FrancophonIA/ELRC3.0 huggingface dataset:
English: Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Croatian: Stupanj 3 Privremeni prekid primjene do oporavka do stupnja 2 (≥1,25x10
English: In rats, everolimus caused embryo/foetotoxicity at systemic exposure below the therapeutic level.
Croatian: U štakora izloženih sistemskim dozama nižim od terapijskih, everolimus se pokazao embrio/fetotoksičnim.
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).
Croatian: Progresije su uočene samo u skupini koja je primala placebo (15,4%; p=0,0002).
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.
Croatian: Kako Votubia tablete za oralnu suspenziju izgledaju i sadržaj pakiranja Votubia 1 mg tablete za oralnu suspenziju su bijele do žućkaste, okrugle, plosnate tablete ukošenoga ruba bez ureza.
English: A total of 10 mg of Votubia dispersible tablets per syringe using a maximum of 5 dispersible tablets must not be exceeded.
Croatian: Paziti da se ne premaši doza od ukupno 10 mg Votubia tableta za oralnu suspenziju po štrcaljki koristeći maksimalno 5 tableta za oralnu suspenziju.
English: Efficacy, safety, concomitant therapy, and the current trough concentration should be considered when planning for dose titration.
Croatian: Prilikom planiranja titriranja doze, potrebno je uzeti u obzir djelotvornost, sigurnost primjene, istodobno primjenjivanu terapiju i trenutnu najnižu koncentraciju.
English: Baseline n=28
Croatian: Početno n=28
English: Starting dose without co-administration of CYP3A4/PgP inducer
Croatian: Početna doza bez istodobne primjene induktora CYP3A4/PgP-a
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).
Croatian: • EXIST-2 (CRAD001M2302): Ovo je bilo randomizirano, dvostruko slijepo, kontrolirano ispitivanje faze III u kojem se ispitivao everolimus (n=79) u usporedbi s placebom (n=39) u bolesnika oboljelih bilo od KTS-a i angiomiolipoma bubrega (n=113) ili od sporadične limfangiolejomiomatoze i angiomiolipoma bubrega (n=5).
English: Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see section “Infections” below).
Croatian: Pneumocystis jirovecii (carinii) (PJP, PCP) (vidjeti dio „Infekcije“ niže u tekstu).
English: Excipient with known effect Each dispersible tablet contains 1.96 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta za oralnu suspenziju sadrži 1,96 mg laktoze.
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).
Croatian: Preporuke za doziranje u pedijatrijskih bolesnika sa SEGA-om su usklađene s onima za odraslu populaciju sa SEGA-om, osim za bolesnike u rasponu dobi od 1 godine do mlađe od 3 godine te u onih s oštećenjem jetre (vidjeti dio „Oštećenje funkcije jetre“ u nastavku i dio 5.2).
English: if you need to receive a vaccine while taking Votubia as vaccination may be less effective.
Croatian: ako se trebate cijepiti tijekom liječenja Votubiom, jer učinkovitost cijepljenja u tom slučaju može biti smanjena.
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).
Croatian: Kumulativni medijan trajanja izloženosti Votubii (361 bolesnik koji je uzeo barem jednu dozu everolimusa) bio je 30,4 mjeseci (raspon od 0,5 do
English: Dispersible tablet.
Croatian: Tableta za oralnu suspenziju.
English: Mouth pain
Croatian: Bol u ustima
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml as described below.
Croatian: Dozu Votubie se mora titrirati na način da se postigne najniža koncentracija lijeka od 5 do 15 ng/ml kako je opisano u nastavku.
English: Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis
Croatian: Konstipacija, mučnina, bol u abdomenu, flatulencija, bol u ustima, gastritis Poremećaji kože i potkožnog tkiva
English: Excipient with known effect Each tablet contains 149 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 149 mg laktoze.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „LCL“, a na drugoj oznaka „NVR“.
