FrancophonIA/ELRC3.0 huggingface dataset:
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
Danish: VEPESID og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af småcellet lungekræft hos voksne.
English: Do not open any <blister> <bottle> in which there is evidence of capsule leakage.
Danish: Du må ikke åbne <blister> <flasker>, hvis der er tegn på lækage fra kapsler.
English: How to take VEPESID and associated names
Danish: Sådan skal du tage VEPESID og associerede navne
English: Date
Danish: Navn
English: VEPESID and associated names contains
Danish: VEPESID og relaterede navneindeholder:
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Danish: VEPESID og relaterede navneer indiceret i kombination med andre godkendte kemoterapimidler til behandling af non-epitelial kræft i æggestokkene hos voksne.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
Danish: VEPESID og relaterede navneer indiceret i kombination med andre godkendte kemoterapimidler til behandling af recidiverende eller refraktær testikelkræft hos voksne.
English: Do not open any blister in which there is evidence of capsule leakage.
Danish: Du må ikke åbne blister, hvis der er tegn på lækage fra kapsler.
English: This includes any possible side effects not listed in this leaflet.
Danish: Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
Danish: VEPESID og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af recidiverende eller refraktær akut myeloid leukæmi hos voksne.
English: Do not open any bottle in which there is evidence of capsule leakage.
Danish: Du må ikke åbne flasker, hvis der er tegn på lækage fra kapsler.
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin's lymphoma in adults.
Danish: VEPESID og relaterede navneer indiceret i kombination med andre godkendte kemoterapimidler til behandling af recidiverende eller refraktær Hodgkins lymfom hos voksne.
English: • feeling weak (asthenia)
Danish: • svaghed (asteni)
English: Date of latest renewal: {DD month YYYY}> [To be completed nationally]
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: Breastfeeding
Danish: Amning
English: VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the second line treatment of Hodgkin's lymphoma in adults.
Danish: VEPESID og relaterede navneer indiceret til behandling af recidiv i kombination med andre godkendte kemoterapimidler til behandling af non-Hodgkins lymfom hos voksne.
English: Events are death due to any cause.
Danish: Hændelserne er død uanset årsag.
English: The MTD was not reached.
Danish: MTD blev ikke opnået.
English: A risk to the newborn/infant cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Representative risk factors for these analyses were:
Danish: Repræsentative risikofaktorer for disse analyser var:
English: The dose of this medicine depends on your body weight.
Danish: Dosis af denne medicin afhænger af din kropsvægt.
English: 4 years.
Danish: 4 år.
English: Thus, it is not likely to have any substantial contribution to the systemic effects of MMAE.
Danish: Det er derfor ikke sandsynligt, at den yder noget væsentligt bidrag til de systemiske virkninger af MMAE.
English: It is given by your doctor or nurse over 30 minutes.
Danish: Den gives af en læge eller sygeplejerske over 30 minutter.
English: Represents pooling of preferred terms.
Danish: Repræsenterer sammenlagte foretrukne termer.
English: The investigator assessments were generally consistent with the independent review of the scans.
Danish: Investigatorvurderingerne var generelt overensstemmende med den uafhængige gennemgang af scanningerne.
English: The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Danish: Sikkerhed og virkning af ADCETRIS hos børn under 18 år er endnu ikke klarlagt.
English: • Two or more prior salvage therapies.
Danish: • To eller flere tidligere salvage-behandlinger.
English: Continue with the same dose and schedule
Danish: Fortsæt med samme dosis og plan
English: Indicates results from non-stratified analysis.
Danish: Angiver resultater fra ikke-stratificeret analyse.
English: Final study report: 31/12/2020
Danish: Endelig studierapport: 31.12.2020
English: Insomnia a.
Danish: Insomni a.
English: Your doctor will perform regular blood tests to make sure that it is safe for you to receive this medicine.
Danish: Din læge vil jævnligt tage blodprøver for at sikre sig, at det er sikkert for dig at få denne medicin.
English: Eligible patients were required to have at least one of the following risk factors:
Danish: Egnede patienter skulle have mindst én af følgende risikofaktorer:
English: Additional follow up and evaluation may be warranted if no alternative diagnosis can be established.
Danish: Yderligere opfølgning og evaluering kan være relevant, hvis der ikke kan stilles nogen alternativ diagnose.
English: There are no data from the use of ADCETRIS in pregnant women.
Danish: Der foreligger ingen data om anvendelse af ADCETRIS til gravide kvinder.
English: Exposures were approximately dose proportional.
Danish: Eksponeringerne var cirka proportionale med dosis.
English: Calculated from a weighted Holm's procedure
Danish: Beregnet ud fra en vægtet Holms procedure
English: Death without either prior progression or more than one missed assessment visit.
Danish: Død enten uden forudgående progression eller udeblivelse fra mere end ét vurderingsbesøg.
