FrancophonIA/ELRC3.0 huggingface dataset:
English: The robustness and consistency of the primary analysis were supported by the: change in primary SEGA volume as per local investigator assessment (p<0.001), with 75.0% and 39.3% of patients experiencing reductions of ≥30% and ≥50%, respectively change in total SEGA volume as per independent central review (p<0.001) or local investigator assessment (p<0.001).
Slovenian: Robustnost in enotnost rezultatov primarne analize potrjujejo naslednja dejstva: po presoji lokalnih raziskovalcev je prišlo do spremembe volumna primarnega SEGA, in sicer je pri 75,0 % bolnikov prišlo do zmanjšanja tumorja za ≥30 %, pri 39,3 % bolnikov pa za ≥50 % (p<0,001); po presoji neodvisnega centralnega pregledovalca (p<0,001) ali lokalnega raziskovalca (p<0,001) je prišlo do spremembe skupnega volumna SEGA.
English: Patients receiving concomitant potent CYP3A4 inducers may require an increased Votubia dose to achieve the same exposure as patients not taking potent inducers.
Slovenian: Pri bolnikih, ki imajo SEGA in sočasno prejemajo močne induktorje CYP3A4, so lahko potrebni višji odmerki zdravila Votubia za enako izpostavljenost zdravilu kot pri bolnikih, ki ne prejemajo močnih induktorjev.
English: 75% resp. 75 to <100
Slovenian: 75-odstotno zmanjšanje 75 do <100
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.
Slovenian: Pregledna analiza bolnikov s tuberozno sklerozo in angiomiolipomom, ki so imeli tudi SEGA, je pokazala, da je bil v času primarne analize delež bolnikov z odzivom SEGA (z ≥ 50-odstotnim zmanjšanjem volumna ciljne lezije v primerjavi z izhodiščnim volumnom brez napredovanja bolezni) v skupini bolnikov z everolimusom 10,3 % (v primerjavi z odsotnostjo odziva pri 13 bolnikih, ki so imeli ob izhodišču SEGA lezijo in so jih randomizirali na prejemanje placeba), v času zaključne analize pa se je delež teh bolnikov z odzivom povečal na 48,0 %.
English: Overactivation of mTOR results in neuronal dysplasia, aberrant axonogenesis and dendrite formation, increased excitatory synaptic currents, reduced myelination, and disruption of the cortical laminar structure causing abnormalities in neuronal development and function.
Slovenian: Prekomerna aktivacija mTOR povzroča nevronalno displazijo, aberanten razvoj aksonov in aberantno tvorbo dendritov, okrepljene ekscitatorne sinaptične tokove, zmanjša mielinizacijo in poruši normalno zgradbo kortikalnih laminarnih struktur, kar povzroča nepravilnosti v razvoju in delovanju nevronov.
English: In total, 28 patients received treatment with Votubia; median age was 11 years (range 3 to 34), 61% male, 86% Caucasian.
Slovenian: Zdravilo Votubia je skupno prejemalo 28 bolnikov, katerih mediana starost je bila 11 let (starih od 3 do 34 let), 61 % jih je bilo moškega spola in 86 % bele rase.
English: Stir the contents with the spoon to remove any medicine left on the glass and spoon.
Slovenian: Vsebino premešajte z žličko, tako da voda spere morebitne ostanke zdravila v kozarcu in na žlički.
English: Caution should be exercised when Votubia is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Slovenian: Pri uporabi zdravila Votubia v kombinaciji s peroralnimi substrati CYP3A4 z nizkim terapevtskim indeksom je potrebna previdnost zaradi možnosti, da pride do interakcij.
English: Hands should be washed thoroughly before and after preparation of the suspension.
Slovenian: Pred pripravljanjem suspenzije in po njem si je treba temeljito umiti roke.
English: • severe itching of the skin, with a red rash or raised bumps
Slovenian: • močno srbenje kože z rdečim izpuščajem ali s kožnimi spremembami, ki se dvigujejo nad površino kože.
