FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism of action and pharmacodynamic effects: Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate.
Danish: Adefovirdipivoxil er et oralt prodrug af adefovir, en acyklisk nukleotidphosphonatanalog af adenosinmonophosphat, som aktivt transporteres ind i mammaliaceller, hvor det af værtsenzymer omdannes til adefovirdiphosphat.
English: Hepatic function: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Danish: Leverfunktion: Spontane eksacerbationer af kronisk hepatitis B er forholdsvis almindelige og er kendetegnet ved kortvarige stigninger i serum-ALAT.
English: Clinical resistance: Lamivudine-refractory patients and patients harbouring HBV with evidence of resistance to lamivudine (mutations at rtL180M, rtA181T and/or rtM204I/V) should not be treated with adefovir dipivoxil monotherapy in order to reduce the risk of resistance to adefovir.
Danish: Klinisk resistens: For at reducere risikoen for resistens over for adefovir bør lamivudin-refraktære patienter og patienter, som har HBV med tegn på resistens over for lamivudin (mutationer ved rtL180M, rtA181T og/eller rtM204I/V), ikke behandles med adefovirdipivoxil-monoterapi.
English: In patients at risk for renal impairment, consideration should be given to more frequent monitoring of renal function.
Danish: Det bør overvejes at monitorerere nyrefunktionen hyppigere hos patienter med risiko for nedsat nyrefunktion.
English: Each tablet contains 113 mg lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 113 mg lactosemonohydrat.
English: • Feeling sick (nausea) or being sick (vomiting) - common
Danish: • Kvalme eller opkastning - almindeligt
English: White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Danish: Hvide/råhvide, runde og flade tabletter med skrå kanter, 7 mm i diameter.
English: Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Danish: Kronisk hepatitis B (en form for leverbetændelse) er en infektion med hepatitis B-virus (HBV).
English: • Stomach pain
Danish: • Mavepine
English: Experience in patients with HIV co-infection and lamivudine-resistant HBV: In an open-label investigator study in 35 chronic hepatitis B patients with lamivudine-resistant HBV and co-infected with HIV, continued treatment with 10 mg adefovir dipivoxil resulted in progressive reductions in serum HBV DNA levels and ALT levels throughout the course of treatment up to 144 weeks.
Danish: Erfaring med patienter med samtidig hiv-infektion og lamivudin-resistent HBV: I en åben investigatorundersøgelse, hvor der deltog 35 kroniske hepatitis B patienter med lamivudin-resistent HBV, der samtidig var inficerede med hiv, resulterede fortsat behandling med 10 mg adefovirdipivoxil i progressive reduktioner i serum-HBV-dna-niveauer og ALAT-niveauer igennem hele behandlingsforløbet på op til 144 uger.
English: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Danish: Adefovir udskilles gennem nyrene ved en kombination af glomerulusfiltration og aktiv tubulær sekretion.
English: Other possible side effects
Danish: Øvrige bivirkninger
English: Adefovir dipivoxil is not recommended in patients with a creatinine clearance of < 30 ml/min or on dialysis.
Danish: Adefovirdipivoxil anbefales ikke til patienter med en kreatininclearance på < 30 ml/min eller til patienter, som er i dialyse.
English: Adefovir dipivoxil is not recommended in patients with creatinine clearance of < 30 ml/min or in patients on dialysis (see section 4.2 and 4.4).
Danish: Adefovirdipivoxil anbefales ikke til patienter med en kreatininclearance på < 30 ml/min eller til patienter, som er i dialyse (se pkt.
English: Clinically and statistically significant improvement in fibrosis was seen in the changes in Ishak scores from the start of adefovir dipivoxil treatment to the end of the study (week 240) (median change: Δ= -1).
Danish: Fra starten af behandlingen med adefovirdipivoxil til slutningen af studiet (uge 240) viste ændringerne af Ishak scores (median forandring: Δ= -1) en klinisk og statistisk signifikant forbedring af fibrose.
English: • Rash and itching - common
Danish: • Udslæt og kløe - almindeligt
English: Renal function: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Danish: Nyrefunktion: Adefovir udskilles gennem nyrerne ved en kombination af glomerulusfiltration og aktiv tubulær sekretion.
English: See section 2 for more details.
Danish: Se indlægssedlen for yderligere oplysninger.
English: HBV that contains the rtA181T mutation, consideration should be given to alternative treatment regimens due to the risk of reduced susceptibility to adefovir (see section 5.1).
Danish: På grund af risikoen for reduceret følsomhed over for adefovir bør alternative behandlingsregimer imidlertid overvejes til patienter, som har HBV med rtA181T-mutationen (se pkt.
English: • Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Danish: • Hvis De bemærker nye eller usædvanlige symptomer eller en forværring af eksisterende symptomer, efter at De er holdt op med at tage Hepsera, skal De omgående fortælle det til
English: If you are lactose-intolerant, or if you have been told that you have an intolerance to some sugars, talk to your doctor before taking Hepsera.
