natgillin/translations-raw huggingface dataset:
To af disse ALK-mutanter, G1202R og I1171T, vides at udvise resistens over for alectinib, brigatinib, ceritinib og crizotinib.
Two of these ALK mutants, G1202R and I1171T, are known to confer resistance to alectinib, brigatinib, ceritinib, and crizotinib.
Vægtstigning
Weight increased
Dyreforsøg har påvist embryo-føtal toksicitet (se pkt.
Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende medicinsk alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing medical seriousness.
Den geometriske middelværdi (CV %) for oral clearance var 17,7 (39) l/t.
The geometric mean (% CV) oral clearance was 17.7 (39) L/h.
Fortsæt lorlatinib ved samme dosis uden afbrydelse.
Continue lorlatinib at the same dose without interruption.
Grad 2: Moderat
Grade 2: Moderate
Behandlingen med lorlatinib anbefales, så længe der ses klinisk gavnlig virkning af behandlingen hos patienten uden uacceptabel toksicitet.
Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity.
Progressionsfri overlevelse Median, måneder (95 % CI)
Progression-free survival Median, months (95% CI)
Du skal især fortælle det til lægen, apotekspersonalet eller sygeplejersken, hvis du tager en eller flere af den følgende medicin: - boceprevir, anvendes til behandling af hepatitis C. - buproprion, anvendes til behandling af depression eller til rygeafvænning.
In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - boceprevir - a medicine used to treat hepatitis C. - buproprion - a medicine used to treat depression or to help people quit smoking.
Du kan få ordineret Lorviqua, - hvis du tidligere er blevet behandlet med et lægemiddel kaldet alectinib eller ceritinib, som er
Lorviqua can be prescribed to you if - you have been previously treated with a medicine called alectinib or ceritinib, which are ALK
Blandt de 284 patienter med PR-interval < 200 msek, havde 14 % forlængelse af PR-interval ≥ 200 msek efter start af lorlatinib.
Among the 284 patients with PR interval < 200 msec, 14% had PR interval prolongation ≥ 200 msec after starting lorlatinib.
Det primære effektendepunkt i fase 2-delen af studiet var objektiv responsrate (ORR), herunder intrakraniel (IC)-ORR i henhold til den uafhængige centrale gennemgang (Independent Central Review, ICR), ifølge modificeret responsevalueringskriterier for solide tumorer (modified Response Evaluation Criteria in Solid Tumours, RECIST), version 1.1).
The primary efficacy endpoint in the Phase 2 portion of the study was objective response rate (ORR), including intracranial (IC)-ORR, as per Independent Central Review (ICR) according to modified response evaluation criteria in solid tumours (modified RECIST version 1.1).
Større end eller lig med grad 3: Alvorlig
Greater than or equal to Grade 3: Severe
Din læge kan undersøge, om der er problemer med dit hjerte under behandlingen med Lorviqua.
Your doctor may check for problems with your heart during treatment with Lorviqua.
Se Lorviqua indeholder lactose og Lorviqua indeholder natrium i afsnit 2.
See Lorviqua contains lactose and Lorviqua contains sodium in section 2.
Hallucinationer (herunder auditive hallucinationer, hallucinationer, visuelle hallucinationer)
d Hallucinations (including auditory hallucination, hallucination, visual hallucination).
Atrioventrikulær blok
Atrioventricular block
Overordnede effektresultater i studie A efter forudgående behandling
Overall efficacy results in Study A by prior treatment
Alectinib, brigatinib eller ceritinib b
a Alectinib, brigatinib, or ceritinib.
Risiko for pankreatitis bør overvejes hos patienter, der får lorlatinib pga. samtidig hypertriglyceridæmi og/eller en potentiel intrinsik mekanisme.
Risk of pancreatitis should be considered in patients receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism.
Forkortelser: CTCAE=Common Terminology Criteria for Adverse Events, EKG=elektrokardiogram, HMG CoA=3-hydroxy-3-methylglutaryl-coenzym A; NCI=National Cancer Institute; ULN=upper limit of normal (øvre normalgrænse).
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events; ECG=electrocardiogram; HMG CoA=3-hydroxy-3-methylglutaryl coenzyme A; NCI=National Cancer Institute; ULN=upper limit of normal.
Patientdemografien for de 139 ALK-positive patienter med fremskreden NSCLC efter behandling med mindst en andengenerations ALK TKI var 56 % kvinder, 48 % hvide, 38 % asiater, og gennemsnitsalderen var 53 år (interval: 29-83 år) hvoraf 16 % af patienterne var ≥ 65 år.
Patient demographics of the 139 ALK-positive advanced NSCLC patients after treatment with at least one second-generation ALK TKI, were 56% female, 48% White, 38% Asian, and the median age was 53 years (range: 29-83 years) with 16% of patients ≥ 65 years of age.
