FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Endvidere er lorlatinibs steady state plasmaeksponeringer lavere end dem, der forventes fra enkeltdosis farmakokinetik, hvilket tyder på en netto-tidsafhængig autoinduktion.
English: 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).
Danish: 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).
English: Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% of patients, respectively.
Danish: Bivirkninger med øget serumkolesterol eller triglycerider blev indberettet hos henholdsvis 84,4 % og 67,1 % af patienterne.
English: Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure compared to fasted conditions.
Danish: Administration af lorlatinib sammen med et måltid med et højt fedt- og kalorieindhold resulterede i 5 % højere eksponering sammenlignet med faste-tilstande.
English: There is no antidote for lorlatinib.
Danish: Der er ingen antidot mod lorlatinib.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Lorlatinib may cause foetal harm when administered to a pregnant woman.
Danish: Lorlatinib kan medføre fosterskader, hvis det administreres til gravide kvinder.
English: Less than 1% of unchanged lorlatinib was detected in urine.
Danish: Mindre end 1 % uomdannet lorlatinib blev fundet i urin.
English: Also some medicines can affect the way Lorviqua works.
Danish: Noget medicin kan desuden påvirke måden, Lorviqua virker på.
English: Lorlatinib should be withheld and/or permanently discontinued based on severity (see section 4.2).
Danish: Lorlatinib skal tilbageholdes og/eller seponeres permanent, baseret på alvorlighedsgrad (se pkt.
English: OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.
Danish: OPA/A1/PVC blisterkort med aluminiumsfolie-bagside indeholdende 10 filmovertrukne tabletter.
English: Median time to onset for cognitive, mood and speech effects was 92, 44 and 42 days, respectively.
Danish: Middeltid til indtræden af kognitive påvirkninger samt virkninger på humøret og talen var henholdsvis 92, 44 og 42 dage.
English: The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours.
Danish: Lorlatinibs plasmahalveringstid efter en enkelt dosis på 100 mg var 23,6 timer.
English: 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.
Danish: 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.
English: Unchanged lorlatinib was the major component of human plasma and faeces, accounting for 44% and 9.1% of total radioactivity, respectively.
Danish: Uomdannet lorlatinib var den største komponent i humant plasma og fæces, der tegnede sig for henholdsvis 44 % og 9,1 % af den samlede radioaktivitet.
English: - ketoconazole, itraconazole, voriconazole, posaconazole - medicines used to treat fungal infections.
Danish: - ketoconazol, itraconazol, voriconazol, posaconazol, anvendes til behandling af svampeinfektioner.
English: Of the 139 patients, 20% received 1 prior ALK TKI, excluding crizotinib, 47% received 2 prior ALK TKIs, and 33% received 3 or more prior ALK TKIs.
Danish: Af de 139 patienter fik 20 % 1 tidligere ALK TKI, eksklusive crizotinib, 47 % fik 2 tidligere ALK TKI'er, og 33 % fik 3 eller flere tidligere ALK TKI'er.
English: - alfentanil and fentanyl - medicines used to treat severe pain.
Danish: - alfentanil og fentanyl, der anvendes til behandling af alvorlige smerter.
English: Withhold lorlatinib until symptoms have returned to baseline and consider initiating corticosteroids.
Danish: Tilbagehold lorlatinib, indtil symptomerne er vendt tilbage til baseline-niveau og overvej påbegyndelse af kortikosteroider.
English: Dose modification recommendations for toxicities and for patients who develop atrioventricular (AV) block are provided in Table 1.
Danish: Anbefalinger til dosisjusteringer for toksiciteter og for patienter, der udvikler atrioventrikulær blok ses i tabel 1.
English: Talk to your doctor about fertility preservation before taking Lorviqua.
Danish: Tal med lægen om frugtbarhed, før du tager Lorviqua.
English: • carbamazepine, phenytoin (used to treat epilepsy)
Danish: • carbamazepin, phenytoin (anvendes til at behandle epilepsi)
English: In the overall efficacy population of 139 patients, 56 patients had a confirmed objective response by ICR with a median TTR of 1.4 months (range: 1.2 to 16.6 months).
