FrancophonIA/ELRC3.0 huggingface dataset:
English: Penciclovir triphosphate resembles deoxyguanosine triphosphate (dGTP), a component of DNA.
Slovenian: Penciklovir trifosfat je podoben deoksigvanozin trifosfatu (dGTP), ki je sestavina DNK.
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.
Slovenian: Glede na zgoraj navedeno CHMP meni, da je razmerje med koristmi in tveganji za zdravilo Famvir ugodno ter da so usklajene informacije o izdelku sprejemljive.
English: Studies 004, 011, and 040 were randomised, multicentre studies.
Slovenian: Študije 004, 011 in 040 so bile randomizirane in multicentrične.
English: Famvir is not to be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Famvir se med nosečnostjo ne sme jemati, razen če je to nedvomno potrebno.
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.
Slovenian: Pogostnost in seznam neželenih učinkov v tem poglavju sta bila posodobljena na podlagi celostne varnostne ocene neželenih učinkov, ugotovljenih v okviru kliničnih preskušanj in izkušenj iz obdobja trženja zdravila.
English: It causes blisters and burning or itching around the genitals, which may be painful.
Slovenian: Povzroča mehurjast izpuščaj in pekoč občutek ali srbenje okrog spolovil, kar je lahko boleče.
English: - For the best results start the medicine as soon as possible after the first signs and symptoms appear.
Slovenian: - Da bi dosegli kar najboljše rezultate zdravljenja, začnite zdravilo jemati čimprej po nastopu prvih znakov in simptomov.
English: Therefore, an interaction of famciclovir/penciclovir with probenecid cannot be ruled out.
Slovenian: Posledično medsebojnega delovanja famciklovirja oziroma penicklovirja s probenecidom ni mogoče izključiti.
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.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Famvir Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Aciclovir was used as a comparator and the primary endpoint was time to cessation of viral shedding.
Slovenian: Kot primerjalna učinkovina je bil uporabljen aciklovir, primarni pokazatelj pa je bil čas do prenehanja izločanja virusa.
English: Children and adolescents (below the age of 18 years) Famvir is not recommended for use in children and adolescents.
Slovenian: Otroci in mladostniki (stari manj kot 18 let) Uporaba zdravila Famvir ni priporočena za otroke in mladostnike.
English: Rare:
Slovenian: zmedenost redki:
English: The deacetylation is catalyzed by the enzyme aldehyde oxidase.
Slovenian: Deacetilacijo katalizira encim aldehid oksidaza.
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.
Slovenian: Na podlagi ocene predloga imetnika dovoljenja za promet z zdravilom ter glede na razprave v odboru je CHMP sprejel usklajene informacije o izdelku za različne oblike zdravila Famvir in z njim povezanih imen, ob upoštevanju farmacevtskih oblik.
English: If you have a normal immune system, the doses are as follows:
Slovenian: Če vaš imunski sistem deluje normalno, so odmerki naslednji:
English: Adverse reactions (Table 2) are ranked under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Neželeni učinki (preglednica 2) so razvrščeni po pogostnosti, in sicer po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
English: Animal studies have shown excretion of penciclovir in breast milk.
Slovenian: Študije na živalih kažejo na izločanje penciklovirja v mleko.
English: Small differences in renal clearance of penciclovir between females and males have been reported and were attributed to gender differences in renal function.
Slovenian: Opisali so majhne razlike ledvičnega očistka penciklovirja med ženskami in moškimi, ki so jih pripisali razliki v ledvični funkciji med spoloma.
English: Very common side effects - Headache
Slovenian: Zelo pogosti neželeni učinki - glavobol
English: Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated.
Slovenian: Bolnike je treba opozoriti, naj se v obdobju izraženih simptomov izogibajo spolnim odnosom, čeprav so se začeli zdraviti s protivirusnim zdravilom.
English: Serious side effects of Famvir are:
Slovenian: Resni neželeni učinki zdravila Famvir so:
English: The patient population was comprised of patients who were candidates for suppressive treatment.
Slovenian: Populacija bolnikov je zajemala bolnike, pri katerih je prišlo v poštev supresivno zdravljenje.
English: The wording of the SPC was updated to reflect this.
Slovenian: Besedilo SPC je bilo ustrezno posodobljeno.
