natgillin/translations-raw huggingface dataset:
Erfaring med patienter med dekompenseret leversygdom og lamivudin-resistent HBV: I 40 HBeAgpositive eller HBeAg-negative patienter med lamivudin-resistent HBV og dekompenseret leversygdom, som blev behandlet med 100 mg lamivudin, resulterede tilføjelsen af behandling med 10 mg adefovirdipivoxil i 52 uger i en median reduktion i HBV-dna på 4,6 log10 kopier/ml.
Experience in patients with decompensated liver disease and lamivudine-resistant HBV: In 40 HBeAg positive or HBeAg negative patients with lamivudine-resistant HBV and decompensated liver disease receiving treatment with 100 mg lamivudine, addition of 10 mg adefovir dipivoxil treatment for 52 weeks resulted in a median reduction in HBV DNA of 4.6 log10 copies/ml.
(kan forekomme hos op til 1 ud af 10 personer)
(may affect up to 1 in 10 people)
b. Resumé af bivirkninger i tabelform
b. Tabulated summary of adverse reactions
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.
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.
Leverfunktion: Spontane eksacerbationer af kronisk hepatitis B er forholdsvis almindelige og er kendetegnet ved kortvarige stigninger i serum-ALAT.
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.
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.
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.
Det bør overvejes at monitorerere nyrefunktionen hyppigere hos patienter med risiko for nedsat nyrefunktion.
In patients at risk for renal impairment, consideration should be given to more frequent monitoring of renal function.
Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 113 mg lactosemonohydrat.
Each tablet contains 113 mg lactose monohydrate.
• Kvalme eller opkastning - almindeligt
• Feeling sick (nausea) or being sick (vomiting) - common
Hvide/råhvide, runde og flade tabletter med skrå kanter, 7 mm i diameter.
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.
Kronisk hepatitis B (en form for leverbetændelse) er en infektion med hepatitis B-virus (HBV).
Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
• Mavepine
• Stomach pain
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.
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.
Adefovir udskilles gennem nyrene ved en kombination af glomerulusfiltration og aktiv tubulær sekretion.
Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Øvrige bivirkninger
Other possible side effects
Adefovirdipivoxil anbefales ikke til patienter med en kreatininclearance på < 30 ml/min eller til patienter, som er i dialyse.
Adefovir dipivoxil is not recommended in patients with a creatinine clearance of < 30 ml/min or on dialysis.
Adefovirdipivoxil anbefales ikke til patienter med en kreatininclearance på < 30 ml/min eller til patienter, som er i dialyse (se pkt.
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).
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.
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).
• Udslæt og kløe - almindeligt
• Rash and itching - common
Nyrefunktion: Adefovir udskilles gennem nyrerne ved en kombination af glomerulusfiltration og aktiv tubulær sekretion.
Renal function: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Se indlægssedlen for yderligere oplysninger.
See section 2 for more details.
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.
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).
• 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
• Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Kontakt lægen, før De tager Hepsera, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
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.
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.
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.
Spørg lægen eller apotekspersonalet, hvis der er noget, De er i tvivl om.
Check with your doctor or pharmacist if you are not sure.
Der skal anvendes sikker kontraception under behandling med adefovirdipivoxil.
The use of adefovir dipivoxil must be accompanied by the use of effective contraception.
• Kraftesløshed
• Weakness
Knogler, led, muskler og bindevæv: Ikke kendt:
Rash, pruritus Musculoskeletal and connective tissue disorders:
Amning
Unimpaired
• 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.
• look out for possible signs of lactic acidosis - see section 4, Possible side effects.
Se ovenfor under Nyrefunktion, hvis disse patienter udvikler nyreinsufficiens.
In the event of these patients developing renal insufficiency, see above Renal function.
Mave-tarm-kanalen: Almindelige:
Gastrointestinal disorders: Common:
En nøje overvågning anbefales alligevel, når et af disse midler gives samtidig med adefovirdipivoxil, eftersom tacrolimus og ciclosporin kan påvirke nyrefunktionen (se pkt.
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).
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.
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.
• Nyresvigt
• Kidney failure
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.
Adefovir diphosphate has an intracellular half-life of 12 to 36 hours in activated and resting lymphocytes.
4, Bivirkninger.
Possible side effects
MF (EU)-nummer
MA (EU) number
Pakningsstørrelse
Immediate Packaging Pack size
Dette sammendrag blev sidst ajourført i 02-2016.
This summary was last updated in 02-2016.
Det gives hver tredje uge ved en infusion, der varer 10 minutter.
It is given once every three weeks as an infusion lasting 10 minutes.
EPAR sammenfatning for offentligheden
EPAR summary for the public
Andre oplysninger om Armisarte
Other information about Armisarte
Lægemidlets navn blev ændret til Armisarte den 10. februar 2016.
The name of the medicine was changed to Armisarte on 10 February 2016.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pemetrexed Actavis den 18. januar 2016.
The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed Actavis on 18 January 2016.
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.
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.
Udvalget anbefalede, at Armisarte godkendes til anvendelse i EU.
The Committee recommended that Armisarte be approved for use in the EU.
Armisarte er et "hybridt lægemiddel".
Armisarte is a ‘hybrid medicine'.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Armisarte.
This is a summary of the European public assessment report (EPAR) for Armisarte.
Den anbefalede dosis er 500 mg pr. kvadratmeter legemsoverflade (beregnet efter patientens højde og vægt).
