FrancophonIA/ELRC3.0 huggingface dataset:
English: However, at therapeutic doses of valaciclovir, no effects on the breastfed newborns/infants are anticipated since the dose ingested by the child is less than 2% of the therapeutic dose of intravenous aciclovir for treatment of neonatal herpes (see Section 5.2).
Danish: Ved terapeutiske doser af valaciclovir forventes der dog ingen påvirkning af det ammede nyfødte barn eller spædbarn, idet barnet indtager mindre end 2 % af den terapeutiske dosis ved intravenøs aciclovirbehandling af neonatal herpes (se pkt.
English: Other medicinal products (including e.g. tenofovir) administered concurrently that compete with or inhibit active tubular secretion may increase aciclovir concentrations by this mechanism.
Danish: Samtidig administration af andre lægemidler (herunder tenofovir), der kompetitivt hæmmer den aktive renale tubulære sekretion, kan muligvis øge koncentrationen af aciclovir via denne mekanisme.
English: • unsteadiness when walking and lack of coordination (ataxia)
Danish: • usikker gang og ukoordinerede bevægelser (ataksi)
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi cedex, France
Danish: Frankrig Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi cedex, Frankrig
English: Valtrex Tablets 500 mg are supplied in cartons containing 10, 30, 42, 90 or 112 film-coated tablets.
Danish: Valtrex 500 mg filmovertrukne tabletter findes i pakninger med 10, 30, 42, 90 eller 112 filmovertrukne tabletter.
English: HSV resistance to aciclovir, the active metabolite of valaciclovir, as determined by plaque reduction assay has been determined to be less than 1% in immunocompetent subjects and approximately 5-6% in immunocompromised subjects.
Danish: HSV-resistens over for aciclovir, den aktive metabolit af valaciclovir, som fastslået ved plaquereduktionsprøve er under 1 % hos immunkompetente personer og ca. 5-6 % hos immunkompromitterede personer.
English: Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients.
Danish: Ældre patienter kan have nedsat nyrefunktion, og hos denne gruppe patienter skal det derfor overvejes, om der er behov for dosisreduktion.
English: Valaciclovir for ocular HSV infections should be given according to applicable treatment guidelines.
Danish: Ved okulære HSV-infektioner bør valaciclovir gives i overensstemmelse med gældende retningslinjer for behandling.
English: • Take Valtrex according to instructions from your doctor or pharmacist.
Danish: • Tag Valtrex som din læge eller apoteket har anvist.
English: The CHMP also asked the MAH to give reassurance that the benefit/risk of valaciclovir can be regarded as similar to that of valganciclovir, currently widely used in clinical practice.
Danish: CHMP bad også indehaveren af markedsføringstilladelsen om at give forsikringer om, at benefit/riskforholdet ved valaciclovir kan betragtes som svarende til valganciclovir, der i øjeblikket er udbredt i klinisk praksis.
English: The Ljungman study demonstrated that valaciclovir was significantly more effective than oral aciclovir in reducing the incidence of CMV infection (P <0.0001), and the safety of oral valaciclovir was similar to that of high-dose oral aciclovir.
Danish: Resultaterne af Ljungman-undersøgelsen viste, at valaciclovir er signifikant mere effektivt end oral aciclovir til at reducere incidensen af CMF-infektion (P <0,0001), og sikkerheden for oral valaciclovir svarede til høj dosis oral aciclovir.
English: Section 4.6 Pregnancy
Danish: Punkt 4.6 Graviditet
English: As requested by the MAH, the Quality Module has been also harmonised.
Danish: Kvalitetsmodulet er efter anmodning fra indehaveren af markedsføringstilladelsen også harmoniseret.
English: Film-coated tablets 10 tablets
Danish: Filmovertrukne tabletter 10 tabletter
English: Herpes labialis infections (HSV-1)
Danish: Infektioner med herpes labialis (HSV-1)
English: Genital Herpes Suppression for Transmission Risk Reduction The MAH presented the Study HS2AB3009 to demonstrate the efficacy of valaciclovir suppressive therapy (500 mg once daily).
Danish: Suppression af genital herpes med henblik på reduktion af transmissionsrisiko Indehaveren af markedsføringstilladelsen fremlagde resultaterne af undersøgelse HS2AB3009 for at påvise effekten af supprimerende behandling med valaciclovir (500 mg en gang dagligt).
English: • if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients
Danish: • hvis du er overfølsom (allergisk) over for valaciclovir, aciclovir eller et af de øvrige indholdsstoffer (se pkt.
