FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the 1-day valaciclovir regimen offers patients a convenient dosing alternative compared to available topical therapies and longer-course aciclovir and valaciclovir regimens.
Danish: Regimet med valaciclovir i 1 dag giver dog patienterne et bekvemt doseringsalternativ sammenlignet med tilgængelige topikale behandlinger og længerevarende aciclovir- og valaciclovir-regimer.
English: • Don't take Valtrex if this applies to you.
Danish: Brug ikke Valtrex, hvis dette gælder for dig.
English: • If you forget to take Valtrex, take it as soon as you remember.
Danish: • Hvis du glemmer at tage Valtrex, skal du tage dosis, så snart du kommer i tanke om det.
English: The CHMP agreed the removal of several more specific indication statements (i.e., herpes labialis, ocular HSV infections, reduction of transmission).
Danish: CHMP vedtog at fjerne flere mere specifikke indikationsudsagn (dvs. herpes labialis, okulære HSVinfektioner, reduktion af transmission).
English: EXPIRY DATE EXP {MM YYYY} SPECIAL STORAGE CONDITIONS Store below 30°C.
Danish: UDLØBSDATO EXP {MM ÅÅÅÅ} SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30 °C 10.
English: The clinical trial safety database is based on 5855 subjects exposed to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster, treatment/suppression of genital herpes & treatment of cold sores).
Danish: Sikkerhedsdatabasen for kliniske studier er baseret på 5.855 patienter eksponeret for valaciclovir under kliniske studier, dækkende over flere indikationer (behandling af herpes zoster, behandling af/profylakse mod genital herpes samt behandling af forkølelsessår).
English: A study of the pharmacokinetics of valaciclovir and aciclovir during late pregnancy indicates that pregnancy does not affect the pharmacokinetics of valaciclovir.
Danish: Et farmakokinetisk studie af valaciclovir og aciclovir under sidste trimester af graviditeten indikerer, at graviditet ikke påvirker farmakokinetikken for valaciclovir.
English: The CHMP endorsed the following wording for the treatment of herpes simplex virus: “Valtrex is indicated
Danish: CHMP godkendte følgende formulering for behandling af herpes simplex-virus: "Valtrex er indiceret
English: Based on results from study P66-09, estimates of relative bioavailability of aciclovir from different valaciclovir dose levels were assumed to be independent of renal function.
Danish: Ud fra resultaterne af undersøgelse P66-09 antoges det, at estimaterne af relativ biotilgængelighed for aciclovir fra forskellige valaciclovirdosisniveauer var uafhængige af nyrefunktionen.
English: Results showed significant reductions in risk of transmission: 75 % (symptomatic HSV-2 acquisition), 50 % (HSV-2 seroconversion), and 48 % (overall HSV-2 acquisition) for valaciclovir compared to placebo.
Danish: Resultater fra studiet viste signifikant nedsat risiko for smitteoverførsel: 75 % (symptomatisk erhvervet HSV-2-infektion), 50 % (HSV-2 med serokonversion) og 48 % (total erhvervet HSV-2-infektion) for valaciclovir sammenlignet med placebo.
English: Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 COLOMBES Cedex France
Danish: Frankrig Laboratoires BIOGARAN 15, boulevard Charles de Gaulle 92707 COLOMBES Cedex Frankrig
English: Based on historical aciclovir experience, valaciclovir appears to be as effective as aciclovir for the treatment of erythema multiforme, eczema herpeticum and herpetic whitlow.
Danish: Baseret på tidligere erfaringer med aciclovir synes valaciclovir at være lige så effektivt som aciclovir til behandling af erythema multiforme, eczema herpeticum og herpetisk whitlow.
English: The CHMP agreed to include a reference to ocular HSV in section 5.1.
Danish: CHMP besluttede at inkludere en henvisning til okulær HSV i punkt 5.1.
English: Sandoz GmbH Biochemiestraße 10, 6250 Kundl Austria
Danish: Sandoz GmbH Biochemiestraße 10, 6250 Kundl Østrig
English: Both elderly patients and patients with renal impairment are at increased risk of developing neurological side-effects and should be closely monitored for evidence of these effects.
Danish: Både ældre patienter og patienter med nedsat nyrefunktion har øget risiko for udvikling af neurologiske bivirkninger og skal derfor overvåges nøje med henblik på tegn herpå.
English: The 5855 subjects are comprised as follows: herpes zoster treatment (n=967); genital herpes treatment (n=1160 high dose and n=1203 low dose); genital herpes suppression (n=1009 high dose and n=269 low dose); cold-sore treatment (n=609 high dose and n=638 low dose).
