FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients who initiated study medication during Period 1 were included in the ITT analysis for that period.
Slovenian: Vsi bolniki, pri katerih je bilo uvedeno zdravljenje v okviru študije v prvem obdobju zdravljenja, so bili vključeni v analizo namere zdravljenja (ITT).
English: Furthermore, degenerative changes of the testicular epithelium were noted in the general toxicity studies.
Slovenian: Poleg tega so v študijah splošne toksičnosti opažali degenerativne spremembe epitelija v testisu.
English: Famvir should not be used in case of hypersensitivity to the active substance, any of the excipients and penciclovir.
Slovenian: Zdravilo Famvir se ne sme uporabljati v primeru preobčutljivosti na učinkovino, na katero koli pomožno snov ali na penciklovir.
English: Probenecid, a known inhibitor of the organic acid transport system, or drugs significantly eliminated by active renal tubular secretion may affect the renal elimination of penciclovir by inhibition or competition at the tubular secretion site.
Slovenian: Pobenecid, znan zaviralec transportnega sistema za organske kisline, in zdravila, ki se v pomembni meri izločajo z aktivnim tubularnim izločanjem skozi ledvice, lahko vplivajo na izločanje penciklovirja skozi ledvice z zaviranjem ali kompeticijo na mestu tubularnega izločanja.
English: • Do not use Famvir if you notice the pack is damaged or shows signs of tampering.
Slovenian: • Ne uporabljajte zdravila Famvir, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: What Famvir is and what it is used for Before you take Famvir How to take Famvir Possible side effects How to store Famvir Further information
Slovenian: Kaj je zdravilo Famvir in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Famvir Kako jemati zdravilo Famvir Možni neželeni učinki
English: The proposed regimen (500mg bid) is also in line with current recommendations and with the SPCs in the vast majority of the MSs.
Slovenian: Predlagani režim (500 mg trikrat dnevno) je tudi v skladu s trenutnimi priporočili in povzetki glavnih značilnosti zdravila v veliki večini držav članic.
English: Section 5.3: Preclinical safety data
Slovenian: Poglavje 5.3: Predklinični podatki o varnosti
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.
Slovenian: Kljub nekaterim pomanjkljivostim osrednje študije za to indikacijo oziroma skupino (083), ki, gledane v celoti, ne dopuščajo zanesljivega zaključka o neinferiornosti famciklovirja v odmerku 500 mg dvakrat dnevno v primeri z aciklovirjem v odmerku 400 mg petkrat dnevno, je bilo sprejeto, da je ta režim odobren v večini držav članic EU.
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.
Slovenian: Bilo je enakovredno acikloviru pri preprečevanju nastanka novih lezij; pri nobenem pokazatelju učinkovitosti ni bilo mogoče opaziti pomembnih razlik med zdravljenima skupinama.
English: Study 083 was presented to show efficacy in immunocompromised patients with herpes simplex virus infections.
Slovenian: Študija 083 je bil predložena z namenom dokazati učinkovitost pri imunokompromitiranih bolnikih, okuženih z virusom Herpes simplex.
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.
Slovenian: Protivirusno delovanje peroralno danega famciklovirja so dokazali na več živalskih modelih: deluje zaradi in vivo pretvorbe v penciklovir.
English: Common side effects - Feeling sick (nausea) - Vomiting - Dizziness - Drowsiness - Rash - Pruritus - Liver function test giving abnormal results
Slovenian: Pogosti neželeni učinki - občutek slabosti (navzea) - bruhanje - omotičnost - dremavost - izpuščaj - srbenje - nenormalni izvidi testov jetrne funkcije
English: The apparent plasma clearance, renal clearance, and plasma elimination rate constant of penciclovir decreased linearly with reductions in renal function, both after single and repeated dosing.
