FrancophonIA/ELRC3.0 huggingface dataset:
English: Eye disorders Vision disorders3)
Danish: Øjne Synsforstyrrelser3)
English: These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin)
Danish: itraconazol, voriconazol, posaconazol) og medicin mod bestemte bakterielle infektioner
English: CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Danish: CNS-objektiv responsrate for patienter med målbare og ikke-målbare CNSmetastaser ved baseline (uafhængig bedømmelseskomité)
English: Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment.
Danish: Alecensa kan give alvorlige og livstruende hævelser i lungerne (inflammation).
English: 79639 Grenzach-Wyhlen
Danish: 79639 Grenzach-Whylen
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Danish: På baggrund af virkningen på den samlede eksponering af alectinib og M4 er dosisjustering ikke nødvendig, når Alecensa administreres samtidig med CYP3A-induktorer.
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
Danish: Startdosis til patienter med svært nedsat leverfunktion (Child-Pugh C) er 450 mg 2 gange dagligt (dosis i alt er 900 mg) (se pkt.
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Danish: På baggrund af virkningen på den samlede eksponering af alectinib og M4 er dosisjustering ikke nødvendig, når Alecensa administreres sammen med CYP3A-hæmmere.
English: If you vomit after taking Alecensa
Danish: Hvis du kaster op, efter du har taget Alecensa
English: Patient demographics were consistent with that of a NSCLC ALK positive population.
Danish: De patientdemografiske data svarede til data for en ikke-småcellet lungekræft ALK-positiv population.
English: The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects.
Danish: De farmakokinetiske parametre for alectinib og den vigtigste aktive metabolit (M4) er karakteriseret hos patienter med ALK-positiv ikke-småcellet lungekræft og raske frivillige.
English: ● Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
Danish: ● Kapselskal: hypromellose, carrageenan, kaliumchlorid, titandioxid (E171), majsstivelse og carnaubavoks
English: Other medicines and Alecensa
Danish: Brug af anden medicin sammen med Alecensa
English: A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients.
Danish: En valideret ALK-test er nødvendig for at udvælge patienter med ALK-positiv ikke-småcellet lungekræft.
English: When you take Alecensa your doctor will do blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
Danish: Lægen vil tage blodprøver, inden du begynder behandlingen med Alecensa, hver 2. uge i de første 3 måneder af behandlingen og derefter med længere mellemrum.
English: ● If Alecensa is packed in bottles, store in the original package and keep the bottle tightly closed to protect from moisture.
Danish: ● Hvis Alecensa er pakket i beholder, skal det opbevares i den original pakning og hold beholderen tæt lukket for at beskytte mod fugt.
English: Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8).
Danish: Der er rapporteret tilfælde af interstitiel lungesygdom/pneumonitis i kliniske studier med Alecensa (se pkt.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du har flere spørgsmål til brugen af denne medicin, skal du kontakte lægen, sundhedspersonalet eller apotekspersonalet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En hård kapsel indeholder alectinibhydrochlorid svarende til 150 mg alectinib.
English: In 1.2% and 1.5% of the patients, AST and ALT elevations, respectively, led to withdrawal from Alecensa treatment.
Danish: Henholdsvis 1,2% og 1,5% af patienterne seponerede Alecensa på grund af forhøjet ASAT og ALAT.
English: Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Danish: Der blev rapporteret grad 3-tilfælde af diarré (0,7%), kvalme (0,5%) og opkastning (0,2%).
English: Tell your doctor straight away if you have any new or worsening signs including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Danish: Kontakt straks lægen, hvis du oplever nye eller forværrede symptomer, for eksempel vejrtrækningsbesvær, åndenød eller hoste med eller uden slim, eller hvis du får feber.
English: Alecensa 600 mg twice daily
Danish: Alecensa 600 mg, 2 gange dagligt
English: Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
Danish: Selvom farmakokinetiske simulationer for Alecensa ikke indikerer lav eksponering hos patienter med ekstrem kropsvægt (dvs. >130 kg), har alectinib et stort fordelingsvolumen.
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
Danish: LÆGEMIDLETS NAVN Alecensa 150 mg hårde kapsler
English: How Alecensa works
Danish: Sådan virker Alecensa
English: Alectinib steady-state is reached within 7 days with continuous 600 mg twice daily dosing.
