natgillin/translations-raw huggingface dataset:
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).
ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CK = kreatinkinase; CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events; ILD = interstitiel lungesygdom.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
Gennemsnitlig in vitro humant blod:plasmakoncentrationsratio for alectinib og M4 er henholdsvis 2,64 og 2,50 ved klinisk relevante koncentrationer.
The mean in vitro human blood-to-plasma concentration ratios of alectinib and M4 are 2.64 and 2.50, respectively, at clinically relevant concentrations.
224 (4 pakker a 56) hårde kapsler
224 (4 packs of 56) hard capsules
Alecensa skal seponeres permanent, hvis patienten ikke tåler en dosis på 300 mg 2 gange dagligt.
Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.
Alecensa-dosis reduceres i trin af 150 mg 2 gange dagligt afhængigt af tolerabilitet.
The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability.
Den absolutte biotilgængelighed af alectinib-kapsler, taget i forbindelse med et måltid, var 36,9% (90% konfidensinterval: 33,9%; 40,3%) hos raske frivillige.
The absolute bioavailability of alectinib capsules was 36.9% (90% CI: 33.9%, 40.3%) under fed conditions in healthy subjects.
Hjælpestoffer, som behandleren skal være opmærksom på En hård kapsel indeholder 33,7 mg lactose (som monohydrat) og 6 mg natrium (som natriumlaurilsulfat).
Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
● Brug ikke lægemidlet efter den udløbsdato, der står på ydre emballage og enten på blisterkort eller beholder efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
● Do not take this medicine after the expiry date which is stated on the carton and either the blister or the bottle after EXP.
En farmakokinetisk populationsanalyse understøtter dosisproportionalitet for alectinib ved doser på 300-900 mg administreret i forbindelse med et måltid.
Population PK analysis supports dose proportionality for alectinib across the dose range of 300 to 900 mg under fed conditions.
Du skal være særlig opmærksom, når du fører motorkøretøj eller bruger maskiner, da du kan få problemer med synet eller langsom hjerterytme eller lavt blodtryk, der kan være forbundet med besvimelse eller svimmelhed, mens du er i behandling med Alecensa.
Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
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%).
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%).
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.
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).
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.
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.
Lægen kan vælge at nedsætte dosis, afbryde behandlingen i en kortere periode eller at stoppe behandlingen helt:
Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:
ILD/pneumonitis af enhver sværhedsgrad
ILD/pneumonitis of any severity grade
● svære smerter, ømhed og svaghed i musklerne (myalgi).
● severe muscle pain, tenderness, and weakness (myalgia).
(interval 0,5 - 29,0)
(range 0.5 - 29.0)
Nedsat leverfunktionJustering af startdosis er ikke nødvendig hos patienter med let (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion.
No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Bradykardia grad 4 (livstruende, akut intervention indiceret)
Grade 4 (life-threatening consequences, urgent intervention indicated)
Kapslerne leveres i blisterkort og fås i pakning med 224 hårde kapsler (4 pakker a 56).
The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56).
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.
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.
Den primære metabolit af alectinib (M4) har udvist tilsvarende potens og aktivitet in vitro.
The major metabolite of alectinib (M4) has shown similar in vitro potency and activity.
Lægen vil tage en blodprøve, inden du begynder behandlingen, hver 2. uge i de første 3 måneder af behandlingen og derefter med længere mellemrum.
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.
Baseret på virkningsmekanismen kan Alecensa skade fostret, hvis det gives til en gravid kvinde.
Based on its mechanism of action, Alecensa may cause foetal harm when administered to a pregnant woman.
Det er særligt vigtigt, at du fortæller lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Alectinib er en yderst selektiv og potent hæmmer af ALK- og RET-tyrosinkinase.
Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.
De demografiske karakteristika for den fulde studiepopulation var 84% var kaukasere, 8% asiater og 55% kvinder; medianalderen var 54 år.
The demographic characteristics of the overall study population were 84% Caucasian, 8% Asian, 55% females.
● nefazodon, medicin mod depresssion
● nefazodone, a medicine used to treat depression
Hjertefrekvens under 60 slag per minut.
Heart rate less than 60 beats per minute (bpm).
Børn og unge Alecensa er ikke undersøgt hos børn og unge.
Alecensa has not been studied in children or adolescents.
Alectinibs indvirkning på andre lægemidler
Effects of alectinib on other medicinal products
Tabel 6 indeholder en oversigt over en poolet analyse af CNS-endepunkter.
A summary of pooled analysis of CNS endpoints is presented in Table 6.
● langsom hjerterytme (bradykardi).
● slow heart beat (bradycardia).
Effekten på den samlede eksponering af alectinib og M4 var begrænset, idet Cmax og AUCinf reduceredes med henholdsvis 4% og 18%.
The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax and AUCinf by 4% and 18%, respectively.
Figur 1: Kaplan Meier-plot af progressionsfri overlevelse vurderet af investigator i BO28984 (ALEX)
Figure 1: Kaplan Meier Plot of INV Assessed PFS in BO28984 (ALEX)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1169/001
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/001
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Alecensa:
Talk to your doctor, pharmacist or nurse before taking Alecensa:
Alecensa kan forårsage svær og livstruende inflammation i lungerne under behandlingen.
Alecensa can cause severe or life-threatening inflammation of the lungs during treatment.
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.
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.
● medicin mod tuberkulose (fx rifampicin, rifabutin)
● medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
Andre lægemidlers virkning på alectinib
Effects of other medicinal products on alectinib
In vitro studier viser, at hverken alectinib eller den aktive hovedmetabolit (M4) hæmmer CYP1A2, CYP2B6, CYP2C9, CYP2C19 eller CYP2D6 ved klinisk relevante koncentrationer.
In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations.