FrancophonIA/ELRC3.0 huggingface dataset:
English: • EXIST-3 (CRAD001M2304): This was a randomised, double-blind, controlled, phase III trial comparing adjunctive treatment of low and high everolimus exposure (low trough [LT] range of 3-7 ng/ml [n=117] and high trough [HT] range of 9-15 ng/ml [n=130]) versus placebo (n=119), in patients with TSC and refractory partial-onset seizures receiving 1 to 3 antiepileptics.
Danish: • EXIST-3 (CRAD001M2304): Dette var et randomiseret, dobbeltblindt, kontrolleret fase III-forsøg, der sammenlignede supplerende behandling med lav og høj everolimus-eksponering (behandling med lavt dal-niveau (LT) på 3-7 nanogram/ml [n=117] og behandling med højt dalniveau (HT) på 9-15 nanogram/ml [n=130]) versus placebo (n=119) hos patienter med TSC og refraktære partielle anfald, der fik 1 til 3 antiepileptika.
English: • <18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C)
Danish: • <18 år med SEGA og samtidig nedsat leverfunktion (Child-Pugh A, B og C) (se pkt.
English: Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
Danish: Subependymalt kæmpecelle-astrocytom (SEGA) i tilknytning til tuberøst sklerosekompleks (TSC)
English: The primary efficacy endpoint was SEGA response rate based on independent central radiology review.
Danish: Det primære endepunkt for virkning var SEGA-reponsraten, baseret på en uafhængig central radiologisk vurdering.
English: Hypertriglyceridaemia, hyperlipidaemia, hypophosphataemia, hyperglycaemia Psychiatric disorders
Danish: Almindelig Hypertriglyceridæmi, hyperlipidæmi, hypofosfatæmi, hyperglykæmia Psykiske forstyrrelser
English: • The blister with Votubia dispersible tablets
Danish: • Blisteren med dine Votubia dispergible tabletter
English: Swallow the tablet(s) whole with a glass of water.
Danish: Synk tabletten/tabletterne hele med et glas vand.
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 tablets.
Danish: Perforeret enkeltdosis aluminium/polyamid/aluminium/PVC-blister indeholdende 10 x 1 tabletter.
English: Uncommon side effects (may affect up to 1 in 100 people) Rash of small fluid-filled blisters, appearing on reddened skin (signs of viral infection that can be potentially severe, also known as herpes zoster) Fever, chills, rapid breathing and heart rate, rash, and possibly confusion and disorientation (signs of serious infection, also known as sepsis)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) Udslæt med små væskefyldte blærer, der fremkommer på rød hud (tegn på en virusinfektion, som muligvis kan være alvorlig, også kendt som herpes zoster) Feber, kuldegysninger, hurtig vejrtrækning og hjertebanken, udslæt og muligvis føle sig konfus og desorienteret (tegn på alvorlig infektion, også kendt som blodforgiftning)
English: No dose adjustment required.
Danish: Dosisjustering ikke nødvendig.
English: Consistent results were found for the supportive analysis of the median percentage reduction from baseline in seizure frequency (other primary endpoint): 29.3% (95% CI: 18.8, 41.9) in the Votubia LT arm, 39.6% (95% CI: 35.0, 48.7) in the Votubia HT arm and 14.9% (95% CI: 0.1, 21.7) in the placebo arm.
Danish: Konsistente resultater blev fundet i den understøttende analyse af den mediane procentvise reduktion i anfaldsfrekvens fra baseline (andet primært endepunkt): 29,3 % (95 % CI: 18,8; 41,9) i Votubia LTarmen, 39,6 % (95 % CI: 35,0; 48,7) i Votubia HT-armen og 14,9 % (95 % CI: 0,1; 21,7) i placeboarmen.
English: Month 48 n=24
Danish: Måned 48 n=24
English: Dose monitoring
Danish: Dosismonitorering
English: If toxicity recurs at Grade 3, consider discontinuation.
Danish: Hvis der igen opstår toksisitet af Grad 3, skal seponering overvejes.
English: Hence, concomitant treatment of Votubia and potent inhibitors is not recommended.
Danish: Derfor frarådes samtidig behandling med Votubia og potente hæmmere.
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.
Danish: Votubias sikkerhed, virkning og farmakokinetiske profil hos børn under 1 år med SEGA i tilknytning til TSC er ikke klarlagt.