English: Following oral administration of a 500 mg dose of valaciclovir, peak aciclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times the corresponding maternal aciclovir serum concentrations.
Danish: Efter oral administration af en dosis på 500 mg valaciclovir varierede de maksimale koncentrationer (Cmax) af aciclovir i brystmælk fra 0,5 til 2,3 gange den korresponderende serumaciclovirkoncentration hos moderen.
English: For AEs identified from clinical trials, a frequency category was assigned based on the overall frequency observed in clinical trials.
Danish: For AE'er, som er identificeret via kliniske undersøgelser, er der etableret en hyppighedskategori ud fra den overordnede hyppighed, som er observeret i kliniske undersøgelser.
English: Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.
Danish: Intravenøs antiviral behandling bør overvejes, når respons på oral behandling anses for at være utilstrækkeligt.
English: In organ transplant patients receiving high doses (8000 mg daily) of Valtrex for CMV prophylaxis, neurological reactions occurred more frequently compared with lower doses used for other indications.
Danish: Hos organtransplanterede patienter, der får store doser Valtrex (8.000 mg daglig) som CMV-profylakse, er neurologiske reaktioner hyppigere end ved lavere doser anvendt ved andre indikationer.
English: For ARs identified from postmarketing experience, but not observed in clinical trials, the most conservative value of point estimate (“rule of three”) has been used to assign the AR frequency category.
Danish: For bivirkninger identificeret efter markedsføring, men ikke observeret under kliniske studier, er den mest konservative værdi for punktestimatet anvendt (”rule of three”) til bestemmelse af bivirkningshyppighed.
English: The MAH gained approval in some Member States for the use of valaciclovir at a higher dose and shorter course (2g twice daily for one day) for the treatment of herpes labialis (Clinical practice recommendation of the International Herpes management Forum (IHMF) [Gilbert, 2007]).
Danish: Indehaveren af markedsføringstilladelsen opnåede i nogle medlemsstater godkendelse af anvendelse af valaciclovir ved en højere dosis og med kortere varighed (2 g 2 gange dagligt i 1 dag) til behandling af herpes labialis (Clinical practice recommendation of the International Herpes Management Forum (IHMF) [Gilbert.
English: The CHMP concluded that the only ocular use that should be noted is the treatment of ophthalmic zoster.
Danish: CHMP konkluderede, at den eneste okulære anvendelse, som skal anføres, er behandling af zoster ophthalmicus.
English: Patients should be closely monitored for changes in renal function, and doses adjusted accordingly (see section 4.2).
Danish: Patienterne skal monitoreres tæt for ændringer i nyrefunktion, og dosis skal justeres i overensstemmelse hermed (se pkt.
English: The MAH did a proposal for the harmonisation of valaciclovir SPCs taking into account the whole pharmaceutical presentations and all the dosages currently approved in at least one European MSs.
Danish: Indehaveren af markedsføringstilladelsen fremlagde et forslag om harmonisering af valaciclovirproduktresuméerne, hvor der tages højde for hele den farmaceutiske dokumentation og alle doseringer, som er godkendt i mindst en europæisk medlemsstat.
English: Adequate fluid intake should be ensured during treatment (see section 4.4).
Danish: Tilstrækkeligt væskeindtag skal opretholdes under behandlingen (se pkt.
English: • skin reaction after exposure to sunlight (photosensitivity).
Danish: • hudreaktioner i forbindelse med sollys (lysfølsomhed)
English: Netherlands GlaxoSmithKline BV Huis ter Heideweg 62
Danish: Holland GlaxoSmithKline BV Huis ter Heideweg 62
English: Varicella Zoster Virus Infection
Danish: Varicella zoster virusinfektion
English: In addition, the MAH assessed reports of pregnancy and pregnancy outcomes available in the MAH's Worldwide Clinical Safety Database.
Danish: Desuden vurderede indehaveren af markedsføringstilladelsen rapporter om graviditet og graviditetsudfald, som er tilgængelige i dennes globale kliniske sikkerhedsdatabase.
English: The CHMP considered Herpes labialis covered by the indication “Treatment and suppression of HSV infections of the skin and mucous membranes”, and concluded that does not deserve to be specified in section 4.1 of the SPC although the short course dosage shall be mentioned in Section 4.2.
Danish: CHMP vurderede, at Herpes labialis er dækket af indikationen "Behandling og suppression af HSVinfektioner i hud og slimhinder", og konkluderede, at den ikke skal specificeres i punkt 4.1 i produktresuméet, men at den korte dosering skal nævnes i punkt 4.2.
English: Some patients with very frequent recurrences (≥ 10/year in absence of therapy) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily).