Danish: I den overordnede effektpopulation på 139 patienter havde 56 patienter et bekræftet objektivt respons efter ICR med en middel TTR på 1,4 måneder (interval: 1,2 til 16,6 måneder).
English: • If your male partner is being treated with Lorviqua, he must use a condom during treatment and for at least 14 weeks after completing therapy.
Danish: • Hvis din mandlige partner bliver behandlet med Lorviqua, skal han anvende kondom, som prævention under behandlingen og i mindst 14 uger efter afsluttet behandling.
English: If you are able to have children, you must use highly effective contraception (for example, double-barrier contraception such as condom and diaphragm) while on treatment and for at least 5 weeks after stopping treatment.
Danish: Hvis du er i stand til at få børn, skal du anvende en meget sikker form for prævention (for eksempel dobbeltbarriere-prævention, såsom kondom og pessar), mens du er i behandling og i mindst 5 uger efter behandlingens afslutning.
English: The adverse reactions listed in Table 2 are presented by system organ class and frequency categories,
Danish: Bivirkningerne angivet i Tabel 2 er angivet efter systemorganklasse.
English: Withhold lorlatinib until lipase or amylase returns to baseline.
Danish: Tilbagehold lorlatinib, indtil lipase eller amylase vender tilbage til baseline-niveau.
English: Lorlatinib is not mutagenic but is aneugenic in vitro and in vivo with a no observed effect level for aneugenicity approximately 16.5 times human clinical exposure at 100 mg based on AUC.
Danish: Lorlatinib er ikke mutagent, men aneugen in vitro og in vivo med et ikke-observeret virkningsniveau for aneugenicitet, der er ca. 16,5 gange den humane kliniske eksponering ved 100 mg baseret på AUC.
English: Intracranial* efficacy results in Study A by prior treatment Efficacy parameter
Danish: Intrakranielle* effektresultater i studie A efter forudgående behandling
English: If a dose of Lorviqua is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours before the next dose, in which case the patient should not take the missed dose.
Danish: Hvis der glemmes en dosis Lorviqua, skal den tages så snart, patienten husker det, medmindre der er mindre end 4 timer til den næste dosis.
English: Permanently discontinue lorlatinib if ILD/pneumonitis recurs or fails to recover after 6 weeks of lorlatinib hold and steroid treatment.
Danish: Seponér lorlatinib permanent, hvis ILS/pneumonitis recidiverer eller ikke forbedres efter 6 ugers pause fra lorlatinib og steroidbehandling.
English: Lorlatinib is not recommended during pregnancy or for women of childbearing potential not using contraception.
Danish: Lorlatinib anbefales ikke under graviditet eller til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: It is unknown whether lorlatinib and its metabolites are excreted in human milk.
Danish: Det er ukendt, om lorlatinib/metabolitter udskilles i human mælk.
English: In humans, lorlatinib undergoes oxidation and glucuronidation as the primary metabolic pathways.
Danish: Hos mennesker undergår lorlatinib oxidering og glucuronidering som de primære metaboliseringsveje.
English: - pimozide - a medicine used to treat mental health problems.
Danish: - pimozid, der anvendes til behandling af psykiske problemer.
English: Tell your doctor right away about changes in your heart beat (fast or slow), light-headedness, fainting, dizziness or shortness of breath.
Danish: Fortæl straks lægen om ændringer i dine hjerteslag (hurtige eller langsomme), omtågethed, besvimelse, svimmelhed eller stakåndethed.
English: What Lorviqua contains - The active substance is lorlatinib.
Danish: Lorviqua indeholder - Aktivt stof: lorlatinib.
English: The safety and efficacy of lorlatinib in paediatric patients below 18 years have not been established.
Danish: Pædiatrisk population Lorlatinibs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
Danish: Lorlatinib skal seponeres permanent, hvis patienten ikke kan tåle dosen på 50 mg oralt en gang dagligt.
English: All target organ findings with the exception of hepatic bile duct hyperplasia were partially to fully reversible.
Danish: Alle målorganresultater med undtagelse af hyperplasi i levergaldeveje var delvist eller helt reversible.
English: Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events.
Danish: Der skal tages et elektrokardiogram (EKG) før påbegyndelse af behandlingen med lorlatinib og månedligt derefter, særligt hos patienter med prædisponerende tilstande mht. forekomst af klinisk signifikante hjertehændelser.
