FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreasing the production of oestrogen is a way of suppressing the growth of the breast cancer because the growth of breast tissue is stimulated by oestrogen.
Danish: At sænke østrogenproduktionen er en måde at hæmme brystkræftens vækst på, eftersom brystvævets vækst stimuleres af østrogen.
English: The European Medicines Agency has completed a review of Arimidex.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Arimidex.
English: For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is five years.
Danish: Til postmenopausale kvinder med tidlig invasiv hormonreceptorpositiv brystkræft er den anbefalede varighed af adjuverende endokrinbehandling fem år.
English: • Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Danish: • Behandling af fremskreden hormonreceptorpositiv brystkræft hos postmenopausale kvinder.
English: It is used to treat breast cancer in women who have already gone through the menopause.
Danish: Det anvendes til at behandle brystkræft hos kvinder, som allerede har været igennem overgangsalderen (menopausen).
English: Questions and answers on Arimidex (anastrozole, 1 mg tablets) EMA/405019/2011
Danish: Spørgsmål og svar vedrørende Arimidex (anastrozol, 1 mg tabletter) EMA/211634/2011
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Arimidex in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Arimidex i Den Europæiske Union (EU).
English: • Adjuvant (add-on) treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women, including those who have received two to three years of adjuvant tamoxifen (another anti-cancer medicine).
Danish: • Adjuverende behandling (tillægsbehandling) af tidlig invasiv hormonreceptorpositiv brystkræft hos postmenopausale kvinder, herunder dem, der har fået tillægsbehandling med tamoxifen (et andet lægemiddel mod kræft).
English: Arimidex was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Arimidex skulle harmoniseres.
English: 13 July 2011
Danish: 13. juli 2011
English: The European Commission issued a decision on 13 July 2011.
Danish: Europa-Kommissionen traf en afgørelse den 13. juli 2011.
English: 2 Bisphosphonates can be authorised nationally or centrally.
Danish: 2 Bisfosfonater kan godkendes på nationalt eller centralt plan.
English: If an atypical fracture is suspected in one leg then the other leg should also be examined.
Danish: Hvis der er mistanke om en atypisk fraktur i et ben, skal det andet ben også undersøges.
English: The working party concluded that there was a need to conduct a further review to determine if any regulatory action was necessary.
Danish: Arbejdsgruppen konkluderede, at der var behov for at gennemføre en yderligere vurdering for at fastslå, hvorvidt der var behov for reguleringsforanstaltninger.
English: The Committee has also looked at epidemiological studies (studies of the causes and distribution of diseases in the population).
Danish: Udvalget har også set på epidemiologiske undersøgelser (undersøgelser af årsagerne til og fordelingen af sygdomme i befolkningen).
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised medicines.
Danish: Samtidig anmodede Europa-Kommissionen CHMP om at foretage samme vurdering af de centralt godkendte lægemidler.
English: Questions and answers on the review of bisphosphonates and atypical stress fractures
Danish: Spørgsmål og svar vedrørende vurdering af bisfosfonater og atypiske stressfrakturer
English: Outcome of nine procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended1
Danish: Resultat af ni indbringelsesprocedurer i henhold til artikel 20 i forordning (EF) nr. 726/2004 og af en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF med senere ændringer1
English: What are the recommendations for prescribers and patients?
Danish: Hvilke anbefalinger blev der fremsat til ordinerende læger og patienter?
English: Procedure numbers: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 and EMEA/H/A-31/001279
Danish: Procedurenumre: EMEA/H/C/000595/A-20/0026, EMEA/H/C/000336/A-20/0036, EMEA/H/C/000101/A-20/0051, EMEA/H/C/000502/A-20/0025, EMEA/H/C/000501/A-20/0024, EMEA/H/C/000759/A-20/0012, EMEA/H/C/000619/A-20/0015, EMEA/H/C/001180/A-20/0005, EMEA/H/C/001195/A-20/0001 og EMEA/H/A-31/001279
English: The full changes made to the information to doctors and patients are available on the Agency's website.
Danish: De fuldstændige ændringer af informationen til læger og patienter kan findes på EMA's websted.
English: They should report to their doctor any pain, weakness or discomfort in the thigh or groin area, as this may be an indication of a possible fracture.
Danish: De skal fortælle deres læge om alle smerter, svækkelse eller ubehag i lår- eller lyskeområdet, da det kan være en indikation af en mulig fraktur.
English: What are bisphosphonates?
Danish: Hvad er bisfosfonater?
English: They have been authorised in the EU since the early 1990s for hypercalcaemia (high levels of calcium in the blood) and the prevention of bone problems in patients with cancer.
