FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Ir-Reazzjonijiet avversi (Tabella 2) jinsabu mqiegħda f'ordni skont il-frekwenza, u qed tintuża lkonvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Distribution Penciclovir and its 6-deoxy precursor are poorly (< 20%) bound to plasma proteins.
Maltese: Distribuzzjoni Il-penciclovir u l-prekursur tiegħu 6-deoxy ftit li xejn jingħaqdu (<20%) mal-proteini tal-plażma.
English: Dose for shingles
Maltese: Doża għax-shingles
English: Based on cross-study comparisons, the mean penciclovir AUC was about 30% higher and penciclovir renal clearance about 20% lower after oral administration of famciclovir in elderly volunteers (65-79 years) compared to younger volunteers.
Maltese: Abbażi ta' paraguni ta' studji intersezzjonali, l-AUC medju ta' penciclovir kien madwar 30% ogħla u l-eliminazzjoni mill-kliewi ta' penciclovir kienet madwar 20% iktar baxxa wara t-teħid orali ta' farmciclovir f'voluntiera anzjani (65-79 sena) meta mqabbel ma' voluntiera żgħażagħ.
English: No clinically significant interactions have been identified.
Maltese: Ma ġewx identifikati interazzjonijiet klinikament sinifikanti.
English: In the two pivotal studies three regimen were investigated: 125mg tid, 250mg bid, 250mg tid.
Maltese: Fiż-żewġ studji pivotali ġew investigati tliet korsijiet: 125mg tid, 250mg bid, 250mg tid.
English: - If you have problems with your body's immune system.
Maltese: - Jekk għandek problemi fis-sistema immunitarja ta' ġismek.
English: Partly this difference may be due to differences in renal function between the two age groups.
Maltese: Din iddifferenza tista' tkun dovuta parzjalment għal differenzi fil-funzjoni tal-kliewi bejn iż-żewġ gruppi ta' età.
English: There is evidence in the literature that probenecid affects the elimination of compounds structurally related to penciclovir.
Maltese: Hemm evidenza fil-letteratura li probenecid jaffettwa l-eliminazzjoni tal-komposti relatati strutturalment ma' penciclovir.
English: Novartis Pharma GmbH Roonstrasse 25
Maltese: Il-Ġermanja Novartis Pharma GmbH Roonstrasse 25
English: The CHMP endorsed the 500mg tid dose during a period of 7 days for this indication.
Maltese: Is-CHMP approva d-doża ta' 500mg tid matul perijodu ta' 7 ijiem għal din l-indikazzjoni.
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.
Maltese: Skont 11 -il studju kliniku madwar id-dinja li kienu jinvolvu penciclovir (formulazzjonijet topiċi jew intravenużi) jew famciclovir f'pazjenti imunokompetenti jew b'immunodefiċjenza inkluż studji fejn il-pazjenti ngħataw il-famciclovir għal 12 -il xahar, intwera li kien hemm għadd żgħir ta' pazjenti individwali b'reżistenza għall-penciclovir: 0.2% (2/913) f'pazjenti immunokompetenti u 2.1% (6/288) f'pazjenti b'immunodefiċjenza.
English: In Study 102, 83% of HIV-infected patients receiving famciclovir remained recurrence-free as compared to 42% of patients receiving placebo.
Maltese: Fi studju 102, 83% talpazjenti infettati bl-HIV li kienu qegħdin jirċievu farmciclovir baqgħu ħielsa mir-rikorrenza meta mqabbla ma' 42% tal-pazjenti li kienu qegħdin jirċievu l-plaċebo.
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.
Maltese: Il-famciclovir jinbidel malajr in vivo f'penciclovir, li in vitro jaħdem kontra l-viruses tal-herpes simplex (HSY tipi 1 u 2), il-virus tal-variċella zoster, ilvirus tal-Epstein-Barr u ċ-ċitomegalovirus.
English: Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: JO5AB09
Maltese: Nucleosides u nucleotides li ma jinkludux impedituri ta' reverse transcriptase, Kodiċi ATC:
English: Over the 4 months of Study 195, 90% of HIV-infected patients remained free from clinically diagnosed recurrences.
Maltese: Matul l-4 xhur ta' Studju 195, 90% tal-pazjenti infettati bl-HIV baqgħu ħielsa minn rikorrenzi dijanjostikati klinikament.