Danish: Kontakt lægen, før De tager Hepsera, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Co-infection with HIV: Limited data are available on the safety and efficacy of 10 mg adefovir dipivoxil in patients with chronic hepatitis B, co-infected with HIV.
Danish: Samtidig infektion med hiv: Hos patienter med kronisk hepatitis B samt infektion med hiv foreligger der kun begrænsede data om sikkerheden og virkningen af 10 mg adefovirdipivoxil.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, De er i tvivl om.
English: The use of adefovir dipivoxil must be accompanied by the use of effective contraception.
Danish: Der skal anvendes sikker kontraception under behandling med adefovirdipivoxil.
English: • Weakness
Danish: • Kraftesløshed
English: Rash, pruritus Musculoskeletal and connective tissue disorders:
Danish: Knogler, led, muskler og bindevæv: Ikke kendt:
English: Unimpaired
Danish: Amning
English: • look out for possible signs of lactic acidosis - see section 4, Possible side effects.
Danish: • Når De er begyndt med at tage Hepsera: • skal De holde øje med mulige tegn på laktatacidose - De kan finde nærmere oplysninger herom i pkt.
English: In the event of these patients developing renal insufficiency, see above Renal function.
Danish: Se ovenfor under Nyrefunktion, hvis disse patienter udvikler nyreinsufficiens.
English: Gastrointestinal disorders: Common:
Danish: Mave-tarm-kanalen: Almindelige:
English: Nevertheless, given that tacrolimus and cyclosporin can affect renal function, close monitoring is recommended when either of these agents is coadministered with adefovir dipivoxil (see section 4.4).
Danish: En nøje overvågning anbefales alligevel, når et af disse midler gives samtidig med adefovirdipivoxil, eftersom tacrolimus og ciclosporin kan påvirke nyrefunktionen (se pkt.
English: However, a signal towards a higher rate of decreased appetite and/or food intake was observed in the adefovir arm as compared to the placebo arm. At week 48 and 96, mean changes from baseline in weight and BMI Z scores tended to decrease in adefovir dipivoxil-treated patients.
Danish: Ved uge 48 og 96 var der tendens til, at de gennemsnitlige ændringer i forhold til baseline i vægt- og BMI-Z-scorer faldt hos patienter, som blev behandlet med adefovirdipivoxil.
English: • Kidney failure
Danish: • Nyresvigt
English: Adefovir diphosphate has an intracellular half-life of 12 to 36 hours in activated and resting lymphocytes.
Danish: Adefovirdiphosphat hæmmer selektivt HBV-dnapolymeraser ved koncentrationer, som er 12, 700 og 10 gange lavere end dem, som er nødvendige for at hæmme humane dna-polymeraser, hhv. α, β og γ. Adefovirdiphosphat har en intracellulær halveringstid på 12 til 36 timer i aktive og hvilende lymfocytter.
English: Possible side effects
Danish: 4, Bivirkninger.
English: MA (EU) number
Danish: MF (EU)-nummer
English: (Invented) name
Danish: (Særnavn) Navn
English: Immediate Packaging Pack size
Danish: Pakningsstørrelse
English: This summary was last updated in 02-2016.
Danish: Dette sammendrag blev sidst ajourført i 02-2016.
English: It is given once every three weeks as an infusion lasting 10 minutes.
Danish: Det gives hver tredje uge ved en infusion, der varer 10 minutter.
English: EPAR summary for the public
Danish: EPAR sammenfatning for offentligheden
English: Other information about Armisarte
Danish: Andre oplysninger om Armisarte
English: The name of the medicine was changed to Armisarte on 10 February 2016.
Danish: Lægemidlets navn blev ændret til Armisarte den 10. februar 2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed Actavis on 18 January 2016.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pemetrexed Actavis den 18. januar 2016.
English: The full EPAR and risk management plan summary for Armisarte can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Armisarte findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee recommended that Armisarte be approved for use in the EU.
Danish: Udvalget anbefalede, at Armisarte godkendes til anvendelse i EU.
English: Armisarte is a ‘hybrid medicine'.
Danish: Armisarte er et "hybridt lægemiddel".
English: This is a summary of the European public assessment report (EPAR) for Armisarte.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Armisarte.
English: The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis er 500 mg pr. kvadratmeter legemsoverflade (beregnet efter patientens højde og vægt).
English: A risk management plan has been developed to ensure that Armisarte is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Armisarte anvendes så sikkert som muligt.
English: What are the benefits and risks of Armisarte?
Danish: Hvilke fordele og risici er der forbundet med Armisarte?
English: What is Armisarte and what is it used for?
Danish: Hvad er Armisarte, og hvad anvendes det til?
English: Armisarte is a cancer medicine used to treat two types of lung cancer:
Danish: Armisarte er et kræftlægemiddel til behandling af to typer af lungekræft:
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.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Armisarte 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 Armisarte er sammenligneligt med Alimta.
English: What measures are being taken to ensure the safe and effective use of Armisarte?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Armisarte?
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of cancer medicines.