Danish: De har siden starten af 1990'erne været godkendt i EU til hyperkalcæmi (høje niveauer af kalcium i blodet) og forebyggelse af knogleproblemer hos kræftpatienter.
English: Bisphosphonates are medicines that are used to treat and prevent bone disorders.
Danish: Bisfosfonater er lægemidler, som anvendes til at behandle og forebygge knoglelidelser.
English: The PhVWP also concluded at the time that it was not possible to rule out the possibility that the effect could be a class effect (an effect common to all bisphosphonates), and decided to keep the issue under close review.
Danish: PhVWP konkluderede på det tidspunkt også, at det ikke var muligt at udelukke, at virkningen kunne være en klassevirkning (en virkning, som er fælles for alle bisfosfonater), og besluttede at holde spørgsmålet under nøje observation.
English: Why were bisphosphonates reviewed?
Danish: Hvorfor blev bisfosfonater vurderet igen?
English: The Committee noted that the number of reports of atypical fractures of the femur in users of bisphosphonates had increased since the 2008 review.
Danish: Udvalget bemærkede, at antallet af indberetninger af atypiske frakturer i femur hos brugere af bisfosfonater var steget siden vurderingen i 2008.
English: They work by stopping the action of the osteoclasts, the cells that are involved in breaking the bone down.
Danish: De virker ved at standse aktiviteten af osteoklasterne, som er de celler, der er med til at nedbryde knoglerne.
English: Consequently, on 20 September 2010, the UK Medicines Regulatory Agency asked the CHMP to issue an opinion on bisphosphonate-containing medicines and atypical stress fractures and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Danish: Derfor anmodede den britiske lægemiddelkontrolmyndighed den 20. september 2010 CHMP om at afgive en udtalelse om bisfosfonatholdige lægemidler og atypiske stressfrakturer og om, hvorvidt markedsføringstilladelserne for disse lægemidler burde opretholdes, ændres, suspenderes eller trækkes tilbage i hele EU.
English: They are available in the EU as tablets and as solutions for infusion (drip into a vein) under various trade names and as generic medicines2.
Danish: De fås i EU som tabletter og som infusionsvæske, opløsning, (drop i en vene) under forskellige handelsnavne og som generiske lægemidler2.
English: In April 2010, the PhVWP noted that further data from both the published literature and postmarketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect.
Danish: I april 2010 bemærkede PhVWP, at der nu forelå yderligere data fra både publiceret litteratur og rapporter efter markedsføring, som tydede på, at atypiske stressfrakturer i femur kan være en klassevirkning.
English: The Committee agreed that this could be related to the mode of action of bisphosphonates, which could lead to a delay in the repair of naturally occurring stress fractures although the exact mechanism is not known.
Danish: Udvalget medgav, at dette kunne skyldes bisfosfonaternes virkningsmekanisme, som kan føre til en forsinkelse i reparationen af naturligt forekommende stressfrakturer, selvom den præcise mekanisme ikke er kendt.
English: The current European public assessment reports for the nine centrally authorised medicines containing bisphosphonates concerned by these referrals (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic acid Teva, Vantavo and Zometa) can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: De aktuelle europæiske offentlige vurderingsrapporter for de ni centralt godkendte lægemidler med bisfosfonater, som er berørt af disse indbringelsesprocedurer (Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronsyre Teva, Vantavo og Zometa) kan findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The CHMP has reviewed all case reports of stress fractures in patients treated with bisphosphonates, relevant data from the published literature and data provided by the companies that make bisphosphonates.
Danish: CHMP har vurderet alle caserapporter om stressfrakturer hos patienter behandlet med bisfosfonater, relevante data fra den publicerede litteratur og data fra de virksomheder, som fremstiller bisfosfonater.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that atypical femoral fractures are likely to be a class effect of bisphosphonates but that such fractures occur only rarely and the benefits of bisphosphonatecontaining medicines continue to outweigh their risks.
Danish: På basis af en vurdering af de aktuelt tilgængelige data og de videnskabelige drøftelser i udvalget konkluderede CHMP, at atypiske frakturer i lårbenet sandsynligvis er en klassevirkning ved bisfosfonater, men at sådanne frakturer er sjældne, og at fordelene ved bisfosfonatholdige lægemidler fortsat opvejer risiciene.
English: As a result, a warning was added to the product information of alendronic acidcontaining medicines across Europe.
Danish: Derfor blev der tilføjet en advarsel i produktinformationen til alendronsyreholdige lægemidler over hele Europa.