Danish: Ved vedvarende dosering af alectinib 600 mg 2 gange dagligt nås steady state inden for 7 dage.
English: ● abnormal results of blood tests to check for liver disease or bone disorders (high level of alkaline phosphatase)
Danish: ● unormale værdier af en blodprøve til kontrol af leversygdomme eller knoglesygdomme (høje værdier af alkalisk fosfatase)
English: Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Danish: Afbryd behandlingen indtil bedring til grad ≤1 (asymptomatisk) bradykardi eller til en hjertefrekvens på ≥60 slag per minut.
English: ● lapatinib, a medicine used to treat certain types of breast cancer
Danish: ● lapatinib, medicin mod bestemte typer brystkræft
English: Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at reduced dose as per Table 1.
Danish: Afbryd behandlingen indtil bedring til baselineniveau eller ≤2,5 gange øvre referencegrænse; herefter genoptages behandlingen med reduceret dosis i overensstemmelse med Tabel 1.
English: Based on a population pharmacokinetic analysis alectinib and M4 exposures were similar in patients with mild and moderate renal impairment and normal renal function.
Danish: Baseret på en farmakokinetisk populationsanalyse svarer eksponeringen af alectinib og M4 hos patienter med let og moderat nedsat nyrefunktion til eksponeringen hos patienter med normal nyrefunktion.
English: SPECIAL STORAGE CONDITIONS Store in the original package and keep the bottle tightly closed in order to protect from moisture
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar i den originale pakning og hold beholderen tæt lukket for at beskytte mod fugt
English: The safety profile of Alecensa was generally consistent across the pivotal phase III clinical trial BO28984 (ALEX) and phase II trials (NP28761, NP28673).
Danish: Sikkerhedsprofilen af Alecensa var generelt tilsvarende i det pivotale fase III kliniske studie BO28984 (ALEX) og i fase II-studier (NP28761, NP28673).
English: For all patients with hepatic impairment, appropriate monitoring (e.g. markers of liver function) is advised, see section 4.4.
Danish: Der anbefales passende monitorering (fx markører for leverfunktionen) for alle patienter med nedsat leverfunktion, se pkt.
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at reduced dose (see Table 1) upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
Danish: Hvis anden samtidig lægemiddelbehandling identificeres som bidragende til tilstanden, og denne seponeres, eller dosis heraf justeres, kan behandling med Alecensa genoptages med reduceret dosis (se Tabel 1), når bradykardien er af grad ≤1 (asymptomatisk) eller ved en hjertefrekvens på ≥60 slag per minut, med hyppig monitorering som klinisk indiceret.
English: ● abnormal results of blood tests to check for muscle damage (high level of creatine phosphokinase)
Danish: ● unormale resultater af blodprøver til vurdering af muskelskader (højt niveau af kreatinkinase)
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
Danish: Patienterne skal monitoreres for pulmonale symptomer indikative for pneumonitis (se pkt.
English: Study NP28761 was a Phase I/II single arm multicentre study conducted in patients with ALK positive advanced NSCLC who have previously progressed on crizotinib treatment.
Danish: Studie NP28761 var et enkeltarmet fase I/II-multicenterstudie med patienter med ALK-positiv fremskreden ikke-småcellet lungekræft, der har oplevet progression under behandling med crizotinib.
English: ● weight gain.
Danish: ● vægtstigning
English: Alecensa 150 mg hard capsules alectinib
Danish: Alecensa 150 mg hårde kapsler alectinib
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies (see section 5.3).
Danish: I de generelle toksicitetsstudier er der ikke observeret negative virkninger på reproduktionsorganer hos hanner eller hunner (se pkt.
English: Red iron oxide (E172) Yellow iron oxide (E172) Indigo carmine aluminum lake (E132) Carnauba wax
Danish: Rød jernoxid (E172) Gul jernoxid (E172) Indigocarminaluminium lake (E132) Carnaubavoks
English: Study NP28673 was a Phase I/II single arm, multicentre study conducted in patients with ALK-positive advanced NSCLC who have previously progressed on crizotinib treatment.
