FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC concluded that, on the basis of its long-standing use, melissa leaf can be used for the relief of mild symptoms of stress and to aid sleep.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at citronmelisse kan anvendes til at lindre milde stresssymptomer og gøre det lettere at falde i søvn.
English: Therefore, the HMPC conclusions on the use of melissa leaf medicines are based on their long-standing use.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med citronmelisse er derforbaseret på den traditionelle anvendelse.
English: What are the risks associated with melissa leaf medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder citronmelisse?
English: Other information about melissa leaf medicines
Danish: Andre oplysninger om lægemidler, der indeholder citronmelisse
English: What is melissa leaf?
Danish: Hvad er citronmelisse?
English: For more information about treatment with melissa leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder citronmelisse, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using melissa leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med citronmelisse, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Melissa leaf preparations are obtained by drying and powdering or comminuting (reducing into tiny pieces) the leaf.
Danish: Citronmelisse forarbejdes ved findeling eller pulverisering af de tørrede blade.
English: Melissa leaf
Danish: Citronmelisse
English: Committee on Herbal Medicinal Products (HMPC)
Danish: EMA/HMPC/310761/2013 Udvalget for Plantelægemidler (HMPC)
English: • are over 75 years
Danish: • er over 75 år
English: + = censored observations.
Danish: + = censorede observationer.
English: Drink the mixture.
Danish: Drik blandingen.
English: Results are based on confirmed and unconfirmed responses.
Danish: c Resulter er baseret på bekræftede og ikke-bekræftede responser.
English: • Median age: 62 years
Danish: • Median alder: 62 år
English: Urine protein should be monitored regularly.
Danish: Urinprotein bør overvåges regelmæssigt.
English: The results of subgroup analyses should be interpreted with caution.
Danish: Resultaterne af subgruppe-analyserne skal fortolkes med forsigtighed.
English: Date of first authorisation: 28 May 2015
Danish: Dato for første markedsføringstilladelse: 28. maj 2015
English: This is because it may seriously harm your baby.
Danish: Dette skyldes, at det kan skade barnet alvorligt.
English: • Take the capsules at about the same time each day.
Danish: • Tag kapslerne på ca. samme tidspunkt hver dag.
English: Then take the next dose at the normal time.
Danish: Tag dernæst den næste dosis til normal tid.
English: ≥ 2 g / 24 hours
Danish: ≥ 2 g/24 timer
English: The Efron method was used for ties.
Danish: Efron-methoden blev anvendt til forbindelser.
English: The following terms have been combined: a:
Danish: Følgende termer er blevet kombineret: a:
English: • belong to an ethnic group other than White or Asian
Danish: • tilhører en anden etnisk gruppe end hvide eller asiater
English: Urgent intervention is indicated.
Danish: Akut intervention er indiceret.
English: Frequencies are defined as:
Danish: Hyppighederne defineres som:
English: Effects in humans are unknown.
Danish: Virkningerne hos mennesker er ukendte.
English: The suspension is to be swallowed.
Danish: Suspensionen skal synkes.
English: First occurrence c
Danish: Første hændelse c
English: • Male: 84%
Danish: • Hankøn: 84 %
English: Age, sex, weight, race
Danish: Alder, køn, vægt, race
English: Estimated with Cox proportional hazard model.
Danish: Estimeret med Cox proportional hazards-model.
English: Your doctor will help you decide whether the treatment should be continued.
Danish: Din læge vil hjælpe dig med at beslutte, om behandlingen skal fortsætte.
English: In vitro transporter studies
Danish: In vitro transporterstudier
English: Includes cases with a fatal outcome.
Danish: Omfatter tilfælde med dødelig udgang.
English: Symptoms depend on where the fistula is located.
Danish: Symptomerne afhænger af, hvor fistlen befinder sig.
English: Independent radiologic review.
Danish: Uafhængig radiologisk gennemgang.
English: • The recommended dose of LENVIMA depends on your body weight when you first start treatment.
Danish: • Den anbefalede dosis af LENVIMA afhænger af din kropsvægt, når du først starter behandling.
English: • Do not take LENVIMA if you are planning to become pregnant during your treatment.
Danish: • Tag ikke LENVIMA, hvis du planlægger at blive gravid under behandlingen.
