natgillin/translations-raw huggingface dataset:
If any of these applies to you, tell your doctor before you take Famvir.
Če karkoli od zgoraj navedenega velja za vas, povejte svojemu zdravniku, preden vzamete zdravilo Famvir.
WHAT FAMVIR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FAMVIR IN ZA KAJ GA UPORABLJAMO
However, the selection of placebo controls for both studies was questionable.
Vendar je bil izbor placeba kot primerjave pri obeh študijah vprašljiv.
Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: JO5AB09
Farmakoterapevtska skupina: nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB09
Dose for genital herpes The dose depends on the state of your immune system, and the stage of your infection.
Odmerek za genitalni herpes Višina odmerka je odvisna od stanja imunskega sistema in od stopnje okužbe.
The CHMP noted the recommended doses for the different posologies as indicated above.
CHMP je potrdil priporočene odmerke za različne režime odmerjanja, kakor je navedeno zgoraj.
Patients who continue to have significant disease may restart suppressive therapy.
Bolniki, pri katerih se bolezen še vedno pojavlja v pomembni meri, lahko ponovno začnejo s supresivnim zdravljenjem.
General toxicity Studies on safety pharmacology and repeated dose toxicity reveal no special hazard for humans.
Podatki študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
Elderly patients (≥ 65 years) Dose modification is not required unless renal function is impaired.
Starejši bolniki (stari 65 let ali več) Spremembe odmerkov niso potrebne, če bolnik nima okvare ledvic.
Blood and lymphatic system disorders Rare:
Bolezni krvi in limfatičnega sistema redki:
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.
Poleg tega je bilo opozorilo spremenjeno tako, da navaja, da čeprav se pogostost izločanja virusa z uporabo protivirusnega zdravila zmanjša, teoretično še obstaja tveganje za prenos, zato je treba bolnikom svetovati, naj se vzdržijo spolnih odnosov.
Animal studies did not indicate any negative effect on female fertility.
Rezultati študij na živalih niso kazali na škodljiv vpliv na plodnost pri samicah.
Section 4.5: Interaction with other medicinal products and other forms of interaction
Poglavje 4.5: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Evidence from preclinical studies has shown no potential for induction of cytochrome P450 enzymes and inhibition of CYP3A4.
Podatki iz predkliničnih študij ne kažejo potenciala za induciranje encimov citokroma P450 ali za zaviranje CYP3A4.
In the event of an overdose supportive and symptomatic therapy should be given as appropriate.
V primeru prevelikega odmerjanja je treba poskrbeti za ustrezno podporno in simptomatsko zdravljenje.
- If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famvir.
- Če imate težave z ledvicami ali ste jih imeli kdaj prej, vam bo zdravnik morda predpisal nižji odmerek zdravila Famvir.
The CHMP recommended also the revocation of the 750 mg film coated tablets for Famvir and associated names.
Odbor CHMP je predlagal tudi razveljavitev 750-miligramskih filmsko obloženih tablet za zdravilo Famvir in z njim povezana imena.
This is because you could pass the herpes infection to your partner.
Pri spolnih stikih bi namreč lahko prenesli herpes na svojega partnerja.
Over the 4 months of Study 195, 90% of HIV-infected patients remained free from clinically diagnosed recurrences.
Po štirih mesecih trajanja raziskave 195 pri 90 % bolnikov, okuženih s HIV, ni prišlo do klinično diagnosticiranih ponovitev.
Do not take Famvir - If you are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famvir listed in section 6, or to penciclovir (the active metabolite of famciclovir and an ingredient of some other medicines).
Ne jemljite zdravila Famvir - če ste alergični (preobčutljivi) na famciklovir, na katerokoli sestavino zdravila Famvir, ki je navedena v poglavju 6, ali na penciklovir (ki je aktivni presnovek famciklovirja in sestavina nekaterih drugih zdravil).
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.
