FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Exforge been studied?
Danish: Hvordan blev Exforge undersøgt?
English: How is Exforge used?
Danish: Hvordan anvendes Exforge?
English: What is Exforge?
Danish: Hvad er Exforge?
English: How does Exforge work?
Danish: Hvordan virker Exforge?
English: This is because it may harm your baby.
Danish: Det er fordi, det kan skade dit barn.
English: 30 June 2024
Danish: 30. juni 2024
English: - Take the dose at about the same time each day.
Danish: - Tag dosen på omkring samme tid hver dag.
English: Date of first authorisation: 6 May 2019
Danish: Dato for første markedsføringstilladelse: 6. maj 2019
English: You may require medical attention.
Danish: Det kan være nødvendigt, at du får medicinsk hjælp.
English: It is important to take Lorviqua every day, for as long as your doctor asks you to.
Danish: Det er vigtigt at tage Lorviqua hver dag, så længe din læge beder dig om det.
English: Delayed or missed doses
Danish: Forsinkede eller manglende doser
English: Talk to your doctor about the right methods of contraception for you and your partner.
Danish: Tal med lægen om de rette præventionsmetoder for dig og din partner.
English: Dosing interruption or dose reduction may be required based on individual safety and tolerability.
Danish: Dosisafbrydelse eller dosisreduktion kan være påkrævet baseret på individuel sikkerhed og tolerabilitet.
English: Children and adolescents This medicine is only indicated in adults and it is not to be given to children and adolescents.
Danish: Børn og unge Denne medicin er kun beregnet til voksne og må ikke gives til børn og unge.
English: Treatment of overdose with the medicinal product consists of general supportive measures.
Danish: Behandling af overdosering med lægemidlet består af generelle støtteforanstaltninger.
English: Refer for cardiac observation and monitoring.
Danish: Henvis til hjerteobservation og monitorering.
English: Tell your doctor immediately if you develop: - heart problems.
Danish: Fortæl det straks til lægen, hvis du udvikler: - hjerteproblemer.
English: Then take the next tablet at the usual time.
Danish: Tag så den næste tablet ved det sædvanlige tidspunkt.
English: Some side effects could be serious.
Danish: Nogle bivirkninger kan blive alvorlige.
English: The main efficacy results for Study A are included in Tables 3 and 4.
Danish: De vigtigste effektresultater for studie A er inkluderet i tabel 3 og 4.
English: In vitro studies with drug transporters
Danish: In vitro-studier med lægemiddeltransportører
English: The prolongation of PR interval occurred in a concentration-dependent manner.
Danish: Forlængelsen af PR-interval forekom på en koncentrationsafhængig måde.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Danish: Det, du skal gøre, hvis du glemmer at tage en tablet, afhænger af, hvor lang tid der er til din næste dosis.
English: • Do not take Lorviqua if you are pregnant.
Danish: • Du må ikke tage Lorviqua, hvis du er gravid.
English: If you are not able to take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with your doctor right away.
Danish: Hvis du ikke kan tage medicinen, som din læge har ordineret, eller du føler, at du ikke længere har brug for den, skal du straks tale med lægen.
English: Your doctor may investigate further and treat you with other medicines such as antibiotics and steroids.
Danish: Din læge kan undersøge det yderligere og behandle dig med andre typer medicin, såsom antibiotika og steroider.
English: - speech problems, difficulty speaking, including slurred or slow speech.
Danish: - taleproblemer, vanskeligt ved at tale, herunder snøvlet eller langsom tale.
English: These symptoms could be signs of heart problems.
Danish: Disse symptomer kan være tegn på hjerteproblemer.
English: You will have blood tests before you start treatment and during your treatment.
Danish: Du får taget blodprøver, før du starter behandlingen og i løbet af din behandling.
English: Lorlatinib may be administered with or without food.
Danish: Lorlatinib kan administreres med eller uden mad.
English: Given the dose-dependent effect on PR interval, ECG monitoring is recommended.
