FrancophonIA/ELRC3.0 huggingface dataset:
English: Valaciclovir is rapidly and almost completely converted to acyclovir and L-valine via intestinal and hepatic first-pass metabolism.
Danish: Valaciclovir metaboliseres hurtigt og næsten fuldstændigt til aciclovir og L-valin via intestinal og hepatisk first-pass-metabolisme.
English: In patients with normal renal function the plasma elimination half-life of aciclovir after both single and multiple dosing with valaciclovir is approximately 3 h.
Danish: Hos patienter med normal nyrefunktion er plasmahalveringstiden for aciclovir efter både enkel og gentagen dosering med valaciclovir ca. 3 timer.
English: No changes in peak concentrations or AUCs are observed with co-administration of valaciclovir and mycophenolate mofetil in healthy volunteers.
Danish: Der er ikke set ændringer i de maksimale koncentrationer eller AUC ved samtidig behandling med valaciclovir og mycophenolatmofetil hos raske forsøgspersoner.
English: This applies to concomitant administration with aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, and tacrolimus.
Danish: Dette omfatter samtidig administration af aminoglykosider, organiske platinforbindelser, ioderede kontrastmidler, methotrexat, pentamidin, foscarnet, ciclosporin og tacrolimus.
English: Valaciclovir did not affect fertility in rats dosed by the oral route.
Danish: Valaciclovir påvirkede ikke fertiliteten hos rotter ved oral administration.
English: • rash, sometimes itchy, hive-like rash (urticaria)
Danish: • udslæt, nogle gange et kløende, nældefeber-lignende udslæt (urticaria)
English: Use in CMV infections
Danish: Anvendelse ved CVM-infektioner
English: The possibility of renal impairment in the elderly must be considered and the dose should be adjusted accordingly (see Renal impairment below).
Danish: Muligheden for nedsat nyrefunktion skal overvejes, og dosis skal justeres i overensstemmelse hermed (se ”Nedsat nyrefunktion” nedenfor).
English: Polysorbate 80 (500 and 1000 mg tablets only) Blue printing ink FT203 containing brilliant blue (E133) (250 mg and 1000 mg tablets only) Carnauba wax
Danish: Polysorbat 80 (kun 500 mg og 1.000 mg tabletter) Blåt trykkeblæk FT203 indeholdende Brilliant Blue (E133) (kun 250 mg og 1.000 mg tabletter) Carnaubavoks.
English: If you are pregnant, or think you could be, or if you are planning to become pregnant, don't take Valtrex without checking with your doctor.
Danish: Hvis du er gravid eller har en mistanke om, at du kan være det, eller hvis du planlægger at blive gravid, må du ikke bruge Valtrex uden at tale med din læge om det. Din læge vil afveje fordelene for dig og ulemperne for dit barn ved, at du tager Valtrex, mens du er gravid eller ammer.
English: After oral administration, valaciclovir is converted to aciclovir and L-valine by first-pass intestinal and/or hepatic metabolism.
Danish: Efter oral administration omdannes valaciclovir til aciclovir og L-valin vha. first-pass metabolisme i tarm og/eller lever.
English: Packs of 10, 30, 42, 90 or 112 tablets Not all pack sizes may be marketed.
Danish: Pakninger med 10, 30, 42, 90 eller 112 tabletter.
English: Monitoring of clinical HSV and VZV isolates from patients receiving aciclovir therapy or prophylaxis has revealed that virus with reduced sensitivity to aciclovir is extremely rare in the immunocompetent host and is found infrequently in severely immunocompromised individuals e.g. organ or bone marrow transplant recipients, patients receiving chemotherapy for malignant disease and people infected with the human immunodeficiency virus (HIV).
Danish: Monitorering af kliniske HSV- og VZV-isolater fra patienter, som er i aciclovirbehandling eller -profylakse viser, at virus med nedsat sensitivitet over for aciclovir er ekstremt sjældne hos immunkompetente patienter og findes sporadisk hos svært immunkompromitterede patienter, f.eks. efter organ- eller knoglemarvstransplantation, hos patienter i kemoterapi for malign sygdom samt hos hiv-inficerede.
English: This conversion is probably mediated by an enzyme isolated from human liver referred to as valaciclovir hydrolase.
Danish: Omdannelsen er sandsynligvis medieret af valaciclovirhydrolase, et enzym isoleret fra human lever.
English: • Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.
Danish: • Nogle personer med hyppigt tilbagevendende infektioner kan med fordel tage 1 tablet på 250
English: The CHMP endorsed the following: “For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Danish: CHMP godkendte følgende: "Til herpes labialis (forkølelsessår) er valaciclovir 2000 mg 2 gange dagligt i 1 dag en effektiv behandling hos voksne og unge.
