natgillin/translations-raw huggingface dataset:
Den mediane kumulative eksponeringsvarighed for Votubia (361 patienter, der tog mindst én dosis everolimus) var 30,4 måneder (interval 0,5 til 48,8). 
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).
Nasopharyngitis, infektion i øvre luftveje, pneumoni a, urinvejsinfektion, sinuitis, 
Infections and infestations Very common Nasopharyngitis, upper respiratory tract infection, pneumonia a, urinary tract infection, sinusitis, pharyngitis
Den mediane kummulative eksponeringsvarighed for Votubia (112 patienter, der tog mindst en dosis everolimus) var 46,9 måneder (interval 0,5 til 63,9). 
The cumulative median duration of exposure to Votubia (112 patients who took at least one dose of everolimus) was 46.9 months (range 0.5 to 63.9).
Anbefalinger vedrørende administration samtidig med andre lægemidler 
Recommendations concerning co-administration
Fald i hæmoglobin, lymfocytter, neutrofile granulocytter og trombocytter er rapporteret hos patienter i behandling med Votubia (se pkt. 
Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Omsorgspersoner bør undgå kontakt med Votubia-suspensionen. 
Caregivers are advised to avoid contact with suspensions of Votubia tablets.
Baseline-data indikerede let til moderat mental retardering hos 6- til 18-årige patienter (scorer på 60-70 iht. 
The baseline data indicated mild to moderate mental retardation in patients 6-18 years of age (scores of 60-70 on the Adaptive Behavior Composite and Communication, Daily Living Skills, and Socialization Domain Scores).
Cellulose, mikrokrystallinsk Silica, kolloid vandfri 
Cellulose microcrystalline Silica colloidal anhydrous
Måned 60 n=23 
Month 60 n=23
Almindelig Obstipation, kvalme, abdominalsmerter, flatulens, oral smerte, gastritis Hud og subkutane væv 
Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis
Hos patienter, der samtidig behandles med en ACE-hæmmer (fx ramipril), kan der være forhøjet risiko for angioødem (se pkt. 
Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
AUC ↑15,3 gange (interval 11,2-22,5) Cmax ↑4,1 gange (interval 2,6-7,0) 
AUC ↑15.3-fold (range 11.2-22.5) Cmax ↑4.1-fold (range 2.6-7.0)
HT-målniveau 9-15 nanogram/ml 
HT target of 9-15 ng/ml
CYP3A4- og PgP-hæmmeres øgning af everolimus-koncentrationer 
CYP3A4 and PgP inhibitors increasing everolimus concentrations
Stomatitis er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Votubia (se pkt. 
Stomatitis is the most commonly reported adverse reaction in patients treated with Votubia (see sections 4.4 and 4.8).
Etnisk tilhørsforhold 
Ethnicity
Opbevar lægemidlet utilgængeligt for børn. 
Keep the medicine out of the reach of children.
Hvis behandling med en induktor afbrydes, bør en udvaskningsperiode på mindst 3-5 dage (passende tid til ophør af signifikant udtalt enzyminduktion) overvejes, før behandlingen fortsætter med den Votubia-dosis, der blev anvendt før initiering af kombinationsbehandlingen (se også ”Terapeutisk lægemiddel-monitorering” i pkt. 
If treatment with the inducer is 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 (see also Therapeutic drug monitoring in section 4.2).
Butylhydroxytoluen (E321) Magnesiumstearat Lactosemonohydrat Hypromellose Crospovidon type A Mannitol 
Butylated hydroxytoluene (E321) Magnesium stearate Lactose monohydrate Hypromellose
Den anbefalede dosis til pædiatriske patienter med anfald svarer til dosis hos voksne med undtagelse af børn i intervallet fra 2 år til under 6 år og børn med nedsat leverfunktion (se afsnittet om ”Nedsat leverfunktion” nedenfor og pkt. 
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).