Izjavo, da so najdbe na testisih v veliki meri reverzibilne, podpirajo ugotovitve iz študij kronične toksičnosti, ki so pokazale na veliko stopnjo reverzibilnosti najdb na testisih po 12-tedenskem okrevanju in delno reverzibilnost po krajših obdobjih okrevanja.
Taking Famvir with food and drink You can take Famvir with or without food.
Jemanje zdravil Famvir skupaj s hrano in pijačo Zdravilo Famvir lahko jemljete s hrano ali brez nje.
Section 4.8: Undesirable effects
Poglavje 4.8: Neželeni učinki
Section 4.6: Pregnancy and lactation
Poglavje 4.6: Nosečnost in dojenje
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.
Če pride do hude omotičnosti, somnolence, zmedenosti ali drugih motenj v delovanju centralnega živčevja, je mogoče razmisliti o znižanju odmerka famciklovirja na 250 mg trikrat na dan.
A total of 14 patients were withdrawn in Period 1 and 7 patients were withdrawn in Period 2.
V prvem obdobju je bilo iz raziskave izključenih 14, v drugem obdobju pa 7 bolnikov.
However, it cannot be excluded that short-term treatment with high dosages (e.g., 500mg tid) may affect male fertility in humans.
Kljub temu ni mogoče izključiti, da lahko kratkoročno zdravljenje z velikimi odmerki (npr. 500 mg trikrat dnevno) vpliva na moško plodnost.
Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.
Z zdravljenjem je treba začeti čimprej po postavitvi diagnoze herpesa zostra.
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.
Krak s placebom zato ni bil vključen, zaradi česar bi bile pripombe o absolutni učinkovitosti protivirusnih učinkovin pri preprečevanju očesnih zapletov v tej študiji dvomljive.
Penciclovir triphosphate resembles deoxyguanosine triphosphate (dGTP), a component of DNA.
Penciklovir trifosfat je podoben deoksigvanozin trifosfatu (dGTP), ki je sestavina DNK.
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.
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.
Studies 004, 011, and 040 were randomised, multicentre studies.
Študije 004, 011 in 040 so bile randomizirane in multicentrične.
Famvir is not to be used during pregnancy unless clearly necessary.
Zdravila Famvir se med nosečnostjo ne sme jemati, razen če je to nedvomno potrebno.
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.
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.
It causes blisters and burning or itching around the genitals, which may be painful.
Povzroča mehurjast izpuščaj in pekoč občutek ali srbenje okrog spolovil, kar je lahko boleče.
- For the best results start the medicine as soon as possible after the first signs and symptoms appear.
- Da bi dosegli kar najboljše rezultate zdravljenja, začnite zdravilo jemati čimprej po nastopu prvih znakov in simptomov.
Therefore, an interaction of famciclovir/penciclovir with probenecid cannot be ruled out.
Posledično medsebojnega delovanja famciklovirja oziroma penicklovirja s probenecidom ni mogoče izključiti.
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.
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.
Aciclovir was used as a comparator and the primary endpoint was time to cessation of viral shedding.
Kot primerjalna učinkovina je bil uporabljen aciklovir, primarni pokazatelj pa je bil čas do prenehanja izločanja virusa.
Children and adolescents (below the age of 18 years) Famvir is not recommended for use in children and adolescents.
Otroci in mladostniki (stari manj kot 18 let) Uporaba zdravila Famvir ni priporočena za otroke in mladostnike.
Rare:
zmedenost redki:
The deacetylation is catalyzed by the enzyme aldehyde oxidase.
Deacetilacijo katalizira encim aldehid oksidaza.
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.
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.
If you have a normal immune system, the doses are as follows:
Če vaš imunski sistem deluje normalno, so odmerki naslednji:
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).
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).
Animal studies have shown excretion of penciclovir in breast milk.
Študije na živalih kažejo na izločanje penciklovirja v mleko.