English: For ARs identified as associated with valaciclovir from post-marketing experience, and observed in clinical trials, study incidence has been used to assign the AR frequency category.
Danish: For bivirkninger associeret med valaciclovir observeret efter markedsføring og under kliniske studier er studieincidens anvendt til bestemmelse af bivirkningsfrekvensen.
English: Valtrex reduces the risk of ocular complications of ophthalmic zoster.
Danish: Valtrex nedsætter risikoen for okulære komplikationer ved zoster ophthalmicus.
English: Varicella-Zoster Virus (VZV) Infections Treatment of herpes zoster (shingles) in immunocompetent and immunocompromised adults
Danish: Varicella zoster virus (VZV)-infektioner Behandling af herpes zoster (helvedesild) hos immunkompetente og immunkompromitterede voksne
English: The MAH stated that higher doses of valaciclovir usually are recommended for dosing in immunocompromised subjects relative to immunocompetent subjects for a common indication.
Danish: Indehaveren af markedsføringstilladelsen har angivet, at der sædvanligvis anbefales højere doser af valaciclovir til immunkompromitterede personer i forhold til immunkompetente personer for samme indikation.
English: The dose in immunocompromised patients is 1000 mg three times daily for at least seven days (3000 mg total daily dose) and for 2 days following crusting of lesions.
Danish: Dosis til immunkompromitterede patienter er 1.000 mg 3 gange daglig i mindst 7 dage (total daglig dosis 3.000 mg) og indtil to dage efter skorpedannelse på læsioner.
English: The second dose should be taken about 12 h (no sooner than 6 h) after the first dose.”
Danish: Den anden dosis bør tages ca. 12 timer (tidligst 6 timer) efter den første dosis."
English: Renal pain may be associated with renal failure.
Danish: Nyresmerter kan være associeret med nyresvigt.
English: However, valaciclovir showed efficacy in the treatment of herpes labialis (cold sores), mucositis due to chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.
Danish: Valaciclovir viste dog effekt ved behandling af herpes labialis (forkølelsessår), mucositis på grund af kemoterapi eller radioterapi, HSV-reaktivering fra genopblussen i ansigtet og herpes gladiatorum.
English: Suppression of HSV infections - immunocompetent adults and adolescents
Danish: Profylakse mod HSV-infektioner - immunkompetente voksne og unge
English: Cytomegalovirus (CMV) Infections CMV prophylaxis in solid organ transplant recipients in adults and adolescents
Danish: Cytomegalovirus (CMV)-infektioner CMV-profylakse hos organtransplanterede voksne og unge
English: HSV Suppression for Outbreak Reduction (recurrent episodes of genital herpes simples) The MAH in order to demonstrate efficacy in the suppression of genital herpes recurrences presented two Studies (123-026 and 123-037).
Danish: HSV-suppression til reduktion af udbrud (tilbagevendende episoder af genital herpes simplex) Indehaveren af markedsføringstilladelsen fremlagde resultaterne af to undersøgelser (123-026 og 123037) for at påvise effekt ved suppression af recidiverende genital herpes.
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4).
Danish: Valtrex er indiceret til behandling af herpes zoster hos voksne patienter med mild eller moderat immunsuppression (se pkt.
English: Rashes including photosensitivity, pruritus.
Danish: lysfølsomhed, pruritus
English: Valtrex Tablets 1000 mg are supplied in cartons containing 21 film-coated tablets.
Danish: Valtrex 1.000 mg filmovertrukne tabletter findes i en pakning med 21 filmovertrukne tabletter.
English: In patients on intermittent haemodialysis, the Valtrex dose should be administered after the haemodialysis has been performed.
Danish: Hos patienter i intermitterende hæmodialyse skal dosis af Valtrex gives, efter hæmodialysen er gennemført.
English: The CHMP recommended a cut-off at 10 ml/min in this case (resulting in an estimated exposure of 39-63 at <10 ml/min and 43-77 at CLcr 10-30 ml/min).
Danish: i disse tilfælde (resulterende i en estimeret eksponering på 39-63 ved <10 ml/min.
English: What Valtrex tablets look like and contents of the pack Valtrex tablets are contained in polyvinyl chloride/aluminium foil blister packs.
Danish: Valtrex filmovertrukne tabletter findes i polyvinylchlorid/aluminium-blisterpakninger.
