FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatment-naïve N=54
Danish: Tabel 13: Behandlingsresultater, daclatasvir i kombination med sofosbuvir og ribavirin i 24 uger, patienter med HCV-genotype 3 med cirrose i ALLY-3C-studiet Behandlingsnaiv N=54
English: The relapse rate was around 15%, and similar for patients with Child-Pugh A, B and C. The programmes do not allow for a direct comparison of efficacy between the 12- and 24-week regimens.
Danish: Recidivraten var ca. 15% og var ens hos patienter med Child-Pugh A, B og C.
English: Patients achieving virologic response [HCV RNA undetectable at weeks 4 and 12] completed therapy after 24 weeks while those who did not achieve virologic response received an additional 24 weeks of treatment with pegIFN/RBV, to complete a total of 48 weeks of study therapy.
Danish: Patienter, der opnåede virologisk respons [ikke-detekterbart HCV-RNA ved uge 4 og 12], afsluttede behandlingen efter 24 uger, mens patienter, som ikke opnåede virologisk respons,
English: The absolute bioavailability
Danish: Tabletformuleringens absolutte biotilgængelighed er 67%.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 60 mg tabletter
English: For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Danish: 4.5 for dosisanbefalinger sammen med antivirale hiv-midler.
English: if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Danish: - phenytoin, carbamazepin, oxcarbazepin eller phenobarbital, bruges til at behandle epileptiske anfald - rifampicin, rifabutin eller rifapentin, antibiotika mod tuberkulose - dexamethason, et steroidhormon, der anvendes mod allergiske reaktioner og betændelsessygdomme - medicin, der indeholder perikon (Hypericum perforatum, et naturlægemiddel).
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 μg [
Danish: Hos patienter, som fik daclatasvir 60 mg tablet oralt efterfulgt af 100 μg [13C,15N]-daclatasvir som intravenøs dosis, var total-clearance
English: Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Danish: Der foreligger kun begrænsede data til at understøtte behandling af genotype 2-infektion med
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 30 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Daklinza 30 mg filmovertrukne tabletter
English: Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 60 mg daclatasvir (som dihydrochlorid).
English: Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg daclatasvir (som dihydrochlorid).
English: Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatmentexperienced N=24
Danish: Tabel 13: Behandlingsresultater, daclatasvir i kombination med sofosbuvir og ribavirin i 24 uger, patienter med HCV-genotype 3 med cirrose i ALLY-3C-studiet
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3 Treatment-naïve N=101
Danish: Tabel 12: Behandlingsresultater, daclatasvir i kombination med sofosbuvir i 12 uger, patienter med HCV-genotype 3 i ALLY-3-studiet
English: HCV genotype: 1a
Danish: Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=301
English: If you have any questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om din medicin.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 60 mg filmovertrukne tabletter
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt ved samtidig administration af potente CYP3A4-hæmmere.
English: Expected due to inhibition of P-gp by
Danish: Forventes på grund perikons induktion ↓ Daclatasvir
English: to complete 48 weeks of treatment.
Danish: fik yderligere 24 ugers behandling med pegIFN/RBV og gennemførte i alt 48 ugers studiebehandling.
English: ↔ Warfarin
Danish: ↑ Daclatasvir
English: Relapse includes observations through follow-up Week 24.
Danish: Recidiv omfatter observationer til
English: There are no clinical data in patients with genotype 5 (see section 5.1).
Danish: Der foreligger ingen kliniske data for patienter med
English: Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24) Dose recommendation for concomitant medicines Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4)
Danish: Seponering af peginterferon alfa og ribavirin (behandling med Daklinza er komplet ved uge 24)
English: For HCV genotype specific activity, see sections 4.4 and 5.1.
Danish: For HCV-genotypespecifik aktivitet se pkt.
English: Biotransformation
Danish: Fremstiller
English: However, transmission is still possible.
Danish: Overførsel er dog stadig mulig.
English: However, the data were considered supportive.
Danish: Dataene blev dog betragtet som understøttende.
English: It is normally spread by sexual contact.
Danish: Den spredes normalt ved seksuel kontakt.
English: The duration of the active treatment period was only 8 weeks.
