FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies 035 and 036 were randomised, double-blind, placebo-controlled multicentre trials designed to compare the efficacy and safety of 3 doses of famciclovir (125mg, 250mg, 500mg) with that of placebo for acute treatment of a recurrent episode of genital herpes.
Danish: Undersøgelse 035 og 036 var randomiserede, dobbeltblindede, placebokontrollerede multicenterundersøgelser, der var udformet til at sammenligne effektiviteten og sikkerheden af tre doser famciclovir (125 mg, 250 mg og 500 mg) med tilsvarende doser placebo til akut behandling af recidiverende genital herpes.
English: Famvir and associated names (see Annex I) 125 mg film-coated tablets Famvir and associated names (see Annex I) 250 mg film-coated tablets Famvir and associated names (see Annex I) 500 mg film-coated tablets
Danish: Famvir og tilhørende navne (Se Bilag I) 125 mg filmovertrukne tabletter Famvir og tilhørende navne (Se Bilag I) 250 mg filmovertrukne tabletter Famvir og tilhørende navne (Se Bilag I) 500 mg filmovertrukne tabletter
English: Study 102 compared the famciclovir 500mg bid dose with placebo.
Danish: I undersøgelse 102 sammenlignedes famciclovir-dosis 500 mg BID med placebo.
English: Study 024 was a randomised, double-blind, placebo-controlled trial which looked at time to first recurrence.
Danish: Undersøgelse 024 var en randomiseret, dobbeltblindet, placebokontrolleret undersøgelse, hvori man undersøgte tiden til første recidivudbrud.
English: Study 102 was a randomised, double-blind, placebo-controlled, crossover study to assess the safety and efficacy of oral famciclovir in the suppression of symptomatic and asymptomatic recurrent genital herpes in HIV-infected patients.
Danish: Undersøgelse 102 var en randomiseret, dobbeltblindet, placebokontrolleret overkrydsningsundersøgelse, der skulle vurdere sikkerheden og effektiviteten af peroral famciclovir ved suppression af symptomatisk og asymptomatisk recidiverende genital herpes hos hiv-inficerede patienter.
English: The doses selected for episodic treatment and suppression of recurrent genital herpes in the immunocompetent patient were determined in replicate, multiple-dose, placebo-controlled trials.
Danish: Den valgte dosis til episodisk behandling og suppression af recidiverende genital herpes hos immunkompetente patienter blev fastsat i gentagne, placebokontrollerede flerdosisundersøgelser.
English: GENITAL HERPES IMMUNOCOMPETENT ADULTS INITIAL (FIRST) EPISODE
Danish: GENITAL HERPES IMMUNKOMPETENTE VOKSNE PRIMÆR (FØRSTE) INFEKTION
English: Two placebo-controlled 12-month studies in immunocompetent patients with recurrent genital herpes showed that famciclovir-treated patients had a significant reduction of recurrences as compared to placebo-treated patients.
Danish: To placebokontrollerede 12 måneders studier hos immunkompetente patienter med recidiverende herpes genitalis viste, at famciclovirbehandlede patienter opnåede signifikant reduktion af recidiv sammenlignet med placebobehandlede patienter.
English: Famvir is not to be used during breast-feeding unless clearly necessary.
Danish: Du må ikke tage Famvir, hvis du ammer, medmindre det er absolut nødvendigt.
English: On this endpoint the 250mg bid dose was superior to the 125mg bid dose.
Danish: For dette endepunkt var 250 mg BIDdosen bedre end 125 mg BID-dosen.
English: However, it agreed that the indication suppression of recurrent genital herpes in immunocompetent and immunocompromised adults was supported by the available data.
Danish: Udvalget fastslog imidlertid, at indikationen suppression af recidiverende genital herpes hos immunkompetente og immunkompromitterede voksne var understøttet af de tilgængelige data.
English: Mild and moderate hepatic impairment had no effect on the extent of systemic availability of penciclovir following oral administration of famciclovir.
