST-2 (CRAD001M2302): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=79) versus placebo (n=39) in patients with either TSC plus renal angiomyolipoma (n=113) or sporadic lymphangioleiomyomatosis (LAM) plus renal angiomyolipoma (n=5).
Slovenian: • EXIST-2 (CRAD001M2302): To je bilo randomizirano, dvojno slepo, kontrolirano preskušanje everolimusa (n=79) faze III v primerjavi s placebom (n=39) pri bolnikih, ki so imeli bodisi TSC in ledvični angiomiolipom (n=113) bodisi sporadično limfangioleiomiomatozo (LAM) in ledvični angiomiolipom (n=5).
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.
Slovenian: Varnost, učinkovitost in farmakokinetične lastnosti zdravila Votubia pri otrocih, ki so stari manj kot 1 leto in imajo tuberozno sklerozo in SEGA, niso bile dokazane.
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 tablets.
Slovenian: Perforirani enoodmerni pretisni omot iz materialov: aluminij/poliamid/aluminij/PVC, ki vsebuje 10 x 1 tableto.
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).
Slovenian: Pri bolnikih, ki so jemali zdravilo Votubia, so opažali primere ledvične odpovedi (vključno z akutno ledvično odpovedjo), v nekaterih primerih s smrtnim izidom (glejte poglavje 4.8).
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Votubia therapy and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Votubia in občasno med zdravljenjem je priporočeno spremljanje ledvične funkcije, vključno z določanjem vrednosti dušika sečnine v krvi (BUN), proteinov v urinu ali kreatinina v serumu.
English: Based on a sensitivity analysis considering patients who prematurely discontinued everolimus as nonresponders, response rates of 38.4% (95% CI: 33.4, 43.7) and 44.4% (95% CI: 38.2, 50.7) were observed after 1 and 2 years of exposure to everolimus, respectively.
Slovenian: Po podatkih analize občutljivosti, ki je upoštevala bolnike, ki so predčasno prekinili zdravljenje z everolimusom, ker niso bili odzivni, so po 54 tednih opažali stopnjo odziva 38,8 % (95-odstotni IZ: 33,7; 44,1), po 102 tednih pa 41,0 % (95-odstotni IZ: 34,6; 47,7).
English: Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-based medicinal products.
Slovenian: Pri bolnikih, zlasti tistih, ki prejemajo steroidna zdravila, je priporočeno spremljanje za odkrivanje in zdravljenje morebitnih glivičnih okužb.
English: Substances that are inducers of CYP3A4 or PgP may decrease everolimus blood concentrations by increasing metabolism or the efflux of everolimus from intestinal cells.
Slovenian: Induktorji CYP3A4 in P-glikoproteina, ki znižujejo koncentracijo everolimusa Snovi, ki inducirajo CYP3A4 ali P-glikoprotein, lahko znižajo koncentracijo everolimusa v krvi, ker povečujejo njegov metabolizem ali njegov transport iz črevesnih celic.
English: Excipient with known effect Each tablet contains 74 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 74 mg laktoze.
English: Response rate (95% CI)
Slovenian: delež bolnikov z odzivom (95-odstotni IZ)
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets
Slovenian: Votubia 2,5 mg tablete Votubia 5 mg tablete Votubia 10 mg tablete
English: • <18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C)
Slovenian: • ki so stari manj kot 18 let in imajo SEGA ter hkrati okvaro jeter (razredov A, B ali C po
English: Large decrease in exposure expected.
Slovenian: Mogoče je pričakovati precej zmanjšano izpostavljenost zdravilu.
English: Votubia 10 mg tablets
Slovenian: Votubia 10 mg tablete
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma of cancer patients given Votubia 10 mg/day.
Slovenian: Pri bolnikih z rakom, ki jemljejo zdravilo Votubia v odmerku 10 mg na dan, je približno 20 % koncentracije everolimusa v celotni krvi omejene na plazmo.
English: Table 6 EXIST-3 - Seizure frequency response rate by age
Slovenian: Preglednica 6 Študija EXIST-3 - Delež bolnikov z odzivom glede na pogostnost epileptičnih napadov po starosti
English: Excipient with known effect Each dispersible tablet contains 1.96 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena disperzibilna tableta vsebuje 1,96 mg laktoze.
English: At the time of the primary analysis, Votubia demonstrated clinically meaningful improvements in skin lesion response (p=0.0004), with response rates of 41.7% (95% CI: 30.2, 53.9) for the Votubia arm and 10.5% (95% CI: 2.9, 24.8) for the placebo arm. At the final analysis, the skin lesion response rate increased to 58.1% (95% CI: 48.1, 67.7).