Slovenian: Navidezni očistek iz plazme, ledvični očistek in konstanta hitrosti izločanja iz plazme penciklovirja so se linerano zmanjševali z manjšanjem ledvične funkcije, in sicer tako po enkratnem odmerku kot po večkratnih odmerkih.
English: A summary of the combined studies 102 and 195 show the benefits of famciclovir in suppressing HSV recurrence in the immunocompetent patient to the HIV-infected patient.
Slovenian: V povzetku združenih študij 102 in 195 so navedene koristi famciklovirja pri supresiji ponovitev manifestacij HSV pri imunokompetentnih bolnikih in bolnikih, okuženih z virusom HIV.
English: When raloxifen is coadministered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.
Slovenian: Pri sočasni uporabi raloksifena in famciklovirja je treba spremljati klinično učinkovitost protivirusnega zdravljenja.
English: Patients were enrolled if they were immunocompromised following bone marrow or solid organ transplantation, or oncology treatment and had uncomplicated herpes zoster.
Slovenian: Vanjo so bili vključeni bolniki, ki so bili imunokompromitirani zaradi presaditve kostnega mozga ali solidnega organa ali onkološkega zdravljenja in ki so imeli nezapleteni herpes zoster.
English: No differences were noted between treatment groups for time of withdrawal.
Slovenian: Glede časa izključitve ni bilo med zdravljenima skupinama nobenih razlik.
English: The frequency of possible side effects listed below is defined using the following convention: - very common (affects more than 1 user in 10) - common (affects 1 to 10 users in 100) - uncommon (affects 1 to 10 users in 1,000) - rare (affects 1 to 10 users in 10,000) - very rare (affects less than 1 user in 10,000)
Slovenian: Pogostnost možnih neželeni učinkov je opredeljena z naslednjim dogovorom: - zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) - pogosti (pojavijo se pri 1 do 10 od 100 bolnikov), - občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov), - redki (pojavijo se pri 1 do 10 od 10.000 bolnikov), - zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov),
English: Famvir is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Slovenian: Uporaba zdravila Famvir ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let, zaradi neobstoja informacij o varnosti in učinkovitosti v tej skupini.
English: In people who already have kidney problems it may, rarely, lead to kidney failure if their dose is not correctly lowered.
Slovenian: Pri ljudeh, ki so imeli že prej težave z ledvicami, lahko v redkih primerih pride do ledvične odpovedi, če jim zdravnik odmerka ne zniža ustrezno.
English: Initiation of treatment is recommended as soon as possible after a diagnosis of first episode of genital herpes.
Slovenian: Priporočeno je, da bolnik z zdravljenjem začne čimprej po postavitvi diagnoze prvega pojava genitalnega herpesa.
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.
Slovenian: Pokazalo se je, da penciklovir tako kot druge učinkovine iz iste skupine povzroča kromosomske poškodbe, ni pa sprožil genskih mutacij niti v bakterijskih celicah niti v celicah sesalcev, pa tudi znakov povečanega popravljanja DNA in vitro ni bilo.
English: If you are pregnant or think you may be, tell your doctor.
Slovenian: Zdravniku povejte, če ste noseči ali mislite, da bi lahko bili.
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.
Slovenian: Bolnikom je bilo naključno predpisano prejemanje famciklovirja v odmerku 500 mg ali placeba dvakrat dnevno v obdobju 8 tednov, čemur je sledilo 7-dnevno obdobje izpiranja in nato znova 8-tedensko zdravljenje, v katerem so imeli bolniki drugačen režim zdravljenja kot v prvem.
English: Overall, adverse reactions reported from clinical studies with immunocompromised patients were similar to those reported in the immunocompetent population.
Slovenian: Na splošno so bili neželeni učinki, o katerih so poročali v kliničnih študijah z bolniki z oslabljenim imunskim odzivom, podobni tistim, ki so jih opisovali v populaciji z normalnim imunskim odzivom.
English: Characteristics in special populations
Slovenian: Značilnosti pri posebnih skupinah bolnikov
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.