Small differences in renal clearance of penciclovir between females and males have been reported and were attributed to gender differences in renal function.
Opisali so majhne razlike ledvičnega očistka penciklovirja med ženskami in moškimi, ki so jih pripisali razliki v ledvični funkciji med spoloma.
Very common side effects - Headache
Zelo pogosti neželeni učinki - glavobol
Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated.
Bolnike je treba opozoriti, naj se v obdobju izraženih simptomov izogibajo spolnim odnosom, čeprav so se začeli zdraviti s protivirusnim zdravilom.
Serious side effects of Famvir are:
Resni neželeni učinki zdravila Famvir so:
The patient population was comprised of patients who were candidates for suppressive treatment.
Populacija bolnikov je zajemala bolnike, pri katerih je prišlo v poštev supresivno zdravljenje.
The wording of the SPC was updated to reflect this.
Besedilo SPC je bilo ustrezno posodobljeno.
Like all medicines, Famvir can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Famvir neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Ker se virus razmnožuje zgodaj v poteku okužbe, so rezultati zdravljenja najboljši, če začnete jemati zdravilo Famvir čimprej po pojavu prvih simptomov.
Additionally, the reduced dosing frequency of famciclovir gave a greater patient acceptability.
Poleg tega je manjša pogostost odmerjanja famciklovirja povečala sprejemljivost zdravljenja za bolnike.
Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.
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.
All regimens were superior to placebo in terms of the two primary endpoints, and these were considered relevant.
Vsi režimi so bili superiorni placebu glede na primarna pokazatelja, za katera je bilo ocenjeno, da sta pomembna.
In studies 033, and 049 it was noted that a dose-response relationship was not observed.
Pri študijah 033 in 049 je bilo omenjeno, da razmerje med odmerkom in odzivom ni bilo obravnavano.
Having considered available data and current scientific knowledge, the CHMP considered the following as the harmonised indications:
Ob upoštevanju razpoložljivih podatkov in trenutnih znanstvenih spoznanj je Odbor za zdravila za uporabo v humani medicini (CHMP) za usklajene štel naslednje indikacije:
Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses.
O navzei, bruhanju in nenormalnih vrednostih testov jetrne funkcije so poročali bolj pogosto, zlasti pri uporabi višjih odmerkov.
The section was also updated to reflect drug interactions due to aldehyde oxidase involvement.
Poglavje je bilo nadalje posodobljeno tako, da odraža medsebojno delovanje med zdravili zaradi aldehid oksidaze.
United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park
Velika Britanija Novartis Pharmaceuticals UK Ltd Frimley Business Park
All genital herpes suppression trials were placebo controlled.
Vse raziskave supresije genitalnega herpesa so bile kontrolirane s placebom.
Distribution Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins.
Penciklovir in njegova 6-deoksi predstopnja se v manjši meri (< 20 %) vežeta na beljakovine v plazmi.
Novartis Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Hungary
Madžarska Novartis Hungaria Kft. Bartók Béla út 43-47
Rare side effects - Hallucinations (seeing or hearing things that are not really there) - Yellowing of the skin and/or eyes - Low platelet count
Redki neželeni učinki - halucinacije (bolnik vidi ali sliši to, česar v resnici ni) - rumenkasto obarvanje kože in/ali oči - znižano število trombocitov
Effects of other medicinal products on famciclovir No clinically significant interactions have been identified.
Delovanje drugih zdravil na famciklovir Klinično pomembnih interakcij niso opažali.
It stops the infecting virus from reproducing.
Preprečuje razmnoževanje virusa v okuženi celici.
The choice of placebo as a comparator was however considered disputable given the available active treatment option aciclovir.
Izbira placeba za primerjalno učinkovino pa je bila ocenjena za sporno glede na razpoložljivo možnost zdravljenja z aciklovirjem.
Your doctor will discuss with you the possible risks of taking Famvir during breastfeeding.