English: Hallucinations.
Maltese: Alluċinazzjonijiet.
English: Famciclovir was considered equivalent to aciclovir if the upper limit of the 2-sided 95% confidence interval was less than 15%.
Maltese: Farmciclovir kien ikkunsidrat bħala l-ekwivalenti ta' aciclovir jekk il-limitu ta' fuq talintervall ta' fiduċja ta' 95% taż-żewġ naħat kien inqas minn 15%.
English: Thus, penciclovir is virustatic.
Maltese: Għalhekk, penciclovir huwa virustatiku.
English: Varicella zoster virus (VZV) infections - herpes zoster Famvir is indicated for
Maltese: Infezzjonijiet bil-virus tal-variċella zoster (VZV) - herpes zoster Famvir huwa indikat għal
English: Famvir 125 mg, 250 mg and 500 mg (country specific) tablets contain lactose.
Maltese: Il-pilloli Famvir ta' 125 mg, 250 mg u 500 mg (speċifiċi għall-pajjiż) fihom il-lactose.
English: Pivotal studies 033 and 049 in immunocompetent patients were randomised, double-blind, placebo controlled trials.
Maltese: Studji pivotali 033 u 049 fil-pazjenti immunokompetenti kienu studji li saru b'mod każwali, double blind u kkontrollati mill-plaċebo.
English: The absolute bioavailability of penciclovir after administration of famciclovir is 77%.
Maltese: Il-bijodisponibbiltà assoluta ta' penciclovir wara t-teħid ta' farmciclovir hija ta' 77%.
English: Reproductive toxicity
Maltese: Tossiċità ġenerali
English: Common side effects - Feeling sick (nausea) - Vomiting - Dizziness - Drowsiness - Rash - Pruritus - Liver function test giving abnormal results
Maltese: Effetti sekondarji komuni - Tħossok imqalla' (nawsja) - Rimettar - Sturdament - Ħedla ta' ngħas - Raxx - Prurite - Test tal-funzjoni tal-fwied li jagħtu riżultati mhux normali
English: In study 086, immunocompromised patients with herpes zoster were treated for 10 days with famciclovir 500mg tid or aciclovir 800mg tid for 10 days.
Maltese: Fl-istudju 086, il-pazjenti immunokompromessi bil-ħerpes żoster ġew ittrattati għal 10 ijiem bi farmciclovir 500mg tid jew b'aciclovir 800mg tid għal 10 ijiem.
English: Herpes zoster in immunocompetent adults 500 mg three times daily for 7 days ≥ 60
Maltese: Herpes zoster f'adulti immunokompetenti 500 mg tliet darbiet kuljum għal 7 ijiem
English: Famciclovir is the oral prodrug of penciclovir.
Maltese: Il-famciclovir huwa prodrug orali tal-penciclovir.
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.
Maltese: Ġew ippreżentati żewġ studji (035 u 036) biex jeżaminaw tliet dożi (125mg, 250mg u 500mg bid għal ħamest ijiem) għat-trattament episodiku tal-ħerpes ġenitali rikorrenti filpazjenti immunokompetenti.
English: Clinical data do not indicate an impact of famciclovir on male fertility following long-term treatment at an oral dose of 250 mg twice daily (see section 5.3).
Maltese: Data klinika ma tindikax impatt ta' famciclovir fuq il-fertilità tar-raġel wara kura fit-tul b'doża orali ta' 250 mg darbtejn kuljum (ara sezzjoni 5.3).
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).
Maltese: Għal reazzjonijiet avversi li qatt ma ġew osservati f'dawn l-istudji, l-limitu superjuri tal-interval tal-kunfidenza ta' 95 % mhuwiex mistenni li jkun ogħla minn 3/X (ibbażat fuq ir-“regola tat-tlieta”), b'X jirrapreżenta d-daqs totali tal-kampjun (n=1,587).
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.
Maltese: Ir-riżultati tażżewġ studji huma simili minn dak li ġie rrappurtat minn (Mertz, et al 1997) għall-pazjenti immunokompetenti fi studju ta' 4 xhur fejn 90% tal-pazjenti li kienu qegħdin jirċievu farmciclovir baqgħu ħielsa mill-ħerpes ġenitali ikkonfermat viroloġikament meta mqabbla mat-48% tal-pazjenti ttrattati bil-plaċebo.
