FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual.
Danish: Fortæl det straks til lægen, hvis du føler dig mere træt end normalt, din hud og det hvide i dine øjne bliver gult, din urin bliver mørk eller brun (tefarvet), du har kvalme, opkastninger eller nedsat appetit, du har smerter i højre side af maven, du har kløe, eller hvis du nemmere får blå mærker end normalt.
English: The IC ORR was 54.5% for Asians (95% CI: 32.2, 75.6) and 46.4% for non-Asians (95% CI: 27.5, 66.1).
Danish: IC ORR var 54,5 % for asiater (95 % CI: 32,2; 75,6) og 46,4 % for ikke-asiater (95 % CI: 27,5; 66,1).
English: CNS adverse reactions were primarily cognitive effects (28.8%), mood effects (22.7%), and speech effects (9.8%), and were generally mild, transient, and reversible spontaneously upon dose delay and/or dose reduction (see sections 4.2 and 4.4).
Danish: Bivirkninger i centralnervesystemet var primært kognitive påvirkninger (28,8 %) virkninger på humøret (22,7 %) og virkninger på talen (9,8 %) og var generelt milde, forbigående og spontant reversible ved dosisforsinkelse og/eller dosisreduktion (se pkt.
English: a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).
Danish: Hyperkolesterolæmi (herunder forhøjet kolesterol i blodet, hyperkolesterolæmi).
English: In addition, the effect of a single oral dose of lorlatinib (50 mg, 75 mg, and 100 mg) with and without 200 mg once daily itraconazole was evaluated in a 2-way crossover study in 16 healthy volunteers.
Danish: Endvidere blev virkningen af en enkelt oral dosis lorlatinib (50 mg, 75 mg og 100 mg) med og uden 200 mg itraconazol en gang dagligt evalueret i et 2-vejs overkrydsningsstudie hos 16 raske frivillige.
English: In vitro, lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2.
Danish: Lorlatinib har in vitro en lav risiko for at forårsage lægemiddelinteraktioner ved induktion af CYP1A2.
English: Blood and lymphatic system disorders Anaemia
Danish: Blod og lymfesystem Anæmi
English: At 100 mg once daily, the geometric mean (% coefficient of variation [CV]) peak plasma concentration was 577 (42) ng/mL and the AUC24 was 5,650 (39) ng·h/mL in patients with cancer.
Danish: Ved 100 mg en gang dagligt var den geometriske middelværdi (variationskoefficient % (CV)) for peakplasmakoncentrationen 577 (42) ng/ml og AUC24 var 5.650 (39) ng·t/ml hos patienter med cancer.
English: Based on non-clinical safety findings, male fertility may be compromised during treatment with lorlatinib (see section 5.3).
Danish: På grundlag af ikke-kliniske sikkerhedsresultater kan mænds fertilitet blive kompromitteret under behandling med lorlatinib (se pkt.
English: • Second dose reduction: 50 mg taken orally once daily
Danish: • Anden dosisreduktion: 50 mg taget oralt en gang dagligt
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Lorviqua.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Lorviqua.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving lorlatinib.
Danish: Fertile kvinder skal rådes til at undgå at blive gravide, mens de får lorlatinib.
English: As lorlatinib is metabolised in the liver, hepatic impairment is likely to increase lorlatinib plasma concentrations.
Danish: Eftersom lorlatinib metaboliseres i leveren, er det sandsynligt, at nedsat leverfunktion øger lorlatinibs plasmakoncentration.
English: The use of lorlatinib in the treatment of ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI was investigated in Study A, a single-arm, multicentre Phase 1/2 study.
Danish: Anvendelsen af lorlatinib i behandlingen af ALK-positiv, fremskreden NSCLC efter behandling med mindst en andengenerations ALK TKI, blev undersøgt i studie A, et multicenterstudie med en enkelt behandlingsgruppe, fase 1/2.
English: Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Danish: Lorviqua indeholder det aktive stof lorlatinib, en medicin, der anvendes til behandling af voksne med en form for fremskreden lungekræft, som kaldes ikke-småcellet lungekræft (NSCLC).
English: The median duration of hypercholesterolaemia and hypertriglyceridaemia was 381 and 405 days, respectively.
Danish: Middelvarigheden af hyperkolesterolæmi og hypertriglyceridæmi var henholdsvis 381 og 405 dage.
English: The recommended dose is 100 mg lorlatinib taken orally once daily.
Danish: Den anbefalede dosis er 100 mg lorlatinib taget oralt en gang dagligt.