English: The adverse reaction frequency category represents the most conservative estimate of frequency from the two individual populations.
Danish: Hyppighedgraden for bivirkninger repræsenterer det mest konservative estimat af hyppighed fra de to individuelle populationer.
English: • Not known
Danish: • Ikke kendt
English: Avoid driving or using machines if you feel dizzy or tired.
Danish: Undgå at føre motorkøretøj eller betjene maskiner, hvis du føler dig svimmel eller er træt.
English: What to do if you forget to take your dose depends on how long it is until your next dose.
Danish: Hvad du skal gøre, hvis du har glemt at tage din dosis, afhænger af, hvor længe der er indtil din næste dosis.
English: • Very common (≥1/10)
Danish: • Meget almindelig (≥ 1/10)
English: Proteinuria‡
Danish: Proteinuri‡
English: When necessary, manage hypertension as recommended in Table 4.
Danish: Når det er nødvendigt, kan hypertension behandles som anbefalet i tabel 4.
English: Recommended action
Danish: Anbefalet handling
English: • If you become pregnant while being treated with LENVIMA, tell your doctor immediately.
Danish: • Hvis du bliver gravid, mens du behandles med LENVIMA, skal du straks fortælle det til lægen.
English: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of
Danish: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) på 0: 63 %, ECOG PS på
English: If the submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: • You can take the capsules with or without food.
Danish: • Du kan tage kapslerne sammen med mad eller uden mad.
English: If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Danish: Hvis en patient glemmer en dosis, og den ikke kan tages inden for 12 timer, skal den dosis springes over, og den næste dosis skal tages på det normale administrationstidspunkt.
English: Not adjusted for crossover effect.
Danish: Ikke justeret for overkrydsningsvirkningen.
English: Similarly, no induction of P-gp mRNA expression was observed .
Danish: Ligeledes blev der ikke observeret en induktion af Pgp mRNA-ekspression.
English: Each carton contains 30 ,60,or 90 hard capsules.
Danish: Hver karton indeholder 30, 60 eller 90 hårde kapsler.
English: The mechanism of action for hypothyroidism is not fully elucidated.
Danish: Virkningsmekanismen for hypotyreoidisme er ikke fuldt belyst.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til lægen, hvis du bemærker nogle af de følgende bivirkninger - du kan have behov for akut medicinsk behandling:
English: Resolves to less than 2 g / 24 hours.
Danish: Fortager sig til under 2 g/24 timer.
English: Haemorrhaged, †,‡ Hypertensione,‡ Hypotension
Danish: Blødningd, †,‡ Hypertensione,‡ Hypotension
English: Data cut-off date = 13 Nov 2016.
Danish: Skæringsdato for data = 13. november 2016.
English: The effects of LENVIMA in people younger than 18 years old are not known.
Danish: Virkningen af LENVIMA hos personer under 18 år er ukendt.
English: Resolves to <480 ms or baseline
Danish: Fortager sig til < 480 ms eller baseline
English: Mild to severe hypertension may be present.
Danish: Let til svær hypertension kan være til stede.
English: The capsules should be taken at about the same time each day, with or without food (see section 5.2).
Danish: Kapslerne skal tages på omtrent samme tidspunkt hver dag, med eller uden mad (se pkt.
English: • Body weight: <60 kg -31%, 60-80 kg - 50%, >80 kg - 19%
Danish: • Kropsvægt < 60 kg - 31 %, 60-80 kg - 50 %, > 80 kg - 19%
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandlingen bør fortsætte, så længe en klinisk fordel er observeret eller indtil der opstår en uacceptabel toksicitet.
English: Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
Danish: Yderligere dosisreduktioner bør overvejes på en individuel patientbasis, da der foreligger begrænsede data for doser under 10 mg.
English: Grades are based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Danish: Gradinddelingen er baseret på National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
English: Not all pack sizes may be marketed .
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Not Known (the following side effects have been reported since the marketing of LENVIMA but the frequency for them to occur is not known)
Danish: Ikke kendt (de følgende bivirkninger er blevet rapporteret efter markedsføring af LENVIMA, men hyppigheden af dem er ukendt):
English: The following side effects may happen with this medicine.
