FrancophonIA/ELRC3.0 huggingface dataset:
English: In additional studies in rats, foetal abnormalities and maternal toxicity were observed at subcutaneous doses that produced plasma aciclovir levels of 100 micrograms/mL (>10-fold higher than 2000 mg single dose valaciclovir in humans with normal renal function).
Danish: I supplerende studier med rotter blev fosterabnormiteter og toksicitet hos moderdyret observeret ved subkutane doser, der gav plasmaniveauer af aciclovir på 100 mikrogram/ml (> 10 gange højere end ved enkeltdosis af 2.000 mg valaciclovir hos mennesker med normal nyrefunktion).
English: Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form.
Danish: Aciclovir hæmmer herpesvirus-DNA-syntesen, efter at aciclovir er blevet fosforyleret til det aktive aciclovirtriphosphat.
English: The MAH completed two studies to determine the safety and efficacy of VACV compared to ACV or placebo for the prophylaxis of CMV infection and disease in solid organ transplant.
Danish: Indehaveren af markedsføringstilladelsen gennemførte to undersøgelser for at fastslå sikkerhed og effekt af VACV sammenlignet med ACV eller placebo til profylakse af CMV-infektioner og sygdomme i transplanteret organ.
English: In plasma as well as CSF, concentrations of aciclovir, CMMG and 8-OH-ACV were on average 2, 4 and 5-6 times higher, respectively, at severe renal impairment compared with normal renal function.
Danish: Koncentrationerne af aciclovir, CMMG og 8-OH-ACV i såvel plasma som CSV var gennemsnitligt henholdsvis 2, 4 og 5-6 gange højere ved svært nedsat nyrefunktion end ved normal nyrefunktion.
English: The valaciclovir and aciclovir pharmacokinetic profiles are similar after single and repeat dosing.
Danish: Valaciclovirs og aciclovirs farmakokinetiske profiler er ens efter enkel og gentagen dosering.
English: Accordingly, evaluation of valaciclovir dosage regimens for patients with renal impairment were primarily derived such that peak acyclovir concentrations (Cmax) would approximate those from 2000mg bid one-day dosing in subjects with CLcr from 50 to 120 mL/min.
Danish: Evalueringen af valaciclovirdosisregimer for patienter med nyreinsufficiens blev derfor primært udledt, således at peakkoncentrationer af aciclovir (Cmax) ville nærme sig koncentrationerne for endagsdosering på 2000 mg 2 gange dagligt hos personer med CLcr fra 50 til 120 ml/min.
English: 50 to <75
Danish: 50 til < 75
English: As requested by the CHMP, the MAH reconsidered the use of valaciclovir for zoster treatment in immunocompromised patients and reviewed treatment guidelines.
Danish: Indehaveren af markedsføringstilladelsen genovervejede efter CHMP's anmodning anvendelse af valaciclovir til zosterbehandling hos immunkompromitterede patienter og gennemgik retningslinjerne for behandling.
English: The CHMP endorses the following wording: “Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents”
Danish: CHMP godkender følgende formulering: “Valtrex er indiceret til profylakse af CMV-infektion og sygdom efter organtransplantation hos voksne og unge”
English: Studies with a 1000 mg dose of valaciclovir in adult patients show that dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained).
Danish: Studier med en dosis på 1.000 mg valaciclovir til voksne patienter viser, at dosisjustering ikke er nødvendig hos patienter med let eller moderat cirrose (leversyntesefunktion opretholdt).
English: Reversible increases in liver function tests (e.g. bilirubin, liver enzymes).
Danish: Reversible stigninger i leverfunktionstest (f.eks. bilirubin, leverenzymer)
English: More serious ARs such as thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome, acute renal failure and neurological disorders are discussed in greater detail in other sections of the label.
Danish: Mere alvorlige bivirkninger såsom trombotisk trombocytopenisk purpura/hæmolytisk-uræmisk syndrom, akut nyresvigt og neurologiske lidelser omtales i detaljer i andre afsnit af produktinformationen.