English: Evidence from preclinical studies has shown no potential for induction of cytochrome P450 enzymes and inhibition of CYP3A4.
Maltese: Skont evidenza minn studji ta' qabel l-użu kliniku ma deher l-ebda potenzjal li jkun hemm induzzjoni tal-enzimi taċ-ċitokromu P450 u inibizzjoni ta' CYP3A4.
English: 125 mg twice daily for 5 days 125 mg once daily for 5 days Haemodialysis patients 125 mg following each dialysis during 5 days
Maltese: 125 mg darbtejn kuljum għal 5 ijiem 125 mg darba kuljum għal 5 ijiem Pazjenti bl-emodijaliżi 125 mg wara kull dijaliżi matul 5 ijiem
English: In analogy with the above reports, it was hypothesized that probenecid may increase penciclovir AUC by approximately 50%.
Maltese: F'analoġija mar-rapporti ta' hawn fuq, ġie ipotetizzat li probenecid jista' jżid l-AUC ta' penciclovir b'madwar 50%.
English: − the treatment of recurrent episodes of genital herpes in immunocompromised adults
Maltese: − it-trattament ta' episodji rikorrenti tal-ħerpes ġenitali fl-adulti immunokompromessi
English: Famciclovir is the oral prodrug of the antivirally active compound penciclovir.
Maltese: Il-famciclovir huwa l-prodrug orali tal-komponent attiv antivirali tal-penciclovir.
English: Raloxifen has been shown to be a potent inhibitor of this enzyme in vitro.
Maltese: Intwera li raloxifen huwa inibitur qawwi ta' dan l-enzim in vitro.
English: Several indications were identified for Famvir in the SPCs of different MSs.
Maltese: Diversi indikazzjonijiet ġew identifikati għal Famvir fl-SPCs ta' SM differenti.
English: Recently two papers on human liver aldehyde oxidase inhibition in in vitro investigations were published (Obach 2004; Obach, et al 2004).
Maltese: Dan l-aħħar ġew ippubblikati żewġ rapporti dwar l-inibizzjoni tal-aldehyde oxidase fil-fwied uman f'investigazzjonijiet in vitro (Obach 2004;
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)
Maltese: Il-frekwenza tal-effetti sekondarji li jistgħu jseħħu li huma elenkati hawn taħt hija ddefinita bl-użu talkonvenzjoni li ġejja: - komuni ħafna (jaffetwaw aktar minn persuna waħda minn kull 10 li jużawh) - komuni (jaffettwaw minn persuna waħda sa 10 persuni minn kull 100 li jużawh) - mhux komuni (jaffettwaw minn persuna waħda sa 10 persuni minn kull 1,000 li jużawh) - rari (jaffettwaw minn persuna waħda sa 10 persuni minn kull 10,000 li jużawh) - rari ħafna (jaffettwaw anqas minn persuna waħda minn kull 10,000 li jużawh)
English: In the pivotal studies 033 and 049, the 250mg bid dose was assessed along with 125mg tid and 250mg tid doses.
Maltese: Fl-istudji pivotali 033 u 049, id-doża ta' 250mg bid ġiet ivvalutata flimkien mad-dożi ta' 125mg tid u 250mg tid.
English: There were 48 patients enrolled and treated.
Maltese: Kien hemm 48 pazjent irreġistrat u ttrattat.
English: The terminal plasma half-life of penciclovir in patients with herpes zoster was 2.8 h and 2.7 h, respectively, after single and repeated dosing of famciclovir.
Maltese: Il-half life terminali tal-plażma filpenciclovir f'pazjenti bil-herpes zoster kienet ta' 2.8 sigħat u 2.7 sigħat, rispettivament, wara li jingħata dożaġġ wieħed jew ripetut ta' famciclovir.
English: Abnormal liver function tests.
Maltese: Testijiet mhux normali tal-funzjoni tal-fwied.
English: The patient population was comprised of patients who were candidates for suppressive treatment.
Maltese: Il-popolazzjoni tal-pazjenti inkludiet pazjenti li kienu kandidati għal trattament soppressiv.
English: HOW TO STORE FAMVIR
Maltese: X'fih Famvir
English: Suppression of recurrent genital herpes in immunocompetent adults 250 mg twice daily.
Maltese: Trażżin ta' każijiet ripetuti ta' erpete ġenitali f'adulti immunokompetenti 250 mg darbtejn kuljum.