English: How to take Votubia
Slovenian: Kako jemati zdravilo Votubia
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.
Slovenian: Po uporabi everolimusa pri bolnikih z napredovalim trdim tumorjem je bila AUC0-τ v stanju dinamičnega ravnovesja v okviru odmerkov od 5 do 10 mg sorazmerna z višino odmerka.
English: Response was defined as: ≥50% reduction in the sum of angiomyolipoma volume relative to baseline, plus absence of new angiomyolipoma ≥1.0 cm in longest diameter, plus no increase in renal volume >20% from nadir, plus absence of grade ≥2 angiomyolipoma-related bleeding.
Slovenian: Odziv je bil definiran kot: ≥50 % zmanjšanje celotnega volumna angiomiolipoma v primerjavi z izhodiščem, odsotnost novega angiomiolipoma, katerega najdaljši premer znaša ≥1,0 cm, odsotnost povečanja volumna ledvice za >20 % glede na najnižjo vrednost ter odsotnost z angiomiolipomom povezane krvavitve stopnje ≥2.
English: Three randomised, double-blind, placebo-controlled pivotal phase III studies, including double-blind and open label treatment periods, and a non-randomised, open-label, single-arm phase II study contribute to the safety profile of Votubia (n=612, including 409 patients <18 years of age; median duration of exposure 36.8 months [range 0.5 to 83.2]).
Slovenian: Varnostni profil zdravila Votubia je bil ugotovljen v treh randomiziranih, dvojno slepih, s placebom kontroliranih osrednjih študijah faze III, ki so vključevale obdobje z dvojno slepim in obdobje z odprtim zdravljenjem, in v nerandomizirani, odprti študiji faze II z eno skupino (n=612, vključno s 409 bolniki, ki so bili stari manj kot 18 let; mediana trajanja izpostavljenosti 27,4 meseca [v razponu od 0,5 do 83,2]).
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).
Slovenian: Od vključenih bolnikov jih je 83,1 % imelo angiomiolipome večje od 4 cm (28,8 % ≥8 cm), 78,0 % jih je imelo obojestranske angiomiolipome, pri 39,0 % pa je bila predhodno opravljena ledvična embolizacija/nefrektomija; 96,6 % jih je na izhodišču imelo patološke spremembe kože, 44,1 % pa jih je imelo ciljne SEGA (najmanj en SEGA, katerega najdaljši premer je znašal 1 cm ali več).
English: Only use water (drinkable tap water or non-sparkling bottled water) to prepare the oral suspension.
Slovenian: Za pripravljanje peroralne suspenzije uporabljajte samo vodo (pitno vodo iz vodovodne pipe ali negazirano ustekleničeno vodo).
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).
Slovenian: Če se sočasni uporabi zmernega zaviralca ali induktorja CYP3A4 in/ali P-glikoproteina ne da izogniti, je morda treba prilagoditi odmerek zdravila Votubia (glejte poglavje 4.5).
English: The patient must drink the suspension immediately after it is prepared.
Slovenian: Bolnik mora suspenzijo zaužiti takoj po pripravi.
English: For children with SEGA or seizures, it is important to have a discussion with the doctor about the childhood vaccination program before treatment with Votubia.
Slovenian: Za otroke s s subependimskim gigantoceličnim astrocitomom je pomembno, da se z zdravnikom pogovorite o programu cepljenja za otroke pred začetkom zdravljenja z zdravilom Votubia.
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml as described below.
Slovenian: S titriranjem odmerka je treba doseči najnižjo koncentracijo pred naslednjim odmerjanjem od 5 do 15 ng/ml, kot je opisano spodaj.
English: No serious cases of renal haemorrhage were reported in the TSC setting.
Slovenian: V okviru zdravljenja TSC niso poročali o nobenem resnem primeru ledvične krvavitve.