English: • shortness of breath (dyspnoea)
Danish: • åndenød (dyspnø)
English: For the proposed valaciclovir dosage regimens, predicted total acyclovir AUCs for subjects with severe renal impairment are greater than those expected in subjects with less severe renal impairment.
Danish: For de foreslåede valaciclovirdosisregimer er de forventede totale aciclovir-AUC'er for personer med svær nyreinsufficiens større end for de forventede værdier hos personer med mindre svær nyreinsufficiens.
English: Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was evidence of an association with valaciclovir.
Danish: Data fra kliniske studier er anvendt til at klassificere hyppigheden af bivirkninger, hvis der i studierne var evidens for en forbindelse med valaciclovir.
English: Cytomegalovirus (CMV) infections:
Danish: Cytomegalovirus (CMV)-infektioner:
English: The Lowance study demonstrated that prophylactic treatment with valaciclovir is a safe and effective way to prevent CMV disease after renal transplantation.
Danish: Resultaterne af Lowance-undersøgelsen viste, at profylaktisk behandling med valaciclovir er en sikker og effektiv måde at forebygge CMV-sygdom på efter nyretransplantation.
English: Don't take Valtrex
Danish: Brug ikke Valtrex
English: The results of the Weller study showed that valaciclovir is comparable to aciclovir in the prevention of herpes keratitis during long term follow-up after surgery.
Danish: Resultaterne af Weller-undersøgelsen viste, at valaciclovir er sammenligneligt med aciclovir til profylakse af herpeskeratitis under langvarig opfølgning efter operation.
English: The MAH clarified that the clinical trial database, composed of pooled clinical trials data for four indications, as described above, was used to re-calculate the frequencies of ARs identified in the post marketing setting.
Danish: Indehaveren af markedsføringstilladelsen forklarede, at den kliniske undersøgelsesdatabase, som bestod af puljede kliniske data for fire indikationer som beskrevet ovenfor, blev brugt til at genberegne hyppighederne for AR'er identificeret efter markedsføring.
English: The MAH presented, in a table of the document responses, the recalculated AR frequencies for those ARs identified from post-marketing experience and the supporting analyses.
Danish: Indehaveren af markedsføringstilladelsen fremlagde i en tabel med svardokumenterne de genberegnede AR-hyppigheder for de AR'er, som er identificeret via erfaringerne efter markedsføring, og de støttende analyser.
English: Valaciclovir was not teratogenic in rats or rabbits.
Danish: Valaciclovir er ikke fundet teratogent hos rotter eller kaniner.
English: Valtrex is an oral tablet containing valaciclovir (VACV), the esterified prodrug of the antiherpetic compound Aciclovir (ACV).
Danish: Valtrex er en oral tablet indeholdende valaciclovir (VACV), som er det esterificerede prodrug af stoffet Aciclovir (ACV), der virker mod herpes.
English: Ataxia, dysarthria, convulsions, encephalopathy, coma, psychotic symptoms.
Danish: Ataksi, dysartri, kramper, encefalopati, koma, psykotiske symptomer.
English: • for the treatment and suppression of HSV infections of the skin and mucous membranes including - treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults - treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults - suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adults
Danish: • til behandling og suppression af HSV-infektioner i hud og slimhinder, herunder - behandling af primær infektion af genital herpes hos immunkompetente voksne og unge og hos immunkompromitterede voksne - behandling af recidiverende genital herpes hos immunkompetente voksne og unge og hos immunkompromitterede voksne - suppression af recidiverende genital herpes hos immunkompetente voksne og unge og hos immunkompromitterede voksne.
English: The CHMP agreed to insert under this section a reference to valaciclovir to reduce the risk of transmission of genital herpes in immunocompetent adults when taken as suppressive therapy and combined with safer sex practices.
