FrancophonIA/ELRC3.0 huggingface dataset:
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml.
Danish: Dosis bør titreres, således at der opnås dal-koncentrationer på 5 til 15 nanogram/ml.
English: Votubia 10 mg tablets
Danish: Votubia 10 mg tabletter
English: 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).
Danish: Den mediane eksponeringsvarighed for denne gruppe patienter var 204,9 uger (interval 8,1 til 253,7) ved tidspunktet for den endelige analyse.
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets
Danish: Votubia tabletter 2,5 mg Votubia tabletter 5 mg Votubia tabletter 10 mg
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).
Danish: Progression blev kun observeret i placebo-armen (15,4 %; p=0,0002).
English: If you do not use it within 60 minutes, throw it away and prepare a new suspension.
Danish: Hvis du ikke bruger den indenfor 60 minutter, så smid den ud og gør en ny suspension klar til brug.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Danish: De er præget med ”LCL” på den ene side og ”NVR” på den anden.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets
Danish: Votubia dispergible tabletter 1 mg Votubia dispergible tabletter 2 mg Votubia dispergible tabletter 3 mg Votubia dispergible tabletter 5 mg
English: 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).
Danish: 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.
English: Votubia 2.5 mg tablets
Danish: Votubia 2,5 mg tabletter
English: Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Votubia 10 mg tabletter er hvide til svagt gullige, aflange tabletter.
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).
Danish: 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).
English: 30 x 1 tablets 100 x 1 tablets
Danish: 30 x 1 tabletter 100 x 1 tabletter
English: (see sections 4.2 and 5.2).
Danish: 4.2 og 5.2).
English: A total of 10 mg of Votubia dispersible tablets per syringe using a maximum of 5 dispersible tablets must not be exceeded.
Danish: Indholdet pr. sprøjte må ikke overstige i alt 10 mg og maksimalt 5 dispergible tabletter.
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).
Danish: 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).
English: 10 x 1 dispersible tablets 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Danish: 10 x 1 dispergible tabletter 30 x 1 dispergible tabletter 100 x 1 dispergible tabletter
English: A total of 10 mg of Votubia dispersible tablets per glass using a maximum of 5 dispersible tablets must not be exceeded.
Danish: Indholdet pr. glas må ikke overstige i alt 10 mg og maksimalt 5 dispergible tabletter.
English: Interrupt Votubia until symptoms resolve to Grade 1.
Danish: Afbryd behandlingen, indtil symptomerne forbedres til Grad 1.
English: Each Votubia 10 mg tablet contains 10 mg of everolimus.
Danish: Hver Votubia 10 mg tablet indeholder 10 mg everolimus.
English: Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Danish: Hver Votubia 2,5 mg tablet indeholder 2,5 mg everolimus.
English: Dry skin, acneiform dermatitis, pruritus, alopecia Uncommon Angioedema Musculoskeletal and connective tissue disorders Uncommon Rhabdomyolysis Renal and urinary disorders Common
Danish: Almindelig Tør hud, akneiform dermatitis, pruritus, alopeci Ikke almindelig
English: Each tablet contains 2.5 mg everolimus.
Danish: Hver tablet indeholder 2,5 mg everolimus.
English: Urinary tract infection
Danish: Urinvejsinfektion
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)
Danish: Højt niveau af lipider (fedtstoffer) i blodet (hyperlipidæmi, forhøjede triglycerider) Lavt niveau af fosfat i blodet (hypofosfatæmi)
English: Excipient with known effect Each tablet contains 149 mg lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 149 mg lactose.
English: If you have any questions about Votubia or why it has been prescribed for you, ask your doctor.
Danish: Spørg din læge, hvis du vil vide mere om Votubia, og hvorfor du har fået det ordineret.
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.
Danish: 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.
English: Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Danish: Inklusive (meget almindelig) udslæt, (almindeligt) erytematøst udslæt, erytem og (ikke almindelig) generaliseret udslæt, makulopapuløst udslæt, makuløst udslæt d
English: 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,
Danish: 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).