Danish: I betragtning af den dosisafhængige virkning på PR-intervallet, anbefales EKG-monitorering.
English: - You can take the tablets with food or between meals always avoiding grapefruit and grapefruit juice.
Danish: - Du kan tage tabletterne med mad eller mellem måltiderne, men undgå altid grapefrugt og grapefrugtjuice.
English: If you have any questions about how Lorviqua works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Lorviqua virker, eller hvorfor denne medicin er ordineret til dig, skal du spørge din læge.
English: Lorlatinib dose reduction levels are summarised below:
Danish: Lorlatinibs dosisreduktions-niveauer er opsummeret nedenfor:
English: Other side effects of Lorviqua may include:
Danish: Andre bivirkninger med Lorviqua kan omfatte:
English: Lorviqua with food and drink
Danish: Brug af Lorviqua sammen med mad og drikke
English: Lorviqua is for oral use.
Danish: Lorviqua er til oral anvendelse.
English: Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older (see section 5.2).
Danish: Grundet de begrænsede data for denne population kan der ikke gives nogen dosisanbefaling for patienter i alderen 65 år og ældre (se pkt.
English: Also troleandomycin, a medicine used to treat certain types of bacterial infections.
Danish: Også troleandomycin, der anvendes til behandling af visse typer bakterieinfektioner.
English: If AV block does not resolve, placement of a permanent pacemaker may be considered.
Danish: Hvis AV-blok ikke forsvinder, kan en indsættelse af en permanent pacemaker overvejes.
English: Terms actually reported in the studies and contributing to the relevant adverse reaction are indicated in parentheses, as listed below.
Danish: Termerne, der rent faktisk blev indberettet i studierne, og som bidrog til den relevante bivirkning, er angivet i parentes, som angivet nedenfor.
English: Your doctor may do blood tests to check your liver function.
Danish: Din læge kan tage blodprøver for at undersøge din leverfunktion.
English: The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 or 1 in 96% patients.
Danish: Performancestatus ifølge Eastern Cooperative Oncology Group (ECOG) ved baseline var 0 eller 1 hos 96 % af patienterne.
English: Grade 4: Life-threatening/Urgent intervention indicated
Danish: Grad 4: Livstruende/akut intervention indiceret
English: Tell your doctor straight away if you notice any of the following side effects (also section 2 What you need to know before you take Lorviqua).
Danish: Fortæl det straks til lægen, hvis du opdager en af de følgende bivirkninger (se også afsnit 2 Det skal du vide, før du begynder at tage Lorviqua).
English: Adverse reactions that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above.
Danish: Bivirkninger, der repræsenterer det samme medicinske begreb eller den samme lidelse, blev grupperet sammen og indberettet som en enkelt bivirkning i tabellen ovenfor.
English: You must not take Lorviqua with certain medicines.
Danish: Du må ikke tage Lorviqua med visse typer medicin.
English: The oxidative cleavage metabolite is pharmacologically inactive.
Danish: Den oxidative spaltningsmetabolit er farmakologisk inaktiv.
English: Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day with or without food (see section 5.2).
Danish: Patienterne skal opfordres til at tage deres dosis lorlatinib på omtrent samme tidspunkt hver dag med eller uden mad (se pkt.
English: Brain metastases were present at baseline in 67% of patients.
Danish: Hjernemetastaser var til stede ved baseline hos 67 % af patienterne.
English: These are listed under Do not take Lorviqua, at the start of section 2.
Danish: Disse er angivet under Tag ikke Lorviqua i begyndelsen af afsnit 2.
English: • If you become pregnant when taking the medicine or during the 5 weeks after taking your last dose, tell your doctor straight away.
Danish: • Hvis du bliver gravid, mens du tager medicinen eller i løbet af 5 uger efter, at du har taget den sidste dosis, skal du straks fortælle det til lægen.
English: Lorlatinib was also capable of penetrating the blood-brain barrier.
Danish: Lorlatinib kunne også penetrere blod-hjerne-barrieren.