English: Monitoring of fasting serum glucose is recommended prior to the start of Votubia therapy and periodically thereafter.
Danish: Det anbefales at monitorere glucoseniveau i serum under faste før opstart af behandling med Votubia og med jævne mellemrum.
English: Month 24 n=24
Danish: Måned 24 n=24
English: Results showed that the primary objective related to best overall angiomyolipoma response was met with best overall response rates of 41.8% (95% CI: 30.8, 53.4) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (p<0.0001) (Table 4).
Danish: Resultaterne viste, at det primære mål relateret til det bedste samlede respons på angiomyolipom blev nået med bedste samlede responsrater på 41,8 % (95 % CI: 30,8; 53,4) for Votubia-armen sammenlignet med 0 % (95 % CI: 0,0; 9,0) for placebo-armen (p<0,0001) (Tabel 4).
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.
Danish: Votubias sikkerhed, virkning og farmakokinetiske profil hos børn under 2 år med TSC og refraktære anfald er ikke klarlagt.
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A, mannitol, cellulose microcrystalline and silica colloidal anhydrous.
Danish: Øvrige indholdsstoffer: butyleret hydroxytoluen (E 321), magnesiumstearat, lactosemonohydrat, hypromellose, crospovidon type A, mannitol, mikrokrystallinsk cellulose, kolloid vandfri silica.
English: Further dose reduction may be required to manage adverse reactions (see sections 4.2 and 4.4).
Danish: Yderligere dosisreduktion kan være nødvendig for at håndtere bivirkninger (se pkt.
English: Starting dose without co-administration of CYP3A4/PgP inducer
Danish: Startdosis uden samtidig administration af CYP3A4/PgP-induktor
English: Month 6 n=27
Danish: Måned 6 n=27
English: • Spoon for stirring
Danish: • En ske til omrøring
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).
Danish: Hvis suspensionen ikke administreres inden for 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 (se afsnit 6.3).
English: Abdominal pain, nausea, vomiting, diarrhoea, swelling and bloating of the abdomen (signs of inflammation of the stomach lining, also known as gastritis or gastroenteritis viral) Dry skin, itching (pruritus)
Danish: Mavesmerter, kvalme, opkastning, diarré, hævet og oppustet mave (tegn på betændelse i maveslimhinden, også kendt som gastritis eller viral gastroenteritis) Tør hud, kløe (pruritus)
English: If patients require co-administration of a potent CYP3A4 inducer, a Votubia dose increase from 10 mg daily up to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer.
Danish: For patienter med renal angiomyolipom forbundet med TSC: Hvis en patient har brug for samtidig behandling med potente CYP3A4-hæmmere, bør det overvejes at øge Votubia-dosis fra 10 mg/dag til 20 mg/dag med stigninger på 5 mg eller mindre på dag 4 og 8 efter opstart af behandling med induktor.
English: Menstruation disorders such as absence of periods (amenorrhoea) or irregular periods Sore throat (pharyngitis)
Danish: Menstruationsforstyrrelser, såsom manglende menstruationer (amenorré) eller uregelmæssige menstruationer
English: Severe pain in the lower abdomen and pelvic area that may be sharp, with menstrual irregularities (ovarian cyst)
Danish: Stærke eventuelt skarpe smerter i den nedre del af maven og bækkenet med uregelmæssige menstruationer (ovariecyster)
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 dispersible tablets.
Danish: Perforeret enkeltdosis aluminium/polyamid/aluminium/PVC-blister indeholdende 10 x 1 dispergible tabletter.
English: Final analysis Votubia Placebo p-value Votubia N=78
Danish: Votubia Placebo p-værdi
English: Avoid the use of concomitant potent CYP3A4 inducers.
Danish: Samtidig administration med potente induktorer af CYP3A4 skal undgås.
English: Month 12 n=26
Danish: Måned 12 n=26
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Danish: Hvis stomatitis recidiverer ved Grad 2, afbrydes behandlingen indtil bedring til Grad 1.
English: Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Danish: Midlertidig behandlingspause indtil bedring til Grad 2 (≥1,25x10
English: AUC ↑4.4-fold (range 2.0-12.6) Cmax ↑2.0-fold (range 0.9-3.5)
Danish: AUC ↑4,4 gange (interval 2,0-12,6) Cmax ↑2,0 gange (interval 0,9-3,5)
English: Problems with wound healing
Danish: Problemer med sårheling
English: Adjust the dose by increments of 1 to 4 mg as necessary to maintain the target trough concentration.
