FrancophonIA/ELRC3.0 huggingface dataset:
English: The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases.
Danish: Fosforyleringsprocessen afsluttes (omdannelsen fra mono- til triphosphat) ved hjælp af cellulære kinaser.
English: Children The efficacy of Valtrex in children below the age of 12 years has not been evaluated.
Danish: Børn Virkningen af Valtrex hos børn og unge under 12 år er ikke klarlagt.
English: Transfer into breast milk
Danish: Overførsel til modermælk
English: The creatinine clearance should be monitored frequently, especially during periods when renal function is changing rapidly e.g. immediately after renal transplantation or engraftment.
Danish: Kreatininclearance skal monitoreres hyppigt, særligt i perioder hvor nyrefunktionen ændrer sig hurtigt, f.eks. umiddelbart efter nyretransplantation eller engraftment.
English: The IDSA (Infectious disease society of America) recommends valaciclovir 1000 mg TID [Dworkin, 2007] and the European Conference on Infections in Leukemia recommends the same valaciclovir dosage for at least 7 days [Styczynski, 2009].
Danish: IDSA (Infectious disease society of America) anbefaler valaciclovir 1000 mg TID [Dworkin, 2007], og European Conference on Infections in Leukemia anbefaler den samme valaciclovirdosis i mindst 7 dage [Styczynski, 2009].
English: • swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema)
Danish: • hævelse af læber, ansigt, hals og svælg, der gør det svært at trække vejret (angioødem)
English: • You will usually start taking Valtrex as soon as possible after your surgery.
Danish: • Du skal normalt begynde at tage Valtrex så hurtigt som muligt efter operationen.
English: • severe allergic reactions (anaphylaxis).
Danish: • svær allergisk reaktion (anafylaksi).
English: Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated.
Danish: Patienter bør rådes til at undgå samleje, når der er symptomer til stede, også selvom antiviral behandling er påbegyndt.
English: A double blind, placebo controlled study was conducted in 1,484 heterosexual, immunocompetent adult couples discordant for HSV-2 infection.
Danish: Et dobbeltblindet, placebokontrolleret studie blev udført med 1.484 heteroseksuelle immunkompetente voksne par disconcordante for HSV-2-infektion.
English: Other rare side effects: • kidney problems where you pass little or no urine.
Danish: Andre sjældne bivirkninger: • nyreproblemer hvor du kun producerer lidt eller ingen urin.
English: Undesirable effects are listed below by body system organ class and by frequency.
Danish: Bivirkninger er angivet nedenfor efter systemorganklasse og frekvens.
English: If cutaneous lesions are extensive or if visceral involvement is suspected, IV aciclovir should be initiated and continued until clinical improvement is evident [Balfour, 1983].
Danish: I tilfælde af omfattende hudlæsioner eller mistanke om organpåvirkning skal IV-aciclovir initieres og fortsættes, indtil klinisk forbedring er evident [Balfour, 1983].
English: Valaciclovir was significantly more effective than placebo in delaying the time to first genital herpes recurrence (Patel, 1997; Reitano, 1998).
Danish: Valaciclovir var væsentligt mere effektivt end placebo til a forsinke tid til første recidiv af genital herpes (Patel, 1997, Reitano, 1998).
English: • For the first infection you should take Valtrex for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days.
Danish: • Hvis det er første gang, du har infektionen, skal du tage Valtrex i 5 dage eller op til 10 dage, hvis lægen har ordineret det. Ved tilbagevendende infektion er behandlingsvarigheden normalt 3-5
English: The metabolite 8-OH-ACV is detected only in small amounts in urine (< 2% of the recovered dose).
Danish: 8-OH-ACV-metabolitten kunne kun påvises i små mængder i urinen (< 2 % af den genfundne dosis).
English: However, if it is nearly time for your next dose, skip the missed dose.
Danish: Hvis det er tæt på næste dosis, skal du springe den glemte dosis over.
English: FI-02200 Espoo, Finland
Danish: FI-02200 Espoo,
English: For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately upon appearance of the first signs or symptoms.
Danish: Ved recidiverende episoder af herpes simplex skal behandlingen ideelt påbegyndes i den prodromale periode eller umiddelbart efter fremkomst af de første tegn eller symptomer.
English: Confusion, hallucinations, decreased consciousness, tremor, agitation
Danish: Konfusion, hallucinationer, nedsat bevidsthed, tremor, agitation
English: Furthermore, the safety of the potentially higher intraocular concentrations of aciclovir after valaciclovir use in infected eyes has not been satisfactorily addressed.