Slovenian: Ob času primarne analize so pri uporabi zdravila Votubia dokazali klinično pomembno izboljšanje glede odziva kožnih sprememb (p=0,0004), pri čemer je bil delež bolnikov z odzivom v skupini z zdravilom Votubia 41,7 % (95-odstotni IZ: 30,2; 53,9), v skupini s placebom pa 10,5 % (95-odstotni IZ: 2,9; 24,8).
English: Number of patients
Slovenian: Posebne skupine bolnikov
English: 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Slovenian: 10 x 1 tableta 30 x 1 tableta 100 x 1 tableta
English: Excipient with known effect Each tablet contains 297 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 297 mg laktoze.
English: Packs containing 30 x 1 dispersible tablets.
Slovenian: Pakiranja vsebujejo 30 x 1 disperzibilno tableto.
English: At the primary analysis, skin lesion response rates of 26.0% (95% CI: 16.6, 37.2) for the Votubia arm and 0% (95% CI: 0.0, 9.5) for the placebo arm were observed (p=0.0002).
Slovenian: V primarni analizi so odziv patoloških sprememb kože opažali pri 26,0 % bolnikov (95 % IZ: 16,6, 37,2) v skupini, ki je prejemala zdravilo Votubia, in pri 0 % (95 % IZ: 0,0, 9,5) v skupini, ki je prejemala placebo (p=0,0002).
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 dispersible tablets.
Slovenian: Perforirani enoodmerni pretisni omot iz materialov: aluminij/poliamid/aluminij/PVC, ki vsebuje 10 x 1 disperzibilno tableto.
English: Statistically significant per Bonferroni-Holm procedure d
Slovenian: c statistična značilnost po Bonferroni-Holmovem izračunu d da da neodzivni bolniki - n (%)
English: Angiomyolipoma response rate 95% CI
Slovenian: Primarna analiza Delež odziva angiomiolipoma 95% IZ
English: This is to measure the amount of Votubia in your blood and find the best daily dose for you.
Slovenian: Da bo zdravnik lahko določil količino zdravila Votubia v vaši krvi in izbral za vas najbolj primeren dnevni odmerek, boste v času zdravljenja z zdravilom Votubia opravljali krvne preiskave.
English: However, oral doses of everolimus in female rats at ≥ 0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Slovenian: V študijah vpliva na sposobnost razmnoževanja pri živalih niso opažali vpliva na plodnost pri samicah, je pa peroralno odmerjanje everolimusa podganjim samicam v odmerkih ≥0,1 mg/kg (kar ustreza približno 4 % vrednosti AUC0-24h pri bolnikih, ki prejemajo odmerek 10 mg dnevno) povzročilo povečano umrljivost zarodkov pred ugnezditvijo.
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets everolimus
Slovenian: Votubia 2,5 mg tablete Votubia 5 mg tablete Votubia 10 mg tablete everolimus
English: Votubia dispersible tablets are used to treat SEGA associated with TSC in adults and children for whom surgery is not appropriate.
Slovenian: Disperzibilne tablete Votubia uporabljamo za zdravljenje odraslih in otrok, ki imajo subependimski gigantocelični astrocitom v povezavi s tuberozno sklerozo in pri katerih operacija ni primerna.
English: Everolimus is a substrate of CYP3A4 and PgP.
Slovenian: Everolimus je substrat sistema CYP3A4 in P-glikoproteina.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Slovenian: Na eni strani imajo vtisnjeno oznako “LCL”, na drugi pa “NVR”.
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Slovenian: V primeru ponovitve stomatitisa stopnje 2 prekinite z uporabo zdravila, dokler ne pride do izboljšanja na raven stopnje 1.
English: Non-clinical studies in rats demonstrated distribution into the brain following administration by both the intravenous and oral routes.
Slovenian: Podatkov iz kliničnih študij o porazdelitvi everolimusa v človeških možganih ni. Predklinične študije na podganah so pokazale porazdelitev v možgane tako po intravenski kot po peroralni uporabi.
English: If all potent inducers are discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction) before the Votubia dose is returned to the dose used prior to initiation of the co-administration.
Slovenian: Pri ukinitvi vseh močnih induktorjev je treba upoštevati, da se induktorji izločajo iz telesa vsaj 3 do 5 dni (sprejemljivo obdobje, v katerem se znatno zmanjša indukcija encima) in po tem času vrniti odmerek zdravila Votubia na odmerek pred začetkom sočasne uporabe.
English: Vaccinations
Slovenian: Cepiva
English: Odds ratio (versus placebo)
Slovenian: Razmerje obetov (v primerjavi s placebom)
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Slovenian: Sočasna uporaba zaviralcev angiotenzinske konvertaze Pri bolnikih, ki se sočasno zdravijo z zaviralci angiotenzinske konvertaze (na primer z ramiprilom), je tveganje za pojav angioedema večje (glejte poglavje 4.4).
