FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Danish: Lægemidlet tages som én tablet dagligt i stedet for de separate clopidogrel- og acetylsalicylsyretabletter, som patienten tidligere har taget.
English: Further information on Clopidogrel/Acetylsalicylic acid Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
Danish: Yderligere information om Clopidogrel/Acetylsalicylic acid Mylan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Clopidogrel/Acetylsalicylic acid Mylan er af sammenlignelig kvalitet og er bioækvivalent med DuoPlavin.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.
Danish: Der er allerede foretaget studier af de aktive stoffers fordele og risici ved godkendt brug med referencelægemidlet, DuoPlavin, og de behøver ikke blive gentaget for Clopidogrel/Acetylsalicylic acid Mylan.
English: Because Clopidogrel/Acetylsalicylic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Clopidogrel/Acetylsalicylic acid Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Clopidogrel/Acetylsalicylic acid Mylan vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets.
Danish: Clopidogrel blokerer stoffet ADP, så det ikke kan binde sig til en receptor (et mål) på overfladen af blodpladerne.
English: This means that Clopidogrel/Acetylsalicylic acid Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DuoPlavin.
Danish: Det betyder, at Clopidogrel/Acetylsalicylic acid Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i EU, og som hedder DuoPlavin.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
Danish: Dette reducerer dannelsen af et stof, der kaldes tromboxan, som normalt medvirker til blodets koagulering ved at få blodpladerne til at klæbe sammen.
English: Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Danish: Clopidogrel/Acetylsalicylic acid Mylan anvendes til forebyggelse af problemer, der skyldes blodpropper og åreforkalkning, f.eks. hjerteanfald hos voksne, der allerede tager både clopidogrel og acetylsalicylsyre som separate tabletter.
English: For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Clopidogrel/Acetylsalicylic acid Mylan, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine'.
Danish: Clopidogrel/Acetylsalicylic acid Mylan indeholder to aktive stoffer, clopidogrel og acetylsalicylsyre (også kendt som aspirin), og er et "generisk lægemiddel".
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Danish: Dette forhindrer blodpladerne i at blive klæbrige og nedsætter dermed risikoen for blodpropper.
English: As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Clopidogrel/Acetylsalicylic acid Mylan.
English: Therefore, the Agency's view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Clopidogrel/Acetylsalicylic acid Mylan opvejer de identificerede risici som for DuoPlavin, og at det kan godkendes til anvendelse i EU.
English: As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Clopidogrel/Acetylsalicylic acid Mylan løbende overvåget.
English: An overview of Clopidogrel/Acetylsalicylic acid Mylan and why it is authorised in the EU
Danish: Oversigt over Clopidogrel/Acetylsalicylic acid Mylan, og hvorfor det er godkendt i EU
English: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid)
Danish: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel/acetylsalicylsyre)
English: What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Clopidogrel/Acetylsalicylic acid Mylan?
English: Other information about Clopidogrel/Acetylsalicylic acid Mylan
Danish: Andre oplysninger om Clopidogrel/Acetylsalicylic acid Mylan
English: What are the benefits and risks of Clopidogrel/Acetylsalicylic acid Mylan?
Danish: Hvilke fordele og risici er der forbundet med Clopidogrel/Acetylsalicylic acid Mylan?
English: What is Clopidogrel/Acetylsalicylic acid Mylan and what is it used for?
Danish: Hvad er Clopidogrel/Acetylsalicylic acid Mylan, og hvad anvendes det til?
English: Why is Clopidogrel/Acetylsalicylic acid Mylan authorised in the EU?
Danish: Hvorfor er Clopidogrel/Acetylsalicylic acid Mylan godkendt i EU?
English: Both active substances in the medicine, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Danish: Begge de aktive stoffer i Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel og acetylsalicylsyre) er blodpladehæmmende lægemidler.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Clopidogrel/Acetylsalicylic acid Mylan.
English: How has Clopidogrel/Acetylsalicylic acid Mylan been studied?
Danish: Hvordan blev Clopidogrel/Acetylsalicylic acid Mylan undersøgt?
English: Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase.
Danish: Acetylsalicylsyre blokerer enzymet prostaglandincyklooxygenase.
English: How is Clopidogrel/Acetylsalicylic acid Mylan used?
Danish: Hvordan anvendes Clopidogrel/Acetylsalicylic acid Mylan?
English: How does Clopidogrel/Acetylsalicylic acid Mylan work?
Danish: Hvordan virker Clopidogrel/Acetylsalicylic acid Mylan?
