FrancophonIA/ELRC3.0 huggingface dataset:
English: Kalydeco 75 mg granules in sachet are white to off-white granules.
Danish: Kalydeco 75 mg granulat i brev er et hvidt eller off-white granulat.
English: 6- to 11-year-olds † (≥ 14 kg to < 25 kg)
Danish: 6- til 11-årige † (≥14 kg til <25 kg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER CARD - 28-TABLET PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL BLISTERKORT - PAKNING MED 28 TABLETTER
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 was 10.6 percentage points (8.6, 12.6) in study 1 and 12.5 percentage points (6.6, 18.3) in study 2.
Danish: Forskellen ved behandling med ivacaftor og placebo med hensyn til den gennemsnitlige absolutte ændring (95 % CI) i procent af forventet FEV1 fra baseline til og med uge 24 var 10,6 procentpoints (8,6; 12,6) i studie 1 og 12,5 procentpoints (6,6; 18,3) i studie 2.
English: • Blister card pack containing 28 film-coated tablets
Danish: • Blisterkortpakning med 28 filmovertrukne tabletter
English: No dose adjustment is considered necessary unless moderate hepatic impairment exists.
Danish: Dosisjustering anses for unødvendig, medmindre patienten har moderat nedsat leverfunktion.
English: No dose adjustment is considered necessary for patients with mild hepatic impairment.
Danish: En dosisjustering vurderes ikke nødvendig hos patienter med let nedsat leverfunktion.
English: Kalydeco 25 mg granules
Danish: Kalydeco 25 mg granulat
English: The mean absolute change from baseline through week 8 in percent predicted FEV1 (primary efficacy endpoint) was 7.5% in the ivacaftor period and -3.2% in the placebo period.
Danish: Den gennemsnitlige absolutte ændring fra baseline til og med uge 8 i procent af forventet FEV1 (primære virkningsendepunkt) var 7,5 % i ivacaftor-perioden, og -3,2 % i placeboperioden.
English: Kalydeco 50 mg granules
Danish: Kalydeco 50 mg granulat
English: The treatment difference between ivacaftor and placebo for the mean relative change (95% CI) in percent predicted FEV1 from baseline through week 24 was 17.1% (13.9, 20.2) in study 1 and 15.8% (8.4, 23.2) in study 2.
Danish: Forskellen ved behandling med ivacaftor og placebo med hensyn til den gennemsnitlige relative ændring (95 % CI) i procent af forventet FEV1 fra baseline til og med uge 24 var 17,1 % (13,9; 20,2) i studie 1 og 15,8 % (8,4; 23,2) i studie 2.
English: Tympanic membrane hyperaemia common
Danish: Hyperæmi af trommehinde almindelig
English: Caution is recommended in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2).
Danish: Der rådes til forsigtighed hos patienter med svært nedsat nyrefunktion (kreatininclearance under eller lig med 30 ml/min), eller med nyresygdom i slutstadiet (se pkt.
English: At the follow-up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -5.9% (9.4%).
Danish: Ved opfølgningsbesøget 4 uger efter afslutning på ivacaftor var den gennemsnitlige (SD) absolutte ændring i procent forventet FEV1 fra del 2 ved uge 16 -5,9 % (9,4 %).
English: Transaminase elevations very common
Danish: Stigninger i aminotransferaser meget almindelig
English: At the follow up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -7.4% (5.5%).
Danish: Ved opfølgningsbesøget 4 uger efter afslutning på ivacaftor var den gennemsnitlige (SD) absolutte ændring i procent forventet FEV1 fra del 2 ved uge 16 -7,4 % (5,5 %).
English: The dose of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5).
Danish: Dosis af Kalydeco (monoterapi eller i kombinationregime med tezacaftor/ivacaftor) skal justeres ved anvendelse sammen med potente eller moderate CYP3A-hæmmere (se pkt.
English: • Talk to your doctor if you have liver problems, or have previously had them.
Danish: • Kontakt lægen, hvis du har leverproblemer eller har haft det tidligere.
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 was -2.8 percentage points in the ivacaftor group and 3.5 percentage points in the placebo group.