English: No data are available for patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Ma teżisti l-ebda informazzjoni għal pazjenti b'indeboliment epatiku gravi (ara sezzjonijiet 4.4 u 5.2).
English: No statistically significant differences were observed between all famciclovir dose groups and aciclovir for all primary efficacy parameters in all three clinical trials.
Maltese: Ma ġewx osservati differenzi statistikament sinifikanti bejn il-gruppi kollha ta' doża ta' farmciclovir u anċiklovir għall-parametri tal-effikaċja primarji kollha fit-tliet provi kliniċi kollha.
English: In study 098 the famciclovir 500mg tid dose proved to be non-inferior to aciclovir 5 x 800 mg/day.
Maltese: Fi studju 098, id-doża ta' farmciclovir ta' 500mg tid tat prova li mhijiex inferjuri għal aciclovir ta' 5 x 800mg kuljum.
English: In studies 033, and 049 it was noted that a dose-response relationship was not observed.
Maltese: Fi studji 033, u 049 ġie nnotat li relazzjoni doża-reazzjoni ma ġietx osservata.
English: No differences in efficacy outcomes were noted between the 250mg and 500mg doses of famciclovir.
Maltese: Ma ġietx innotati differenza fir-riżultati ta'effikaċja bejn id-dożi ta' 250mg u 500mg ta' farmciclovir.
English: In an active-controlled clinical study, famciclovir was shown to be effective in the treatment of ophthalmic zoster in immunocompetent patients.
Maltese: Fi studju attivament ikkontrollat, famciclovir intwera effettiv fil-kura talherpes zoster f'pazjenti immunokompetenti.
English: Study 102 compared the famciclovir 500mg bid dose with placebo.
Maltese: Studju 102 qabbel id-doża ta' farmciclovir ta' 500mg mal-plaċebo.
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).
Maltese: Is-CHMP innota li d-doża kwotidjana rrakkomandata għat-trattament episodiku tal-ħerpes ġenitali rikorrenti (125mg bid) fil-pazjenti immunokompetenti hija inqas mid-doża rrakkomandata għassuppressjoni (250mg bid).
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.
Maltese: Sabiex jappoġġja l-benefiċċju terapewtiku ta' farmciclovir għat-trattament soppressiv tal-ħerpes ġenitali, ġie ppreżentati studju wieħed ta' sejbien tad-doża (studju 024) u żewġ studji pivotali (studji 033 u 049) fil-pazjenti immunokompetenti, u studju wieħed ta' sejbien tad-doża (studju 102) filpazjenti immunokompromessi.
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.
Maltese: Is-CHMP ikkunsidra li l-istudju sottomess biex jappoġġja din l-indikazzjoni (086) kellu diversi nuqqasijiet (pereżempju l-punt ta' tmiem primarju “formazzjoni ġdida ta' leżjonijiet waqt il-medikazzjoni” ta' rilevanza dubjuża, studju mhux potenzjat biex jipparaguna punti ta' tmiem sekondarji), iżda d-dejta indikat effikaċja simili kemm għal farmciclovir kif ukoll għal aciclovir 5 x 800mg kuljum.
English: Study 008 demonstrated statistically significant differences of famciclovir 750mg tid (ter in die, three times a day) as compared to placebo with respect to the primary as well as several secondary endpoints.
Maltese: Studju 008 wera differenzi statistikament sinifikanti ta' farmciclovir 750mg tid (ter in die, tliet darbiet kuljum) meta mqabbel mal-plaċebo fir-rigward tal-punti tat-tmiem primarji kif ukoll ta' diversi punti tat-tmiem sekondarji.
English: Famciclovir has not been studied in patients with severe hepatic impairment.
Maltese: Il-famciclovir għadu ma ġiex studjat f'pazjenti b'indeboliment epatiku gravi.
English: Section 5.1: Pharmacodynamic properties
Maltese: Sezzjoni 5.1: Tagħrif farmakodinamiku
English: The CHMP agreed that the indication treatment of ophthalmic zoster in immunocompetent patients was supported by the available data.
