FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the 250mg bid dose had the greatest effect on suppression in analysis of time to the first clinically confirmed recurrence of genital herpes.
Danish: 250 mg BID-dosen havde imidlertid den største effekt på suppression ved analyse af tiden til første klinisk bekræftede recidivudbrud af genital herpes.
English: Key secondary efficacy parameters were the number (%) of days of viral shedding from any site and the number (%) of days of site-specific viral shedding during each treatment period.
Danish: Vigtige sekundære effektparametre var antallet (%) af dage for virusudskillelse alle steder fra og antallet (%) af dage for stedspecifik virusudskillelse i løbet af hver behandlingsperiode.
English: Section 4.7: Effects on ability to drive and use machines
Danish: Afsnit 4.7: Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: In Study 102, 83% of HIV-infected patients receiving famciclovir remained recurrence-free as compared to 42% of patients receiving placebo.
Danish: I undersøgelse 102 forblev 83 % af de hiv-inficerede patienter, der modtog famciclovir, fri for recidivudbrud sammenlignet med 42 % af placebopatienterne.
English: Section 4.3: Contraindications
Danish: Afsnit 4.3: Kontraindikationer
English: For the 125mg famciclovir dose group there appeared to be a decrease in efficacy for some endpoints when compared with the higher dose groups that was consistent across the two trials.
Danish: Hvad angår gruppen med famciclovir-dosen på125 mg, var der tilsyneladende en nedsat effekt med hensyn til visse endepunkter ved sammenligning med højere dosisgrupper, og denne var konsistent i begge undersøgelser.
English: Common side effects - Feeling sick (nausea) - Vomiting - Dizziness - Drowsiness - Rash - Pruritus - Liver function test giving abnormal results
Danish: Almindelige bivirkninger - Kvalme - Opkastning - Svimmelhed - Døsighed - Hududslæt - Kløe - Leverundersøgelse, der giver unormale resultater
English: Pivotal studies 033 and 049 in immunocompetent patients were randomised, double-blind, placebo controlled trials.
Danish: De pivotale undersøgelser 033 og 049 af immunkompetente patienter var randomiserede, dobbeltblindede, placebokontrollerede undersøgelser.
English: Patients with complicated herpes zoster, i.e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy.
Danish: Patienter med kompliceret herpes zoster, d.v.s. patienter med organpåvirkning, dissemineret zoster, motoriske neuropatier, encefalitis og cerebrovaskulære komplikationer, bør behandles med intravenøs antiviral behandling.
English: Adverse reactions (Table 2) are ranked under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: Bivirkningerne (Tabel 2) er opstillet efter frekvens ved anvendelse af følgende definition: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); Ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMA
English: Secondary endpoints included time to loss of each vesicles, ulcers and crusts; duration of viral shedding; time to loss of acute pain; and duration of post-herpetic neuralgia (PHN).
Danish: De sekundære endepunkter omfattede tiden til tab af vesikler, sår og skorpedannelser, varigheden af virusudskillelse, tiden til aftaget akut smerte og varigheden af postherpetisk neuralgi (PHN).
English: Study 083 was presented to show efficacy in immunocompromised patients with herpes simplex virus infections.
Danish: Undersøgelse 083 blev forelagt for at vise effektiviteten hos immunkompromitterede patienter med herpes simplex-infektioner.
English: The viral DNA polymerase mistakenly incorporates the nucleoside analogue, penciclovir triphosphate, into the growing viral DNA strand instead of dGTP, which results in termination of the viral DNA chain and halting of viral replication.
Danish: Den virale DNA-polymerase indarbejder fejlagtigt den nukleoside analog, penciclovirtrifosfat, i den voksende virale DNA-streng i stedet for dGTP, hvilket medfører, at den virale DNA-kæde afsluttes, og formeringen af viralt DNA hæmmes.
English: Study 083 showed that famciclovir was as effective against herpes simplex in HIV positive patients as aciclovir.
Danish: Undersøgelse 083 viste, at famciclovir var lige så effektivt mod herpes simplex hos hiv-positive patienter som aciclovir.
English: Section 4.6: Pregnancy and lactation
Danish: Afsnit 4.6: Graviditet og amning
English: Secondary efficacy parameters included time to full crusting of lesions, time to complete healing, and evaluations of pain and dissemination.
Danish: De sekundære effektparametre omfattede tiden til fuldstændig skorpedannelse for læsioner, tiden til komplet heling og evalueringer af smerte og dissemination.
