natgillin/translations-raw huggingface dataset:
Hvad er Istodax?
What is Istodax?
Det kunne derfor ikke konkluderes, at lægemidlets fordele overstiger risiciene, og CHMP bekræftede sin indledende negative udtalelse.
Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Den 15. november 2012 EMA/725439/2012
EMA/725439/2012
Navnlig kunne udvalget ikke drage konklusioner om lægemidlets kliniske fordel.
In particular, the Committee could not conclude on the clinical benefit of the medicine.
Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Virkningerne af Istodax blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Istodax were first tested in experimental models before being studied in humans.
Istodax er et lægemiddel, der indeholder det aktive stof romidepsin.
Istodax is a medicine that contains the active substance romidepsin.
Behandlingens virkning blev hovedsagelig målt på den andel af patienterne, der udviste fuldstændig respons på behandlingen.
The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
I undersøgelsen blev Istodax ikke sammenlignet med nogen anden behandling.
In the study, Istodax was not compared with any other treatment.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Istodax findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin) EMA/725439/2012
Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Da lægemidlet ikke var sammenlignet med nogen anden behandling, kunne det ikke fastslås, om de iagttagne virkninger skyldtes lægemidlet eller sygdommens egenskaber hos patienterne i hovedundersøgelsen.
As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 15. november 2012 afslaget på ansøgningen om markedsføringstilladelse.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Hvad forventedes Istodax anvendt til?
What was Istodax expected to be used for?
CHMP konstaterede desuden, at virksomheden ved en fejl havde undladt at fremlægge et tilfredsstillende certifikat for god fremstillingspraksis for fremstillingsstedet for lægemidlet, hvilket kræves ifølge loven.
The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Da Istodax ikke blev sammenlignet med nogen anden behandling, kunne udvalget imidlertid ikke drage konklusioner om lægemidlets kliniske fordel i form af samlet overlevelse (hvor længe patienterne levede) eller progressionsfri overlevelse (hvor længe patienterne levede uden forværring af sygdommen).
However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin)
Refusal of the marketing authorisation for Istodax (romidepsin)
Perifert T-cellelymfom er kræft, der udgår fra hvide blodlegemer af typen T-celler, som er en del af immunsystemet.
Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Efter den fornyede overvejelse i november 2012 bortfaldt CHMP's betænkeligheder vedrørende certifikatet for god fremstillingspraksis, men de øvrige betænkeligheder bestod.
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Den 19. juli 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Istodax, som er bestemt til behandling af perifert T-cellelymfom.
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Virksomheden fremlagde resultaterne af én hovedundersøgelse med Istodax, hvori der deltog 131 patienter med perifert T-cellelymfom, som tidligere var blevet behandlet.
The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Hvordan forventes Istodax at virke?
How is Istodax expected to work?
I juli 2012 konstaterede CHMP, at hovedundersøgelsen viste, at Istodax havde virkning på sygdommen, målt som patienternes respons på behandlingen.
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Istodax.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Den 28. oktober 2005 blev Istodax udpeget som “lægemiddel til sjældne sygdomme” til behandling af perifert T-cellelymfom (nodalt, andet ekstranodalt og leukæmisk/dissemineret).
Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Istodax forventedes anvendt til behandling af voksne med perifert T-cellelymfom ved manglende behandlingsvirkning eller tilbagefald af sygdommen efter mindst to forudgående behandlinger.
Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Det vides ikke nøjagtigt, hvordan romidepsin virker ved perifert T-cellelymfom, men romidepsin forventes at bremse kræftcellernes vækst og deling ved sin indvirkning på de gener, der regulerer cellernes formering og død.
The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Det aktive stof i Istodax, romidepsin, virker ved at blokere enzymer af typen histonedeacetylaser, som slår generne “fra” eller “til” i cellerne.
The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Det leveres som et pulver, der efter opløsning i den medfølgende væske indgives ved infusion (med drop i en vene).
It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
I begge studier var der ingen tilfælde af resistens over for behandling efter 48 uger.
In both studies there were no cases of resistance to treatment after 48 weeks.
Som for alle lægemidler bliver data vedrørende brug af Dovato løbende overvåget.
As for all medicines, data on the use of Dovato are continuously monitored.
Andre oplysninger om Dovato
Other information about Dovato
Begge aktive stoffer er allerede godkendt i Den Europæiske Union som separate tabletter:dolutegravir i 2014 og lamivudin i 1996.
Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Den anbefalede dosis er én tablet én gang dagligt.