Danish: Endvidere er sikkerheden ved potentielt højere intraokulære koncentrationer af aciclovir efter valaciclovir-brug i inficerede øjne ikke tilstrækkeligt belyst.
English: The CHMP endorsed also contraindications regarding hypersensitivity to ACV, VACV or formulations of VACV.
Danish: CHMP godkendte også kontraindikationer vedrørende overfølsomhed over for ACV, VACV eller formuleringer af VACV.
English: Valaciclovir should only be used in pregnancy if the potential benefits of treatment outweigh the potential risk.
Danish: Valaciclovir bør kun anvendes under graviditet, hvis de potentielle fordele ved behandlingen opvejer de mulige risici.
English: Clinical response should be closely monitored, particularly in immunocompromised patients.
Danish: Det kliniske respons bør monitoreres tæt, især hos immunkompromitterede patienter.
English: Transmission of genital herpes
Danish: Overførsel af genital herpes
English: Given that expected peak concentrations in this group appear to be near the low end of the range for subjects with CLcr ≥ 50 mL/min and that only a single dose would be administered, assurance is provided regarding the appropriateness of the proposed regimens.
Danish: Eftersom de forventede peakkoncentrationer i denne gruppe synes at være tæt på den lave ende af intervallet for personer med CLcr ³ 50 ml/min., og der kun ville blive administreret en enkelt dosis, gives der forsikring for, at de foreslåede regimer er passende.
English: The prevalence of aciclovir-resistant HSV has remained low and stable despite increasing clinical use of antiviral agents directed at herpes viruses for nearly three decades.
Danish: Prævalensen af aciclovirresistent HSV er forblevet lav og stabil til trods for en stigning i den kliniske anvendelse af antivirale stoffer rettet mod herpesvirus over næsten tre årtier.
English: It is also used to help prevent these infections from returning.
Danish: Det anvendes også til forebyggelse af tilbagevendende infektioner
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified an official referral under Article 30(2) of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise the SPCs across the EU.
Danish: På grund af de forskellige nationale beslutninger i medlemsstaterne om godkendelse af førnævnte lægemidler (og tilknyttede navne) indgav Europa-Kommissionen meddelelse om en officiel indbringelse af sagen i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF for at løse divergenserne mellem de nationalt godkendte produktresuméer og dermed harmonisere produktresuméerne i EU.
English: A strict monitoring of the evolution of lesions is advised.
Danish: Omhyggelig monitorering af udvikling af læsionen tilrådes.
English: Pharmacokinetic variability (% CV) in Cmax and AUC are expected to be similar for different doses and degrees of renal impairment.
Danish: Den farmakokinetiske variabilitet (% CV) i Cmax og AUC forventes at være sammenlignelige for forskellige doser og grader af nyreinsufficiens.
English: They usually get better when Valtrex is stopped or the dose reduced.
Danish: De får det normalt bedre, når de stopper med at tage Valtrex eller tager en mindre dosis.
English: However, the use of valaciclovir in prophylaxis of transplant should be restricted to solid organ transplant.
Danish: Anvendelse af valaciclovir til profylakse af transplantat skal dog begrænses til organtransplantater.
English: Neither valaciclovir nor aciclovir is metabolized by cytochrome P450 enzymes.
Danish: Hverken valaciclovir eller aciclovir metaboliseres af cytokrom P450-enzymer.
English: Î If you have an allergic reaction, stop taking Valtrex and see a doctor straight away.
Danish: Î Hvis du får en allergisk reaktion, skal du stoppe med at bruge Valtrex og straks kontakte lægen.
English: However, minor changes to the text were recommended as such as the amount of experience accumulated with valacicovir and aciclovir in pregnancy was quantified (designated as limited or moderate, respectively), the historical corresponding numbers from the final study report of the Pregnancy Registry were inserted to illustrate the data available.
Danish: Det blev dog anbefalet at indføre mindre ændringer i teksten, såsom omfanget af den høstede erfaring med valaciclovir og aciclovir under graviditet, hvilket blev kvantificeret (angivet som henholdsvis begrænset eller moderat), og de historiske tilsvarende tal fra den endelige undersøgelsesrapport af graviditetsregistret blev indsat for at illustrere de foreliggende data.
English: The included study reports have shown that no additional clinical benefit was found with 2-day vs. 1-day treatment (Spruance, 2003).
Danish: Undersøgelsesrapporterne har vist, at der ikke fandtes nogen yderligere klinisk gavnlig virkning med 2 dages kontra 1 dags behandling (Spruance, 2003).