Danish: Den gennemsnitlige absolutte ændring fra baseline til og med uge 24 i procent forventet FEV1 var -2,8 procentpoint i ivacaftorgruppen og 3,5 procentpoint i placebogruppen.
English: − Blister card pack containing 28 film-coated tablets
Danish: − Blisterkortpakning med 28 filmovertrukne tabletter
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients with baseline predicted FEV1 greater than 90% in study 2 was 6.9 percentage points (-3.8, 17.6).
Danish: Behandlingsforskellen mellem ivacaftor og placebo for den gennemsnitlige absolutte ændring (95 % CI) i procent af forventet FEV1 fra baseline til og med uge 24 hos patienter med forventet FEV1 ved baseline over 90 % i studie 2 var 6,9 procentpoint (-3,8; 17,6).
English: Table 5: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Danish: Tabel 5: Ivacaftors virkning på virkningsvariable i den samlede population og for specifikke CFTR-mutationer
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Danish: En tablet med tezacaftor 100 mg/ivacaftor 150 mg en gang dagligt
English: However, caution is recommended when administering ivacaftor to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Danish: Der rådes imidlertid til forsigtighed, når ivacaftor administreres til patienter med svært nedsat nyrefunktion (kreatininclearance under eller lig med 30 ml/min), eller med nyresygdom i slutstadiet (se pkt.
English: Headache very common
Danish: Hovedpine meget almindelig
English: Caution is recommended while using ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Danish: Der bør udvises forsigtighed, når ivacaftor, enten som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor, anvendes til patienter med svært nedsat nyrefunktion eller med nyresygdom i slutstadiet (se pkt.
English: Cmin, ss (ng/mL) AUCτ,ss (ng*h/mL)
Danish: Cmin, ss (ng/ml)
English: After oral administration of ivacaftor 150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Danish: Efter en oral administration af ivacaftor på 150 mg hver 12. time i 7 dage hos raske frivillige, som havde indtaget mad, var det gennemsnitlige (±SD) tilsyneladende fordelingsvolumen 353 (122) l.
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 (primary efficacy endpoint) was 2.57 percentage points in the ivacaftor group and 0.46 percentage points in the placebo group.
Danish: Den gennemsnitlige absolutte ændring fra baseline til og med uge 24 i procent forventet FEV1 (primært virkningsendepunkt) var 2,57 procentpoint i ivacaftorgruppen og 0,46 procentpoint i placebogruppen.
English: The mean absolute change from baseline through week 16 in percent predicted FEV1 (primary efficacy endpoint) was 1.5 percentage points in the ivacaftor group and -0.2 percentage points in the placebo group.
Danish: Den gennemsnitlige absolutte ændring fra baseline til og med uge 16 i procent af forventet FEV1 (primært endepunkt for virkning) var 1,5 procentpoints i ivacaftor-gruppen, og -0,2 procentpoints i placebo-gruppen.
English: Kalydeco 50 mg granules in sachet are white to off-white granules.
Danish: Kalydeco 50 mg granulat i brev er et hvidt eller off-white granulat.
English: Oropharyngeal pain very common
Danish: Orofaryngeale smerter meget almindelig
English: Kalydeco 25 mg granules in sachet are white to off-white granules.
Danish: Kalydeco 25 mg granulat i brev er et hvidt eller off-white granulat.
English: Kalydeco 150 mg film-coated tablets
Danish: Kalydeco 150 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD - 28-TABLET PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BLISTERKORT - PAKNING MED 28 TABLETTER
English: The mean (± SD) CL/F for a single 150 mg dose was 17.3 (8.4) L/hr in healthy subjects.
Danish: Den tilsyneladende clearance (CL/F) for ivacaftor var sammenlignelig for raske personer og for patienter med CF. Gennemsnits-CL/F (±SD) for en enkelt 150 mg dosis var 17,3 (8,4) l/t hos raske personer.
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see section 4.2)
Danish: Baseret på disse resultater anbefales et modificeret program med Kalydecoregime-monoterapi til patienter med moderat nedsat leverfunktion (se pkt.
English: If so, contact your child's doctor or pharmacist to ask for advice.
Danish: Hvis dit barn gør det, skal du spørge dit barns læge eller apotekspersonalet til råds.
