FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Pemetrexed Lilly is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pemetrexed Lilly anvendes så sikkert som muligt.
English: The Committee recommended that Pemetrexed Lilly be approved for use in the EU.
Danish: Udvalget anbefalede, at Pemetrexed Lilly godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Lilly has been shown to be comparable to Alimta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pemetrexed Lilly er sammenligneligt med Alimta.
English: Pemetrexed Lilly is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed Lilly er et kræftlægemiddel til behandling af to typer af lungekræft:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed Lilly, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pemetrexed Lilly, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: This means that Pemetrexed Lilly is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Danish: Det betyder, at Pemetrexed Lilly svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
English: Other information about Pemetrexed Lilly
Danish: Andre oplysninger om Pemetrexed Lilly
English: What is Pemetrexed Lilly and what is it used for?
Danish: Hvad er Pemetrexed Lilly, og hvad anvendes det til?
English: No additional studies were needed as Pemetrexed Lilly is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Danish: Der var ikke brug for yderligere undersøgelser, da Pemetrexed Lilly er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Lilly?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed Lilly?
English: What are the benefits and risks of Pemetrexed Lilly?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed Lilly?
English: Because Pemetrexed Lilly is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed Lilly er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
English: Pemetrexed Lilly contains the active substance pemetrexed.
Danish: Pemetrexed Lilly indeholder det aktive stof pemetrexed.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Lilly.
Danish: For at mindske bivirkningerne bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12 under behandlingen med Pemetrexed Lilly.
English: The active substance in Pemetrexed Lilly, 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 Pemetrexed Lilly, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: For more information about treatment with Pemetrexed Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pemetrexed Lilly, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Pemetrexed Lilly.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed Lilly bør anvendes.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Danish: Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi Pemetrexed Lilly er et "generisk lægemiddel".
English: For practical information about using Pemetrexed Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed Lilly, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Pemetrexed Lilly approved?
Danish: Hvorfor blev Pemetrexed Lilly godkendt?
English: When Pemetrexed Lilly is given with cisplatin, an ‘antiemetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Pemetrexed Lilly gives sammen med cisplatin, bør der desuden før og efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
English: Pemetrexed Lilly is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed Lilly fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How is Pemetrexed Lilly used?
Danish: Hvordan anvendes Pemetrexed Lilly?
English: How has Pemetrexed Lilly been studied?
Danish: Hvordan blev Pemetrexed Lilly undersøgt?
English: How does Pemetrexed Lilly work?
Danish: Hvordan virker Pemetrexed Lilly?
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: • kræft i lungehinderne (malignt pleuramesoteliom), der sædvanligvis skyldes udsættelse for asbest.
English: 4 September 2014 EMA/544268/2014
Danish: Den 4. september 2014 EMA/544268/2014
English: Diacerein-containing medicines are taken by mouth and are currently authorised in the following EU Member States: Austria, Czech Republic, France, Greece, Italy, Portugal, Slovakia and Spain.
Danish: Lægemidler indeholdende diacerein til indtagelse gennem munden er på nuværende tidspunkt godkendt i følgende EU-medlemsstater: Østrig, Tjekkiet, Frankrig, Grækenland, Italien, Portugal, Slovakiet og Spanien.
English: • Due to the risks associated with severe diarrhoea:
Danish: • På grund af de risici, der er knyttet til svær diarré:
English: The review of diacerein-containing medicines was initiated on 29 November 2012 at the request of the French medicines agency under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende diacerein blev indledt den 29. november 2012 på anmodning af den franske lægemiddelstyrelse i henhold til artikel 31 i direktiv 2001/83/EF.
English: In the majority of cases diacerein-induced diarrhoea started in the first weeks of treatment.
Danish: I størstedelen af tilfældene satte diacereininduceret diarré ind i de første uger af behandlingen.
English: Restrictions to the use of diacerein-containing medicines
Danish: Begrænsninger for anvendelsen af lægemidler indeholdende diacerein
English: Patients are advised of the following:
Danish: Som patient har du brug for at vide følgende:
English: The review of diacerein was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen af diacerein blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
English: Contact your doctor if you have symptoms of liver problems.
Danish: Kontakt lægen, hvis du får symptomer på leverproblemer.
English: The PRAC's final recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which endorsed the recommendations and adopted a position by majority vote.