English: Of these, 7 patients had a baseline PR > 200 msec.
Danish: Af disse havde 7 patienter en baseline PR > 200 msek.
English: Patients should not take 2 doses at the same time to make up for a missed dose.
Danish: Patienter må ikke tage 2 doser samtidig som erstatning for den manglende dosis.
English: Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Danish: Tag ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget eller viser tegn på at have været åbnet.
English: - cough, chest pain, or a worsening of existing respiratory symptoms.
Danish: - hoste, brystsmerter eller en forværring af eksisterende åndedrætssymptomer.
English: Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med lorlatinib skal påbegyndes og overvåges af en læge med erfaring i administration af lægemidler mod cancer.
English: This is because it is not known if Lorviqua can pass into breast milk and could therefore harm your baby.
Danish: Det er fordi, man ikke ved, om Lorviqua kan udskilles i brystmælk og derved skade dit barn.
English: Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorder.
Danish: Inden for disse virkninger blev termer fra systemorganklassen Nervesystemet hyppigere indberettet end termer fra systemorganklassen Psykiske forstyrrelser.
English: The clinical study report will be submitted by:
Danish: Studierapporten skal indsendes:
English: You must not drink grapefruit juice or eat grapefruit while on treatment with Lorviqua as they may change the amount of Lorviqua in your body.
Danish: Du må ikke drikke grapefrugtsaft eller spise grapefrugt, mens du er i behandling med Lorviqua, da de kan ændre mængden af Lorviqua i kroppen.
English: The effects on male reproductive organs were partially to fully reversible.
Danish: Virkningerne på de hanlige forplantningsorganer var delvist til helt reversible.
English: See Possible side effects in section 4 for more information.
Danish: Se Bivirkninger i afsnit 4 for at få yderligere oplysninger.
English: No increases in the mean QTc were observed at the mean observed lorlatinib concentrations in this study.
Danish: Der blev ikke observeret nogen stigning i middelværdien for QTc ved de observerede middelværdikoncentrationer af lorlatinib i dette studie.
English: The most frequent adverse reaction that led to permanent discontinuations was cognitive effects.
Danish: Den hyppigste bivirkning, der førte til permanent seponering, var kognitive virkninger.
English: Contains lactose (see leaflet for further information).
Danish: Indeholder lactose (se indlægssedlen for yderligere oplysninger).
English: - quinidine - a medicine used to treat irregular heartbeat and other heart problems.
Danish: - quinidin, anvendes til behandling af uregelmæssige hjerteslag og andre hjerteproblemer.
English: The tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing).
Danish: Tabletterne skal synkes hele (tabletterne må ikke tygges, knuses eller deles, inden de synkes).
English: Lipase increased
Danish: Forhøjet lipase
English: Tests and checks
Danish: Prøver og kontrolundersøgelser
English: There are no data from the use of lorlatinib in pregnant women.
Danish: Der er ingen data fra anvendelse af lorlatinib til gravide kvinder.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Do not breast-feed while taking this medicine and for 7 days after the last dose.
Danish: Du må ikke amme, mens du tager denne medicin og i 7 dage efter den sidste dosis.
English: Atrioventricular block occurred in 1.0% of patients.
Danish: Atrioventrikulær blok forekom hos 1,0 % af patienterne.
English: This medicinal product contains lactose as an excipient.
Danish: Dette lægemiddel indeholder lactose som et hjælpestof.
English: Grapefruit products may also increase lorlatinib plasma concentrations and should be avoided.
Danish: Grapefrugtprodukter kan også øge lorlatinibs plasmakoncentration og skal undgås.
English: Effective contraception must be continued for at least 35 days after completing therapy.
Danish: Der skal fortsat bruges effektiv kontraception i mindst 35 dage efter afsluttet behandling.
English: - ciclosporin, sirolimus, and tacrolimus - medicines used in organ transplantation to prevent organ rejection.
Danish: - ciclosporin, sirolimus og tacrolimus, anvendes ved organtransplantation for at forhindre organafstødning.