Patienter med renal angiomyolipom forbundet med TSC: 
For patients with renal angiomyolipoma associated with TSC:
Hvis den moderate hæmmer seponeres, bør en udvaskningsperiode på mindst 2-3 dage (gennemsnitlig eliminationstid for de hyppigst anvendte moderate hæmmere) overvejes, før behandlingen fortsætter med den Votubia-dosis, der blev anvendt før initiering af kombinationsbehandlingen. 
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.
Dosisanbefalinger for pædiatriske patienter med SEGA stemmer overens med anbefalingerne for voksne med SEGA, bortset fra for patienter mellem 1 år til under 3 år og patienter med nedsat nyrefunktion (se afsnitted om ”Nedsat nyrefunktion” nedenfor og pkt. 
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).
Midlertidig behandlingspause indtil bedring til Grad 2 (≥1x10 
Temporary dose interruption until recovery to Grade 2 (≥1x10
LT-målniveau 3-7 nanogram/ml 
LT target of 3-7 ng/ml
Andre symptomer kan omfatte ændret nyrefunktionstest (stigning i kreatinin) Symptomer på hjertesvigt såsom åndenød, vejrtrækningsbesvær, når du ligger ned, hævelse af fødder eller ben 
Symptoms of heart failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
Titrering 
Titration
Øvrige indholdsstoffer: butyleret hydroxytoluen (E 321), magnesiumstearat, lactosemonohydrat, hypromellose, crospovidon type A og vandfri lactose. 
The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Aggressiv adfærd 
Aggression
Almindelig Otitis media, cellulitis, streptokok-faryngitis, viral gastroenteritis, gingivitis Ikke almindelig 
Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Almindelig Overfølsomhed 
Hypersensitivity
Det primære endepunkt var ændring i SEGA-volumen i løbet af den centrale 6 måneder lange behandlingsfase, vurderet ved uafhængig central radiologisk gennemgang. 
Change in SEGA volume during the core 6-month treatment phase, as assessed via an independent central radiology review, was the primary efficacy endpoint.
Forværring 
Exacerbation
Hvis toksiciteten ikke tolereres, pauseres behandlingen indtil bedring til Grad 1. 
If toxicity becomes intolerable, temporary dose interruption until recovery to Grade 1.
Indholdet omrøres forsigtigt med en ske lige inden administration. 
The contents should be gently stirred with a spoon and then administered immediately.
Hvis alle potente induktorer seponeres, bør en udvaskningsperiode på mindst 3-5 dage (passende tid til ophør af signifikant udtalt enzyminduktion) overvejes, før behandlingen fortsætter med den Votubia-dosis, der blev anvendt før initiering af kombinationsbehandlingen. 
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.
Hovedpine, tryk i øjet, næsen eller kinderne (tegn på betændelse i bihulerne og næsepassagen, også kendt som bihulebetændelse) 
Headache, pressure in the eyes, nose or cheek area (signs of inflammation of the sinuses and nasal passages, also known as sinusitis)
Hold den orale sprøjte, så spidsen peger opad. 
Hold the oral syringe with the tip pointing upwards.
Hvis du ikke bruger den inden for 30 minutter, skal du kassere den og lave en ny suspension. 
If you do not use it within 30 minutes, throw it away and prepare a new suspension.
Justér dosis i trin af 1 til 2,5 mg efter behov for at opretholde mål-dal-koncentrationen. 
Adjust the dose by increments of 2.5 mg as necessary to maintain the target trough concentration.
Fald i eksponering forventes. 
Decreased exposure expected.
Pakning indeholdende 30 x 1dispergible tabletter. 
Packs containing 30 x 1 dispersible tablets.
Votubia 2,5 mg tabletter Votubia 5 mg tabletter Votubia 10 mg tabletter everolimus 
Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets everolimus
Renal angiomyolipom i tilknytning til TSC 
Renal angiomyolipoma associated with TSC
Behandling med Votubia kan genoptages i en daglig dosis, der er ca. 50 % lavere end den tidligere administrerede dosis. 
Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered.
Startdosis ved samtidig administration af CYP3A4/PgP-induktor 
Starting dose with co-administration of CYP3A4/PgP inducer
Der er dog observeret sekundær amennoré og associeret ubalance i luteiniseringshormon (LH)/follikelstimulerende hormon hos kvinder (se også pkt. 