The patient should take one tablet once a day.
Dovato er et lægemiddel til behandling af infektion med humant immundefektvirus type 1 (hiv-1) hos voksne og unge over 12 år, der vejer mindst 40 kg.
Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dovato?
What measures are being taken to ensure the safe and effective use of Dovato?
For mere information om brug af Dovato, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Dovato (dolutegravir / lamivudin)
Dovato (dolutegravir / lamivudine)
En oversigt over Dovato, og hvorfor det er godkendt i EU
An overview of Dovato and why it is authorised in the EU
De indberettede bivirkninger ved Dovato vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Dovato fås som tabletter, der indeholder 50 mg dolutegravir og 300 mg lamivudin.
Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Tredobbelt kombinationsbehandling anvendes til hiv-behandling for at mindske risikoen for, at virussen bliver resistent over for behandling.
Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Hvorfor er Dovato godkendt i EU?
Why is Dovato authorised in the EU?
De hyppigste alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 100 personer) er allergiske reaktioner, herunder udslæt og alvorlige leverproblemer.
The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Dovato helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
I disse studier var der hos 91 % af de patienter med hiv-1, som fik Dovato-kombinationen, ikke længere målelige koncentrationer af hiv (under 50 kopier pr. ml) efter 48 uge sammenlignet med 93 % af dem, der tog den tredobbelte kombination.
In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Hvad er Dovato, og hvad anvendes det til?
What is Dovato and what is it used for?
Dovato (dolutegravir / lamivudin) EMA/276259/2019
Dovato (dolutegravir / lamivudine) EMA/276259/2019
Hvilke risici er der forbundet med Dovato?
What are the risks associated with Dovato?
De hyppigste bivirkninger ved Dovato (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, diarré, kvalme og søvnbesvær.
The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Dovato fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
De to aktive stoffer i Dovato, dolutegravir og lamivudin, blokerer de enzymer, som virussen bruger til at fremstille nye eksemplarer af sig selv.
The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
I to hovedstudier var Dovato-kombinationen lige så effektiv som en tredobbelt kombination hos patienter med hiv-1, og der var ingen tegn på udvikling af resistens hos disse patienter.
In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Dolutegravir blokerer et enzym kaldet integrase (og kaldes en integrasehæmmer), mens lamivudin forhindrer revers transkriptase (og kaldes en nukleotid revers transkriptase-hæmmer eller NRTI).
Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Dette lægemiddel indeholder de aktive stoffer dolutegravir og lamivudin og anvendes til behandling af infektioner, der ikke er resistente over for lægemidler i samme klasse som dolutegravir eller lamivudin.
This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
To hovedstudier, hvori der indgik 1.433 patienter, har vist, at kombinationen af de to aktive stoffer i Dovato er lige så effektiv til at reducere mængden af hiv i blodet som en tredobbelt kombinationsbehandling (dolutegravir, tenofovir og emtricitabin).
Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Yderligere information om Dovato findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/dovato
Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Hvilke fordele viser studierne, at der er ved Dovato?
What benefits of Dovato have been shown in studies?
Hvordan anvendes Dovato?
How is Dovato used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Dovato.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dovato opvejer risiciene, og at det kan godkendes til anvendelse i EU.
Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Hvordan virker Dovato?
How does Dovato work?
3 (3x1) inhalatorer (360(3x120) pust) (multipakning)
3 (3x1) inhalers (360(3x120) actuations) (multipack)
1 inhalator (120 pust)
1 inhaler (120 actuations)
EU-nummer
Pack size
(Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse EU/1/16/1152/001 Roteas
Strength Pharmaceutical Form
• Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
• Not known (frequency cannot be estimated from the available data)
Der var en signifikant og gavnlig effekt på livskvaliteten (målt på PD-QUALIF skalaen).
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
597 678 01 Blansko Tjekkiet
597 678 01 Blansko Czech Republic
Hyppigheden af mulige bivirkninger er anført nedenfor i henhold til følgende konvention:
The frequency of possible side effects listed below is defined using the following convention:
Tag den næste dosis på det tidspunkt, hvor De normalt ville gøre det.
Take the next dose normally, when it is time to take it.
Lægen kan være nødt til at ændre Deres dosis eller stoppe behandlingen.
Your doctor may need to adjust or stop your dose.
Mindre end 1% rasagilin udskilles som uændret stof i urinen.
Less than 1% of rasagiline is excreted as unchanged product in urine.