Danish: Studie NP28673 var et enkeltarmet fase I/II-multicenterstudie med patienter med ALK-positiv fremskreden ikke-småcellet lungekræft, der har oplevet progression under tidligere crizotinibbehandling.
English: Alecensa contains sodium
Danish: Alecensa indeholder natrium
English: Oral contraceptives If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Danish: Hvis du bruger oral prævention (såsom p-piller), mens du er i behandling med Alecensa, kan præventionen være mindre sikker.
English: Co-administration of multiple oral doses of 400 mg posaconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 300 mg alectinib increased alectinib exposure Cmax and AUCinf by 1.18 and 1.75-fold respectively, and reduced M4 Cmax and AUCinf by 71% and 25% respectively.The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax by 7% and increasing AUCinf 1.36-fold.
Danish: Samtidig administration af gentagne orale doser af 400 mg posaconazol 2 gange dagligt, en potent CYP3A-hæmmer, og en enkelt oral dosis af 300 mg alectinib øgede alectinib-Cmax og -AUCinf henholdsvis 1,18- og 1,75-fold og reducerede M4-Cmax og -AUCinf henholdsvis 71% og 25%.
English: Stomatitis 5)
Danish: Ødem10)
English: Photosensitivity to sunlight has been reported with Alecensa administration (see section 4.8).
Danish: Der er rapporteret tilfælde af øget følsomhed for sollys i forbindelse med Alecensa (se pkt.
English: Cases of myalgia (28%) including myalgia events (22%) and musculoskeletal pain (7.4%) have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Danish: Der er rapporteret tilfælde af myalgi (28%), herunder myalgi-hændelser (22%) og muskuloskeletale smerter (7,4%) hos patienter, der i de kliniske fstudier (NP28761, NP28673, BO28984) er behandlet med Alecensa.
English: ● abnormal results of blood tests to check kidney function (high level of creatinine)
Danish: ● unormale værdier af en blodprøve til kontrol af nyrefunktionen (høje værdier af kreatinin)
English: Based on a population pharmacokinetic analysis, alectinib and M4 exposures were similar in patients with mild hepatic impairment and normal hepatic function.
Danish: Baseret på en farmakokinetisk populationsanalyse svarer eksponeringen af alectinib og M4 hos patienter med let nedsat leverfunktion til eksponeringen hos patienter med normal leverfunktion.
English: The co-primary endpoint was to evaluate the ORR as per central IRC assessment using RECIST 1.1 in patients with prior exposure of cytotoxic chemotherapy treatments.
Danish: Det co-primære endepunkt var at evaluere objektiv responsrate, bedømt af uafhængig bedømmelseskomité ved anvendelse af RECIST, version 1.1, hos patienter, der tidligere havde været behandlet med cytotoksisk kemoterapi.
English: Across clinical trials (NP28761, NP28673, BO28984), 1 out of 405 patients treated with Alecensa (0.2%) had a Grade 3 ILD.
Danish: I studierne (NP28761, NP28673, BO28984) oplevede 1 ud af 405 patienter behandlet med Alecensa (0,2%) interstitiel lungesygdom af grad 3.
English: Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Danish: En hård kapsel indeholder alectinibhydrochlorid svarende til 150 mg alectinib.
English: Median time to onset for constipation, nausea, diarrhea, and/or vomiting events across clinical trials (NP28761, NP28673, BO28984) was 21 days.
Danish: Mediantiden til debut af obstipation, kvalme, diarré og/eller opkastning i de kliniske studier (NP28761, NP28673, BO28984) var 21 dage.
English: N=122
Danish: N=122a
English: Across clinical trials (NP28761, NP28673, BO28984) two patients with Grade 3-4 AST/ALT elevations had documented drug induced liver injury by liver biopsy.
Danish: I studierne (NP28761, NP28673,BO28984) havde 2 patienter grad 3-4 ASAT/ALAT-stigninger med dokumenteret lægemiddelinduceret leverskade ved leverbiopsi.
English: Patients should be monitored for liver function including ALT, AST, and total bilirubin as outlined in section 4.4 and managed as recommended in section 4.2.
Danish: Patienternes leverfunktion bør monitoreres, inklusive ALAT, ASAT og total-bilirubin, som beskrevet i pkt.
English: Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase'.
Danish: Alecensa blokerer virkningen af enzymet ALK-tyrosinkinase.