English: AUC ↑3.5-fold (range 2.2-6.3) Cmax ↑2.3-fold (range1.3-3.8)
Danish: AUC ↑3,5 gange (interval 2,2-6,3) Cmax ↑2,3 gange (interval 1,3-3,8)
English: Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Votubia 5 mg tabletter er hvide til svagt gullige, aflange tabletter.
English: Votubia 5 mg tablets
Danish: Votubia 5 mg tabletter
English: 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Danish: 30 x 1 dispergible tabletter 100 x 1 dispergible tabletter
English: Renal impairment No dose adjustment is required (see section 5.2).
Danish: Nedsat nyrefunktion Der er ikke behov for dosisjustering (se pkt.
English: Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 0,98 mg lactose.
English: • 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.
Danish: • Den største mængde du kan tage på én gang, ved brug af den orale sprøjte eller det lille glas, er
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
Danish: Pakninger indeholdende 10 x 1, 30 x 1 eller 100 x 1 tabletter.
English: • difficulty breathing or swallowing
Danish: • vejtræknings- eller synkebesvær
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.
Danish: Votubia 1 mg dispergible tabletter fås i pakninger, der indeholder 30 dispergible tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter.
English: Menorrhagia, ovarian cyst, vaginal haemorrhage Uncommon Menstruation delayed d
Danish: Almindelig Menoragi, ovariecyste, vaginalblødning Ikke almindelig
English: Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 2,94 mg lactose.
English: Reproductive system and breast disorders Very common Amenorrhoea d, menstruation irregular d
Danish: Amenoré d, uregelmæssige menstruationer d
English: Each tablet contains 10 mg everolimus.
Danish: Hver tablet indeholder 10 mg everolimus.
English: Each Votubia 1 mg dispersible tablet contains 1 mg of everolimus.
Danish: Hver Votubia 1 mg dispergibel tablet indeholder 1 mg everolimus.
English: Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dispergibel tablet indeholder 4,90 mg lactose.
English: 100 x 1 tablets
Danish: 100 x 1 tabletter
English: Votubia 2.5 mg tablets everolimus
Danish: Votubia tabletter 2,5 mg everolimus
English: 10 x 1 tablets
Danish: 10 x 1 tabletter
English: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin
Danish: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir
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.
Danish: 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
English: If the suspension is not used within 60 minutes, throw it away and prepare a new suspension.
Danish: Hvis den ikke bruges inden for 60 minutter, skal den kasseres og en ny suspension skal gøres klar.
English: If you take more Votubia than you should
Danish: Hvis du har taget for meget Votubia
English: The addition of another concomitant strong CYP3A4 inducer may not require additional dose adjustment.
Danish: Yderligere dosisjustering er muligvis ikke nødvendig ved tillæg af en ekstra samtidig potent CYP3A4-induktor.
English: Each Votubia 5 mg tablet contains 5 mg of everolimus.
Danish: Hver Votubia 5 mg tablet indeholder 5 mg everolimus.
English: 30 x 1 dispersible tablets
Danish: 30 x 1 dispergible tabletter
English: 10 x 1 dispersible tablets
Danish: 10 x 1 dispergible tabletter
English: Placebo p-value Votubia n=79
Danish: Placebo p-værdi
English: 100 x 1 dispersible tablets
Danish: 100 x 1 dispergible tabletter
English: They are engraved with “UHE” on one side and “NVR” on the other.
Danish: De er præget med ”UHE” på den ene side og ”NVR” på den anden.
English: 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.
Danish: 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.
English: 30 x 1 tablets
Danish: 30 x 1 tabletter
English: Votubia dose adjustment
Danish: Dosisjustering af Votubia
English: Votubia may affect the way some other medicines work.
Danish: Brug af anden medicin sammen med Votubia Votubia kan påvirke virkningen af anden medicin.
