natgillin/translations-raw huggingface dataset:
Under vurderingen bekræftede indehaveren af markedsføringstilladelsen at have fremlagt alle foreliggende data og at være ude af stand til at fremlægge yderligere data til påvisning af den kliniske fordel ved oralt almitrin til behandling af kronisk hypoksæmi ved KOL.
During the assessment, the MAH confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical benefit of oral almitrine in in the management of chronic hypoxemia in COPD.
PRAC er af den opfattelse, at de af markedsføringstilladelsesindehaveren foreslåede risikominimeringsforanstaltninger ikke vil kunne mindske risiciene for alvorlige bivirkninger til et klinisk acceptabelt niveau: Risiciene for neuropati og vægttab er i forvejen velkendt af de ordinerende læger, og eventuel yderligere information herom vil ikke bidrage til sikrere anvendelse af produktet.
The PRAC is of the view that the risk minimisation measures proposed by the MAH would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level: any additional communication on risks of neuropathies and weight loss, already well known to prescribers, would not contribute to a safer use of the product.
Til gennemgangen af virkning og sikkerhed udvalgtes kun de kliniske undersøgelser ved kronisk obstruktiv lungesygdom (KOL), hvor mere end 30 patienter var blevet behandlet med terapeutiske doser af almitrin i mindst tre måneder.
Among the clinical studies in Chronic Obstructive Pulmonary Disease (COPD) patients, only those with more than 30 patients treated with therapeutic doses of almitrine for at least 3-month were selected for an efficacy and safety overview.
Efter gennemgang af de foreliggende data om virkning, herunder data der blev tilgængelige efter den oprindelige markedsføringsgodkendelse, konkluderede PRAC, at almitrin ved oral anvendelse til de godkendte indikationer kun har en meget begrænset virkning, som ikke er ensbetydende med for en fordel for patienterne i sammenhæng med den nuværende behandlingsstrategi og viden om luftvejssygdomme.
Further to the review of the available efficacy data, including data which became available since the initial marketing authorisation, the PRAC concluded that the available data only showed very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
Almitrinbismesylat er indiceret til respirationsinsufficiens med hypoksæmi ved obstruktiv bronkitis.
Almitrine bismesylate is indicated in patients with respiratory failure with hypoxemia related to obstructive bronchitis.
• PRAC tog til efterretning markedsføringstilladelsesindehaverens erklæring om, at alle foreliggende data er fremlagt, og at det ikke er muligt at fremlægge yderligere data til påvisning af den kliniske fordel ved oralt almitrin til behandling af kronisk obstruktiv lungesygdom (KOL).
• The PRAC took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of oral almitrine in chronic obstructive pulmonary disease (COPD).
På ovenstående grundlag fandt PRAC, at de foreliggende data om virkning, herunder data, der blev tilgængelige efter den oprindelige markedsføringsgodkendelse, viste, at almitrin ved oral anvendelse til de godkendte indikationer har en meget begrænset virkning, som ikke kan betragtes som evidens for en fordel for patienterne i sammenhæng med den nuværende behandlingsstrategi og viden om luftvejssygdomme.
Based on the above, the PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited efficacy of oral almitrine in its approved indications which does not translate in evidence of a benefit for patients in the current context of the therapeutic strategy and knowledge acquired in respiratory diseases.
1 Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C. The therapeutic value and acceptability of Vectarion 50 mg coated tablets (almitrin bismesylate) at the dose of 100 mg per day.
Ansquer J.C., Bertrand A., Blaive B., Charpin J., Chretien J., Decroix G., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C. The therapeutic value and acceptability of Vectarion 50 mg coated tablets (Almitrine bismesylate) at the dose of 100 mg per day.
5 Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J.. Treatment of chronic respiratory failure by almitrin bismesylate.
5 Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J..
PRAC konkluderede derfor, at risk/benefit-forholdet for orale produkter indeholdende almitrin ikke er positivt i henhold til artikel 116 i direktiv 2001/83/EF.
The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC the risk-benefit balance for almitrine containing products for oral administration is not favourable.
CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's (Udvalget for Risikovurdering inden for Lægemiddelvurdering) anbefaling af 16. maj 2013 for lægemidler indeholdende almitrin til oral anvendelse, og CMDh kan tilslutte sig anbefalingen, således som det fremgår af følgende:
The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the Almitrine containing medicinal products for oral use, agrees with the recommendation therein as stated below:
Nowak D., Wywiol A., Magnussen H.. almitrin in the treatment of chronic obstructive pulmonary disease with hypoxemia - a multicentre clinical study comparing two dosages.
2003 ; 70 : 275-283 (PE32001) Nowak D., Wywiol A., Magnussen H.. Almitrine in the treatment of chronic obstructive pulmonary disease with hypoxemia - a multicentre clinical study comparing two dosages.
Der er desuden ingen data til støtte for den af markedsføringstilladelsesindehaveren påberåbte fordel, at langtidsoxygenterapi kan forsinkes med almitrin.
In addition, the benefit claimed by the MAH that long-term oxygen therapy can be delayed with almitrine is not substantiated by supporting data.
Siden den oprindelige markedsføringsgodkendelse er der indført dosisreduktion og en sekventiel behandlingsplan som risikominimeringsforanstaltninger.
Risk minimisation measures (reduction of the dose and implementation of a sequential treatment scheme ) were implemented since the initial marketing authorisation.
I størstedelen af de foreliggende publicerede kliniske undersøgelser med sekventiel behandlingsplan891011 (dvs. to måneders behandling efterfulgt af én måneds behandlingspause) var andelen af udtrædelser i almitrin-grupperne større end i placebogruppern
• Central nervous events (sleep disorders such as insomnia, drowsiness, agitation, anxiety, palpitations, dizziness) Based on the available publications of clinical studies with sequential treatment scheme891011 (i.e. two months of treatment followed by one month treatment interruption), the rate of withdrawal remained predominant in the almitrine groups as compared to placebo groups in the majority of the publications.
e.
Whereas,
• PRAC fandt, at de foreliggende data kun viser meget begrænset klinisk virkning af almitrin ved de godkendte indikationer.
• The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of almitrine in its approved indications.
Gorecka D., Sliwinski P, Palasiewicz G, Pachocki R., Zielinski J.. Effects of almitrin bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of almitrin in patients with chronic obstrutive lung disease.
Pneumology 1998 Mar;52(3):121-7 (PE24412) Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
almitrin bismesylate: a long-term placebo- controlled double-blind study in COAD.
Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
• PRAC fandt, at oral anvendelse at almitrin er forbundet med alvorlige reaktioner i form af perifer neuropati og vægttab, undertiden med sequelae.
• The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
CMDh nåede til enighed om tilbagekaldelse af markedsføringstilladelserne for lægemidler indeholdende almitrin til oral anvendelse efter gennemgang af PRAC's anbefaling af 16. maj 2013 i medfør af artikel 107, stk. 1 og 2, i direktiv 2001/83/EF.
The CMDh, having considered the PRAC recommendation dated 16 May 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the revocation of the marketing authorisations of almitrine containing products for oral use.
PRAC fandt, at oral anvendelse at almitrin er forbundet med alvorlige reaktioner i form af perifer neuropati og vægttab, undertiden med sequelae.
The PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
PRAC tog markedsføringstilladelsesindehaverens erklæring til efterretning.
The PRAC took in account the MAH's position.
På ovenstående grundlag fandt PRAC, at oral anvendelse at almitrin er forbundet med alvorlige reaktioner i form af perifer neuropati og vægttab, undertiden med sequelae.
Based on the above the PRAC considered that the use of oral almitrine is associated with serious adverse peripheral neuropathy and weight loss reactions sometimes with sequelae.
Indehaveren af markedsføringstilladelsen fremlagde ingen publicerede data vedrørende selve mekanismen af almitrin i disse bivirkninger.
No published data focusing on the proper mechanism of almitrine in the occurrence of those adverse events was provided by the MAH.
Trods flere års anvendelse af risikominimeringsforanstaltninger indberettes der i forbindelse med almitrin fortsat om betydelige vægttab og perifere neuropatier, som potentielt ikke restitueres eller medfører sequelae.
Important weight losses and peripheral neuropathies which can potentially not recover or lead to sequelae, are still reported with almitrine despite risk minimisation measures in place for several years.