English: 450 mg twice daily
Danish: 450 mg 2 gange dagligt
English: In the phase III clinical trial BO28984 15% of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 20% of patients treated with crizotinib.
Danish: I det fase-III kliniske studie BO28984 havde 15% af patienterne, som fik Alecensa, en post-dosis hjertefrekvens på under 50 slag per minut versus 20% af patienterne, som fik crizotinib.
English: Female patients of child-bearing potential receiving Alecensa, must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa (see sections 4.6 and 5.3).
Danish: Fertile kvindelige patienter skal anvende højeffektiv prævention under behandling med Alecensa og i mindst 3 måneder efter sidste dosis (se pkt.
English: ● Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: The data described below reflect exposure to Alecensa in 405 patients with ALK-positive advanced NSCLC who participated in one randomised Phase III clinical trial (BO28984) and in two single-arm phase II clinical trials (NP28761, NP28673).
Danish: Data beskrevet nedenfor afspejler Alecensa-eksponering hos 405 patienter med ALK-positiv fremskreden ikke-småcellet lungekræft i et randomiseret fase-III klinisk studie (BO28984) og to enkeltarmede fase-II studier (NP28761, NP28673).
English: ● Keep this medicine out of the sight and reach of children.
Danish: ● Opbevar lægemidlet utilgængeligt for børn.
English: 12-month cumulative incidence of CNS progression (IRC) [95% CI]
Danish: Kumulativ incidens af CNSprogression ved 12 måneder (uafhængig bedømmelseskomité) [95% konfidensinterval]
English: Table 4 Summary of efficacy results from study BO28984 (ALEX)
Danish: Tabel 4 Oversigt over effektresultater fra studie BO28984 (ALEX) Crizotinib N=151
English: Stratified log-rank p-value p <0.0001
Danish: Årsagsspecifik Hazardratio [95% konfidensinterval] Stratificeret log-rank p-værdi p < 0,0001
English: The subjects in the Child Pugh B group however did in general not suffer from abnormal bilirubin, albumin or prothrombin time, indicating that they may not be fully representative of moderately hepatically impaired subjects with decreased metabolic capacity.
Danish: Forsøgspersonerne i Child Pugh B-gruppen havde dog generelt ikke unormale værdier af bilirubin, albumin eller prothrombin-tid,
English: ● Alecensa is taken by mouth.
Danish: ● Alecensa skal synkes.
English: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the ULN as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alecensa (see section 4.8).
Danish: I pivotale kliniske studier med Alecensa er der set stigninger i alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT) over 5 x øvre referencegrænse såvel som stigninger i bilirubin på mere end 3 x øvre referencegrænse (se pkt.
English: Concurrent elevations in ALT or AST greater than or equal 3 times the ULN and total bilirubin greater than or equal 2 times the ULN, with normal alkaline phosphatase, occurred in one patient treated in Alecensa clinical trials.
Danish: Samtidig stigning i ALAT eller ASAT ≥3 gange øvre referencegrænse og total-bilirubin ≥2 gange øvre referencegrænse med samtidig normal alkalisk fosfatase sås hos 1 patient behandlet med Alecensa i kliniske studier.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget for krav for brailleskrift
English: ● topotecan, a medicine used to treat certain types of cancer
Danish: ● topotecan, medicin mod bestemte typer kræft.
English: Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Danish: Alecensa er indiceret som monoterapi til behandling af voksne patienter med ALK-positiv, fremskreden ikke-småcellet lungekræft tidligere behandlet med crizotinib.
English: Table 3 ADRs reported in Alecensa clinical trials (NP28761, NP28673, BO28984; N=405) and during post-marketing
Danish: Tabel 3 Bivirkninger rapporteret i Alecensa studierne (NP28761, NP28673, BO28984; n=405) og efter markedsføring hos patienter, der fik Alecensa
English: Interstitial lung disease / pneumonitis
Danish: Interstitiel lungesygdom /pneumonitis
English: CPK elevation > 10 times ULN or second occurrence of CPK elevation of > 5 times ULN
Danish: CK-stigning >10 gange øvre referencegrænse eller 2. gang, der forekommer CK-stigning >5 gange øvre referencegrænse
English: Hypersensitivity to alectinib or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for alectinib eller over for et eller flere af hjælpestofferne anført i pkt.