Slovenian: Bolnike z zapletenim herpesom zostrom, kar pomeni, da so pri njih zajeti visceralni organi ali gre za diseminiran herpes zoster, motorično nevropatijo, encefalitis ali cerebrovaskularne zaplete, je treba zdraviti z intravenskimi protivirusnimi zdravili.
English: 2007; 44 (Suppl. 1): S1-26, Volpi A. Herpes 2007; 14 (Suppl. 2): 35A-39A).
Slovenian: Omenjeno je bilo, da je navedeni odmerek tudi v skladu s trenutnimi priporočili strokovne literature (Dworkin, R.H., et al: Clinical Infectious Diseases, 2007, str. 44 (dodatek 1): S1-26, Volpi, A.: Herpes, 2007, 14 (dodatek 2): 35A-39A).
English: Creatinine clearance [ml/min]
Slovenian: [ml/min]
English: Famvir is used to treat genital herpes infections in adults.
Slovenian: Zdravilo Famvir uporabljamo za zdravljenje genitalnega herpesa pri odraslih.
English: The recommended dose regimens for haemodialysis patients are included in Table 1.
Slovenian: Priporočene sheme odmerjanja za bolnike, ki se zdravijo s hemodializo, so prikazane v preglednici 1.
English: Key secondary efficacy parameters were the number (%) of days of viral shedding from any site and the number (%) of days of site-specific viral shedding during each treatment period.
Slovenian: Ključna sekundarna pokazatelja učinkovitosti sta bila število (odstotek) dni izločanja virusa iz katerega koli predela in število (odstotek) dni izločanja virusa iz posameznega predela v obeh obdobjih zdravljenja.
English: An article by (Strick, et al 2006) discussed the merits of suppressive versus episodic treatment of HSV in the HIV-infected patient.
Slovenian: Članek Stricka in drugih (2006) obravnava koristi supresivnega zdravljenja v primerjavi z zdravljenjem epizod HSV pri bolnikih, okuženih z virusom HIV.
English: Following oral administration, famciclovir is rapidly and extensively absorbed and converted to penciclovir.
Slovenian: Po peroralni uporabi se famciklovir hitro in v veliki meri absorbira in pretvori v penciklovir.
English: People who have frequent episodes of genital herpes can also take Famvir to help to prevent the attacks.
Slovenian: Ljudje s pogostimi izbruhi genitalnega herpesa lahko jemljejo zdravilo Famvir tudi za preprečevanje takih izbruhov.
English: The primary efficacy parameter was the proportion of patients with new lesions while on study medication.
Slovenian: Osnovni pokazatelj učinkovitosti je bil delež bolnikov, pri katerih so se med prejemanjem zdravila v okviru študije pojavile nove lezije.
English: However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking Famvir should refrain from driving or operating machinery.
Slovenian: Kljub temu bolniki, pri katerih v času jemanja zdravila Famvir pride do omotičnosti, zaspanosti, zmedenosti ali drugih motenj delovanja centralnega živčevja, ne smejo voziti ali upravljati s stroji.
English: The pivotal studies were conducted with different famciclovir dosing arms.
Slovenian: Osrednje študije so bile izvedene s kraki z drugačnimi odmerki famciklovirja.
English: Reproductive toxicity
Slovenian: Splošna toksičnost
English: This triphosphate persists in infected cells in excess of 12 hours and inhibits viral DNA chain elongation by competitive inhibition with deoxyguanosine triphosphate for incorporation into the growing viral DNA, thus halting virus replication of viral DNA.
Slovenian: Nastali trifosfat ostane v okuženi celici več kot 12 ur in zavira podaljševanje verige virusne DNA, tako da kompetitivno zavira vgrajevanje deoksigvanozin-trifosfata v rastočo virusno DNA, s čimer ustavi replikacijo virusne DNA.
English: Section 4.1 Therapeutic indication
Slovenian: Poglavje 4.1 Terapevtske indikacije
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV1-infection (see section 5.1).