Det fås som tabletter (200 mg, 400 mg).
It is available as tablets (200 mg; 400 mg).
Den blev ændret til en fuldstændig markedsføringstilladelse den 1. juli 2013.
This was switched to a full marketing authorisation on 1 July 2013.
Votrient skal tages med vand, men ikke med mad, mindst én time før eller to timer efter indtagelse af et måltid.
Votrient should be taken with water but without food, at least one hour before or two hours after a meal.
Europa-Kommissionen udstedte en betinget markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Votrient den 14. juni 2010.
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient on 14 June 2010.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Votrient.
This document is a summary of the European Public Assessment Report (EPAR) for Votrient.
Den fuldstændige EPAR for Votrient findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Votrient can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Votrient:
Other information about Votrient:
"Fremskredent" betyder, at kræften er begyndt at sprede sig
‘Advanced' means that the cancer has started to spread;
I alle undersøgelserne blev virkningen hovedsagelig målt på den progressionsfrie overlevelse (hvor lang tid patienterne levede, uden at deres sygdom forværredes).
In all of the studies, the main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Til patienter med moderate leverproblemer bør dosis reduceres til 200 mg én gang dagligt.
In patients with moderate liver problems the dose should be reduced to 200 mg once a day.
Ved at blokere disse enzymer kan Votrient mindske kræftcellernes vækst og spredning.
By blocking these enzymes, Votrient can reduce the growth and spread of the cancer.
Den anbefalede dosis er 800 mg én gang dagligt, men denne dosis skal muligvis reduceres, hvis patienten oplever bivirkninger.
The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects.
Votrients sikkerhedsprofil vurderes acceptabel og generelt overskuelig.
The safety profile of Votrient is considered acceptable and generally manageable.
Votrient anbefales ikke til patienter med svære leverproblemer.
Votrient is not recommended in patients with severe liver problems.
EPAR - Sammendrag for offentligheden pazopanib
EPAR summary for the public pazopanib
Votrient anvendes til behandling af voksne med følgende kræftformer:
Votrient is used to treat adults with the following types of cancer:
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Votrient.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Votrient.
Hvis du ønsker yderligere oplysninger om behandling med Votrient, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Votrient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De hyppigste bivirkninger ved Votrient (som optræder hos flere end 1 ud af 10 patienter) omfatter nedsat appetit, dysgeusi (smagsforstyrrelser), hypertension (forhøjet blodtryk), diarré, kvalme, opkastning, smerter, hårfarveændringer, udmattelse (træthed), hypopigmentering af huden (affarvning af huden), skællende udslæt, hovedpine, stomatitis (betændelse i mundslimhinden), vægttab samt øget indhold af visse enzymer i blodet.
The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes.
Disse enzymer findes i visse receptorer på overfladen af celler, der er med til at danne og sprede kræftceller, såsom "VEGFR", "PDGFR" og "KIT".
These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR', ‘PDGFR' and ‘KIT'.
Behandlingen med Votrient bør kun indledes af en læge med erfaring i anvendelse af lægemidler mod kræft.
Treatment with Votrient should only be started by a doctor who has experience in giving anticancer medicines.
Udvalget besluttede derfor, at fordelene ved Votrient opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Votrient's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det anvendes til patienter, der tidligere er blevet behandlet med kemoterapi (lægemidler til behandling af kræft), fordi deres kræft havde spredt sig, eller til patienter, hvis kræft har udviklet sig inden for 12 måneder efter at have fået adjuvant eller neoadjuvant terapi (behandling modtaget efter eller før den egentlige behandling).
It is used in patients who have been previously treated with chemotherapy (medicines to treat cancer) because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Votrient må ikke anvendes til personer, som er overfølsomme (allergiske) over for pazopanib eller andre af indholdsstofferne.
Votrient must not be used in people who are hypersensitive (allergic) to pazopanib or any of the other ingredients.
Hvilken risiko er der forbundet med Votrient?
What is the risk associated with Votrient?
• visse former for blødtvævssarcom, en kræftform, der udvikles fra kroppens bløde støttevæv.
