FrancophonIA/ELRC3.0 huggingface dataset:
English: Such TK deficient strains would generally be expected to be cross-resistant to both penciclovir and aciclovir.
Danish: Sådanne TK-defekte stammer forventes normalt at være krydsresistente over for både penciclovir og acyclovir.
English: As primary patients typically experience a more severe first episode than patients experiencing a recurrent episode (Sacks 1995), it was deemed that a starting dose of 125mg famciclovir would be less efficacious than a higher dose.
Danish: Eftersom patienter med primær infektion typisk oplever en sværere primær infektion end patienter, der oplever recidivudbrud (Sacks 1995), blev det skønnet, at en startdosis på 125 mg famciclovir ville have en ringere effekt end en højere dosis.
English: Famvir is used to treat genital herpes infections in adults.
Danish: Famvir bruges til at behandle genital herpes hos voksne.
English: Therefore, 125mg bid dose was identified as the lowest effective dose.
Danish: Dosen på 125 mg BID blev derfor identificeret som den laveste effektive dosis.
English: Patients with localized herpes zoster involving the ophthalmic branch of the trigeminal nerve were enrolled.
Danish: Patienter med lokaliseret herpes zoster, der omfattede den oftalmiske del af trigeminusnerven, blev inkluderet.
English: Hence the probability of toxicity to mammalian host cells is low and uninfected cells are unlikely to be affected by therapeutic concentrations of penciclovir.
Danish: Derfor er sandsynligheden for toksicitet over for værtsceller i pattedyr lav, og det er ikke sandsynligt, at uinficerede celler vil blive påvirket af terapeutiske koncentrationer af penciclovir.
English: United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park
Danish: Storbritannien Novartis Pharmaceuticals UK Ltd Frimley Business Park
English: Always take Famvir exactly as your doctor has told you.
Danish: SÅDAN SKAL DU TAGE FAMVIR Tag altid Famvir nøjagtigt efter lægens anvisning.
English: If the woman's condition mandates treatment with famciclovir, discontinuation of breast-feeding may be considered.
Danish: Hvis kvindens situation kræver behandling med famciclovir, skal afbrydelse af amning overvejes.
English: Results from 11 worldwide clinical studies involving penciclovir (topical or intravenous formulations) or famciclovir in immunocompetent or immunocompromised patients, including studies of up to 12 months treatment with famciclovir, have shown a small overall frequency of penciclovir resistant isolates: 0.2% (2/913) in immunocompetent patients and 2.1% (6/288) in immunocompromised patients.
Danish: Resultater fra 11 globale forsøg med penciclovir (topikale eller intravenøse formuleringer) eller famciclovir hos immunkompetente eller immunkompromitterede patienter, inklusive undersøgelser af op til 12 måneders behandling med famciclovir, har vist en lille samlet frekvens af penciclovir-resistente isolater: 0,2% (2/913) hos immunkompetente og 2,1% (6/288) immunkompromitterede patienter.
English: Additionally, the reduced dosing frequency of famciclovir gave a greater patient acceptability.
Danish: Den reducerede doseringshyppighed for famciclovir medførte desuden større patientaccept.
English: The results of both studies are similar to what was reported by (Mertz, et al 1997) for immunocompetent patients in a 4-month study where 90% of patients receiving famciclovir remained free from virologically confirmed genital herpes as compared with 48% of placebo-treated patients.
Danish: Resultaterne af begge undersøgelser svarer til, hvad der blev indberettet af (Mertz, et al. 1997) for immunkompetente patienter i en firemåneders-undersøgelse, hvor 90 % af de patienter, der modtog famciclovir, forblev fri for virologisk bekræftet genital herpes sammenlignet med 48 % for de placebobehandlede patienter.
English: Famvir (famciclovir) was included in the list of products for SPC harmonisation and a referral was triggered in order to resolve divergences and harmonise the nationally authorised SPCs across Europe.
Danish: Famvir (famciclovir) var medtaget på listen over lægemidler, for hvilke produktresuméet skulle harmoniseres, og der blev foretaget en indbringelse for at løse spørgsmål om afvigelser og harmonisere de nationalt godkendte produktresuméer i Europa.
English: In contrast with toxicological findings, where famciclovir produced testicular toxicity in rats, mice and dogs at doses of at least 150mg/kg, these clinical studies clearly demonstrate that at therapeutic doses of 250mg bid (about 6mg/kg), famciclovir does not affect human spermatogenesis or semen quality.