English: Multi-dose vial (glass)
Danish: Multidosishætteglas (glas)
English: Packaging Content (concentration)
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: Single-dose prefilled syringe (glass) without needle
Danish: Fyldt injektionssprøjte med en enkelt dosis (glas) uden nåle injektionssprøjte
English: The main measure of effectiveness was how long the patients lived.
Danish: Det primære effektmål var, hvor længe patienterne overlevede.
English: Paclitaxel is an anticancer medicine which has been available in the European Union since 1993.
Danish: Paclitaxel er et kræftlægemiddel, der har kunnet fås i Den Europæiske Union siden 1993.
English: What is Opaxio?
Danish: Hvad er Opaxio?
English: The effects of Opaxio were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Opaxio blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Questions and answers on the withdrawal of the marketing authorisation application for Opaxio paclitaxel poliglumex
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Opaxio paclitaxel poliglumex
English: The CHMP also had concerns about the side effects of the medicine, especially neuropathy (damage to the nerves) and unexplained deaths.
Danish: CHMP havde også betænkeligheder med hensyn til lægemidlets bivirkninger, navnlig neuropati (nerveskader) og uforklarlige dødsfald.
English: There were also concerns about impurities in the medicine and about the way paclitaxel is released and distributed in the body when Opaxio is given.
Danish: Der var ligeledes betænkeligheder med hensyn til urenheder i lægemidlet og den måde, som paclitaxel frigives og fordeles i kroppen på, når Opaxio indgives.
English: Paclitaxel works by blocking the ability of cancer cells to break down the internal ‘skeleton' that allows them to divide and multiply.
Danish: Paclitaxel virker ved at hæmme kræftcellernes evne til at nedbryde det interne "skelet", som gør det muligt for dem at dele og formere sig.
English: In this study, Opaxio was compared with gemcitabine or vinorelbine (two other anticancer medicines).
Danish: I denne undersøgelse blev Opaxio sammenlignet med gemcitabin eller vinorelbin (to andre kræftlægemidler).
English: In addition, the studies did not show that Opaxio was more effective than the two comparators.
Danish: Desuden viste undersøgelserne ikke, at Opaxio var mere effektivt end de to sammenligningslægemidler.
English: The company informed the CHMP that the withdrawal has no impact on patients in the European Union (EU) as there are no ongoing clinical trials or compassionate use programmes in the EU.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter i Den Europæiske Union (EU), eftersom der ikke er nogen igangværende kliniske undersøgelser eller programmer med særlig udleveringstilladelse i EU.
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here
Danish: Brevet fra virksomheden, hvori CHMP underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: However, outside the EU, the company is continuing to study Opaxio in several cancers including ovarian, oesophageal and non-small cell lung cancer.
Danish: Uden for EU fortsætter virksomheden dog med at undersøge brugen af Opaxio ved adskillige kræfttyper, herunder æggestokkræft, øsofaguskræft og ikke-småcellet lungekræft.
English: What was Opaxio expected to be used for?
Danish: Hvad forventedes Opaxio anvendt til?
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Opaxio?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Opaxio eller i programmer for anvendelse af Opaxio med særlig udleveringstilladelse?
English: How is Opaxio expected to work?
Danish: Hvordan forventes Opaxio at virke?
English: It contains the active substance paclitaxel poliglumex.
Danish: Det indeholder det aktive stof paclitaxel poliglumex.
English: The active substance in Opaxio, paclitaxel poliglumex, is expected to be converted into paclitaxel in the cancer cells.
Danish: Det forventes, at det aktive stof i Opaxio, paclitaxel poliglumex, omdannes til paclitaxel i kræftcellerne.
English: In Opaxio, paclitaxel is attached to poliglumex to make it more soluble.
Danish: I Opaxio er paclitaxel forbundet med poliglumex for at gøre det mere opløseligt.
English: The company's view that the study showed that Opaxio was as least as good as the comparators was not accepted by the Committee because it was not clear that the comparators themselves were effective in the type of patients involved in the main study.
Danish: Udvalget delte ikke virksomhedens opfattelse af, at undersøgelsen viste, at Opaxio var mindst lige så effektivt som sammenligningslægemidlerne, eftersom det ikke fremgik klart, at sammenligningslægemidlerne selv var effektive hos den type patienter, der deltog i hovedundersøgelsen.
English: Opaxio is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Opaxio er et pulver, der anvendes til at fremstille en infusionsvæske, opløsning (drop i en vene).
English: A performance status of 2 means that the patient can take care of him or herself without help but is too ill to do any work.