English: Like all medicines, Famvir can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Famvir neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Ker se virus razmnožuje zgodaj v poteku okužbe, so rezultati zdravljenja najboljši, če začnete jemati zdravilo Famvir čimprej po pojavu prvih simptomov.
English: Additionally, the reduced dosing frequency of famciclovir gave a greater patient acceptability.
Slovenian: Poleg tega je manjša pogostost odmerjanja famciklovirja povečala sprejemljivost zdravljenja za bolnike.
English: Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.
Slovenian: Priporočeno je, da bolnik z zdravljenjem začne čimprej po nastopu prodromalnih simptomov (na primer zbadanja, srbenja, pekočega občutka ali bolečine) ali sprememb na koži ali sluznici.
English: All regimens were superior to placebo in terms of the two primary endpoints, and these were considered relevant.
Slovenian: Vsi režimi so bili superiorni placebu glede na primarna pokazatelja, za katera je bilo ocenjeno, da sta pomembna.
English: In studies 033, and 049 it was noted that a dose-response relationship was not observed.
Slovenian: Pri študijah 033 in 049 je bilo omenjeno, da razmerje med odmerkom in odzivom ni bilo obravnavano.
English: Having considered available data and current scientific knowledge, the CHMP considered the following as the harmonised indications:
Slovenian: Ob upoštevanju razpoložljivih podatkov in trenutnih znanstvenih spoznanj je Odbor za zdravila za uporabo v humani medicini (CHMP) za usklajene štel naslednje indikacije:
English: Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses.
Slovenian: O navzei, bruhanju in nenormalnih vrednostih testov jetrne funkcije so poročali bolj pogosto, zlasti pri uporabi višjih odmerkov.
English: The section was also updated to reflect drug interactions due to aldehyde oxidase involvement.
Slovenian: Poglavje je bilo nadalje posodobljeno tako, da odraža medsebojno delovanje med zdravili zaradi aldehid oksidaze.
English: United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park
Slovenian: Velika Britanija Novartis Pharmaceuticals UK Ltd Frimley Business Park
English: All genital herpes suppression trials were placebo controlled.
Slovenian: Vse raziskave supresije genitalnega herpesa so bile kontrolirane s placebom.
English: Distribution Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins.
Slovenian: Penciklovir in njegova 6-deoksi predstopnja se v manjši meri (< 20 %) vežeta na beljakovine v plazmi.
English: Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Hungary
Slovenian: Madžarska Novartis Hungaria Kft. Bartók Béla út 43-47
English: Rare side effects - Hallucinations (seeing or hearing things that are not really there) - Yellowing of the skin and/or eyes - Low platelet count
Slovenian: Redki neželeni učinki - halucinacije (bolnik vidi ali sliši to, česar v resnici ni) - rumenkasto obarvanje kože in/ali oči - znižano število trombocitov
English: Effects of other medicinal products on famciclovir No clinically significant interactions have been identified.
Slovenian: Delovanje drugih zdravil na famciklovir Klinično pomembnih interakcij niso opažali.
English: It stops the infecting virus from reproducing.
Slovenian: Preprečuje razmnoževanje virusa v okuženi celici.
English: The choice of placebo as a comparator was however considered disputable given the available active treatment option aciclovir.
Slovenian: Izbira placeba za primerjalno učinkovino pa je bila ocenjena za sporno glede na razpoložljivo možnost zdravljenja z aciklovirjem.
English: Your doctor will discuss with you the possible risks of taking Famvir during breastfeeding.
Slovenian: Zdravnik se bo z vami pogovoril o možnih tveganjih jemanja zdravila Famvir v obdobju dojenja.
English: The results of both studies are similar to what was reported by (Mertz, et al 1997) for immunocompetent patients in a 4-month study where 90% of patients receiving famciclovir remained free from virologically confirmed genital herpes as compared with 48% of placebo-treated patients.
Slovenian: Rezultati obeh študij so podobni rezultatom, o katerih so poročali Mertz in drugi (1997), dobljenim pri imunokompetentnih bolnikih v 4-mesečni raziskavi, v kateri se pri 90 % bolnikov, ki so prejemali famciklovir, ni pojavil virološko potrjeni genitalni herpes, medtem ko je bil pri bolnikih, ki so se zdravili s placebom, ta delež 48-odstoten.
