natgillin/translations-raw huggingface dataset:
Virkningen af samtidigt administrerede orale kontraceptiva kan være reduceret. 
The effectiveness of concomitant administration of oral contraceptives may be reduced.
Patienten må ikke tage 2 doser på samme tid for at kompensere for en manglende dosis. 
Patients should not take two doses at the same time to make up for a missed dose.
Meget almindelig (kan påvirke flere end 1 ud af 10 patienter) 
Very common (may affect more than 1 in 10 people):
Øget følsomhed for sollys 
Sensitivity to sunlight
Det kan også gøre, at kræften svinder. 
It may also help to shrink your cancer.
Det kan ikke udelukkes, at amning vil indebære en risiko for den nyfødte/spædbarnet. 
A risk to the newborn/infant cannot be excluded.
Nervesystemet Dysgeusi 2) 
Nervous system disorders Dysgeusia 2)
Kapslerne er også tilgængelige i plastbeholder indeholdende 240 hårde kapsler. 
The capsules are also available in plastic bottles containing 240 hard capsules.
Størstedelen af patienterne havde ikke røget (62%). 
The majority of patients had no history of smoking (62%).
Alecensa påvirker i beskeden grad evnen til at føre motorkøretøj og betjene maskiner. 
Alecensa has minor influence on the ability to drive and use machines.
Det geometriske gennemsnit af estimaterne for alectinibs individuelle halveringstid var 32,5 time. 
The geometric mean of the individual elimination half-life estimates for alectinib was 32.5 hours.
Alecensa-behandling 
Alecensa treatment
Alecensas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of Alecensa in children and adolescents below 18 years of age have not been established.
Alecensa kan hæmme eller stoppe væksten af kræftceller. 
Alecensa may slow down or stop the growth of your cancer.
Tilfældene opstod som regel inden for de første 3 behandlingsmåneder, var oftest forbigående og de fleste forsvandt ved dosisændring. 
The events generally occurred during the first 3 months of treatment, were usually transient and the majority resolved upon dose modification.
Hjertefrekvens og blodtryk bør monitoreres i det omfang, det er klinisk relevant. 
Heart rate and blood pressure should be monitored as clinically indicated.
Det gælder også medicin, der kan købes uden recept, og naturlægemidler. 
This includes medicines obtained without a prescription, and herbal medicines.
Læs afsnit 4 ‘Bivirkninger' for mere information. 
See ‘Side effects' in section 4 for more information.
* Inklusiv en bivirkning af grad 5 ** Forhøjet alkalisk fosfatase blev rapporteret i perioden efter markedsføring og i pivotale fase II og fase III kliniske studier. 
* Includes one Grade 5 event ** Increased alkaline phosphatase was reported in the post-marketing period and in pivotal phase II and phase III clinical trials.
● hvis du er allergisk over for alectinib eller et af de øvrige indholdsstoffer i Alecensa (angivet i afsnit 6). 
● if you are allergic to alectinib or any of the other ingredients of this medicine (listed in section 6).
Seponér behandlingen permanent, såfremt der ikke identificeres bidragende samtidig behandling. 
Permanently discontinue if no contributing concomitant medicinal product is identified.
Størstedelen af patienterne havde ikke røget (70%). 
The majority of patients had no history of smoking (70%).
Alecensa kan ordineres til dig som første behandling af lungekræft, eller hvis du tidligere er blevet behandlet med medicin, som indeholder 'crizotinib'. 
Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib'.
● ændring i smagssans 
● alteration in sense of taste
Alectinib forårsagede embryo-føtal toksicitet hos drægtige rotter og kaniner. 
Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Grad 3-4* 
Grades 3-4
● Tag aldrig en dobbeltdosis som erstatning for en glemt dosis. 
● Do not take a double dose to make up for a missed dose.
Seponér Alecensa permanent. 
Permanently discontinue Alecensa.
Dato for første markedsføringstilladelse: 16. februar 2017 Dato for fornyelse af tilladelsen: 1. december 2017 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 February 2017
Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}. 
This leaflet was last revised in {MM/YYYY}.
Kontakt straks lægen, hvis du bemærker en eller flere af nedenstående bivirkninger. 
Tell your doctor straight away if you notice any of the following side effects.