English: Epistaxis, pneumonitis Gastrointestinal disorders Very common Stomatitis b, diarrhoea, vomiting
Danish: Stomatitis b, diarré, opkastning
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets.
Danish: Pakninger indeholdende 10 x 1, 30 x 1 eller 100 x 1 dispergible tabletter.
English: They are engraved with “5” on one side and “NVR” on the other.
Danish: De er præget med ”5” på den ene side og ”NVR” på den anden.
English: Each Votubia 2 mg dispersible tablet contains 2 mg of everolimus.
Danish: Hver Votubia 2 mg dispergibel tablet indeholder 2 mg everolimus.
English: Each Votubia 3 mg dispersible tablet contains 3 mg of everolimus.
Danish: Hver Votubia 3 mg dispergibel tablet indeholder 3 mg everolimus.
English: Packs containing 30 x 1 or 100 x 1 tablets.
Danish: Pakninger indeholdende 30 x 1 eller 100 x 1 tabletter.
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.
Danish: Hvide til svagt gullige aflange tabletter (ca. 10,1 x 4,1 mm) med facetslebet kant og uden delekærv, præget med ”LCL” på den ene side og ”NVR” på den anden side.
English: Trough concentrations should be assessed 2 to 4 weeks after initiation of or change in co-administration of CYP3A4 inducers (see sections 4.4 and 4.5) since the natural degradation time of the induced enzymes has to be taken into account.
Danish: Efter initiering af eller ændring i samtidig administration af CYP3A4-induktorer skal dal-koncentrationen vurderes efter 2 til 4 uger (se pkt.
English: • If you need to take a higher dose or need to use more than 5 dispersible tablets, split the dose and repeat the steps using the same oral syringe or small glass.
Danish: skal du dele dosis op og gentage de nævnte trin ved brug af samme orale sprøjte eller lille glas.
English: Each tablet contains 5 mg everolimus.
Danish: Hver tablet indeholder 5 mg everolimus.
English: Each dispersible tablet contains 1 mg everolimus.
Danish: Hver dispergibel tablet indeholder 1 mg everolimus.
English: Each Votubia 5 mg dispersible tablet contains 5 mg of everolimus.
Danish: Hver Votubia 5 mg dispergibel tablet indeholder 5 mg everolimus.
English: White to slightly yellow, elongated tablets of approximately 15.1 x 6.0 mm, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Danish: Hvide til svagt gullige aflange tabletter (ca. 15,1 x 6,0 mm) med facetslebet kant og uden delekærv, præget med ”UHE” på den ene side og ”NVR” på den anden side.
English: Dose adjustments due to adverse reactions
Danish: Dosisjustering som følge af bivirkninger
English: Votubia 10 mg tablets everolimus
Danish: Votubia tabletter 10 mg everolimus
English: Feeling tired
Danish: Pyreksi, træthed
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apoteketspersonalet.
English: Votubia 1 mg dispersible tablets everolimus
Danish: Votubia 1 mg dispergible tabletter everolimus
English: Votubia 5 mg dispersible tablets everolimus
Danish: Votubia 5 mg dispergible tabletter everolimus
English: Each dispersible tablet contains 2 mg everolimus.
Danish: Hver dispergibel tablet indeholder 2 mg everolimus.
English: Votubia 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Danish: Votubia 5 mg dispergible tabletter er hvide til svagt gullige, runde, flade tabletter med en facetslebet kant og ingen delekærv.
English: White to slightly yellow, elongated tablets of approximately 12.1 x 4.9 mm, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Danish: Hvide til svagt gullige aflange tabletter (ca. 12,1 x 4,9 mm) med facetslebet kant og uden delekærv, præget med ”5” på den ene side og ”NVR” på den anden side.
English: Each dispersible tablet contains 3 mg everolimus.
Danish: Hver dispergibel tablet indeholder 3 mg everolimus.
English: Packs containing 30 x 1 or 100 x 1 dispersible tablets
Danish: Pakninger indeholdende 30 x 1 eller 100 x 1 dispergible tabletter.