English: Infusion reactions to this medicine may affect more than 1 in 10 people.
Danish: Infusionsreaktioner på denne medicin kan ramme flere end 1 ud af 10 personer.
English: However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C-8 °C.
Danish: Dog er kemisk og fysisk anvendelsesstabilitet påvist i 24 timer ved 2 °C-8 °C
English: In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Danish: Generelt forekommer disse former for reaktioner inden for minutter til flere timer efter afsluttet infusion.
English: Dose and frequency
Danish: Dosering og hyppighed
English: Serious infections and opportunistic infections
Danish: Alvorlige infektioner og opportunistiske infektioner
English: It is not known how frequently infusion-related reactions to this medicine are serious or fatal.
Danish: Det vides ikke, hvor hyppigt infusionsrelaterede reaktioner på grund af denne medicin er alvorlige eller dødelige.
English: Do NOT use Adcetris if you:
Danish: Du bør ikke få Adcetris, hvis du:
English: One patient in each arm had incomplete staging data and are not included in the table
Danish: Én patient i hver arm havde ufuldstændige stadieinddelingsdata og er ikke medtaget i tabellen
English: However, they may develop more than several hours after completion of the infusion but this is uncommon.
Danish: Men de kan forekomme mere end adskillige timer efter afslutning af infusionen, selv om det er usædvanligt.
English: You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.
Danish: Du skal også informere din partner eller dine plejere om din behandling, da de kan bemærke symptomer, som du ikke selv er opmærksom på.
English: Gastrointestinal complications
Danish: Gastrointestinale komplikationer
English: Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Danish: Den samlede opbevaringstid fra rekonstitution til infusion bør ikke overskride 24 timer.
English: You and your partner must use two methods of effective contraception during your treatment with this medicine.
Danish: Du og din partner skal benytte to effektive præventionsmetoder under behandlingen med denne medicin.
English: Adcetris is to be given to adults only.
Danish: Adcetris må kun gives til voksne.
English: After reconstitution/dilution, from a microbiological point of view, the product should be used immediately.
Danish: Efter rekonstitution/fortyding bør produktet fra et mikrobiologisk synspunkt anvendes umiddelbart.
English: In vitro, the binding of MMAE to human serum plasma proteins ranged from 68-82%.
Danish: In vitro lå bindingen af MMAE til humane serumplasmaproteiner mellem 68-82 %.
English: Estimated mPFS
Danish: Estimeret mPFS
English: MMAE does not inhibit other isoforms.
Danish: MMAE hæmmer ikke andre isoformer.
English: It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Danish: Det er vigtigt at fortælle lægen før og under behandlingen, hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid.
English: You may experience the following side effects:
Danish: Du kan opleve følgende bivirkninger:
English: Table 14 includes the results for ORR4 and other key secondary endpoints.
Danish: Tabel 14 indeholder resultaterne for ORR4 og andre vigtige sekundære endepunkter.
English: These features make CD30 a target for therapeutic intervention.
Danish: Disse egenskaber gør CD30 til et mål for terapeutisk intervention.
English: A negative JCV PCR does not exclude PML.
Danish: En negativ JCV PCR udelukker ikke PML.
English: Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
Danish: Grad 1 (paræstesi og/eller tab af reflekser, uden tab af funktion)
English: Previously Untreated HL
Danish: Ikke tidligere behandlet HL
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer registreres tydeligt.
English: Stratification factors at randomisation.
Danish: Stratifikationsfaktorer ved randomisering.
English: The safety and efficacy results in these studies were consistent with results in Study C25001.
Danish: Sikkerheds- og effektresultaterne i disse studier svarede til resultaterne af studie C25001.
English: The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
Danish: Resultaterne af disse post-hoc-analyser tyder på en øget klinisk fordel for patienter med to eller flere risikofaktorer, men ingen forskel baseret på hver af de individuelle risikofaktorer.
English: Proper aseptic technique throughout the handling of this medicinal product should be followed.
Danish: Korrekt aseptisk teknik gennem hele håndteringen af dette lægemiddel skal følges.
English: Your treatment may influence your ability to drive or operate machines.
Danish: Din behandling kan påvirke din evne til at køre eller betjene maskiner.
English: Number of deaths c
Danish: Antal dødsfald c
English: Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Danish: Ann Arbor-stadieinddeling IPFP = International Prognostic Factor Project
English: A lesser amount of MMAE (28%) was excreted in the urine.
Danish: En mindre mængde MMAE (28 %) blev udskilt i urinen.
English: Procedures for proper handling and disposal of anticancer medicines should be considered.
Danish: Procedurer for korrekt håndtering og bortskaffelse af lægemidler mod cancer skal følges.
English: HL at increased risk of relapse or progression
Danish: HL med øget risiko for recidiv eller progression
English: Not reached
Danish: Ikke nået
English: See the package leaflets for these medicines for additional information on their use and effects.
