FrancophonIA/ELRC3.0 huggingface dataset:
English: Elimination Following administration of a single dose of 14C-labeled alectinib administered orally to healthy subjects the majority of radioactivity was excreted in faeces (mean recovery 97.8%) with minimal excretion in urine (mean recovery 0.46%).
Danish: Elimination Efter administration af en enkelt oral dosis 14C-mærket alectinib til raske frivillige udskiltes størstedelen af radioaktiviteten i fæces (gennemsnitlig genfindelse 97,8%) med minimal udskillelse i urinen (gennemsnitlig genfindelse 0,46%).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Alecensa in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Alecensa i alle undergrupper af den pædiatriske population ved lungekarcinom (småcellet og ikke-småcellet karcinom) (se pkt.
English: Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay but induced a slight increase in numerical aberrations in the in vitro cytogenetic assay using Chinese Hamster Lung (CHL) cells with metabolic activation, and micronuclei in a rat bone marrow micronucleus test.
Danish: Alectinib var ikke mutagent in vitro i en bakteriel tilbagemutationstest (Ames), men inducerede en svag stigning i numeriske afvigelser i den cytogene in vitro test i kinesiske hamsterlunge (CHL)-celler med metabolisk aktivering og i mikronuklei i en mikronukleustest i knoglemarv fra rotter.
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:
Danish: Lægen kan vælge at nedsætte dosis, afbryde behandlingen i en kortere periode eller at stoppe behandlingen helt:
English: ILD/pneumonitis of any severity grade
Danish: ILD/pneumonitis af enhver sværhedsgrad
English: ● severe muscle pain, tenderness, and weakness (myalgia).
Danish: ● svære smerter, ømhed og svaghed i musklerne (myalgi).
English: (range 0.5 - 29.0)
Danish: (interval 0,5 - 29,0)
English: No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Danish: Nedsat leverfunktionJustering af startdosis er ikke nødvendig hos patienter med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion.
English: Grade 4 (life-threatening consequences, urgent intervention indicated)
Danish: Bradykardia grad 4 (livstruende, akut intervention indiceret)
English: The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56).
Danish: Kapslerne leveres i blisterkort og fås i pakning med 224 hårde kapsler (4 pakker a 56).
English: If you are able to become pregnant, you must use highly effective contraception while on treatment and for at least 3 months after stopping treatment.
Danish: Hvis du kan blive gravid, skal du bruge meget sikker prævention, mens du er i behandling og i mindst 3 måneder efter, du har afsluttet behandlingen.
English: The major metabolite of alectinib (M4) has shown similar in vitro potency and activity.
Danish: Den primære metabolit af alectinib (M4) har udvist tilsvarende potens og aktivitet in vitro.
English: Your doctor will take 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 en blodprøve, inden du begynder behandlingen, hver 2. uge i de første 3 måneder af behandlingen og derefter med længere mellemrum.
English: Based on its mechanism of action, Alecensa may cause foetal harm when administered to a pregnant woman.
Danish: Baseret på virkningsmekanismen kan Alecensa skade fostret, hvis det gives til en gravid kvinde.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Det er særligt vigtigt, at du fortæller lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.
Danish: Alectinib er en yderst selektiv og potent hæmmer af ALK- og RET-tyrosinkinase.
English: The demographic characteristics of the overall study population were 84% Caucasian, 8% Asian, 55% females.
Danish: De demografiske karakteristika for den fulde studiepopulation var 84% var kaukasere, 8% asiater og 55% kvinder; medianalderen var 54 år.
English: ● nefazodone, a medicine used to treat depression
Danish: ● nefazodon, medicin mod depresssion
English: Heart rate less than 60 beats per minute (bpm).
Danish: Hjertefrekvens under 60 slag per minut.
English: Alecensa has not been studied in children or adolescents.
Danish: Børn og unge Alecensa er ikke undersøgt hos børn og unge.
English: Effects of alectinib on other medicinal products
Danish: Alectinibs indvirkning på andre lægemidler
English: A summary of pooled analysis of CNS endpoints is presented in Table 6.