• certain forms of soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
Det anvendes til patienter, der ikke tidligere har modtaget behandling, eller til patienter, der allerede er blevet behandlet for deres fremskredne sygdom med kræftmidler kaldet "cytokiner".
It is used in patients who have not received any previous treatment or in patients who have already been treated for their advanced disease with anticancer medicines called ‘cytokines'.
Det aktive stof i Votrient, pazopanib, er en proteinkinasehæmmer.
The active substance in Votrient, pazopanib, is a protein kinase inhibitor.
Patienterne, som fik Votrient, levede i gennemsnit 20 uger, uden at deres sygdom blev forværret, sammenlignet med syv uger for de patienter, der fik placebo.
On average, the patients who took Votrient lived for 20 weeks without their disease getting worse, compared with seven weeks for the patients who took placebo.
Votrient er et lægemiddel, der indeholder det aktive stof pazopanib.
Votrient is a medicine that contains the active substance pazopanib.
Patienterne, som fik Votrient, levede i gennemsnit 9,2 måneder, inden sygdommen forværredes, sammenlignet med 4,2 måneder for de patienter, der fik placebo.
On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
Den fuldstændige liste over indberettede bivirkninger ved Votrient fremgår af indlægssedlen.
For the full list of all side effects reported with Votrient, see the package leaflet.
CHMP vurderede det som påvist, at Votrient er et effektivt lægemiddel til patienter med fremskredent renalcellecarcinom og blødtvævssarcom med en klinisk relevant forbedring i progressionsfri overlevelsestid.
The CHMP considered that Votrient has been shown to be an effective medicine for patients with advanced renal cell carcinoma and soft-tissue sarcoma, with a clinically relevant improvement in progression-free survival.
Votrient blev oprindeligt godkendt under "særlige omstændigheder", eftersom der afventedes yderligere dokumentation om lægemidlet, navnlig vedrørende behandlingen af renalcellecarcinom.
Votrient was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
• fremskredent renalcellecarcinom, en form for nyrekræft.
• advanced renal cell carcinoma, a type of kidney cancer.
Hvorfor blev Votrient godkendt?
Why has Votrient been approved?
Votrient er desuden blevet sammenlignet med placebo i en hovedundersøgelse af 369 patienter med blødtvævssarcom, hvis sygdom havde udviklet sig under eller efter tidligere kemoterapi.
Votrient has also been compared with placebo in a main study involving 369 patients with soft-tissue sarcoma whose disease had progressed during or following previous chemotherapy.
Votrient er blevet sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse af 435 patienter med fremskredent renalcellecarcinom, hvoraf nogle tidligere var blevet behandlet med cytokiner.
Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines.
Votrient var mere effektivt end placebo til behandling af fremskredent renalcellecarcinom.
Votrient was more effective than placebo at treating advanced renal cell carcinoma.
Votrient var også mere effektivt end placebo til behandling af blødtvævssarcom.
Votrient was also more effective than placebo at treating soft-tissue sarcoma.
Hvad er Votrient?
What is Votrient?
Hvilken fordel viser undersøgelserne, at der er ved Votrient?
What benefit has Votrient shown during the studies?
Hvad anvendes Votrient til?
What is Votrient used for?
Hvordan blev Votrient undersøgt?
How has Votrient been studied?
Hvordan anvendes Votrient?
How is Votrient used?
Hvordan virker Votrient?
How does Votrient work?
Den fuldstændige EPAR for Levetiracetam Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Levetiracetam Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Epilepsi skyldes overdreven elektrisk aktivitet i hjernen.
Epilepsy is caused by excessive electrical activity in the brain.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Accord den 3. oktober 2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Accord on3 October 2011.
Det fås som tabletter (250 mg, 500 mg, 750 mg og 1 000 mg).
It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Accord.
This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
Det en form for epilepsi, hvor for stærk elektrisk aktivitet i en side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Hos børn, der vejer under 50 kg, afhænger dosis af legemsvægten.
For patients weighing less than 50 kg, the dose depends on body weight.
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Levetiracetam Accord skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Accord.
Det er med til at bevirke, at Levetiracetam Accord kan stabilisere den elektriske aktivitet i hjernen og forhindre anfald.
This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.