Danish: CHMP vedtog at indsætte en henvisning til valaciclovir i dette punkt for at mindske risikoen for transmission af genital herpes hos immunkompetente voksne, når det tages som supprimerende behandling og kombineres med sikker sex.
English: with a median CD4 count of > 100cells/mm3.
Danish: Disse patienter havde et gennemsnitligt CD4tal på mere end 100 celler/mm3.
English: Peak plasma concentrations of unchanged valaciclovir are only about 4% of peak aciclovir levels, occur at a median time of 30 to 100 min post-dose, and are at or below the limit of quantification 3 h after dosing.
Danish: Den maksimale plasmakoncentration af uomdannet valaciclovir er kun 4 % af den maksimale koncentration af aciclovir, forekommer gennemsnitligt 30-100 minutter efter dosering og ligger ved eller under kvantificeringsgrænsen 3 timer efter administration.
English: The MAH, to show the safety and efficacy of valaciclovir for the prophylaxis of CMV disease in transplant recipients, presented four randomized, controlled clinical trials: Lowance, 1999; Egan, 2002; Ljungman, 2002; Winston, 2003.
Danish: Indehaveren af markedsføringstilladelsen fremlagde fire randomiserede, kontrollerede kliniske undersøgelser med henblik på at vise sikkerhed og effekt af valaciclovir til profylakse af CMVsygdom hos transplanterede patienter: Lowance, 1999, Egan, 2002, Ljungman, 2002, Winston, 2003.
English: GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Danish: GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex,
English: With a maternal valaciclovir dosage of 500 mg twice daily, this level would expose a nursing infant to a daily oral aciclovir dosage of about 0.61 mg/kg/day.
Danish: Ved en dosis på 500 mg valaciclovir 2 gange daglig til moderen ville dette medføre, at det ammede spædbarn blev eksponeret for en dosis, der svarer til en daglig oral aciclovirdosis på ca. 0,61 mg/kg/dag.
English: Aciclovir is a purine (guanine) nucleoside analogue.
Danish: Aciclovir er en purin (guanin) nukleosidanalog.
English: Resistance to aciclovir is normally due to a thymidine kinase deficient phenotype which results in a virus which is disadvantaged in the natural host.
Danish: Resistens over for aciclovir skyldes normalt en virusfænotype, der mangler thymidinkinase, og som vil have nedsat virulens i værtsorganismen.
English: The elimination half-life of aciclovir from breast milk was similar to that for serum.
Danish: Halveringstiden for aciclovir i brystmælk svarede til halveringstiden i serum.
English: The CHMP asked the MAH to substantiate all proposed frequencies and to submit, with adequate supportive data, a revised section 4.8 in line with the SPC guideline.
Danish: CHMP bad indehaveren af markedsføringstilladelsen om at dokumentere alle foreslåede hyppigheder og indlevere et revideret punkt 4.8 i overensstemmelse med produktresumévejledningen sammen med tilstrækkelige støttende data.
English: Values for Tmax denote median and range.
Danish: Værdier for Tmax betegner median og interval.
English: The CHMP asked the MAH to give an estimate of the frequency of resistance in immunocompetent and immunocompromised across clinical trials to be put in perspective to post marketing data.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at estimere hyppigheden af resistens hos immunkompetente og immunkompromitterede i de kliniske undersøgelser, som skulle perspektiveres i forhold til data efter markedsføring.
English: Aciclovir, the principle metabolite of valaciclovir, is excreted in breast milk.
Danish: Aciclovir, den væsentligste valaciclovirmetabolit, udskilles i modermælk.
English: Aciclovir inhibits herpes virus DNA polymerase.
Danish: Aciclovir hæmmer herpes virus DNA-polymerase.
English: Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly.
Danish: Hydreringsstatus Det skal sikres, at patienter med risiko for dehydrering, især ældre, får tilstrækkelig væske.