English: Kalydeco 150 mg tablets ivacaftor
Danish: Kalydeco 150 mg tabletter ivacaftor.
English: Each sachet contains 109.8 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert brev indeholder 109,8 mg lactose (som monohydrat) Alle hjælpestoffer er anført under pkt.
English: • Blister pack containing 56 film-coated tablets
Danish: • Blisterpakning med 56 filmovertrukne tabletter
English: 12 months to less than 24 months (7 kg to < 14 kg)
Danish: 12 måneder til under 24 måneder (7 kg til <14 kg)
English: 6 months to less than 12 months (7 kg to < 14 kg)
Danish: 6 måneder til under 12 måneder (7 kg til <14 kg)
English: − Blister pack containing 56 film-coated tablets
Danish: − Blisterpakning med 56 filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL BREV
English: Giving Kalydeco to your child:
Danish: Sådan giver du Kalydeco til dit barn
English: • If you have any further questions, ask your child's doctor or pharmacist.
Danish: Er du i tvivl, så spørg dit barns læge.
English: Kalydeco 50 mg granules ivacaftor
Danish: Kalydeco 50 mg granulat ivacaftor.
English: ≥ 14 kg to < 25 kg 75 mg granules taken orally every 12 hours with fat-containing food
Danish: ≥14 kg til <25 kg 75 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: Ear congestion uncommon
Danish: Tilstoppet øre ikke almindelig
English: The dose of Kalydeco must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5).
Danish: Dosis af Kalydeco skal justeres ved anvendelse sammen med potente eller moderate CYP3Ahæmmere (se pkt.
English: ≥ 7 kg to < 14 kg 50 mg granules taken orally every 12 hours with fat-containing food
Danish: ≥7 kg til <14 kg 50 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: Kalydeco tablets are also indicated in a combination regimen with tezacaftor 100 mg/ivacaftor 150 mg tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E,
Danish: Kalydeco tabletter er også indiceret i et kombinationsregime med tezacaftor 100 mg/ivacaftor 150 mg tabletter til behandling af voksne og unge i alderen 12 år og ældre med cystisk fibrose (CF), som er homozygote for F508del-mutationen, eller som er heterozygote for F508del-mutationen og har en af de følgende mutationer i CFTR-genet: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G og 3849+10kbC→T.
English: Give Kalydeco to your child for as long as your child's doctor recommends.
Danish: Giv Kalydeco til dit barn så længe, som dit barns læge anbefaler det. Du må ikke stoppe, medmindre dit barns læge råder dig til det. Spørg dit barns læge eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: If you take more Kalydeco than you should
Danish: Hvis du har taget for meget Kalydeco
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BEHOLDERETIKET
English: Kalydeco 150 mg film-coated tablets ivacaftor
Danish: Kalydeco 150 mg filmovertrukne tabletter ivacaftor.
English: Kalydeco 75 mg granules ivacaftor
Danish: Kalydeco 75 mg granulat ivacaftor.
English: During the 48-week placebo-controlled studies 1 and 2 of ivacaftor monotherapy in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Danish: I løbet af de 48 ugers placebokontrollerede studier 1 og 2 af ivacaftor-monoterapi hos patienter i alderen 6 år og derover var forekomsten af maksimal aminotransferase (ALAT eller ASAT) >8, >5 eller >3 x øverste normal værdi (ULN) hhv. 3,7 %, 3,7 % og 8,3 % hos ivacaftor-behandlede patienter,
English: Each sachet contains 75 mg of ivacaftor.
Danish: Hvert brev indeholder 75 mg ivacaftor.
English: Each sachet of granules contains 75 mg of ivacaftor.
Danish: Hvert brev med granulat indeholder 75 mg ivacaftor.
English: Kalydeco 25 mg granules ivacaftor
Danish: Kalydeco 25 mg granulat ivacaftor.
English: 14 kg to less than 25 kg One sachet of 75 mg granules taken orally every 12 hours with fat-containing food
Danish: 14 kg til mindre end 25 kg Et brev med 75 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: ≥5 kg to < 7 kg 25 mg granules taken orally every 12 hours with fat-containing food
Danish: ≥5 kg til <7 kg 25 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: Based on clinical (percent predicted FEV1) and pharmacodynamic (sweat chloride) responses to ivacaftor, efficacy in patients with the G970R mutation could not be established.