Danish: Varigheden af den aktive behandlingsperiode var på kun otte uger.
English: Show them your pack of tablets.
Danish: Vis dem din pakke med tabletter.
English: Then take your next dose as scheduled.
Danish: Tag derefter den næste dosis som planlagt.
English: Section 4.6 was updated accordingly.
Danish: Afsnit 4.6 blev opdateret i overensstemmelse hermed.
English: 40 to 59
Danish: 40 til 59
English: 2100 Kopenhagen Ø Denmark
Danish: 2100 Kopenhagen Ø Danmark
English: * Never reported in clinical trials; category is based on the “rule of three”
Danish: * Aldrig rapporteret i kliniske forsøg; kategori er baseret på “3-reglen”
English: Taking Famvir with food and drink You can take Famvir with or without food.
Danish: Brug af Famvir sammen med mad og drikke Du kan tage Famvir sammen med eller uden mad og drikke.
English: The section was reviewed, in particular the regarding special populations, as the elderly.
Danish: Dette afsnit blev revideret, særlig vedrørende særlige populationer, såsom ældre.
English: - If you have kidney problems (or have had them before).
Danish: Hvis du har nyreproblemer (eller tidligere har haft det).
English: - If you have liver problems.
Danish: Hvis du har leverproblemer.
English: Metabolism and elimination
Danish: Metabolisering og elimination
English: It was noted that this dose is also in line with current literature recommendations (Dworkin RH et al, Clin.
Danish: Det blev bemærket, at denne dosis også er i overensstemmelse med de nuværende anbefalinger i litteraturen (Dworkin RH et al, Clin.
English: The CHMP noted that the Study 098 appeared acceptable with respect to design as well as results.
Danish: CHMP bemærkede, at undersøgelse 098 forekom acceptabel med hensyn til både udformning og resultater.
English: Your doctor will tell you how long you need to continue taking your tablets.
Danish: Din læge vil fortælle dig, hvor længe du skal fortsætte med at tage dine tabletter.
English: This is important to prevent you passing the infection on to others.
Danish: Dette er vigtigt for at undgå, at du overfører infektionen til andre.
English: • Raloxifen (used to prevent and treat osteoporosis).
Danish: • Raloxifen (bruges til at forebygge og behandle osteoporose).
English: Famvir can cause dizziness, drowsiness or confusion.
Danish: Famvir kan forårsage svimmelhed, døsighed eller forvirring.
English: Famciclovir should only be used during pregnancy when the potential benefits of treatment outweigh the potential risks.
Danish: Famciclovir bør kun bruges under graviditet, når den potentielle gavn af behandlingen opvejer de potentielle risici.
English: The 10-day treatment duration was chosen to maximize the efficacy in this ‘at risk' population.
Danish: Behandlingen af en varighed på 10 dage blev valgt for at maksimere effekten hos denne "risiko"-population.
English: Famvir stops the virus from spreading in the body so that healing can occur faster.
Danish: Famvir forhindrer virus i at spredes i kroppen, så helbredelse kan ske hurtigere.
English: Hallucinations.
Danish: Hallucinationer.
English: Of these, only 27 completed the study.
Danish: 27 gennemførte undersøgelsen.
English: - The daily dose and length of treatment will depend on the type of viral infection you have - see below.
Danish: Den daglige dosis og varigheden af behandlingen vil afhænge af den type virusinfektion, du har - se nedenfor.
English: It causes blisters and burning or itching around the genitals, which may be painful.
Danish: Den giver blistre og brænden eller kløe omkring kønsdelene, hvilket kan være smertefuldt.
English: This is because you could pass the herpes infection to your partner.
Danish: Dette er fordi, du kan overføre herpesinfektionen til din partner.
English: The minimum period of reassessment should include two recurrences.
Danish: Revurderingsperioden bør omfatte mindst 2 recidiver.
English: You should not have sex if you have genital sores or blisters.
Danish: Du bør ikke have sex, hvis du har genitale sår eller blistre.
English: Famvir is an antiviral medicine.
Danish: Famvir er en antiviral medicin.
English: The pivotal studies 007 and 008 formed the basis of initial registration dossiers.