English: Take Votubia dispersible tablets as an oral suspension only Do not chew or crush the dispersible tablets.
Slovenian: Disperzibilne tablete Votubia lahko jemljete samo v obliki peroralne suspenzije Disperzibilnih tablet ne žvečite in ne drobite.
English: The cumulative median duration exposure to Votubia (361 patients who took at least one dose of everolimus) was 30.4 months (range 0.5 to 48.8).
Slovenian: Mediana kumulativnega trajanja izpostavljenosti zdravilu Votubia (361 bolnikov, ki so prejeli najmanj en odmerek everolimusa) je bila 20,8 meseca (v razponu od 0,5 do 37,9).
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Slovenian: V stanju dinamičnega ravnovesja obstaja statistično značilna korelacija med AUC0-τ in najnižjo koncentracijo pred naslednjim odmerkom.
English: Votubia 2.5 mg tablets everolimus
Slovenian: Votubia 2,5 mg tablete everolimus
English: If you stop taking Votubia Do not stop taking Votubia dispersible tablets unless your doctor tells you to.
Slovenian: Ne prekinite jemanja disperzibilnih tablet zdravila Votubia, če vam tega ni naročil zdravnik.
English: If not administered within 30 minutes of preparation when using an oral syringe or 60 minutes when using a small glass, the suspension must be discarded and a new suspension must be prepared (see section 6.3).
Slovenian: Če bolnik suspenzije ne zaužije v 30 minutah po pripravi, kadar uporablja brizgo za peroralno dajanje, ali v 60 minutah po pripravi, kadar uporablja majhen kozarec, jo je treba zavreči in pripraviti novo suspenzijo (glejte poglavje 6.3).
English: Votubia dispersible tablets contain an active substance called everolimus.
Slovenian: Zdravilo Votubia disperzibilne tablete vsebuje učinkovino everolimus.
English: If the suspension is not used within 60 minutes, throw it away and prepare a new suspension.
Slovenian: Če suspenzije ne uporabite v 60 minutah, jo zavrzite in pripravite novo.
English: Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnoea, flushing, chest pain or angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus (see section 4.3).
Slovenian: Pri uporabi everolimusa so opažali preobčutljivostne reakcije s simptomi, kot so med drugimi anafilaksija, dispneja, navali rdečice, bolečina v prsnem košu ali angioedem (na primer otekanje dihalnih poti ali jezika, z oteženim dihanjem ali brez njega) (glejte poglavje 4.3).
English: Votubia contains lactose
Slovenian: Zdravilo Votubia vsebuje laktozo
English: Excipient with known effect Each tablet contains 149 mg lactose.
Slovenian: Pomožna snov z znanim učinkom Ena tableta vsebuje 149 mg laktoze.
English: EXIST-1 (Study CRAD001M2301), a randomised, double-blind, multicentre phase III study of Votubia versus placebo, was conducted in patients with SEGA, irrespective of age.
Slovenian: EXIST-1 (študija CRAD001M2301) je bila randomizirana, dvojno slepa, multicentrična študija faze III, v kateri so proučevali zdravilo Votubia v primerjavi s placebom pri bolnikih s SEGA ne glede na njihovo starost.
English: Votubia 10 mg tablets everolimus
Slovenian: Votubia 10 mg tablete everolimus
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 3 below.
Slovenian: V preglednici 3 spodaj so navedene ugotovljene in teoretične interakcije z izbranimi zaviralci in induktorji CYP3A4 in P-glikoproteina.
English: What Votubia dispersible tablets looks like and contents of the pack Votubia 1 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Slovenian: Izgled zdravila Votubia disperzibilne tablete in vsebina pakiranja Votubia 1 mg disperzibilne tablete so okrogle ploščate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze.
English: 30 x 1 tablets 100 x 1 tablets
Slovenian: 30 x 1 tableta 100 x 1 tableta
English: Votubia 2.5 mg tablets
Slovenian: Votubia 2,5 mg tablete
English: Median time to SEGA progression based on central radiology review was not reached in either treatment arm. Progressions were only observed in the placebo arm (15.4%; p=0.0002).
Slovenian: Napredovanje bolezni so opažali samo v skupini s placebom (15,4 %; p=0,0002).
English: Consistent treatment effects were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex and age) at the primary analysis.
Slovenian: Ob primarni analizi so opažali podobne učinke zdravljenja v vseh ocenjevanih podskupinah bolnikov (kar pomeni v podskupini z uporabo antiepileptikov, ki inducirajo encime in v podskupini brez uporabe teh zdravil ter v podskupinah po spolu in starosti).