Danish: Nogle patienter med meget hyppige recidiver (≥ 10 pr. år uden behandling) kan opnå en yderligere fordel ved at dele den daglige dosis på 500 mg i to doser (250 mg 2 gange daglig).
English: The MAH presented two studies in order to support the safety use of VACV (Study 123-016 and Study 123-039).
Danish: Indehaveren af markedsføringstilladelsen fremlagde resultaterne af to undersøgelser til støtte for sikkerheden ved anvendelse af VACV (undersøgelse 123-016 og 123-039).
English: Data on the efficacy of valaciclovir from transplant patients (~200) at high risk of CMV disease (e.g. donor CMV-positive/recipient CMV negative or use of anti-thymocyte globulin induction therapy) indicate that valaciclovir should only be used in these patients when safety concerns preclude the use of valganciclovir or ganciclovir.
Danish: Data om valaciclovirs virkning hos transplanterede patienter (~ 200) med høj risiko for udvikling af CMV-sygdom (f.eks. ved CMV-positiv donor, CMV-negativ modtager eller ved anvendelse af antithymocytglobulin-induktionsbehandling) indikerer, at valaciclovir kun bør anvendes hos de patienter, hvor sikkerhedshensyn udelukker anvendelse af valganciclovir eller ganciclovir.
English: The CHMP considering the above trials results endorsed the use of valaciclovir for the prophylaxis of CMV infection.
Danish: CHMP godkendte i betragtning af ovenstående undersøgelsesresultater anvendelse af valaciclovir til profylakse af CMV-infektion.
English: The CHMP considered that herpes labialis should not be a specific treatment indication, however the dosage for herpes labialis could be mentioned under this section.
Danish: CHMP vurderede, at herpes labialis ikke skal være en specifik behandlingsindikation, men doseringen til herpes labialis kan nævnes i dette punkt.
English: Clinical Trial Data Nervous system disorders Very common:
Danish: Data fra kliniske studier Nervesystemet Meget almindelig:
English: In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8).
Danish: I de rapporterede tilfælde var disse bivirkninger generelt reversible ved behandlingsophør (se pkt.
English: Like all medicines, Valtrex can cause side effects in some people.
Danish: Valtrex kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In transplant recipients receiving valaciclovir 2000 mg 4 times daily, aciclovir peak concentrations are similar to or greater than those in healthy volunteers receiving the same dose.
Danish: Hos transplanterede patienter i behandling med valaciclovir 2.000 mg fire gange daglig er de maksimale koncentrationer af aciclovir de samme som eller højere end dem, der er set hos raske, frivillige forsøgspersoner, der fik samme dosis.
English: The dose is reduced by 50% already at CLcrea 30-49 ml/min, while for varicella-zoster infections, which have a normal dose in about the same range as that proposed for herpes labialis, the dose is reduced by 33% at CLcrea 30-49 ml/min.
Danish: Dosis reduceres allerede med 50 % ved CLcrea 30-49 ml/min., mens dosis ved varicella zoster-infektioner, som har en normal dosis i omtrent samme interval som foreslået for herpes labialis, reduceres med 33 % ved CLcrea 30-49 ml/min.
English: 1500 mg once daily a For patients on intermittent haemodialysis, the dose should be given after dialysis on dialysis days.
Danish: 1.500 mg 1 gang daglig a Hos patienter i intermitterende hæmodialyse skal dosis på dialysedage gives efter dialysen.
English: Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
Danish: Bivirkninger i nervesystemet kan være forvirring eller uro, eller du kan føle dig unormalt søvnig eller sløv.
English: The MAH provided several key documents describing Study HS230027 and Study HS230028, and data analysis supporting short-course, high-dose therapy in immunocompetent adolescents and adults.
Danish: Indehaveren af markedsføringstilladelsen fremlagde flere vigtige dokumenter, som beskrev undersøgelse HS230027 og HS230028, og dataanalyser, som understøtter kortvarig højdosisbehandling hos immunkompetente unge og voksne.
English: GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Danish: GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16,
English: Valaciclovir is almost completely metabolised to aciclovir.
Danish: Valaciclovir metaboliseres næsten fuldstændigt til aciclovir.
English: These studies showed that valaciclovir was superior to placebo and/or as effective as aciclovir in reducing episode duration, viral shedding and lesion healing time.
Danish: Disse undersøgelser viste, at valaciclovir var overlegen i forhold til placebo og/eller lige så effektivt som aciclovir til reduktion af varighed af episoder, virusudskillelse og tid til opheling af læsioner.