English: In study 086, immunocompromised patients with herpes zoster were treated for 10 days with famciclovir 500mg tid or aciclovir 800mg tid for 10 days.
Danish: I undersøgelse 086 blev immunkompromitterede patienter med herpes zoster behandlet i 10 dage med famciclovir 500 mg TID eller aciclovir 800 mg TID.
English: In people who already have kidney problems it may, rarely, lead to kidney failure if their dose is not correctly lowered.
Danish: Hos patienter, der på forhånd har nyreproblemer, kan det i sjældne tilfælde medføre nyresvigt, hvis deres dosis ikke er korrekt nedsat.
English: Grünwalder Gesundheitsprodukte GmbH
Danish: Grünwalder Gesundheitsprodukte GmbH Ruhlandstr.
English: Nevertheless, in comparison with literature reports for untreated or placebo-treated patients, famciclovir appeared to reduce important ocular manifestations.
Danish: Ikke desto mindre havde famciclovir, sammenlignet med rapporterne fra litteraturen vedrørende ubehandlede eller placebobehandlede patienter, tilsyneladende en reducerende virkning på vigtige øjenmanifestationer.
English: The pharmacokinetics of penciclovir have not been evaluated in patients with severe hepatic impairment.
Danish: Penciclovirs farmakokinetik er ikke evalueret hos patienter med alvorligt nedsat leverfunktion.
English: Bioavailability of penciclovir after oral administration of famciclovir was 77%.
Danish: Penciclovirs biotilgængelighed efter oral administration af famciclovir var 77 %.
English: Uncomplicated herpes zoster infection does not significantly alter the pharmacokinetics of penciclovir measured after the oral administration of famciclovir.
Danish: Ukompliceret herpes zoster-infektion ændrer ikke signifikant penciclovirs farmakokinetik målt efter oral administration af famciclovir.
English: The CHMP regarded the MAH's response not fully satisfactory.
Danish: CHMP anså ikke svaret fra indehaveren af markedsføringstilladelsen for at være fuldt ud tilfredsstillende.
English: Therefore, patients receiving famciclovir at a dose of 500 mg three times daily co-administered with probenecid, should be monitored for toxicity.
Danish: Patienter, der behandles med famciclovir i en dosis på 500 mg 3 gange daglig samtidig med probenecid, bør derfor monitoreres for toksicitet.
English: This triphosphate persists in infected cells in excess of 12 hours and inhibits viral DNA chain elongation by competitive inhibition with deoxyguanosine triphosphate for incorporation into the growing viral DNA, thus halting virus replication of viral DNA.
Danish: Dette triphosphat forbliver i de inficerede celler i mere end 12 timer og hæmmer viral DNA-kæde-elongering ved kompetitiv hæmning af inkorporering af deoxiguanosintrifosfat i det voksende virale DNA, dermed forhindres virusreplikation af viralt DNA.
English: Famvir is not recommended for use in children and adolescents below 18 years of age as no safety and efficacy data have been generated in this patient population.
Danish: Famvir anbefales ikke til børn og unge under 18 år på grund af manglende data om sikkerhed og effekt for denne patientpopulation.
English: Transmission of genital herpes
Danish: Overførsel af herpes genitalis
English: In line with the information in section 5.3, this section was updated, in particular regarding male fertility.
Danish: Dette afsnit blev opdateret, særlig med hensyn til mandlig fertilitet, i overensstemmelse med oplysningerne i afsnit 5.3.
English: Most of the analyses performed showed that only famciclovir 250mg bid gave significantly better results than placebo.
Danish: De fleste af analyserne viste, at kun famciclovir-dosen på 250 mg BID gav væsentlig bedre resultater end placebo.
English: Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.
Danish: Behandlingen bør påbegyndes hurtigst muligt efter at herpes zoster er diagnosticeret.
English: In the acute treatment of herpes zoster famciclovir 750mg tid resulted in a shorter time to full crusting than placebo, and both 750mg and 500mg tid resulted in shortened time to loss of vesicles and time to loss of ulcers.
Danish: Ved akut behandling af herpes zoster resulterede famciclovir-dosen på 750 mg TID i en reduktion af tiden til fuldstændig skorpedannelse i forhold til placebo, og både 750 mg og 500 mg TID resulterede i en reduktion af tiden til tab af vesikler og tiden til tab af sår.
