FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of the study was considered too short to allow for a reliable assessment of the prophylactic efficacy of famciclovir.
Danish: Det blev vurderet, at undersøgelsen var for kortvarig til at give en pålidelig vurdering af famciclovirs profylaktiske effekt.
English: Largo Umberto Boccioni 1 I-21040 Origgio Italy
Danish: Largo Umberto Boccioni 1 I-21040 Origgio Italien
English: General toxicity Studies on safety pharmacology and repeated dose toxicity reveal no special hazard for humans.
Danish: Studier vedrørende sikkerhedsfarmakologi og toksicitet efter gentagne doser viste ingen særlig risiko for mennesker.
English: The CHMP recommended also the revocation of the 750 mg film coated tablets for Famvir and associated names.
Danish: CHMP anbefalede endvidere en tilbagekaldelse af 750 mg filmovertrukne tabletter for Famvir og tilknyttede navne.
English: It was however noted that although the secondary endpoints results did not indicate a difference, the study was not powered for proving non-inferiority.
Danish: Det blev imidlertid bemærket, at undersøgelsen, selv om resultaterne af de sekundære endepunkter ikke indikerede en forskel, ikke havde styrke til at give evidens for noninferioritet.
English: These clinical studies were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below.
Danish: Disse kliniske forsøg blev gennemgået retrospektivt for at fastsætte en frekvenskategori for alle bivirkninger nævnt nedenfor.
English: Like aciclovir, the most common form of resistance encountered among HSV strains is a deficiency in the production of the thymidine kinase (TK) enzyme.
Danish: Som for aciclovir er den mest almindelige form for resistens, der opstår blandt HSV-stammer en defekt i produktionen af thymidinkinase (TK)-enzymet.
English: Additionally, a warning was revised to state that even though the frequency of viral shedding was reduced with the use of an antiviral, the risk of transmission is still theoretically possible so patients should be advised to avoid intercourse.
Danish: Endvidere blev en advarsel revideret for at fastslå, at der, selv om forekomsten af virusudskillelse blev reduceret med brugen af et antiviralt lægemiddel, stadig teoretisk set var risiko for overførsel, og at patienterne derfor skulle rådes til at undgå samleje.
English: Clinical response should be closely monitored, particularly in immunocompromised patients.
Danish: Det kliniske respons bør monitoreres tæt især hos immunokompromitteredepatienter.
English: While it appears paradoxical that the dose recommended to suppress recurrence of genital herpes is larger than that used to treat the active flare of a recurrence, the key endpoint was the time to clinically confirmed recurrence.
Danish: Selv om det virker paradoksalt, at den anbefalede dosis til suppression af recidiverende genital herpes er højere end den dosis, der anvendes til behandling af aktiv opblussen af recidivudbrud, var det vigtige endepunkt tiden til klinisk bekræftet recidivudbrud.
English: The CHMP thus recommends the revocation of this strength in the concerned MSs.
Danish: CHMP anbefaler derfor, at denne styrke kaldes tilbage i de berørte medlemsstater.
English: The antiviral effect of orally administered famciclovir has been demonstrated in several animal models: this effect is due to in vivo conversion to penciclovir.
Danish: Den antivirale virkning af oralt administreret famciclovir er demonstreret i flere dyremodeller: denne virkning skyldes in vivo omdannelse til penciclovir.
English: Aciclovir was used as a comparator and the primary endpoint was time to cessation of viral shedding.
Danish: Aciclovir blev anvendt som sammenligningslægemiddel, og det primære endepunkt var tiden til ophør af virusudskillelse.
English: - Do not have sexual contact with anyone if you have symptoms of genital herpes - even if you have started treatment with Famvir.
Danish: Undgå seksuel kontakt med andre, hvis du har symptomer på genital herpes - også selvom du har startet behandlingen med Famvir.
English: If you forget to take a dose of Famvir, you should take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis Famvir-tabletter, bør du tage den så snart du kommer i tanker om det.
English: - If you have problems with your body's immune system.
Danish: Hvis du har problemer med dit immunforsvar.
English: There were no differences in efficacy noted among the three active dose groups.
Danish: Der blev ikke observeret nogen effektforskelle mellem de tre aktive doseringsgrupper.