Danish: De 5855 personer består af følgende: behandling af herpes zoster (n=967), behandling af genital herpes (n=1160 høj dosis og n=1203 lav dosis), suppression af genital herpes (n=1009 høj dosis og n=269 lav dosis), behandling af forkølelsessår (n=609 høj dosis og n=638 lav dosis).
English: Binding of valaciclovir to plasma proteins is very low (15%).
Danish: Valaciclovir bindes i meget lav udstrækning (15 %) til plasmaproteiner.
English: Renal impairment, acute renal failure (especially in elderly patients or in patients with renal impairment receiving higher than the recommended doses).
Danish: Nedsat nyrefunktion, akut nyresvigt (især hos ældre patienter eller patienter med nedsat nyrefunktion, der får højere doser end de anbefalede)
English: • You should take Valtrex until your doctor tells you to stop.
Danish: • Du skal tage Valtrex, indtil lægen beder dig om at holde op.
English: The CHMP concluded that there was no data to suggest that patients with renal impairment need higher exposure for treatment effect.
Danish: CHMP konkluderede, at der ikke forelå nogen data, som tyder på, at patienter med nyreinsufficiens har behov for højere eksponering for at opnå behandlingseffekt.
English: The CHMP endorsed the wording and considered acceptable the posology 1000 mg three times daily.
Danish: CHMP godkendte formuleringen og anså doseringen 1000 mg 3 gange dagligt for acceptabel.
English: Vomiting, diarrhoea.
Danish: Opkastning, diarré
English: In the case of HSV, VZV and EBV this enzyme is the viral thymidine kinase (TK), which is only present in virus-infected cells.
Danish: Ved HSV-, VZV- og EBV-infektion er dette enzym viral thymidinkinase (TK), som kun er til stede i virusinficerede celler.
English: The success of chemotherapy or transplantation is often compromise by infection during the period of immunosuppression after treatment or surgery reactivation of latent viruses is particularly common (Bustamante, 1991: Houglund, 2001).
Danish: Dels kompromitteres et vellykket resultat af kemoterapi eller transplantation ofte af infektion i immunsupprimeringsperioden efter behandling, dels er en reaktivering af latente virus ved operation særligt almindelig (Bustamante, 1991: Houglund, 2001).
English: You should not have sex if you have genital sores or blisters.
Danish: Du bør ikke dyrke sex, hvis du har sår eller blærer på kønsorganerne.
English: The MAH believed that the use of valaciclovir in pregnancy should not be contraindicated.
Danish: Indehaveren af markedsføringstilladelsen mente, at anvendelse af valaciclovir under graviditet ikke burde være kontraindiceret.
English: The CHMP asked the MAH to evaluate all other sections of the nationally approved EU SPCs and suggest appropriate changes in the text where divergences exist.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at evaluere alle andre punkter i de nationalt godkendte EU-produktresuméer og foreslå passende ændringer i teksten, når der er divergenser.
English: If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy.
Danish: Hvis du har taget for mange tabletter, kan du få kvalme eller kaste op eller være forvirret, ophidset eller unormalt søvnig.
English: The most common adverse reactions (ARs) reported in at least one indication by patients treated with Valtrex in clinical trials were headache and nausea.
Danish: De hyppigste bivirkninger observeret ved mindst en indikation hos patienter i behandling med Valtrex i kliniske studier var hovedpine og kvalme.
English: Regarding the prevention of ocular complications, present in some MS SPC, the CHMP noted that it is a secondary benefit of the treatment of VZV infection, therefore this part of the indication was covered by a statement in section 5.1.
Danish: Med hensyn til forebyggelse af øjenkomplikationer, som findes i nogle medlemsstaters produktresuméer, bemærkede CHMP, at det er en sekundær fordel ved behandling af VZV-infektion, og at denne del af indikationen derfor er dækket af udsagnet i punkt 5.1.
English: Dosage selection for treatment of cold sores was based on administration of high-dose valaciclovir during prodrome, targeting plasma concentrations to exceed the in vitro IC99, based on the hypothesis that optimal antiviral effect would be obtained from high systemic exposure during the time that viral replication dominates temporarily over the host immune response.
Danish: Valg af dosis til behandling af forkølelsessår var baseret på administration af højdosis-valaciclovir under prodrom, og hvor målet var, at plasmakoncentrationerne skulle ligge over in vitro IC99, ud fra den hypotese, at optimal antiviral effekt opnås ved høj systemisk eksponering i den tid, hvor den virale replikation midlertidigt dominerer over værtens immunrespons.
English: Specific studies of valaciclovir have not been conducted in liver transplantation, and hence caution should be exercised when administering daily doses greater than 4000 mg to these patients.