Hvis du har svært nedsat leverfunktion før du begynder i behandling med Alecensa: 
If you have severe liver problems before starting your treatment with Alecensa:
Baseret på prækliniske data er alectinib ikke substrat for p-glykoprotein eller BCRP, der begge er efflux-transportører i blod-hjerne-barrieren, og kan derfor passere til og tilbageholdes i centralnervesystemet. 
Based on preclinical data, alectinib is not a substrate of p-glycoprotein or BCRP, which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system.
Hvis du har spørgsmål til, hvordan Alecensa virker, eller hvorfor lægen har ordineret denne medicin, skal du spørge lægen, sygeplejersken eller apotekspersonalet. 
If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Bivirkningerne i tabel 3 præsenteres efter systemorganklasse og hyppighed, defineret på følgende måde: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), 
The ADRs listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Bradykardia grad 2 eller 3 (symptomatisk, kan være svær og klinisk signifikant; intervention indiceret) 
Grade 2 or Grade 3 (symptomatic, may be severe and medically significant, medical intervention indicated)
M4 har udvist samme in vitro potens og aktivitet mod ALK. 
M4 has shown similar in vitro potency and activity against ALK.
Yderligere oplevede en patient en bivirkning af grad 4 i form af lægemiddelinduceret leverskade. 
In addition, one patient experienced a Grade 4 adverse event of drug-induced liver injury.
Mekanismen bag mikronukleus-induktionen var abnorm kromosomsegregering (aneugenicitet) og ikke en klastogen påvirkning af kromosomer. 
The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.
Baseret på in vitro-data er alectinib ikke et P-gp-substrat. 
Based on in vitro data, alectinib is not a substrate of P-gp.
Obstipation (35%), kvalme (19%), diarré (16%) og opkastning (11%) var de hyppigst rapporterede gastrointestinale bivirkninger. 
Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
● Aktivt stof: alectinib. 
● The active substance is alectinib.
Baseret på en farmakokinetisk populationsanalyse var alectinibs tilsyneladende clearance (CL/F) 81,9 l/time. 
Based on a population PK analysis, the apparent clearance (CL/F) of alectinib was 81.9 L/hour.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Roche Pharma AG 
Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
Det drejer sig om: 
These include:
Evaluér samtidig behandling med lægemidler, der vides at forårsage bradykardi, samt antihypertensiva. 
Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
De begrænsede data vedrørende Alecensas sikkerhed og virkning hos patienter på 65 år og derover tyder ikke på, at dosisjustering er nødvendig hos ældre patienter (se pkt. 
The limited data on the safety and efficacy of Alecensa in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Der var ingen dødelige tilfælde af interstitiel lungesygdom i de kliniske studier. 
There were no fatal cases of ILD in any of the clinical trials.
Almindelige (kan påvirke op til 1 ud af 10 patienter) 
Common (may affect up to 1 in 10 people):
HDPE beholder med børnesikret lukning og et integreret tørremiddel. 
HDPE bottle with a child-resistant closure and an integrated desiccant.
Der er ikke gennemført karcinogenicitetsstudier med henblik på at undersøge Alecensas karcinogene potentiale. 
Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of Alecensa.
Glycerylmonooleat 
Glyceryl monooleate
De demografiske karakteristika for den samlede studiepopulation var 67% kaukasere, 26% asiater og 56% kvinder; medianalderen var 52 år. 
The demographic characteristics of the overall study population were 67% Caucasian, 26% Asian, 56% females, and the median age was 52 years.
Der er ikke udført fertilitetsstudier hos dyr med henblik på at evaluere effekten af Alecensa. 
No fertility studies in animals have been performed to evaluate the effect of Alecensa.
De skal tages i forbindelse med et måltid (se pkt. 
They must be taken with food (see section 5.2).
Gentagne doser af alectinib 600 mg påvirkede ikke eksponeringen af midazolam (2 mg), et følsomt CYP3A-substrat. 
Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate.
Metabolitten M1b er detekteret som en mindre væsentlig metabolit in vitro og i plasma hos raske frivillige. 
Metabolite M1b was detected as a minor metabolite from in vitro and in human plasma in healthy subjects.
Leverfunktion, inklusive ALAT, ASAT og total-bilirubin, bør bestemmes ved baseline og monitoreres hver 2. uge i løbet af de første 3 behandlingsmåneder. 
Liver function, including ALT, AST, and total bilirubin should be monitored at baseline and then every 2 weeks during the first 3 months of treatment.