English: Rare side effects - Hallucinations (seeing or hearing things that are not really there) - Yellowing of the skin and/or eyes - Low platelet count
Danish: Sjældne bivirkninger - Hallucinationer (ser eller hører ting, der ikke reelt findes) - Gulfarvning af huden og/eller øjne - Lavt blodpladetal
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,
Danish: - produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets faglige drøftelse,
English: A break down of the discussions held per indication is shown below.
Danish: Nedenfor gives et overblik over drøftelserne inddelt efter indikation.
English: Since the virus reproduces very early in the infection, you will benefit most from treatment if you take Famvir as soon as the first symptoms appear.
Danish: Da virus formerer sig meget tidligt i infektionen, vil du have størst gavn af behandlingen, hvis du begynder på behandlingen med Famvir så tidligt som muligt efter, at de første symptomer opstår.
English: Animal studies have shown excretion of penciclovir in breast milk.
Danish: Dyreforsøg har påvist udskillelse af penciclovir i brystmælk.
English: Thrombocytopenia.
Danish: Trombocytopeni.
English: It was equivalent to aciclovir in the prevention of new lesion formation and there were no significant differences between the 2 treatment groups in any of the efficacy parameters.
Danish: Det svarede til aciclovir med hensyn til forebyggelse af nye læsioner, og der var ingen signifikante forskelle mellem de to behandlingsgrupper i nogen af effektparametrene.
English: For adverse reactions which have never been observed in these studies, the upper limit of the 95% confidence interval is not expected to be higher than 3/X (based on the “rule of three”), with X representing the total sample size (n=1,587).
Danish: For bivirkninger som ikke er observeret i disse forsøg forventes den øvre grænse af 95%-konfidensintervallet ikke at være højere end 3/X (baseret på rule of three ) hvor X repræsenterer det samlede antal patienter (n=1.587).
English: Important information about some of the ingredients of Famvir If you have been told by your doctor that you have an intolerance to some sugars, e.g. lactose, contact your doctor before taking this medicine.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Famvir Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, fx lactose, skal du kontakte din læge, inden du tager denne medicin.
English: The deacetylation is catalyzed by the enzyme aldehyde oxidase.
Danish: Deacetyleringen katalyseres af enzymet aldehydoxidase.
English: Thus, penciclovir is virustatic.
Danish: Penciclovir er således virostatisk.
English: Moreover, famciclovir 500 mg bid was found in clinical trials to be effective, safe and well tolerated in this group of patients.
Danish: Famciclovir 500 mg BID viste sig endvidere i kliniske undersøgelser at være mere effektivt, sikkert og veltolereret hos denne gruppe patienter.
English: If you have a normal immune system, the doses are as follows:
Danish: Hvis du har et normalt immunsystem, er doseringen:
English: The statement that the testicular findings were largely reversible is supported by observations made in the chronic dose toxicity studies in which the testicular findings were largely reversible after a 12-week duration of recovery and partially reversed after shorter recovery periods.
Danish: Udtalelsen om, at resultaterne vedrørende testikler overordnet set var reversible, understøttes af de observationer, der blev foretaget i undersøgelsen af kronisk dosistoksicitet, hvori resultaterne vedrørende testikler overordnet set var reversible efter en restitutionsperiode på 12 uger og delvis reversible efter kortere restitutionsperioder.
English: Overall, there were no differences in the nature, frequency or severity of adverse events among the three active dose groups or placebo.
Danish: Overordnet set var der ingen forskelle i hverken arten, forekomsten eller sværhedsgraden af bivirkninger mellem de tre aktive dosisgrupper eller placebo.
English: While both Studies 102 and 195 were small in size and breadth of patients included, the results for suppression of viral recurrence were consistent and extended to both patients with CD4+ cell counts below and above 200 cells/mm3.
Danish: Selv om både undersøgelse 102 og 195 var af beskedent omfang og bredde med hensyn til de inkluderede patienter, var resultaterne for suppression af virale recidivudbrud konsekvente og omfattede både patienter med CD4+-celletal under og over 200 celler/mm3.
English: If any of these applies to you, tell your doctor before you take Famvir.
Danish: Hvis noget af ovenstående passer på dig, skal du fortælle det til din læge, før du begynder at tage Famvir.
English: If you forget to take Famvir
Danish: Hvis du har glemt at tage Famvir
English: Therefore, an interaction of famciclovir/penciclovir with probenecid cannot be ruled out.