Danish: Mildt til moderat nedsat leverfunktion havde ingen effekt på omfanget af systemisk biotilgængelighed af penciclovir efter oral administration af famciclovir.
English: Acute renal failure has been reported rarely in patients with underlying renal disease where the famciclovir dose has not been appropriately reduced for the level of renal function.
Danish: I sjældne tilfælde er der forekommet akut nyresvigt hos patienter med eksisterende nyresygdom, hvor dosis af famciclovir ikke var tilstrækkeligt afpasset efter graden af nyrefunktionsnedsættelse.
English: The study was a randomised, aciclovir-controlled, double-blind, double-dummy multicentre study of famciclovir vs. aciclovir in clinic-initiated episodic treatment of recurrent mucocutaneous herpes simplex virus infections in HIV-infected patients.
Danish: Undersøgelsen var en randomiseret, aciclovir-kontrolleret, dobbeltblindet, dobbelt-dummy multicenterundersøgelse af famciclovir over for aciclovir i klinik-initieret, episodisk behandling af recidiverende mukokutane herpes simplex-infektioner hos hiv-inficerede patienter.
English: • Famvir has been prescribed for you.
Danish: • Lægen har ordineret Famvir til dig personligt.
English: Section 4.8: Undesirable effects
Danish: Afsnit 4.8: Bivirkninger
English: In the two pivotal studies three regimen were investigated: 125mg tid, 250mg bid, 250mg tid.
Danish: I de to pivotale undersøgelser undersøgtes følgende tre regimer: 125 mg TID, 250 mg BID og 250 mg TID.
English: In an active-controlled clinical study, famciclovir was shown to be effective in the treatment of ophthalmic zoster in immunocompetent patients.
Danish: Et aktivt kontrolleret klinisk forsøg viste, at famciclovir er effektivt ved behandling af oftalmisk zoster hos immunkompetente patienter.
English: Therefore, the 250mg dose of famciclovir was selected as the lowest effective dose to treat first episode genital herpes.
Danish: Dosen på 250 mg famciclovir blev derfor valgt som den laveste effektive dosis til behandling af primære infektioner med genital herpes.
English: The dose recommendations proposed for patients with renal impairment, renal impairment on haemodialysis, hepatic impairment and elderly were endorsed by the CHMP.
Danish: De doser, der anbefales til patienter med nyreinsufficiens, nyreinsufficiens i hæmodialyse, leverinsufficiens og til ældre, blev godkendt af CHMP.
English: A dose ranging study (024) found that both 125mg and 250mg bid regimens were significantly better than placebo.
Danish: En dosisundersøgelse (024) viste, at både regime 125 mg BID og 250 mg BID var væsentlig bedre end placebo.
English: The recommended dose regimens for haemodialysis patients are included in Table 1.
Danish: Det anbefalede dosisregimen til hæmodialysepatienter findes i Tabel 1
English: Package leaflet The package leaflet was updated to reflect the SPC harmonisation.
Danish: Indlægsseddel Indlægssedlen blev opdateret, så den afspejlede harmoniseringen af produktresuméet.
English: Two placebo-controlled studies in immunocompetent patients and one-active controlled study in HIV-infected patients with recurrent genital herpes showed that famciclovir was effective.
Danish: To placebokontrollerede studier hos immunkompetente patienter og et aktivt kontrolleret studie hos HIV-smittede patienter med recidiverende herpes genitalis viste, at famciclovir er effektivt.
English: No dose adjustment based on age is recommended unless renal function is impaired (see section 4.2).
Danish: Dosisjustering baseret på alder anbefales ikke, medmindre nyrefunktionen er nedsat (se pkt.
English: Section 5.2: Pharmacokinetic properties
Danish: Afsnit 5.2: Farmakokinetiske egenskaber
English: However, famciclovir is rapidly converted in vivo to penciclovir, which is eliminated from plasma predominantly by renal excretion.
Danish: Famciclovir omdannes imidlertid hurtigt in-vivo til penciclovir, som hovedsagelig udskilles fra plasma gennem nyrerne.