English: The results of Study 123-031 showed a significant difference in time to development of CMV antigenemia and similar delays of acute rejection and fewer opportunistic or other herpes infections in favour of VACV.
Danish: Resultaterne af undersøgelse 123-031 viste en signifikant difference i tid til udvikling af CMV-antigenæmi og tilsvarende forsinkelser af akut afstødning og færre opportunistiske eller andre herpesinfektioner til fordel for VACV.
English: Pharmacokinetic data indicate that hepatic impairment decreases the rate of conversion of valaciclovir to aciclovir but not the extent of conversion.
Danish: Farmakokinetiske data indikerer, at nedsat leverfunktion nedsætter metaboliseringshastigheden af valaciclovir til aciclovir, men ikke omfanget af metabolisering.
English: Leucopenia, thrombocytopenia Leucopenia is mainly reported in immunocompromised patients.
Danish: Leukopeni, trompocytopeni Leukopeni ses hovedsageligt hos immunkompromitterede patienter.
English: In patients with end-stage renal disease, the average elimination half-life of aciclovir after valaciclovir administration is approximately 14 hours, compared with about 3 hours for normal renal function (see section 4.2).
Danish: Hos patienter med nyresygdom i slutstadiet er den gennemsnitlige halveringstid af aciclovir efter administration af valaciclovir ca. 14 timer, sammenlignet med ca. 3 timer ved normal nyrefunktion (se pkt.
English: If you are taking Valtrex to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms.
Danish: Undgå at overføre herpes på kønsorganerne til andre Hvis du bruger Valtrex for at behandle eller forebygge herpes på kønsorganerne, eller hvis du har haft herpes på kønsorganerne tidligere, skal du stadig dyrke sikker sex, herunder anvende kondom.
English: Exposure to aciclovir and its metabolites CMMG and 8-OH-ACV in plasma and cerebrospinal fluid (CSF) was evaluated at steady-state after multiple-dose valaciclovir administration in 6 subjects with normal renal function (mean creatinine clearance 111 mL/min, range 91-144 mL/min) receiving 2000 mg every 6 hours and 3 subjects with severe renal impairment (mean CLcr 26 mL/min, range 17-31 mL/min) receiving 1500 mg every 12 hours.
Danish: Eksponering for aciclovir og dets metabolitter CMMG og 8-OH-ACV i plasma og cerebrospinalvæske (CSV) blev evalueret ved steady state efter flere doser valaciclovir administreret til 6 patienter med normal nyrefunktion (gennemsnitlig kreatininclearance 111 ml/min, interval 91-144 ml/min), der fik 2.000 mg hver 6. time, og til 3 patienter med svært nedsat nyrefunktion (gennemsnitlig kreatininclearance 26 ml/min, interval 17-31 ml/min), der fik 1.500 mg hver 12. time.
English: Estimations of relationships between aciclovir pharmacokinetics and renal function are obtained from subjects in Studies P66-01, P66-02, P66-09 and P66-10 who received valaciclovir 1000mg doses.
Danish: Skøn over forbindelserne mellem aciclovirs farmakokinetik og nyrefunktion blev indhentet fra personer i undersøgelse P66-01, P66-02, P66-09 og P66-10, som fik valaciclovir i doser på 1000 mg. Aciclovirs biotilgængelighed fra valaciclovir falder noget med stigende dosis.
English: Valaciclovir is a prodrug of aciclovir.
Danish: Valaciclovir er et prodrug af aciclovir.
English: If you forget to take Valtrex
Danish: Hvis du har glemt at tage Valtrex
English: The MAH had no data indicating that patients with renal impairment have an altered PK/PD relationship compared with patients with normal renal function such that they would require higher aciclovir exposure for comparable treatment effect.
Danish: Indehaveren af markedsføringstilladelsen havde ingen data, som indicerede, at patienter med nyreinsufficiens har et ændret PK/PD-forhold sammenlignet med patienter med normal nyrefunktion, således at de ville kræve højere aciclovireksponering for at opnå en sammenlignelig behandlingseffekt.
English: Always take Valtrex exactly as your doctor has told you.
Danish: Tag altid Valtrex nøjagtigt efter lægens anvisning.
English: The MAH also stated that the pivotal studies of valaciclovir for treatment of HSV and VZV infections and for suppression of HSV recurrences had enrolment criteria that excluded most subjects with significant renal impairment.
Danish: Indehaveren af markedsføringstilladelsen anførte også, at hovedundersøgelserne af valaciclovir til behandling af HSV- og VZV-infektioner og til suppression af recidiverende HSV havde rekrutteringsskriterier, som udelukkede de fleste personer med signifikant nyreinsufficiens.