Danish: Derfor kan interaktion mellem famciclovir/penciclovir og probenecid ikke udelukkes.
English: Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses.
Danish: Kvalme, opkastning og unormale leverfunktionstests blev rapporteret hyppigere, specielt ved høje doser.
English: Cholestatic jaundice.
Danish: Cholestatisk gulsot.
English: No unchanged famciclovir has been detected in urine.
Danish: Der er ikke fundet uomdannet famciclovir i urinen.
English: These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment.
Danish: Disse var generelt milde eller moderate af natur og forekom med lignende hyppighed hos patienter, der blev behandlet med placebo.
English: This section of the SPC was thus revised to reflect current knowledge on viral resistance.
Danish: Dette afsnit i produktresuméet blev således revideret, således at det afspejler den aktuelle viden om viral resistens.
English: Urticaria, serious skin reactions* (e.g. erythema multiforme, StevensJohnson Syndrome, Toxic Epidermal Necrolysis).
Danish: Nældefeber, alvorlige hudreaktioner* (f.eks. erythema multiforme, Stevens-Johnson Syndrom, Toksisk Epidermal Nekrolyse).
English: Your doctor may decide to give you a lower dose of Famvir.
Danish: Din læge kan beslutte at give dig en lavere Famvir-dosis.
English: The proposed regimen (500mg bid) is also in line with current recommendations and with the SPCs in the vast majority of the MSs.
Danish: Det foreslåede regime (500 mg BID) er endvidere i overensstemmelse med de nuværende anbefalinger og med produktresuméerne i størstedelen af medlemsstaterne.
English: Although uncontrolled, study -195 provided some supportive evidence for the suppressive efficacy also in terms of other endpoints (virological/clinical recurrence).
Danish: Selv om undersøgelse 195 var ukontrolleret, gav den en vis understøttende evidens for den suppressive effekt, også med hensyn til andre endepunkter (virologiske/kliniske recidivudbrud).
English: The posology was thus endorsed by the CHMP.
Danish: Doseringen blev således godkendt af CHMP.
English: The wording of the SPC was updated to reflect this.
Danish: Formuleringen af produktresuméet blev opdateret for at afspejle dette.
English: Evidence from preclinical studies has shown no potential for induction of cytochrome P450 enzymes and inhibition of CYP3A4.
Danish: Prækliniske studier har ikke vist potentiale for induktion af cytocrom P450-enzymer og hæmning af CYP3A4.
English: The resistant isolates were mostly found at the start of treatment or in a placebo group, with resistance occurring on or after treatment with famciclovir or penciclovir only in two immunocompromised patients.
Danish: De resistente isolater blev fortrinsvis fundet ved behandlingsstart eller i en placebo-gruppe, hvor resistens kun forekom under eller efter behandling med famciclovir eller penciclovir hos 2 immunkompromitterede patienter.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: However, do not take two doses within a time interval of less than 1 hour, in that case you should skip the missed dose.
Danish: Tag dog ikke to doser inden for et tidsinteval på mindre end en time.
English: There was no effect on the incidence of neoplasia in male rats or in mice of either sex.
Danish: Der var ingen effekt på forekomsten af neoplasier hos hanrotter eller hos mus af begge køn.
English: Animal studies have not shown any embryotoxic or teratogenic effects with famciclovir or penciclovir (the active metabolite of famciclovir).
Danish: Dyreforsøg har ikke vist embryotoksisk eller teratogen effekt af famciclovir eller penciclovir (den aktive metabolit af famciclovir).
English: • Probenecid (used to treat high blood levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics), or any other medicine that can affect your kidneys.
Danish: • Probenecid (bruges til at behandle højt indhold af urinsyre i blodet i forbindelse med gigt og til at øge blodets antibiotikaindhold af penicillin-typen), eller enhver anden medicin, som kan påvirke nyrerne.
English: Elderly patients (≥ 65 years) Dose modification is not required unless renal function is impaired.
Danish: Ældre patienter (≥ 65 år) Ændring af dosis er ikke nødvendig, medmindre nyrefunktionen er nedsat.
English: Distribution Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins.
Danish: Distribution Penciclovir og dets 6-deoxy precursor har en ringe (< 20 %) plasmaproteinbinding.
English: There is evidence in the literature that probenecid affects the elimination of compounds structurally related to penciclovir.