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE36. 
Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Du skal være forsigtig med at drikke grapefrugtjuice eller spise grapefrugt eller pomerans, mens du er i behandlig med Alecensa, eftersom disse fødevarer kan påvirke mængden af Alecensa i din krop. 
You should use caution when drinking grapefruit juice or eating grapefruit or Seville oranges while on treatment with Alecensa as they may change the amount of Alecensa in your body.
Patienterne skal monitoreres for pulmonale symptomer, der er indikative for pneumonitis. 
Patients should be monitored for pulmonary symptoms indicative of pneumonitis.
Dannelse af M1b-metabolitten og dens mindre væsentlige M1a-isomer katalyseres sandsynligvis af en kombination af CYP-isozymer (også andre isozymer end CYP3A) og aldehyddehydrogenase (ALDH)-enzymer. 
Formation of metabolite M1b and its minor isomer M1a is likely to be catalyzed by a combination of CYP isozymes (including isozymes other than CYP3A) and aldehyde dehydrogenase (ALDH) enzymes.
(interval 0,3 - 27,0) 
(range 0.3 - 27.0)
Børn og unge under 18 år må ikke få dette lægemiddel. 
Do not give this medicine to children or adolescents under the age of 18 years.
INFORMATION I BRAILLESKRIFT alecensa 
INFORMATION IN BRAILLE alecensa
Risiko for induktion af CYP2B6 og pregnan X-receptor (PXR)-regulerede enzymer ud over CYP3A4 kan ikke fuldstændigt udelukkes. 
A risk for induction of CYP2B6 and PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion. 
No dose adjustment is required in patients with mild or moderate renal impairment.
Svær myalgi er ikke rapporteret i det kliniske studie BO28984. 
Severe myalgia has not been reported in the clinical trial BO28984.
● Hvis du bliver gravid, mens du tager dette lægemiddel eller inden for 3 måneder efter, du har afsluttet behandlingen, skal du straks kontakte lægen. 
● If you become pregnant when taking the medicine or during the 3 months after taking your last dose, tell your doctor straight away.
● everolimus, medicin mod bestemte typer kræft eller for at forebygge, at kroppens immunsystem afstøder en transplanteret nyre, hjerte eller lever 
● everolimus, a medicine used to treat certain types of cancer or used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Patienterne skal også opfordres til at bruge bredspektret UVA/UVB (ultraviolet A/ultraviolet B) solfaktor og læbepomade (SPF ≥50) for at beskytte mod solskoldning. 
Patients should also be advised to use a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sun screen and lip balm (SPF ≥50) to help protect against potential sunburn.
Patienterne blev behandlet med den anbefalede dosis på 600 mg to gange dagligt. 
These patients were treated with the recommended dose of 600 mg twice daily.
Udover crizotinib kunne patienterne tidligere have været behandlet med kemoterapi. 
In addition to crizotinib, patients may have received previous treatment with chemotherapy.
Symptomerne kan være de samme som for lungekræften. 
The signs may be similar to those from your lung cancer.
Alectinib absorberer UV-lys mellem 200 og 400 nm og har udvist fototoksisk potentiale i en in vitro lyssikkerhedstest efter UVA-bestråling af dyrkede musefibroblaster. 
Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Håndtering af bivirkninger kan nødvendiggøre dosisreduktion, midlertidig behandlingsafbrydelse eller seponering af Alecensa. 
Management of adverse events may require dose reduction, temporary interruption, or discontinuation of treatment with Alecensa.
Alectinib og den vigtigste metabolit M4 bindes i udstrakt grad til humane plasmaproteiner (>99%), uafhængigt af koncentrationen af det aktive stof. 
Alectinib and its major metabolite M4 are highly bound to human plasma proteins (>99%), independent of active substance concentration.
Patienterne bør informeres om, at de skal rapportere enhver form for uforklarlige muskelsmerter, muskelømhed eller muskelsvaghed. 
Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Dosisjustering er derfor ikke nødvendig, når Alecensa administreres sammen med protonpumpehæmmere eller andre lægemidler, som øger gastrisk pH (fx H2-receptorantagonister eller antacida). 
Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
I prækliniske studier har hæmning af ALK-tyrosinkinase-aktivitet medført blokering af de efterfølgende signalveje, inklusive STAT 3 og PI3K/AKT og induktion af tumorcelledød (apoptose). 