Danish: Tabel 6 indeholder en oversigt over en poolet analyse af CNS-endepunkter.
English: ● slow heart beat (bradycardia).
Danish: ● langsom hjerterytme (bradykardi).
English: The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax and AUCinf by 4% and 18%, respectively.
Danish: Effekten på den samlede eksponering af alectinib og M4 var begrænset, idet Cmax og AUCinf reduceredes med henholdsvis 4% og 18%.
English: Figure 1: Kaplan Meier Plot of INV Assessed PFS in BO28984 (ALEX)
Danish: Figur 1: Kaplan Meier-plot af progressionsfri overlevelse vurderet af investigator i BO28984 (ALEX)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1169/001
English: Talk to your doctor, pharmacist or nurse before taking Alecensa:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Alecensa:
English: Alecensa can cause severe or life-threatening inflammation of the lungs during treatment.
Danish: Alecensa kan forårsage svær og livstruende inflammation i lungerne under behandlingen.
English: Increased hepatic alkaline phosphatase (ALP) and direct bilirubin as well as vacuolation/degeneration/necrosis of bile duct epithelium and enlargement/focal necrosis of hepatocytes was observed in rats and/or monkeys at exposures equal to or greater than 20-30% of the human exposure by AUC at the recommended dose.
Danish: Forhøjet hepatisk alkalisk fosfatase (ALP) og konjugeret bilirubin såvel som vakuolation/degeneration/nekrose af galdevejsepitel og forstørrelse/fokal nekrose af hepatocytter blev observeret hos rotter og/eller aber ved eksponeringer svarende til eller højere end 20-30% af den humane eksponering (AUC ved den anbefalede dosis.
English: ● medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
Danish: ● medicin mod tuberkulose (fx rifampicin, rifabutin)
English: Effects of other medicinal products on alectinib
Danish: Andre lægemidlers virkning på alectinib
English: In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations.
Danish: In vitro studier viser, at hverken alectinib eller den aktive hovedmetabolit (M4) hæmmer CYP1A2, CYP2B6, CYP2C9, CYP2C19 eller CYP2D6 ved klinisk relevante koncentrationer.
English: Multiple doses of esomeprazole, a proton pump inhibitor, 40 mg once daily, demonstrated no clinically relevant effect on the combined exposure of alectinib and M4.
Danish: Gentagne doser af esomeprazol 40 mg én gang dagligt, en protonpumpehæmmer, har ikke vist klinisk relevant indvirkning på den samlede eksponering af alectinib og M4.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: ● Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Negligible amounts of alectinib and the active metabolite M4 are excreted unchanged in urine (< 0.2%
Danish: En ubetydelig del af alectinib og den aktive metabolit M4 udskilles uomdannet i urinen (<0,2% af dosis).
English: The trial met its primary endpoint at the primary analysis, demonstrating a statistically significant improvement in PFS by investigator.
Danish: Studiet opfyldte det primære endepunkt ved den primære analyse, hvor der påvistes en statistisk signifikant forbedring i progressionsfri overlevelse, vurderet af investigator.
English: ● Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose'), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium'), magnesium stearate and carmellose calcium
Danish: ● Kapselindhold: lactosemonohydrat (se afsnit 2 ‘Alecensa indeholder lactose'), hydroxypropylcellulose, natriumlaurilsulfat (se afsnit 2 ”Alecensa indeholder natrium”, magnesiumstearat og carmellosecalcium
English: In faeces, 84% and 5.8% of the dose was excreted as unchanged alectinib or M4, respectively.
Danish: Henholdsvis 84% og 5,8% af dosis udskiltes som uomdannet alectinib og M4.
English: ● If it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
Danish: ● Hvis der er mere end 6 timer til din næste dosis, skal du tage den manglende dosis straks, du kommer i tanker om det.
English: The incidence of Grade 3 elevations of CPK was 3.7%.