Danish: Justér dosis i trin af 1 til 4 mg efter behov for at opretholde mål-dal-koncentrationen.
English: CYP3A4 and PgP inducers decreasing everolimus concentrations
Danish: CYP3A4- og PgP-induktorers nedsættelse af everolimus-koncentrationer
English: Month 36 n=23
Danish: Måned 36 n=23
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).
Danish: Den mediane kumulative eksponeringsvarighed for Votubia (361 patienter, der tog mindst én dosis everolimus) var 30,4 måneder (interval 0,5 til 48,8).
English: Infections and infestations Very common Nasopharyngitis, upper respiratory tract infection, pneumonia a, urinary tract infection, sinusitis, pharyngitis
Danish: Nasopharyngitis, infektion i øvre luftveje, pneumoni a, urinvejsinfektion, sinuitis,
English: 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).
Danish: Den mediane kummulative eksponeringsvarighed for Votubia (112 patienter, der tog mindst en dosis everolimus) var 46,9 måneder (interval 0,5 til 63,9).
English: Recommendations concerning co-administration
Danish: Anbefalinger vedrørende administration samtidig med andre lægemidler
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Danish: Fald i hæmoglobin, lymfocytter, neutrofile granulocytter og trombocytter er rapporteret hos patienter i behandling med Votubia (se pkt.
English: Caregivers are advised to avoid contact with suspensions of Votubia tablets.
Danish: Omsorgspersoner bør undgå kontakt med Votubia-suspensionen.
English: 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).
Danish: Baseline-data indikerede let til moderat mental retardering hos 6- til 18-årige patienter (scorer på 60-70 iht.
English: Cellulose microcrystalline Silica colloidal anhydrous
Danish: Cellulose, mikrokrystallinsk Silica, kolloid vandfri
English: Month 60 n=23
Danish: Måned 60 n=23
English: Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis
Danish: Almindelig Obstipation, kvalme, abdominalsmerter, flatulens, oral smerte, gastritis Hud og subkutane væv
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Danish: Hos patienter, der samtidig behandles med en ACE-hæmmer (fx ramipril), kan der være forhøjet risiko for angioødem (se pkt.
English: AUC ↑15.3-fold (range 11.2-22.5) Cmax ↑4.1-fold (range 2.6-7.0)
Danish: AUC ↑15,3 gange (interval 11,2-22,5) Cmax ↑4,1 gange (interval 2,6-7,0)
English: HT target of 9-15 ng/ml
Danish: HT-målniveau 9-15 nanogram/ml
English: CYP3A4 and PgP inhibitors increasing everolimus concentrations
Danish: CYP3A4- og PgP-hæmmeres øgning af everolimus-koncentrationer
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Votubia (see sections 4.4 and 4.8).
Danish: Stomatitis er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Votubia (se pkt.
English: Ethnicity
Danish: Etnisk tilhørsforhold
English: Keep the medicine out of the reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: 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).
Danish: 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.
English: Butylated hydroxytoluene (E321) Magnesium stearate Lactose monohydrate Hypromellose
Danish: Butylhydroxytoluen (E321) Magnesiumstearat Lactosemonohydrat Hypromellose Crospovidon type A Mannitol
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).
Danish: 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.
English: For patients with renal angiomyolipoma associated with TSC:
Danish: Patienter med renal angiomyolipom forbundet med TSC:
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.
Danish: 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.
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).
Danish: 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.
English: Temporary dose interruption until recovery to Grade 2 (≥1x10
Danish: Midlertidig behandlingspause indtil bedring til Grad 2 (≥1x10
English: LT target of 3-7 ng/ml
Danish: LT-målniveau 3-7 nanogram/ml
English: Symptoms of heart failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
Danish: Andre symptomer kan omfatte ændret nyrefunktionstest (stigning i kreatinin) Symptomer på hjertesvigt såsom åndenød, vejrtrækningsbesvær, når du ligger ned, hævelse af fødder eller ben
English: Titration
Danish: Titrering
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Danish: Øvrige indholdsstoffer: butyleret hydroxytoluen (E 321), magnesiumstearat, lactosemonohydrat, hypromellose, crospovidon type A og vandfri lactose.
English: Aggression
Danish: Aggressiv adfærd
English: Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Danish: Almindelig Otitis media, cellulitis, streptokok-faryngitis, viral gastroenteritis, gingivitis Ikke almindelig
English: Hypersensitivity
Danish: Almindelig Overfølsomhed
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.
