natgillin/translations-raw huggingface dataset:
De to undersøgelser viste, at behandlingen efter ét år virkede hos 84 % af de patienter, der fik Edurant, sammenholdt med 82 % af de patienter, der fik efavirenz.
Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.
Edurant er et lægemiddel, der indeholder det aktive stof rilpivirin.
Edurant is a medicine that contains the active substance rilpivirine.
De hyppigste bivirkninger ved Edurant (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, søvnløshed, svimmelhed, kvalme og forhøjede værdier af total kolesterol, low-densitylipoprotein (LDL), kolesterol, pankreasamylase (et enzym, der produceres i bugspytkirtlen og nedbryder stivelse til sukkerarter) og transaminaser (leverenzymer).
The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes).
CHMP var derfor af den opfattelse, at fordelene ved Edurant opvejer risiciene hos patienter med lavt indhold af hiv-1, og anbefalede udstedelse af markedsføringstilladelse for denne gruppe af patienter.
Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Hvorfor blev Edurant godkendt?
Why has Edurant been approved?
Hvilken risiko er der forbundet med Edurant?
What is the risk associated with Edurant?
Edurant blev givet sammen med en fast kombination af antivirale lægemidler og blev ikke sammenlignet med andre behandlinger.
Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
I alle undersøgelser blev behandlingens virkning hovedsagelig bedømt på mindskelsen af virusindholdet.
In all studies, the main measure of effectiveness was based on the reduction in viral load.
Ved at blokere dette enzym mindsker Edurant, anvendt i kombination med andre antivirale lægemidler, hiv-mængden i blodet og holder den nede.
By blocking this enzyme, Edurant, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
• carbamazepin, oxcarbazepin, phenobarbital, fenytoin (lægemidler mod krampeanfald)
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
Edurant var genstand for to hovedundersøgelser med 1 368 tidligere ubehandlede patienter, der var inficeret med hiv-1.
Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Edurant anvendes i kombination med andre antivirale lægemidler til behandling af voksne og unge i alderen 12 år og opefter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er et virus, der forårsager erhvervet immundefektsyndrom (aids).
Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Lægemidlet anvendes kun til patienter, der ikke tidligere er behandlet mod hiv, og hvis indhold af hiv i blodet højst er 100 000 hiv-1 RNA-kopier/ml.
It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Den fuldstændige liste over indberettede bivirkninger ved Edurant fremgår af indlægssedlen.
For the full list of all side effects reported with Edurant, see the package leaflet.
Edurant var også genstand for en anden undersøgelse omfattende 36 tidligere ubehandlede unge (mellem 12 og 18 år) smittet med hiv-1.
Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Hos voksne var Edurant, i kombination med andre antiretrovirale lægemidler, lige så effektivt som sammenligningspræparatet til at mindske indholdet af hiv-1 i patienternes blod.
In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood.
I den anden undersøgelse blev Edurant sammenlignet med efavirenz, når begge lægemidler blev givet sammen med en fast kombination af de antivirale lægemidler tenofovirdisoproxil og emtricitabin eller sammen med to andre nukleosid- eller nukleotidreverse transkriptasehæmmere.
In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.
Hvordan blev Edurant undersøgt?
How has Edurant been studied?
I den første undersøgelse blev Edurant sammenlignet med et andet NNRTI, efavirenz, og de to lægemidler blev givet sammen med en fast kombination af de antivirale lægemidler tenofovirdisoproxil og emtricitabin.
In the first study, Edurant was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine.
Hvad er Edurant?
What is Edurant?
Hvilken fordel viser undersøgelserne, at der er ved Edurant?
What benefit has Edurant shown during the studies?
Hvad anvendes Edurant til?
What is Edurant used for?
CHMP konkluderede, at Edurant i kombination med andre antiretrovirale lægemidler er lige så effektivt som de vigtigste NNRTI, der i dag anvendes som førstevalgsbehandling af patienter med hiv-1infektion.
The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Hvordan anvendes Edurant?
How is Edurant used?
• prikbladet perikum (naturlægemiddel mod depression).
• St John's wort (a herbal antidepressant medicine).
Hvordan virker Edurant?
How does Edurant work?
Ud fra et mikrobiologisk synspunkt skal produktet anvendes umiddelbart.
From a microbiological point of view, the product must be used immediately.
Dette syndrom kan være dødeligt.
This syndrome can be fatal.
Samme dosis anbefales til voksne og ældre.
The same dose is recommended for adults and elderly.
Forsigtighed er påkrævet hos disse patienter.
Caution is needed in these patients.
Monitorering og styring i forbindelse med disse patienter skal ske som beskrevet ovenfor.
Monitoring and management for these patients should be as described above.
Disse kan bl.a. være:
These include:
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data)
Not known (frequency cannot be estimated from the available data):
Vd er også vægtafhængig og stiger med stigende kropsvægt.