Danish: I modsætning til toksikologiske resultater, hvor famciclovir dannede testikeltoksicitet hos rotter, mus og hunde ved doser på mindst 150 mg/kg, påviser disse kliniske undersøgelser tydeligt, at terapeutiske doser på 250 mg BID (ca. 6 mg/kg) famciclovir ikke påvirker spermatogenesen eller sædkvaliteten hos mennesker.
English: Considerations on the 750mg dose
Danish: Betragtninger vedrørende 750-mg-dosen
English: At that time the clinical benefits of aciclovir treatment had been well established and aciclovir was the standard of care for minimizing the ocular complications associated with ophthalmic zoster.
Danish: På det tidspunkt var de kliniske fordele ved behandling med aciclovir veldokumenterede, og aciclovir var standardbehandlingen for at minimere de øjenkomplikationer, der var forbundet med zoster ophthalmicus.
English: However, patients who experience certain adverse events should refrain from driving or operating machinery.
Danish: Patienter, som oplever visse bivirkninger, skal imidlertid undgå at føre motorkøretøj eller betjene maskiner.
English: In studies 033, and 049 it was noted that a dose-response relationship was not observed.
Danish: I undersøgelse 033 og 049 blev det bemærket, at der ikke blev observeret noget forhold mellem dosis og respons.
English: The results from trials show the lack of any effect on sperm count or concentration in particular, which provides strong evidence that the type of testicular toxicity seen in animals was not evident in patients.
Danish: Resultater af undersøgelser viser især en manglende effekt på sædcelletal eller -koncentration, hvilket giver en stærk evidens for, at den form for testikeltoksicitet, der er set hos dyr, ikke blev påvist hos mennesker.
English: D-90429 Nürnberg
Danish: D-90429 Nürnberg Tyskland
English: Regarding suppression, the posology of 250mg bid is in accordance with existing guidelines.
Danish: Doseringen på 250 mg BID for suppression er i overensstemmelse med de eksisterende retningslinjer.
English: • Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets, for frequency see below).
Danish: • Uforklarlige blå mærker, rødlige eller rødviolette mærker på huden eller næseblod (dette kan være tegn på et nedsat antal af blodplader, se hyppighed nedenfor).
English: Patients with herpes zoster infection
Danish: Patienter med herpes zoster-infektion
English: The CHMP agreed that the active treatments lead to a reduction in the rate of complications of ophthalmic zoster; the extent of which however remains disputable.
Danish: CHMP fastslog, at de aktive behandlinger medførte en reduktion i komplikationsraten for zoster ophthalmicus, men omfanget heraf er fortsat omtvisteligt.
English: Hypersensitivity to penciclovir.
Danish: Overfølsomhed over for penciclovir.
English: Effects of other medicinal products on famciclovir No clinically significant interactions have been identified.
Danish: Andre lægemidlers effekt på famciclovir Der er ikke identificeret klinisk relevante interaktioner.
English: All dose regimens were effective compared to placebo and similar to each other based on time to first clinically confirmed recurrence and proportion of patients free from virologically confirmed lesion episodes at 6 months.
Danish: Alle dosisregimer var effektive i sammenligning med placebo og var indbyrdes tilsvarende baseret på tiden til første klinisk bekræftede recidivudbrud og andelen af patienter, der var fri for virologisk bekræftede læsioner efter seks måneder.
English: The recommended dose for treating HIV-infected patients is larger than that recommended for immunocompetent patients as clinical experience and prescribing practice suggested that higher doses of antivirals are required to provide adequate suppression in HIV-infected patients.
Danish: Den anbefalede dosis til behandling af hiv-inficerede patienter er højere end den anbefalede dosis til immunkompetente patienter, idet klinisk erfaring og ordinationspraksis antydede, at tilstrækkelig suppression hos hiv-inficerede patienter kræver højere doser af antivirale lægemidler.
English: Children and adolescents (below the age of 18 years) Famvir is not recommended for use in children and adolescents.
Danish: Børn og unge (under 18 år) Det frarådes at bruge Famvir til børn og unge.
English: Study 008 demonstrated statistically significant differences of famciclovir 750mg tid (ter in die, three times a day) as compared to placebo with respect to the primary as well as several secondary endpoints.
Danish: Undersøgelse 008 påviste statistisk signifikante forskelle mellem famciclovir 750 mg TID (ter in die (tre gange daglig) times a day) og placebo med hensyn til de primære såvel som adskillige af de sekundære endepunkter.
English: The pivotal studies were conducted with different famciclovir dosing arms.
Danish: De pivotale undersøgelser blev foretaget med forskellige doseringsgrupper af famciclovir.
