FrancophonIA/ELRC3.0 huggingface dataset:
English: No additional studies were needed as Pemetrexed medac 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 medac er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Alimta.
English: Pemetrexed medac is a cancer medicine used to treat two types of lung cancer:
Danish: Pemetrexed medac er et kræftlægemiddel til behandling af to typer af lungekræft:
English: Pemetrexed medac is a ‘generic medicine'.
Danish: Pemetrexed medac er et "generisk lægemiddel".
English: What are the benefits and risks of Pemetrexed medac?
Danish: Hvilke fordele og risici er der forbundet med Pemetrexed medac?
English: It is not intended to provide practical advice on how to use Pemetrexed medac.
Danish: Det er ikke en praktisk vejledning i, hvordan Pemetrexed medac bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed medac?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pemetrexed medac?
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet (ligeledes en del af denne EPAR).
English: Pemetrexed medac contains the active substance pemetrexed.
Danish: Pemetrexed medac indeholder det aktive stof pemetrexed.
English: Because Pemetrexed medac is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pemetrexed medac er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Pemetrexed medac
Danish: Andre oplysninger om Pemetrexed medac
English: The active substance in Pemetrexed medac, 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 medac, 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 medac, 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 medac, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Pemetrexed medac and what is it used for?
Danish: Hvad er Pemetrexed medac, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed medac 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 medac er af sammenlignelig kvalitet og er bioækvivalent med Alimta.
English: For practical information about using Pemetrexed medac, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pemetrexed medac, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
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 medac.
Danish: For at mindske bivirkningerne under behandlingen med Pemetrexed medac bør patienten få binyrebarkhormon (en type lægemiddel, der mindsker inflammation), folsyre (en type vitamin) og indsprøjtninger med vitamin B12.
English: When Pemetrexed medac 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 Pemetrexed medac gives sammen med cisplatin, bør der desuden før eller efter cisplatin gives medicin mod opkastninger samt væsketilskud for at forhindre udtørring.
English: Why is Pemetrexed medac approved?
Danish: Hvorfor er Pemetrexed medac blevet godkendt?
English: Pemetrexed medac is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Pemetrexed medac fås som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: How has Pemetrexed medac been studied?
Danish: Hvordan er Pemetrexed medac blevet undersøgt?
English: How does Pemetrexed medac work?
Danish: Hvordan virker Pemetrexed medac?
English: How is Pemetrexed medac used?
Danish: Hvordan anvendes Pemetrexed medac?
English: Results at week 16
Danish: Resultater ved uge 16
English: This can sometimes lead to serious medical conditions.
Danish: Det kan i nogle tilfælde føre til alvorlige medicinske tilstande.
English: Outcomes a
Danish: Resultat a
English: You will need to take Agenerase every day.
Danish: Du vil være nødt til at tage Agenerase hver dag.
English: You should keep in regular contact with your doctor.
Danish: Du bør holde regelmæssig kontakt med din læge.
English: In some patients, additional factor VIII was given.
Danish: Hos nogle patienter blev der givet ekstra faktor VIII.
English: For this reason, it is very important that you inform your doctor about any changes in your health.
Danish: Derfor er det meget vigtigt, at du fortæller lægen om enhver ændring af dit helbred.
English: Appropriate precautions should continue to be taken.
Danish: Der bør fortsat tages passende forholdsregler.
English: Of note, the following interaction data was obtained in adults.
Danish: Bemærk, følgende interaktionsdata er opnået hos voksne.
English: However, the information currently available is not sufficient for determining the nature of the interaction.
Danish: Den nuværende information er dog ikke tilstrækkelig til at fastslå interaktionens art.
English: Note that the background rates in comparator groups were not taken into account.
Danish: Vær opmærksom på, at der ikke er taget højde for baggrundsraten i comparator gruppen.
English: In vivo a) ART-naïve or PI-naïve patients
Danish: In vivo a) ART-naive eller PI-naive patienter
English: You should continue to use appropriate precautions to prevent this.
Danish: Du bør fortsat tage passende forholdsregler for at undgå dette.
English: Medicinal products - interactions
Danish: Lægemidler - interaktioner
English: Therefore this combination must be avoided.
Danish: Derfor skal denne kombination undgås.
English: These medicines are used for treating human immunodeficiency virus (HIV) infection.
Danish: Disse lægemidler bruges til behandling af Human Immunodeficiency Virus (HIV)infektion.
English: It might also be necessary to reconsider the treatment with Agenerase oral solution.
Danish: Det kan også være nødvendigt at genoverveje behandlingen med Agenerase oral opløsning.