English: Placebo-controlled and uncontrolled studies of up to 16 weeks duration showed that famciclovir was effective in the suppression of recurrent genital herpes in HIV-infected patients; the placebo-controlled study showed that famciclovir significantly decreased the proportion of days of both symptomatic and asymptomatic HSV shedding.
Danish: Placebokontrollerede og ukontrollerede studier af op til 16 måneders varighed viste, at famciclovir er effektivt i suppressionen af recidiverende herpes genitalis hos HIVsmittede patienter; det placebokontrollerede studie viste, at famciclovir signifikant nedsætter andelen af dage med såvel symptomatisk som asymptomatisk HSV-udskillelse.
English: Famciclovir was not found to be genotoxic in a comprehensive battery of in vivo and in vitro tests designed to detect gene mutation, chromosomal damage and repairable damage to DNA.
Danish: Famciclovir er ikke fundet genotoksisk i en stor samling af in vivo og in vitro tests designet til at opdage genmutationer, kromosomal skade og reparerbar skade (repairable damage) på DNA.
English: Two studies (035 and 036) were presented to examine three doses (125mg, 250mg and 500mg bid for five days) for the episodic treatment of recurrent genital herpes in immunocompetent patients.
Danish: Der blev fremlagt to undersøgelser (035 og 036) af tre doser (125 mg, 250 mg og 500 mg BID i fem dage) til episodisk behandling af recidiverende genital herpes hos immunkompetente patienter.
English: Famciclovir is rapidly converted in vivo into penciclovir, which has in vitro activity against herpes simplex viruses (HSV types 1 and 2), varicella zoster virus, Epstein-Barr virus and cytomegalovirus.
Danish: Famciclovir omdannes hurtigt in vivo til penciclovir, som har in vitro aktivitet mod herpes simplex virus (HSV type 1 og 2), varicella zoster virus, Epstein-Barr virus og cytomegalovirus.
English: Section 5.3: Preclinical safety data
Danish: Afsnit 5.3: Prækliniske sikkerhedsdata
English: Section 4.1 Therapeutic indication
Danish: Afsnit 4.1 Terapeutiske indikationer
English: In study 098 the famciclovir 500mg tid dose proved to be non-inferior to aciclovir 5 x 800 mg/day.
Danish: I undersøgelse 098 blev famciclovir-dosen på 500 mg TID påvist ikke at være dårligere end aciclovir 5 x 800 mg/dag.
English: Take special care with Famvir
Danish: Vær ekstra forsigtig med at tage Famvir
English: The approved daily dose regimen for either episodic or suppressive therapy of recurrent genital herpes in HIV-infected patients is 500mg bid.
Danish: Det godkendte daglige dosisregime for både episodisk og suppressiv behandling af recidiverende genital herpes hos hiv-inficerede patienter er 500 mg BID.
English: In study 004 the 750mg tid famciclovir dose was not superior to either the 250mg tid or 500mg tid dose on the primary efficacy endpoints and was not included in subsequent studies.
Danish: I undersøgelse 004 var famciclovir-dosen på 750 mg TID ikke bedre end hverken 250 mg TID-dosen eller 500 mg TID-dosen med hensyn til de primære effektmål, og dosen blev ikke medtaget i de efterfølgende undersøgelser.
English: The frequency of possible side effects listed below is defined using the following convention: - very common (affects more than 1 user in 10) - common (affects 1 to 10 users in 100) - uncommon (affects 1 to 10 users in 1,000) - rare (affects 1 to 10 users in 10,000) - very rare (affects less than 1 user in 10,000)
Danish: Hyppigheden af bivirkninger, som er nævnt nedenfor, er defineret på følgende måde: - Meget almindelig (forekommer hos flere end 1 ud af 10 patienter) - Almindelig (forekommer hos mellem 1 og 10 ud af 100 patienter) - Ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 patienter) - Sjældne (forekommer hos mellem 1 og 10 ud af 10.000 patienter) - Meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter)
English: However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking Famvir should refrain from driving or operating machinery.
Danish: Dog bør patienter, der under behandling med Famvir oplever svimmelhed, døsighed, forvirring eller andre forstyrrelser i centralnervesystemet, afstå fra at føre motorkøretøj eller betjene maskiner.
English: Initiation of treatment is recommended as soon as possible after a diagnosis of first episode of genital herpes.
Danish: Initiering af behandlig anbefales så hurtigt som muligt efter diagnosticering af primær herpes genitalis.