English: Use in patients with renal impairment and in elderly patients Aciclovir is eliminated by renal clearance, therefore the dose of valaciclovir must be reduced in patients with renal impairment (see section 4.2).
Danish: Patienter med nedsat nyrefunktion og ældre patienter Aciclovir udskilles gennem nyrerne, og dosis af valaciclovir skal derfor reduceres hos patienter med nedsat nyrefunktion (se pkt.
English: Treatment and Suppression of HSV-Related Ocular Infections The MAH presented several studies to evaluate the efficacy of oral aciclovir for HSV keratitis after penetrating keratoplasty (Barney, 1994; van Rooij, 1995, 2003).
Danish: Behandling og suppression af HSV-relaterede øjeninfektioner Indehaveren af markedsføringstilladelsen fremlagde resultaterne af flere undersøgelser for at evaluere effekten af oral aciclovir på HSV-keratitis efter penetrerende keratoplastik (Barney, 1994, van Rooij,
English: High dose valaciclovir as required for CMV prophylaxis may result in more frequent adverse events, including CNS abnormalities, than observed with lower doses administered for other indications (see section 4.8).
Danish: Høje doser af valaciclovir, som er påkrævet ved CMV-profylakse, kan resultere i hyppigere bivirkninger, herunder CNS-abnormaliteter, i forhold til det, der observeres ved lavere doser administreret ved andre indikationer (se pkt.
English: Results from Egan study indicated that high-dose valaciclovir significantly delayed the incidence of CMV antigenemia and had positive effects on time to CMV infections, symptoms and disease compared to low-dose oral aciclovir.
Danish: Resultaterne af Egan-undersøgelsen viste, at høje doser af valaciclovir signifikant forsinker incidensen af CMV-antigenæmi og har positiv indvirkning på tid til CMV-infektioner, symptomer og sygdom sammenlignet med lav dosis oral aciclovir.
English: In study 123-012 the results indicate that prophylaxis with oral VACV in renal transplant patients reduced the incidence or delayed the onset of CMV disease in both the seropositive and the seronegative recipients.
Danish: I undersøgelse 123-012 viser resultaterne, at profylakse med oral VACV hos nyretransplanterede patienter reducerede incidensen af indtræden af CMV-sygdom hos både seropositive og seronegative transplanterede patienter.
English: The CHMP concluded that the MAH has provided a comprehensive account for the frequency of resistance in immunocompetent and immunocompromised individuals across the clinical trials.
Danish: CHMP konkluderede, at indehaveren af markedsføringstilladelsen har indleveret en omfattende begrundelse for hyppigheden af resistens hos immunkompetente og immunkompromitterede personer i de kliniske undersøgelser.
English: Animal studies do not show reproductive toxicity for valaciclovir (see section 5.3).
Danish: Dyreforsøg med valaciclovir viser ingen reproduktionstoksicitet (se pkt.
English: Valaciclovir pharmacokinetics is not dose-proportional.
Danish: Farmakokinetikken for valaciclovir er ikke dosisafhængig.
English: For other indications where the normal dose is in the lower range, dose reductions in renal impairment are not made until CLcrea is below 30 ml/min, since at these exposure levels, the expected increase in exposure at CLcrea 30-49 ml/min is not considered a great safety risk.
Danish: For andre indikationer, hvor den normale dosis er i den lavere ende, reduceres dosis ved nyreinsufficiens først, når CLcrea er under 30 ml/min., da den forventede øgning i eksponering ved CLcrea 30-49 ml/min.
English: • increase in substances produced by the liver.
Danish: • stigninger i leverenzymer.
English: The CHMP asked for the rationale behind the proposed doses in herpes labialis due to a concern that a dose reduction already at CLcrea 49 ml/min might possibly lead to underexposure.
Danish: CHMP bad om begrundelsen for de foreslåede doser til herpes labialis på grund af bekymring for, at en dosisreduktion allerede ved CLcrea 49 ml/min.