English: The CHMP endorsed the proposal from the MAH considering it in line with currently applicable guidelines and accurately reflects data available.
Danish: CHMP godkendte forslaget fra indehaveren af markedsføringstilladelsen, da man mente, at det var i overensstemmelse med gældende retningslinjer og er en nøjagtig afspejling af de foreliggende data.
English: The CHMP endorsed the MAH's proposal to delete “Valtrex accelerates the resolution of pain….and postherpetic neuralgia” and the information was moved under section 5.1.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag om at slette "Valtrex fremmer resolution af smerter… og postherpetisk neuralgi”, og oplysningerne er flyttet til punkt 5.1.
English: Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of valaciclovir.
Danish: Der er rapporteret akut nyresvigt og neurologiske symptomer, herunder konfusion, hallucinationer, agitation, nedsat bevidtshed og koma hos patienter, der fik overdoser af valaciclovir.
English: A limited amount of data on the use of valaciclovir and a moderate amount of data on the use of aciclovir in pregnancy is available from pregnancy registries (which have documented the pregnancy outcomes in women exposed to valaciclovir or to oral or intravenous aciclovir (the active metabolite of valaciclovir); 111 and 1246 outcomes (29 and 756 exposed during the first trimester of pregnancy, respectively) and postmarketing experience indicate no malformative or foeto/neonatal toxicity.
Danish: Disse data stammer fra graviditetsregistre (som har dokumenterede resultater af graviditeter hos kvinder eksponeret for valaciclovir eller for aciclovir (den aktive metabolit af valaciclovir) givet oralt eller intravenøst); 111 og 1.246 udfald (henholdsvis 29 og 756 eksponeret i det første trimester af graviditeten) samt erfaringer gjort efter markedsføring indikerer ingen misdannelser eller føtal/neonatal toksicitet.
English: ≥1/100 to < 1/10,
Danish: ≥ 1/100 til < 1/10
English: Section 4.2 Posology and method of administration There were differences in Section 4.2 between Member States.
Danish: Der var forskelle mellem medlemsstaterne i punkt 4.2.
English: Each tablet contains 250 mg, 500 mg or 1000 mg of valaciclovir (as valaciclovir hydrochloride).
Danish: Hver tablet indeholder 250 mg, 500 mg eller 1.000 mg valaciclovir (som valaciclovirhydrochlorid).
English: The elimination of aciclovir is correlated to renal function, and exposure to aciclovir will increase with increased renal impairment.
Danish: Eliminationen af aciclovir korrelerer med nyrefunktionen, og eksponeringen for aciclovir øges i takt med nedsættelsen i nyrefunktionen.
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 studier hos HSV-inficerede patienter, der er immunkompromitterede på grund af hiv-infektion (se pkt.
English: The authors of Winston study concluded that oral valaciclovir can be an effective alternative to IV ganciclovir for prophylaxis of CMV disease after bone marrow transplant.
Danish: Winston-undersøgelsens forfattere konkluderede, at oral valaciclovir kan være et effektivt alternativ til IV-ganciclovir til profylakse af CMV-sygdom efter knoglemarvstransplantation.
English: Denmark GlaxoSmithKline Pharma A/S, Nykaer 68
Danish: Danmark GlaxoSmithKline Pharma A/S, Nykaer 68
English: This dose should be reduced according to creatinine clearance (see Renal impairment below).
Danish: Denne dosis skal reduceres i forhold til kreatininclearance (se ”Nedsat nyrefunktion” nedenfor).
English: Psychiatric and nervous system disorders Common:
Danish: Psykiske forstyrrelser og nervesystemet Almindelig:
English: Always tell your doctor or pharmacist about other medicines if you are taking Valtrex for treatment of shingles or after having an organ transplant.
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, hvis du tager Valtrex til behandling af helvedesild eller efter organtransplantation.
English: • prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old)
Danish: • forebygge infektion med CMV efter organtransplantation (hos voksne og unge over 12 år).
English: Post Marketing Data Blood and lymphatic system disorders Uncommon:
Danish: Kvalme Data fra rapporter efter markedsføring Blod og lymfesystem Ikke almindelige:
English: In immunocompromised patients, antiviral treatment is suggested for patients presenting within one week of vesicle formation or at any time before full crusting of lesions.
Danish: Hos immunkompromitterede patienter anbefales antiviral behandling inden for en uge efter dannelse af vesikler eller på et hvilket som helst tidspunkt før fuldstændig skorpedannelse på læsioner.