Danish: PRAC's endelige anbefalinger blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh), som vedtog anbefalingerne og vedtog sit standpunkt ved en flertalsafgørelse.
English: The recommendations are based on a review of available data on the efficacy and safety of diacerein.
Danish: Anbefalingerne bygger på en gennemgang af de foreliggende data om virkningen og sikkerheden af diacerein.
English: The proportion of patients who develop drug-induced liver injury following treatment with diacerein is estimated to be 0.03%.
Danish: Andelen af patienter, der får lægemiddelinduceret leverskade efter behandling med diacerein, anslås til 0,03 %.
English: It is also advised that patients start treatment on half the normal dose (i.e. 50 mg daily instead of 100 mg) and should stop taking diacerein if diarrhoea occurs.
Danish: Desuden tilrådes det, at patienterne begynder med det halve af den normale dosis (dvs. 50 mg dagligt i stedet for 100 mg) og holder op med at tage diacerein, hvis de får diarré.
English: to 4 weeks, after which the recommended dose is 50 mg twice a day.
Danish: de første 2-4 uger, hvorefter den anbefalede dosis er 50 mg to gange dagligt
English: In November 2013, the PRAC initially recommended the suspension of the marketing authorisations for diacerein-containing medicines.
Danish: I november 2013 anbefalede PRAC i første instans ophævelse (suspendering) af markedsføringstilladelserne for lægemidler indeholdende diacerein.
English: In clinical studies, around 0.5% of patients on diacerein had some kind of liver reaction, with most cases being mild, reversible increases in serum transaminases.
Danish: I de kliniske undersøgelser fik omkring 0,5 % af patienterne på diacerein en eller anden form for leverreaktion, hvoraf størstedelen var lette, reversible forhøjelser af serumtransaminaser.
English: Restrictions intended to limit risks of severe diarrhoea and effects on the liver
Danish: Begrænsninger, der skal nedsætte risikoen for svær diarré og påvirkning af leveren
English: With regard to safety, loose stools or diarrhoea were the most frequently reported adverse events in clinical studies with diacerein at a dose of 100 mg per day.
Danish: Vedrørende sikkerheden var tynd afføring og diarré de oftest indberettede bivirkninger i kliniske undersøgelser med diacerein i en dosering på 100 mg dagligt.
English: The first beneficial effects of diacerein in these studies were seen after 2 to 4 weeks of continuous use.
Danish: Gavnlig virkning af diacerein blev i disse undersøgelser konstateret efter 2-4-ugers kontinuerlig behandling.
English: The CMDh position was sent to the European Commission which endorsed it and issued an EU-wide legally binding decision on 4 September 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, der godkendte den, og som den 4. september 2014 vedtog en afgørelse, der er retligt bindende i hele EU.
English: On 19 March 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed recommendations to restrict the use of diacerein-containing medicines in order to manage the risks of severe diarrhoea and effects on the liver.
Danish: Den 19. marts 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh)1 anbefalinger om begrænsning af anvendelsen af lægemidler indeholdende diacerein for at imødegå risiciene for svær diarré og leverpåvirkning.
English: The CMDh endorsed the PRAC's final recommendations to address these concerns and ensure that diacerein's benefits continue to outweigh its known risks.
Danish: CMDh vedtog PRAC's endelige anbefalinger, der skal imødegå disse betænkeligheder og sikre, at fordelene ved diacerein fortsat opvejer de kendte risici.
English: These recommendations are based on the review of the benefits and risks of diacerein conducted by the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) and follow concerns raised by the French medicines agency (ANSM) about diacerein's gastro-intestinal and liver effects.
Danish: Disse anbefalinger bygger på den gennemgang af fordele og risici ved diacerein, som er foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), og er en opfølgning på de betænkeligheder, der er rejst af den franske lægemiddelstyrelse (ANSM), vedrørende diacereins virkninger på mave-tarmkanalen og leveren.
English: Due to the risks associated with severe diarrhoea, diacerein is no longer recommended in patients aged 65 years and above.
Danish: På grund af risiciene ved svær diarré frarådes anvendelse af diacerein nu hos patienter i alderen 65 år og derover.
English: The proportion of patients with diarrhoea in clinical trials ranged from 0% to 54.4%.
Danish: Andelen af patienter med diarré var mellem 0 % og 54,4 % i de kliniske undersøgelser.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: • If you are taking diacerein and you are 65 years or above, contact your doctor to discuss your treatment.