English: • treat shingles (in adults)
Danish: • behandle helvedesild (hos voksne)
English: • The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose
Danish: • Du skal tage den anden dosis 12 timer (tidligst 6 timer) efter den første dosis.
English: • slow, slurred speech (dysarthria)
Danish: • taleforstyrrelser (dysartri)
English: • reduction in the number of blood platelets which are cells that help blood to clot
Danish: • nedsat antal blodplader, som er de celler, der får blodet til at størkne (trombocytopeni)
English: Î Talk to your doctor before taking Valtrex if any of the above apply.
Danish: Î Tal med lægen, før du tager Valtrex, hvis noget af dette gælder for dig.
English: The MAH, as requested, re-calculated the adverse reactions (ARs) frequency categories for those reactions identified from post-marketing data to take into account the revised SPC guidelines.
Danish: Indehaveren af markedsføringstilladelsen genberegnede efter anmodning bivirkningshyppighedskategorierne (AR) for de bivirkninger, som er identificeret ved data efter markedsføring, for at tage højde for de reviderede retningslinjer for produktresuméet.
English: Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)
Danish: Profylakse mod cytomegalovirus (CMV)-infektion og -sygdom hos voksne og unge (≥ 12 år)
English: Among subjects participating in a viral shedding sub-study, valaciclovir significantly reduced shedding by 73 % compared to placebo (see section 4.4 for additional information on transmission reduction).
Danish: Hos patienter med virusspredning, der deltog i et sub-studie, reducerede valaciclovir spredning signifikant med 73 % sammenlignet med placebo (se pkt.
English: Section 4.1 Therapeutic Indications
Danish: Punkt 4.1 - Terapeutiske indikationer
English: Valaciclovir Dosage a
Danish: Valaciclovir doseringa
English: Herpes simplex virus (HSV) infections
Danish: Herpes simplex virus (HSV)-infektioner
English: • treat and prevent HSV infections of the eye
Danish: • behandle og forebygge HSV-infektioner i øjnene.
English: Valaciclovir has been proven to reduce the risk of transmission of genital herpes in immunocompetent adults when taken as suppressive therapy and combined with safer sex practices.
Danish: Det er vist, at valaciclovir nedsætter risikoen for overførsel af genital herpes hos immunkompetente voksne, når det tages profylaktisk og ved samtidig anvendelse af "sikker sex"-procedurer.
English: For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Danish: Til herpes labialis (forkølelsessår) er 2.000 mg valaciclovir 2 gange daglig i 1 dag effektiv behandling hos voksne og unge.
English: • Take Valtrex at the same time each day.
Danish: • Tag tabletten på samme tid hver dag.
English: Hypersensitivity to valaciclovir or aciclovir or any of the excipients (see section 6.1).
Danish: Overfølsomhed over for valaciclovir, aciclovir eller et eller flere af hjælpestofferne (se pkt.
English: There have been reports of renal insufficiency, microangiopathic haemolytic anaemia and thrombocytopenia (sometimes in combination) in severely immunocompromised adult patients, particularly those with advanced HIV disease, receiving high doses (8000 mg daily) of valaciclovir for prolonged periods in clinical trials.
Danish: Yderligere information om særlige patientpopulationer I kliniske studier er der set tilfælde af nyreinsufficiens, mikroangiopatisk hæmolytisk anæmi og trombocytopeni (i visse tilfælde samtidig) hos svært immunkompromitterede voksne patienter, særligt hos patienter med fremskreden hiv-sygdom, som får høje doser valaciclovir (8.000 mg daglig) i længere perioder.
English: • fits (convulsions)
Danish: • kramper (anfald)
English: The Wellcome Foundation Ltd. Greenford, Middlesex, United Kingdom
Danish: Finland The Wellcome Foundation Ltd. Greenford, Middlesex,
English: Valtrex Tablets 250 mg are supplied to you in cartons containing 60 film-coated tablets.
Danish: Valtrex 250 mg tabletter findes i en pakning med 60 filmovertrukne tabletter.
English: The following frequency categories are used for classification of adverse effects: Very common ≥ 1/10,
Danish: Følgende hyppigheder anvendes til klassificering af bivirkninger:
English: - immunocompromised adults
Danish: - immunkompromitterede voksne
English: Use of higher doses of valaciclovir in hepatic impairment and liver transplantation There are no data available on the use of higher doses of valaciclovir (4000 mg or more per day) in patients with liver disease.
Danish: Der er ingen data for anvendelse af højere doser valaciclovir (4.000 mg eller mere om dagen) til patienter med leversygdom.
English: • treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old).
