natgillin/translations-raw huggingface dataset:
Hos mennesker var steady state-distributionsvolumenet cirka 6-10 l for ADC.
In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Antidiabetisk behandling skal administreres efter behov.
Anti-diabetic treatment should be administered as appropriate.
Hvis en gravid kvinde behøver behandles, bør hun tydeligt vejledes om den potentielle risiko for fosteret.
If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
Hvis du føler dig utilpas under behandlingen, bør du ikke køre bil eller bruge maskiner.
If you feel unwell during treatment then do not drive or operate machines.
Ingen patienter i alderen < 12 år (0 af 11) og 2 patienter i alderen ≥ 12 år (2 af 23) blev vedvarende ADA-positive.
No patients aged < 12 years (0 of 11) and 2 patients aged ≥ 12 years (2 of 23) became persistently ADA positive.
Seponer behandlingen a.
Discontinue treatment a.
Patienterne i studiet fik deres første dosis efter restitution efter ASCT (mellem dag 30 og 45 efter ASCT).
In the study, patients were to receive their first dose after recovery from ASCT (between days 30-45 following ASCT).
Brug ikke dette lægemidlet, hvis der bemærkes partikler eller misfarvning før administrationen.
Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Niveauerne af MMAE-metabolitter er ikke blevet målt i humant plasma.
The levels of MMAE metabolites have not been measured in human plasma.
ADC forventes at blive kataboliseret som protein med aminosyrer komponenter genbrugt eller udskilt.
The ADC is expected to be catabolised as a protein with component amino acids recycled or eliminated.
Det primære endepunkt PFS blev nået og viste en forskel i median-PFS på 18,8 måneder til fordel for behandlingsarmen.
The primary endpoint of PFS was met and showed a difference in median PFS of 18.8 months in favour of the treatment arm.
Hvis du er i tvivl om noget vedrørende brugen af denne medicin, så spørg den læge eller sygeplejerske, der giver dig infusionen.
If you have any questions on the use of this medicine, ask the doctor or nurse who is giving you the infusion.
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.
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.
Disse data tyder på, at virkningen og sikkerheden kan ekstrapoleres til andre undertyper af CD30+ CTCL.
These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Disse infusionsreaktioner kan være alvorlige eller tilmed dødelige (kendt som en anafylaktisk reaktion).
These infusion reactions can be serious or even fatal (known as an anaphylactic reaction).
Dosisanbefalingerne for patienter på 65 år og derover er de samme som for voksne.
The dosing recommendations for patients aged 65 and older are the same as for adults.
Patientvægt (kg):
Patient weight (kg)
Andre antistof-associerede funktioners bidrag til virkningsmekanismen er ikke udelukket.
Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Hvis din infusion genstartes, kan din læge forlænge den tid, som infusionen tager, så du måske bedre kan tåle den.
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.
Fremskreden alder var en risikofaktor for febril neutropeni hos patienter i begge arme.
Advanced age was a risk factor for febrile neutropenia in patients in both arms.
Der findes ingen kendt antidot mod overdosering af ADCETRIS.
There is no known antidote for overdose of ADCETRIS.
Post-hoc risikofaktoranalyse
Post-hoc Risk Factor Analyses
Kvinder skal fortsætte med at bruge prævention i 6 måneder efter den sidste dosis Adcetris.
Women must continue using contraception for 6 months following the last dose of Adcetris.
Se nedenstående afsnit om fertilitet i forbindelse med rådgivning af kvinder, hvis mandlige partnere behandles med ADCETRIS.
See the fertility section below pertaining to advice for women whose male partners are being treated with ADCETRIS.
Dette svarer til 0,7 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
This is equivalent to 0.7% of the recommended maximum daily dietary intake of sodium for an adult.
Medicinen gives i en vene (intravenøst) som en infusion.
This medicine is given to you into a vein (intravenously) as an infusion.
Der er ikke observeret nogen fordel hvad angår PFS eller OS hos patienter med én risikofaktor for recidiv eller progression.
No benefit in terms of PFS or OS has been observed in patients with one risk factor for relapse or progression.
Et monoklonalt antistof er et protein, der genkender visse kræftceller.
A monoclonal antibody is a protein which recognises certain cancer cells.
I dette studie med 36 patienter er der ikke rapporteret ændringer til lægemidlets sikkerhedsprofil.
In this study in 36 patients, no new safety concerns were reported.
• 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.
• 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
MMAE er et substrat af CYP3A4 og muligvis CYP2D6.