English: Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir.
Danish: Omdannelse af famciclovir til den aktive metabolit penciclovir kan muligvis blive nedsat hos disse patienter resulterende i lavere plasmakoncentrationer af penciclovir og dermed mulig nedsat effekt af famciclovir.
English: IMMUNOCOMPROMISED ADULTS EPISODIC TREATMENT OF RECURRENT HERPES
Danish: IMMUNKOMPROMITTEREDE VOKSNE EPISODISK BEHANDLING AF RECIDIVERENDE HERPES
English: Patients who met eligibility criteria were randomly assigned to receive either famciclovir (125mg tid, 250mg bid, or 250mg tid.)
Danish: Patienter, som opfyldte deltagelseskriterierne blev randomiseret til at modtage behandling med enten famciclovir (125 mg TID, 250 mg BID eller 250 mg TID) eller placebo i 52 uger.
English: The proportion of patients who experienced an ocular manifestation during the study was similar between famciclovir and aciclovir recipients.
Danish: Andelen af patienter, der oplevede en øjenmanifestation i løbet af undersøgelsen, var tilsvarende for patienter, der modtog famciclovir, og patienter, der modtog aciclovir.
English: The CHMP endorsed the 500mg tid dose during a period of 7 days for this indication.
Danish: CHMP godkendte dosen på 500 mg TID i syv dage for denne indikation.
English: An analysis of current data on viral resistance to famciclovir was reviewed and reflected in this section.
Danish: Der blev i dette afsnit gennemgået og afspejlet en analyse af aktuelle data om viral resistens over for famciclovir.
English: Episodic treatment of recurrent genital herpes: 125 mg twice daily for five days.
Danish: Episodisk behandling af recidiverende genital herpes: 125 mg 2 gange daglig i 5 dage.
English: Famciclovir is the oral prodrug of the antivirally active compound penciclovir.
Danish: Famciclovir er det orale prodrug af det antiviralt aktive stof penciclovir.
English: Herpes simplex virus (HSV) infections - genital herpes Famvir is indicated for
Danish: Herpes simplex (HSV)-virus-infektioner - herpes genitalis Famvir er indiceret til
English: At high doses in female rats, there was an increased incidence of mammary adenocarcinoma, a tumour commonly observed in the strain of rats used in the carcinogenicity study.
Danish: Der var ikke øget forekomst af adenokarcinomer i mamma, en tumorform som ofte observeres hos den rottestamme, som bruges til karcinogenicitetsstudier.
English: Penciclovir reaches its maximum plasma concentration within 1 hour of administration.
Danish: De højeste plasmakoncentrationer for penciclovir nås inden for en time efter indgift.
English: In virus-infected cells the viral thymidine kinase (TK) phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases.
Danish: I virusinficerede celler fosforylerer den virale thymidinkinase (TK) penciclovir til en monofosfatform, som igen omdannes til penciclovirtrifosfat ved hjælp af cellulære kinaser.
English: Creatinine clearance [ml/min]
Danish: [ml/min]
English: Varicella zoster virus (VZV) infections - herpes zoster Famvir is indicated for
Danish: Varicella-zoster-virus (VZV)-infektioner - herpes zoster Famvir er indiceret til
English: Uncommon side effects - Confusion - Severe skin reactions
Danish: Forvirring - Alvorlige hudreaktioner
English: Section 5.1: Pharmacodynamic properties
Danish: Afsnit 5.1: Farmakodynamiske egenskaber
English: The CHMP agreed that the indication treatment of ophthalmic zoster in immunocompetent patients was supported by the available data.
Danish: CHMP fastslog, at indikationen behandling af zoster ophthalmicus hos immunkompetente patienter, var understøttet af de tilgængelige data.
English: The CHMP agreed that the indication treatment of first and recurrent episodes of genital herpes in immunocompetent patients and treatment of recurrent episodes of genital herpes in immunocompromised patients was supported by the available data.