Slovenian: Klinične študije niso bile opravljene pri bolnikih, okuženih s HSV, ki so imunokompromitirani iz razlogov, ki niso povezani z okužbo z virusom HIV1 (glejte poglavje 5.1.
English: A total of 1,587 patients have received famciclovir at recommended doses in placebo- (n=657) and active- (n=930) controlled studies.
Slovenian: Skupaj je v izbranih študijah prejemalo famciklovir v priporočenih odmerkih 1.587 bolnikov, in sicer v študijah, kontroliranih s placebom 657, v študijah s primerjalnim zdravilom pa 930.
English: Based on results of these three studies, the 250mg bid dose was selected for suppression of genital herpes since it was superior to the once daily and 125mg bid regimens in study 024, its effectiveness was demonstrated in all three studies, and there was no clear advantage of the tid regimens over it in studies 033 and 049.
Slovenian: Na podlagi rezultatov omenjenih treh študij je bil odmerek 250 mg dvakrat dnevno izbran za supresijo genitalnega herpesa, ker je bil v študiji 024 superioren režimu z odmerkom enkrat dnevno in režimu z odmerkom 125 mg dvakrat dnevno, ker se je v vseh treh študijah izkazal za učinkovitega in ker režimi odmerjanja zdravila trikrat dnevno v študijah 033 in 049 niso izkazali nobene očitne prednosti pred tem odmerkom.
English: Taking too much Famvir may affect the kidneys.
Slovenian: Jemanje prevelikih odmerkov zdravila Famvir lahko škoduje ledvicam.
English: Your doctor will discuss with you the potential risks of taking Famvir during pregnancy.
Slovenian: Zdravnik vam bo razložil možna tveganja pri jemanju zdravila Famvir med nosečnostjo.
English: No differences in efficacy outcomes were noted between the 250mg and 500mg doses of famciclovir.
Slovenian: Kar zadeva rezultate učinkovitosti, med famciklovirjem v odmerkih 250 mg in 500 mg ni bilo opaziti nobenih razlik.
English: Take special care with Famvir
Slovenian: Bodite posebno pozorni pri uporabi zdravila Famvir
English: Regarding suppression, the posology of 250mg bid is in accordance with existing guidelines.
Slovenian: Kar zadeva supresijo, je odmerek 250 mg dvakrat dnevno v skladu z obstoječimi smernicami.
English: The CHMP noted that the daily dose recommended for episodic treatment of recurrent genital herpes (125mg bid) in immunocompetent patients is lower than the recommended dose for suppression (250mg bid).
Slovenian: CHMP je omenil, da je priporočeni dnevni odmerek za zdravljenje epizod ponavljajočega se genitalnega herpesa (125 mg dvakrat dnevno) pri imunokompetentnih bolnikih manjši od odmerka, priporočenega za supresijo (250 mg dvakrat dnevno).
English: Based on the available data, the CHMP agreed that the indication treatment of herpes zoster in immunocompetent and immunocompromised patients was recommended.
Slovenian: Na podlagi razpoložljivih podatkov se je odbor CHMP strinjal, da se indikacija za zdravljenje herpesa zoster pri imunokompetentnih in imunokompromitiranih bolnikih priporoči.
English: Famvir is used to treat two types of viral infections in adults: - Shingles (herpes zoster), which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox).
Slovenian: Zdravilo Famvir uporabljamo za zdravljenje dveh vrst virusnih okužb pri odraslih: - pasovca (herpesa zostra), ki je virusna okužba, ki jo povzroča virus z imenom varicella zoster (isti virus, ki povzroča tudi norice ali vodene koze).
English: Placebo-controlled and uncontrolled studies of up to 16 weeks duration showed that famciclovir was effective in the suppression of recurrent genital herpes in HIV-infected patients; the placebo-controlled study showed that famciclovir significantly decreased the proportion of days of both symptomatic and asymptomatic HSV shedding.