English: The statement regarding the reversibility of the degenerative testicular epithelium was updated.
Slovenian: Dopolnjena je bila izjava o reverzibilnosti degeneracije testikularnega epitelija.
English: Overdose experience with famciclovir is limited.
Slovenian: Izkušenj s prevelikim odmerjanjem famciklovirja je malo.
English: Results from studies 033 and 049 showed a significant effect of famciclovir with regard to suppression of recurrent genital herpes.
Slovenian: Rezultati študij 033 in 049 so pokazali pomemben učinek famciklovirja pri supresiji ponavljajočega se genitalnega herpesa.
English: Secondary variables included proportion of patients who developed new lesions during the study period (including time off study medication), time to complete healing, time to cessation of viral shedding and time to loss of lesion pain.
Slovenian: Sekundarne spremenljivke so zajemale delež bolnikov, pri katerih so se med študijo (vključno s časom, ko niso prejemali zdravila v okviru študije) pojavile nove lezije, čas do popolne ozdravitve, čas do prenehanje izločanja virusa in čas do izginotja bolečine zaradi lezij.
English: Famvir 125 mg, 250 mg and 500 mg (country specific) tablets contain lactose.
Slovenian: Tablete Famvir 125 mg, 250 mg in 500 mg (specifično za posamezno državo) vsebujejo laktozo.
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).
Slovenian: CHMP je podprl omejitev na zdravljenje ponavljajočega se genitalnega herpesa pri bolnikih, okuženih z virusom HIV, kar ustreza rezultatom klinične študije 083.
English: Secondary endpoints included time to loss of each vesicles, ulcers and crusts; duration of viral shedding; time to loss of acute pain; and duration of post-herpetic neuralgia (PHN).
Slovenian: Sekundarni pokazatelji so bili čas do izginotja posameznih vezikul, ulkusov in krast; trajanje izločanja virusa; čas do izginotja akutne bolečine; in trajanje postherpetične nevralgije (PHN).
English: Section 4.7: Effects on ability to drive and use machines
Slovenian: Poglavje 4.7: Vpliv na sposobnost vožnje in upravljanja s stroji
English: In uninfected cells treated with penciclovir, concentrations of penciclovir-triphosphate are only barely detectable.
Slovenian: V neokuženih celicah, ki so izpostavljene penciklovirju, je koncentracija penciklovir-trifosfata komaj zaznavna.
English: Famciclovir is eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine.
Slovenian: Famciklovir se izloča večinoma kot penciklovir in njegova 6-deoksi predstopnja, ki se izločata z urinom.
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.
Slovenian: • probenecid (uporabljamo ga za zdravljenje visoke koncentracije sečne kisline v krvi, kar povzroča protin, in za zviševanje koncentracije antibiotikov penicilinske vrste v krvi) ali katerokoli zdravilo, ki vpliva na ledvice.
English: However, patients who experience certain adverse events should refrain from driving or operating machinery.
Slovenian: Kljub temu bolniki, pri katerih pride do neželenih učinkov, ne smejo voziti ali upravljati s stroji.
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.
Slovenian: Kumulativna analiza tako prospektivnih kot retrospektivnih primerov nosečnosti na podlagi tako omejenega obsega podatkov ni dala rezultatov, ki bi kazali, da bi zdravilo lahko povzročalo kakršnokoli specifično okvaro ploda oziroma kongenitalno anomalijo.
English: As primary patients typically experience a more severe first episode than patients experiencing a recurrent episode (Sacks 1995), it was deemed that a starting dose of 125mg famciclovir would be less efficacious than a higher dose.
Slovenian: Ker so prve epizode pri bolnikih praviloma resnejše od ponavljajočih se epizod (Sacks, 1995), je bilo ocenjeno, da bi bil famciklovir v začetnem odmerku 125 mg manj učinkovit od večjega odmerka.
English: • Severe blistering of the skin or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (these could be signs of a serious allergic skin reaction, for frequency see below).
Slovenian: • huda oblika mehurjastega izpuščaja kože ali sluznice na ustnicah, očeh, v ustih, nosnih kanalih ali na spolovilih (to so lahko znaki resne alergijske kožne reakcije, njena pogostnost je navedena spodaj);
English: Secondary efficacy parameters included time to full crusting of lesions, time to complete healing, and evaluations of pain and dissemination.