Danish: Forekomst af grad 3-stigning i kreatinkinase var 3,7%.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1169/002
English: ● inflammation of the mucous membrane of the mouth
Danish: ● betændelse i slimhinderne i munden
English: [95% CI]
Danish: [95% konfidensinterval]
English: Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa.
Danish: Du vil få taget blodprøver mindst hver 2. uge i den første måned og derefter efter behov under resten af behandlingen med Alecensa.
English: In the pivotal Alecensa clinical trials it was reported that three patients with Grade 3-4 AST/ALT elevations had drug induced liver injury.
Danish: I de pivotale kliniske studier med Alecensa er der rapporteret 3 patienter med grad 3-4 ASAT/ALAT-stigning som havde lægemiddelinduceret leverskade.
English: In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
Danish: Hos drægtige kaniner forårsagede alectinib embryo-føtalt tab, små fostre og øget forekomst af skeletale variationer ved eksponeringer 2,9 gange den humane eksponering (AUC) ved den anbefalede dosis.
English: CTCAE grade
Danish: CTCAE-grad
English: What Alecensa contains
Danish: Alecensa indeholder
English: 240 hard capsules
Danish: 240 hårde kapsler
English: ● This means you take a total of 6 capsules (900 mg) each day.
Danish: ● Det betyder, at du skal tage 6 kapsler (900 mg) hver dag.
English: Severe ILD/pneumonitis occurred in patients treated with Alecensa.
Danish: Der er observeret tilfælde af svær interstitiel lungesygdom/pneumonitis hos patienter behandlet med Alecensa.
English: In pregnant rats, alectinib caused total embryo-foetal loss (miscarriage) at exposures 4.5-fold of the human AUC exposure and small foetuses with retarded ossification and minor abnormalities of the organs at exposures 2.7-fold of the human AUC exposure.
Danish: Hos drægtige rotter forårsagede alectinib totalt embryo-føtalt tab (abort) ved eksponeringer 4,5 gange den humane eksponering (AUC) samt små fostre med forsinket ossifikation og mindre organmisdannelser ved eksponeringer 2,7 gange den humane eksponering (AUC).
English: When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Danish: Hvis Alecensa administreres sammen med BCRP-substrater (fx methotrexat, mitoxantron, topotecan og lapatinib) anbefales passende monitorering.
English: ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy.
Danish: ALK-positiv ikke-småcellet lungekræft -status skal fastlægges inden påbegyndelse af Alecensa-behandling.
English: The primary endpoint of the trial was to demonstrate superiority of Alecensa versus crizotinib based on Progression Free survival (PFS) as per investigator assessment using RECIST 1.1.
Danish: Det primære endepunkt i studiet var at påvise bedre effekt af Alecensa versus crizotinib på baggrund af progressionsfri overlevelse efter investigators vurdering baseret på RECIST 1.1.
English: Therefore, no dose adjustment is required for co-administered CYP3A substrates.
Danish: Dosisjustering er derfor ikke nødvendig for samtidigt administrerede CYP3Asubstrater.
English: ● swelling caused by fluid build-up in the body (oedema)
Danish: ● hævelser på grund af væskeansamlinger i kroppen (ødem).
English: ● medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
Danish: ● medicin mod krampeanfald (antiepileptika såsom phenytoin, carbamazepin eller phenobarbital)
English: The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
Danish: Det primære endepunkt var at evaluere virkningen af Alecensa ved objektiv responsrate, bedømt af en central uafhængig bedømmelseskomité ved anvendelse af RECIST (Response Evaluation Criteria in Solid Tumors), version 1.1, i hele populationen (med og uden tidligere behandling med cytotoksisk kemoterapi).
English: Alecensa contains lactose
Danish: Alecensa indeholder lactose
English: ● You must take Alecensa with food.
Danish: ● Alecensa skal tages i forbindelse med et måltid.
English: As elimination of alectinib is predominantly through metabolism in the liver, hepatic impairment may increase the plasma concentration of alectinib and/or its major metabolite M4.
Danish: Da alectinib primært metaboliseres i leveren kan nedsat leverfunktion øge plasmakoncentrationen af alectinib og/eller den primære metabolit M4.