Danish: CHMP fastslog, at indikationen behandling af primær infektion og recidivudbrud af genital herpes hos immunkompetente patienter og behandling af recidiverende genital herpes hos immunkompromitterede patienter var understøttet af de tilgængelige data.
English: The primary efficacy endpoint in both studies was time to full crusting of lesions in the primary affected dermatomal region in the intent-to-treat (ITT) population.
Danish: for læsioner i det primære berørte dermatomale område hos "intent to treat"-populationen (ITT).
English: In infected cells, penciclovir is rapidly converted via viral thymidine kinase to penciclovir monophosphate which, in turn, is converted to penciclovir triphosphate by cellular kinases.
Danish: I inficerede celler omdannes penciclovir hurtigt til penciclovirmonofosfat ved hjælp af viral thymidinkinase, som igen omdannes til penciclovirtrifosfat ved hjælp af cellulære kinaser.
English: Dose recommendations for adult patients with renal impairment are provided in Table 1.
Danish: Anbefalet dosering til voksne patienter med nedsat nyrefunktion er givet i Tabel 1
English: Efficacy of famciclovir in immunocompetent patients with first episode of genital herpes was shown in three active-controlled studies.
Danish: Der er påvist effekt af famciclovir hos immunkompetente patienter med primær herpes genitalis i tre aktivt kontrollerede forsøg.
English: PHARMACEUTICAL FORM Film-coated tablet [To be completed nationally]
Danish: LÆGEMIDDELFORM Filmovertrukket tablet [Udfyldes nationalt]
English: Recently two papers on human liver aldehyde oxidase inhibition in in vitro investigations were published (Obach 2004; Obach, et al 2004).
Danish: Der blev for nylig publiceret to dokumenter (Obach 2004 og Obach, et al. 2004) om human lever-aldehydoxidasehæmning i in vitroundersøgelser.
English: Following oral administration, famciclovir undergoes extensive first-pass metabolism to be transformed into penciclovir.
Danish: Efter peroral administration omdannes famciclovir via omfattende førstepassagemetabolisme til penciclovir.
English: If you have taken more tablets than you have been told to take, or if someone else accidentally takes your medicine, go to your doctor or hospital for advice immediately.
Danish: Kontakt straks din læge eller hospitalet, hvis du har taget flere tabletter, end du har fået besked på at tage, eller hvis nogen ved et uheld tager din medicin.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukne tabletter [Udfyldes nationalt]
English: Film-coated tablets [To be completed nationally]
Danish: Filmovertrukne tabletter [Udfyldes nationalt]
English: In placebo-controlled and active-controlled studies both in immunocompetent and immunocompromised patients with uncomplicated herpes zoster, famciclovir was effective in the resolution of lesions.
Danish: Placebo- og aktivt kontrollerede studier hos både immunkompetente og immunkompromitterede patienter med ukompliceret herpes zoster, har vist, at famciclovir har effekt på forbedring af læsioner.
English: Study 008 was a randomised, double-blind, placebo-controlled study.
Danish: Undersøgelse 008 var en randomiseret, dobbeltblindet, placebokontrolleret undersøgelse.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Se bilag I - Udfyldes nationalt]
English: The absolute bioavailability of penciclovir after administration of famciclovir is 77%.
Danish: Den absolutte biotilgængelighed for penciclovir efter administration af famciclovir er på
English: Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: JO5AB09
Danish: revers transcriptase-hæmmere, ATC-kode: J05A B09
English: • [To be completed nationally]
Danish: • [Udfyldes nationalt].
English: GENITAL HERPES, FIRST AND RECURRENT EPISODES IN IMMUNOCOMPETENT ADULTS AND RECURRENT EPISODES IN IMMUNOCOMPROMISED ADULTS
Danish: GENITAL HERPES, PRIMÆR INFEKTION OG RECIDIVUDBRUD HOS IMMUNKOMPETENTE VOKSNE OG RECIDIVUDBRUD HOS IMMUNKOMPROMITTEREDE VOKSNE
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med mildt til moderat nedsat leverfunktion.