English: Dosing recommendations for paediatric patients with seizures are consistent with those for the adult population, except for patients in the range from 2 years to less than 6 years of age, and those with hepatic impairment (see section “Hepatic impairment” below and section 5.2).
Slovenian: Priporočila za odmerjanje pri pediatričnih bolnikih z epilepsijo so enaka kot pri odrasli populaciji, razen pri bolnikih, ki so stari od 2 let do manj kot 6 let, ter pri tistih z okvaro jeter (glejte poglavje “Okvara jeter” spodaj in poglavje 5.2).
English: A total of 49 out of 137 patients (36%) aged <6 years had Grade 3/4 infections, compared to 53 out of 272 patients (19%) aged 6 to <18 years and 27 out of 203 patients (13%) aged ≥18 years.
Slovenian: Okužbo stopnje 3/4 je imelo skupaj 46 (34 %) od 137 bolnikov, starih manj kot 6 let, v primerjavi z 49 (18 %) od 272 bolnikov, ki so bili stari od 6 do manj kot 18 let, in 24 (12 %) od 203 bolnikov, ki so bili stari najmanj 18 let.
English: Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment.
Slovenian: Ženske v rodni dobi morajo v času jemanja everolimusa in do 8 tednov po zaključku zdravljenja z njim uporabljati zelo učinkovito kontracepcijsko metodo (kot so peroralne, injekcijske ali implantacijske hormonske metode za nadzor rojstev brez estrogenov, kontraceptivi, ki temeljijo na progesteronu, histerektomija, podvezovanje jajcevodov, popolna abstinenca, metode z uporabo fizične pregrade, maternični vložek [IUD], in/ali sterilizacija ženske ali moškega).
English: Votubia exists as tablets and dispersible tablets.
Slovenian: Zdravilo Votubia je na voljo kot tablete in kot disperzibilne tablete.
English: Renal impairment No dose adjustment is required (see section 5.2).
Slovenian: Okvara ledvic Prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: A total of 118 patients were randomised, 79 to Votubia 10 mg daily and 39 to placebo.
Slovenian: V dve skupini je bilo randomiziranih skupno 118 bolnikov, 79 v skupino, ki je prejemala zdravilo Votubia v odmerku 10 mg na dan, 39 pa v skupino, ki je prejemala placebo.
English: Votubia is not to be used in children below the age of 2 years with TSC and seizures.
Slovenian: Zdravila Votubia se ne sme uporabljati pri otrocih, ki so stari manj kot 2 leti in imajo tuberozno sklerozo in epileptične napade.
English: Votubia with food and drink Avoid grapefruit and grapefruit juice while you are on Votubia.
Slovenian: Zdravilo Votubia skupaj s hrano in pijačo V času zdravljenja z zdravilom Votubia ne uživajte grenivk ali soka grenivk.
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.
Slovenian: Če predpisani odmerek presega 10 mg ali ga morate pripraviti z uporabo več kot 5 disperzibilnih tablet, ponovite korake od 2 do 17 in tako zaužijte odmerek do konca.
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.
Slovenian: Če predpisani odmerek presega 10 mg ali ga morate pripraviti z uporabo več kot 5 disperzibilnih tablet, ponovite korake od 2 do 10 in tako zaužijte odmerek do konca.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors
Slovenian: Sočasna uporaba zaviralcev angiotenzinske konvertaze
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 7]).
Slovenian: Po 6 mesecih se je volumen primarnega SEGA zmanjšal v primerjavi z izhodiščno vrednostjo (p<0,001 [glejte preglednico 7]).
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.
Slovenian: Zmanjšanje se je ohranjalo, kar je bilo opazno v 24. tednu: pri 41,9 % bolnikov (31/74) je prišlo do najmanj 50-odstotnega zmanjšanja in pri 78,4 % bolnikov (58/74) do najmanj 30-odstotnega zmanjšanja volumna SEGA.