English: • Doctors who are prescribing these medicines for the prevention or treatment of osteoporosis should regularly review the need for continued treatment, especially after five or more years of use.
Danish: • Læger, som ordinerer disse lægemidler til forebyggelse eller behandling af osteoporose, skal jævnligt vurdere, hvorvidt der er behov for at fortsætte behandlingen, især efter fem eller flere års behandling.
English: However, the product information should be amended to add a warning concerning this risk, and, for bisphosphonates used in osteoporosis, to advise doctors to periodically review treatment, in particular after five or more years of treatment.
Danish: Produktinformationen skal imidlertid ændres, så den indeholder en advarsel om denne risiko, og i forbindelse med bisfosfonater, som anvendes til osteoporose, skal lægerne anbefales at evaluere behandlingen jævnligt, især efter fem eller flere års behandling.
English: They have also been available since the mid 1990s for the treatment of osteoporosis (a disease that makes bones fragile) and Paget's disease (a disease involving bone growth that causes bone deformity).
Danish: De har også siden midten af 1990'erne været anvendt til behandling af osteoporose (knogleskørhed) og Pagets sygdom (en sygdom, der forårsager knoglevækst, der giver deforme knogler).
English: In 2008, the CHMP's Pharmacovigilance Working Party (PhVWP) noted that alendronic acid was associated with an increased risk of atypical fracture of the femur (thigh bone) that developed with low or no trauma.
Danish: I 2008 bemærkede CHMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP), at alendronsyre var forbundet med en øget risiko for atypiske frakturer i femur (lårbenet), som udviklede sig med lille eller slet intet traume.
English: Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid.
Danish: Bisfosfonater indeholder alendronsyre, clodronsyre, etidronsyre, ibandronsyre, neridronsyre, pamidronsyre, risedronsyre, tiludronsyre og zoledronsyre.
English: • Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of atypical fracture of the thigh bone.
Danish: • Patienter, som tager bisfosfonatholdige lægemidler, skal være bekendt med risikoen for atypiske frakturer i lårbenet.
English: • Doctors who prescribe bisphosphonate-containing medicines should be aware that atypical fractures may occur rarely in the femur (thigh bone), especially after long term use.
Danish: • Læger, som ordinerer bisfosfonatholdige lægemidler, skal være bekendt med, at der i sjældne tilfælde kan forekomme atypiske frakturer i femur (lårbenet), især efter langvarig brug.
English: The CHMP also noted that these fractures had a distinct pattern on X-rays and may be related to bisphosphonate use, especially during long-term use in osteoporosis.
Danish: Udvalget bemærkede endvidere, at disse frakturer havde et tydeligt mønster på røntgenbilleder og kan have en årsagsmæssig sammenhæng med anvendelse af bisfosfonater, især langvarig anvendelse i forbindelse med osteoporose.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bisphosphonates continue to outweigh their risks but that warnings of the risk of atypical femoral fractures should be added to the prescribing information for all bisphosphonate-containing medicines in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved bisfosfonater fortsat opvejer risiciene, men at der skal tilføjes advarsler om risikoen for atypiske stressfrakturer i lårbenet i ordinationsoplysningerne til alle bisfosfonatholdige lægemidler i EU.
English: The centrally authorised bisphosphonate-containing medicines concerned by these referrals are Aclasta and Zometa (zoledronic acid), Bondenza, Bonviva, Bondronat and Ibandronic acid Teva (ibandronic acid), and Adrovance and Fosavance (alendronic acid and vitamin D3).
Danish: De centralt godkendte bisfosfonatholdige lægemidler, som er berørt af disse indbringelsesprocedurer, er Aclasta og Zometa (zoledronsyre), Bondenza, Bonviva, Bondronat og Ibandronsyre Teva (ibandronsyre), og Adrovance og Fosavance (alendronsyre og D3-vitamin).
English: The European Medicines Agency has completed a review of bisphosphonate-containing medicines at the request of the United Kingdom and the European Commission, following reports of an increased risk of atypical stress fractures of the femur associated with these medicines.
Danish: Det Europæiske Lægemiddelagentur har på anmodning fra Det Forenede Kongerige og EuropaKommissionen gennemført en vurdering af bisfosfonatholdige lægemidler efter rapporter om øget risiko for atypiske stressfrakturer i femur (lårbenet) i forbindelse med disse lægemidler.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Danish: Det gives hver tredje uge som en infusion, der varer 10 minutter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Alimta on 20 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Alimta den 20. september 2004.
English: It contains the active substance pemetrexed.
Danish: Det indeholder det aktive stof pemetrexed.