English: Study 007 was a randomised, double-blind, double-dummy, active-controlled study.
Danish: Undersøgelse 007 var en randomiseret, dobbeltblindet, dobbelt-dummy, aktivt kontrolleret undersøgelse.
English: EPISODIC TREATMENT OF RECURRENT HERPES AND SUPPRESSION OF RECURRENT HERPESNo inconsistencies were observed with regards to episodic treatment across MSs therefore 125mg twice bid for five days was considered as the acceptable posology for this indication.
Danish: Der blev ikke observeret nogen afvigelser med hensyn til episodisk behandling i de forskellige medlemsstater, og 125 mg BID i fem dage blev derfor betragtet som den acceptable dosering for denne indikation.
English: Recurrent genital herpes in immunocompromised adults Episodic treatment of recurrent genital herpes: 500 mg twice daily for seven days.
Danish: Recidiverende herpes genitalis hos immunkompromitterede voksne Episodisk behandling af recidiverende herpes genitalis: 500 mg 2 gange daglig i 7 dage.
English: First episode of genital herpes: 250 mg three times daily for five days.
Danish: Primær herpes genitalis: 250 mg 3 gange daglig i 5 dage.
English: − the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section
Danish: • behandling af herpes zoster og oftalmisk zoster hos immunkompetente voksne (se pkt.
English: The CHMP thus endorsed the 500mg bid for seven days as the approved posology in this indication.
Danish: CHMP godkendte således doseringen 500 mg BID i syv dage for denne indikation.
English: Study 086 was a randomised, double-blind, double-dummy, active-controlled multicentre study.
Danish: Undersøgelse 086 var en randomiseret, dobbeltblindet, dobbelt-dummy, aktivt kontrolleret multicenterundersøgelse.
English: Section 4.2: Posology and Method of Administration
Danish: Afsnit 4.2: Dosering og indgivelsesmåde
English: HERPES ZOSTER HERPES ZOSTER IN IMMUNOCOMPETENT ADULTS
Danish: HERPES ZOSTER HERPES ZOSTER HOS IMMUNKOMPETENTE VOKSNE
English: Filmtabletten
Danish: INDLÆGSSEDDEL
English: Prevent passing genital herpes to others
Danish: Undgå at smitte andre med genital herpes
English: Clinical data do not indicate an impact of famciclovir on male fertility following long-term treatment at an oral dose of 250 mg twice daily (see section 5.3).
Danish: Kliniske data fra langtidsbehandling med en oral dosis på 250 mg 2 gange daglig tyder ikke på, at famciclovir har indflydelse på den mandlige fertilitet (se pkt.
English: Conversion of famciclovir to its active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus a decrease of efficacy of famciclovir may occur.
Danish: Omdannelsen af famciclovir til den aktive metabolit penciclovir kan være nedsat hos disse patienter, hvilket resulterer i lavere plasmakoncentrationer af penciclovir.
English: HERPES ZOSTER IN IMMUNOCOMPROMISED ADULTS
Danish: HERPES ZOSTER HOS IMMUNKOMPROMITTEREDE VOKSNE
English: Dose adjustment is necessary in patients with renal impairment (see section 4.2).
Danish: Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Suppression of recurrent genital herpes in immunocompetent adults 250 mg twice daily.
Danish: Suppression af recidiverende genital herpes hos immunkompetente voksne 250 mg 2 gange daglig.
English: What Famvir is and what it is used for Before you take Famvir How to take Famvir Possible side effects How to store Famvir Further information
Danish: Det skal du vide, før du begynder at tage Famvir Sådan skal du tage Famvir Bivirkninger
English: Haemodialysis patients 125 mg following each dialysis
Danish: Hæmodialysepatienter 125 mg efter hver dialyse
English: To prevent future outbreaks, the dose is - one tablet of 500 mg twice a day.
Danish: For at forebygge fremtidige udbrud, er dosis - én tablet på 500 mg to gange daglig.
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1).