English: Votubia will only be prescribed by a doctor with experience in treating patients with SEGA or seizures and with access to blood tests which will measure how much Votubia is in your blood.
Slovenian: Zdravilo Votubia vam lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem bolnikov s subependimskim gigantoceličnim astrocitomom ali epileptičnimi napadi in ima možnost izvajanja krvnih preiskav, s katerimi lahko določi, koliko zdravila Votubia je v vaši krvi.
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.
Slovenian: Mediana trajanja slepe študije je znašala 52,2 tedna (v razponu od 24 do 89) pri bolnikih, ki so prejemali zdravilo Votubia, in 46,6 tedna (v razponu od 14 do 88 ) pri tistih, ki so prejemali placebo.
English: • CRAD001C2485: This was a prospective, open-label, single-arm phase II study of everolimus in patients with SEGA (n=28).
Slovenian: • CRAD001C2485: To je bila prospektivna, odprta študija everolimusa faze II pri eni skupini bolnikov s SEGA (n=28).
English: A population pharmacokinetic analysis including 111 patients with SEGA who ranged from 1.0 to 27.4 years (including 18 patients 1 to less than 3 years of age with BSA 0.42 m to 0.74 m 2) showed that BSA-normalised clearance is in general higher in younger patients.
Slovenian: Populacijska farmakokinetična analiza, ki je vključevala podatke 111 bolnikov s SEGAv starosti od 1,0 do 27,4 leta (vključno z 18 bolniki, ki so bili stari od 1 leta do manj kot 3 leta in so imeli telesno površino od 0,42 m do 0,74 m2), je pokazala, da je na telesno površino normaliziran očistek pri mlajših bolnikih praviloma večji.
English: Presence of at least one angiomyolipoma ≥3 cm in longest diameter using CT/MRI (based on local radiology assessment) was required for entry.
Slovenian: Za vključitev je bila potrebna prisotnost najmanj enega angiomiolipoma, katerega najdaljši premer je znašal 3 cm ali več, kar so izmerili z uporabo CT/MRI (na osnovi lokalne radiološke ocene).
English: Table 4 shows the incidence of adverse reactions based on pooled data of patients receiving everolimus in the three TSC studies (including both the double-blind and open-label extension phase, where applicable).
Slovenian: V preglednici 4 so prikazane incidence neželenih učinkov, ki temeljijo na zbranih podatkih bolnikov, ki so prejemali everolimus v treh TSC študijah (vključno z obdobji dvojno slepega zdravljenja in obdobji odprtega podaljšanja, kjer je bilo to izvedeno).
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 8]).
Slovenian: Po 6 mesecih se je volumen primarnega SEGA zmanjšal v primerjavi z izhodiščno vrednostjo (p<0,001 [glejte preglednico 8]).
English: Table 3 shows the incidence of adverse reactions based on pooled data of patients receiving everolimus in the three TSC studies (including both the double-blind and open-label extension phase, where applicable).
Slovenian: V preglednici 3 so prikazane incidence neželenih učinkov, ki temeljijo na zbranih podatkih bolnikov, ki so prejemali everolimus v treh TSC študijah (vključno z obdobji dvojno slepega zdravljenja in obdobji odprtega podaljšanja, kjer je bilo to izvedeno).
English: Table 1 Votubia starting dose for patients with TSC and refractory seizures
Slovenian: Preglednica 1 Začetni odmerek zdravila Votubia za bolnike s tuberozno sklerozo in neodzivno epilepsijo
English: Therapeutic drug monitoring of everolimus blood concentrations, using a validated assay, is required.
Slovenian: Potrebno je terapevtsko spremljanje uporabe zdravila, in sicer spremljanje koncentracije everolimusa v krvi z validiranim testom.
English: If the dose of your anti-seizure medicine changes, please inform your doctor.
Slovenian: Ob spremembi odmerka antiepileptika obvestite svojega zdravnika.
English: Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment.