English: The importance of complying with the full recommended dosing regimen should be stressed to all patients.
Danish: Vigtigheden af at overholde hele det anbefalede doseringsregime bør understreges over for samtlige patienter.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructose intolerance bør ikke tage denne medicin.
English: This leaflet was last approved on
Danish: Denne indlægsseddel blev senest godkendt den
English: It may harm them even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: The reason for this is not known.
Danish: Årsagen til dette er ukendt.
English: On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
Danish: Ved sjældne lejligheder har disse muskelforstyrrelser været alvorlige (rhabdomyolyse).
English: You should tell your doctor about any medical conditions that you have or have had.
Danish: Du bør fortælle lægen om enhver medicinsk tilstand, som du har eller har haft.
English: Amprenavir did not affect fertility.
Danish: Amprenavir påvirkede ikke fertiliteten.
English: Clinical examination should include evaluation for physical signs of fat redistribution.
Danish: Klinisk undersøgelse bør inkludere evaluering af fysiske tegn på omfordeling af fedt.
English: Knowledge about the mechanism is incomplete.
Danish: Kendskabet til virkningsmekanismen er ufuldstændig.
English: The clinical relevance of these changes is unknown.
Danish: Den kliniske relevans af disse ændringer er ukendt.
English: Clearance also decreased in a corresponding manner to the AUC.
Danish: Clearance faldt også svarende til ændringen i AUC.
English: There are limited reports of overdose with Agenerase.
Danish: Der er begrænsede rapporter om overdosering med Agenerase.
English: Elimination: the plasma elimination half-life of amprenavir ranges from 7.1 to 10.6 hours.
Danish: Elimination: Halveringstiden for plasmaeliminationen af amprenavir ligger fra 7,1 til 10,6 timer.
English: Clinical efficacy and safety have not been determined in this patient group.
Danish: Klinisk effekt og sikkerhed er ikke fastlagt hos denne patientgruppe.
English: 1 Primary mutations were as defined by the IAS USA at the time of the original analysis, 2002 D30N,
Danish: 1 Primære mutationer var, som defineret af IAS USA på det oprindelige analysetidspunkt i 2002;
English: Elevations in cholesterol were of grade 3-4 intensity.
Danish: Forhøjet kolesterolniveau var grad 3-4 i intensitet.
English: You can still continue to develop other infections and other illnesses associated with HIV disease.
Danish: Du kan fortsat rammes af andre infektioner og sygdomme, som er knyttet til HIV-sygdommen.
English: Like all medicines, Agenerase can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Agenerase have bivirkninger, selvom ikke alle får bivirkninger.
English: (−21, 9)c a Intent To Treat (Exposed) Population: Observed analysis b Mean stratified difference c 95% confidence interval
Danish: (−21; 9)c a ”Intent To Treat” (Exponeret)-population: Observeret analyse b Middelstratificeret forskel c 95 % konfidensinterval
English: The absolute bioavailability is unknown due to the lack of an acceptable intravenous formulation for use in man.
Danish: Den absolutte biotilgængelighed er ukendt, da der ikke findes en acceptabel intravenøs formulering til anvendelse hos mennesker.
English: (Note: Agenerase is not approved in ART-naive or PI-naive patients).
Danish: (Bemærk: Agenerase er ikke godkendt til ART-naive eller PI-naive patienter).
English: This medicine helps to control your condition, but it is not a cure for HIV infection.
Danish: Dette lægemiddel hjælper med at kontrollere din tilstand, men kurerer ikke HIV-infektionen.
English: Agenerase is also available as capsules.
Danish: Agenerase findes også som kapsler.
English: Stevens Johnson syndrome
Danish: Stevens-Johnsons syndrom
English: Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.
Danish: Agenerase kan reagere med andre lægemidler, som du eventuelt tager, så det er vigtigt, at du læser det næste afsnit ”Brug af anden medicin”, før du tager dette lægemiddel.
English: The clinical significance of these possible interactions is not known and has not been investigated.
Danish: Den kliniske betydning af disse mulige interaktioner er ukendt og er ikke undersøgt.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som således gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: This is very important, as taking some types of medicines at the same time as Agenerase can strengthen or weaken the effect of the medicines.
Danish: Dette er meget vigtigt, idet indtagelse af nogle typer lægemidler samtidig med Agenerase kan forstærke eller nedsætte virkningen af lægemidlerne.
English: A causal relationship has been evoked, although the mechanism of action has not been elucidated.
Danish: En kausal sammenhæng mistænkes, skønt virkningsmekanismen ikke er blevet belyst.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværring af leversygdommen hos disse patienter, bør afbrydelse eller ophør af behandlingen overvejes.