English: Votubia 2.5 mg tablets everolimus
Croatian: Votubia 2,5 mg tablete everolimus
English: Insomnia, aggression, irritability Nervous system disorders Very common Headache Uncommon Dysgeusia Vascular disorders Very common Hypertension Common
Croatian: Insomnija, agresivnost, razdražljivost Poremećaji živčanog sustava Vrlo često
English: 30 x 1 tablets 100 x 1 tablets
Croatian: 30 x 1 tableta 100 x 1 tableta
English: Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Croatian: Votubia 10 mg tablete su bijele do žućkaste izdužene tablete.
English: Take Votubia dispersible tablets as a suspension only.
Croatian: Važne informacije: Votubia tablete za oralnu suspenziju uzimajte samo u obliku suspenzije.
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).
Croatian: Votubia je pokazala klinički značajna poboljšanja u odgovoru kožnih lezija (p=0,0004), sa stopama odgovora od 41,7% (95% CI: 30,2, 53,9) za skupinu koja je primala Votubiu i 10,5% (95% CI: 2,9, 24,8) za skupinu koja je primala placebo.
English: Votubia 10 mg tablets everolimus
Croatian: Votubia 10 mg tablete everolimus
English: Votubia exists as tablets and dispersible tablets.
Croatian: Postoje Votubia tablete i Votubia tablete za oralnu suspenziju.
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.
Croatian: Procijenjene stope bez progresije nakon 6 mjeseci bile su 98,4% za skupinu koja je primala everolimus i 83,4% za placebo skupinu.
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets
Croatian: Votubia 2,5 mg tablete Votubia 5 mg tablete
English: and 5.2).
Croatian: (vidjeti dio 4.2).
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) and viral infections including reactivation of hepatitis B virus, have been described in patients taking everolimus.
Croatian: Lokalizirane i sistemske infekcije, uključujući upalu pluća, druge bakterijske infekcije, invazivne gljivične infekcije, kao što je aspergiloza, kandidijaza ili pneumonija koju uzrokuje
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.
Croatian: CYP3A4 i PgP induktori snižavaju koncentraciju everolimusa Tvari koje induciraju CYP3A4 ili PgP mogu sniziti koncentraciju everolimusa u krvi povećanjem metabolizma everolimusa ili njegovog izbacivanja iz stanica crijeva.
English: Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
Croatian: Pneumocystis jirovecii (carinii) (PJP, PCP) i virusne infekcije uključujući reaktivaciju hepatitis B virusa, opisane su u bolesnika koji su uzimali everolimus.
English: Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Croatian: Jedna Votubia 2,5 mg tableta sadrži 2,5 mg everolimusa.
English: Urinary tract infection
Croatian: Infekcija mokraćnog sustava
English: Switching pharmaceutical forms
Croatian: Prelazak s jednog farmaceutskog oblika na drugi
English: Table 6 EXIST-3 - Seizure frequency response rate by age
Croatian: Tablica 6 EXIST-3 - Stopa odgovora s obzirom na učestalost napadaja prema dobi
English: AUC ↑3.5-fold (range 2.2-6.3) Cmax ↑2.3-fold (range1.3-3.8)
Croatian: AUC ↑3,5-puta (raspon 2,2-6,3) Cmax ↑2,3-puta (raspon 1,3-3,8)
English: Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Croatian: Votubia 5 mg tablete su bijele do žućkaste izdužene tablete.
English: Being sick (vomiting)
Croatian: Poremećaj spavanja (nesanica)
English: Dispersible tablet
Croatian: Tableta za oralnu suspenziju
English: Dexamethasone
Croatian: Deksametazon
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).
Croatian: Stope odgovora bile su 34,6% (95% CI: 24,2, 46,2) za skupinu koja je primala Votubiu, u usporedbi s 0% (95% CI: 0,0, 9,0) za skupinu koja je primala placebo (Tablica 6).
English: Each Votubia 10 mg tablet contains 10 mg of everolimus.
Croatian: Jedna Votubia 10 mg tableta sadrži 10 mg everolimusa.
English: Votubia 5 mg tablets
Croatian: Votubia 5 mg tablete
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Croatian: U rasponu doza od 5 do 10 mg, Cmax je razmjeran primijenjenoj dozi.