Slovenian: Če se pri bolniku status jeter (glede na razrede po Child-Pughovi lestvici) med zdravljenjem spremeni, je treba odmerke prilagoditi.
English: Everolimus whole blood trough concentrations should be assessed at least 1 week after any change in hepatic status (Child-Pugh).
Slovenian: Najnižjo koncentracijo everolimusa v polni krvi pred naslednjim odmerjanjem je treba izmeriti najmanj 1 teden po kakršni koli spremembi statusa jeter (glede na razrede po Child-Pughovi lestvici).
English: A single-arm study in postmenopausal breast cancer patients treated with Afinitor (everolimus) 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).
Slovenian: Po podatkih študije z eno študijsko skupino pri pomenopavzalnih bolnicah z rakom dojke, ki so prejemale zdravilo Afinitor (everolimus) skupaj z eksemestanom, lahko kortikosteroidna oralna raztopina brez alkohola, ki jo bolniki uporabljajo kot raztopino za izpiranje ust v prvih 8 tednih zdravljenja, zmanjša pogostnost in izraženost stomatitisa (glejte poglavje 5.1).
English: Reported experience with overdose in humans is very limited.
Slovenian: Opisanih je zelo malo izkušenj s prevelikim odmerjanjem pri ljudeh.
English: The most frequent grade 3-4 adverse reactions (incidence ≥1%) were pneumonia, stomatitis, amenorrhoea, neutropenia, pyrexia, menstruation irregular, hypophosphataemia, diarrhoea, and cellulitis.
Slovenian: Najpogostejši neželeni učinki 3.- 4. stopnje (pojavnost ≥1 %) so bili pljučnica, stomatitis, amenoreja, nevtropenija, zvišana telesna temperatura, neredne menstruacije, flegmona in hipofosfatemija.
English: Everolimus trough concentrations should be assessed at least 1 week after the addition of a moderate CYP3A4 or PgP inhibitor.
Slovenian: Najnižjo koncentracijo everolimusa pred naslednjim odmerjanjem je treba izmeriti najmanj 1 teden po uvedbi dodatnega zdravljenja z zmernim zaviralcem CYP3A4 ali P-glikoproteina.
English: HT target of 9-15 ng/ml
Slovenian: HT ciljna koncentracija 9-15 ng/ml
English: 94.0% had skin lesions at baseline and 37.6% had target renal angiomyolipoma lesions (at least one angiomyolipoma ≥1 cm in longest diameter).
Slovenian: 94,0 % jih je imelo ob izhodišču kožne spremembe, 37,6 % pa jih je imelo ciljne lezije ledvičnih angiomiolipomov (najmanj en angiomiolipom z najdaljšim premerom najmanj 1 cm).
English: Votubia is indicated for the treatment of adult and paediatric patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.
Slovenian: Zdravilo Votubia je indicirano za zdravljenje odraslih in pediatričnih bolnikov, ki imajo subependimski gigantocelični astrocitom (SEGA) v povezavi s tuberozno sklerozo, pri katerih je potreben zdravstveni poseg, vendar jih ni mogoče operirati.
English: Caution is advised in patients taking Votubia, particularly during concomitant use with active substances known to affect platelet function or that can increase the risk of haemorrhage as well as in patients with a history of bleeding disorders.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Votubia, je priporočena previdnost, zlasti pri sočasni uporabi z učinkovinami, za katere je znano, da vplivajo na delovanje trombocitov ali povečujejo tveganje za krvavitev.
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 5 mg (an increase of 2.5 mg from the current daily dose).
Slovenian: Da bi dosegli ciljno koncentracijo, ki presega spodnjo mejo Cmin 5 ng/ml, na primer ciljno koncentracijo 8 ng/ml, mora biti novi odmerek everolimusa 5 mg (kar pomeni zvišanje trenutnega dnevnega odmerka za 2,5 mg).
English: The suspension must be administered immediately after preparation.