Slovenian: Sekundarni pokazatelji učinkovitosti so vključevali čas do popolnega nastanka krast na lezijah, čas do popolne ozdravitve ter oceno bolečine in širjenja.
English: A break down of the discussions held per indication is shown below.
Slovenian: Razčlenitev razprav o posamezni indikaciji je podana v nadaljevanju.
English: The 500mg bid regimen is recommended by some of the guidelines and no other regimen was studied.
Slovenian: Režim odmerjanja 500 mg dvakrat dnevno se priporoča v nekaterih smernicah; drugi režimi niso bili proučeni.
English: Results from 11 worldwide clinical studies involving penciclovir (topical or intravenous formulations) or famciclovir in immunocompetent or immunocompromised patients, including studies of up to 12 months treatment with famciclovir, have shown a small overall frequency of penciclovir resistant isolates: 0.2% (2/913) in immunocompetent patients and 2.1% (6/288) in immunocompromised patients.
Slovenian: Rezultati 11 svetovnih kliničnih študij, v katerih so proučevali penciklovir (oblike zdravila za lokalno ali intravensko uporabo) ali famciklovir pri bolnikih z normalnim ali z oslabljenim imunskim odzivom, vključno s študijami z do 12-mesečnim zdravljenjem s famciklovirjem, so pokazali majhno skupno pogostnost na penciklovir rezistentnih izolatov: 0,2 % (2/913) pri bolnikih z normalnim imunskim odzivom in 2,1 % (6/288) pri bolnikih z oslabljenim imunskim odzivom.
English: These clinical studies were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below.
Slovenian: Z retrospektivnim pregledom podatkov iz teh študij so ugotovili kategorije pogostnosti za vse spodaj navedene neželene učinke.
English: If you have a reduced immune system, the doses are as follows:
Slovenian: Če je vaš imunski sistem oslabljen, so odmerki naslednji:
English: - Do not have sexual contact with anyone if you have symptoms of genital herpes - even if you have started treatment with Famvir.
Slovenian: - Če imate simptome genitalnega herpesa, ne imejte spolnih stikov z nikomer - tudi če se ste že začeli jemati zdravilo Famvir.
English: Section 4.3: Contraindications
Slovenian: Poglavje 4.3: Kontraindikacije
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).
Slovenian: Primarni pokazatelj učinkovitosti je bil delež bolnikov, ki so imeli v času študije (7-dnevnega zdravljenja in 6-mesečnega spremljanja) očesni herpes.
English: If you forget to take Famvir
Slovenian: Če ste pozabili vzeti zdravilo Famvir
English: In contrast with toxicological findings, where famciclovir produced testicular toxicity in rats, mice and dogs at doses of at least 150mg/kg, these clinical studies clearly demonstrate that at therapeutic doses of 250mg bid (about 6mg/kg), famciclovir does not affect human spermatogenesis or semen quality.
Slovenian: V nasprotju z ugotovitvami o toksičnosti, v skladu s katerimi povzroča famciklovir v odmerku najmanj 150 mg/kg pri podganah, miših in psih testikularno toksičnost, navedene klinične študije jasno kažejo, da pri terapevtskih odmerkih 250 mg dvakrat dnevno (približno 6 mg/kg) famciklovir ne vpliva na spermatogenezo ali na kvaliteto sperme.
English: Method of administration Famvir can be taken without regard to meals (see section 5.2).
Slovenian: Način uporabe Zdravilo Famvir je mogoče jemati ne glede na obroke (glejte poglavje 5.2).
English: The CHMP considered that the study submitted in support of this indication (086) had several deficiencies (e.g. primary endpoint “new lesion formation while on medication”of questionable relevance, study not powered for comparison of secondary endpoints), but the data indicated a similar efficacy for famciclivir as aciclovir 5 x 800mg/day.
Slovenian: CHMP je menil, da ima študija (086), ki je bila predložena v podporo tej indikaciji, vrsto pomanjkljivosti (na primer, pomembnost primarnega pokazatelja „nastanek novih lezij med prejemanjem zdravila“ je vprašljiva, zasnova študije ni primerna za primerjavo sekundarnih pokazateljev), vendar so podatki nakazali podobno učinkovitost famciklovirja kot jo zagotavlja aciklovir v odmerku 800 mg petkrat dnevno.