English: Votubia 3 mg dispersible tablets everolimus
Danish: Votubia 3 mg dispergible tabletter everolimus
English: Range
Danish: faryngitis
English: Votubia 2 mg dispersible tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Danish: Votubia 2 mg dispergible tabletter fås i pakninger, der indeholder 10 x 1, 30 x 1 eller 100 x 1 dispergible tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter.
English: No data are available (see sections 5.1 and 5.2).
Danish: 5.1 og 5.2).
English: Each dispersible tablet contains 5 mg everolimus.
Danish: Hver dispergibel tablet indeholder 5 mg everolimus.
English: Consider re-initiating Votubia at approximately 50% lower than the daily dose previously administered.
Danish: Overvej at genoptage behandlingen med Votubia i en dosis, der er 50 % lavere and den tidligere anvendte daglige dosis.
English: Votubia 2 mg dispersible tablets everolimus
Danish: Votubia 2 mg dispergible tabletter everolimus
English: Votubia 5 mg tablets are available in packs containing 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Danish: Votubia 5 mg tabletter fås i pakninger, der indeholder 30 x 1 eller 100 x 1 tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter.
English: TSC with angiomyolipoma of the kidney in adults who do not require immediate surgery.
Danish: Votubia tabletter anvendes til at behandle: - voksne med TSC og renalt angiomyolipom, som ikke kræver umiddelbart indgreb.
English: Votubia 2 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Danish: Votubia 2 mg dispergible tabletter er hvide til svagt gullige, runde, flade tabletter med en facetslebet kant og ingen delekærv.
English: Votubia 3 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Danish: Votubia 3 mg dispergible tabletter er hvide til svagt gullige, runde, flade tabletter med en facetslebet kant og ingen delekærv.
English: Votubia 1 mg dispersible tablets
Danish: Votubia dispergible tabletter 1 mg
English: They are engraved with “D5” on one side and “NVR” on the other.
Danish: De er præget med ”D5” på den ene side og ”NVR” på den anden.
English: Votubia 10 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Danish: Votubia 10 mg tabletter fås i pakninger, der indeholder 10 x 1, 30 x 1 eller 100 x 1 tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter.
English: Insomnia, aggression, irritability Nervous system disorders Very common Headache Uncommon Dysgeusia Vascular disorders Very common Hypertension Common
Danish: Almindelig Søvnløshed, aggression, irritabilitet Nervesystemet
English: What Votubia tablets looks like and contents of the pack Votubia 2.5 mg tablets are white to slightly yellowish, elongated tablets.
Danish: Votubia 2,5 mg tabletter er hvide til svagt gullige, aflange tabletter.
English: Votubia 2.5 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Danish: Votubia 2,5 mg tabletter fås i pakninger, der indeholder 10 x 1, 30 x 1 eller 100 x 1 tabletter i perforerede enkeltdosis blisterkort med hver 10 x 1 tabletter.
English: Discontinuation of one of multiple strong CYP3A4 inducers may not require additional dose adjustment.
Danish: Dosisjustering er muligvis ikke nødvendig ved seponering af en af flere potente CYP3A4-induktorer.
English: They are engraved with “D2” on one side and “NVR” on the other.
Danish: De er præget med ”D2” på den ene side og ”NVR” på den anden.
English: What Votubia is and what it is used for What you need to know before you take Votubia How to take Votubia
Danish: Det skal du vide, før du begynder at tage Votubia Sådan skal du tage Votubia Bivirkninger
English: Special populations
Danish: Specielle patientgrupper
English: They are engraved with “D3” on one side and “NVR” on the other.
Danish: De er præget med ”D3” på den ene side og ”NVR” på den anden.
English: Votubia 5 mg tablets everolimus
Danish: Votubia tabletter 5 mg everolimus
English: Votubia 2 mg dispersible tablets
Danish: Votubia 2 mg dispergible tabletter forkortet [disp.tabl.]