Danish: Der findes evidens i litteraturen for, at probenecid påvirker udskillelsen af forbindelser, der er strukturelt relateret til penciclovir.
English: Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.
Danish: Initiering af behandling anbefales så hurtigt som muligt efter forekomst af prodromale symptomer (prikken, kløe, brændende fornemmelse, smerte) eller udslæt.
English: For the primary efficacy parameter, confidence intervals for the difference in proportions (famciclovir minus aciclovir) were used to assess treatment effects.
Danish: For det primære effektparameter anvendtes der konfidensintervaller for forholdsforskellene (famciclovir minus aciclovir) til at vurdere behandlingens effekt.
English: Superiority was not shown for the main outcome measures and concluding from statistically not different results on non-inferiority was not possible.
Danish: Der blev ikke påvist overlegenhed for de primære effektendepunkter, og det var ikke muligt at drage konklusion på baggrund af statistisk ikke-forskellige resultater vedrørende noninferioritet.
English: The primary efficacy parameter was the proportion of patients with new lesions while on study medication.
Danish: Det primære effektparameter var andelen af patienter, der fik nye læsioner, mens de blev behandlet med undersøgelsesmedicinen.
English: Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2.
Danish: Genital herpes er en virusinfektion, som forårsages af herpes simplex-virus type 1 eller 2.
English: The primary efficacy endpoint was the proportion of patients who had an ocular manifestation during the study (7-day treatment phase and 6month follow-up period).
Danish: Det primære effektendepunkt var andelen af patienter, der fik en øjenmanifestation i løbet af undersøgelsen (syv dages behandlingsperiode og seks måneders opfølgningsperiode).
English: Skin and subcutaneous tissue disorders Common:
Danish: Hud og subkutant væv Almindelig:
English: The 750mg tid regimen did not demonstrate any advantage compared to the 500mg tid regimen.
Danish: Regimet 750 mg TID påviste ingen fordel i forhold til 500 mg TID.
English: Following oral administration, famciclovir is rapidly and extensively absorbed and converted to penciclovir.
Danish: Efter oral administration absorberes famciclovir hurtigt og fuldstændigt og omdannes til penciclovir.
English: Penciclovir triphosphate resembles deoxyguanosine triphosphate (dGTP), a component of DNA.
Danish: Penciclovirtrifosfat ligner deoxyguanosintrifosfat (dGTP), som er en DNA-komponent.
English: If patients experience severe dizziness, somnolence, confusion or other central nervous system disturbances, a dose reduction of famciclovir to 250 mg three times daily may be considered.
Danish: Hvis patienter oplever svær svimmelhed, døsighed, forvirring eller andre forstyrrelser i centralnervesystemet, kan det overvejes at reducere dosis af famciclovir til 250 mg 3 gange daglig.
English: Studies 004, 011, and 040 were randomised, multicentre studies.
Danish: Undersøgelse 004, 011 og 040 var randomiserede multicenterundersøgelser.
English: However, the CHMP endorsed the MAH's proposal to commit to specifically monitor and report malignancies within future PSURs.
Danish: CHMP godkendte imidlertid indehaveren af markedsføringstilladelsens forslag om en forpligtelse til specifikt at overvåge og rapportere maligniteter i fremtidige periodiske sikkerhedsopdateringer.
English: Penciclovir, in common with other substances of this class, has been shown to cause chromosomal damage, but did not induce gene mutation in bacterial or mammalian cell systems, nor was there evidence of increased DNA repair in vitro.
Danish: Penciclovir har, som andre stoffer i denne klasse, vist sig at forårsage beskadigelser på kromosomer, men forårsagede ikke genmutation i cellesystemer i bakterier eller pattedyr, og der blev ikke fundet tegn på øget DNA-repair in vitro.
English: All genital herpes suppression trials were placebo controlled.
Danish: Alle undersøgelserne af suppression af genital herpes var placebokontrollerede.
English: The frequencies and listing of adverse events in this section were updated based on an integrated safety evaluation of adverse events observed in clinical trials and post marketing experience.
Danish: Forekomsten og optegnelsen af bivirkningerne i dette afsnit blev opdateret på baggrund af en integreret sikkerhedsevaluering af de bivirkninger, der var blevet observeret i kliniske undersøgelser og efter markedsføring.
English: Tubular secretion contributes to the renal elimination of penciclovir.
Danish: Tubulær sekretion medvirker til den renale eliminering af penciclovir.