Danish: Det primære endepunkt var ændring i SEGA-volumen i løbet af den centrale 6 måneder lange behandlingsfase, vurderet ved uafhængig central radiologisk gennemgang.
English: Exacerbation
Danish: Forværring
English: If toxicity becomes intolerable, temporary dose interruption until recovery to Grade 1.
Danish: Hvis toksiciteten ikke tolereres, pauseres behandlingen indtil bedring til Grad 1.
English: The contents should be gently stirred with a spoon and then administered immediately.
Danish: Indholdet omrøres forsigtigt med en ske lige inden administration.
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.
Danish: 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.
English: Headache, pressure in the eyes, nose or cheek area (signs of inflammation of the sinuses and nasal passages, also known as sinusitis)
Danish: Hovedpine, tryk i øjet, næsen eller kinderne (tegn på betændelse i bihulerne og næsepassagen, også kendt som bihulebetændelse)
English: Hold the oral syringe with the tip pointing upwards.
Danish: Hold den orale sprøjte, så spidsen peger opad.
English: If you do not use it within 30 minutes, throw it away and prepare a new suspension.
Danish: Hvis du ikke bruger den inden for 30 minutter, skal du kassere den og lave en ny suspension.
English: Adjust the dose by increments of 2.5 mg as necessary to maintain the target trough concentration.
Danish: Justér dosis i trin af 1 til 2,5 mg efter behov for at opretholde mål-dal-koncentrationen.
English: Decreased exposure expected.
Danish: Fald i eksponering forventes.
English: Packs containing 30 x 1 dispersible tablets.
Danish: Pakning indeholdende 30 x 1dispergible tabletter.
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets everolimus
Danish: Votubia 2,5 mg tabletter Votubia 5 mg tabletter Votubia 10 mg tabletter everolimus
English: Renal angiomyolipoma associated with TSC
Danish: Renal angiomyolipom i tilknytning til TSC
English: Votubia may be reinitiated at a daily dose approximately 50% lower than the dose previously administered.
Danish: Behandling med Votubia kan genoptages i en daglig dosis, der er ca. 50 % lavere end den tidligere administrerede dosis.
English: Starting dose with co-administration of CYP3A4/PgP inducer
Danish: Startdosis ved samtidig administration af CYP3A4/PgP-induktor
English: 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).
Danish: Der er dog observeret sekundær amennoré og associeret ubalance i luteiniseringshormon (LH)/follikelstimulerende hormon hos kvinder (se også pkt.
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).
Danish: 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).
English: Excipient with known effect Each tablet contains 74 mg lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 74 mg lactose.
English: AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
Danish: AUC ↑2,7 gange (interval 1,5-4,7) Cmax ↑1,8 gange (interval 1,3-2,6)
English: 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Danish: 10 x 1 tabletter 30 x 1 tabletter 100 x 1 tabletter
English: Respiratory, thoracic and mediastinal disorders Very common Cough
Danish: Almindelig Lymfødem Luftveje, thorax og mediastinum Meget almindelig
English: Excipient with known effect Each dispersible tablet contains 1.96 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 1,96 mg lactose.
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg or 2.5 mg daily may be considered.
Danish: 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.
English: The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4).
Danish: Dal-everolimus-koncentrationen bør vurderes mindst 1 uge senere (se pkt.
English: 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).
Danish: Den mediane kummulative eksponeringsvarighed for Votubia (111 patienter, der tog mindst en dosis everolimus) var 47,1 måneder (interval 1,9 til 58,3).
English: Excipient with known effect Each tablet contains 297 mg lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 297 mg lactose.
English: Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Danish: Metaboliske bivirkninger (f.eks. hyperglykæmi, dyslipidæmi)
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Danish: Votubia 1 mg dispergible tabletter Votubia 2 mg dispergible tabletter Votubia 3 mg dispergible tabletter Votubia 5 mg dispergible tabletter everolimus
English: Blood lipids
Danish: Blodlipider
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.
Danish: Den estimerede progressionsfrie rate efter 6 måneder var 98,4 % for everolimus-armen og 83,4 % for placebo-armen.
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).
Danish: 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.
English: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Danish: Renal angiomyolipom i forbindelse med tuberøst sklerosekompleks (TSC)
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).
Danish: 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.