Danish: • behandle HSV-infektioner i huden og herpes på kønsorganerne (herpes genitalis) (hos voksne og unge over 12 år).
English: The CHMP requested the MAH to further discuss the proposed dose adjustment for renal impairment at one-day treatment of herpes labialis.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at drøfte dosisjustering for nyreinsufficiens ved endagsbehandling af herpes labialis yderligere.
English: The second dose should be taken about 12 h (no sooner than 6 h) after the first dose.
Danish: Den anden dosis bør tages ca. 12 timer (tidligst 6 timer) efter den første dosis.
English: Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4)
Danish: Valtrex er indiceret til profylakse mod CMV-infektion og -sygdom efter organtransplantation hos voksne og unge (se pkt.
English: Valaciclovir has shown efficacy in the treatment of herpes labialis (cold sores), mucositis due to chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.
Danish: Valaciclovir er vist effektivt i behandlingen af herpes labialis (forkølelsessår), mucositis pga. kemoterapi eller stråleterapi, HSV-reaktivering efter ansigtskorrektion samt herpes gladiatorum.
English: Patients with complicated herpes zoster, i.e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy.
Danish: Intravenøs antiviral behandling bør anvendes til patienter med kompliceret herpes zoster, dvs. patienter med visceral involvering, dissemineret zoster, motoriske neuropatier, encefalitis og cerebrovaskulære komplikationer.
English: For higher doses (4000 mg or more per day), see section 4.4.
Danish: 4.4 for højere doser (4.000 mg eller mere om dagen).
English: 2000 mg four times daily
Danish: 2.000 mg 4 gange daglig
English: Treatment of HSV infections of the skin and genital herpes
Danish: Behandling af HSV-infektioner i huden og herpes på kønsorganerne (herpes genitalis)
English: • low back pain (kidney pain)
Danish: • smerter i nederste del af ryggen (nyresmerter)
English: CMV prophylaxis with valaciclovir in subjects receiving solid organ transplantation (kidney, heart) reduces the occurrence of acute graft rejection, opportunistic infections and other herpes virus infections (HSV, VZV).
Danish: CMV-profylakse med valaciclovir reducerer forekomsten af akut afstødning af transplantat, opportunistiske infektioner og andre herpes virusinfektioner (HSV, VZV) hos organtransplanterede patienter (nyrer, hjerte).
English: Aciclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and thus blocking virus replication.
Danish: Inkorporering af denne nukleosidanalog resulterer i obligat afslutning af kæden, hvorved DNA-syntesen stoppes, og virusreplikationen blokeres.
English: To stop you being infected with CMV (Cytomegalovirus)
Danish: Forebyggelse af infektion med CMV (cytomegalovirus)
English: Zemouto - Coina 2830 Barreiro Portugal
Danish: Alter, SAEstrada Marco do Grilo Zemouto - Coina 2830 Barreiro
English: Belgium GlaxoSmithKline s.a.
Danish: Belgien GlaxoSmithKline s.a.
English: Aciclovir PK Parameter
Danish: Farmakokinetiske parametre for aciclovir
English: For HSV suppression in immunocompetent subjects with a history of ≥10 recurrences/year, better results may be obtained with 250 mg twice daily.
Danish: b Immunkompetente patienter, som har haft ≥ 10 udbrud pr. år, opnår muligvis bedre resultater med 250 mg to gange daglig.
English: 2000mg twice in one day 1000 mg twice in one day 500 mg twice in one day 500 mg single dose
Danish: 2.000 mg 2 gange på samme dag 1.000 mg 2 gange på samme dag 500 mg 2 gange på samme dag 500 mg som enkeltdosis
English: The MAH provided the dosage adjustment rationale for the treatment of herpes labialis in subjects with renal impairment.
Danish: Indehaveren af markedsføringstilladelsen fremlagde yderligere begrundelse for dosisjustering ved behandling af herpes labialis hos personer med nyreinsufficiens.
English: • you have kidney problems.
Danish: • har nyreproblemer.
English: Intratubular precipitation of aciclovir crystals in the kidney has also been reported.
Danish: Der er set tilfælde af intratubulær udfældning af aciclovirkrystaller i nyrerne.
English: Therefore, in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices.
Danish: Derfor anbefales det, at patienter, i tillæg til behandling med valaciclovir, beskytter sig mod seksuelt overførbare sygdomme.
English: Tmax hours (h)
Danish: Tmax timer (t) AUC t·mikrogram/ml
English: White, biconvex, elongated tablet with a white to off-white core, with a partial scorebar on both sides and marked “GX CF2” in blue ink on one side.