English: Famvir should not be used in case of hypersensitivity to the active substance, any of the excipients and penciclovir.
Danish: Famvir må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, et eller flere af hjælpestofferne eller penciclovir.
English: dosing, indicating that there is no accumulation of penciclovir on repeated dosing with famciclovir.
Danish: Dette indikerer, at der ikke er nogen akkumulering af penciclovir ved gentagen dosering af famciclovir.
English: Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.
Danish: Endvidere bør immunkompromitterede patienter med oftalmisk zoster, eller med høj risiko for dissimineret sygdom eller organpåvirkning, behandles med intravenøs antiviral behandling.
English: The famciclovir 500mg tid dose regimen was chosen as representing the highest approved dose for herpes zoster in immunocompetent patients.
Danish: Dosisregimet famciclovir 500 mg TID blev valgt til at udgøre den højeste godkendte dosis til behandling af herpes zoster hos immunkompetente patienter.
English: Method of administration Famvir can be taken without regard to meals (see section 5.2).
Danish: Indgivelsesmåde Famvir kan tages uafhængigt af måltider (se pkt.
English: Therefore, in addition to therapy with famciclovir, it is recommended that patients use safer sex practices.
Danish: I tillæg til famciclovirbehandling bør patienterne derfor dyrke sikker sex.
English: The CHMP concluded that the available data supported the efficacy and safety of the selected doses, both, the 125mg bid for treatment of recurrent episodes and the 250bid for suppressive therapy of genital herpes.
Danish: CHMP konkluderede, at de tilgængelige data understøttede effekten og sikkerheden af den valgte dosis, både 125 mg BID til behandling af recidivudbrud og 250 BID til suppressiv behandling af genital herpes.
English: The percentage of patients who experienced a loss in visual acuity during the study was twice as high for the aciclovir recipients as compared to those who received famciclovir.
Danish: Procentdelen af patienter, der oplevede et tab i synsstyrke i løbet af undersøgelsen var dobbelt så høj blandt patienter, der modtog aciclovir, som for patienter, der modtog famciclovir.
English: Based on results of these three studies, the 250mg bid dose was selected for suppression of genital herpes since it was superior to the once daily and 125mg bid regimens in study 024, its effectiveness was demonstrated in all three studies, and there was no clear advantage of the tid regimens over it in studies 033 and 049.
Danish: På baggrund af resultaterne af de tre undersøgelser blev 250 mg BID-dosen valgt til suppression af genital herpes, idet den var bedre end henholdsvis 250 mg én gang daglig og 125 mg BID i undersøgelse 024, dosens effekt blev påvist i alle tre undersøgelser, og TID-regimerne viste ingen tydelig fordel i forhold til denne dosis i undersøgelse 033 og 049.
English: − the treatment of herpes zoster in immunocompromised adults (see section 4.4)
Danish: − behandling af herpes zoster hos immunkompromitterede voksne (se afsnit 4.4).
English: Famciclovir is the oral prodrug of penciclovir.
Danish: Famciclovir er den orale prodrug af penciclovir.
English: Several indications were identified for Famvir in the SPCs of different MSs.
Danish: Der blev identificeret en række indikationer for Famvir i produktresuméerne i de forskellige medlemsstater.
English: There is no evidence of any increase in resistance despite the progressive increase in antiviral use The ability of HSV to establish a lifelong latent infection, together with the finding that the vast majority of resistant HSV isolates studied to date have reduced pathogenicity relative to wild-type virus, help to explain this observation.
Danish: HSV's evne til at etablere en livslang latent infektion sammen med den konklusion, at langt størstedelen af undersøgelserne af resistente HSV-isolater til dato har reduceret patogenecitet i relation til vildtypevirus, bidrager til at forklare denne observation.
English: Famciclovir was effective in the treatment of herpes zoster in immunocompromised patients.
Danish: Famciclovir var effektivt til behandling af herpes zoster hos immunkompromitterede patienter.
English: Famvir is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Danish: Famvir bør ikke anvendes til børn og unge under 18 år, p.g.a. manglende dokumentation for sikkerhed og virkning.
English: No dose adjustment based on age is recommended unless renal function is impaired.
Danish: Der anbefales ingen dosisjustering på baggrund af alder, medmindre nyrefunktionen er hæmmet.