English: A unique combination of virus-, host- and drug-related factors explains why resistance has not emerged in the general population and also why the use of valaciclovir is unlikely to increase the prevalence of aciclovir-resistant HSV.
Danish: En unik kombination af virus-, værts- og lægemiddelrelaterede faktorer forklarer, hvorfor der ikke er udviklet resistens i den almindelige befolkning, og også, hvorfor det er usandsynligt, at anvendelse af valaciclovir vil øge prævalensen af aciclovirresistent HSV.
English: • unconsciousness (coma)
Danish: • bevidstløshed (koma)
English: The first stage of phosphorylation requires the activity of a virus-specific enzyme.
Danish: Det første trin i fosforylering kræver tilstedeværelse af et virusspecifikt enzym.
English: • The active substance is valaciclovir.
Danish: • Aktivt stof: valaciclovir.
English: However, the primary safety concerns with aciclovir pertain primarily to reversible acute effects on renal function due to the potential for crystallization in renal tubules.
Danish: De primære betænkeligheder ved sikkerheden med aciclovir vedrører dog hovedsageligt reversible akutte effekter på nyrefunktionen på grund af potentialet for krystallisering i de renale tubuli.
English: The first one was a pivotal trial (Study 123-012) in renal transplant patients and the second one was a smaller trial (Study 123-031) in adult heart transplant recipients.
Danish: Det første var en hovedundersøgelse (undersøgelse 123-012) af nyretransplanterede patienter, og det andet var en mindre undersøgelse (undersøgelse 123-031) af voksne hjertetransplanterede patienter.
English: • reduction in the number of white blood cells (leucopenia)
Danish: • nedsat antal hvide blodlegemer (leukopeni)
English: The benefit and risk assessment of the use of valaciclovir in specific indications and in specific individual pregnant or lactating women falls within the remit of the treating physician.
Danish: Vurderingen af gavnlig virkning og risici ved anvendelse af valaciclovir til specifikke indikationer og hos specifikke gravide eller ammende kvinder falder inden for den behandlende læges kompetenceområde.
English: As requested, the MAH conducted a review of available information since closure of the Pregnancy Registry.
Danish: Indehaveren af markedsføringstilladelsen gennemførte efter anmodning en gennemgang af de tilgængelige oplysninger siden lukningen af graviditetsregistret.
English: The safety profile of prophylactic IV treatment with ganciclovir and oral treatment with VACV were comparable and were both similar to that of the placebo group.
Danish: Sikkerhedsprofilen for profylaktisk IV-behandling med ganciclovir og oral behandling med VACV var sammenlignelig, og begge svarede til placebogruppens.
English: • You should take Valtrex for around 90 days after your surgery, until your doctor tells you to stop.
Danish: • Du skal tage Valtrex i ca. 90 dage efter operationen, indtil lægen beder dig om at holde op.
English: Other uncommon side effects:
Danish: Andre ikke almindelige bivirkninger:
English: Valaciclovir should be used with caution during breast feeding and only when clinically indicated.
Danish: Valaciclovir bør anvendes med forsigtighed under amning, og kun når det er klinisk indiceret.
English: Virus (EBV), and human herpes virus 6 (HHV-6).
Danish: (EBV) og human herpes virus 6 (HHV-6).
English: This includes medicines obtained without a prescription, including herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, herunder naturmedicin.
English: Valtrex can be used to:
Danish: Valtrex kan bruges til at:
English: refers to the last day of that month.
Danish: Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: The following side effects may happen with this medicine:
Danish: De følgende bivirkninger er set ved brug af denne medicin:
English: <10 or on dialysis
Danish: < 10 eller i dialyse
English: 2007] recommends short course, high dose therapy for treatment of herpes labialis as an alternative to other approved regimens.
Danish: 2007] kortvarig højdosisbehandling af herpes labialis som alternativ til andre godkendte regimer.
English: The bioavailability of aciclovir from 1000 mg valaciclovir is 54%, and is not reduced by food.
Danish: Biotilgængeligheden af aciclovir fra 1.000 mg valaciclovir er 54 % og påvirkes ikke af fødeindtagelse.
English: The selection of the studies included in this clinical trial database reflects the product safety profile for the general population exposed to valaciclovir.
Danish: Udvælgelsen af undersøgelserne til denne kliniske undersøgelsesdatabase afspejler produktsikkerhedsprofilen for den almindelige befolkning, som er eksponeret for valaciclovir.
English: Many of the reported cases involved renally impaired and elderly patients receiving repeated overdoses, due to lack of appropriate dosage reduction.