Danish: Der er ikke udført specifikke studier med valaciclovir i forbindelse med levertransplantation, og der skal derfor udvises forsigtighed, når der gives højere doser end 4.000 mg daglig til disse patienter.
English: The CHMP concluded that the indication about prophylaxis for transmission of genital herpes with VACV can not be regarded to as indication itself but rather to be associated with the treatment of initial and recurrent treatment of genital herpes.
Danish: CHMP konkluderede, at indikationen med profylakse af transmission af genital herpes med VACV ikke kan betragtes som selve indikationen, men snarere associeres med behandling af initial og recidiverende genital herpes.
English: The dosage of Valtrex is 2000 mg four times a day, to be initiated as early as possible post-transplant.
Danish: Dosis er 2.000 mg Valtrex 4 gange daglig, og behandling skal indledes så hurtigt som muligt efter transplantationen.
English: • you have a weak immune system
Danish: • har et svækket immunforsvar
English: Herpes zoster, herpes simplex and HIV infection do not significantly alter the pharmacokinetics of valaciclovir and aciclovir after oral administration of valaciclovir compared with healthy adults.
Danish: Herpes zoster, herpes simplex og hiv-infektion ændrer ikke i signifikant grad farmakokinetikken af valaciclovir og aciclovir efter oral administration af valaciclovir, sammenlignet med raske, voksne forsøgspersoner.
English: The criteria varied among studies, but excluded subjects with either serum creatinine greater than the upper limit of normal (Scr > ULN), Scr > 1.5 mg/dL (~133 uM), or with creatinine clearance less than 35 mL/min.
Danish: Kriterierne varierede i undersøgelserne, men udelukkede personer med serumkreatinin over den øvre grænse for normal (Scr > ULN), Scr > 1,5 mg/dl (~133 uM) eller med en kreatininclearance på under 35 ml/min.
English: These include also a Clinical Overview describing safety and efficacy of the pivotal efficacy trials.
Danish: De indeholder også en klinisk oversigt, som beskriver sikkerhed og virkning i hovedundersøgelserne af effekt.
English: The CHMP noted that, the studies supporting the safe and efficacy use of valaciclovir were performed in HIV-patients only, and for the most in patients without severe CD4 depletion.
Danish: CHMP bemærkede, at de undersøgelser, som understøtter sikker og effektiv anvendelse af valaciclovir, er udført på HIV-patienter alene, og for de fleste patienters vedkommende uden svær CD4-depletering.
English: HSV Treatment
Danish: Behandling af HSV
English: Microcrystalline cellulose Crospovidone Povidone
Danish: Mikrokrystallinsk cellulose Crospovidon
English: Treatment of cold sores
Danish: Behandling af forkølelsessår
English: Valtrex accelerates the resolution of pain: it reduces the duration of and the proportion of patients with zoster-associated pain, which includes acute and, in patients older than 50 years, also post-herpetic neuralgia.
Danish: Valtrex fremskynder smertelindring: Valtrex reducerer varigheden af og andelen af patienter med zosterassocierede smerter, hvilket omfatter akut neuralgi og hos patienter over 50 år desuden postherpetisk neuralgi.
English: The MAH, as requested, included an introductory statement in Section 4.8 to clarify the sample size/exposure from clinical trials.
Danish: Indehaveren af markedsføringstilladelsen inkluderede efter anmodning et indledende udsagn i punkt 4.8 for at tydeliggøre populationsstørrelse/eksponering fra kliniske undersøgelser.
English: The CHMP noted that these findings would support an additional effect of VACV although this can not be addressed as a primary indication for treatment but can be annotated in section 5.1.
Danish: CHMP bemærkede, at disse fund ville støtte en yderligere effekt af VACV, selvom dette ikke kan anføres som en primær behandlingsindikation, men kan anføres i punkt 5.1.
English: The MAH to support this proposed indication presented two randomised, placebo controlled studies (HS230027 and HS0028) [Spruance, 2003] evaluating the efficacy and safety of one dosing regimen of VACV, 2000 mg twice daily for 1 day, compared to placebo.
Danish: Indehaveren af markedsføringstilladelsen fremlagde til støtte for denne indikation to randomiserede, placebokontrollerede undersøgelser (HS230027 og HS0028) [Spruance, 2003], som evaluerer effekten og sikkerheden af et dosisregime af VACV, 2000 mg 2 gange dagligt i 1 dag sammenlignet med placebo.
English: Studies 123-007 and HS230018 were conducted to evaluate the safety and efficacy of valaciclovir in the suppression of recurrent ano-genital HSV episodes in HIV-infected subjects (Conant, 2002).