English: Dry skin, acneiform dermatitis, pruritus, alopecia Uncommon Angioedema Musculoskeletal and connective tissue disorders Uncommon Rhabdomyolysis Renal and urinary disorders Common
Croatian: Suha koža, akneiformni dermatitis, pruritus, alopecija Manje često Angioedem Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često Rabdomioliza Poremećaji bubrega i mokraćnog sustava Često
English: If the patient does not drink it within 30 minutes if an oral syringe has been used or within 60 minutes if a small glass has been used, throw it away and prepare a new suspension.
Croatian: Ako je bolesnik ne popije unutar 30 minuta od pripreme ako je korištena štrcaljka za usta ili unutar 60 minuta od pripreme ako je korištena mala čaša, bacite ju i pripremite novu suspenziju.
English: Each tablet contains 2.5 mg everolimus.
Croatian: Jedna tableta sadrži 2,5 mg everolimusa.
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).
Croatian: Stope odgovora bile su 34,6% (95% CI: 24,2, 46,2) za skupinu koja je primala Votubiu, u usporedbi s 0% (95% CI: 0,0, 9,0) za skupinu koja je primala placebo (Tablica 7).
English: 10 x 1 tablets
Croatian: 10 x 1 tableta
English: 30 x 1 tablets
Croatian: 30 x 1 tableta
English: Reduction from baseline in seizure frequency (%)
Croatian: Smanjenje napadaja u odnosu na početnu vrijednost (%)
English: This is because these can also be affected by Votubia.
Croatian: Ovo je stoga što Votubia može utjecati na sve gore navedeno.
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered.
Croatian: Votubia se može iznova započeti u dnevnoj dozi približno 50% nižoj od prethodno primjenjivane.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Croatian: Votubia 1 mg tablete za oralnu suspenziju Votubia 2 mg tablete za oralnu suspenziju Votubia 3 mg tablete za oralnu suspenziju Votubia 5 mg tablete za oralnu suspenziju everolimus
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
Croatian: Pakiranja sadrže 10 x 1, 30 x 1 ili 100 x 1 tabletu.
English: Votubia 2.5 mg tablets
Croatian: Votubia 2,5 mg tablete
English: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin
Croatian: Ritonavir, atazanavir, sakvinavir, darunavir, indinavir, nelfinavir
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.
Croatian: Subependymal Giant Cell Astrocytoma) povezanim s kompleksom tuberozne skleroze (KTS), u kojih je nužna terapijska intervencija, a nisu podobni za kirurški zahvat.
English: If the suspension is not used within 60 minutes, throw it away and prepare a new suspension.
Croatian: Ako se suspenzija ne popije unutar 60 minuta od pripreme, bacite ju i pripremite novu.
English: Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta za oralnu suspenziju sadrži 0,98 mg laktoze.
English: Votubia 5 mg tablets everolimus
Croatian: Votubia 5 mg tablete everolimus
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets
Croatian: Votubia 1 mg tablete za oralnu suspenziju Votubia 2 mg tablete za oralnu suspenziju Votubia 3 mg tablete za oralnu suspenziju Votubia 5 mg tablete za oralnu suspenziju
English: Respiratory, thoracic and mediastinal disorders Very common Cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često
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.
Croatian: Ispitivanje faze III u bolesnika oboljelih od SEGA-e EXIST-1 (ispitivanje CRAD001M2301), randomizirano, dvostruko slijepo, multicentrično ispitivanje faze III u kojem se ispitivala Votubia u usporedbi s placebom, provedeno je u bolesnika oboljelih od SEGA-e, bez obzira na dob.
English: You will have blood tests before and periodically during treatment.
Croatian: Prije početka, a i redovito tijekom liječenja, bit ćete upućeni na krvne pretrage.
English: Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Croatian: Uključuje (vrlo često) osip; (često) eritematozni osip, eritem i (manje često) generalizirani osip, makulopapularni osip, makularni osip d
English: Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Croatian: Manje često Herpes zoster, sepsa, virusni bronhitis Poremećaji krvi i limfnog sustava
English: Hold the oral syringe with the tip pointing upwards.