Danish: Lægemidlet udleveres kun på recept og bør kun gives under overvågning af en læge, der er specialiseret i brug af kræftmedicin.
English: It is not intended to provide practical advice on how to use Armisarte.
Danish: Det er ikke en praktisk vejledning i, hvordan Armisarte bør anvendes.
English: Why is Armisarte approved?
Danish: Hvorfor er Armisarte blevet godkendt?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Armisarte, 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 Armisarte, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Alimta.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Danish: • fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekarcinom, hvor det enten anvendes i kombination med cisplatin hos tidligere ubehandlede patienter eller som eneste behandling hos patienter, der tidligere har fået kræftbehandling.
English: The company provided data from the published literature on pemetrexed.
Danish: Virksomheden fremlagde data fra faglitteraturen om pemetrexed.
English: Because Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Armisarte er et hybridt lægemiddel, der gives ved infusion og indeholder samme aktive stof som referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: No additional studies were needed as Armisarte is a hybrid 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 Armisarte er et hybridt lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
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, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider (byggestenene i DNA og RNA, cellernes genetiske materiale).
English: Previously known as Pemetrexed Actavis.
Danish: Tidligere kaldet Pemetrexed Actavis
English: For more information about treatment with Armisarte, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Armisarte, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Armisarte, 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 Armisarte, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
English: Armisarte contains the active substance pemetrexed.
Danish: Armisarte indeholder det aktive stof pemetrexed.
English: This means that Armisarte is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta, but it is available in a different form.
Danish: Det betyder, at Armisarte svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Danish: Det får kræftcellerne til at dele sig langsommere, men har kun ringe virkning på normale celler.
English: For practical information about using Armisarte, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Armisarte, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Armisarte used?
Danish: Hvordan anvendes Armisarte?
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 Armisarte.
Danish: For at mindske bivirkningerne under behandlingen med Armisarte bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: While Alimta is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is available as a concentrated liquid to be made up into a solution for infusion.
Danish: Alimta fås som et pulver, der anvendes til fremstilling af en opløsning til drop i en vene (infusionsvæske), mens Armisarte fås som en koncentreret væske, der anvendes til fremstilling af en infusionsvæske.
English: How has Armisarte been studied?
Danish: Hvordan er Armisarte blevet undersøgt?
English: How does Armisarte work?
Danish: Hvordan virker Armisarte?
English: When Armisarte is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Armisarte gives sammen med cisplatin, bør der desuden før og efter cisplatin gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Danish: I kræftceller omdannes pemetrexed hurtigere til den aktive form end i normale celler.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Danish: Hvis patienten får unormale blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller ophøre.
English: Armisarte is available as a concentrate for solution for infusion into a vein.
Danish: Armisarte fås som et koncentrat til infusionsvæske, opløsning, til infusion i en vene.
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.
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 pleuramesoteliom (kræft i lungehinderne, der sædvanligvis skyldes udsættelse for asbest).
English: This summary was last updated in 08-2013.
Danish: Dette sammendrag blev sidst ajourført i 08-2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vipidia den 19. september 2013.
English: The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Vipidia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Vipidia.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vipidia.
English: A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vipidia anvendes så sikkert som muligt.
English: Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Danish: Vipidia blev undersøgt i syv hovedundersøgelser, som omfattede 5 675 voksne med type 2- diabetes.
English: Other information about Vipidia
Danish: Andre oplysninger om Vipidia
English: Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Danish: Vipidia fås som tabletter (6,25, 12,5 og 25 mg) og udleveres kun efter recept.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vipidia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vipidia opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Vipidia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vipidia?
English: What is Vipidia and what is it used for?
Danish: Hvad er Vipidia, og hvad anvendes det til?
English: In patients with reduced kidney function, the daily dose of Vipidia should be reduced.
Danish: Hos patienter med nedsat nyrefunktion skal dosis af Vipidia nedsættes.
English: It is not intended to provide practical advice on how to use Vipidia.
Danish: Det er ikke en praktisk vejledning i, hvordan Vipidia bør anvendes.
English: The most common side effect with Vipidia (which may affect up to 1 in 10 people) is pruritus (itching).
Danish: De mest almindelige bivirkninger ved Vipidia (som kan forekomme hos op til 1 ud af 10 personer) er kløe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vipidia, 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 Vipidia, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Vipidia is a diabetes medicine that contains the active substance alogliptin.
Danish: Vipidia er et lægemiddel, der indeholder det aktive stof alogliptin.
English: Why is Vipidia approved?
Danish: Hvorfor er Vipidia blevet godkendt?
English: The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Danish: Det aktive stof i Vipidia, alogliptin, er en dipeptidylpeptidase-4- (DPP-4) hæmmer).
English: When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Danish: Når Vipidia anvendes alene eller sammen med andre midler mod sukkersyge, reducerer det mængden af HbA1c med 0,48-0,61 % mere end placebo.
English: Alogliptin does not work when the blood glucose is low.
Danish: Alogliptin virker ikke, når blodsukkeret er lavt.