English: Consider pacemaker placement if symptomatic AV block persists.
Danish: Overvej indsættelse af pacemaker, hvis symptomatisk AV-blok varer ved.
English: Lorviqua is only given to patients who have an alteration in the ALK gene, see How Lorviqua works below.
Danish: Lorviqua gives kun til patienter, der har en ændring i genet for ALK. Se Sådan virker Lorviqua nedenfor.
English: If concurrent use of the strong CYP3A4/5 inhibitor is discontinued, lorlatinib should be resumed at the dose used prior to the initiation of the strong CYP3A4/5 inhibitor and after a washout period of 3 to 5 half-lives of the strong CYP3A4/5 inhibitor.
Danish: Hvis samtidig anvendelse af den stærke CYP3A4/5hæmmer seponeres, bør behandlingen med lorlatinib genoptages ved den dosis, der anvendtes før påbegyndelsen af den stærke CYP3A4/5-hæmmer og efter en udvaskningsperiode på 3 til 5 halveringstider af den stærke CYP3A4/5-hæmmer.
English: Nervous system disorders Cognitive effectse Peripheral neuropathyf Headache Speech effectsg
Danish: Nervesystemet Kognitive virkninger Perifer neuropati Hovedpine Virkninger på talen
English: Median time of occurrence of severe increase in serum cholesterol and triglycerides is 201 days (range: 42 to 518 days) and 127 days (range: 15 to 358 days), respectively.
Danish: Mediantiden til forekomst af kraftig øgning af serumkolesterol og triglycerider er henholdsvis 201 dage (interval: 42 til 518 dage) og 127 dage (interval: 15 til 358 dage).
English: In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including LVEF assessment at baseline and during treatment, should be considered.
Danish: Hos patienter med kardiale risikofaktorer eller med tilstande, der kan påvirke LVEF, skal kardiologisk monitorering, herunder måling af LVEF ved baseline og under behandling, overvejes.
English: No dose adjustment is needed for patients with normal renal function and mild or moderate (CLcr: ≥ 30mL/min) renal impairment based on a population pharmacokinetic analysis.
Danish: Dosisjustering er ikke nødvendig for patienter med normal nyrefunktion og let eller moderat (CLcr: ≥ 30 ml/min) nedsat nyrefunktion baseret på en populationsfarmakokinetisk analyse.
English: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Danish: Hver pakning indeholder 90 filmovertrukne tabletter i 9 blisterkort eller 120 filmovertrukne tabletter i 12 blisterkort.
English: Monitor ECG/symptoms potentially related to AV block closely.
Danish: Monitorér nøje EKG/symptomer, der kan være relateret til AV-blok.
English: Cardiac electrophysiology
Danish: Hjerte-elektrofysiologi
English: If severe hypercholesterolaemia and/or hypertriglyceridaemia recur despite maximal lipid-lowering therapyb in accordance with respective prescribing information, reduce lorlatinib by 1 dose level.
Danish: Hvis alvorlig hyperkolesterolæmi og/eller hypertriglyceridæmi recidiverer på trods af maksimal lipidsænkende behandling b i henhold til den respektive doseringsanvisning, reduceres lorlatinib med 1 dosisniveau.
English: Population pharmacokinetic analyses in patients with advanced NSCLC and healthy volunteers indicate that there are no clinically relevant effects of age, gender, race, body weight, and phenotypes for CYP3A5 and CYP2C19.
Danish: Populationsfarmakokinetiske analyser hos patienter med fremskreden NSCLC og raske frivillige indikerer, at alder, køn, race, kropsvægt og fænotyper for CYP3A5 og CYP2C19 ikke har nogen klinisk relevant indvirkning.
English: Withhold lorlatinib until symptoms resolve to less than or equal to Grade 2 or baseline.
Danish: Tilbagehold lorlatinib, indtil symptomer forbedres til mindre end eller lig med grad 2 eller baseline.
English: Of those, mild or moderate adverse reactions of hypercholesterolaemia or hypertriglyceridaemia occurred in 67.8% and 50.5% of patients, respectively (see section 4.4).
Danish: Af disse forekom lette eller moderate bivirkninger med hyperkolesterolæmi eller hypertriglyceridæmi hos henholdsvis 67,8 % og 50,5 % af patienterne (se pkt.
English: Abbreviations: ALK=anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent Central Review; N/n=number of patients; NR=not reached; TKI= tyrosine kinase inhibitor.