Danish: Følgende bivirkninger kan forekomme med denne medicin:
English: Food does not affect the extent of absorption, but slows the rate of absorption.
Danish: Mad påvirker ikke absorptionsgraden, men sænker absorptionshastigheden.
English: Baseline demographics and disease characteristics were well balanced for both treatment groups.
Danish: Baselinedemografi og sygdomskarakteristika var velafbalanceret i begge behandlingsgrupper.
English: Paediatric patients have not been studied.
Danish: Pædiatriske patienter er ikke blevet undersøgt.
English: CI, confidence interval; NE, not estimable.
Danish: CI: konfidensinterval, NE: kan ikke estimeres.
English: Reversibility of the toxicologic changes was observed at the end of a 4-week recovery period in all animal species investigated.
Danish: Reversibilitet af de toksikologiske ændringer blev observeret ved slutningen af en 4-ugers rekonvalescensperiode hos alle de undersøgte dyrearter.
English: The capsules should be swallowed whole with water.
Danish: Kapslerne skal synkes hele sammen med vand.
English: Grade 4 (despite medical management)
Danish: Grad 4 (trods medicinsk behandling)
English: These findings were reversible at the end of a 4-week recovery period.
Danish: Disse fund var reversible ved slutningen af en 4-ugers rekonvalescensperiode.
English: Lung metastases may also increase the risk of pneumothorax.
Danish: Lungemetastaser kan også øge risikoen for pneumothorax.
English: • White: 29%, Asian: 69%, Black or African American: 1.4%
Danish: • Hvide: 29 %, asiatiske: 69 %, sorte eller afroamerikanere: 1,4 %
English: Table 4 Recommended management of hypertension
Danish: Tabel 4 Anbefalet behandling af hypertension
English: Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances.
Danish: Samtidig administration af lenvatinib, carboplatin og paclitaxel har ingen signifikant påvirkning af farmakokinetikken for nogen af disse 3 stoffer.
English: • Your doctor may reduce your dose if you have problems with side effects.
Danish: • Din læge kan nedsætte din dosis, hvis du har problemer med bivirkninger.
English: Resolves to Grade 0, 1 or See detailed guidance in Table 4 in section 4.4.
Danish: Fortager sig til grad 0, 1 eller Se detaljeret vejledning i tabel 4 i pkt.
English: The median time to first dose reduction was 2.8 months.
Danish: Den mediane tid til første dosisreduktion var 2,8 måneder.
English: The primary efficacy endpoint was Overall Survival (OS).
Danish: Det primære effekt-endepunkt var samlet overlevelse (OS).
English: Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Danish: Patienter var kvalificeret til at deltage, hvis de havde en leverfunktion med Child-Pugh klasse A og Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
English: LENVIMA is not recommended for use in children and adolescents.
Danish: LENVIMA anbefales ikke til børn og unge.
English: Your doctor can give you medicine to reduce these side effects.
Danish: Din læge kan give dig lægemidler, der kan reducere disse bivirkninger.
English: There are no data on the use of lenvatinib immediately following sorafenib or other anticancer treatments and there may be a potential risk for additive toxicities unless there is an adequate washout period between treatments.
Danish: Der foreligger ingen data for anvendelsen af lenvatinib umiddelbart efter sorafenib eller andre anticancer-behandlinger, og der kan være en mulig risiko for additive toksiciteter, medmindre der er en tilstrækkelig udvaskningsperiode mellem behandlingerne.
English: A treatment decision should be made based upon an assessment of the individual patient's benefit/risk.
Danish: Der bør tages en beslutning om behandlingen efter en vurdering af den enkelte patients benefit/riskforhold.
English: Your doctor will discuss the results of these tests with you and decide whether you can be given LENVIMA.
Danish: Din læge vil diskutere resultaterne af disse prøver med dig og beslutte, om du kan få LENVIMA.
English: Grade 3 (despite optimal antihypertensive therapy)
Danish: Grad 3 (trods optimal antihypertensiv behandling)
English: Noninferiority margin for hazard ratio (HR: lenvatinib vs sorafenib = 1.08).
Danish: Noninferioritets margen for hazard ratio (HR: lenvatinib vs sorafenib = 1,08).
English: Prior surgery and radiotherapy may be contributing risk factors.