Danish: Mange af de rapporterede tilfælde omfattede patienter med nedsat nyrefunktion og ældre patienter, der fik gentagne overdoser pga. manglende dosisreduktion.
English: The MAH was requested to consider adverse events irrespective of statistical significance
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at overveje hændelser uanset statistisk signifikans.
English: Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion.
Danish: Aciclovir elimineres primært uomdannet i urinen via aktiv renal tubulær sekretion.
English: The HSV resistance in the immunocompetent is low; less than 1% and in the immunosuppressed subjects ~5-6% which similarly is considered to be low.
Danish: HSV-resistensen hos immunkompetente er lav, mindre end 1 %, og hos immunsupprimerede personer ~5-6 %, hvilket ligeledes betragtes som lavt.
English: Thus, in addition to altered acyclovir pharmacokinetics in renal impairment, this factor also needs to be taken into account in developing dosage adjustments based on Cmax and/or AUC.
Danish: Derfor skal denne faktor, ud over den aciclovirs ændrede farmakokinetik ved nyreinsufficiens, også tages i betragtning ved udvikling af dosisjusteringer baseret på Cmax og/eller AUC.
English: Indication 3 Cytomegalovirus (CMV) infections The prophylaxis of cytomegalovirus was not approved in some Member States.
Danish: Indikation 3 Infektioner med cytomegalovirus (CMV) Profylakse af cytomegalovirus var ikke godkendt i nogle medlemsstater.
English: Some Member States have revised the dose recommendations in patients with renal impairment in treatment of herpes zoster based on safety signals.
Danish: Nogle medlemsstater har revideret dosisanbefalingerne hos patienter med nyreinsufficiens ved behandling af herpes zoster baseret på sikkerhedssignaler.
English: Unchanged valaciclovir was not detected in maternal serum, breast milk, or infant urine.
Danish: Uomdannet valaciclovir blev ikke detekteret i moderens serum, brystmælken eller spædbarnets urin.
English: There is limited clinical experience with the use of this combination.
Danish: Klinisk erfaring med denne kombinationsbehandling er begrænset.
English: Additionally, the model results chosen for predictions of Cmax and AUC were conservative by their provision of higher estimates for subjects with severe renal impairment.
Danish: Desuden var de modelresultater, som blev udvalgt til forudsigelse af Cmax og AUC, konservative med hensyn til at give højere estimater for personer med svær nyreinsufficiens.
English: The clinical status of the patient and the adverse reaction profile of Valtrex should be borne in mind when considering the patient`s ability to drive or operate machinery.
Danish: Patientens kliniske status og bivirkningsprofilen for Valtrex skal tages i betragtning, når patientens evne til at føre motorkøretøj eller betjene maskiner vurderes.
English: This information is included in section 4.4 of the SPC.
Danish: Denne oplysning findes i punkt 4.4 i produktresuméet.
English: At high parenteral doses of aciclovir testicular atrophy and aspermatogenesis have been observed in rats and dogs.
Danish: Ved høje parenterale aciclovirdoser blev der observeret testikelatrofi og aspermatogenese hos rotter og hunde.
English: The bioavailability of aciclovir from valaciclovir is about 3.3 to 5.5-fold greater than that historically observed for oral aciclovir.
Danish: Biotilgængeligheden af aciclovir fra valaciclovir er omkring 3,3 til 5,5 gange større end den historisk observerede biotilgængelighed af oral aciclovir.
English: Use for zoster treatment
Danish: Anvendelse ved zoster-behandling
English: These findings have also been observed in patients not treated with valaciclovir who have the same underlying or concurrent conditions.
Danish: Dette er også observeret hos patienter, som ikke var i behandling med valaciclovir, men som havde samme underliggende eller samstemmende lidelser.
English: Thus the effectiveness of different valaciclovir doses in patients with similar degrees of renal function could not been compared.
Danish: Derfor kunne effekten af forskellige valaciclovirdoser hos patienter med samme nyrefunktion ikke sammenlignes.
English: The efficacy of valaciclovir for the treatment of other HSV skin infections has been documented.
Danish: Virkningen af valaciclovir til behandling af andre HSV-hudinfektioner er dokumenteret.
English: It is very important while you are taking Valtrex that you drink water regularly during the day.
Danish: Det er meget vigtigt, at du drikker vand regelmæssigt i løbet af dagen, mens du tager Valtrex.
English: Indication 2 - Herpes simplex virus (HSV) infections Regarding herpes simplex there were differences between Member States regarding site of infection and recommendations for treatment, suppression or prevention.