Vd is also weight dependent, increasing with increasing body weight.
Du skal fortælle om alle nye og usædvanlige symptomer og omstændigheder, når du ser lægen.
You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Dato for første markedsføringstilladelse: 5. marts 2002 Dato for seneste fornyelse: 5. marts 2007
Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
Observation er den anbefalede forholdsregel, kun med intervention i særlige tilfælde.
Observation is the recommended approach with intervention only in selected cases.
Responshyppigheden var ens for de to køn.
The response rate was similar for both genders.
Der foreligger ingen data for børn under 5 år.
No data are available for children under 5 years.
- Derudover vil du få taget et elektrokardiogram to gange ugentlig.
- In addition, you will receive electrocardiograms twice weekly.
NY KONCENTRATION
NEW CONCENTRATION
Du skal sørge for at fortælle din læge om al den medicin, du tager.
You must be sure to tell your doctor about all medicines you are taking.
Denne akkumulering var en smule højere end forventet ud fra enkeltdosisresultater.
This accumulation was slightly more than expected based on single-dose results.
TRISENOX gives normalt af en læge eller en sygeplejerske.
TRISENOX is normally given by a doctor or a nurse.
Procedure for korrekt bortskaffelse
Procedure for proper disposal
18-måneders overlevelse
18-Month survival
Monitorér patienterne for udvikling af anden primær malignitet.
Monitor patients for the development of second primary malignancies.
Gem ikke de ikke-anvendte portioner til senere indgift.
Do not save any unused portions for later administration.
Resultaterne er opsummeret i Tabel 4 nedenfor.
The results are summarised in the table 4 below.
Negativ Positiv Kan ikke evalueres
Negative Positive Not evaluable
Hun fortsatte med konsolidering uden yderligere tegn på QT-forlængelse.
She went onto consolidation without further evidence of QT prolongation.
Patienter udviste tendens til at tolerere konsolidering og vedligeholdelse med mindre toksicitet end i induktionen.
Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Patienterne skal indlægges i behandlingens begyndelse på grund af sygdomssymptomer og for at sikre tilstrækkelig monitorering.
Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Tid til CR (median)
Time to CR (median)
Tabel 1 Anbefaling for påbegyndelse af hydroxyurea WBC
Table 1 Recommendation for initiation of hydroxyurea WBC
Patienter, der oplever en gentagelse af toksiciteten, skal tages ud af behandlingen.
Patients who experience a recurrence of toxicity must be removed from treatment.
Meget almindelig Meget almindelig
Very Common Very Common
Mens du er i behandling med TRISENOX, kan du opleve nogle af følgende reaktioner:
While on treatment with TRISENOX, you may experience some of the following reactions:
- Opfølgning af dine kognitive funktioner og din mobilitet, hvis du har risiko for B1vitaminmangel.
- Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.
Udvikling af anden primær malignitet
Development of second primary malignancies
Det betyder, at medicinen i det væsentlige er natriumfri.
This means that the medicine is essentially ‘sodium-free'.
AsV findes kun i relativt lave koncentrationer i plasma.
AsV is present in plasma only at relatively low levels.
Akkumuleringsgraden af disse metabolitter afhænger af doseringsregimet.
The extent of accumulation of these metabolites is dependent on the dosing regimen.
De vigtigste effektresultater er opsummeret i Tabel 3 nedenfor:
The key efficacy results are summarised in table 3 below:
95 % CI for forskellen, 2-22 procentpoints p < 0,001 for noninferioritet p = 0,02 for superioritet af ATRA+TRISENOX
95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX
Hvis dette lægemiddel anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager lægemidlet, bør patienten informeres om den mulige skade på fostret.
If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking this product, the patient must be informed of the potential harm to the foetus.
Alvorlige bivirkninger var almindeligt forekommende (1-10 %) og ikke uventede i den recidiverende/refraktære patientgruppe.
Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population.
Personalet skal uddannes i håndtering og fortynding af arsentrioxid og skal bruge passende beskyttelsesbeklædning.
Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Nogle tilfælde gik væk med B1-vitamintilskud.
Some cases recovered with vitamin B1 supplementation.
Konsolideringsbehandling skal begyndes 3 til 4 uger efter afslutning af induktionsbehandlingen.
Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
Alle tilfældene blev imidlertid håndteret på vellykket vis med hydroxyurea.
However all cases were successfully managed with hydroxyurea therapy.
Børn og unge TRISENOX anbefales ikke til børn og unge under 18 år.
Children and adolescents TRISENOX is not recommended in children and adolescents below 18 years of age.
Kaplan-Meier medianvarigheden af CR for enkeltinstitutionsstudiet var 14 måneder og blev ikke nået for multicenterstudiet.
The Kaplan-Meier median CR duration for the single institution study is 14 months and has not been reached for the multicentre study.