Danish: Se indlægssedlerne til disse lægemidler for at få yderligere oplysning om brugen af dem og deres virkning.
English: Your doctor or nurse will also monitor you during and after the infusion.
Danish: Lægen eller sygeplejersken vil også holde øje med dig under og efter infusionen.
English: Number of patients with disease progression or death a
Danish: Antal patienter med sygdomsprogression eller død
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
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/tiltag:
English: Estimated 5-year OS Rate a.
Danish: Estimeret 5-års OS-rate a.
English: Once steady-state was achieved, the PK of ADC did not appear to change with time.
Danish: Efter at steady state var opnået, ændredes PK for ADC tilsyneladende ikke over tid.
English: Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Danish: De bivirkningsfrekvenser, der er beskrevet nedenfor og i tabel 3, er blevet fastsat på baggrund af data fra kliniske studier.
English: Determining dosage amount:
Danish: Bestemmelse af doseringsmængde:
English: Post-hoc analyses were performed to evaluate the impact of increased risk (number of risk factors) on clinical benefit (Table 8).
Danish: Der blev udført post-hoc-analyser for at evaluere indvirkningen af øget risiko (antal risikofaktorer) på den kliniske fordel (tabel 8).
English: Lonza AG Lonzastrasse 3930 Visp Switzerland
Danish: Lonza AG Lonzastrasse 3930 Visp Schweiz
English: Like all medicines, this medicine may cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: It is not for use in children.
Danish: Den er ikke beregnet til brug hos børn.
English: If you have these symptoms prior to treatment with this medicine, tell your doctor immediately about any changes in these symptoms.
Danish: Hvis du har disse symptomer før behandlingen med denne medicin, skal du omgående fortælle lægen om eventuelle ændringer af disse symptomer.
English: The influence of age on pharmacokinetics was investigated in each analysis and it was not a significant covariate.
Danish: Alderens indflydelse på farmakokinetikken blev undersøgt i hver analyse, og den var ikke en signifikant kovariant.
English: Testicular atrophy and degeneration were partially reversible following a 16-week treatment-free period.
Danish: Testikelatrofi og degeneration var delvist reversible efter en 16-ugers behandlingsfri periode.
English: The frequency of unique serious adverse drug reactions was ≤ 1%.
Danish: Hyppigheden af unikke alvorlige bivirkninger var ≤ 1 %.
English: White to off-white cake or powder.
Danish: Hvid til off-white substans eller pulver.
English: Severe and prolonged (≥ 1 week) neutropenia can occur with this treatment which may increase the risk of patients developing serious infections.
Danish: Svær og længerevarende (≥ 1 uge) neutropeni kan forekomme ved denne behandling og kan øge risikoen for, at patienterne får alvorlige infektioner.
English: MMAE is further metabolised mainly to an equally potent metabolite; however, its exposure is an order of magnitude lower than that of MMAE.
Danish: MMAE metaboliseres yderligere, hovedsagelig til en lige så potent metabolit; dens eksponering er dog en størrelsesorden lavere end MMAE's.
English: Fatal outcomes have been reported.
Danish: Der er rapporteret dødelige tilfælde.
English: The RP2D was determined to be 1.8 mg/kg.
Danish: RP2D blev fastlagt til 1,8 mg/kg.
English: Patients who have experienced a prior IRR should be premedicated for subsequent infusions.
Danish: Patienter, der tidligere har oplevet en IRR, bør præmedicineres ved efterfølgende infusioner.
English: There were no relevant differences in the patient and disease characteristics between the two arms.
Danish: Der var ingen relevante forskelle i patient- og sygdomskarakteristika i de to arme.
English: In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Danish: Hos mennesker var steady state-distributionsvolumenet cirka 6-10 l for ADC.
English: Anti-diabetic treatment should be administered as appropriate.
Danish: Antidiabetisk behandling skal administreres efter behov.
English: If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
Danish: Hvis en gravid kvinde behøver behandles, bør hun tydeligt vejledes om den potentielle risiko for fosteret.
English: If you feel unwell during treatment then do not drive or operate machines.
Danish: Hvis du føler dig utilpas under behandlingen, bør du ikke køre bil eller bruge maskiner.
English: No patients aged < 12 years (0 of 11) and 2 patients aged ≥ 12 years (2 of 23) became persistently ADA positive.
Danish: Ingen patienter i alderen < 12 år (0 af 11) og 2 patienter i alderen ≥ 12 år (2 af 23) blev vedvarende ADA-positive.
English: Discontinue treatment a.
Danish: Seponer behandlingen a.
English: In the study, patients were to receive their first dose after recovery from ASCT (between days 30-45 following ASCT).