In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
● besvimelse, svimmelhed og lavt blodtryk (kan være tegn på langsom hjerterytme) 
● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
● sløret syn, synstab, sorte eller hvide pletter for øjnene og dobbeltsyn (øjenproblemer) 
● blurred vision, loss of sight, black dots or white spots in your vision, and seeing double (problems with your eyes)
Baseline-demografi og sygdomskarakteristika for Alecensa var medianalder på 58 år (54 år for crizotinib), 55% kvinder (58% for crizotinib), 55% ikke-asiatiske (54% for crizotinib), 61% der aldrig havde røget (65% for crizotinib), 93% med ECOG PS 0 eller 1 (93% for crizotinib), 97% med stadie IV-sygdom (96% for crizotinib), 90% med adenocarcinomhistologi (94% for crizotinib), 40% med CNS-metastaser ved baseline (38% for crizotinib) og 17% som tidligere havde fået CNS-strålebehandling (14% for crizotinib). 
Baseline demographic and disease characteristics for Alecensa were median age 58 years (54 years for crizotinib), 55% female (58% for crizotinib), 55% non-Asian (54% for crizotinib), 61% with no smoking history (65% for crizotinib), 93% ECOG PS of 0 or 1 (93% for crizotinib), 97% Stage IV disease (96% for crizotinib), 90% adenocarcinoma histology (94% for crizotinib), 40% CNS metastases at baseline (38% for crizotinib) and 17% having received prior CNS radiation (14% for crizotinib).
Disse studier er udført med rotter og aber eksponeret for doser svarende til eller højere end henholdsvis 2,6 og 0,5 gange den humane eksponering, målt ved AUC, ved den anbefalede dosis på 600 mg 2 gange dagligt. 
These studies were conducted in rats and monkeys at exposures equal to or greater than 2.6- and 0.5-fold, respectively, of the human exposure, measured by AUC, at the recommended dose of 600 mg twice daily.
(interval 1-30) 
(range 1 - 30)
Systemorganklasse Bivirkninger (MedDRA) 
System organ class ADRs (MedDRA)
Resultater fra et humant massebalancestudie har vist, at alectinib og M4 er de vigtigste cirkulerende lægemiddeldele i plasma; de redegør for ca. 76% af den totale radioaktivitet i plasma. 
Results from the human mass balance study demonstrated that alectinib and M4 were the main circulating moieties in plasma with 76% of the total radioactivity in plasma.
Kreatinkinase bør monitoreres hver 2. uge under den første måneds behandling og derefter som klinisk indiceret hos patienter, der rapporterer symptomer. 
CPK levels should be assessed every two weeks for the first month of treatment and as clinically indicated in patients reporting symptoms.
Frekvensen af disse bivirkninger faldt efter den første måneds behandling. 
The events declined in frequency after the first month of treatment.
Afbryd straks behandlingen og seponér Alecensa permanent, hvis der ikke identificeres anden potentiel årsag til ILD/pneumonitis. 
Immediately interrupt and permanently discontinue Alecensa if no other potential causes of ILD/pneumonitis have been identified.
En let hypotensiv effekt er observeret hos aber ved eksponeringer nogenlunde svarende til den klinisk relevante eksponering. 
A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
Alectinib har udvist in vitro og in vivo aktivitet mod muterede former af ALK-enzymet, inklusive de mutationer, der forårsager resistens over for crizotinib. 
Alectinib demonstrated in vitro and in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.
Det vides ikke, om Alecensa udskilles i mælken og derfor kan skade barnet. 
This is because it is not known if Alecensa can pass over into breast milk and could therefore harm your baby.
Dosisjustering er ikke nødvendig ved asymptomatisk bradykardi (se pkt. 
Dose modification is not required in case of asymptomatic bradycardia (see section 4.2).
Effektdata opsummeres i Tabel 4 og Kaplan-Meier-kurven for progressionsfri overlevelse vurderet af investigator er vist i Figur 
Efficacy data are summarised in Table 4 and the Kaplan-Meier curve for investigator assessed PFS is shown in Figure 1.
Alectinib og M4 er ikke BCRP-substrater eller substrater for organisk anion-transporterende polypeptid (OATP) 1B1/B3. 
Alectinib and M4 are not substrates of BCRP or organic anion-transporting polypeptide (OATP) 1B1/B3.