Danish: Undersøgelse 123-007 og HS230018 blev gennemført for at evaluere sikkerheden og effekten af valaciclovir til suppression af recidiverende anogenitale HSV-episoder hos personer med HIV (Conant, 2002).
English: Aciclovir is converted to a small extent to the metabolites 9(carboxymethoxy)methylguanine (CMMG) by alcohol and aldehyde dehydrogenase and to 8-hydroxy-aciclovir (8-OH-ACV) by aldehyde oxidase.
Danish: Aciclovir omdannes i mindre grad til metabolitterne 9carboxymethoxymethylguanin (CMMG) af alkohol- og aldehyddehydrogenase og til 8hydroxyaciclovir (8-OH-ACV) af aldehydoxidase.
English: Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.
Danish: Hæmodialyse øger signifikant eliminationen af aciclovir fra blodet og kan derfor være en behandlingsmulighed i tilfælde af symptomatisk overdosering.
English: Table 1: DOSAGE ADJUSTMENT FOR RENAL IMPAIRMENT Therapeutic Indication
Danish: Tabel 1: DOSISJUSTERING VED NEDSAT NYREFUNKTION Terapeutisk indikation
English: Valtrex (and associated names) has been included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Valtrex (og tilknyttede navne) er medtaget på den liste over lægemidler, hvis produktresuméer skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer.
English: The CHMP agreed a reduced dosage in renal impairment.
Danish: CHMP vedtog en reduceret dosis ved nyreinsufficiens.
English: The MAH revised section 4.8 accordingly.
Danish: Indehaveren af markedsføringstilladelsen reviderede punkt 4.8 i overensstemmelse hermed.
English: Reduced sensitivity to aciclovir has been described as a result of subtle alterations in either the virus thymidine kinase or DNA polymerase.
Danish: Nedsat sensitivitet over for aciclovir er blevet beskrevet som resultat af minimale ændringer i enten virus-thymidinkinase eller -DNA-polymerase.
English: These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valtrex a day.
Danish: Disse bivirkninger fra nervesystemet forekommer normalt kun hos personer med nyreproblemer, hos ældre eller hos organtransplanterede personer, der får høje doser Valtrex på 8 g eller mere om dagen.
English: Less than 1% of the administered dose of valaciclovir is recovered in the urine as unchanged drug.
Danish: Mindre end 1 % af den administrerede valaciclovirdosis kan genfindes uomdannet i urinen.
English: A significant proportion of the congenital anomalies described in the articles were consistent with the known foetal adverse effects of intra-uterine infection with CMV.
Danish: En signifikant andel af de medfødte misdannelser, som er beskrevet i artiklerne, er i overensstemmelse med kendte føtale bivirkninger af intrauterin infektion med CMV.
English: The dose of Valtrex should be reduced in patients with impaired renal function as shown in Table 1 below.
Danish: Dosis af Valtrex skal reduceres hos patienter med nedsat nyrefunktion som vist i tabel 1 nedenfor.
English: Valaciclovir has not been studied in patients with severe immune deficiency.
Danish: Valaciclovir er ikke undersøgt hos patienter med svært nedsat immunforsvar.
English: • Store below 30°C.
Danish: • Opbevares ved temperaturer under 30 ºC.
English: Similarly, valaciclovir administration may increase plasma concentrations of the concurrently administered substance.
Danish: På samme måde kan administration af valaciclovir muligvis øge plasmakoncentrationen af andet samtidigt administreret lægemiddel.
English: The safety and efficacy of valaciclovir for the treatment of HSV in immunocompromised patients was evaluated in Study 123-008 but there are limited data available to demonstrate the efficacy and the optimal dosage of VACV for treating HSV in immunocompromised patients.
Danish: Sikkerheden og effekten af valaciclovir til behandling af HSV hos immunkompromitterede patienter blev evalueret i undersøgelse 123-008, men der foreligger kun begrænsede data til at påvise effekt og normal dosering af VACV til behandling af HSV hos immunkompromitterede patienter.
English: Valtrex can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.
Danish: Valtrex kan forhindre udvikling af læsioner, når det tages ved de første tegn og symptomer på en recidiverende HSV-infektion.
English: • You should take each dose about 6 hours apart.
Danish: • Der skal gå ca. 6 timer mellem hver dosis.
English: HSV Suppression in HIV-infected Patients
Danish: HSV-suppression hos patienter med HIV
English: Skin and subcutaneous tissue disorders Common:
Danish: Hud og subkutant væv Almindelige:
English: After oral administration valaciclovir is well absorbed and rapidly and almost completely converted to aciclovir and valine.