Slovenian: V do 16-tedenskih študijah, kontroliranih s placebom, in v nekontroliranih študijah se je pokazalo, da je famciklovir uspešno preprečeval ponovitve genitalnega herpesa pri bolnikih, okuženih z virusom HIV; v študiji, kontrolirani s placebom, se je pokazalo, da je famciklovir bistveno zmanjšal delež dni, ko je prihajalo tako do simptomatskega kot do asimptomatskega širjenja virusa herpesa simpleksa.
English: No data are available for patients with severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Za bolnike s hudo okvaro jeter ni na voljo nobenih podatkov (glejte poglavji 4.4 in 5.2).
English: Considerations on the 750mg dose
Slovenian: Pojasnila o odmerku 750 mg
English: Demetriades & Papaellinas Ltd 21 Kasou P.O.
Slovenian: Demetriades & Papaellinas Ltd 21 Kasou P.O. Box 23490 Nicosia
English: Efficacy of famciclovir in immunocompetent patients with first episode of genital herpes was shown in three active-controlled studies.
Slovenian: Učinkovitost famciklovirja pri bolnikih z normalnim imunskim odzivom, pri katerih je prišlo do prvega pojava genitalnega herpesa, so dokazali v treh aktivno kontroliranih študijah.
English: Patients with herpes zoster infection
Slovenian: Bolniki z okužbo herpes zoster
English: • Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets, for frequency see below).
Slovenian: • nepojasnjene podplutbe, rdečkaste ali vijolične lise na koži ali krvavitve iz nosu (to so lahko znaki znižane koncentracije trombocitov, njena pogostnost je navedena spodaj).
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.
Slovenian: Rezistentne izolate so večinoma našli na začetku zdravljenja ali v skupini bolnikov, ki so prejemali placebo, pri tem pa so med bolniki, ki so se še zdravili s famciklovirjem ali penciklovirjem oziroma so zdravljenje z njima že zaključili, odkrili primer rezistence samo pri dveh bolnikih z oslabljenim imunskim odzivom.
English: There is no evidence of any increase in resistance despite the progressive increase in antiviral use The ability of HSV to establish a lifelong latent infection, together with the finding that the vast majority of resistant HSV isolates studied to date have reduced pathogenicity relative to wild-type virus, help to explain this observation.
Slovenian: Ugotovitev je mogoče pojasniti s sposobnostjo HSV, da povzroči doživljenjsko latentno okužbo, in z ugotovitvijo, da ima velika večina do danes proučenih odpornih izolatov HSV v primerjavi z divjim tipom virusa zmanjšano patogenost.
English: Animal studies have not shown any embryotoxic or teratogenic effects with famciclovir or penciclovir (the active metabolite of famciclovir).
Slovenian: Študije na živalih niso pokazale, da bi famciklovir ali penciklovir (aktivni metabolit famciklovirja) lahko delovala embriotoksično ali teratogeno.
English: • [To be completed nationally]
Slovenian: • [Izpolni država članica]
English: Pivotal studies 033 and 049 in immunocompetent patients were randomised, double-blind, placebo controlled trials.
Slovenian: Osrednji študiji 033 in 049, izvedeni na imunokompetentnih bolnikih, sta bili randomizirani, dvojno slepi in kontrolirani s placebom.
English: Famciclovir is rapidly converted in vivo into penciclovir, which has in vitro activity against herpes simplex viruses (HSV types 1 and 2), varicella zoster virus, Epstein-Barr virus and cytomegalovirus.
Slovenian: Famciklovir se in vivo hitro pretvori v penciklovir, ta pa ima in vitro aktivnost proti virusom herpes simpleks (HSV tipov 1 in 2), virusu varicella zoster, virusu Epstein-Barr in citomegalovirusu.
English: Moreover, famciclovir 500 mg bid was found in clinical trials to be effective, safe and well tolerated in this group of patients.