English: Patients were enrolled if they were immunocompromised following bone marrow or solid organ transplantation, or oncology treatment and had uncomplicated herpes zoster.
Danish: Patienter blev inkluderet, hvis de var immunkompromitterede som følge af knoglemarvstransplantation, transplantation af solide organer eller onkologisk behandling og led af ukompliceret herpes zoster.
English: - For the best results start the medicine as soon as possible after the first signs and symptoms appear.
Danish: Det bedste resultat af behandling opnås, hvis behandlingen startes så hurtigt som muligt efter, at de første tegn og symptomer opstår.
English: Penciclovir is dialysable; plasma concentrations are reduced by approximately 75% following 4 h haemodialysis.
Danish: Penciclovir kan dialyseres; plasmakoncentrationer reduceres med ca. 75 % efter 4 timers hæmodialyse.
English: It is unknown whether famciclovir is excreted in human breast milk.
Danish: Det vides ikke, om famcoclovir udskilles i brystmælk fra kvinder.
English: The primary efficacy parameter was the number (%) of days of viral shedding from anogenital sites.
Danish: Det primære effektparameter var antallet (%) af dage for virusudskillelse fra anogenitale steder.
English: Impaired fertility (including histopathological changes in the testis, altered sperm morphology, reduced sperm concentration and motility, and reduced fertility) was observed in male rats given 500 mg/kg/day.
Danish: Der blev observeret nedsat fertilitet (inklusive histopatologiske ændringer i testikler, ændret sædmorfologi, nedsat sædkoncentration og sædmotilitet og reduceret fertilitet) hos hanrotter, der fik 500 mg/kg/dag.
English: Small differences in renal clearance of penciclovir between females and males have been reported and were attributed to gender differences in renal function.
Danish: Der er rapporteret små forskelle i den renale clearance af penciclovir hos mænd og kvinder, og forskellene skyldes kønsspecifikke forskelle i nyrefunktionen.
English: However, it was noted that the proportion of placebo recipients with shedding from anogenital sites in Period 1 was approximately 4 times greater than that of famciclovir-treated patients with anogenital shedding, and differences between treatment groups in proportions of patients with shedding were statistically significant in both Period 1 and cross-over analyses.
Danish: Det blev imidlertid observeret, at andelen af placeborecipienter med udskillelse fra anogenitale steder i den første periode var ca. fire gange større end for famciclovir-behandlede patienter med anogenital udskillelse, og der var statistisk signifikante forskelle mellem behandlingsgrupperne på andelen af patienter med udskillelse i både den første periode og overkrydsningsanalyserne.
English: Famvir 125 mg, 250 mg and 500 mg (country specific) tablets contain lactose.
Danish: Famvir 125 mg, 250 mg og 500 mg (landespecifikt) tabletter indeholder laktose.
English: The CHMP considered that the study submitted in support of this indication (086) had several deficiencies (e.g. primary endpoint “new lesion formation while on medication”of questionable relevance, study not powered for comparison of secondary endpoints), but the data indicated a similar efficacy for famciclivir as aciclovir 5 x 800mg/day.
Danish: CHMP var af den opfattelse, at den undersøgelse, der blev indsendt som støtte for denne indikation (086), var mangelfuld på flere områder (f.eks. var det primære endepunkt "dannelse af nye læsioner, mens der modtages medicin" af tvivlsom relevans, og undersøgelsen havde ikke tilstrækkelig styrke til sammenligning af sekundære endepunkter), men dataene indikerede en lignende effekt for famciclovir og aciclovir 5 x 800 mg/dag.
English: Adjusted dose regimen
Danish: Justeret dosering
English: Over the 4 months of Study 195, 90% of HIV-infected patients remained free from clinically diagnosed recurrences.
Danish: I løbet af undersøgelse 195, som varede i fire måneder, forblev 90 % af de hiv-inficerede patienter fri for klinisk diagnosticerede recidivudbrud.
English: The results showed that both bid (bis in die, twice a day) regimens (125 and 250 bid) were significantly better than placebo.
Danish: Resultaterne viste, at begge BID-regimer (bis in die, to gange daglig) (125 og 250 BID) var væsentlig bedre end placebo.
English: Secondary variables included proportion of patients who developed new lesions during the study period (including time off study medication), time to complete healing, time to cessation of viral shedding and time to loss of lesion pain.
Danish: De sekundære variabler omfattede andelen af patienter, som udviklede nye læsioner i løbet af undersøgelsen (herunder i perioder, hvor de ikke modtog undersøgelsesmedicinen), tiden til komplet heling, tiden til ophør af virusudskillelse og tiden til aftaget læsionssmerte.