The potential for everolimus to cause infertility in male and female patients is unknown, however secondary amenorrhoea and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients (see also section 5.3 for preclinical observations on the male and female reproductive systems).
Ved den primære analyse blev der observeret responsrater for hudlæsioner på 26,0 % (95 % CI: 16,6; 37,2) i Votubia-armen og 0 % (95 % CI: 0,0, 9,5) i placebo-armen (p=0,0002). 
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).
Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 74 mg lactose. 
Excipient with known effect Each tablet contains 74 mg lactose.
AUC ↑2,7 gange (interval 1,5-4,7) Cmax ↑1,8 gange (interval 1,3-2,6) 
AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
10 x 1 tabletter 30 x 1 tabletter 100 x 1 tabletter 
10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Almindelig Lymfødem Luftveje, thorax og mediastinum Meget almindelig 
Respiratory, thoracic and mediastinal disorders Very common Cough
Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 1,96 mg lactose. 
Excipient with known effect Each dispersible tablet contains 1.96 mg lactose.
For patienter med renal angiomyolipim forbundet med TSC: Hvis patienten har brug for samtidig administration med en moderat CYP3A4- eller PgP-hæmmer, kan dosisreduktion til 5 mg eller 2,5 mg daglig overvejes. 
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.
Dal-everolimus-koncentrationen bør vurderes mindst 1 uge senere (se pkt. 
The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4).
Den mediane kummulative eksponeringsvarighed for Votubia (111 patienter, der tog mindst en dosis everolimus) var 47,1 måneder (interval 1,9 til 58,3). 
The cumulative median duration of exposure to Votubia (111 patients who took at least one dose of everolimus) was 47.1 months (range 1.9 to 58.3).
Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 297 mg lactose. 
Excipient with known effect Each tablet contains 297 mg lactose.
Metaboliske bivirkninger (f.eks. hyperglykæmi, dyslipidæmi) 
Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Votubia 1 mg dispergible tabletter Votubia 2 mg dispergible tabletter Votubia 3 mg dispergible tabletter Votubia 5 mg dispergible tabletter everolimus 
Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Blodlipider 
Blood lipids
Den estimerede progressionsfrie rate efter 6 måneder var 98,4 % for everolimus-armen og 83,4 % for placebo-armen. 
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.
Ved tidspunktet for den primære analyse viste Votubia klinisk relevante forbedringer i hudlæsion-respons (p=0,0004) med responsrate 41,7 % (95 % CI: 30,2, 53,9) for Votubia-armen og 10,5 % (95 % CI: 2,9, 24,8) for placebo-armen. 
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).
Renal angiomyolipom i forbindelse med tuberøst sklerosekompleks (TSC) 
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Der er observeret overfølsomhedsreaktioner ved everolimus, der bl.a. viser sig ved anafylaktisk dyspnø, rødmen, brystsmerter eller angioødem (fx hævede luftveje eller tunge, med eller uden nedsat respiratorisk funktion) (se pkt. 
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).
Dosis bør titreres, således at der opnås dal-koncentrationer på 5 til 15 nanogram/ml. 
Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml.
Votubia 10 mg tabletter 
Votubia 10 mg tablets
Den mediane eksponeringsvarighed for denne gruppe patienter var 204,9 uger (interval 8,1 til 253,7) ved tidspunktet for den endelige analyse. 
At the time of the final analysis, the median duration of exposure among all such patients was 204.9 weeks (range: 8.1 to 253.7).
Votubia tabletter 2,5 mg Votubia tabletter 5 mg Votubia tabletter 10 mg 
Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets
Progression blev kun observeret i placebo-armen (15,4 %; p=0,0002). 
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).
Hvis du ikke bruger den indenfor 60 minutter, så smid den ud og gør en ny suspension klar til brug. 
If you do not use it within 60 minutes, throw it away and prepare a new suspension.
De er præget med ”LCL” på den ene side og ”NVR” på den anden. 
They are engraved with “LCL” on one side and “NVR” on the other.