Danish: Der er kun udført kliniske forsøg hos HSV-inficerede patienter, der var immunkompromitterede på grund af HIV-infektion (se pkt.
English: HERPES ZOSTER IN IMMUNOCOMPETENT AND IMMUNOCOMPROMISED ADULTS
Danish: HERPES ZOSTER HOS IMMUNKOMPETENTE OG IMMUNKOMPROMITTEREDE VOKSNE
English: BEFORE YOU TAKE FAMVIR
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE FAMVIR
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelse Særnavn
English: OPHTHALMIC ZOSTER IN IMMUNOCOMPETENT ADULTS
Danish: ZOSTER OPHTHALMICUS HOS IMMUNKOMPETENTE VOKSNE
English: To treat further outbreaks, the recommended dose is: - one tablet of 125 mg twice a day, for five days.
Danish: For at behandle yderligere udbrud, er den anbefalede dosis: - én tablet på 125 mg, to gange daglig i 5 dage.
English: No data are available for patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Der er ingen tilgængelige data for patienter med alvorlig nedsat leverfunktion (se pkt.
English: To treat the current outbreak, the recommended dose is: - one tablet of 500 mg twice a day, for seven days.
Danish: For at behandle det aktuelle udbrud, er den anbefalede dosis: - én tablet på 500 mg, to gange daglig i syv dage.
English: Genital herpes in immunocompetent adults
Danish: Herpes genitalis hos immunkompetente voksne
English: Contact a doctor or go to the emergency department at your nearest hospital straight away if you get any of these effects.
Danish: Hvis du oplever nogle af disse bivirkninger, skal du straks kontakte lægen eller tage på skadestuen på det nærmeste hospital.
English: Do not take Famvir - If you are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famvir listed in section 6, or to penciclovir (the active metabolite of famciclovir and an ingredient of some other medicines).
Danish: Tag ikke Famvir - Hvis du er overfølsom (allergisk) over for famciclovir, et af de øvrige indholdsstoffer i Famvir,
English: 125 mg twice daily for 5 days
Danish: 125 mg 2 gange daglig i 5 dage
English: Haemodialysis patients 250 mg following each dialysis
Danish: Hæmodialysepatienter 250 mg efter hver dialyse
English: If you have a normal immune system, the recommended dose is - one tablet of 500 mg, three times a day, for seven days
Danish: Hvis dit immunsystem er normalt, er den anbefalede dosis - én tablet på 500 mg, tre gange daglig i syv dage
English: To prevent future outbreaks, the recommended dose is: - one tablet of 250 mg twice a day.
Danish: For at forebygge yderligere udbrud, er den anbefalede dosis: - én tablet på 250 mg to gange daglig.
English: If you have a reduced immune system, the recommended dose is - one tablet of 500 mg three times a day, for ten days.
Danish: Hvis dit immunsystem er nedsat, er den anbefalede dosis - én tablet på 500 mg, tre gange daglig i 10 dage.
English: Plasma concentration-time curves of penciclovir are similar following single and repeat (t.i.d.
Danish: Penciclovirs plasmakoncentration/tid-kurver er de samme efter enkelt dosis og gentagne doser (2 gange daglig og 3 gange daglig).
English: For the first outbreak, the recommended dose is: - one tablet of 250 mg three times a day, for five days.
Danish: Ved første udbrud er den anbefalede dosis: - én tablet på 250 mg, tre gange daglig i 5 dage.
English: 250 mg three times daily for 5 days
Danish: 250 mg 3 gange daglig i 5 dage
English: Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated.
Danish: Selvom behandling med et antiviralt middel er påbegyndt, bør det tilrådes, at patienten undgår samleje, så længe der er symptomer til stede.
English: 250 mg twice daily for 5 days 250 mg once daily for 5 days Haemodialysis patients 250 mg following each dialysis during 5 days
Danish: 250 mg 2 gange daglig i 5 dage 250 mg 1 gang daglig i 5 dage Hæmodialysepatienter 250 mg efter hver dialyse i 5 dage