Croatian: Primite štrcaljku za usta tako da je vrh okrenut prema gore.
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).
Croatian: 8 ng/ml, nova doza everolimusa bila bi 8 mg (povećanje od 4 mg u odnosu na sadašnju dnevnu dozu).
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported in patients taking Votubia.
Croatian: U bolesnika koji uzimaju Votubiu prijavljena je dislipidemija (uključujući hiperkolesterolemiju i hipertrigliceridemiju).
English: For patients with renal angiomyolipoma associated with TSC:
Croatian: Za bolesnike s angiomiolipomom bubrega povezanim s KTS-om:
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)
Croatian: Visoka razina lipida (masnoća) u krvi (hiperlipidemija, povišeni trigliceridi) Niska razina fosfata u krvi (hipofosfatemija)
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.
Croatian: Ako se ne popije unutar 30 minuta od pripreme kada se koristi štrcaljka za usta ili unutar 60 minuta kada se koristi mala čaša, suspenzija se mora baciti i mora se pripremiti nova suspenzija.
English: Cellulose microcrystalline Silica colloidal anhydrous
Croatian: A manitol celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni
English: Packs containing 30 x 1 or 100 x 1 tablets.
Croatian: Pakiranja sadrže 30 x 1 ili 100 x 1 tabletu.
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma of cancer patients given Votubia 10 mg/day.
Croatian: U bolesnika oboljelih od raka liječenih Votubiom u dozi od 10 mg/dan, približno 20% koncentracije everolimusa u punoj krvi bilo je ograničeno na plazmu.
English: impact your kidney function.
Croatian: Oštećenje funkcije bubrega
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome (see section 4.4).
Croatian: Pneumocystis jirovecii (carinii) (PJP, PCP), od kojih su neki imali smrtni ishod (vidjeti dio 4.4).
English: Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta za oralnu suspenziju sadrži 4,90 mg laktoze.
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.
Croatian: Ako ju ne popijete unutar 30 minuta od pripreme ako koristite štrcaljku za usta ili unutar 60 minuta od pripreme ako koristite malu čašu, bacite ju i pripremite novu suspenziju.
English: Stomach upset like feeling sick (nausea)
Croatian: Nelagoda u želucu (mučnina)
English: Packs containing 30 x 1 dispersible tablets.
Croatian: Pakiranja sadrže 30 x 1 tabletu za oralnu suspenziju.
English: Each tablet contains 10 mg everolimus.
Croatian: Jedna tableta sadrži 10 mg everolimusa.
English: Each Votubia 5 mg tablet contains 5 mg of everolimus.
Croatian: Jedna Votubia 5 mg tableta sadrži 5 mg everolimusa.
English: Consider re-initiating Votubia at approximately 50% lower than the daily dose previously administered.
Croatian: Razmotriti ponovno započinjanje primjene Votubie u dozi koja je otprilike 50% niža od prethodno primjenjivane dnevne doze.
English: Blood lipids
Croatian: Lipidi u krvi
English: ANNEX III
Croatian: Dublin 4
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported in patients treated with Votubia (see section 4.8).
Croatian: U bolesnika liječenih Votubiom prijavljeno je povišenje kreatinina u serumu, obično blago, te proteinurija (vidjeti dio 4.8).
English: Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta za oralnu suspenziju sadrži 2,94 mg laktoze.
English: Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Croatian: Jedna Votubia 1 mg tableta za oralnu suspenziju sadrži 1 mg everolimusa.
English: Starting dose with co-administration of CYP3A4/PgP inducer
Croatian: Početna doza uz istodobnu primjenu induktora CYP3A4/PgP-a
English: Metabolism and nutrition disorders Very common Decreased appetite, hypercholesterolaemia Common
Croatian: Smanjeni apetit, hiperkolesterolemija
English: If you do not use it within 30 minutes, throw it away and prepare a new suspension.
Croatian: Ako ne uzmete suspenziju unutar 30 minuta od pripreme, bacite ju i pripremite novu.