Det er vigtigt, fordi Alecensa kan påvirke andre lægemidlers virkning, og fordi andre lægemidler kan påvirke, hvordan Alecensa virker. 
This is because Alecensa can affect the way some other medicines work.
Kvindelige patienter, som bliver gravide under behandling med Alecensa eller inden for 3 måneder efter sidste dosis Alecensa, skal kontakte lægen og bør informeres om den potentielle risiko for fostret. 
Female patients, who become pregnant while taking Alecensa or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the foetus.
Alecensa indeholder lactose (en sukkerart). 
Alecensa contains lactose (a type of sugar).
Tag altid medicinen nøjagtigt efter lægens eller apotekspersonalet anvisning. 
Always take this medicine exactly as your doctor or pharmacist has told you.
Stratifikationsfaktorer for randomisering var ECOG PS (0/1 vs. 2), race (asiatisk vs. ikke-asiatisk) og CNS-metastaser ved baseline (ja vs. nej). 
ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Patienternes ECOG- performancestatus (Eastern Cooperative Oncology Group) ved baseline var 0 eller 1 hos 90,6% af patienterne og 2 hos 9,4% af patienterne. 
The ECOG (Eastern Cooperative Oncology Group) performance status at baseline was 0 or 1 in 90.6% of patients and 2 in 9.4% of patients.
Alecensa kan skade fostret, hvis det administreres til en gravid kvinde. 
Alecensa may cause foetal harm when administered to a pregnant woman.
Det geometrisk gennemsnitlige fordelingsvolumen ved steady state (Vss) for alectinib efter i.v.administration er 475 l, hvilket indikerer udtalt vævsfordeling. 
The geometric mean volume of distribution at steady state (Vss) of alectinib following IV administration was 475 L, indicating extensive distribution into tissues.
● Du må ikke amme, mens du tager dette lægemiddel. 
● Do not breast-feed while taking this medicine.
● unormale resultater af blodprøver til vurdering af leverfunktionen (højt niveau af alanin aminotransferase, aspartat-aminotransferase og bilirubin) 
● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
Alecensa er medicin mod kræft og indeholder det aktive indholdsstof alectinib. 
What Alecensa is Alecensa is a cancer medicine that contains the active substance alectinib.
56 hårde kapsler. 
56 hard capsules
De objektive responsrater i studierne NP28673 og NP28761 var konsistente på tværs af subgrupper med hensyn til patienternes baseline-karakteristika som alder, køn, race, ECOG-performancestatus, metastaser i centralnervesystemet (CNS) og tidligere behandling med kemoterapi, særligt når man tager det lille antal patienter i nogle subgrupper i betragtning. 
ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Det er for at kontrollere, at du ikke får lever- eller muskelproblemer, mens du tager Alecensa. 
This is to check you do not have any liver or muscle problems while taking Alecensa.
Patienternes ECOG- performancestatus ved baseline var 0 eller 1 hos 89,7% af patienterne og 2 hos 10,3% af patienterne. 
The ECOG performance status at baseline was 0 or 1 in 89.7% of patients and 2 in 10.3% of patients.
Dette lægemiddel indeholder 48 mg natrium per daglig dosis (1200 mg), svarende til 2,4% af den anbefalede WHO maksimale daglige indtagelse af 2 g natrium for en voksen. 
This medicinal product contains 48 mg sodium per daily dose (1200 mg), equivalent to 2.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Patienterne skulle have positiv central vævsprøvetest for ALK-proteinekspression ved Ventana anti-ALK (D5F3) immunhistokemi (IHC), inden de kunne randomiseres i studiet. 
Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana anti-ALK (D5F3) immunohistochemistry (IHC) was required before randomisation into the study.
● Det betyder, at du i alt skal tage 8 kapsler (1200 mg) hver dag. 
● This means you take a total of 8 capsules (1200 mg) each day.
Bivirkningerne opstod som regel inden for de første 3 behandlingsmåneder, var oftest forbigående og forsvandt ved midlertidig afbrydelse af Alecensa-behandlingen (rapporteret for henholdsvis 1,5% og 3,0% af patienterne) eller dosisreduktion 
The events generally occurred during the first 3 months of treatment, were usually transient and resolved upon temporary interruption of Alecensa treatment (reported for 1.5% and 3.0% of the patients, respectively) or dose reduction (2.2% and 1.2%, respectively).