English: Blisters: Store in the original package in order to protect from moisture.
Danish: Blisterpakning: Opbevares i originalpakningen for at beskytte mod fugt.
English: ● liver injury (hepatotoxicity).
Danish: ● leverskade (levertoksicitet).
English: Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig for arvelig lactasemangel (Lapp Lactase deficiency) eller glucosegalactose-malabsorption.
English: ● mitoxantrone, a medicine used to treat certain types of cancer or autoimmune diseases (e.g.
Danish: ● mitoxantron, medicin mod bestemte typer kræft og autoimmune sygdomme (fx sklerose)
English: ● if you have an inherited problem called ‘galactose intolerance', ‘congenital lactase deficiency' or
Danish: ● hvis du lider af galactoseintolerans (arvelig), medfødt lactasemangel eller glucose-galactose malabsorption.
English: ● rapid loss of kidney function (kidney problems).
Danish: ● hurtig nyrefunktionstab (nyreproblemer)
English: Temporarily withhold until recovery to baseline or to ≤ 2.5 times ULN, then resume at the same dose.
Danish: CK-stigning > 5 gange øvre referencegrænse Afbryd behandlingen indtil bedring til baselineniveau eller ≤2,5 gange øvre referencegrænse; herefter genoptages behandlingen med samme dosis.
English: Alecensa treatment modified, resume at reduced dose (see Table 1)
Danish: Herefter genoptages behandling med reduceret dosis (se Tabel 1).
English: The safety and efficacy of Alecensa in ALK-positive NSCLC patients pre-treated with crizotinib were studied in two Phase I/II clinical trials (NP28673 and NP28761).
Danish: Patienter, der tidligere er behandlet med crizotinib Alecensas sikkerhed og virkning hos patienter med ALK-positiv ikke-småcellet lungekræft, der tidligere er behandlet med crizotinib, er undersøgt i to kliniske fase I/II-studier (NP28673 og NP28761).
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies.
Danish: I generelle toksikologiske studier er der ikke observeret indvirkning på hanners eller hunners reproduktionsorganer.
English: The primary endpoint was to evaluate the efficacy of Alecensa by ORR as per central IRC assessment using RECIST version 1.1.
Danish: Det primære endepunkt var at evaluere virkning af Alecensa ved objektiv responsrate, bedømt af en central uafhængig bedømmelseskomité ved anvendelse af RECIST, version 1.1.
English: ● If it is less than 6 hours until your next dose, skip the missed dose.
Danish: ● Hvis der er mindre end 6 timer til din næste dosis, skal du springe den glemte dosis over og bare tage næste dosis til almindelig tid.
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Danish: Hvis anden samtidig lægemiddelbehandling identificeres som bidragende til tilstanden, og denne seponeres, eller dosis heraf justeres, kan behandling med Alecensa genoptages med den tidligere dosis, når bradykardien er af grad ≤1 (asymptomatisk) eller ved en hjertefrekvens på ≥60 slag per minut.
English: rheumatoid arthritis)
Danish: (antibiotika som telithromycin)
English: Primary efficacy parameters ORR (IRC) in RE population Responders N (%) [95% CI]
Danish: Objektiv responsrate (uafhængig bedømmelseskomité) i RE-populationen Respondere N (%) [95% konfidensinterval]
English: 300 mg twice daily
Danish: 300 mg 2 gange dagligt
English: ● methotrexate, a medicine used to treat certain types of cancer or to treat autoimmune diseases (e.g.
Danish: ● methotrexat, medicin mod bestemte typer kræft og autoimmune sygdomme (fx leddegigt)
English: ALK (‘anaplastic lymphoma kinase'), see ‘How Alecensa works', below
Danish: Læs mere i afsnittet ‘Sådan virker Alecensa' nedenfor
English: The majority of these events were of Grade 1 and 2 intensity, and events of Grade ≥ 3 were reported in 3.7% and 3.7% of the patients, respectively.
Danish: Bivirkninger af grad ≥3 blev rapporteret hos henholdsvis 3,7% og3,7% af patienterne.
English: How to take Alecensa
Danish: Sådan skal du tage Alecensa