Danish: ECOG-performancestatus er en skala, der viser, hvor syg en kræftpatient er. En performancestatus på 2 betyder, at patienten kan klare sig selv uden hjælp, men er for syg til at udføre nogen form for arbejde.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Opaxio could not have been approved for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Opaxio ikke kunne have været godkendt som førstevalgsbehandling til patienter med fremskreden ikke-småcellet lungekræft, som har en ECOGperformancestatus på 2.
English: On 21 September 2009, CTI Life Sciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opaxio, for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Danish: Den 21. september 2009 meddelte CTI Life Sciences Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Opaxio som førstevalgsbehandling til patienter med fremskreden ikke-småcellet lungekræft, som har en ECOG-performancestatus på 2.
English: The company presented results of one main study involving 477 patients with advanced non-small cell lung cancer and a performance status of 2.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse, der omfattede 477 patienter med fremskreden ikke-småcellet lungekræft og en ECOG-performancestatus på 2.
English: Opaxio was expected to be used in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Danish: Opaxio forventedes anvendt til patienter med fremskreden ikke-småcellet lungekræft, som har en ECOG-performancestatus på 2.
English: The CHMP noted that the main study did not show that Opaxio was effective in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Danish: CHMP bemærkede, at hovedundersøgelsen ikke viste Opaxios virkning hos patienter med fremskreden ikke-småcellet lungekræft, som har en ECOG-performancestatus på 2.
English: In conclusion, the following harmonised indications were adopted for Femara:
Danish: Som konklusion blev følgende harmoniserede indikationer vedtaget for Femara:
English: Overall summary of the scientific evaluation of Femara and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Femara og relaterede navne (se bilag I)
English: The CHMP moved the statement from Section 4.4 to Section 5.1.
Danish: CHMP flyttede angivelsen fra punkt 4.4 til punkt 5.1.
English: A referral under Article 30(2) of Directive 2001/83/EC, as amended was therefore triggered to resolve these divergences and thus harmonise the product information (PI) across the EU.
Danish: Der blev derfor indledt en henvisning i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, som ændret, med henblik på afklaring af disse divergenser og harmonisering af produktoplysningerne i hele EU.
English: In addition, letrozole is not considered to have a narrow therapeutic index.
Danish: Desuden anses letrozol ikke for at have et smalt terapeutisk indeks.
English: Regarding “invasive”, it is not common practice to prescribe aromatase inhibitors to patients with no invasive component.
Danish: Vedrørende “invasiv” er det ikke sædvanlig praksis at ordinere aromatasehæmmere til patienter uden en invasiv komponent.
English: Regarding children, invasive breast cancer is extremely rare in children and adolescents but has been reported.
Danish: Vedrørende børn er invasiv mammacancer ekstremt sjældent hos børn og unge, men er blevet beskrevet.
English: Other sections
Danish: Øvrige punkter
English: The CHMP endorsed the 2.5 mg daily dose in adults, based on several dose-finding studies.
Danish: CHMP godkendte dagsdosen 2,5 mg til voksne på grundlag af flere dosisfastlæggelsesundersøgelser.
English: The CHMP therefore considered it justified to qualify the indication with “invasive”.
Danish: CHMP anså det derfor for berettiget at indskrænke indikationen med betegnelsen “invasiv”.
English: In particular, for Section 4.8 - Undesirable Effects, the wording was significantly shortened and condensed.
Danish: Dette gjaldt navnlig for punkt 4.8 - Bivirkninger, hvor ordlyden blev afkortet og beskåret væsentligt.
English: Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer.”
Danish: Der er ikke påvist virkning hos patienter med hormonreceptornegativ mammacancer.”
English: The CHMP therefore added a statement regarding bone effects associated with the use of Femara.
Danish: CHMP tilføjede derfor en erklæring om effekter på knoglerne i forbindelse med anvendelse af Femara.
English: The CHMP considered that reviews of clinical databases are poorly suited to assess the risk for interactions or to assess reports of lack of interaction and therefore removed references to these reviews.
Danish: CHMP fandt gennemgang af kliniske databaser uegnet som middel til at vurdere risikoen for interaktioner eller vurdere rapporter om manglende interaktion, og slettede derfor omtalen af sådanne gennemgange.
English: In addition, no studies on DCIS (ductal carcinoma in situ) or LCIS (lobular carcinoma in situ) patients have been performed.
Danish: Endvidere bemærkede udvalget, at der ikke er udført undersøgelser vedrørende DCIS (duktalt carcinoma in situ) eller LCIS (lobulært carcinoma in situ).
English: The neoadjuvant (pre-operative) treatment indication represented the major deviation across the nationally approved SmPCs, as it was approved in some member states in 2001 but the application was withdrawn in others, primarily because neoadjuvant endocrine treatment was not a validated concept at the time and because the results of the pivotal adjuvant study were not yet available.