Votubia dispergible tabletter 1 mg Votubia dispergible tabletter 2 mg Votubia dispergible tabletter 3 mg Votubia dispergible tabletter 5 mg 
Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets
Dal-koncentrationerne skal vurderes mindst 1 uge efter første dosis, efter enhver dosisændring eller ændring til anden lægemiddelform, efter initiering af eller ændringer i samtidig administration af CYP3A4-hæmmere (se pkt. 
Trough concentrations should be assessed at least 1 week after the initial dose, after any change in dose or pharmaceutical form, after initiation of or change in co-administration of CYP3A4 inhibitors (see sections 4.4 and 4.5) or after any change in hepatic status (Child-Pugh) (see “Hepatic impairment” below and section 5.2).
Votubia 2,5 mg tabletter 
Votubia 2.5 mg tablets
Votubia 10 mg tabletter er hvide til svagt gullige, aflange tabletter. 
Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Responsrater var 34,6 % (95 % CI: 24,2, 46,2) for Votubia-armen sammenlignet med 0 % (95 % CI: 0,0, 9,0) for placebo-armen (Tabel 6). 
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).
30 x 1 tabletter 100 x 1 tabletter 
30 x 1 tablets 100 x 1 tablets
4.2 og 5.2). 
(see sections 4.2 and 5.2).
Indholdet pr. sprøjte må ikke overstige i alt 10 mg og maksimalt 5 dispergible tabletter. 
A total of 10 mg of Votubia dispersible tablets per syringe using a maximum of 5 dispersible tablets must not be exceeded.
Responsrater var 34,6 % (95 % CI: 24,2, 46,2) for Votubia-armen sammenlignet med 0 % (95 % CI: 0,0, 9,0) for placebo-armen (Tabel 7). 
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).
10 x 1 dispergible tabletter 30 x 1 dispergible tabletter 100 x 1 dispergible tabletter 
10 x 1 dispersible tablets 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Indholdet pr. glas må ikke overstige i alt 10 mg og maksimalt 5 dispergible tabletter. 
A total of 10 mg of Votubia dispersible tablets per glass using a maximum of 5 dispersible tablets must not be exceeded.
Afbryd behandlingen, indtil symptomerne forbedres til Grad 1. 
Interrupt Votubia until symptoms resolve to Grade 1.
Hver Votubia 10 mg tablet indeholder 10 mg everolimus. 
Each Votubia 10 mg tablet contains 10 mg of everolimus.
Hver Votubia 2,5 mg tablet indeholder 2,5 mg everolimus. 
Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Almindelig Tør hud, akneiform dermatitis, pruritus, alopeci Ikke almindelig 
Dry skin, acneiform dermatitis, pruritus, alopecia Uncommon Angioedema Musculoskeletal and connective tissue disorders Uncommon Rhabdomyolysis Renal and urinary disorders Common
Hver tablet indeholder 2,5 mg everolimus. 
Each tablet contains 2.5 mg everolimus.
Urinvejsinfektion 
Urinary tract infection
Højt niveau af lipider (fedtstoffer) i blodet (hyperlipidæmi, forhøjede triglycerider) Lavt niveau af fosfat i blodet (hypofosfatæmi) 
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)
Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 149 mg lactose. 
Excipient with known effect Each tablet contains 149 mg lactose.
Spørg din læge, hvis du vil vide mere om Votubia, og hvorfor du har fået det ordineret. 
If you have any questions about Votubia or why it has been prescribed for you, ask your doctor.
Hvis du ikke drikker den inden for 30 minutter, ved brug af sprøjte, eller inden for 60 minutter, ved brug af et lille glas, så skal du kassere den og lave en ny suspension. 
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.
Inklusive (meget almindelig) udslæt, (almindeligt) erytematøst udslæt, erytem og (ikke almindelig) generaliseret udslæt, makulopapuløst udslæt, makuløst udslæt d 
Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Evalueret på de primære effektendepunkter blev der observeret en homogen og konsistent everolimuseffekt på tværs af alle undergrupper: aldersgrupper (tabel 6), køn, race og etnicitet, anfaldstype, anfaldsfrekvens ved baseline, antal og navn på samtidige antiepileptika, og TSC-karakteristika (angiomyolipom, SEGA, status for kortikale tubera). 