Zdravnik se bo z vami pogovoril o možnih tveganjih jemanja zdravila Famvir v obdobju dojenja.
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.
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.
The statement regarding the reversibility of the degenerative testicular epithelium was updated.
Dopolnjena je bila izjava o reverzibilnosti degeneracije testikularnega epitelija.
Overdose experience with famciclovir is limited.
Izkušenj s prevelikim odmerjanjem famciklovirja je malo.
Results from studies 033 and 049 showed a significant effect of famciclovir with regard to suppression of recurrent genital herpes.
Rezultati študij 033 in 049 so pokazali pomemben učinek famciklovirja pri supresiji ponavljajočega se genitalnega herpesa.
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.
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.
Famvir 125 mg, 250 mg and 500 mg (country specific) tablets contain lactose.
Tablete Famvir 125 mg, 250 mg in 500 mg (specifično za posamezno državo) vsebujejo laktozo.
Thus the CHMP endorsed the restriction to recurrent genital herpes in HIV infected patients which reflects the outcome of the respective clinical study (083).
CHMP je podprl omejitev na zdravljenje ponavljajočega se genitalnega herpesa pri bolnikih, okuženih z virusom HIV, kar ustreza rezultatom klinične študije 083.
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).
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).
Section 4.7: Effects on ability to drive and use machines
Poglavje 4.7: Vpliv na sposobnost vožnje in upravljanja s stroji
In uninfected cells treated with penciclovir, concentrations of penciclovir-triphosphate are only barely detectable.
V neokuženih celicah, ki so izpostavljene penciklovirju, je koncentracija penciklovir-trifosfata komaj zaznavna.
Famciclovir is eliminated principally as penciclovir and its 6-deoxy precursor, which are excreted in urine.
Famciklovir se izloča večinoma kot penciklovir in njegova 6-deoksi predstopnja, ki se izločata z urinom.
• 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.
• 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.
However, patients who experience certain adverse events should refrain from driving or operating machinery.
Kljub temu bolniki, pri katerih pride do neželenih učinkov, ne smejo voziti ali upravljati s stroji.
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.
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.
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.
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.
• 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).
• 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);
Secondary efficacy parameters included time to full crusting of lesions, time to complete healing, and evaluations of pain and dissemination.
Sekundarni pokazatelji učinkovitosti so vključevali čas do popolnega nastanka krast na lezijah, čas do popolne ozdravitve ter oceno bolečine in širjenja.
A break down of the discussions held per indication is shown below.
Razčlenitev razprav o posamezni indikaciji je podana v nadaljevanju.
The 500mg bid regimen is recommended by some of the guidelines and no other regimen was studied.
Režim odmerjanja 500 mg dvakrat dnevno se priporoča v nekaterih smernicah; drugi režimi niso bili proučeni.
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.
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.
These clinical studies were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below.
Z retrospektivnim pregledom podatkov iz teh študij so ugotovili kategorije pogostnosti za vse spodaj navedene neželene učinke.
If you have a reduced immune system, the doses are as follows:
Če je vaš imunski sistem oslabljen, so odmerki naslednji:
- Do not have sexual contact with anyone if you have symptoms of genital herpes - even if you have started treatment with Famvir.
- Če imate simptome genitalnega herpesa, ne imejte spolnih stikov z nikomer - tudi če se ste že začeli jemati zdravilo Famvir.
Section 4.3: Contraindications
Poglavje 4.3: Kontraindikacije
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).
Primarni pokazatelj učinkovitosti je bil delež bolnikov, ki so imeli v času študije (7-dnevnega zdravljenja in 6-mesečnega spremljanja) očesni herpes.
If you forget to take Famvir
Če ste pozabili vzeti zdravilo Famvir
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.
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.
Method of administration Famvir can be taken without regard to meals (see section 5.2).
Način uporabe Zdravilo Famvir je mogoče jemati ne glede na obroke (glejte poglavje 5.2).