Danish: • Hvis du er 65 år eller derover og får diacerein, skal du kontakte lægen for at drøfte din behandling.
English: Your doctor will monitor your liver function on a regular basis and advise about the symptoms of liver problems (such as pruritus
Danish: Lægen vil regelmæssigt overvåge din leverfunktion og gøre dig opmærksom på leverproblemer (såsom kløe
English: (itching) and jaundice).
Danish: (pruritus) og gulsot (ikterus)).
English: As the CMDh position on diacerein was adopted by majority vote, it was sent to the European Commission which endorsed it and issued a final legally binding decision valid throughout the European Union (EU) on 4 September 2014.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og den 4. september 2014 vedtog en retligt bindende beslutning, der er gyldig i hele EU.
English: • You should not take diacerein if you have or have had liver problems.
Danish: • Du skal ikke tage diacerein, hvis du har leverproblemer eller tidligere har haft det.
English: • If you have diarrhoea while taking diacerein, stop taking your medicine and contact your doctor to discuss which other treatments you can take.
Danish: • Hvis du får diarré, mens du tager diacerein, skal du holde op med at tage lægemidlet og kontakte lægen med henblik på valg af en anden behandling.
English: Following an EU-wide review of diacerein, its use has been restricted in order to minimise the risks of severe diarrhoea and liver problems.
Danish: Efter en EU-gennemgang af diacerein er dets anvendelse blevet begrænset for at nedsætte risikoen for svær diarré og leverproblemer til det mindst mulige.
English: In addition, diacerein-containing medicines must now not be used in any patient with liver disease or a history of liver disease, and doctors should be monitoring their patients for early signs of liver problems.
Danish: Lægemidler indeholdende diacerein må endvidere heller ikke længere anvendes hos patienter med nuværende eller tidligere leversygdom, og lægen bør overvåge patienten for begyndende tegn på leverproblemer.
English: − it is advisable to start treatment with half the normal dose (i.e. 50 mg per day) for the first 2
Danish: − tilrådes det, behandlingen indledes med det halve af den normale dosis (dvs. 50 mg dagligt)
English: Doctors should be monitoring their patients for early signs of liver problems and advising them how to recognise early symptoms.
Danish: Lægen bør overvåge patienten for begyndende tegn på leverproblemer og forklare patienten, hvordan denne kan genkende de indledende symptomer.
English: − treatment should be stopped if diarrhoea occurs.
Danish: − bør behandlingen seponeres ved diarré
English: However, following re-examination, the PRAC considered additional proposals to manage diacerein's risks and was satisfied that with new restrictions diacerein's benefits would outweigh its risks.
Danish: Ved den fornyede overvejelse tog PRAC imidlertid stilling til yderligere forslag til imødegåelse af risiciene ved diacerein og fandt, at de nye begrænsninger gjorde, at fordelene ved diacerein opvejer risiciene.
English: Efficacy in the symptomatic treatment of osteoarthritis of the hip or knee was shown in published studies where diacerein was superior to placebo in relieving pain1-5.
Danish: Der er påvist virkning til symptomatisk behandling af osteoartritis i hofter og knæ i publicerede undersøgelser, hvor den smertelindrende virkning af diacerein var overlegen i forhold til placebo1-5.
English: • Treatment should only be started by doctors experienced in treating osteoarthritis.
Danish: • Behandlingen bør kun initieres af læger med erfaring i behandling af osteoartritis.
English: It works by blocking the actions of interleukin-1 beta, a protein involved in the inflammation and destruction of cartilage that play a role in the development of symptoms of degenerative joint diseases such as osteoarthritis.
Danish: Det virker ved at blokere virkningerne af proteinet interleukin-1 beta, som er medvirkende ved den betændelse (inflammation) og nedbrydning af brusken, der forekommer ved degenerative ledsygdomme såsom slidgigt.
English: • Diacerein should only be used to treat symptoms of osteoarthritis of the hip or knee and it is not recommended for rapidly progressive hip osteoarthritis.
Danish: • Diacerein bør kun anvendes til symptomatisk behandling af osteoartritis i hofter eller knæ og frarådes anvendt til hurtigt progredierende osteoartritis i hofterne.
English: − diacerein is not recommended in patients aged 65 years or above.