English: What Valtrex contains
Danish: Valtrex indeholder
English: Immunocompetent Adults
Danish: Immunkompetente voksne
English: 10 to <25
Danish: 10 til < 25
English: The CDC advocates that prompt antiviral therapy should be instituted in all immune-suppressed herpes zoster patients within 1 week of rash onset or any time before full crusting of lesions.
Danish: CDC taler for, at der straks skal iværksættes antiviral behandling hos alle immunsupprimerede herpes zoster-patienter inden 1 uge efter indtræden af udslæt eller på et tidspunkt før fuldstændig skorpedannelse på læsioner.
English: Herpes Simplex Virus Infection
Danish: Herpes simplex virusinfektion
English: CSF penetration, determined by CSF/plasma AUC ratio, is independent of renal function and was about 25% for aciclovir and the metabolite 8-OH-ACV, and about 2.5% for the metabolite CMMG.
Danish: Penetration til cerebrospinalvæske (CSV), bestemt ved CSV/plasma AUC-ratio, er uafhængig af nyrefunktionen og var ca. 25 % for aciclovir og 8-hydroxyaciclovir (8-OH-ACV)-metabolitten og cirka 2,5 % for carboxymethoxymethylguanin (CMMG)-metabolitten.
English: Cytomegalovirus is a leading cause of virus-associated birth defects, including mental retardation and deafness and may cause severe and fatal diseases in immunocompromised individuals, particularly bone marrow transplant (BMT), solid organ transplantation recipients, and immunosuppressed patients as those with HIV.
Danish: Cytomegalovirus er en af de hyppigste årsager til virusassocierede medfødte misdannelser, herunder mental retardering og døvhed, og kan forårsage svære og fatale sygdomme hos immunkompromitterede personer, især knoglemarvstransplanterede (BMT), organtransplanterede og immunsupprimerede patienter som f.eks. patienter med HIV.
English: Valaciclovir is rapidly and almost completely converted in man to aciclovir and valine, probably by the enzyme referred to as valaciclovir hydrolase.
Danish: Valaciclovir omdannes hurtigt og næsten fuldstændigt til aciclovir og valin, sandsynligvis af enzymet valaciclovirhydrolase.
English: Magnesium stearate Colloidal silicon dioxide
Danish: Magnesiumstearat Kolloid silica
English: In patients receiving higher aciclovir exposures from valaciclovir (e.g., at doses for zoster treatment or CMV prophylaxis), caution is required during concurrent administration with drugs which inhibit active renal tubular secretion.
Danish: Hos patienter, der bliver eksponeret for større påvirkning af aciclovir fra valaciclovir (f.eks. ved doser anvendt til behandling af zoster eller ved CMV-profylakse), skal der udvises forsigtighed ved samtidig administration af lægemidler, som hæmmer den aktive renale tubulære sekretion.
English: ≥ 1/10,000 to < 1/1000,
Danish: ≥ 1/10.000 til < 1/1.000
English: 25 to <50
Danish: 25 til < 50
English: The dose is 500 mg of Valtrex twice daily.
Danish: Dosis er 500 mg Valtrex 2 gange daglig.
English: • you have liver problems
Danish: • har leverproblemer
English: The CHMP endorsed the MAH proposal to state, under this section, that valaciclovir should only be used in pregnancy if the potential benefits of treatment outweigh the potential risks.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag om i dette punkt at anføre, at valaciclovir kun bør anvendes under graviditet, hvis den gavnlige virkning ved behandling opvejer risikoen.
English: Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr
Danish: Aciclovir er en specifik hæmmer af herpesvirus med in vitro aktivitet mod herpes simplex virus (HSV) type 1 og type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr virus
English: It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).
Danish: Det virker ved at dræbe eller standse væksten af herpes simplex virus (HSV), varicella zoster virus (VZV) og cytomegalovirus (CMV).