Danish: Indikationen neoadjuverende (præoperativ) behandling repræsenterede den største afvigelse mellem de nationalt godkendte produktresuméer, idet den blev godkendt i nogle medlemsstater i 2001, mens ansøgningen i andre stater blev trukket tilbage, primært fordi neoadjuverende endokrin behandling på daværende tidspunkt ikke var valideret som begreb, og fordi hovedundersøgelsens resultater for adjuverende behandling endnu ikke forelå.
English: While a contraindication in these patients was not warranted, the CHMP inserted a precaution.
Danish: Der er ikke behov for en kontraindikation hos sådanne patienter, men CHMP indsatte en forsigtighedsregel.
English: The CHMP instead included a warning in Section 4.4 stating that safety data in patients with significant organ impairment are lacking.
Danish: CHMP indsatte i stedet en advarsel i punkt 4.4 om, at der savnes sikkerhedsdata for patienter med væsentligt nedsat organfunktion.
English: In addition, it is essential to avoid pregnancy during letrozole therapy because of the risk of embryotoxicity and foetotoxicity.
Danish: Desuden er det essentielt at undgå graviditet under behandlingen med letrozol på grund af risikoen for embryo- og føtotoksicitet.
English: Letrozole is thus predicted to have a potential for adverse effects on the embryo-foetus, as confirmed by studies in pregnant rats and rabbits.
Danish: Letrozol må således forventes at have potentiale for negative effekter på embryoet og føtus, hvilket bekræftes af undersøgelserne hos drægtige rotter og kaniner.
English: The CHMP also added a warning that oestrogens and/or tamoxifen may reduce letrozole plasma levels, thus reducing its pharmacological action, and that co-administration should therefore be avoided.
Danish: CHMP tilføjede desuden en advarsel om, at østrogener og/eller tamoxifen kan nedsætte plasmaniveauet af letrozol og derved forringe dets farmakologiske virkning, hvorfor koadministration bør undgås.
English: The CHMP reviewed the potential for interaction of a number of substances, including cimetidine and anti-cancer agents, as well as the role played by CYP2A6 and CYP3A4 in the metabolism of letrozole.
Danish: CHMP gennemgik potentialet for interaktion med en række stoffer, herunder cimetidin og andre midler mod kræft, samt betydningen af CYP2A6 og CYP3A4 i metaboliseringen af letrozol.
English: For Section 5.1Pharmacodynamic Properties, the wording was substantially shortened to focus on information relevant to the prescriber for the approved indications.
Danish: I punkt 5.1 - Farmakodynamiske egenskaber blev ordlyden forkortet væsentligt og fokuseret på information, der er relevant for den ordinerende læge med henblik på de godkendte indikationer.
English: Regarding the pre-operative use of letrozole if receptor status is negative or unknown, the CHMP considered a contraindication to be unnecessary, as this is already sufficiently explained in Section 4.4.
Danish: Vedrørende præoperativ anvendelse af letrozol ved negativ eller ukendt receptorstatus anså CHMP en kontraindikation for unødvendig, da der allerede er redegjort fyldestgørende herfor i punkt 4.4.
English: The CHMP noted the pivotal study for the adjuvant treatment indication, BIG 1-98, coordinated by the collaborative group IBCSG (International Breast Cancer Study Group) and the parent organization BIG (Breast International Group), which specifically excluded patients who did not have a confirmed diagnosis of invasive breast cancer.
Danish: CHMP fremhævede hovedundersøgelsen vedrørende indikationen adjuverende behandling, BIG 198, der var koordineret af samarbejdsgruppen IBCSG (International Breast Cancer Study Group) og moderorganisationen BIG (Breast International Group), og som specifikt udelukkede patienter, der ikke har fået bekræftet diagnosen invasiv mammacancer.
English: A statement on the absence of studies on the use of Femara in male breast cancer was also added.
Danish: Desuden blev der tilføjet en erklæring om de manglende undersøgelser af anvendelse af Femara ved brystkræft hos mænd.
English: Femara contains letrozole, an aromatase inhibitor which inhibits the conversion of androgens to oestrogens.
Danish: Femara indeholder letrozol, der er en aromatasehæmmer, som hæmmer omdannelsen af androgener til østrogener.
English: Regarding adjuvant and extended adjuvant treatment, studies show that efficacy was sustained over the median duration of 5 years of treatment.
Danish: Vedrørende adjuverende og forlænget adjuverende behandling viser undersøgelserne, at virkningen blev opretholdt i den mediane behandlingsvarighed på fem år.