Danish: Patienterne i studiet fik deres første dosis efter restitution efter ASCT (mellem dag 30 og 45 efter ASCT).
English: Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Danish: Brug ikke dette lægemidlet, hvis der bemærkes partikler eller misfarvning før administrationen.
English: The levels of MMAE metabolites have not been measured in human plasma.
Danish: Niveauerne af MMAE-metabolitter er ikke blevet målt i humant plasma.
English: The ADC is expected to be catabolised as a protein with component amino acids recycled or eliminated.
Danish: ADC forventes at blive kataboliseret som protein med aminosyrer komponenter genbrugt eller udskilt.
English: The primary endpoint of PFS was met and showed a difference in median PFS of 18.8 months in favour of the treatment arm.
Danish: Det primære endepunkt PFS blev nået og viste en forskel i median-PFS på 18,8 måneder til fordel for behandlingsarmen.
English: If you have any questions on the use of this medicine, ask the doctor or nurse who is giving you the infusion.
Danish: Hvis du er i tvivl om noget vedrørende brugen af denne medicin, så spørg den læge eller sygeplejerske, der giver dig infusionen.
English: You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine.
Danish: Du får måske medicin, så som - Antihistaminer, kortikosteroider eller paracetamol for at hjælpe med til at reducere nogle af de ovennævnte reaktioner, hvis du tidligere har oplevet disse, når du fik denne form for medicin.
English: These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Danish: Disse data tyder på, at virkningen og sikkerheden kan ekstrapoleres til andre undertyper af CD30+ CTCL.
English: These infusion reactions can be serious or even fatal (known as an anaphylactic reaction).
Danish: Disse infusionsreaktioner kan være alvorlige eller tilmed dødelige (kendt som en anafylaktisk reaktion).
English: The dosing recommendations for patients aged 65 and older are the same as for adults.
Danish: Dosisanbefalingerne for patienter på 65 år og derover er de samme som for voksne.
English: Patient weight (kg)
Danish: Patientvægt (kg):
English: Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Danish: Andre antistof-associerede funktioners bidrag til virkningsmekanismen er ikke udelukket.
English: If your infusion is restarted, your doctor may increase the time over which your infusion is given so that you may be able to tolerate it better.
Danish: Hvis din infusion genstartes, kan din læge forlænge den tid, som infusionen tager, så du måske bedre kan tåle den.
English: Advanced age was a risk factor for febrile neutropenia in patients in both arms.
Danish: Fremskreden alder var en risikofaktor for febril neutropeni hos patienter i begge arme.
English: There is no known antidote for overdose of ADCETRIS.
Danish: Der findes ingen kendt antidot mod overdosering af ADCETRIS.
English: Post-hoc Risk Factor Analyses
Danish: Post-hoc risikofaktoranalyse
English: Women must continue using contraception for 6 months following the last dose of Adcetris.
Danish: Kvinder skal fortsætte med at bruge prævention i 6 måneder efter den sidste dosis Adcetris.
English: See the fertility section below pertaining to advice for women whose male partners are being treated with ADCETRIS.
Danish: Se nedenstående afsnit om fertilitet i forbindelse med rådgivning af kvinder, hvis mandlige partnere behandles med ADCETRIS.
English: This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,7 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: This medicine is given to you into a vein (intravenously) as an infusion.
Danish: Medicinen gives i en vene (intravenøst) som en infusion.
English: No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Danish: Der er ikke observeret nogen fordel hvad angår PFS eller OS hos patienter med én risikofaktor for recidiv eller progression.
English: A monoclonal antibody is a protein which recognises certain cancer cells.
Danish: Et monoklonalt antistof er et protein, der genkender visse kræftceller.
English: In this study in 36 patients, no new safety concerns were reported.
Danish: I dette studie med 36 patienter er der ikke rapporteret ændringer til lægemidlets sikkerhedsprofil.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering er nået.
English: MMAE is a substrate of CYP3A4 and possibly CYP2D6.
Danish: MMAE er et substrat af CYP3A4 og muligvis CYP2D6.
English: Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Danish: Patienter skal nøje monitoreres under behandlingen for mulige opstående alvorlige og opportunistiske infektioner.
English: These patients should be monitored closely and managed according to best medical practice.
Danish: Disse patienter skal nøje monitoreres og behandles i henhold til bedste medicinske praksis.
English: Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk.
Danish: Allerede eksisterende leversygdom, comorbiditet og samtidig medicinering kan også forøge risikoen.
English: • Extranodal involvement at time of pre-ASCT relapse, including extranodal extension of nodal masses into adjacent vital organs
Danish: • Ekstranodal involvering på tidspunktet for recidiv før ASCT, herunder ekstranodal ekstension af nodale masser i nærliggende vitale organer
English: The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
Danish: Den mediane tid fra initiel sALCL-diagnose til første dosis med ADCETRIS var 16,8 måneder.