English: You should take special care when driving and using machines when taking Lorviqua because of its effects on your mental state.
Danish: Du skal passe særligt på, når du fører motorkøretøj og betjener maskiner, når du tager Lorviqua på grund af indvirkningen på din mentale tilstand.
English: Effective contraception must be continued for at least 35 days after completing therapy (see section 4.6).
Danish: Der skal fortsat bruges effektiv kontraception i mindst 35 dage efter afsluttet behandling (se punkt 4.6).
English: Based on the available clinical study data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and lorlatinib.
Danish: Ud fra de foreliggende data fra kliniske studier er det ikke muligt at bestemme en årsagssammenhæng mellem ændringer i hjertets kontraktilitet og lorlatinib.
English: In embryo-foetal toxicity studies, conducted in rats and rabbits, respectively, increased embryolethality and lower foetal body weights and malformations were observed.
Danish: I embryo-føtale toksicitetsforsøg, der blev udført med henholdsvis rotter og kaniner, blev der observeret øget embryoletalitet og lavere fostervægt samt misdannelser.
English: Fertility and pregnancy
Danish: Fertilitet og graviditet
English: In vitro binding of lorlatinib to human plasma proteins is 66% with moderate binding to albumin or to α1-acid glycoprotein.
Danish: In vitro-binding af lorlatinib til humane plasmaproteiner er 66 % med moderat binding til albumin eller til et α1-syre-glycoprotein.
English: The exposure at the lowest doses with embryo-foetal effects in animals was equivalent to the human clinical exposure at 100 mg, based on AUC.
Danish: Eksponeringen ved de laveste doser med embryo-føtale virkninger hos dyr svarede til den humane kliniske eksponering ved 100 mg, baseret på AUC.
English: Withhold dose until toxicity is less than or equal to Grade 1.
Danish: Tilbagehold dosis, indtil toksicitet er mindre end eller lig med grad 1.
English: Carcinogenicity studies have not been conducted with lorlatinib.
Danish: Der er ikke udført carcinogenicitetsstudier med lorlatinib.
English: The most common adverse reactions that led to dose reductions were oedema and peripheral neuropathy.
Danish: De mest almindelige bivirkninger, der førte til dosisreduktion var ødem og perifer neuropati.
English: - If your next dose is in less than 4 hours away, skip the missed tablet.
Danish: - Hvis din næste dosis er om mindre end 4 timer, skal du springe den manglende tablet over.
English: Pacemaker placement may be indicated for severe symptoms associated with AV block.
Danish: Indsættelse af pacemaker kan være indiceret for alvorlige symptomer forbundet med AVblok.
English: Secondary endpoints included duration of response (DOR), IC-DOR, time-to-tumour response (TTR), and progression-free survival (PFS).
Danish: De sekundære endepunkter omfattede responsvarighed (DOR), IC-DOR, tid-til-tumor-respons (TTR) og progressionsfri overlevelse (PFS).
English: Central nervous system effects (changes in cognition, mood or speech) Grade 2: Moderate
Danish: Virkninger på centralnervesystemet (ændringer i kognition, humør eller tale) Grad 2: Moderat
English: Two of these ALK mutants, G1202R and I1171T, are known to confer resistance to alectinib, brigatinib, ceritinib, and crizotinib.
Danish: To af disse ALK-mutanter, G1202R og I1171T, vides at udvise resistens over for alectinib, brigatinib, ceritinib og crizotinib.
English: Weight increased
Danish: Vægtstigning
English: Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Danish: Dyreforsøg har påvist embryo-føtal toksicitet (se pkt.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing medical seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende medicinsk alvorlighed.
English: The geometric mean (% CV) oral clearance was 17.7 (39) L/h.
Danish: Den geometriske middelværdi (CV %) for oral clearance var 17,7 (39) l/t.
English: Continue lorlatinib at the same dose without interruption.
Danish: Fortsæt lorlatinib ved samme dosis uden afbrydelse.