Danish: Forkortelser: ALK=anaplastisk lymfomkinase; CI=konfidensinterval; ICR=Uafhængig central gennemgang; N/n=antal patienter; IN=ikke nået; TKI=tyrosinkinasehæmmer.
English: A total of 139 patients with ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI were enrolled in the Phase 2 portion of the study.
Danish: Der blev inkluderet i alt 139 patienter med ALK-positiv, fremskreden NSCLC efter behandling med mindst en andengenerations ALK TKI til studiets fase 2.
English: - hallucinations (seeing or hearing things that are not there)
Danish: Almindelige (kan forekomme hos 1 ud af 10 personer) - hallucinationer (se eller høre ting, der ikke er der)
English: Repeat-dose toxicity
Danish: Toksicitet ved gentagne doser
English: This medicine contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. 25 mg eller 100 mg tablet, dvs. den er i det væsentlige natriumfri.
English: Interstitial lung disease/Pneumonitis
Danish: Interstitiel lungesygdom/pneumonitis
English: The European Medicines Agency has waived the obligation to submit the results of studies with lorlatinib 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 lorlatinib i alle undergrupper af den pædiatriske population med lungecarcinom (småcellet og ikke-småcellet carcinom) (se pkt.
English: - dihydroergotamine, ergotamine - medicines used to treat migraine headaches.
Danish: - dihydroergotamin, ergotamin, anvendes til behandling af migrænehovedpine.
English: uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: Inden for hver systemorganklasse er bivirkningerne listet efter hyppighed i henhold til følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: What you need to know before you take Lorviqua 3.
Danish: Det skal du vide, før du begynder at tage Lorviqua 3.
English: Table 2 presents adverse reactions occurring in 295 adult patients treated with lorlatinib 100 mg once daily with advanced NSCLC from Study A.
Danish: Tabel 2 præsenterer bivirkninger, der forekom hos 295 voksne patienter fra studie A, der blev behandlet med lorlatinib 100 mg en gang dagligt og havde fremskreden NSCLC.
English: During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms.
Danish: Under behandling med lorlatinib og i mindst 14 uger efter den sidste dosis, skal mænd med fertile kvindelige partnere anvende effektiv kontraception, herunder et kondom, og mænd med gravide partnere skal anvende kondom.
English: Initiate or increase the dose of lipid-lowering medicinal products, if indicated (see section 4.2).
Danish: Initier behandling med eller øg dosis af lipidsænkende lægemidler, hvis indiceret (se pkt.
English: Grades 3-4
Danish: % Grad 3-4 Alle grader
English: The most common mood effect of any grade was irritability (6.1%), which was also the most common Grade 3 or 4 reaction (1.0%).
Danish: Den mest almindelige kognitive påvirkning af en hvilken som helst grad var irritabilitet (6,1 %), som også var den mest almindelige bivirkning af grad 3 og 4 (1,0 %).
English: In plasma, a benzoic acid metabolite of lorlatinib resulting from the oxidative cleavage of the amide and aromatic ether bonds of lorlatinib was observed as a major metabolite, accounting for 21% of the circulating radioactivity.
Danish: I plasma blev der observeret en større benzoesyre-metabolit af lorlatinib, forårsaget af oxidativ spaltning af lorlatinibs amidbindinger og aromatiske etherbindinger, som tegnede sig for 21 % af den cirkulerende radioaktivitet.
English: If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away.
Danish: Hvis du ved et uheld tager for mange tabletter, skal du straks fortælle det til lægen, apotekspersonalet eller sygeplejersken.
English: The median time to onset for both hypercholesterolaemia and hypertriglyceridaemia was 15 days (range: 1 to 399 days).
Danish: Middeltiden til forekomst af både hyperkolesterolæmi og hypertriglyceridæmi var 15 dage (interval: 1 til 399 dage).
English: Strong cytochrome P-450 (CYP) 3A4/5 inhibitors
Danish: Stærke cytochrom P-450 (CYP) 3A4/5-hæmmere
English: The most common speech effect of any grade was dysarthria (4.1%), and the most common Grade 3 or 4 reaction was slow speech (0.3%).
Danish: Den mest almindelige virkning på talen af en hvilken som helst grad var dysartri (4,1 %) og den mest almindelige bivirkning af grad 3 og 4 var langsom tale (0,3 %).
English: Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
Danish: Lorviqua, som monoterapi, er indiceret til behandling af voksne patienter med anaplastisk lymfomkinase-positiv (ALK-positiv), fremskreden ikke-småcellet lungecancer (NSCLC), ved sygdomsprogression efter behandling med:
English: Film-coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172), and iron oxide red (E172).