English: The full EPAR for Alimta can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Alimta findes på agenturets websted under website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Alimta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Alimta.
English: Alimta is used to treat two types of lung cancer:
Danish: Alimta anvendes til behandling af to typer af lungekræft:
English: The CHMP concluded that Alimta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Alimta er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The main measures of effectiveness were how long the patients survived and how long they lived without their cancer getting worse.
Danish: Det primære effektmål var, hvor længe patienterne overlevede, og hvor længe de levede, uden at kræften forværredes.
English: 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 Alimta.
Danish: 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 Alimta.
English: The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis for Alimta er 500 mg pr. kvadratmeter legemsoverflade (beregnet på basis af patientens højde og vægt).
English: Other information about Alimta
Danish: Andre oplysninger om Alimta:
English: In the second maintenance study, the figures were 4.1 months in the Alimta and 2.8 months in the placebo group.
Danish: I den anden undersøgelse af vedligeholdelsesbehandlingen var tallene 4,1 måneder i Alimta-gruppen og 2,8 måneder i placebogruppen.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Danish: Det kan også anvendes som vedligeholdelsesbehandling til patienter, der tidligere har fået platinbaseret kemoterapi.
English: For more information about treatment with Alimta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Alimta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Alimta increased the survival time of patients with malignant pleural mesothelioma.
Danish: Alimta øgede overlevelsestiden hos patienter med malignt pleura mesotheliom.
English: What is the risk associated with Alimta?
Danish: Hvilken risiko er der forbundet med Alimta?
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Danish: Dette nedbringer delingen af kræftceller, hvorimod det kun har ringe virkning på normale celler.
English: For the full list of all side effects reported with Alimta, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Alimta fremgår af indlægssedlen.
English: Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
Danish: De patienter, der fik Alimta og cisplatin, overlevede i gennemsnit i 12,1 måneder, sammenholdt med 9,3 måneder for dem, der kun fik cisplatin.
English: It must not be used during breast-feeding or at the same time as the vaccine for yellow fever.
Danish: Det bør ikke anvendes hos patienter, der ammer, og bør ikke gives samtidig med vaccination mod gul feber.
English: Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Alimta bør kun gives under tilsyn af en læge med speciale i kemoterapi.
English: Alimta must not be used in people who are hypersensitive (allergic) to pemetrexed or any of the other ingredients.
Danish: Alimta må ikke anvendes til patienter, som er overfølsomme (allergiske) over for pemetrexed eller andre af indholdsstofferne.
English: Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Alimta er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Danish: I kroppen omdannes pemetrexed til en aktiv form, som blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i dna og rna, cellernes genetiske materiale).
English: In one maintenance treatment study, patients receiving Alimta lived for a further 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months in those receiving placebo.
Danish: I den ene undersøgelse af vedligeholdelsesbehandlingen levede patienter, der fik Alimta, yderligere 4,3 måneder fra begyndelsen af vedligeholdelsesbehandlingen uden at der skete en forværring af kræften sammenlignet med 2,6 måneder hos dem, der fik placebo.
English: Why has Alimta been approved?
Danish: Hvorfor blev Alimta godkendt?
English: The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Danish: Det aktive stof i Alimta, pemetrexed, er et vævsgiftigt stof (dvs. det dræber celler, der deler sig, f.eks. kræftceller) og tilhører gruppen af antimetabolitter (stofskiftehæmmere).
English: Improved survival times with Alimta were only seen in patients with non small cell lung cancer of the non-squamous type.
Danish: Forbedret overlevelsestid med Alimta sås kun hos patienter med ikke-småcellet lungekræft, der ikke var af pladecelletypen.
English: The gastrointestinal toxicities seen with Alimta are loss of appetite, nausea (feeling sick), vomiting, diarrhoea, constipation, pharyngitis (sore throat), and mucositis or stomatitis (inflammation of the lining of the digestive system and mouth).
Danish: Den gastrointestinale toksicitet, der kan opstå ved brug af Alimta, er appetitløshed, kvalme, opkastning, diarré, forstoppelse, pharyngitis (ondt i halsen) og mucositis eller stomatitis (slimhindebetændelse i fordøjelsessystemet og munden).
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Danish: Dannelsen af dna og rna bremses derved af den aktive form af pemetrexed, så cellerne forhindres i at dele og formere sig.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos),where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Danish: • malignt pleura mesotheliom (lungehindekræft, der sædvanligvis skyldes udsættelse for asbest), hvor det anvendes sammen med cisplatin til patienter, der ikke tidligere har fået kemoterapibehandling, og hvis kræft ikke kan fjernes ved operation