Danish: De pivotale undersøgelser 007 og 008 dannede grundlag for de indledende registreringsdossierer.
English: Patients had to have lesions in the genital area.
Danish: Patienterne skulle have læsioner i genitalområdet.
English: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison France
Danish: 2 - 4, rue Lionel Terray 92500 Rueil-Malmaison Frankrig
English: A total of 14 patients were withdrawn in Period 1 and 7 patients were withdrawn in Period 2.
Danish: Sammenlagt blev 14 patienter trukket ud i første periode, og syv patienter blev trukket ud i anden periode.
English: This finding was reversible and has also been observed with other substances of this class.
Danish: Dette fund var reversibelt og er også set ved andre stoffer i denne klasse.
English: Animal studies did not indicate any negative effect on female fertility.
Danish: Dyrestudier har ikke vist negativ effekt på den kvindelige fertilitet.
English: A recent publication, by Money B et al, supported the inclusion of this warning, which was endorsed by the CHMP.
Danish: En nylig publikation af Money B et al. understøttede medtagelsen af denne advarsel, som godkendtes af CHMP.
English: The patient population was comprised of patients who were candidates for suppressive treatment.
Danish: Patientpopulationen bestod af patienter, som var kandidater til suppressiv behandling.
English: The CHMP acknowledged that no comparative study with aciclovir was conducted.
Danish: CHMP anerkendte, at der ikke var foretaget nogen komparativ undersøgelse med aciclovir.
English: 12th Km National Road No. 1 GR-144 51 Metamorphosis Greece
Danish: 12th Km National Road No. 1 GR-144 51 Metamorphosis Grækenland
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FAMVIR AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF FAMVIR OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Within the EEA, the 750mg tablet strength is currently approved only in Ireland, UK and Spain.
Danish: De eneste lande inden for EØS, hvor tabletstyrke 750 mg på nuværende tidspunkt er godkendt, er i Irland, Det Forenede Kongerige og Spanien.
English: All patients who initiated study medication during Period 1 were included in the ITT analysis for that period.
Danish: Alle patienter, som påbegyndte undersøgelsesmedicinen under den første periode, blev inkluderet i ITT-analysen for denne periode.
English: It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Det er især vigtigt, at du fortæller det til din læge eller på apoteket, hvis du tager nogen af følgende lægemidler:
English: However, the selection of placebo controls for both studies was questionable.
Danish: Valget af placebokontroller for begge undersøgelser var imidlertid tvivlsomt.
English: All regimens were superior to placebo in terms of the two primary endpoints, and these were considered relevant.
Danish: Alle regimer var overlegne i forhold til placebo med hensyn til de to primære endepunkter, og disse betragtedes som relevante.
English: No dose adjustment based on gender is recommended.
Danish: Dosisjustering baseret på køn anbefales ikke.
English: All other adverse reactions were added during postmarketing.
Danish: Alle andre bivirkninger er tilføjet efter markedsføring.
English: Several doses were investigated in pivotal studies (004, 011, 040).
Danish: Adskillige doser blev undersøgt i pivotale undersøgelser (004, 011, 040).
English: Section 4.4: Special warnings and precautions for use This section was updated to reflect the use in special populations which had previously been included in section 4.3.
Danish: Afsnit 4.4: Særlige advarsler og forsigtighedsregler vedrørende brugen Dette afsnit blev opdateret for at afspejle brugen hos særlige patientpopulationer, der tidligere var omfattet af afsnit 4.3.
English: Furthermore, do not take a double dose to make up for a forgotten dose.
Danish: Tag heller aldrig en dobbeltdosis som erstatning for den glemte dosis.
English: Patients who continue to have significant disease may restart suppressive therapy.
Danish: Patienter, der fortsat har signifikant sygdom, kan genstarte suppressiv behandling.
English: Ask your doctor for advice, if you think you may be allergic.
Danish: Spørg din læge til råds, hvis du tror, du er overfølsom.
English: Like all medicines, Famvir can cause side effects, although not everybody gets them.
Danish: Famvir kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The 500mg bid regimen is recommended by some of the guidelines and no other regimen was studied.