Danish: Filmovertræk: Hypromellose, lactosemonohdyrat, macrogol, triacetin, titandioxid (E171), jernoxid, sort (E172) samt jernoxid, rød (E172).
English: In the study population, the maximum mean change from baseline for PR interval was 16.4 msec (2-sided 90% upper CI 19.4 msec) (see sections 4.2, 4.4 and 4.8).
Danish: I studiepopulationen, var den maksimale middelændring i forhold til baseline for PR-interval 16,4 msek (2-sidet, 90 % øvre CI 9,4 msek) (se pkt.
English: In order to further confirm the efficacy of lorlatinib in patients who progressed after alectinib or ceritinib as the first ALK TKI therapy, the MAH should conduct a prospective single arm study investigating patients in that same setting.
Danish: For yderligere at bekræfte virkning og sikkerhed af lorlatinib ved behandling af patienter, som er progredieret efter alectinib eller ceritinib som første ALKTKI-behandling skal markedsføringstilladelsesindehaveren gennemføre et prospektivt enkeltarms-studie under samme betingelser.
English: Lipase and amylase increase
Danish: Lipase- og amylasestigning
English: In a study conducted in healthy volunteers, the concomitant use of lorlatinib and rifampin, a strong CYP3A4/5 inducer, was associated with increases of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) with no increase of total bilirubin and alkaline phosphatase (see section 4.5).
Danish: I et studie med raske frivillige blev samtidig anvendelse af lorlatinib og rifampin, en stærk CYP3A4/5inducer, forbundet med stigninger i alaninaminotransferase (ALAT) og aspartataminotransferase (ASAT) uden en stigning af total-bilirubin og alkalisk phosphatase (se pkt.
English: Withhold lorlatinib.
Danish: Tilbagehold lorlatinib.
English: Women of childbearing potential/Contraception in males and females
Danish: Fertile kvinder/prævention til mænd og kvinder
English: Your doctor may do further assessments and may decide to reduce the dose of Lorviqua or stop your treatment if you develop: - liver problems.
Danish: Din læge kan foretage yderligere vurderinger og kan beslutte sig for at nedsætte dosen af Lorviqua eller standse behandlingen, hvis du udvikler: - leverproblemer.
English: First degree AV block: Asymptomatic
Danish: Grad 1 AV-blok: Asymptomatisk
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.
Danish: Tabletkerne: mikrokrystallinsk cellulose, calciumhydrogenphosfat, natriumstivelsesglycolat, magnesiumstearat.
English: Introduce or modify lipid-lowering therapyb in accordance with respective prescribing information; continue lorlatinib at same dose.
Danish: Introducér eller regulér den lipidsænkende behandling i henhold til den respektive doseringsanvisning; fortsæt lorlatinib ved samme dosis.
English: Lorlatinib should not be used during breast-feeding.
Danish: Lorlatinib må ikke anvendes under amning.
English: Lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets (9 blisters) or 120 tablets (12 blisters).
Danish: Lorviqua 25 mg leveres i blistere med 10 tabletter, som fås i pakker med 90 tabletter (9 blisterkort) 120 tabletter (12 blisterkort).
English: Lorlatinib 150 mg orally once daily for 15 days decreased AUCinf and Cmax of a single oral 2 mg dose of midazolam (a sensitive CYP3A substrate) by 61% by 50%, respectively; hence, lorlatinib is a moderate CYP3A inducer.
Danish: Lorlatinib 150 mg oralt en gang dagligt i 15 dage reducerede AUCinf og Cmax af en enkelt oral 2 mg dosis midazolam (et sensitivt CYP3A-substrat) med henholdsvis 61 % og 50 %; derfor er lorlatinib en moderat CYP3A-inducer.
English: In vitro studies indicated that lorlatinib is a time-dependent inhibitor as well as an inducer of CYP3A4/5 and it activates the human pregnane-X-receptor (PXR), with the net effect in vivo being induction.
Danish: In vitro-studier indikerede, at lorlatinib er en tidsafhængig hæmmer samt en inducer af CYP3A4/5, og at det aktiverer den humane pregnan-X-receptor (PXR) med induktion som nettovirkningen in vivo.
English: Complete AV block
Danish: Komplet AV-blok
English: Patients received lorlatinib orally at the recommended dose of 100 mg once daily, continuously.