Danish: Tidligere kirurgi og strålebehandling kan være medvirkende risikofaktorer.
English: Store in the original blister in order to protect from moisture.
Danish: Opbevares i det originale blister for at beskytte mod fugt.
English: HR was estimated from the Cox proportional hazard model with treatment as independent variable and stratified by IxRS stratification factors.
Danish: HR blev estimeret fra Cox proportional hazard model med behandling som uafhængig variabel og stratificeret med IxRS stratifikations-faktorer.
English: The median OS had not been reached for either the lenvatinib group or the placebo crossover group.
Danish: Den mediane OS blev ikke nået, hverken for lenvatinib-gruppen eller placebo-overkrydsningsgruppen.
English: • painful infection or irritation near the anus
Danish: • smertefuld infektion eller irritation nær endetarmsåbningen
English: • weigh less than 60 kg
Danish: • vejer under 60 kg
English: • Absence of macroscopic portal vein invasion (MPVI): 79%
Danish: • Fravær af makroskopisk portalvene invasion (MPVI): 79 %
English: Lenvatinib is a substrate for P-gp and BCRP.
Danish: Lenvatinib er et substrat for P-gp og BCRP.
English: Therefore, mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Danish: Derfor kunne mortaliteten tilskrives komplikationer i relation til primære duodenale læsioner med et muligt bidrag fra ekstra toksiciteter i umodne målorganer.
English: Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Danish: Lenvatinib bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt, og først efter en nøje afvejning af moderens behov og risikoen for fosteret.
English: • Demographic and baseline disease characteristics were similar between the lenvatinib and the sorafenib groups and are shown below for all 954 randomised patients:
Danish: • Demografiske og baseline sygdomskarakteristika var ens mellem grupperne med lenvatinib og sorafenib og vises herunder for alle 954 randomiserede patienter:
English: Lenvatinib was not genotoxic.
Danish: Lenvatinib var ikke genotoksisk.
English: Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials.
Danish: Utilsigtede medicineringsfejl, der førte til enkeltdoser på 40 til 48 mg, er også forekommet i kliniske studier.
English: • have high blood pressure
Danish: • har højt blodtryk
English: Patients who experience these symptoms should use caution when driving or operating machines.
Danish: Patienter, der oplever sådanne symptomer, bør udvise forsigtighed, når de fører motorkøretøjer eller betjener maskiner.
English: • high or low blood pressure
Danish: • højt eller lavt blodtryk
English: No significant drug-drug interaction is therefore expected between lenvatinib and other CYP3A4/Pgp substrates.
Danish: Der forventes derfor ingen signifikant lægemiddelinteraktion mellem lenvatinib og andre CYP3A4/Pgp-substrater.
English: Secondary efficacy outcome measures included overall response rate and overall survival.
Danish: Sekundære målinger af virkningsudfaldet omfattede samlet responsrate og samlet overlevelse.
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 20%; BCLC stage C: 80%
Danish: • Barcelona Clinic Liver Cancer (BCLC) stadie B: 20 %; BCLC stadie C: 80 %
English: The minimal washout period in clinical trials was 4 weeks.
Danish: Den minimale udvaskningsperiode i kliniske studier var på 4 uger.
English: Recommended daily dose
Danish: Anbefalet daglig dosis
English: Contraception, pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Prævention, graviditet og amning Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Juvenile animal toxicity studies
Danish: Juvenile dyretoksicitetsstudier
English: You may need to have additional treatment with other medicines, to take a lower dose of LENVIMA, or to take extra care due to an increased risk of side effects.
Danish: Du kan have behov for at få ekstra behandling med andre lægemidler, tage en lavere dosis LENVIMA eller være ekstra forsigtig på grund af en øget risiko for bivirkninger.
English: Lenvatinib is for oral use.
Danish: Lenvatinib er til oral anvendelse.
English: Dose proportionality and accumulation
Danish: Dosisproportionalitet og akkumulering
English: Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification
Danish: Vedvarende og intolerabel grad 2 eller grad 3 toksiciteta Bivirkning
English: These in vivo metabolic routes align with the data provided in the in vitro studies using human biomaterials.
Danish: Disse metabolismeveje in vivo er i overensstemmelse med de data, der foreligger fra in vitro-studier med humant biomateriale.