The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Der er udarbejdet en risikostyringsplan for at sikre, at Armisarte anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Armisarte is used as safely as possible.
Hvilke fordele og risici er der forbundet med Armisarte?
What are the benefits and risks of Armisarte?
Hvad er Armisarte, og hvad anvendes det til?
What is Armisarte and what is it used for?
Armisarte er et kræftlægemiddel til behandling af to typer af lungekræft:
Armisarte is a cancer medicine used to treat two types of lung cancer:
Det kan desuden anvendes som vedligeholdelsesbehandling hos patienter, der har fået platinbaseret kemoterapi.
It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Armisarte er sammenligneligt med Alimta.
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Armisarte?
What measures are being taken to ensure the safe and effective use of Armisarte?
Lægemidlet udleveres kun på recept og bør kun gives under overvågning af en læge, der er specialiseret i brug af kræftmedicin.
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.
Det er ikke en praktisk vejledning i, hvordan Armisarte bør anvendes.
It is not intended to provide practical advice on how to use Armisarte.
Hvorfor er Armisarte blevet godkendt?
Why is Armisarte approved?
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Armisarte, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
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.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Alimta.
Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
• 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.
• 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.
Virksomheden fremlagde data fra faglitteraturen om pemetrexed.
The company provided data from the published literature on pemetrexed.
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.
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.
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.
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.
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).
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).
Tidligere kaldet Pemetrexed Actavis
Previously known as Pemetrexed Actavis.
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.
For more information about treatment with Armisarte, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Armisarte, pemetrexed, er et vævsgiftigt (cytotoksisk) lægemiddel (dvs. det dræber celler, der deler sig, såsom kræftceller) i gruppen "antimetabolitter".
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'.
Armisarte indeholder det aktive stof pemetrexed.
Armisarte contains the active substance pemetrexed.
Det betyder, at Armisarte svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU).
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.
Det får kræftcellerne til at dele sig langsommere, men har kun ringe virkning på normale celler.
This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Hvis du ønsker praktisk vejledning om anvendelsen af Armisarte, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Armisarte, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Armisarte?
How is Armisarte used?
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.
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.
Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
For more information, see the summary of product characteristics (also part of the EPAR).
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.
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.
Hvordan er Armisarte blevet undersøgt?
How has Armisarte been studied?
Hvordan virker Armisarte?
How does Armisarte work?
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.
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.
I kræftceller omdannes pemetrexed hurtigere til den aktive form end i normale celler.
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.
Hvis patienten får unormale blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller ophøre.
Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Armisarte fås som et koncentrat til infusionsvæske, opløsning, til infusion i en vene.
Armisarte is available as a concentrate for solution for infusion into a vein.
Dannelsen af DNA og RNA bremses derved af den aktive form af pemetrexed.
As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
• malignt pleuramesoteliom (kræft i lungehinderne, der sædvanligvis skyldes udsættelse for asbest).
• 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;
Dette sammendrag blev sidst ajourført i 08-2013.
This summary was last updated in 08-2013.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vipidia den 19. september 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Den fuldstændige EPAR for Vipidia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vipidia.
This is a summary of the European public assessment report (EPAR) for Vipidia.
Der er udarbejdet en risikostyringsplan for at sikre, at Vipidia anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Vipidia blev undersøgt i syv hovedundersøgelser, som omfattede 5 675 voksne med type 2- diabetes.
Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Andre oplysninger om Vipidia
Other information about Vipidia
Vipidia fås som tabletter (6,25, 12,5 og 25 mg) og udleveres kun efter recept.
Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vipidia opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vipidia?
What measures are being taken to ensure the safe and effective use of Vipidia?
Hvad er Vipidia, og hvad anvendes det til?
What is Vipidia and what is it used for?
Hos patienter med nedsat nyrefunktion skal dosis af Vipidia nedsættes.
In patients with reduced kidney function, the daily dose of Vipidia should be reduced.
Det er ikke en praktisk vejledning i, hvordan Vipidia bør anvendes.
It is not intended to provide practical advice on how to use Vipidia.
De mest almindelige bivirkninger ved Vipidia (som kan forekomme hos op til 1 ud af 10 personer) er kløe.
The most common side effect with Vipidia (which may affect up to 1 in 10 people) is pruritus (itching).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vipidia, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
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.
Vipidia er et lægemiddel, der indeholder det aktive stof alogliptin.
Vipidia is a diabetes medicine that contains the active substance alogliptin.
Hvorfor er Vipidia blevet godkendt?
Why is Vipidia approved?
Det aktive stof i Vipidia, alogliptin, er en dipeptidylpeptidase-4- (DPP-4) hæmmer).
The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Når Vipidia anvendes alene eller sammen med andre midler mod sukkersyge, reducerer det mængden af HbA1c med 0,48-0,61 % mere end placebo.
When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Alogliptin virker ikke, når blodsukkeret er lavt.
Alogliptin does not work when the blood glucose is low.
Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets glukoseniveau, eller når kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Disse hormoner udskilles efter et måltid og stimulerer bugspytkirtlen til at producere insulin.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Hvilken risiko er der forbundet med Vipidia?
What are the risks associated with Vipidia?
Når Vipidia føjes til et sulfonylurinstof (et lægemiddel mod sukkersyge) eller insulin, kan det være nødvendigt for lægen at nedsætte dosis af disse lægemidler for at reducere risikoen for hypoglycæmi (lavt blodsukkerindhold).
When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).