English: They are engraved with “D1” on one side and “NVR” on the other.
Danish: De er præget med ”D1” på den ene side og ”NVR” på den anden.
English: Stomach upset like feeling sick (nausea)
Danish: Ondt i halsen og løbende næse (forkølelse)
English: The most common adverse reactions leading to discontinuation were pneumonitis (including interstitial lung disease), fatigue, dyspnoea, and stomatitis.
Danish: interstitiel lungesygdom), træthed, dyspnø og stomatitis.
English: Votubia 3 mg dispersible tablets
Danish: Votubia dispergible tabletter 3 mg
English: Cough
Danish: Spids
English: Re-initiate Votubia at approximately 50% lower than the daily dose previously administered.
Danish: Genoptag behandlingen med Votubia i en dosis, der er 50 % lavere and den tidligere anvendte daglige dosis.
English: Therapeutic drug monitoring of everolimus blood concentrations, using a validated assay, is an option to be considered for patients treated for renal angiomyolipoma associated with TSC (see section 5.1) after initiation of or change in co-administration of CYP3A4 inducers or inhibitors (see sections 4.4 and 4.5) or after any change in hepatic status (Child-Pugh) (see section “Hepatic impairment” below and section 5.2).
Danish: Terapeutisk lægemiddelmonitorering af blod-everolimus ved brug af en valideret analyse er en mulighed hos patienter, der behandles for renal angiomyolipom i tilknytning til TSC (se pkt.
English: White to slightly yellowish, round, flat tablets of approximately 12.1 mm in diameter, with a bevelled edge and no score, engraved with “D5” on one side and “NVR” on the other.
Danish: Hvide til svagt gullige, runde, flade tabletter med facetslebet kant og uden delekærv (ca. 12,1 mm i diameter), præget med ”D5” på den ene side og ”NVR” på den anden side.
English: White to slightly yellowish, round, flat tablets of approximately 9.1 mm in diameter, with a bevelled edge and no score, engraved with “D2” on one side and “NVR” on the other.
Danish: Hvide til svagt gullige, runde, flade tabletter med facetslebet kant og uden delekærv (ca. 9,1 mm i diameter), præget med ”D2” på den ene side og ”NVR” på den anden side.
English: Votubia 5 mg dispersible tablets
Danish: Votubia dispergible tabletter 5 mg
English: • EXIST-1 (CRAD001M2301): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=78) versus placebo (n=39) in patients with TSC who have SEGA, irrespective of age.
Danish: • EXIST-1 (CRAD001M2301): Dette var et randomiseret, dobbeltblindet, kontrolleret fase III-forsøg med everolimus (n=78) versus placebo (n=39) hos patienter med TSC, som havde SEGA, uden hensyntagen til alder. Medianvarigheden for blindet studiebehandling var 52,2 uger (interval 24 til 89) for patienter, der fik Votubia, og 46,6 uger (interval 14 til 88) for dem, der fik placebo.
English: White to slightly yellowish, round, flat tablets of approximately 10.1 mm in diameter, with a bevelled edge and no score, engraved with “D3” on one side and “NVR” on the other.
Danish: Hvide til svagt gullige, runde, flade tabletter med facetslebet kant og uden delekærv (ca. 10,1 mm i diameter), præget med ”D3” på den ene side og ”NVR” på den anden side.
English: Other medicines and Votubia
Danish: Metabolisme og ernæring
English: Proteinuria
Danish: Forstoppelse
English: General disorders and administration site conditions Very common Pyrexia, fatigue Investigations
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: Plunger
Danish: Cylinder
English: Nefazodone
Danish: Mavesmerter
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur,
English: From a microbiological point of view, it is recommended that the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt anbefales det, at produktet bruges med det samme.
English: • This can help to reduce the effects of this illness.
Danish: • Dette kan hjælpe med at reducere effekterne af denne sygdom.
English: • Low or high blood pressure
Danish: • Lavt eller højt blodtryk