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted harmonised Product Information documents for the various presentations of Famvir and associated names, taking into account the pharmaceutical forms.
Danish: CHMP vedtog således, baseret på bedømmelsen af forslag og svar fra indehaveren af markedsføringstilladelsen og efter drøftelser i udvalget, at harmonisere produktinformationsdokumenterne for de forskellige formuleringer af Famvir og tilknyttede navne, under hensyntagen til lægemiddelformerne.
English: Abnormal liver function tests.
Danish: Unormale leverfunktionstests.
English: Based on these limited amounts of information, the cumulative analysis of both prospective and retrospective pregnancy cases did not provide evidence indicating that the product causes any specific foetal defect or congenital anomaly.
Danish: Kumulerede analyser, der er baseret på disse begrænsede data i både prospektive og retrospektive graviditeter, viste ikke tegn på, at lægemidlet forårsager nogen specifik føtal defekt eller medfødt anomali.
English: Therefore, a placebo arm was not included, which makes comments on the absolute effectiveness of antiviral agents in preventing ocular complications in this study tenuous.
Danish: Der blev derfor ikke inkluderet en placebogruppe, hvilket svækker bemærkningerne om den absolutte effektivitet af antivirale stoffer med hensyn til at forebygge øjenkomplikationer i denne undersøgelse.
English: These studies demonstrated that famciclovir was significantly better than placebo in the treatment of recurrent genital herpes.
Danish: Undersøgelserne viste, at famciclovir var væsentligt bedre end placebo til behandling af recidiverende genital herpes.
English: The design of Study 007 was considered to have some deficiencies.
Danish: Det blev vurderet, at der var visse mangler i udformningen af undersøgelse 007.
English: When raloxifen is coadministered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.
Danish: Når raloxifen gives samtidig med famciclovir, bør den kliniske effekt af den antivirale behandling monitoreres.
English: - Famvir is also used for the treatment of shingles in the area around the eye or of the eye itself (ophthalmic zoster).
Danish: - Famvir bruges også til behandling af helvedesild i området omkring øjet eller i selve øjet.
English: No statistically significant differences were observed between all famciclovir dose groups and aciclovir for all primary efficacy parameters in all three clinical trials.
Danish: Der blev ikke observeret nogen statistisk signifikante forskelle mellem nogen af famciclovir-dosisgrupperne og aciclovir med hensyn til alle de primære effektparametre i alle de tre kliniske undersøgelser.
English: An article by (Strick, et al 2006) discussed the merits of suppressive versus episodic treatment of HSV in the HIV-infected patient.
Danish: I en artikel af (Strick, et al. 2006) diskuteres fordelene ved suppressiv i forhold til episodisk behandling af HSV hos hiv-inficerede patienter.
English: Taking too much Famvir may affect the kidneys.
Danish: Indtagelse af for mange Famvir-tabletter kan påvirke nyrerne.
English: Although the pivotal study for this indication/group (083) presented with some deficiencies, which taken together preclude a reliable conclusion on non-inferiority of the 500mg famciclovir bid regimen versus 5x 400mg aciclovir, it was acknowledged that this regimen is approved for the majority of the EU MSs.
Danish: På trods af at den pivotale undersøgelse af denne indikation/gruppe (083) havde visse mangler, som sammenlagt udelukker, at der kan træffes en pålidelig konklusion om noninferioritet vedrørende 500 mg BID famciclovir i forhold til 5 x 400 mg aciclovir, blev det anerkendt, at dette regime er godkendt i størstedelen af EU-medlemsstaterne.
English: Participants were randomly assigned to receive either famciclovir 500mg or placebo bid for 8 weeks, followed by a 7-days wash-out period and then by a second 8-week period during which the patients had the regimen not experienced during the first period.
Danish: Deltagerne blev randomiseret til at modtage enten famciclovir 500 mg eller placebo BID i otte uger efterfulgt af en udvaskningsperiode på syv dage og derpå af endnu en periode på otte uger, hvor patienten modtog det modsatte regime af det, denne modtog i den første periode.
English: Your doctor will discuss with you the potential risks of taking Famvir during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici, der er ved at tage Famvir under graviditet.
English: Section 4.5: Interaction with other medicinal products and other forms of interaction
Danish: Afsnit 4.5: Interaktion med andre lægemidler og andre former for interaktion