Danish: Patienter fik kontinuerligt lorlatinib ved den anbefalede dosis på 100 mg en gang dagligt oralt.
English: - The recommended dose is one tablet of 100 mg taken by mouth once daily.
Danish: - Den anbefalede dosis er en tablet med 100 mg, der sluges, en gang dagligt.
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely: - cough, shortness of breath, chest pain, or worsening breathing problems - slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint, or losing consciousness - abdominal (belly) pain, back pain, nausea, vomiting, itching, yellowing of the skin and eyes - mental status changes; changes in cognition including confusion, memory loss, and reduced ability to concentrate; changes in mood including irritability and mood swings; and changes in speech including difficulty speaking, such as slurred or slow speech
Danish: Din læge kan nedsætte din dosis, standse behandlingen i en kort periode eller standse behandlingen helt ved: - hoste, stakåndethed, brystsmerter eller en forværring af vejrtrækningsproblemer - langsom puls (50 slag pr. minut eller mindre), træthedsfornemmelse, svimmelhed, svaghed eller ved tab af bevidsthed - mavesmerter, rygsmerter, kvalme, opkastninger, kløe, gulfarvning af hud og øjne - ændringer i mental tilstand, ændringer i opfattelsesevnen, herunder forvirring, hukommelsestab og nedsat koncentrationsevne, ændringer i humør, herunder irritabilitet og humørsvingninger og ændringer i tale, herunder talebesvær, såsom snøvlet eller langsom tale.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucosegalactosemalabsorption.
English: Pfizer PFE, spol.
Danish: Česká republika Pfizer PFE, spol.
English: In vitro studies indicated that lorlatinib may have the potential to inhibit P-glycoprotein (P-gp, systemically and at the gastrointestinal [GI] tract), BCRP (GI tract), OATP1B1, OATP1B3, OCT1, MATE1 and OAT3 at clinically relevant concentrations.
Danish: In vitro-studier indikerede, at lorlatinib muligvis kan hæmme P-glycoprotein (P-gp, systemisk og ved mave-tarm-kanalen), BCRP (mave-tarm-kanal), OATP1B1, OATP1B3, OCT1, MATE1 og OAT3 ved klinisk relevante koncentrationer.
English: Objective response rateb (95% CI) Complete response, n Partial response, n Duration of intra-cranial response Median, months (95% CI)
Danish: Komplet respons, n Partielt respons, n Varighed af intrakranielt respons Median, måneder (95 % CI)
English: Efficacy parameter
Danish: Effektparametre
English: If symptoms and the second degree AV block resolve or if patients revert to asymptomatic first degree AV block, resume lorlatinib at 1 reduced dose level.
Danish: Hvis symptomer og grad 2 AV-blok forsvinder, eller hvis patienten vender tilbage til asymptomatisk grad 1 AVblok, genoptages behandlingen med lorlatinib ved 1 reduceret dosisniveau.
English: During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms (see section 4.6).
Danish: Under behandling med lorlatinib og i mindst 14 uger efter den sidste dosis, skal mandlige patienter med fertile kvindelige partnere anvende effektiv kontraception, herunder kondom, og mandlige patienter med gravide partnere skal anvende kondom (se pkt.
English: b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).
Danish: Hypertriglyceridæmi (herunder forhøjede triglycerider i blodet, hypertriglyceridæmi).
English: If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method.
Danish: Hvis det ikke er muligt at undgå hormonel kontraception, skal der ud over den hormonelle metode bruges kondom.
English: In the prostate, minimal to mild glandular atrophy was observed in dogs at dose equivalent to human clinical exposure at the recommended posology).
Danish: Der blev observeret minimal til let glandulær atrofi i prostata hos hunde ved doser, der svarede til den humane kliniske eksponering ved den anbefalede dosering.
English: If hormonal contraception is unavoidable it must be used in combination with a condom.
Danish: Hvis det ikke er muligt at undgå hormonel prævention, skal der også bruges kondom samtidigt.
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild hepatic impairment (n = 50).
Danish: Populationsfarmakokinetiske analyser har vist, at lorlatinibeksponeringen ikke blev ændret klinisk relevant hos patienter med let nedsat leverfunktion (n = 50).
English: Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and grapefruit juice products may increase lorlatinib plasma concentrations.
Danish: Samtidig anvendelse af lorlatinib med lægemidler, der er stærke CYP3A4/5-hæmmere og produkter med grapefrugtsaft kan øge lorlatinibs plasmakoncentration.