Danish: Virkningen hos patienter med G970R-mutationen kan ikke klarlægges på basis af det kliniske (procent af forventet FEV1) og farmakodynamiske (svedchlorid) respons på ivacaftor.
English: Each sachet of granules contains 50 mg of ivacaftor.
Danish: Hvert brev med granulat indeholder 50 mg ivacaftor.
English: No dose adjustments are recommended for mild and moderate renal impairment.
Danish: Dosisjusteringer anbefales ikke for patienter med let til moderat nedsat nyrefunktion.
English: 5 kg to less than 7 kg One sachet of 25 mg granules taken orally every 12 hours with fat-containing food
Danish: 5 kg til mindre end 7 kg Et brev med 25 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: 7 kg to less than 14 kg One sachet of 50 mg granules taken orally every 12 hours with fat-containing food
Danish: 7 kg til mindre end 14 kg Et brev med 50 mg granulat, der tages oralt hver 12. time sammen med fedtholdig mad
English: Each sachet of granules contains 25 mg of ivacaftor.
Danish: Hvert brev med granulat indeholder 25 mg ivacaftor.
English: Posology
Danish: Prægeblæk
English: Nipple disorder uncommon
Danish: Sygdom i brystvorter ikke almindelig
English: If your child takes more Kalydeco than he/she should
Danish: Hvis dit barn har taget for meget Kalydeco
English: Each sachet contains 50 mg of ivacaftor.
Danish: Hvert brev indeholder 50 mg ivacaftor.
English: Each sachet contains 25 mg of ivacaftor.
Danish: Hvert brev indeholder 25 mg ivacaftor.
English: Caution is recommended while using ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Danish: Der bør udvises forsigtighed, når ivacaftor anvendes til patienter med svært nedsat nyrefunktion eller med nyresygdom i slutstadiet (se pkt.
English: Adults (≥ 18 years old) n = 389
Danish: n=389
English: The use of Kalydeco in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see section 4.2 and section 4.4).
Danish: Kalydeco anbefales derfor ikke til patienter med svært nedsat leverfunktion, medmindre fordelene opvejer risiciene (se pkt.
English: • Talk to your doctor if you have kidney problems, or have previously had them.
Danish: • Kontakt lægen, hvis du har nyreproblemer eller har haft det tidligere.
English: Study 6: study in patients with CF with an R117H mutation in the CFTR gene
Danish: Studie 6: studie med patienter med CF i med en R117H-mutation i CFTR-genet Studie 6 var en evaluering af 69 patienter i alderen 6 år eller derover.
English: Kalydeco 75 mg granules in sachet ivacaftor
Danish: Kalydeco 75 mg granulat i brev ivacaftor
English: Study 1 evaluated 161 patients who were 12 years of age or older; 122 (75.8%) patients had the F508del mutation in the second allele.
Danish: Studie 1 evaluerede 161 patienter, som var i alderen 12 år eller derover.
English: At baseline, mean predicted FEV1 was 84.2% (range: 44.0% to 133.8%) and mean age was 9 years (range: 6 to 12 years); 8 (30.8%) patients in the placebo group and 4 (15.4%) patients in the ivacaftor group had an FEV1 less than 70% predicted at baseline.
Danish: 8 (30,8 %) patienter i placebogruppen og 4 (15,4 %) patienter i ivacaftor-gruppen havde en FEV1 under 70 % af den forventede ved baseline.
English: Transaminase elevations
Danish: Nedsat nyrefunktion
English: Kalydeco tablets are indicated for the treatment of adults, adolescents and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Danish: Kalydeco tabletter er indiceret til behandling af voksne, unge og børn i alderen 6 år og derover, der vejer 25 kg eller mere, med cystisk fibrose (CF), som har en af de følgende gating-mutationer i CFTRgenet: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N eller S549R.