English: Grade 2: Moderate
Danish: Grad 2: Moderat
English: Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity.
Danish: Behandlingen med lorlatinib anbefales, så længe der ses klinisk gavnlig virkning af behandlingen hos patienten uden uacceptabel toksicitet.
English: Progression-free survival Median, months (95% CI)
Danish: Progressionsfri overlevelse Median, måneder (95 % CI)
English: 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.
Danish: 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.
English: Lorviqua can be prescribed to you if - you have been previously treated with a medicine called alectinib or ceritinib, which are ALK
Danish: Du kan få ordineret Lorviqua, - hvis du tidligere er blevet behandlet med et lægemiddel kaldet alectinib eller ceritinib, som er
English: Among the 284 patients with PR interval < 200 msec, 14% had PR interval prolongation ≥ 200 msec after starting lorlatinib.
Danish: Blandt de 284 patienter med PR-interval < 200 msek, havde 14 % forlængelse af PR-interval ≥ 200 msek efter start af lorlatinib.
English: 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).
Danish: 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).
English: Greater than or equal to Grade 3: Severe
Danish: Større end eller lig med grad 3: Alvorlig
English: Your doctor may check for problems with your heart during treatment with Lorviqua.
Danish: Din læge kan undersøge, om der er problemer med dit hjerte under behandlingen med Lorviqua.
English: See Lorviqua contains lactose and Lorviqua contains sodium in section 2.
Danish: Se Lorviqua indeholder lactose og Lorviqua indeholder natrium i afsnit 2.
English: d Hallucinations (including auditory hallucination, hallucination, visual hallucination).
Danish: Hallucinationer (herunder auditive hallucinationer, hallucinationer, visuelle hallucinationer)
English: Atrioventricular block
Danish: Atrioventrikulær blok
English: Overall efficacy results in Study A by prior treatment
Danish: Overordnede effektresultater i studie A efter forudgående behandling
English: a Alectinib, brigatinib, or ceritinib.
Danish: Alectinib, brigatinib eller ceritinib b
English: Risk of pancreatitis should be considered in patients receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism.
Danish: Risiko for pankreatitis bør overvejes hos patienter, der får lorlatinib pga. samtidig hypertriglyceridæmi og/eller en potentiel intrinsik mekanisme.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: Age, gender, race, body weight, and phenotype
Danish: Alder, køn, race, kropsvægt og fænotype
English: Lipase/Amylase increase Grade 3: Severe
Danish: Lipase-/amylasestigning Grad 3: Alvorlig
English: - Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell.
Danish: - Din læge kan eventuelt nedsætte din dosis, standse behandlingen i en kort periode eller standse behandlingen helt, hvis du ikke har det godt.
English: In vitro studies also indicated that lorlatinib is an inducer of CYP2B6 and activates the human constitutive androstane receptor (CAR).
Danish: In vitro-studier indikerede ligeledes, at lorlatinib er en inducer af CYP2B6 og aktiverer den humane konstitutive androstanreceptor (CAR).
English: This is because Lorviqua can affect the way some other medicines work.
Danish: Det er fordi, Lorviqua kan påvirke den måde, anden medicin virker på.
English: After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 75.7, 86.2) compared to intravenous administration.
Danish: Efter oral administration af lorlatinib tabletter, er den absolutte middelværdi for biotilgængelighed 80,8 % (90 % CI: 75,7;86,2) sammenlignet med intravenøs administration.
English: No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Danish: Tabletterne må ikke indtages, hvis de er gået i stykker, revnede eller på anden måde ikke er intakte.
English: Lorlatinib has moderate influence on the ability to drive and use machines.
Danish: Lorlatinib påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Men should seek advice on effective fertility preservation before treatment.
Danish: Mænd bør søge rådgivning vedrørende bevarelse af fertiliteten inden behandling.
English: g Speech effects (dysarthria, slow speech, speech disorder).
Danish: Virkninger på talen (dysartri, langsom tale, taleforstyrrelse).