English: - pain in the back or abdomen (belly), yellowing of the skin and eyes (jaundice), nausea or vomiting.
Danish: - smerter i ryggen eller maven, gulfarvning af huden og øjne (gulsot), kvalme eller opkastninger.
English: In 295 patients who received lorlatinib at the recommended dose of 100 mg once daily and had a ECG measurement in Study A, lorlatinib was studied in a population of patients that excluded those with QTc interval > 470 msec.
Danish: Hos 295 patienter, som fik den anbefalede dosis på 100 mg lorlatinib en gang dagligt og som fik en EKG-måling i studie A, blev lorlatinib undersøgt i en patientpopulation, som udelukkede patienter med QTc interval > 470 msek.
English: Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.
Danish: Lorlatinib er en selektiv adenosintriphosphat (ATP)-kompetitiv hæmmer af ALK og c-ros-onkogen 1 (ROS1) tyrosinkinase.
English: It is not known whether lorlatinib affects female fertility.
Danish: Det er ikke kendt, om lorlatinib påvirker den kvindelige fertilitet.
English: Dose reductions due to adverse reactions occurred in 23.4% of patients receiving lorlatinib.
Danish: Der blev foretaget dosisreduktion grundet bivirkninger hos 23,4 % af de patienter, der fik lorlatinib.
English: The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive effects (28.8%), fatigue (28.1%), weight increased (26.4%) and mood effects (22.7%).
Danish: De hyppigst indberettede bivirkninger var hyperkolesterolæmi (84,4 %), hypertriglyceridæmi (67,1 %), ødem (54,6 %), perifer neuropati (47,8 %), kognitive virkninger (28,8 %), træthed (28,1 %), vægtstigning (26,4 %) og virkninger på humøret (22,7 %).
English: Do not take Lorviqua - if you are allergic to lorlatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Lorviqua - hvis du er allergisk over for lorlatinib eller et af de øvrige indholdsstoffer i Lorviqua (angivet i afsnit 6) - hvis du tager en af disse medicintyper:
English: Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g. dyspnoea, cough and fever) should be promptly evaluated for ILD/pneumonitis.
Danish: De patienter, der får en forværring af respirationssymptomer, der tyder på ILS/pneumonitis (f.eks. dyspnø, hoste og feber), skal straks evalueres med henblik på ILS/pneumonitis.
English: In order to further confirm the efficacy and safety of lorlatinib in the treatment of patients with ALK-positive NSCLC, the MAH should submit the clinical study report of the phase III study CROWN (1006) comparing lorlatinib versus crizotinib for the first-line treatment of advanced ALK-positive NSCLC.
Danish: For yderligere at bekræfte virkning og sikkerhed af lorlatinib ved behandling af patienter med ALK-positiv NSCLC, skal markedsføringstilladelsesindehaveren indsende rapporten for fase 3 studiet CROWN (1006), som sammenligner lorlatinib versus crizotinib ved 1. linje behandling af ALK-positiv NSCLC.
English: Consider no dose modification or reduce by 1 dose level, as clinically indicated.
Danish: Overvej ingen dosisjustering eller reducér med 1 dosisniveau, efter den kliniske indikation.
English: Among the 31 patients with a confirmed IC objective tumour response and at least one measurable brain metastasis at baseline by ICR, the median IC-TTR was 1.4 months (range: 1.2 to 16.2 months).
Danish: Blandt de 31 patienter med et bekræftet IC objektivt tumorrespons og mindst en målbar hjernemetase ved baseline efter ICR, var middelværdien for IC-TTR 1,4 måneder (interval: 1,24 til 16,2 måneder).
English: Each pack contains 30 film-coated tablets in 3 blisters.
Danish: Hver pakning indeholder 30 filmovertrukne tabletter i 3 blisterkort.
English: Permanent treatment discontinuation associated with adverse reactions occurred in 3.1% of patients receiving lorlatinib.
Danish: Der blev foretaget en permanent seponering af behandlingen forbundet med bivirkninger hos 3,1 % af de patienter, der fik lorlatinib.