A homogeneous and consistent everolimus effect was observed across all subgroups evaluated for the primary efficacy endpoints by: age categories (Table 6), gender, race and ethnicity, seizure types,
AUC ↑3,5 gange (interval 2,2-6,3) Cmax ↑2,3 gange (interval 1,3-3,8) 
AUC ↑3.5-fold (range 2.2-6.3) Cmax ↑2.3-fold (range1.3-3.8)
Votubia 5 mg tabletter er hvide til svagt gullige, aflange tabletter. 
Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Votubia 5 mg tabletter 
Votubia 5 mg tablets
30 x 1 dispergible tabletter 100 x 1 dispergible tabletter 
30 x 1 dispersible tablets 100 x 1 dispersible tablets
Nedsat nyrefunktion Der er ikke behov for dosisjustering (se pkt. 
Renal impairment No dose adjustment is required (see section 5.2).
Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 0,98 mg lactose. 
Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
• Den største mængde du kan tage på én gang, ved brug af den orale sprøjte eller det lille glas, er 
• The most you can take at one time using the oral syringe or small glass is 10 mg, using a maximum of 5 dispersible tablets.
Pakninger indeholdende 10 x 1, 30 x 1 eller 100 x 1 tabletter. 
Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
• vejtræknings- eller synkebesvær 
• difficulty breathing or swallowing
Votubia 1 mg dispergible tabletter fås i pakninger, der indeholder 30 dispergible tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter. 
Votubia 1 mg dispersible tablets are available in packs containing 30 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Almindelig Menoragi, ovariecyste, vaginalblødning Ikke almindelig 
Menorrhagia, ovarian cyst, vaginal haemorrhage Uncommon Menstruation delayed d
Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 2,94 mg lactose. 
Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Amenoré d, uregelmæssige menstruationer d 
Reproductive system and breast disorders Very common Amenorrhoea d, menstruation irregular d
Hver tablet indeholder 10 mg everolimus. 
Each tablet contains 10 mg everolimus.
Hver Votubia 1 mg dispergibel tablet indeholder 1 mg everolimus. 
Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 4,90 mg lactose. 
Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
100 x 1 tabletter 
100 x 1 tablets
Votubia tabletter 2,5 mg everolimus 
Votubia 2.5 mg tablets everolimus
10 x 1 tabletter 
10 x 1 tablets
Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir 
Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin
Hvis suspensionen ikke administreres indenfor 30 minutter efter klargøring, når der anvendes en oral sprøjte, eller 60 minutter når der anvendes et lille glas, skal den kasseres og en ny suspension skal klargøres 
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.
Hvis den ikke bruges inden for 60 minutter, skal den kasseres og en ny suspension skal gøres klar. 
If the suspension is not used within 60 minutes, throw it away and prepare a new suspension.
Hvis du har taget for meget Votubia 
If you take more Votubia than you should
Yderligere dosisjustering er muligvis ikke nødvendig ved tillæg af en ekstra samtidig potent CYP3A4-induktor. 
The addition of another concomitant strong CYP3A4 inducer may not require additional dose adjustment.
Hver Votubia 5 mg tablet indeholder 5 mg everolimus. 
Each Votubia 5 mg tablet contains 5 mg of everolimus.
30 x 1 dispergible tabletter 
30 x 1 dispersible tablets
10 x 1 dispergible tabletter 
10 x 1 dispersible tablets
Placebo p-værdi 
Placebo p-value Votubia n=79
100 x 1 dispergible tabletter 
100 x 1 dispersible tablets
De er præget med ”UHE” på den ene side og ”NVR” på den anden. 
They are engraved with “UHE” on one side and “NVR” on the other.
Votubia 3 mg og Votubia 5 mg dispergible tabletter fås i pakninger, der indeholder 30 x 1 eller 100 x 1 dispergible tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter. 
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.
30 x 1 tabletter 
30 x 1 tablets
Dosisjustering af Votubia 
Votubia dose adjustment