English: If you have a reduced immune system, the doses are as follows:
Danish: Hvis dit immunsystem er nedsat, er doseringen:
English: The terminal plasma half-life of penciclovir in patients with herpes zoster was 2.8 h and 2.7 h, respectively, after single and repeated dosing of famciclovir.
Danish: Penciclovirs terminale plasmahalveringstid hos patienter med herpes zoster var henholdsvis 2,8 timer og 2,7 timer efter indgift af enkelt dosis og gentagen dosering af famciclovir.
English: Famvir is indicated for episodic treatment of recurrent herpes simplex infections in the HIV-infected patient where the recommended dose regimen is 500 mg twice daily for seven days.
Danish: Famvir er indiceret til episodisk behandling af recidiverende herpes simplex-infektioner hos hivinficerede patienter, hvor det anbefalede dosisregime er 500 mg to gange daglig i syv dage.
English: For either the primary or secondary efficacy endpoints, there were no significant differences.
Danish: Der var ingen signifikante forskelle med hensyn til hverken de primære eller de sekundære effektmål.
English: Study 098 was a multicentre randomised, double-blind, double-dummy study, comparing famciclovir 500mg tid with aciclovir 800mg 5 times daily.
Danish: Undersøgelse 098 var en randomiseret, dobbeltblindet, dobbelt-dummy multicenterundersøgelse, hvor famciclovir 500 mg TID sammenlignes med aciclovir 800 mg fem gange daglig.
English: The CHMP agreed that famciclovir resulted in a significant reduction in time to resolution of cutaneous signs of herpes zoster.
Danish: CHMP fastslog, at famciclovir medførte en signifikant reduktion af den tid, det tager at bringe de kutane symptomer på herpes zoster til ophør.
English: The scope of the referral included all strengths (125mg, 250mg, 500mg and 750mg) and licenses.
Danish: Indbringelsen omfattede alle styrker (125 mg, 250 mg, 500 mg og 750 mg) og tilladelser.
English: The terminal plasma half-life of penciclovir after both single and repeat dosing with famciclovir was approximately 2 hours.
Danish: Den terminale plasmahalveringstid for penciclovir efter både en enkelt dosis og gentagne doser af famciclovir var ca. 2 timer.
English: Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, the active metabolite of famciclovir, by competing for elimination.
Danish: Samtidig brug af probenecid kan medføre en øget plasmakoncentration af penciclovir, famciclovirs aktive metabolit, ved kompetitiv elimination.
English: No disharmony on the dosage regimen for this indication was noted across MS.
Danish: Der blev ikke observeret nogen uenighed blandt medlemsstaterne med hensyn til dosisregimet for denne indikation.
English: Table 1 Dose recommendations for adult patients with renal impairment Indication and nominal dose regimen
Danish: Table 1 Anbefalet dosering til voksne patienter med nedsat nyrefunktion Indikation og angivet dosering Kreatinineclearance
English: Famciclovir is the oral prodrug of the antiviral nucleoside analogue penciclovir, which has activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV).
Danish: Famciclovir er det perorale prodrug af den antivirale nukleoside analog penciclovir, som er virksomt mod herpes simplex-virus type 1 (HSV-1) og 2 (HVS-2) og varicella zoster-virus (VZV).
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 [See Annex I - To be completed nationally]
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 [Se bilag I - Udfyldes nationalt]
English: Based on the available data, the CHMP agreed that the indication treatment of herpes zoster in immunocompetent and immunocompromised patients was recommended.
Danish: CHMP fastslog på baggrund af de tilgængelige data, at indikationen behandling af herpes zoster hos immunkompetente og immunkompromitterede patienter blev anbefalet.
English: In the pivotal studies 033 and 049, the 250mg bid dose was assessed along with 125mg tid and 250mg tid doses.
Danish: I de pivotale undersøgelser 033 og 049 vurderedes 250 mg BID-dosen sammen med 125 mg TIDdosen og 250 mg TID-dosen.
English: The apparent plasma clearance, renal clearance, and plasma elimination rate constant of penciclovir decreased linearly with reductions in renal function, both after single and repeated dosing.
Danish: Penciclovirs plasmaclearance, renal clearance og plasma-eliminations-hastighedskonstant aftager lineært med reduktion i nyrefunktion, både efter enkelt og gentagen dosering.
English: Demetriades & Papaellinas Ltd 21 Kasou P.O.
Danish: Demetriades & Papaellinas Ltd 21 Kasou P.O. Box 23490 Nicosia