Slovenian: Suspenzijo je treba zaužiti takoj po pripravi.
English: Concomitant antiepileptic therapy may affect the metabolism of everolimus and may contribute to this variance (see section 4.5).
Slovenian: K temu lahko prispeva tudi sočasno zdravljenje z antiepileptiki, ki lahko vplivajo na metabolizem everolimusa (glejte poglavje 4.5).
English: Dosing recommendations for paediatric patients with SEGA are consistent with those for the adult SEGA population, except for patients in the range from 1 year to less than 3 years of age, and those with hepatic impairment (see section “Hepatic impairment” below and section 5.2).
Slovenian: Priporočila za odmerjanje pri pediatričnih bolnikih s SEGA so enaka kot pri odrasli populaciji s SEGA, razen pri bolnikih, ki so stari od 1 leta do manj kot 3 leta, ter pri tistih z okvaro jeter (glejte poglavje “Okvara jeter” spodaj in poglavje 5.2).
English: Estimated progression-free rates at 6 months were 100% for the Votubia arm and 85.7% for the placebo arm.
Slovenian: Ocenjeni delež bolnikov brez napredovanja bolezni po 6 mesecih je v skupini z zdravilom Votubia znašal 100 %, v skupini s placebom pa 85,7 %.
English: Instructions for caregivers preparing the suspension using an oral syringe:
Slovenian: Navodila za negovalce, ki pripravljajo suspenzijo z uporabo brizge za peroralno dajanje zdravila
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.
Slovenian: Mediana starost je znašala 31 let (v razponu od 18 do 61 let; 46,6 % jih je bilo ob vključitvi mlajših od 30 let), 33,9 % jih je bilo moškega spola, 89,0 % pa jih je bilo bele rase.
English: These metabolites were also identified in animal species used in toxicity studies, and showed approximately 100 times less activity than everolimus itself.
Slovenian: Pokazalo se je, da imajo ti metaboliti približno 100-krat manjšo aktivnost kot sam everolimus.
English: The everolimus trough concentrations should be assessed 2 to 4 weeks later since the natural degradation time of the induced enzymes has to be taken into account (see sections 4.2 and 4.4).
Slovenian: Približno 2 do 4 tedne po tem je treba izmeriti najnižjo koncentracijo everolimusa pred naslednjim odmerjanjem, upoštevati je namreč treba čas, ki je potreben za razgradnjo induciranih encimov (glejte poglavji 4.2 in 4.4).
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 8 mg (an increase of 4 mg from the current daily dose).
Slovenian: Da bi dosegli ciljno koncentracijo, ki presega spodnjo mejo Cmin 5 ng/ml, na primer ciljno koncentracijo 8 ng/ml, mora biti novi odmerek everolimusa 8 mg (kar pomeni zvišanje trenutnega dnevnega odmerka za 4 mg).
English: If concentrations are below 5 ng/ml, the daily dose may be increased by 2.5 mg every 2 weeks, checking the trough level and assessing tolerability before increasing the dose.
Slovenian: Če je ta koncentracija pod 5 ng/ml, je treba dnevni odmerek zviševati za 2,5 mg vsaka 2 tedna z ozirom na najnižjo koncentracijo pred naslednjim odmerjanjem in prenašanje zdravila pred zvišanjem odmerka.
English: Table 1 summarises dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Slovenian: Preglednica 1 povzema priporočila za prilagajanje odmerka pri posameznih neželenih učinkih (glejte tudi poglavje 4.4).
English: If you miss a dose, take your next dose as scheduled.
Slovenian: Če pozabite vzeti odmerek, vzemite naslednji odmerek, ko bo čas za to po običajnem urniku.
English: The dispersible tablets must not be broken or crushed.
Slovenian: Disperzibilnih tablet se ne sme lomiti ali drobiti.
English: Table 7 Change in primary SEGA volume over time
Slovenian: Preglednica 7 Časovni potek spreminjanja volumna primarnega SEGA