Fordeling Fordelingsvolumen (Vd) for AsIII er stort (> 400 l), hvilket tyder på en betydelig fordeling ind i vævene med en ubetydelig proteinbinding.
Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding.
Der foreligger begrænsede kliniske data vedrørende anvendelsen af TRISENOX i den ældre population.
There is limited clinical data on the use of TRISENOX in the elderly population.
Den gives som et drop (infusion) i en vene i løbet af 1-2 timer, men infusionen kan vare længere, hvis der optræder bivirkninger som blussen og svimmelhed.
It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.
TRISENOX er indiceret til induktion af remission og konsolidering hos voksne patienter med:
TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
Meget almindelig: (kan forekomme hos mere end 1 ud af 10 personer)
Very common (may affect more than 1 in 10 people):
Der sås respons hen over alle testede aldersgrupper, varierende fra 6 til 75 år.
Responses were seen across all age groups tested, ranging from 6 to 75 years.
Hvis du er gravid, eller du bliver gravid under behandlingen med TRISENOX, skal du spørge din læge til råds.
If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Erfaringer efter frigørelse på markedet tyder på, at et tilsvarende syndrom kan forekomme hos patienter med andre former for maligniteter.
Post-marketing experience suggests that a similar syndrome may occur in patients with other types of malignancy.
Hvis dette sker, skal behandlingen med TRISENOX omgående stoppes, og din læge vil behandle arsen-overdoseringen.
If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
- Du skal have taget et elektrokardiogram (ekg) inden din første dosis.
- You should have an electrical recording of the heart (electrocardiogram ECG) performed before your first dose.
FORSIGTIG, BEMÆRK NY KONCENTRATION (2 mg/ml)
CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)
Komplet hæmatologisk remission (HCR)
Haematologic complete remission (HCR)
Totalt arsen akkumuleres hovedsagligt i lever, nyre og hjerte og i mindre grad i lunge, hår og negle.
Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Lægemidler, der anvendes til at sænke antallet af hvide blodlegemer, forværrer ofte toksiciteten i forbindelse med leukocytose, og ingen standardbehandling har vist sig effektiv.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leucocytosis, and no standard approach has proven effective.
Cirka 15 % af den indgivne TRISENOX-dosis udskilles i urinen som uændret AsIII.
Approximately 15 % of the administered TRISENOX dose is excreted in the urine as unchanged AsIII.
- hvis du tager eller for nyligt har taget medicin, der kan påvirke leveren.
- if you are taking or have recently taken any medicine which may affect your liver.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva B.V.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
De metylerede metabolitter af AsIII (MMAV, DMAV) bliver primært udskilt i urinen.
The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
I disse studier blev leukocytose ikke behandlet med kemoterapeutiske lægemidler.
In these studies, leucocytosis was not treated with chemotherapeutic medicinal products.
Den daglige dosis kan igen optrappes til 100 % af den oprindelige dosis, hvis der ikke opstår nogen forlængelse.
The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Almindelig: (kan forekomme hos op til 1 ud af 10 personer)
Common (may affect up to 1 in 10 people):
2-års samlet overlevelse (OS)
2-Year overall survival (OS)
Åbning af ampullen: Hold ampullen med TRISENOX med det farvede punkt opad og foran dig.
Opening the ampoule: Hold the ampoule of TRISENOX with the coloured point upwards and in front of you.
Faldet fra maksimal plasmakoncentration af AsIII sker bifasisk og er karakteriseret ved en initial hurtig distributionsfase efterfulgt af en langsommere terminal eliminationsfase.
The decline from peak plasma concentration of AsIII occurs in a biphasic manner and is characterized by an initial rapid distribution phase followed by a slower terminal elimination phase.
Grad≥3
Grades ≥ 3
- Din læge vil overvåge dit helbred under og efter behandlingen, da arsentrioxid, det aktive stof i TRISENOX, kan forårsage andre kræftformer.
- Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in TRISENOX, may cause other cancers.
Kaplan-Meier skøn for 18-måneders overlevelse for begge forsøg er vist nedenfor.
Kaplan-Meier estimates of 18-month survival for each study are shown below.
Perifer neuropati, karakteriseret ved paræstesi/dysæstesi, er en almindelig og velkendt miljøeffekt af arsen.
Peripheral neuropathy, characterised by paraesthesia/dysaesthisia, is a common and well known effect of environmental arsenic.
TRISENOX' sikkerhed og virkning hos børn i alderen op til 17 år er ikke klarlagt.
The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Der skal tages elektrokardiogram to gange ugentlig, og endnu hyppigere for klinisk ustabile patienter, under induktion og konsolidering.
Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
27 patienter havde leukocytose (WBC 10 x 103/l) under induktion, hvoraf 4 havde værdier over 100,000/l.