• Unormale drømme
• abnormal dreams
Patienterne bør regelmæssigt kontrolleres for udvikling af impulskontrolforstyrrelser.
Patients should be regularly monitored for the development of impulse control disorders.
Det kan bruges sammen med eller uden levodopa (et andet lægemiddel, som anvendes til behandling af Parkinsons sygdom).
It can be used together with or without levodopa (another medicine that is used to treat Parkinson's disease).
I tilfælde af overdosering bør patienten overvåges, og passende symptomatisk og understøttende behandling iværksættes.
In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
Den absolutte biotilgængelighed af en enkelt dosis rasagilin er ca. 36%.
The absolute bioavailability of a single rasagiline dose is about 36%.
Parkinsons sygdom er forbundet med symptomer som hallucinationer og forvirring.
Parkinson's disease is associated with symptoms of hallucinations and confusion.
Resultaternes styrke for det primære effektmåls vedkommende blev bekræftet af en ekstra række statistiske modeller og blev påvist i tre kohorter (ITT, pr. protokol og gennemførende deltagere).
The robustness of the results for the primary efficacy end point, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Enhver mistænkelig hudforandring bør vurderes af en speciallæge.
Any suspicious skin lesion should be evaluated by a specialist.
Rasagilin absorberes hurtigt og når peak plasmakoncentration (Cmax) efter ca. 0,5 timer.
Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager nogen form for medicin.
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 any medicine.
Bivirkningerne var milde eller moderate og ikke relaterede til rasagilin behandlingen.
Adverse events were mild or moderate and not related to rasagiline treatment.
Børn og unge Rasagilin Mylan anbefales ikke til unge under 18 år.
Children and adolescents Rasagiline Mylan is not recommended for use under the age of 18.
Dosisjustering er ikke nødvendig hos ældre patienter.
Elderly No change in dose is required for elderly patients.
Rasagilin bør ikke anvendes til børn og unge pga. manglende dokumentation for sikkerhed og virkning.
Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
I denne undersøgelse var det primære effektmål ændringen fra baseline i total score på Unified Parkinson's Disease Rating Scale (UPDRS, del I-III).
In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS, parts I-III).
Parkinsons sygdom forårsager et tab af celler, som producerer dopamin i hjernen.
With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og reproduktionstoksicitet.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and reproduction toxicity.
ÆSKE TIL BLISTERPAKNING
CARTON FOR BLISTER PACK
• På anmodning fra Det Europæiske Lægemiddelagentur 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
Der sås også en statistisk signifikant forbedring i forhold til placebo i rasagilin 0,5 mg gruppen, men forbedringen var mindre.
There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Rasagilin fremviste ikke genotoksisk potentiale in vivo eller i adskillige in vitro systemer med bakterier eller hepatocyter.
Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Desuden observeredes hudcancer hos ca. 1% af patienterne, der deltog i placebokontrollerede, kliniske undersøgelser.
In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Følgende bivirkninger er observeret i placebokontrollerede, kliniske undersøgelser:
The following side effects have been reported in placebo controlled clinical trials:
Rasagilin Mylan anvendes til behandling af Parkinsons sygdom.
Rasagiline Mylan is used for the treatment of Parkinson's disease.
Der er flere kendte interaktioner mellem ikke-selektive MAO-hæmmere og andre lægemidler.
There are a number of known interactions between non-selective MAO inhibitors and other medicinal products.
Rasagilin indtages peroralt i en dosis på 1 mg én gang dagligt med eller uden levodopa.
Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i: Appendiks V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Patienter bør tilrådes forsigtighed ved betjening af maskiner, herunder også bilkørsel eller motorcykelkørsel, indtil de er forholdsvis sikre på, at rasagilin ikke påvirker dem ugunstigt.
Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that Rasagiline does not affect them adversely.
Dyreforsøg indikerer ikke direkte eller indirekte skadelige virkninger på drægtighed, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
• Smerter i brystet (angina pectoris)
• chest pain (angina pectoris)
I begge undersøgelser var det primære effektmål ændringen fra baseline til behandlingsperiodens afslutning målt som det gennemsnitlige antal timer i ”off-periode” (bestemt ud fra ”24-timers” dagbøger udfyldt i hjemmet i 3 dage inden hvert kontrolbesøg).
In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
Rasagilin Mylan er med til at øge og opretholde dopaminniveauet i hjernen.
Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain.
blisterpakninger med 7, 10, 28, 30, 100 eller 112 tabletter PVC/PVDC/Al.
Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al.