English: If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.
Danish: Hvis du glemmer at tage en dosis Agenerase, skal du tage den, så snart du husker det. Fortsæt derefter som før.
English: The frequency categories used are:
Danish: Frekvenserne er defineret som:
English: Median number of PI primary mutations 1
Danish: Median antal af primære PI-mutationer
English: Antiviral activity in vitro
Danish: Antiviral in vitro-aktivitet
English: • A severe or life-threatening skin reaction (Stevens Johnson syndrome)
Danish: - En alvorlig eller livstruende hudreaktion (Stevens Johnson syndrom)
English: These active substances include flecainide and propafenone.
Danish: Disse aktive stoffer inkluderer flecainid og propafenon.
English: Greater effects may be expected when fluticasone propionate is inhaled.
Danish: Større påvirkning kan forventes når fluticasonpropionat inhaleres.
English: Oral use Read the package leaflet before use
Danish: Oral anvendelse Læs indlægssedlen inden brug.
English: In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Danish: Hos nogle af disse var hyperglykæmien alvorlig og i visse tilfælde også ledsaget af ketoacidose.
English: In in vitro studies, the protein binding of amprenavir is approximately 90 %.
Danish: I in vitro-undersøgelser er proteinbindingen af amprenavir ca. 90 %.
English: Associations contraindicated (see section 4.3)
Danish: Associerede kontraindikationer (se afsnit 4.3)
English: Limited experience with Agenerase oral solution indicate a similar safety profile as for the capsules.
Danish: Begrænset erfaring med Agenerase oral opløsning indikerer en sikkerhedsprofil, som svarer til den for kapslerne.
English: If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.
Danish: Hvis du har taget mere end den ordinerede dosis af Agenerase, bør du straks kontakte din læge eller apoteket for rådgivning.
English: You should not take more than 2400 mg per day.
Danish: Du bør ikke tage mere end 2400 mg pr. døgn.
English: These capsules also contain sorbitol.
Danish: Disse kapsler indeholder sorbitol.
English: The cause and long-term health effects of these conditions are not known at this time.
Danish: Årsagen og den langsigtede sundhedsrisiko ved disse tilstande er endnu ikke kendt.
English: You may need additional factor VIII to control
Danish: Du kan få brug for ekstra faktor VIII for at
English: Toxicity studies in young animals, treated from four days of age, resulted in high mortality in both the control animals and those receiving amprenavir.
Danish: Toksicitetsundersøgelser hos unge dyr, som blev behandlet fra de var 4 dage gamle, resulterede i høj mortalitet hos både kontroldyr og dem, der fik amprenavir.
English: A 20 ml measuring cup is provided, to help you measure out the correct amount of oral solution for each dose.
Danish: Der er vedlagt et 20 ml målebæger som hjælp til at afmåle den korrekte mængde oral opløsning til hver dosis.
English: Therefore, such combinations should be avoided in children.
Danish: Derfor bør sådanne kombinationer undgås til børn.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisjustering af midazolam bør overvejes, specielt hvis der skal gives mere end en enkelt dosis af midazolam.
English: Patients should therefore be monitored for toxic reactions associated with these medicinal products when these are administered in combination with Agenerase.
Danish: Patienter bør derfor monitoreres for toksiske reaktioner knyttet til disse lægemidler, når de gives i kombination med Agenerase.
English: Do not stop taking your medicine without first talking to your doctor.
Danish: Hold ikke op med at tage medicinen uden at have talt med lægen om det først.
English: Should this happen to you, seek immediate advice from your doctor.
Danish: Hvis det sker for dig, så søg omgående hjælp hos din læge.
English: Other possible interactions
Danish: Andre mulige interaktioner
English: However, the possibility of anaphylactic reaction related to PEG 400 cannot be excluded.
Danish: Muligheden for anafylaktisk reaktion over for PEG 400 kan dog ikke udelukkes.
English: In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
Danish: I over halvdelen af de rapporterede tilfælde blev behandling med proteasehæmmere fortsat eller genoptaget, hvis den havde været afbrudt.
English: Pregnancy: there are no adequate data from the use of amprenavir in pregnant women.
Danish: Graviditet: Der foreligger ikke fyldestgørende data om brugen af amprenavir under graviditet.
English: - bepridil (used to treat hypertension).
Danish: bepridil (anvendt til at behandle hypertension).
English: The dosage should therefore be reduced in these patients (see section 4.2).
Danish: Dosis bør derfor nedsættes til disse patienter (se afsnit 4.2).
English: To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.