English: Median duration of cognitive, mood and speech effects was 224, 83 and 106 days, respectively.
Danish: Middelvarighed af kognitive påvirkninger, samt virkninger på humøret og talen var henholdsvis 224, 83 og 106 dage.
English: The ORR for Asians was 49.1% (95% CI: 35.1, 63.2) and 31.5% for non-Asians (95% CI: 21.1, 43.4).
Danish: ORR for asiater var 49,1 % (95 % CI: 35,1; 63,2) og 31,5 % for ikke-asiater (95 % CI: 21,1; 43,4).
English: In non-clinical studies, lorlatinib inhibited catalytic activities of non-mutated ALK and clinically relevant ALK mutant kinases in recombinant enzyme and cell-based assays.
Danish: I ikke-kliniske studier hæmmede lorlatinib de katalytiske aktiviteter af ikke-muteret ALK og klinisk relevante ALK-mutantkinaser i rekombinant enzym- og cellebaserede analyser.
English: Following oral administration of a 100 mg radiolabelled dose of lorlatinib, a mean 47.7% of the radioactivity was recovered in urine and 40.9% of the radioactivity was recovered in faeces, with overall mean total recovery of 88.6%.
Danish: Efter oral administration af en 100 mg radiomærket dosis lorlatinib blev en middelværdi for radioaktivitet på 47,7 % genfundet i urin og 40,9 % af radioaktiviteten blev genfundet i fæces med en samlet genfindingsmiddelværdi på 88,6 %.
English: Less than 1% of the administered dose is detected as unchanged lorlatinib in urine.
Danish: Mindre end 1 % af den administrerede dosis findes som uomdannet lorlatinib i urin.
English: • rifampicin (used to treat tuberculosis)
Danish: • rifampicin (anvendes til at behandle tuberkulose)
English: Concurrent administration of lorlatinib in patients resulted in decreased oral midazolam AUC when midazolam was administered alone, suggesting that lorlatinib is an inducer of CYP3A4/5.
Danish: Samtidig administration af lorlatinib hos patienter resulterede i et fald i AUC af oral midazolam, når midazolam blev administreret alene, hvilket antyder, at lorlatinib er en inducer af CYP3A4/5.
English: If no pacemaker placed, resume lorlatinib at 1 reduced dose level only when symptoms resolve and PR interval is less than 200 msec.
Danish: Hvis der ikke indsættes en pacemaker, genoptages behandlingen med lorlatinib ved 1 reduceret dosisniveau først, når symptomerne er forsvundet og PR-intervallet er mindre end 200 msek.
English: At steady-state, the systemic exposure (AUC24 and Cmax) increased less than proportionally over the 10 to 200 mg dose range.
Danish: Ved steady state steg lorlatinibs systemiske eksponering (AUC24 og Cmax) mindre end proportionalt i dosisintervallet 10 til 200 mg.
English: Psychiatric disorders Mood effectsc Hallucinationsd
Danish: Psykiske forstyrrelser Virkninger på humøret Hallucinationer
English: Lorlatinib demonstrated marked antitumour activity in mice bearing tumour xenografts that express echinoderm microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK mutations L1196M, G1269A, G1202R, and I1171T.
Danish: Lorlatinib udviste markant antitumor-aktivitet hos mus, der bar tumor-xenografter, der udtrykker pighuds-mikrotubulusassocieret protein-lignende 4 (EML4) fusioner med ALK variant 1 (v1), herunder ALK-mutationerne L1196M, G1269A, G1202R og I1171T.
English: Grade 3: Severe
Danish: Grad 3: Alvorlig
English: For those patients who develop PR prolongation, dose modification may be required (see section 4.2).
Danish: For de patienter, der udvikler forlængelse af PR, kan en dosisjustering være nødvendig (se pkt.
English: - mood or memory problems, such as change in your mood (including depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or a change in your personality and episodes of confusion.
Danish: - problemer med humør eller hukommelse, f.eks. ændring i dit humør (herunder depression, eufori og humørsvingninger), irritabilitet, aggression, ophidselse, angst eller en ændring i din personlighed og episoder med forvirring.
English: Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval.
Danish: Overvej virkningerne ved samtidig brug af andre lægemidler og vurdér og korrigér eventuelle elektrolytforstyrrelser, der kan forlænge PR-intervallet.