MMAE is a substrate of CYP3A4 and possibly CYP2D6.
Patienter skal nøje monitoreres under behandlingen for mulige opstående alvorlige og opportunistiske infektioner.
Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Disse patienter skal nøje monitoreres og behandles i henhold til bedste medicinske praksis.
These patients should be monitored closely and managed according to best medical practice.
Allerede eksisterende leversygdom, comorbiditet og samtidig medicinering kan også forøge risikoen.
Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk.
• Ekstranodal involvering på tidspunktet for recidiv før ASCT, herunder ekstranodal ekstension af nodale masser i nærliggende vitale organer
• Extranodal involvement at time of pre-ASCT relapse, including extranodal extension of nodal masses into adjacent vital organs
Den mediane tid fra initiel sALCL-diagnose til første dosis med ADCETRIS var 16,8 måneder.
The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
2 for yderligere oplysninger om natrium.
See section 2 for further information about sodium.
Alternativt kan behandlingen startes med den sidst tolererede dosis (se pkt.
Alternatively, treatment may be started at the last tolerated dose (see section 5.1).
ADCETRIS sikkerhedsprofil er baseret på de tilgængelige data fra kliniske forsøg, udleveringstilladelser (Named Patient Program (NPP)) og postmarketing-erfaringen til dato.
The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Du må ikke bruge denne medicin, hvis du er gravid, medmindre du og din læge beslutter, at den gavn, du har af medicinen, opvejer den mulige risiko for dit ufødte barn.
You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Hvis der udvikles neutropeni under behandlingen, skal den behandles med dosis udsættelse.
If neutropenia develops during treatment it should be managed by dose delays.
Af de 33 patienter, som fik RP2D, kunne respons evalueres hos de 32.
Of these 33 patients who received the RP2D, 32 were evaluable for response.
Sikkerhedsprofilen hos ældre patienter svarede til den for voksne patienter.
The safety profile in elderly patients was consistent with that of adult patients.
Af de 329 patienter blev 165 patienter randomiseret til behandlingsarmen, og 164 patienter blev randomiseret til placeboarmen.
Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Median ADC AUC hos børn og unge i dette studie var ca. henholdsvis 14 % og 3 % lavere end hos voksne patienter, mens MMAE-eksponering var henholdsvis 53 % lavere og 13 % højere end hos voksne patienter.
Median ADC AUC in children and adolescents from this study was approx. 14% and 3% lower than in adult patients, respectively, while MMAE exposures were 53% lower and 13% higher, respectively, than in adult patients.
For yderligere virkningsresultater henvises til Tabel 12 og figur 5.
For further efficacy results, see Table 12 and Figure 5.
Grad 3 (påvirker almindelige dagligdags aktiviteter)
Grade 3 (interfering with activities of daily living)
Bivirkninger for ADCETRIS er opstillet efter MedDRA Systemorganklasse og foretrukken term (se Tabel 3).
Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Hvis du får infusionsreaktioner (som angivet ovenfor), kan din læge måske stoppe med at give dig denne medicin og påbegynde en støttebehandling.
If you develop infusion reactions (as stated previously), your doctor may stop giving this medicine and start support treatment.
Lægens valg (methotrexat eller bexaroten) n = 64
Physician's Choice (Methotrexate or Bexarotene) n = 64
Mindst en metabolit af MMAE har vist sig aktiv in vivo.
At least one metabolite of MMAE has been shown to be active in vitro.
Der blev ikke observeret nogen forskel i livskvalitet mellem behandlings- og placeboarmen.
No differences were observed in quality of life between the treatment and placebo arms.
Akut pancreatitis er blevet observeret hos patienter i behandling med ADCETRIS.
Acute pancreatitis has been observed in patients treated with ADCETRIS.
Betydningen af dette resultat hos patienter med stadie IV HL uden ekstranodal sygdom er ikke vist pga. det lille antal patienter og den lave rate af tilfælde (14 tilfælde).
The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Disse resultater var overensstemmende med den farmakologiske virkning af MMAE på det mitotiske apparat (nedbrydning af mikrotubulus-netværket) i celler.
These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
• Recidiverende eller progredierende HL, som forekom < 12 måneder efter afslutningen af primærbehandlingen
• Relapsed or progressive HL that occurred <12 months from the end of frontline treatment
Efter den første dosis af Adcetris i kombination med kemoterapi vil din læge muligvis også give dig et lægemiddel, der vil hjælpe med at forhindre eller nedsætte sværhedsgraden af neutropeni (nedsat antal hvide blodlegemer), som kan øge risikoen for infektion.