English: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules.
Danish: Polyamid/aluminium/PVC/aluminium-blister indeholdende 10 kapsler.
English: The choice of antihypertensive treatment should be individualised to the patient's clinical circumstances and follow standard medical practice.
Danish: Valget af antihypertensiv behandling bør justeres individuelt til patientens kliniske omstændigheder, og følge standard medicinsk praksis.
English: Further dose adjustments may be necessary on the basis of individual tolerability.
Danish: Yderligere dosisjusteringer kan være nødvendige på basis af individuel tolerabilitet.
English: Lenvatinib displays minimimal accumulation at steady state.
Danish: Lenvatinib udviser minimal akkumulering ved steady-state.
English: Cardiac dysfunction Grade 3
Danish: Hjertedysfunktion Grad 3
English: There have also been reports of overdose with lenvatinib involving single administrations of 6 to 10 times the recommended daily dose.
Danish: Der har også været rapporter om overdosering med lenvatinib med enkeltadministrationer på 6 til 10 gange den anbefalede daglige dosis.
English: Lenvatinib exhibited good oral bioavailability in dogs (70.4%) and monkeys (78.4%).
Danish: Lenvatinib udviste god oral biotilgængelighed hos hunde (70,4 %) og aber (78,4 %).
English: Differentiated Thyroid Cancer (DTC)
Danish: Differentieret thyroideacancer (DTC)
English: In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
Danish: I tilfælde af en formodet overdosering bør lenvatinib tilbageholdes, og der bør gives passende støttebehandling efter behov.
English: There are no data on the use of lenvatinib in pregnant women.
Danish: Der er ingen data fra anvendelse af lenvatinib til gravide kvinder.
English: Electrolytes (magnesium, potassium and calcium) should be monitored periodically during treatment.
Danish: Elektrolytter (magnesium, kalium og calcium) bør monitoreres periodisk i løbet af behandlingen.
English: Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Danish: Baseret på AUC(0 - inf) udgjorde lenvatinib 60 % og 64 % af den totale radioaktivitet i hhv. plasma og blod.
English: Increased alanine aminotransferase ‡
Danish: Forhøjet niveau af alaninaminotransferase‡
English: Number of capsules
Danish: Antal kapsler
English: • Aetiology: Hepatitis B (50%), Hepatitis C (23%), alcohol (6%)
Danish: • Ætiologi: Hepatitis B (50 %), hepatitis C (23 %), alkohol (6 %)
English: Talk to your doctor if you experience any new or unsual symptoms such as coughing when swallowing.
Danish: Kontakt lægen, hvis du oplever nye eller usædvanlige symptomer, såsom hoste, når du synker.
English: Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications.
Danish: Rapporter om fistler, der involverer andre kropsområder end maven eller tarmen, blev observeret for forskellige indikationer.
English: The percentage of the dose of lenvatinib excreted in urine was low in all cohorts (<2.16% across treatment cohorts).
Danish: Procentdelen af dosis af lenvatinib udskillet i urinen var lav i alle kohorter (< 2,16 % på tværs af behandlingskohorter).
English: • If it is 12 hours or more until your next dose: take the missed dose as soon as you remember.
Danish: • Hvis der er 12 timer eller længere indtil din næste dosis: tag den glemte dosis, så snart du husker det.
English: • decrease in the number of white blood cells
Danish: • nedsat antal hvide blodceller
English: Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Danish: Der foreligger begrænsede data for patienter med anden etnisk oprindelse end kaukasisk eller asiatisk og hos patienter i alderen ≥ 75 år.
English: Resolves to Grade 0-1.
Danish: Fortager sig til grad 0-1.
English: Effect of lenvatinib on other medicinal products
Danish: Lenvatinibs virkning på andre lægemidler
English: The median cumulative RAI activity administered prior to study entry was 350 mCi (12.95 GBq).
Danish: Den mediane kumulative RAI-aktivitet administreret før indgåelse i studiet var 350 mCi (12,95 GBq).
English: This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin.
Danish: Denne binding var primært til albumin med en mindre binding til α1-syre glykoprotein og γ-globulin.
English: • loss of body fluids (dehydration)
Danish: • tab af kropsvæsker (dehydrering)