English: The hepatic impairment study also included a group with moderate (Child-Pugh B) hepatic impairment, and a modestly higher alectinib exposure was observed in this group compared with matched healthy subjects.
Danish: Studiet vedrørende nedsat leverfunktion inkluderede også en gruppe med moderat (Child-Pugh B) nedsat leverfunktion og viste begrænset højere eksponering af alectinib hos denne gruppe sammenlignet med eksponeringen hos tilsvarende raske forsøgspersoner.
English: White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
Danish: Hvid hård kapsel, 19,2 mm i længden, med “ALE” præget i sort blæk på hætten og “150 mg” præget i sort blæk på bunden.
English: (range 1 - 29)
Danish: (interval 1-29)
English: Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Danish: In vitro hæmmede alectinib ikke OATP1B1/OATP1B3, OAT1, OAT3 eller OCT2 ved klinisk relevante koncentrationer.
English: The majority of the events were of Grade 1 and 2 intensity; Grade 3 events were reported in 3.2% of the patients.
Danish: Størstedelen af tilfældene var af grad 1 og 2; grad 3-tilfælde blev rapporteret hos 3,2% af patienterne.
English: ● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Danish: ● sirolimus, medicin, der forebygger, at kroppens immunsystem afstøder en transplanteret nyre,
English: You need to apply sunscreen and lip balm with a Sun Protection Factor of 50 or higher to help prevent sunburn.
Danish: Du skal bruge solcreme og læbepomade med faktor 50 eller højere beskyttelse for at undgå at blive skoldet.
English: ● The recommended dose is 3 capsules (450 mg) twice a day.
Danish: ● Den anbefalede dosis er 3 kapsler (450 mg) 2 gange dagligt.
English: Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer' (‘NSCLC').
Danish: Alecensa bruges til at behandle voksne med en type lungekræft, der kaldes ikke-småcellet lungekræft.
English: In vitro, alectinib and M4 show weak time-dependent inhibition of CYP3A4, and alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations.
Danish: In vitro viser Alectinib og M4 svag tidsafhængig hæmning af CYP3A4, og alectinib viser svagt induktionspotentiale for CYP3A4 og CYP2B6 ved kliniske koncentrationer.
English: If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours.
Danish: Hvis en planlagt Alecensa-dosis springes over, kan patienten tage den manglende dosis, medmindre der er mindre end 6 timer til næste planlagte dosis.
English: The majority of events were Grades 1 or 2 and three patients (0.7%) had a Grade 3 event.
Danish: De fleste af tilfældene var af grad 1 eller 2; tre patienter (0,7%) havde en grad 3bivirkning.
English: ● sensitivity to sunlight - do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Danish: ● øget følsomhed for sollys - du må ikke opholde dig i solen i længere tid, mens du er i behandling med Alecensa og i 7 dage efter, du er stoppet med behandlingen.
English: A total of 303 patients were included in the Phase III trial, 151 patients randomised to the crizotinib arm and 152 patients randomised to the Alecensa arm receiving Alecensa orally, at the recommended dose of 600 mg twice daily.
Danish: Ialt blev 303 patienter inkluderet i fase III-studiet; 151 patienter blev randomiseret til crizotinib-armen og 152 patienter til Alecensa-armen, hvor de fik Alecensa oralt, i den anbefalede dosis på 600 mg, 2 gange dagligt.
English: Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Danish: Baseret på in vitro-data er CYP3A4 det primære enzym, der indgår i metaboliseringen af såvel alectinib og den primære aktive metabolit M4, og CYP3A bidrager til 40-50% af den totale levermetabolisme.
English: The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg).
Danish: Anbefalet Alecensa-dosis er 600 mg (4 kapsler a 150 mg) 2 gange dagligt i forbindelse med et måltid (daglig dosis i alt er 1200 mg).