Danish: Indikation 2 - Infektioner med herpes simplex-virus (HSV) I forhold til herpes simplex var der forskelle mellem medlemsstaterne med hensyn til infektionssted og anbefalinger for behandling, suppression eller profylakse.
English: Very Common (affects more than 1 in 10 people): • headache
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 patienter): • hovedpine
English: • altered brain function (encephalopathy)
Danish: • ændret hjernefunktion (encefalopati)
English: Aciclovir half-life is not affected.
Danish: Halveringstiden for aciclovir påvirkes ikke.
English: Subcutaneous administration of aciclovir in internationally accepted tests did not produce teratogenic effects in rats or rabbits.
Danish: Subkutan administration af aciclovir i internationalt accepterede studier viste ingen teratogen effekt hos rotter eller kaniner.
English: Approximately 88% of the total combined plasma exposure is attributable to aciclovir, 11% to CMMG and 1% to 8-OH-ACV.
Danish: Ca. 88 % at den totale plasmaeksponering kan tilskrives aciclovir, 11 % CMMG og 1 % 8-OH-ACV.
English: For AEs identified from spontaneous reporting, the frequency will be referred to as “not known” as requested.
Danish: For AE'er, som er identificeret ved spontan rapportering, betegnes hyppigheden efter anmodning som "ikke kendt".
English: Some Member States have an additional contraindication for virus resistant to aciclovir.
Danish: Nogle medlemsstater har en yderligere kontraindikation for virusresistens over for aciclovir.
English: A switch from IV aciclovir to oral antiviral therapy (to complete a 10-14 day treatment course) is reasonable when formation of new cutaneous lesions has ceased and the signs and symptoms of visceral VZV infection are improving [CDC, 2009].
Danish: Skift fra IV-aciclovir til oral antiviral behandling (for at gennemføre et 10-14 dages behandlingsforløb) er rimeligt, når dannelse af nye hudlæsioner er ophørt, og tegn og symptomer på organinfektion med VZV er i bedring [CDC, 2009].
English: Valaciclovir achieves high bioavailability of aciclovir allowing less frequent dosing.
Danish: Valaciclovir opnår høj biotilgængelighed af aciclovir, hvilket tillader mindre hyppig dosering.
English: Selectivity is maintained in CMV with phosphorylation, at least in part, being mediated through the phosphotransferase gene product of UL97.
Danish: Denne selektivitet opretholdes ved CMV-infektion, hvor fosforylering i hvert fald delvist, medieres af fosfotransferase-genproduktet af UL97.
English: Valaciclovir is eliminated in the urine principally as aciclovir (greater than 80% of the recovered dose) and the aciclovir metabolite CMMG (about 14% of the recovered dose).
Danish: Valaciclovir elimineres i urinen overvejende som aciclovir (mere end 80 % af den genfundne dosis) og aciclovirmetabolitten CMMG (ca. 14 % af den genfundne dosis).
English: However, the modelled data presented indicated that the Cmax (suggested to be important for the short-term treatment of herpes labialis) and the AUC will still be sufficient in the group with CLcrea 30-49 ml/min.
Danish: De fremlagte modeldata viste imidlertid, at Cmax (som synes vigtig for korttidsbehandling af herpes labialis) og AUC stadig vil være tilstrækkelige i gruppen med CLcrea 30-49 ml/min.
English: Two randomized, double-blind, placebo-controlled safety and efficacy studies were described to support the use of valaciclovir in the treatment of cold sores (herpes labialis).
Danish: To randomiserede, dobbeltblindede, placebokontrollerede undersøgelser af sikkerhed og virkning blev beskrevet til støtte for anvendelse af valaciclovir til behandling af forkølelsessår (herpes labialis).
English: No human fertility studies were performed with valaciclovir, but no changes in sperm count, motility or morphology were reported in 20 patients after 6 months of daily treatment with 400 to 1000 mg aciclovir.
Danish: Der er ikke udført humane fertilitetsstudier med valaciclovir, men der blev ikke rapporteret ændringer i sædkvalitet, motilitet eller morfologi hos 20 patienter efter 6 måneders behandling med 400-1.000 mg aciclovir dagligt.
English: 4.4 Special warnings and precautions for use Hydration status
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Oral valaciclovir 1000 mg TID for 7-10 days is a recommended treatment option for acute localized dermatomal herpes zoster in HIV-infected patients.
Danish: Oral valaciclovir 1000 mg TID i 7-10 dage er den anbefalede behandling for akut lokal dermatomal herpes zoster hos HIV-patienter.