English: • Breast mass
Danish: • tilstoppede bihuler
English: 25 mg q12h 336
Danish: 25 mg hver 12. time
English: Kalydeco granules are indicated for the treatment of infants aged at least 6 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Danish: Kalydeco-granulat er indiceret til behandling af spædbørn i alderen mindst 6 måneder, småbørn og børn, der vejer fra 5 kg til mindre end 25 kg, med cystisk fibrose (CF), som har en af de følgende gating (klasse III)-mutationer i CFTR-genet: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N eller S549R (se pkt.
English: Kalydeco tablets are indicated for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Danish: Kalydeco tabletter er indiceret til behandling af voksne, unge og børn i alderen 6 år og derover, der vejer 25 kg eller mere, med cystisk fibrose (CF), som har en af de følgende gating (klasse III)mutationer i CFTR-genet: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N eller S549R (se pkt.
English: Kalydeco granules are indicated for the treatment of babies and children aged 6 months and older and weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Danish: Kalydeco-granulat anvendes til behandling af spædbørn og børn i alderen 6 måneder og derover, der vejer fra 5 kg til mindre end 25 kg, med cystisk fibrose (CF), som har en af de følgende gatingmutationer i CFTR-genet: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N eller S549R.
English: Endpoint
Danish: Endepunkt
English: • Bottle containing 56 film-coated tablets
Danish: • Beholder med 56 filmovertrukne tabletter
English: Concomitant use of CYP3A inhibitors
Danish: Anvendelse sammen med CYP3A-hæmmere
English: − Bottle containing 56 film-coated tablets
Danish: − Beholder med 56 filmovertrukne tabletter
English: Study 6 evaluated 69 patients who were 6 years of age or older; 53 (76.8%) patients had the F508del mutation in the second allele.
Danish: Den gennemsnitlige (SD) kropsvægt var 30,9 (8,63) kg, 42 (80,8 %) patienter havde F508del-mutationen i den anden allel.
English: Take Kalydeco for as long as your doctor recommends.
Danish: Tag Kalydeco så længe, som lægen anbefaler det. Du må ikke stoppe, medmindre lægen råder dig til det. Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: In study 4 patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
Danish: behandlingsvarigheden med ivacaftor var mindst 96 uger for patienter i placebo/ivacaftor-gruppen, og mindst 144 uger for patienter i ivacaftor/ivacaftor-gruppen.
English: The recommended dose is one Kalydeco 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food (see Method of administration).
Danish: Kalydeco-monoterapi til voksne, unge og børn i alderen 6 år og ældre, der vejer 25 kg eller derover Den anbefalede dosis er én Kalydeco 150 mg tablet, der tages oralt hver 12. time (i alt en daglig dosis på 300 mg) sammen med fedtholdig mad (se Administration).
English: • Redness inside the ear
Danish: • tilstoppede ører
English: Breast mass common
Danish: Øresmerter almindelig
English: Kalydeco 50 mg granules in sachet ivacaftor
Danish: Kalydeco 50 mg granulat i brev ivacaftor.
English: Kalydeco 25 mg granules in sachet ivacaftor
Danish: Kalydeco 25 mg granulat i brev ivacaftor.
English: 2 AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms)
Danish: 2 AS01B adjuvanssystem består af planteekstrakt Quillaja saponaria Molina, fraktion 21 (QS-21) (50 mikrogram) og 3-O-desacyl-4'-monophosphoryllipid A (MPL) fra Salmonella minnesota (50 mikrogram).
English: --¹ After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen1 adjuvanted with AS01B2.
Danish: --1 Efter rekonstitution indeholder 1 dosis (0,5 ml) 50 mikrogram gE antigen1 adjuveret med ASO1B2.
English: 1 Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by recombinant DNA technology in Chinese Hamster Ovarian (CHO) cells
Danish: 1 Varicella zoster-virus (VZV) glykoprotein E (gE) produceret i ovarieceller fra kinesisk hamster (CHO) med rekombinant DNA-teknologi.
English: Alecensa received a marketing authorisation valid throughout the EU on 16 February 2017.
Danish: Alecensa modtog en markedsføringstilladelse med gyldighed i hele EU den 16. februar 2017.
English: In certain cases treatment should be permanently stopped.
Danish: I visse tilfælde bør behandlingen standses fuldstændigt.
English: Further information on Alecensa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Alecensa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.