English: Breast-feeding should be discontinued during treatment with lorlatinib and for 7 days after the final dose.
Danish: Amning skal ophøre under behandling med lorlatinib og i 7 dage efter den sidste dosis.
English: Concomitant administration of lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate.
Danish: Samtidig administration af lorlatinib med CYP2B6-substrater (f.eks. bupropion, efavirenz) kan resultere i reducerede plasmakoncentrationer af CYP2B6-substratet.
English: Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 to 696 days) and 41 days (range: 7 to 489 days), respectively.
Danish: Mediantiden til forekomst af stigning i serumlipase og -amylase er henholdsvis 70 dage (interval: 7 til 696 dage) og 41 dage (interval: 7 til 489 dage).
English: Seminiferous tubular degeneration and/or atrophy in the testes, and epididymal changes (inflammation and/or vacuolation) were observed in the rat and dog.
Danish: Der blev observeret seminiferøs tubulær degeneration og/eller atrofi i testes og ændringer i epididymis (inflammation og/eller vakuolisering) hos rotter og hunde.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1355/001 (120 film-coated tablets) EU/1/19/1355/003 (90 film-coated tablets)
Danish: EU/1/19/1355/001 (120 filmovertrukne tabletter) EU/1/19/1355/003 (90 filmovertrukne tabletter)
English: The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see section 4.8).
Danish: Anvendelsen af lorlatinib er blevet forbundet med øgning i serumkolesterol og triglycerider (se pkt.
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring, including LVEF assessment, should be considered.
Danish: Hos patienter, som udvikler relevante kardiale symptomer under behandlingen, skal kardiologisk monitorering, herunder måling af LVEF, overvejes.
English: • First dose reduction: 75 mg taken orally once daily
Danish: • Første dosisreduktion: 75 mg taget oralt en gang dagligt
English: If there is any possibility that you may father a child while taking this medicine, you must use a condom during treatment, and for at least 14 weeks after completing therapy.
Danish: Hvis der er mulighed for, at du kan gøre en kvinde gravid, mens du tager denne medicin, skal du anvende et kondom under behandlingen, og i mindst 14 uger efter behandlingens afslutning.
English: Left ventricular ejection fraction (LVEF) decrease has been reported in patients receiving lorlatinib who had baseline and at least one follow-up LVEF assessment.
Danish: Der er rapporteret fald i venstre ventrikels uddrivningsfraktion (LVEF) hos patienter, der fik lorlatinib, og som havde baseline-måling og mindst én opfølgende måling af LVEF.
English: (6.0, NR)
Danish: (6,0; IN)
English: Central nervous system (CNS) effects have been observed in patients receiving lorlatinib, including changes in cognitive function, mood or speech (see section 4.8).
Danish: Der er blevet observeret virkninger i centralnervesystemet hos patienter, der fik lorlatinib, herunder ændringer af den kognitive funktion, humør eller tale (se pkt.
English: Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment and regularly thereafter as clinically indicated (see section 4.2).
Danish: Patienter skal monitoreres for lipase- og amylasestigninger før start af lorlatinibbehandling og regelmæssigt derefter i henhold til den kliniske indikation (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE44
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE44
English: Peak lorlatinib concentrations in plasma are rapidly reached with the median Tmax of 1.2 hours following a single 100 mg dose and 2.0 hours following multiple dosing of 100 mg once daily.
Danish: Peakkoncentrationer af lorlatinib i plasma nås hurtigt med en middelværdien af Tmax på 1,2 timer efter en enkelt dosis på 100 mg og 2,0 timer efter flere doseringer af 100 mg en gang dagligt.
English: Serum cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4 and 8 weeks after initiating lorlatinib; and regularly thereafter.
Danish: Serumkolesterol og triglycerider skal monitoreres før behandlingen med lorlatinib og 2, 4 og 8 uger efter start af behandling med lorlatinib og regelmæssigt derefter.
English: - If your next dose is in 4 hours or more, take the missed tablet as soon as you remember.
Danish: - Hvis der er 4 timer eller mere til din næste dosis, skal du tage den manglende tablet så snart, du kommer i tanker om det.