Twenty-seven patients had leucocytosis (WBC  10 x 103/l) during induction, 4 of whom had values above 100,000/l.
Anbefalinger for ekg og elektrolyt-monitorering
ECG and electrolyte monitoring recommendations
Infusionsvarigheden kan forlænges op til 4 timer, hvis der observeres vasomotoriske reaktioner.
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
TRISENOX er kun til engangsbrug.
TRISENOX is for single use only.
Derefter kan der gives penicillamin i en dosis ≤ 1 g pr. dag.
Thereafter, penicillamine at a daily dose ≤ 1 g per day may be given.
Tidligere behandling med antracykliner kan øge risikoen for QT-forlængelse.
Previous treatment with anthracyclines may increase the risk of QT prolongation.
Arsen udskilles i human mælk.
Arsenic is excreted in human milk.
TRISENOX skal indgives intravenøst over 1-2 timer.
TRISENOX must be administered intravenously over 1-2 hours.
Varigheden af behandlingen med penicillamin skal evalueres under hensyntagen til laboratorieværdien for arsen i urinen.
The duration of treatment with penicillamine must be evaluated taking into account the urinary arsenic laboratory values.
TRISENOX' virkningsmekanisme er ikke helt klarlagt.
The mechanism of action of TRISENOX is not completely understood.
De hyppigst rapporterede reaktioner var hyperglykæmi, hypokaliæmi, neutropeni og forhøjet alanin-aminotransferase (ALAT).
The most commonly reported reactions were hyperglycaemia, hypokalaemia, neutropenia, and increased alanine amino transferase (ALT).
Clearance er ikke afhængig af personens vægt eller den indgivne dosis i det undersøgte dosisinterval.
Clearance is not dependent on the weight of the subject or the dose administered over the dose range studied.
Tryk nu med tommelfingeren på det farvede punkt og knæk ampullen ved at holde godt fast om ampullens hoveddel med den anden hånd.
Now press your thumb on the coloured point and break the ampoule by holding firmly the body of the ampoule with the other hand.
Behandlingen skal fortsættes i 4 uger med behandling og 4 uger uden, i alt 4 cyklusser.
Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles.
Din læge vil tage følgende forsigtighedsregler: - Der vil blive taget prøver for at kontrollere mængden af kalium, magnesium, calcium og kreatinin i blodet, inden du får din første dosis TRISENOX.
Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of TRISENOX.
Recidiverende/refraktær APL
Relapsed/refractory APL
TRISENOX dosis, mg/kg/dag (median, interval) Komplet remission Tid til knoglemarvsremission (median)
TRISENOX dose, mg/kg/day (median, range) Complete remission Time to bone marrow remission (median)
Dette skyldes sandsynligvis en sammenblanding af bivirkninger med den ukontrollerede sygdomsproces tidligt i behandlingsforløbet og de myriader af samtidige lægemidler, som er påkrævet for at kontrollere symptomer og morbiditet.
This is probably due to the confounding of adverse events by the uncontrolled disease process early on in the treatment course and the myriad concomitant medicinal products required to control symptoms and morbidity.
Hepatotoksicitet (grad 3-4)
Hepatotoxicity (grade 3-4)
Fortæl det især altid til lægen hvis du bruger forskellige typer medicin, som kan forårsage en ændring i din hjerterytme.
In particular tell your doctor - if you are taking any of various types of medicines which could cause a change in the rhythm of your heartbeat.
ATRA + kemoterapi (n = 79)
ATRA + Chemotherapy (n = 79)
Hvis du mærker ubehag eller føler dig utilpas efter en TRISENOXinfusion, skal du vente, indtil symptomerne forsvinder, før du fører motorkøretøj eller betjener maskiner.
If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
TRISENOX er kun til engangsbrug, og alle ubrugte portioner fra hver ampul eller fra hvert hætteglas skal bortskaffes forsvarligt.
TRISENOX is for single use only and any unused portions of each ampoule or of each vial must be discarded properly.
Farmakoterapeutisk klassifikation: Andre neoplastiske midler, ATC-kode: L01XX27
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Der er ikke gennemført nogen formel vurdering af farmakokinetiske interaktioner mellem TRISENOX og andre terapeutiske lægemidler.
No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted.
For patienter med alvorlig, akut arsenoverdosis skal man overveje dialyse.
For patients with severe, acute arsenic overdose, dialysis should be considered
De pentavalente metabolitter, MMAV og DMAV optræder langsomt i plasma (cirka 10-24 timer efter første administration af arsentrioxid), men på grund af deres længere halveringstid, akkumuleres de mere ved gentagen dosering end AsIII.
The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Der blev ikke set nogen klar tendens til øget systemisk eksponering for AsIII, AsV, MMAV eller DMAV ved faldende leverfunktionsniveau vurderet ved dosisnormaliseret (pr mg dosis) AUC.
No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.