English: Using an oral syringe
Slovenian: Uporaba brizge za peroralno dajanje
English: Each tablet contains 2.5 mg everolimus.
Slovenian: Ena tableta vsebuje 2,5 mg everolimusa.
English: For patients with renal angiomyolipoma associated with TSC:
Slovenian: Bolniki z ledvičnim angiomiolipomom v povezavi s TSC:
English: Efficacy, safety, concomitant therapy, and the current trough concentration should be considered when planning for dose titration.
Slovenian: Pri načrtovanju titracije odmerka je treba upoštevati učinkovitost in varnost zdravljenja, sočasna zdravljenja in trenutno najnižjo koncentracijo everolimusa pred naslednjim odmerjanjem.
English: Add about 25 ml of water to the 30 ml dose cup.
Slovenian: V 30-mililitrsko odmerno skodelico nalijte približno 25 ml vode, pri čemer ni treba, da je količina vode natančno odmerjena.
English: Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Slovenian: Učinki na presnovo (kot sta hiperglikemija, dislipidemija)
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 2 below.
Slovenian: V preglednici 2 spodaj so navedene ugotovljene in teoretične interakcije z izbranimi zaviralci in induktorji CYP3A4 in P-glikoproteina.
English: Not studied.
Slovenian: Interakcije niso raziskane.
English: Placebo p-value Votubia n=79
Slovenian: Votubia placebo vrednost p
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml.
Slovenian: S titriranjem odmerka je treba doseči najnižjo koncentracijo pred naslednjim odmerjanjem od 5 do 15 ng/ml.
English: Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Slovenian: Stopnja 3 Začasno prekinite zdravljenje, dokler se simptomi ne izboljšajo do stopnje 2 (≥1,25x10
English: Do not chew or crush the tablets.
Slovenian: Tablet ne žvečite in ne drobite.
English: Radiological evidence of serial SEGA growth was required for entry.
Slovenian: Pogoj za vključitev v študijo je bilo več zaporednih radioloških izvidov, ki so dokazovali rast SEGA.
English: Blood lipids
Slovenian: Lipidi v krvi
English: If toxicity recurs at Grade 2, interrupt Votubia until recovery to Grade 1.
Slovenian: Če se škodljivi učinki ponovijo na ravni stopnje 2, prenehajte z uporabo zdravila Votubia, dokler ne pride do izboljšanja na raven stopnje 1.
English: Change in SEGA volume during the core 6-month treatment phase, as assessed via an independent central radiology review, was the primary efficacy endpoint.
Slovenian: Primarni cilj opazovanja učinkovitosti je bila sprememba volumna subependimskega gigantoceličnega astrocitoma v glavnem 6-mesečnem obdobju zdravljenja po presoji neodvisnega centralnega pregledovalca radioloških izvidov.
English: 10 x 1 tablets
Slovenian: 10 x 1 tableta
English: 30 x 1 tablets
Slovenian: 30 x 1 tableta
English: Temporary dose interruption until recovery to Grade 2 (≥1x10
Slovenian: Začasno prekinite zdravljenje, dokler se simptomi ne izboljšajo do stopnje 2 (≥1x10
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Slovenian: Do tega je po vsej verjetnosti prišlo zato, ker je everolimus zaviral delovanje CYP3A4 v črevesu.
English: If you do not use it within 60 minutes, throw it away and prepare a new suspension.
Slovenian: Če je ne zaužijete v 60 minutah po pripravi, jo zavrzite in pripravite novo suspenzijo.
English: Votubia 5 mg tablets
Slovenian: Votubia 5 mg tablete
English: Mix the medicine by slowly turning the oral syringe upside down and back again five times just before using the dose.
Slovenian: To naredite tako, da petkrat počasi obrnete brizgo za peroralno dajanje navzdol in spet navzgor.
English: Monitoring of fasting serum glucose 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 koncentracije glukoze v serumu na tešče.
English: A higher starting dose of 7 mg/m is therefore recommended for patients 1 to less than 3 years of age with SEGA (see section 4.2).
Slovenian: Iz tega razloga je pri bolnikih s SEGA, ki so stari od 1 leta do manj kot 3 leta, priporočen višji začetni odmerek 7 mg/m
English: 10 x 1 dispersible tablets 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Slovenian: 10 x 1 disperzibilna tableta 30 x 1 disperzibilna tableta 100 x 1 disperzibilna tableta
English: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin
Slovenian: telitromicin, klaritromicin nefazodon ritonavir, atazanavir, sakvinavir, darunavir, indinavir, nelfinavir
English: Adjust the dose by increments of 2.5 mg as necessary to maintain the target trough concentration.
Slovenian: korakih po 2,5 mg, če je to potrebno za vzdrževanje ciljne koncentracije pred naslednjim odmerjanjem.