English: Each tablet contains 5 mg everolimus.
Croatian: Jedna tableta sadrži 5 mg everolimusa.
English: Each Votubia 2 mg dispersible tablet contains 2 mg of everolimus.
Croatian: Jedna Votubia 2 mg tableta za oralnu suspenziju sadrži 2 mg everolimusa.
English: cause shortness of breath, cough and fever (see section 4 ‘Possible side effects').
Croatian: Stoga će Vam liječnik pratiti funkciju bubrega dok uzimate Votubiu. uzrokovati nedostatak zraka, kašalj i vrućicu (pogledajte dio 4. „Moguće nuspojave“).
English: Adding the dispersible tablets
Croatian: Dodavanje tableta za oralnu suspenziju
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.
Croatian: Votubia 1 mg tablete za oralnu suspenziju dostupne su u pakiranjima od 30 tableta za oralnu suspenziju u perforiranim blisterima s jediničnim dozama koji sadrže 10 x 1 tabletu.
English: Each Votubia 3 mg dispersible tablet contains 3 mg of everolimus.
Croatian: Jedna Votubia 3 mg tableta za oralnu suspenziju sadrži 3 mg everolimusa.
English: Re-initiate Votubia at approximately 50% lower than the daily dose previously administered.
Croatian: Ponovno započeti primjenu Votubie u dozi koja je otprilike 50% niža od prethodno primjenjivane dnevne doze.
English: Menorrhagia, ovarian cyst, vaginal haemorrhage Uncommon Menstruation delayed d
Croatian: Amenoreja d, neredovita menstruacija d
English: Prophylaxis for PJP/PCP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required.
Croatian: Kada je potrebna istodobna primjena kortikosteroida ili drugih imunosupresiva, potrebno je razmotriti profilaksu za PJP/PCP.
English: BSA = (W
Croatian: PT = (T
English: Primary analysis for double blind period
Croatian: U vrijeme primarne analize
English: Votubia 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Croatian: Votubia 2 mg tablete za oralnu suspenziju su bijele do žućkaste, okrugle, plosnate tablete ukošenoga ruba bez ureza.
English: Making sure all of the medicine has been taken
Croatian: Pobrinite se da je uzet cijeli sadržaj lijeka 12.
English: A prospective, open-label, single-arm phase II study (Study CRAD001C2485) was conducted to evaluate the safety and efficacy of Votubia in patients with SEGA.
Croatian: U svrhu utvrđivanja sigurnosti primjene i djelotvornosti Votubie u oboljelih od SEGA-e, provedeno je prospektivno otvoreno ispitivanje faze II s jednom skupinom (ispitivanje CRAD001C2485).
English: A limited number of paediatric patients have been exposed to doses higher than 10 mg/m 2/day.
Croatian: Doze lijeka više od 10 mg/m2/dan primio je tek ograničen broj pedijatrijskih bolesnika.
English: They are engraved with “5” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „5“, a na drugoj oznaka „NVR“.
English: Removing air
Croatian: Uklanjanje zraka iz štrcaljke
English: They are engraved with “UHE” on one side and “NVR” on the other.
Croatian: Na jednoj strani utisnuta je oznaka „UHE“, a na drugoj oznaka „NVR“.
English: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Croatian: Angiomiolipom bubrega povezan s kompleksom tuberozne skleroze
English: Votubia 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Croatian: Votubia 5 mg tablete za oralnu suspenziju su bijele do žućkaste, okrugle, plosnate tablete ukošenoga ruba bez ureza.
English: If you receive Votubia for the treatment of TSC with SEGA, 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: Ako uzimate Votubiu za liječenje KTS-a sa SEGA-om, dozu Votubie koju morate uzimati odredit će Vaš liječnik na temelju:
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.
Croatian: Bijele do žućkaste, izdužene tablete dimenzija približno 10,1 x 4,1 mm, ukošenoga ruba bez ureza, s utisnutom oznakom „LCL“ na jednoj te oznakom „NVR“ na drugoj strani.