Danish: Hvide, bikonvekse, aflange tabletter med en hvid eller offwhite kerne, delekærv på begge sider og mærket ”GX CF2” med blåt blæk på den ene side.
English: The MAH, in order to prove the safety and efficacy of valaciclovir for the treatment of HSV, evaluated the product in a clinical development programme of six studies focusing on genital herpes (HSV-2) infection.
Danish: Indehaveren af markedsføringstilladelsen evaluerede lægemidlet i et klinisk udviklingsprogram bestående af seks undersøgelser med fokus på genital herpes (HSV-2)-infektion med henblik på at bevise sikkerhed og effekt af valaciclovir til behandling af HSV.
English: Whereas - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Danish: - formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen,
English: Allen Farmacéutica S.A. Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spain
Danish: Spanien Allen Farmacéutica S.A. Severo Ochoa, 2 ,28760, Tres Cantos Madrid
English: Cimetidine and probenecid taken together with valaciclovir increased aciclovir AUC by about 65%.
Danish: AUC for aciclovir øges med ca. 65 %, når cimetidin og probenecid administreres sammen med valaciclovir.
English: The combination of valaciclovir with nephrotoxic medicinal products should be made with caution, especially in subjects with impaired renal function, and warrants regular monitoring of renal function.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der skal udvises forsigtighed ved kombination af valaciclovir med nefrotoksiske lægemidler, særligt hos patienter med nedsat nyrefunktion, og regelmæssig monitorering af nyrefunktionen er påkrævet.
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Valtrex and associated names (see Annex I).
Danish: har CHMP anbefalet ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Valtrex og tilknyttede navne (se bilag I).
English: GlaxoSmithKline Pharma GmbH, Albert SchweitzerGasse 6,
Danish: GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien,
English: GlaxoSmithKline Latvia SIA, Bruņinieku iela 5, Riga, LV-1001
Danish: Letland GlaxoSmithKline Latvia SIA, Bruņinieku iela 5,
English: Immunocompromised Adults
Danish: Immunkompromitterede voksne
English: • Treatment and suppression of recurrent ocular HSV infections.
Danish: • Behandling og suppression af recidiverende HSV-øjeninfektioner
English: The CHMP agreed that for herpes labialis, valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Danish: CHMP vedtog, at valaciclovir 2000 mg 2 gange dagligt i 1 dag er en effektiv behandling af herpes labialis hos voksne og unge.
English: Read the package leaflet before use.
Danish: Oral anvendelse Læs indlægssedlen inden brug
English: Use in ocular HSV infections
Danish: Anvendelse ved okulære HSV-infektioner
English: Intravenous therapy generally is considered standard for zoster treatment in immunocompromised patients; however, limited data indicate a clinical benefit of valaciclovir in the treatment of VZV infection (herpes zoster) in certain immunocompromised patients, including those with solid organ cancer, HIV, autoimmune diseases, lymphoma, leukaemia and stem cell transplants.
Danish: Begrænsede data indikerer dog klinisk fordel ved valaciclovir til behandling af VZV-infektion (herpes zoster) hos visse immunkompromitterede patienter, herunder patienter med solide, maligne tumorer i organerne, hiv, autoimmun sygdom, lymfom og leukæmi samt stamcelletransplanterede patienter.
English: • The usual dose is one 500 mg tablet once a day.
Danish: • Den sædvanlige dosis er 1 tablet på 500 mg 1 gang daglig.
English: Packs of 60 tablets
Danish: Pakninger med 60 tabletter.
English: What Valtrex is and what it is used for Before you take Valtrex How to take Valtrex Possible side effects How to store Valtrex Further information
Danish: Det skal du vide, før du begynder at tage Valtrex Sådan skal du tage Valtrex Bivirkninger
English: GlaxoSmithKline, S.A Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spain
Danish: Spanien GlaxoSmithKline, S.A Severo Ochoa, 2 ,28760, Tres Cantos Madrid Spanien
English: The rate and extent of absorption decreases with increasing dose, resulting in a less than proportional increase in Cmax over the therapeutic dose range and a reduced bioavailability at doses above 500 mg. Aciclovir pharmacokinetic (PK) parameter estimates following single doses of 250 to 2000 mg valaciclovir to healthy subjects with normal renal function are shown below.
Danish: Hastigheden og absorptionsgraden aftager med stigende dosis, hvilket resulterer i en mindre end proportional stigning i Cmax i det terapeutiske dosisområde og en nedsat biotilgængelighed ved doser over 500 mg.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Andre punkter i produktresuméet