English: Famciclovir needs aldehyde oxidase to be converted into penciclovir, its active metabolite.
Danish: Famciclovir behøver aldehydoxidase for at blive omdannet til penciclovir, dets aktive metabolit.
English: Mean peak plasma concentration of penciclovir, following a 125 mg, 250 mg, 500 mg and 750 mg oral dose of famciclovir, was 0.8 microgram/ml, 1.6 micrograms/ml, 3.3 micrograms/ml and 5.1 micrograms/ml, respectively, and occurred at a median time of 45 minutes post-dose.
Danish: Den gennemsnitlige maksimale plasmakoncentration af penciclovir, efter en oral dosis af famciclovir på 125 mg, 250 mg, 500 mg og 750 mg, var henholdsvis 0,8 mikrogram/ml, 1,6 mikrogram /ml, 3,3 mikrogram/ml og 5,1 mikrogram /ml, og forekom ca. 45 minutter efter indtagelse.
English: The CHMP agreed that patients treated with 500mg tid co-administered with probenecid should be monitored for toxicity.
Danish: CHMP fastslog, at patienter behandlet med 500 mg TID administreret sammen med probenecid skulle overvåges for toksicitet.
English: Raloxifen has been shown to be a potent inhibitor of this enzyme in vitro.
Danish: Det er påvist, at raloxifen hæmmer dette enzym kraftigt in vitro.
English: All three doses were significantly superior to placebo in the time to healing of lesions, loss of symptoms and the time to cessation of viral shedding.
Danish: Alle tre doser var signifikant bedre end placebo med hensyn til tiden til heling af læsioner, tab af symptomer og tiden til ophør af virusudskillelse.
English: During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced.
Danish: Under suppressionsbehandling med antivirale midler er virusudskillelsen reduceret i betydelig grad.
English: Furthermore, long-term famciclovir treatment, at a dose of 250mg bid for 52 weeks, was well tolerated in men with recurrent genital herpes and demonstrated a safety profile comparable to placebo.
Danish: Endvidere var langvarig behandling med famciclovir ved en dosis på 250 mg BID i 52 uger veltolereret hos mænd med recidiverende genital herpes, og sikkerhedsprofilen var sammenlignelig med placebo.
English: Because reduced clearance of penciclovir is related to reduced renal function, as measured by creatinine clearance, special attention should be given to doses in patients with impaired renal function.
Danish: Da nedsat clearance af penciclovir er relateret til nedsat nyrefunktion, målt ved kreatininclearance, skal man være særlig opmærksom på doseringen hos patienter med nedsat nyrefunktion.
English: Results from studies 033 and 049 showed a significant effect of famciclovir with regard to suppression of recurrent genital herpes.
Danish: Resultaterne af undersøgelse 033 og 049 viste, at famciclovir havde en signifikant effekt med hensyn til suppression af recidiverende genital herpes.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke anvende dette lægemiddel.
English: Based on cross-study comparisons, the mean penciclovir AUC was about 30% higher and penciclovir renal clearance about 20% lower after oral administration of famciclovir in elderly volunteers (65-79 years) compared to younger volunteers.
Danish: Baseret på cross-over-studie-sammenligninger er det fundet, at den gennemsnitlige AUC for penciclovir var ca. 30 % højere, og penciclovirs renale clearance var ca. 20 % lavere efter oral administration af famciclovir hos ældre frivillige (65-79 år) sammenlignet med yngre frivillige.
English: SUPPRESSION OF RECURRENT HERPES
Danish: SUPPRESSION AF RECIDIVERENDE HERPES
English: Co-administration of raloxifene could affect the formation of penciclovir and thus the efficacy of famciclovir.
Danish: Samtidig administration af raloxifen kan måske påvirke dannelsen af penciclovir og dermed virkningen af famciclovir.
English: The famciclovir 125mg dose also appeared inferior to the higher doses in primary patients experiencing new lesions after start of antiviral treatment.
Danish: Famciclovir-dosen på 125 mg var tilsyneladende også ringere end de højere doser hos patienter med primær infektion, som oplevede nye læsioner efter at have påbegyndt antiviral behandling.
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes 764.E-08013 Barcelona Spain
Danish: Gran Via de les Corts Catalanes 764.E08013 Barcelona
English: In uninfected cells treated with penciclovir, concentrations of penciclovir-triphosphate are only barely detectable.
Danish: I uinficerede celler behandlet med penciclovir, er koncentrationerne af penciclovir-triphosphat kun lige akkurat påviselige.