Danish: 500 mg BID-regimet anbefales i nogle af retningslinjerne, og ingen andre regimer blev undersøgt.
English: In analogy with the above reports, it was hypothesized that probenecid may increase penciclovir AUC by approximately 50%.
Danish: I analogi med ovennævnte rapporter blev der fremsat hypoteser om, at probenecid evt. kan forøge penciclovir AUC med ca. 50 %.
English: Serious side effects of Famvir are:
Danish: Alvorlige bivirkninger ved Famvir er:
English: The side effects caused by Famvir are usually mild to moderate in intensity.
Danish: Bivirkninger, som forårsages af Famvir, er normalt milde til moderate i intensitet.
English: No differences were noted between treatment groups for time of withdrawal.
Danish: Der blev ikke observeret nogen forskelle mellem behandlingsgrupperne med hensyn til tilbagetrækningstiden.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of famciclovir in pregnant women.
Danish: Der er en begrænset mængde data fra brug af famciclovir hos gravide kvinder (mindre en 300 graviditeter).
English: People who have frequent episodes of genital herpes can also take Famvir to help to prevent the attacks.
Danish: Personer, som ofte har genital herpes, kan også tage Famvir som hjælp til at forebygge angrebene.
English: This section was updated to remove patient populations not studied as this should be mentioned in section 4.4.
Danish: Dette afsnit blev opdateret for at fjerne de patientpopulationer, der ikke var blevet undersøgt, idet disse skal behandles i afsnit 4.4.
English: In the event of an overdose supportive and symptomatic therapy should be given as appropriate.
Danish: I tilfælde af overdosering bør der gives passende støttende og symptomatisk behandling.
English: It stops the infecting virus from reproducing.
Danish: Den forhindrer den inficerende virus i at formere sig.
English: Several doses and regimens (bid, tid) were studied in different clinical trials.
Danish: Der blev undersøgt en række doser og regimer (BID og TID) i forskellige kliniske undersøgelser.
English: Also was agreed that dose reduction to 250mg tid is the best option when significant toxicity occurs.
Danish: Det blev endvidere fastslået, at en dosisreduktion til 250 mg TID er den bedste mulighed, når der forekommer signifikant toksicitet.
English: • Do not use Famvir if you notice the pack is damaged or shows signs of tampering.
Danish: • Brug ikke Famvir, hvis du opdager, at pakningen er beskadiget eller viser tegn på at have været åbnet.
English: Having considered available data and current scientific knowledge, the CHMP considered the following as the harmonised indications:
Danish: På baggrund af de tilgængelige data og den eksisterende faglige viden betragtede CHMP følgende som de harmoniserede indikationer:
English: However, it cannot be excluded that short-term treatment with high dosages (e.g., 500mg tid) may affect male fertility in humans.
Danish: Det kan imidlertid ikke udelukkes, at kortvarig behandling med høje doser (f.eks. 500 mg TID) kan påvirke den mandlige fertilitet hos mennesker.
English: Overdose experience with famciclovir is limited.
Danish: Erfaringer med overdosering af famciclovir er begrænsede.
English: - If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famvir.
Danish: Hvis du har eller har haft nyreproblemer, kan din læge beslutte at give dig en lavere dosis af Famvir.
English: There were 48 patients enrolled and treated.
Danish: Der var 48 patienter, der deltog og modtog behandling, hvoraf kun
English: The highest dose to be administered based on the assessment of the data submitted is 500mg famciclovir.
Danish: Den højeste dosis, der må administreres på baggrund af vurderingen af de indsendte data, er 500 mg famciclovir.
English: The CHMP noted the recommended doses for the different posologies as indicated above.
Danish: CHMP bemærkede de anbefalede doser for de forskellige doseringer som anført ovenfor.
English: If you are taking Famvir to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practise safe sex, including the use of condoms.
Danish: Hvis du tager Famvir for at behandle eller undertrykke genital herpes, eller hvis du tidligere har haft genital herpes, bør du fortsat praktisere sikker sex, inklusive brug af kondom.
English: Partly this difference may be due to differences in renal function between the two age groups.
Danish: Denne forskel kan til dels skyldes forskelle i nyrefunktion mellem de to aldersgrupper.