Danish: For at få det fulde udbytte af Agenerase, er det meget vigtigt, at du tager hele den ordinerede døgndosis.
English: • Other combinations
Danish: Andre kombinationer
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af HIV-infektion.
English: DATE OF THE REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu
English: There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase' for further information).
Danish: Der er visse lægemidler du ikke må anvende sammen med Agenerase (se ”Tag ikke Agenerase” for yderligere information)
English: They can be taken with or without food.
Danish: De kan tages med eller uden mad.
English: While administration of amprenavir with food results in a 25 % reduction in AUC, it had no effect on the concentration of amprenavir 12 hours after dosing (C12).
Danish: Selv om administration af amprenavir sammen med mad giver en reduktion af AUC på 25 %, har det ingen virkning på koncentrationen af amprenavir 12 timer efter indtagelse (C12).
English: This medicinal product should be used during pregnancy only after careful weighing of the potential benefits compared to the potential risk to the foetus.
Danish: Dette lægemiddel bør kun anvendes under graviditet efter nøje afvejning af de potentielle fordele mod den potentielle risiko for fosteret.
English: No studies on the effects on ability to drive and use machines have been performed (see section 4.8).
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner (se afsnit 4.8).
English: The concentration of amprenavir in the cerebrospinal fluid is less than 1 % of plasma concentration.
Danish: Koncentrationen af amprenavir i cerebrospinalvæsken er mindre end 1 % af plasmakoncentrationen.
English: In pregnant mice, rabbits and rats there were no major effects on embryo-foetal development.
Danish: Hos drægtige mus, kaniner og rotter sås ingen større påvirkning af den embryo-føtale udvikling.
English: No dose recommendations can be made regarding this combination.
Danish: Der kan derfor ikke gives doseringsanbefalinger til denne kombination.
English: The mechanism of this interaction remains unknown.
Danish: Mekanismen bag denne interaktion er ukendt.
English: In the event of overdosage, monitoring and management of acid-base abnormalities are recommended.
Danish: I tilfælde af overdosering anbefales overvågning og behandling af syre-base abnormiteter.
English: At present, there is insufficient information to recommend the use of Agenerase in children less than four years of age.
Danish: På nuværende tidspunkt er der ikke tilstrækkelig information til at anbefale brugen af Agenerase til børn under 4 år.
English: However, significant liver toxicity has not been observed in patients treated in clinical studies, either during administration of Agenerase or after discontinuation.
Danish: Der er dog ikke set betydende levertoksicitet hos patienter behandlet i kliniske undersøgelser, hverken under administration af Agenerase eller efter seponering.
English: Glycerol can cause headache, stomach upset and diarrhoea.
Danish: Glycerol kan give hovedpine, dårlig mave og diarré.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Danish: Hvis din læge har fortalt dig, at du har intolerance over for visse sukkerarter bør du kontakte lægen før du tager dette lægemiddel.
English: The frequency of this is unknown (see section 4.4).
Danish: Hyppigheden heraf er ukendt (se afsnit 4.4).
English: Most patients with mild or moderate rash can continue Agenerase.
Danish: De fleste patienter med mildt eller moderat udslæt kan fortsætte med Agenerase.
English: You should take Agenerase capsules as soon as you are able to swallow them.
Danish: Du bør tage Agenerase kapsler, ligeså snart du er i stand til at synke dem.
English: The active substance is amprenavir
Danish: Det aktive stof er amprenavir.
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Danish: Hæmofilipatienter bør derfor gøres opmærksom på muligheden for øget blødningstendens.
English: Amprenavir is a competitive inhibitor of HIV-1 protease.
Danish: Amprenavir er en kompetitiv hæmmer af HIV-1-proteasen.
English: Ask your doctor or pharmacist before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: While absolute free active substance concentrations remain constant, the percent of free active substance will fluctuate directly with total active substance concentrations at steady-state go from Cmax,ss to Cmin,ss over the course of the dosing interval.
Danish: Mens den absolutte koncentration af frit aktivt stof forbliver konstant, svinger procenten af frit aktivt stof direkte med den totale koncentration af aktivt stof ved steady state og går fra Cmax,ss til Cmin,ss i løbet af doseringsintervallet.
English: Date of last renewal: 17 November 2005
Danish: Dato for første markedsføringstilladelse: 20. oktober 2000 Fornyelse af tilladelsen: 17. november 2005
English: The long-term consequences of these events are currently unknown.
Danish: Langtidskonsekvenserne er i øjeblikket ukendte.
English: It is recommended that antacids and Agenerase should be administered at least one hour apart.
Danish: Det anbefales, at antacida og Agenerase administreres med mindst én times mellemrum.