English: Probenecid, a known inhibitor of the organic acid transport system, or drugs significantly eliminated by active renal tubular secretion may affect the renal elimination of penciclovir by inhibition or competition at the tubular secretion site.
Danish: Probenecid, som er en kendt hæmmer af transportsystemet for organisk syre, eller lægemidler, der hovedsagelig udskilles gennem aktiv renal tubulær sekretion, kan påvirke udskillelsen gennem nyrerne af penciclovir på grund af hæmning eller konkurrence på stedet for den tubulære sekretion.
English: Based on available data, the CHMP considered that the 500mg tid regimen appeared to be more efficacious than the 250mg tid regimen, with respect to the investigated endpoints.
Danish: CHMP fastslog på baggrund af de tilgængelige data, at regimet 500 mg TID forekom mere effektivt end 250 mg TID med hensyn til de undersøgte endepunkter.
English: The suggested dose of 500 mg tid famciclovir for 7 days could be endorsed.
Danish: Den foreslåede dosis på 500 mg TID famciclovir i syv dage kunne godkendes.
English: Overall, adverse reactions reported from clinical studies with immunocompromised patients were similar to those reported in the immunocompetent population.
Danish: Generelt var bivirkningerne rapporteret fra kliniske forsøg med immunkompromitterede patienter sammenlignelige med dem, som er rapporteret fra immunkompetente patienter.
English: The in vivo conversion of famciclovir to penciclovir involves two steps: the deacetylation of famciclovir to 6-deoxy penciclovir and the oxidation of 6-deoxy penciclovir to penciclovir.
Danish: In vivo-omdannelsen af famciclovir til penciclovir sker i to trin, nemlig deacetylering af famciclovir til 6-deoxy-penciclovir og oxidering af 6-deoxy-penciclovir til penciclovir.
English: To support the therapeutic benefit of famciclovir for the suppressive treatment of genital herpes, one dose-finding study (study 024) and two pivotal studies (studies 033 and 049) in immunocompetent patients, and one dose finding study (study 102) in immunocompromised patients were presented.
Danish: Som støtte for den terapeutiske fordel ved famciclovir til suppression af genital herpes blev der fremlagt en undersøgelse til bestemmelse af dosis (undersøgelse 024) og to pivotale undersøgelser (undersøgelse 033 og 049) hos immunkompetente patienter og en undersøgelse til bestemmelse af dosis (undersøgelse 102) hos immunkompromitterede patienter.
English: Famciclovir is eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine.
Danish: Famciclovir elimineres som penciclovir og dets 6-deoxy forstadium, som udskilles i urinen.
English: Immunocompetent patients with uncomplicated herpes zoster were enrolled in both studies.
Danish: Immunkompetente patienter med ukompliceret herpes zoster indgik i begge undersøgelserne.
English: The dose regimen for suppression of recurrent genital herpes in immunocompetent patients was addressed in three studies too.
Danish: Dosisregimet for suppression af recidiverende genital herpes hos immunkompetente patienter blev også behandlet i tre undersøgelser.
English: No consistent changes were observed in several sperm parameters following long-term treatment with 250mg famciclovir bid.
Danish: Der blev for en række sædcelleparametre ikke observeret nogen konsistente ændringer efter langvarig behandling med 250 mg BID famciclovir.
English: The CHMP noted that the daily dose recommended for episodic treatment of recurrent genital herpes (125mg bid) in immunocompetent patients is lower than the recommended dose for suppression (250mg bid).
Danish: CHMP bemærkede, at den anbefalede daglige dosis til episodisk behandling af recidiverende genital herpes (125 mg BID) hos immunkompetente patienter var lavere end den anbefalede dosis til suppression (250 mg BID).
English: A summary of the combined studies 102 and 195 show the benefits of famciclovir in suppressing HSV recurrence in the immunocompetent patient to the HIV-infected patient.
Danish: Et sammendrag af de kombinerede undersøgelser 102 og 195 viser fordelene ved famciclovir med hensyn til suppression af recidiverende HSV hos immunkompetente patienter for hiv-inficerede patienter.
English: Famvir is used to treat two types of viral infections in adults: - Shingles (herpes zoster), which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox).
Danish: Famvir bruges til at behandle to typer af virusinfektion hos voksne: - Helvedesild (herpes zoster), der er en virusinfektion, som forårsages af en virus, som kaldes varicella zoster (den samme virus, som giver skoldkopper).
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV1-infection (see section 5.1).
Danish: Der er ikke blevet foretaget kliniske undersøgelser blandt HSV-patienter, som er immunkompromitterede af andre årsager end HIV1-infektion (se afsnit 5.1).