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 skønnes utilstrækkelig.
English: • Do not use Famvir after the expiry date which is stated on the label after the expiry date.
Danish: • Brug ikke Famvir efter den udløbsdato, der står på pakningen.
English: No clinically significant interactions have been identified.
Danish: Der er ikke blevet identificeret nogen kliniske signifikant interaktion.
English: Thus the CHMP endorsed the restriction to recurrent genital herpes in HIV infected patients which reflects the outcome of the respective clinical study (083).
Danish: CHMP godkendte således begrænsningen til recidiverende genital herpes hos hiv-inficerede patienter, hvilket afspejler resultatet af den relevante kliniske undersøgelse (083).
English: Dose for genital herpes The dose depends on the state of your immune system, and the stage of your infection.
Danish: Dosering ved genital herpes Dosis afhænger af tilstanden i dit immunsystem og stadiet af din infektion.
English: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Hungary
Danish: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Ungarn
English: A total of 1,587 patients have received famciclovir at recommended doses in placebo- (n=657) and active- (n=930) controlled studies.
Danish: Totalt 1.587 patienter har fået famciclovir i de anbefalede doser i placebokontrollerede forsøg (n=657) og aktivt kontrollerede forsøg (n=930).
English: Thus, the 750mg tablet strength is considered obsolete.
Danish: Tabletstyrke 750 mg betragtes således som forældet.
English: Use for zoster treatment
Danish: Anvendelse til behandling af zoster
English: 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 Famvir and associated names (see Annex I).
Danish: har CHMP anbefalet ændringen af markedsføringstilladelserne, for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Famvir og tilknyttede navne (se bilag I).
English: Suppressive therapy should be discontinued after a maximum of 12 months of continuous antiviral therapy to reassess recurrence frequency and severity.
Danish: Suppressiv behandling bør afbrydes efter maksimalt 12 måneders kontinuerlig antiviral behandling med henblik på at revurdere frekvensen og sværhedsgraden af recidiver.
English: Famciclovir was considered equivalent to aciclovir if the upper limit of the 2-sided 95% confidence interval was less than 15%.
Danish: Famciclovir blev betragtet som svarende til aciclovir, når den øvre grænse for det tosidede 95 %-konfidensinterval var mindre end 15 %.
English: Headache and nausea have been reported in clinical studies.
Danish: Der er rapporteret hovedpine og kvalme i kliniske studier.
English: The most potent inhibitor identified in these in vitro studies was raloxifene.
Danish: Den mest potente hæmmer, der blev identificeret i disse in vitro-undersøgelser, var raloxifen.
English: The statement regarding the reversibility of the degenerative testicular epithelium was updated.
Danish: Udtalelsen om reversibiliteten af det degenerative testikelepitel blev opdateret.
English: Very common side effects - Headache
Danish: Meget almindelige bivirkninger - Hovedpine
English: HIV: human immunodeficiency virus
Danish: HIV: humant immundefektvirus.
English: The proportion of patients with severe ocular manifestations was also similar in both treatment groups.
Danish: Andelen af patienter med svære øjenmanifestationer var også tilsvarende for begge behandlingsgrupper.
English: Based on the above, the CHMP considers the benefit/risk ratio of Famvir to be favourable and the harmonised Product Information documents to be approvable.
Danish: På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Famvir for positivt og de harmoniserede produktinformationsdokumenter som egnede til godkendelse.
English: The section was also updated to reflect drug interactions due to aldehyde oxidase involvement.
Danish: Afsnittet blev også opdateret for at afspejle lægemiddelinteraktion som følge af påvirkning af aldehydoxidase.
English: Characteristics in special populations
Danish: Karakteristika i specielle populationer
English: Furthermore, degenerative changes of the testicular epithelium were noted in the general toxicity studies.
Danish: Der blev yderligere set degenerative forandringer i testikelepitelet i de generelle toksicitetsstudier.
English: The choice of placebo as a comparator was however considered disputable given the available active treatment option aciclovir.
Danish: Valget af placebo som sammenligningslægemiddel ansås imidlertid for omtvisteligt i betragtning af den tilgængelige aktive behandlingsmulighed aciclovir.