English: Thus, penciclovir is virustatic.
Slovenian: Penciklovir je zato virostatik.
English: If you have taken more tablets than you have been told to take, or if someone else accidentally takes your medicine, go to your doctor or hospital for advice immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Famvir, kot bi smeli Če ste vzeli več tablet, kot vam je naročil zdravnik, ali če kdo drug nehote vzame vaše zdravilo, pojdite takoj k zdravniku ali v bolnišnico po nasvet.
English: Therefore, patients receiving famciclovir at a dose of 500 mg three times daily co-administered with probenecid, should be monitored for toxicity.
Slovenian: Iz tega razloga je treba bolnike, ki prejemajo famciklovir v odmerku 500 mg trikrat na dan sočasno s probenecidom, spremljati glede toksičnosti.
English: The in vivo conversion of famciclovir to penciclovir involves two steps: the deacetylation of famciclovir to 6-deoxy penciclovir and the oxidation of 6-deoxy penciclovir to penciclovir.
Slovenian: In vivo pretvorba famciklovirja v penciklovir zajema dve stopnji: deacetilacijo famciklovirja v 6-deoksi penciklovir in oksidacijo 6-deoksi penciklovirja v penciklovir.
English: Superiority was not shown for the main outcome measures and concluding from statistically not different results on non-inferiority was not possible.
Slovenian: Na podlagi glavnega pokazatelja superiornost ni bila dokazana, na podlagi statistično neodstopajočih rezultatov pa ni bilo mogoče sklepanje o neinferiornosti.
English: The primary efficacy parameter was the number (%) of days of viral shedding from anogenital sites.
Slovenian: Primarni pokazatelj učinkovitosti je bilo število (odstotek) dni izločanja virusa iz anogenitalnih predelov.
English: To support the therapeutic benefit of famciclovir for the suppressive treatment of genital herpes, one dose-finding study (study 024) and two pivotal studies (studies 033 and 049) in immunocompetent patients, and one dose finding study (study 102) in immunocompromised patients were presented.
Slovenian: Da bi potrdili terapevtske koristi famciklovirja pri supresivnem zdravljenju genitalnega herpesa, so bile predložene študija 024 za določitev ustreznega odmerka in dve osrednji študiji (študiji 033 in 049) pri imunokompetentnih bolnikih ter študija 102 za določitev ustreznega odmerka pri imunokompromitiranih bolnikih.
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).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet, za katera so Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Dodatku III za zdravilo Famvir in z njim povezana imena (glejte Dodatek I).
English: All dose regimens were effective compared to placebo and similar to each other based on time to first clinically confirmed recurrence and proportion of patients free from virologically confirmed lesion episodes at 6 months.
Slovenian: V primerjavi s placebom so bili vsi režimi odmerjanja učinkoviti in medsebojno podobni glede na čas do prve klinično potrjene ponovitve in glede na delež bolnikov, pri katerih se v šestih mesecih niso pojavile virološko potrjene epizode lezij.
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.
Slovenian: Čeprav študiji 102 in 195 nista bili obsežni po številu in vrsti bolnikov, so bili rezultati supresije ponovitve manifestacije virusnih obolenj skladni in prisotni pri bolnikih s številom celic CD4+ pod in nad 200 celic/mm3.
English: The absolute bioavailability of penciclovir after administration of famciclovir is 77%.
Slovenian: Absolutna biološka uporabnost penciklovirja po uporabi famciklovirja je 77-odstotna.
English: In Study 102, 83% of HIV-infected patients receiving famciclovir remained recurrence-free as compared to 42% of patients receiving placebo.
Slovenian: V študiji 102 pri 83 % bolnikov, ki so bili okuženi s HIV in so prejemali famciklovir, ni prišlo do ponovitev, medtem ko je bil pri bolnikih, ki so prejemali placebo, ta delež 42 %.
English: Hypersensitivity to penciclovir.
Slovenian: Preobčutljivost za penciklovir.
English: The famciclovir 125mg dose also appeared inferior to the higher doses in primary patients experiencing new lesions after start of antiviral treatment.
Slovenian: Famciklovir v odmerku 125 mg se je prav tako zdel inferioren glede na višje odmerke pri bolnikih s prvo epizodo, pri katerih so se po začetku protivirusnega zdravljenja pojavile nove lezije.