After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection.
Patienter med stadie IV-sygdom
Patients with Stage IV Disease
Umiddelbare og forsinkede infusionsrelaterede reaktioner (IRR) samt anafylaktiske reaktioner er blevet rapporteret.
Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Selvom der ikke er etableret en kausal sammenhæng med ADCETRIS, kan risikoen for lungetoksicitet ikke udelukkes.
Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Ni og halvtreds procent (59 %) af patienterne havde fremskreden sygdomsstadie (stadie III eller IV) ved initial diagnose.
Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Følgende bivirkninger er rapporteret med Adcetris alene:
The following side effects have been reported with Adcetris alone:
ADCETRIS bør ikke anvendes under graviditet, medmindre fordelen for moderen vejer tungere end den potentielle risiko for fosteret.
ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus.
Denne præsentation er uafhængig af sygdommens fase, behandlingstypen eller transplantation status.
This expression is independent of disease stage, line of therapy or transplant status.
• PR eller SD (stabil sygdom) som bedste respons på den seneste salvage-behandling fastlagt med CT- og/eller PET-scanning
• Best response of PR or SD to most recent salvage therapy as determined by CT and/or PET scanning
Febril neutropeni (feber af ukendt oprindelse uden klinisk eller mikrobiologisk dokumenteret infektion med et absolut neutrofiltal på <1,0 x 10
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
ADCETRIS-induceret perifer neuropati er typisk et resultat af kumulativ eksponering for dette lægemiddel, og det er i de fleste tilfælde reversibelt.
ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Der blev ikke observeret betydende forskel i livskvalitet (vurderet med EQ-5D [EuroQol-spørgeskema med fem dimensioner] og FACT-G [Functional Assessment of Cancer Therapy-General]) mellem behandlingsarmene.
No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Antal dødsfald (%)
Number of deaths (%)
Stratificeret log-rank-test blev ikke udført for PFS iht.
Stratified log-rank test was not performed for PFS per Investigator.
40,5 måneder
40.5 months
Leversygdom og andre medicinske tilstande, som kan have eksisteret, før du begyndte at få behandling med Adcetris, og visse lægemidler, du tager kan øge risikoen for leverskader.
Liver disease and other medical conditions that may have been present before you start taking Adcetris and some medications that you are currently taking might increase the risk of liver injury.
27,9 måneder
27.9 months
Den bedste overordnede responsrate (ORR) ifølge Independent Review Facility (IRF) blev analyseret på tværs af begge studiefaser ved RP2D.
The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Træthed, pyreksi, infusionsrelaterede reaktioner
Fatigue, pyrexia, infusion-related reactions
Alvorlige tilfælde af levertoksicitet, inkluderende dødelige udgange, er også forekommet.
Serious cases of hepatotoxicity, including fatal outcomes, have also occurred.
På tidspunktet for analyse var den mediane opfølgningstid for modificeret PFS for begge arme 24,6 måneder Data fra en foreløbig OS-analyse
At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
Doxorubicin, vinblastin og dacarbazin (AVD)
Doxorubicin, vinblastine and dacarbazine (AVD)
Det mediane antal behandlingsserier var cirka 12 behandlingsserier i ADCETRIS-armen.
The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Enhver patient, der oplever en hyperglykæmisk hændelse, skal have serum-glucose nøje monitoreret.
However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored.
Inden for hver Systemeorganklasse er bivirkninger angivet under frekvenskategorierne: 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); Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
Within each System Organ Class, adverse reactions are listed under frequency categories of: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Patienter, der udvikler lymfopeni i Grad 3 eller Grad 4, kan fortsætte behandlingen uden afbrydelse.
Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
Den rekonstituerede opløsning skal kontrolleres visuelt for eventuelle fremmed partikler og/eller misfarvning.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
Leverfunktionen bør testes, før behandling igangsættes og monitoreres rutinemæssigt hos patienter, der behandles med ADCETRIS.
Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS.
CTCL er en form for kræft i en bestemt type hvide blodlegemer kaldet "T-celler", som hovedsagelig påvirker huden.
CTCL is a cancer of a certain type of white blood cell called a ‘T-cell' that mainly affects the skin.
Symptomer på en anafylaktisk reaktion kan omfatte, men er ikke begrænset til urticaria, angioødem, hypotension og bronkospasme.
Symptoms of an anaphylactic reaction may include, but are not limited to, urticaria, angioedema, hypotension and bronchospasm.
MMAE inducerede ikke nogen vigtigere CYP-enzymer i primære kulturer af humane hepatocytter.
MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
Behandling med ADCETRIS bør starte efter restitution fra ASCT på baggrund af klinisk vurdering.
ADCETRIS treatment should start following recovery from ASCT based on clinical judgment.
Det er usandsynligt, at MMAE erstatter eller erstattes af stærkt protein-bundne lægemidler.
MMAE is not likely to displace or to be displaced by highly protein-bound medicines.
In vitro var MMAE et substrat af P-gp og var ikke en P-gp-hæmmer ved kliniske koncentrationer.
In vitro, MMAE was a substrate of P-gp and was not an inhibitor of P-gp at clinical concentrations.
Adcetris bruges til at behandle CTCL, hvis der er en bestemt type protein til stede på cellernes overflade.
Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Der er rapporteret PML hos patienter, der modtog behandling efter at have fået flere forudgående kemoterapiregimer.
PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens.
6,7 måneder
6.7 months
Patienterne blev inddelt efter disse sygdomstyper og randomiseret 1:1 til at få enten ADCETRIS eller lægens valg af enten methotrexat eller bexaroten.
Patients were stratified by these disease types and randomised 1:1 to receive either ADCETRIS or the physician's choice of either methotrexate or bexarotene.
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Storbritannien
Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Østrig
Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Den rekonstituerede opløsning i hætteglasset er en klar til let uklar, farveløs opløsning med en endelig pH på 6,6.
The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Infusionen kan genstartes ved lavere hastighed efter, at symptomerne er ophørt.
The infusion may be restarted at a slower rate after symptom resolution.
Tidligere ASCT
Prior ASCT
Farmakokinetikken for ADCETRIS i kombination med AVD blev evalueret i et enkelt fase 3-studie med 661 patienter.
The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Klassisk Hodgkins lymfom udtrykker specifikke proteiner på celleoverfladen, som adskiller sig fra ikke-klassisk Hodgkins lymfom.
Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Dette lægemiddel indeholder 13,2 mg natrium (hovedkomponent i madlavnings-/bordsalt) pr. hætteglas.
This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
Baseret på et populationfarmakokinetisk skøn var MMAE's typiske tilsyneladende centrale distributionsvolumen 35,5 l.
Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Inde i cellen frisættes en enkelt defineret aktiv art, MMAE via proteolytisk spaltning.
Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Patienterne skal nøje monitoreres under og efter en infusion.
Patients should be carefully monitored during and after infusion.
I tilfælde af overdosering bør patienten nøje monitoreres for bivirkninger, specielt neutropeni, og støttebehandling bør administreres (se pkt.
In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4).
4.8, 5.1 og 5.2, men der kan ikke gives en anbefaling om dosering.
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Din læge kan nedsætte startdosis til 1,2 mg/kg, hvis du har nyre- eller leverproblemer.
Your doctor may lower your starting dose to 1.2 mg/kg if you have kidney or liver problems.
Hvis du mener, at du tidligere har haft en tilsvarende reaktion, skal du fortælle lægen om det, FØR du får medicinen.
If you think you have previously had a similar reaction, tell your doctor BEFORE you are given this medicine.
Præmedicineringen kan omfatte paracetamol, antihistamin og corticosteroid.
Premedication may include paracetamol, an antihistamine and a corticosteroid.
Farmakokinetik hos specielle populationer
Pharmacokinetics in special populations
Mindre end halvdelen af patienterne i den pivotale fase 2-population med Grad 3 eller Grad 4 neutropeni havde midlertidigt associerede infektioner, og størstedelen af de midlertidigt associerede infektioner var Grad 1 eller Grad 2.
Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler undtagen dem nævnt i pkt.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Følgende bivirkninger er rapporteret med Adcetris i kombination med kemoterapi-lægemidler:
The following side effects have been reported with Adcetris in combination with chemotherapy medicines:
Lægen skal være specielt opmærksom på symptomer, der tyder på PML, som patienten måske ikke selv opdager (fx kognitive, neurologiske eller psykiatriske symptomer).
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).
Der blev rapporteret flere alvorlige bivirkninger og dosismodifikationer (herunder udsat dosering, reduktioner og seponeringer) hos ældre patienter sammenlignet med den samlede studiepopulation.
More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
John Cunningham virus (JCV) reaktivering, som medfører progredierende multifokal leukoencefalopati (PML) og død, kan forekomme hos patienter behandlet med ADCETRIS.
John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
Figur 5: Kaplan-Meier-plot af OS
Figure 5: Kaplan-Meier Plot of OS