English: ● vomiting - if you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time
Danish: ● opkastning - hvis du kaster op efter at have taget en dosis Alecensa, skal du ikke tage en ekstra dosis; du tager bare næste dosis til sædvanlig tid
English: * Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
Danish: * Sekundære nøgle-endepunkter i det hierakiske testforløb ** Konkurrerende risikoanalyse af CNS-progression, systemisk progression og død som konkurrerende hændelser *** 2 patienter i crizotinib-armen og 6 patienter i alectinib-armen havde komplet respons CNS = centralnervesystem, NE = ikke-estimérbar;
English: Women of childbearing potential must be advised to avoid pregnancy while on Alecensa.
Danish: Fertile kvinder skal informeres om, at de skal undgå at blive gravide under behandling med Alecensa.
English: This is to check you do not have any liver problems while taking Alecensa.
Danish: Det er for at kontrollere, at du ikke får leverproblemer, mens du tager Alecensa.
English: The geometric mean steady-state Cmax, Cmin and AUC0-12hr for M4 were approximately 246 ng/mL (45.4%), 222 ng/mL (46.6%) and 2810 ng*h/mL (45.9%), respectively.
Danish: De geometrisk gennemsnitlige Cmax, Cmin og AUC0-12t for M4 ved steady state var henholdsvis ca. 246 ng/ml (45,4%), 222 ng/ml (46,6%) og 2.810 ng∙time/ml (45,9%).
English: M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Danish: Cmax og AUCinf for M4 var henholdsvis 39% og 34 % lavere og resulterede i at den samlede eksponering af alectinib og M4 (AUCinf) var 1,8 gange højere hos patienter med svært nedsat leverfunktion sammenlignet med eksponeringen hos tilsvarende raske forsøgspersoner.
English: Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Danish: Der er observeret abnorm erytrocytmorfologi ved eksponeringer svarende til eller højere end 10-60% af den humane eksponering (AUC) ved den anbefalede dosis.
English: As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
Danish: Da alectinib hæmmer P-gp, forventes det ikke, at samtidig administration af P-gp-hæmmere har relevant effekt på eksponeringen af M4.
English: The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (35%), oedema (30%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema), and myalgia (28%, including myalgia and musculoskeletal pain).
Danish: De hyppigste bivirkninger (≥20%) var obstipation (35%), ødem (30%, inklusive perifert ødem, ødem, generaliseret ødem, øjenlågsødem, periorbitalt ødem, ansigtsødem og lokaliseret ødem) og myalgi (28%, inklusive myalgi og muskuloskeletale smerter).
English: However, since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see section 5.2).
Danish: Da alectinib kun i ubetydelig grad elimineres gennem nyrerne, er dosisjustering ikke nødvendig hos patienter med svært nedsat nyrefunktion (se pkt.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grapefruit or Seville oranges).
Danish: Relevant monitorering anbefales hos patienter i samtidig behandling med potente CYP3A-hæmmere (inklusive, men ikke begrænset til ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon, grapefrugt og pomerans).
English: Permanently discontinue in case of recurrence.
Danish: Ved recidiv skal behandlingen seponeres permanent.
English: Primary efficacy parameter
Danish: Primære virkningsparametre
English: CNS-ORR in patients with measurable CNS metastases at baseline
Danish: CNS-objektiv responsrate for patienter med målbare CNS- metastaser ved baseline
English: Following oral administration of 600 mg twice daily under fed conditions in ALK-positive NSCLC patients, alectinib was absorbed reaching Tmax after approximately 4 to 6 hours.
Danish: Efter oral administration af 600 mg 2 gange dagligt til patienter med ALK-positiv ikke småcellet lungekræft i forbindelse med et måltid absorberes alectinib, og Tmax nås efter 4-6 timer.
English: When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Danish: Hvis Alecensa administreres samtidig med P-gp-substrater (fx digoxin, dabigatranetexilat, topotecan, sirolimus, everolimus, nilotinib og lapatinib) anbefales passende monitorering.
English: Symptomatic bradycardia can occur with Alecensa (see section 4.8).
Danish: Symptomatisk bradykardi kan forekomme i forbindelse med behandling med Alecensa (se pkt.