Alder, køn, race, kropsvægt og fænotype
Age, gender, race, body weight, and phenotype
Lipase-/amylasestigning Grad 3: Alvorlig
Lipase/Amylase increase Grade 3: Severe
- Din læge kan eventuelt nedsætte din dosis, standse behandlingen i en kort periode eller standse behandlingen helt, hvis du ikke har det godt.
- Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell.
In vitro-studier indikerede ligeledes, at lorlatinib er en inducer af CYP2B6 og aktiverer den humane konstitutive androstanreceptor (CAR).
In vitro studies also indicated that lorlatinib is an inducer of CYP2B6 and activates the human constitutive androstane receptor (CAR).
Det er fordi, Lorviqua kan påvirke den måde, anden medicin virker på.
This is because Lorviqua can affect the way some other medicines work.
Efter oral administration af lorlatinib tabletter, er den absolutte middelværdi for biotilgængelighed 80,8 % (90 % CI: 75,7;86,2) sammenlignet med intravenøs administration.
After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 75.7, 86.2) compared to intravenous administration.
Tabletterne må ikke indtages, hvis de er gået i stykker, revnede eller på anden måde ikke er intakte.
No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Lorlatinib påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
Lorlatinib has moderate influence on the ability to drive and use machines.
Mænd bør søge rådgivning vedrørende bevarelse af fertiliteten inden behandling.
Men should seek advice on effective fertility preservation before treatment.
Virkninger på talen (dysartri, langsom tale, taleforstyrrelse).
g Speech effects (dysarthria, slow speech, speech disorder).
Endvidere er lorlatinibs steady state plasmaeksponeringer lavere end dem, der forventes fra enkeltdosis farmakokinetik, hvilket tyder på en netto-tidsafhængig autoinduktion.
Also, at steady-state lorlatinib plasma exposures are lower than those expected from single dose pharmacokinetics, indicative of a net time-dependent auto-induction effect.
Ændringer i blodtryk og hjertefrekvens, og QRS-kompleks og PR-interval blev også observeret hos dyr efter akut dosering (ca. 2,6 gange den humane kliniske eksponering ved 100 mg efter en enkelt dosis baseret på Cmax).
Changes in blood pressure and heart rate, and QRS complex and PR interval were also observed in animals after acute dosing (approximately 2.6 times the human clinical exposure at 100 mg after a single dose based on Cmax).
Bivirkninger med øget serumkolesterol eller triglycerider blev indberettet hos henholdsvis 84,4 % og 67,1 % af patienterne.
Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% of patients, respectively.
Administration af lorlatinib sammen med et måltid med et højt fedt- og kalorieindhold resulterede i 5 % højere eksponering sammenlignet med faste-tilstande.
Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure compared to fasted conditions.
Der er ingen antidot mod lorlatinib.
There is no antidote for lorlatinib.
I studie A havde 2 patienter (0,7 %) absolutte Fridericias QTc (QTcF) korrektionsværdier > 500 msek, og 5 patienter (1,8 %) havde en ændring i QTcF i forhold til baseline > 60 msek.
In Study A, 2 patients (0.7%) had absolute Fridericia's correction QTc (QTcF) values > 500 msec and 5 patients (1.8%) had a change in QTcF from baseline > 60 msec.
De udførte kliniske studier ekskluderede patienter med ASAT eller ALAT > 2,5 x ULN, eller hvis grundet underliggende malignitet, > 5,0 x ULN eller med total bilirubin > 1,5 x ULN.
Clinical studies that were conducted excluded patients with AST or ALT > 2.5 × ULN, or if due to underlying malignancy, > 5.0 × ULN or with total bilirubin > 1.5 × ULN.
Lorlatinib kan medføre fosterskader, hvis det administreres til gravide kvinder.
Lorlatinib may cause foetal harm when administered to a pregnant woman.
Mindre end 1 % uomdannet lorlatinib blev fundet i urin.
Less than 1% of unchanged lorlatinib was detected in urine.
Noget medicin kan desuden påvirke måden, Lorviqua virker på.
Also some medicines can affect the way Lorviqua works.
Lorlatinib skal tilbageholdes og/eller seponeres permanent, baseret på alvorlighedsgrad (se pkt.
Lorlatinib should be withheld and/or permanently discontinued based on severity (see section 4.2).
OPA/A1/PVC blisterkort med aluminiumsfolie-bagside indeholdende 10 filmovertrukne tabletter.
OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.
Middeltid til indtræden af kognitive påvirkninger samt virkninger på humøret og talen var henholdsvis 92, 44 og 42 dage.
Median time to onset for cognitive, mood and speech effects was 92, 44 and 42 days, respectively.
Lorlatinibs plasmahalveringstid efter en enkelt dosis på 100 mg var 23,6 timer.
The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours.
Prøverne tages for at undersøge indholdet af kolesterol, triglycerider og enzymerne amylase eller lipase i dit blod, før du starter behandlingen med Lorviqua, og regelmæssigt i løbet af behandlingen.
These tests are to check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before you start treatment with Lorviqua and regularly during treatment.