English: Indication 1 Varicella zoster virus (VZV) infections - herpes zoster The following indication was agreed: “Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.
Danish: Indikation 1 Infektioner med varicella zoster-virus (VZV) - herpes zoster Man blev enig om følgende indikation: "Valtex er indiceret til behandling af herpes zoster og zoster ophthalmicus hos immunkompetente voksne.
English: GSK do.o., Ljubljana Knezov štradon 90 1001 Ljubljana Slovenija
Danish: Slovenien GSK do.o., Ljubljana Knezov štradon 90
English: • treat cold sores (in adults and adolescents over 12 years old)
Danish: • behandle forkølelsessår (hos voksne og unge over 12 år)
English: “Valtrex reduces the risk of ocular complications of ophthalmic zoster”.
Danish: “Valtrex reducerer risikoen for øjenkomplikationer ved zoster ophthalmicus”.
English: The CHMP noted that the suggested dose reductions for renal impairment at treatment of herpes labialis are somewhat different from that for other indications, since the dose is halved already at CLcrea 30-49 ml/min, despite the relatively low dose.
Danish: CHMP bemærkede, at de foreslåede dosisreduktioner for nyreinsufficiens ved behandling af herpes er noget anderledes end for andre indikationer, da dosis allerede halveres ved CLcrea 30-49 ml/min.
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression”.
Danish: Valtex er indiceret til behandling af herpes zoster hos voksne patienter med mild til moderat immunsuppression".
English: If you are not sure, talk to your doctor or pharmacist before taking Valtrex.
Danish: Hvis du er i tvivl, så tal med lægen eller apoteket, inden du tager Valtrex.
English: The dose in immunocompetent patients is 1000 mg three times daily for seven days (3000 mg total daily dose).
Danish: Dosis til immunkompetente patienter er 1.000 mg 3 gange daglig i 7 dage (total daglig dosis 3.000 mg).
English: Aciclovir is a potent and selective inhibitor of a number of herpes viruses, including the human pathogens herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).
Danish: Aciclovir er en potent og selektiv hæmmer af en række herpesvirus, herunder de humane patogener herpes simplex-virus (HSV), varicella zoster-virus (VZV) og cytomegalovirus (CMV).
English: 250 mg tablets, 1000 mg tablets Two years
Danish: 250 mg filmovertrukne tabletter, 1.000 mg filmovertrukne tabletter: 2 år.
English: Studies of valaciclovir treatment and suppression for genital herpes were performed in HIV/HSV coinfected patients.
Danish: Der er udført studier med valaciclovir omhandlende behandling af og profylakse mod genital herpes hos patienter, der samtidig er inficeret med hiv og HSV.
English: Valaciclovir, an antiviral, is the L-valine ester of aciclovir.
Danish: Valaciclovir, et antiviralt middel, er en L-valinester af aciclovir.
English: Glaxo Group Ltd Greenford Road Greenford
Danish: Bulgarien Glaxo Group Ltd Greenford Road
English: The CHMP found satisfactory the responses and the justification presented by the MAH.
Danish: CHMP fandt svar og begrundelser fra indehaveren af markedsføringstilladelsen tilfredsstillende.
English: Varicella zoster virus (VZV) infections - herpes zoster and ophthalmic zoster
Danish: Varicella zoster virus (VZV)-infektioner - herpes zoster og zoster ophthalmicus
English: The MAH stated that valaciclovir offered proven efficacy for prophylaxis of CMV infection and disease and influenced positively other outcomes such as graft rejection and opportunistic infections.
Danish: Indehaveren af markedsføringstilladelsen anførte, at valaciclovir gav dokumenteret effekt til profylakse af CMV-infektion og sygdom og påvirkede andre udfald, f.eks. graftafstødning og opportunistiske infektioner, positivt.
English: GlaxoSmithKline a.e.b.e, Leof.
Danish: Grækenland GlaxoSmithKline a.e.b.e, Leof.