Slovenian: Poleg tega se je v kliničnih preskušanjih famciklovir v odmerku 500 mg dvakrat dnevno izkazal za učinkovitega in varnega pri tej skupini bolnikov, ki ga je tudi dobro prenašala.
English: IMMUNOCOMPROMISED ADULTS EPISODIC TREATMENT OF RECURRENT HERPES
Slovenian: IMUNOKOMPROMITIRANI ODRASLI BOLNIKI ZDRAVLJENJE EPIZOD PONAVLJAJOČEGA SE HERPESA
English: The scope of the referral included all strengths (125mg, 250mg, 500mg and 750mg) and licenses.
Slovenian: Napotitev je obsegala vse jakosti (125 mg, 250 mg, 500 mg in 750 mg) in odobritve.
English: - Genital herpes.
Slovenian: GENITALNI HERPES
English: The CHMP agreed that famciclovir resulted in a significant reduction in time to resolution of cutaneous signs of herpes zoster.
Slovenian: Odbor CHMP se je strinjal, da je uporaba famciklovirja privedla bo pomembnega skrajšanja časa do izginotja znakov herpesa zoster na koži.
English: For the 125mg famciclovir dose group there appeared to be a decrease in efficacy for some endpoints when compared with the higher dose groups that was consistent across the two trials.
Slovenian: Pri skupini, ki je prejemala famciklovir v odmerku 125 mg, se je zdelo, da je prišlo do zmanjšanja učinkovitosti glede na nekatere pokazatelje v primerjavi s skupinami, ki so prejemale večje odmerke, to zmanjšanje pa je bilo skladno pri obeh raziskavah.
English: Hence the probability of toxicity to mammalian host cells is low and uninfected cells are unlikely to be affected by therapeutic concentrations of penciclovir.
Slovenian: Iz tega razloga je pri sesalcih verjetnost toksičnega delovanja na gostiteljske celice majhna, terapevtske koncentracije penciklovirja pa po vsej verjetnosti ne morejo prizadeti celic, ki niso okužene.
English: Patients with localized herpes zoster involving the ophthalmic branch of the trigeminal nerve were enrolled.
Slovenian: Vanjo so bili vključeni bolniki z lokaliziranim herpesom zoster, ki je zajemal oftalmično vejo trigeminalnega živca.
English: Two studies (035 and 036) were presented to examine three doses (125mg, 250mg and 500mg bid for five days) for the episodic treatment of recurrent genital herpes in immunocompetent patients.
Slovenian: Študiji 035 in 036 sta bili predloženi z namenom, da bi proučili tri odmerke (125 mg, 250 mg in 500 mg dvakrat dnevno v obdobju pet dni) za zdravljenje epizod ponavljajočega se genitalnega herpesa pri imunokompetentnih bolnikih.
English: For the primary efficacy parameter, confidence intervals for the difference in proportions (famciclovir minus aciclovir) were used to assess treatment effects.
Slovenian: Kot primarni pokazatelj učinkov zdravljenja so upoštevali intervale zaupanja razlike med deleži (famciklovir minus aciklovir).
English: Table 1 Dose recommendations for adult patients with renal impairment Indication and nominal dose regimen
Slovenian: Preglednica 1 Priporočila za odmerjanje pri odraslih bolnikih z okvaro ledvic Indikacija in shema odmerjanja Očistek kreatinina
English: The pivotal studies 007 and 008 formed the basis of initial registration dossiers.
Slovenian: Osnova za prvo registracijsko dokumentacijo sta bili osrednji študiji 007 in 008.
English: The results showed that both bid (bis in die, twice a day) regimens (125 and 250 bid) were significantly better than placebo.
Slovenian: Rezultati so pokazali, da sta bila oba režima odmerjanja dvakrat dnevno (tj. 125 mg in 250 mg dvakrat dnevno) znatno boljša od placeba.