Danish: − frarådes anvendelse af diacerein hos patienter i alderen 65 år og derover.
English: Doctors should also note that, based on available data, the use of diacerein is to be limited to treating symptoms of osteoarthritis affecting the hip or knee.
Danish: Lægen bør desuden være opmærksom på, at anvendelsen af diacerein på grundlag af de foreliggende data bør begrænses til symptomatisk behandling af slidgigt i hofter eller knæ.
English: Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Danish: Diacerein er et lægemiddel til behandling af ledsygdomme såsom slidgigt (hævelse og smerter i leddene).
English: Treatment should only be started by doctors experienced in treating osteoarthritis.
Danish: Behandlingen bør kun indledes af læger med erfaring i behandling af slidgigt.
English: Diacerein is a slow-acting medicine of the class ‘anthraquinones' used to treat joint diseases such as osteoarthritis (swelling and pain in the joints).
Danish: Diacerein er et langsomtvirkende lægemiddel, der tilhører klassen anthraquinoner, som anvendes til behandling af ledsygdomme såsom slidgigt (hævelse og smerter i leddene).
English: • Diacerein should only be used for treating symptoms of osteoarthritis affecting the hip or knee.
Danish: • Diacerein bør kun anvendes til behandling af symptomer på slidgigt i hofter eller knæ.
English: • Diacerein must not be used in any patient with liver disease or a history of liver disease.
Danish: • Diacerein bør ikke anvendes hos patienter med nuværende eller tidligere leversygdom.
English: Elevated serum liver enzymes and cases of symptomatic acute hepatic injury have been reported in the post-marketing phase with diacerein.
Danish: Efter markedsføring af diacerein er der indberettet forhøjede leverenzymer i serum og symptomgivende akutte leverskader.
English: • If you have any questions about your treatment, please contact your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide om din behandling.
English: Pack size l t o r
Danish: Administration Emballage Pakningsstørrelse r l
English: (Invented)name Strength Pharmaceutical Form
Danish: (Særnavn) Navn
English: Immediate Packaging
Danish: Styrke Lægemiddelfor m
English: Package size l t o r
Danish: Pakningsstørrelse r l
English: Invented name Strength Pharmaceutical Form
Danish: Særnavn Styrke
English: Route of administration Packaging
Danish: Emballage
English: The recommended dose is calculated using the patient's height and weight).
Danish: Den anbefalede dosis beregnes på baggrund af patientens højde og vægt.
English: Patients with moderate or severe liver problems should be treated with lower doses.
Danish: Patienter med moderate eller alvorlige leverproblemer skal behandles med lavere doser.
English: Blocking the proteasome system causes the cell to die.
Danish: Blokering af proteasomsystemet får cellerne til at dø.
English: If a patient develops severe side effects, treatment must be discontinued, delayed or the dose adjusted.
Danish: Hvis patienten udvikler alvorlige bivirkninger, skal behandlingen afbrydes eller udskydes, eller dosen skal justeres.
English: The full EPAR for Bortezomib Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bortezomib Sun findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It blocks proteasome, which is a system in cells that breaks down proteins that are no longer needed.
Danish: Det blokerer proteasomet, der er cellernes system til nedbrydning af proteiner, som der ikke længere er brug for.
English: Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.
Danish: Kræftceller er mere følsomme end normale celler over for virkningen af proteasomhæmmere som bortezomib.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Sun.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bortezomib Sun.
English: This means that Bortezomib Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Danish: Det betyder, at Bortezomib Sun er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Velcade.
English: At least 72 hours must pass between two doses of Bortezomib Sun.
Danish: Der skal gå mindst 72 timer mellem hver dosis af Bortezomib Sun.
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, blood stem-cell transplantation.
Danish: • voksne, hvis sygdom er i forværring efter mindst én anden behandling, og som allerede har fået eller ikke kan gennemgå en transplantation af blodstamceller (knoglemarvstransplantation).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Sun has been shown to be comparable to Velcade.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Bortezomib Sun er sammenligneligt med Velcade.
English: The Committee recommended that Bortezomib Sun be approved for use in the EU.
Danish: Udvalget anbefalede, at Bortezomib Sun godkendes til anvendelse i EU.
English: No additional studies were needed as Bortezomib Sun is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Bortezomib Sun er et generisk lægemiddel, der indgives ved injektion og indeholder det samme aktive stof som referencelægemidlet Velcade.