Danish: Efter oral administration absorberes valaciclovir godt og omdannes hurtigt og næsten fuldstændigt til aciclovir og valin.
English: Your doctor may adjust the dose of Valtrex if:
Danish: Lægen ændrer måske din Valtrex-dosis, hvis du:
English: These are rare in people taking Valtrex.
Danish: Dette sker i sjælden tilfælde hos patienter, der tager Valtrex.
English: The CHMP proposed to reduce doses in renal impairment but the MAH was of the opinion that the precautionary statements regarding use in the elderly and patients with renal impairment, the maintenance of adequate hydration, and adherence to the recommended dosage reductions for patients with renal impairment were adequate and appropriate.
Danish: CHMP foreslog at reducere dosis ved nyreinsufficiens, men indehaveren af markedsføringstilladelsen mente, at sikkerhedssætningerne vedrørende ældre og patienter med nyreinsufficiens, opretholdelse af tilstrækkelig hydrering og overholdelse af de anbefalede dosisreduktioner for patienter med nyreinsufficiens var tilstrækkelige og passende.
English: Valtrex is indicated
Danish: Valtrex er indiceret til
English: The CHMP endorsed the MAH's proposal not to include the insertion of viral resistance in the Section 4.3.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag om ikke at inkludere indsættelse af viral resistens i punkt 4.3.
English: Neurological disorders, sometimes severe, may be linked to encephalopathy and include confusion, agitation, convulsions, hallucinations, coma.
Danish: Neurologiske lidelser, undertiden alvorlige, kan være forbundet med encefalopati og inkludere konfusion, agitation, kramper, hallucinationer og koma.
English: Values for Cmax and AUC denote mean ± standard deviation.
Danish: Værdier for Cmax og AUC betegner median ± standardafvigelse.
English: France, Belgium, Denmark, Italy, Luxembourg, Netherlands: Zelitrex This leaflet was last approved in {MM/YYYY}.
Danish: Belgien, Danmark, Frankrig, Holland, Italien, Luxembourg: Zelitrex.
English: These events are generally reversible and usually seen in patients with renal impairment or with other predisposing factors (see section 4.4).
Danish: Disse bivirkninger er generelt reversible og ses normalt hos patienter med nedsat nyrefunktion eller med andre prædisponerende faktorer (se pkt.
English: Pharmacokinetic data in adult patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dose adjustment; however, clinical experience is limited.
Danish: Farmakokinetiske data hos voksne patienter med fremskreden cirrose (nedsat hepatisk syntese og tegn på portosystemisk shunt) indikerer ikke, at der er behov for dosisjustering, men den kliniske erfaring er begrænset.
English: The MAH retained an appropriate cautionary statement in the Pregnancy and Lactation Section 4.6 in the harmonised EU SPC.
Danish: Indehaveren af markedsføringstilladelsen bevarede et passende udsagn om forsigtighed i punkt 4.6 Graviditet og amning i det harmoniserede EU-produktresumé.
English: The sample size of the clinical trial database is based on pooled data from valaciclovir pivotal studies for 4 different indications.
Danish: Populationsstørrelse for den kliniske undersøgelsesdatabase er baseret på puljede data fra hovedundersøgelser af valaciclovir til 4 forskellige indikationer.
English: Following 1000 mg valaciclovir, cimetidine and probenecid reduce aciclovir renal clearance and increase the AUC of aciclovir by about 25% and 45%, respectively, by inhibition of the active renal secretion of aciclovir.
Danish: Ved administration af 1.000 mg valaciclovir reducerer cimetidin og probenecid den renale clearance af aciclovir og øger AUC for aciclovir med henholdsvis 25 % og 45 % ved at hæmme den aktive renale sekretion af aciclovir.
English: For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at least 5 days, following assessment of the severity of the clinical condition and immunological status of the patient.
Danish: Til behandling af HSV-infektion hos immunkompromitterede voksne er dosis 1.000 mg 2 gange daglig i mindst 5 dage efter vurdering af sværhedsgraden af den kliniske tilstand og patientens immunologiske status.
English: Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching or burning).
Danish: Behandlingen skal påbegyndes ved de allerførste symptomer på forkølelsessår (f.eks. prikken, kløe eller brænden).
English: There is no direct comparative study versus valganciclovir to define the optimal therapeutic management of solid organ transplant patients.
Danish: Der er ikke udført studier med direkte sammenligning med valganciclovir med det formål at definere den optimale behandling af organtransplanterede patienter.
English: France sanofi-aventis France 1 - 13 boulevard Romain Rolland
Danish: Frankrig sanofi-aventis France 1 - 13 boulevard Romain Rolland 75014 PARIS