Maltese: Is-CHMP qabel li t-trattament ta' indikazzjoni taż-żoster oftalmiku fil-pazjenti immunokompetenti kien appoġġjat mid-dejta disponibbli.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, b'defiċjenza ta' Lapp lactase jew li ma jassorbux tajjeb il-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finland
Maltese: Il-Finlandja Novartis Finland Oy Metsänneidonkuja 10
English: Famciclovir was effective in the treatment of herpes zoster in immunocompromised patients.
Maltese: Farmciclovir kien effettiv fit-trattament tal-ħerpes żoster fil-pazjenti immunokompromessi.
English: The pivotal studies 007 and 008 formed the basis of initial registration dossiers.
Maltese: L-istudji pivotali 007 u 008 iffurmaw il-bażi għal dossiers ta' reġistrazzjoni inizjali.
English: The primary efficacy parameter was the number (%) of days of viral shedding from anogenital sites.
Maltese: Il-parametru primarju tal-effikaċja kien innumru (%) ta' jiem ta' tixrid virali minn siti anoġenitali.
English: Overall, there were no differences in the nature, frequency or severity of adverse events among the three active dose groups or placebo.
Maltese: B'mod ġenerali, ma kienx hemm differenzi fin-natura, il-frekwenza u s-serjetà tal-avvenimenti avversi fost it-tliet gruppi tad-doża attivi jew il-plaċebo.
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.
Maltese: Probenecid, inibitur magħruf tas-sistema tat-trasport tal-aċidi organiċi, jew mediċini eliminati b'mod sinifikanti bl-eskrezzjoni tubulari attiva tal-kliewi jistgħu jaffettwaw l-elminazzjoni mill-kliewi ta' penciclovir bl-inbizzjoni jew il-kompetizzjoni fis-sit tat-tnixxija tubulari.
English: The viral DNA polymerase mistakenly incorporates the nucleoside analogue, penciclovir triphosphate, into the growing viral DNA strand instead of dGTP, which results in termination of the viral DNA chain and halting of viral replication.
Maltese: Il-polimerażi tad-DNA virali tinkorpora bi żball l-analogu tan-nukleosid, penciclovir triphosphate, fl-istrixxa virali li tkun qiegħda tikber tad-DNA minflok dGTP, li jirriżulta fit-terminazzjoni tal-katina tad-DNA virali u t-twaqqif tar-replikazzjoni virali.
English: Inf. Dis.
Maltese: Uġigħ ta' ras.
English: Study 083 showed that famciclovir was as effective against herpes simplex in HIV positive patients as aciclovir.
Maltese: Studju 083 wera li farmciclovir kien effettiv kontra l-ħerpes simplex fil-pazjenti pożittivi għall-HIV daqs aciclovir.
English: - Genital herpes.
Maltese: - Erpete ġenitali.
English: Considerations on the 750mg dose
Maltese: Kunsiderazzjonijiet dwar id-doża ta' 750mg
English: Herpes simplex virus (HSV) infections - genital herpes Famvir is indicated for
Maltese: Infezzjonijiet bil-virus tal-herpes simplex (HSV) - erpete ġenitali Famvir huwa indikat għal
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.
Maltese: Dan it-trifosfat jibqa' jidher f'ċelloli infettati sa wara 12-il siegħa u ma jħallix it-tiġbid tal-katina tad-DNA tal-virus permezz ta' inibizzjoni kompettitiva ma' trifosfat deoxyguanosine għall-inkorporazzjoni fid-DNA virali li jkun qed jikber, biex b'hekk iwaqqaf it-tkattir tal-virus tad-DNA virali.
English: Patients with herpes zoster infection
Maltese: Pazjenti bl-infezzjoni tal-herpes zoster
English: • Do not use Famvir after the expiry date which is stated on the label after the expiry date.
Maltese: • Tużax Famvir wara d-data ta' skadenza li tidher fuq it-tikketta wara d-data ta' skadenza.
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV1-infection (see section 5.1).
Maltese: Ma sarux Studji kliniċi fuq pazjenti immunokompromessi infettati bl-HSV għal kawżi oħrajn apparti infezzjoni mill-HIV 1 (ara sezzjoni 5.1).
English: In virus-infected cells the viral thymidine kinase (TK) phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases.
Maltese: F'ċelloli infettati bil-virus, it-timdina kinażi virali (TK) jiffosforilata penciclovir għal forma ta' monofosfat li min-naħa tieħu jinbidel għal penciclovir trifosfat permezz ta' kinażi ċellulari.
English: Episodic treatment of recurrent genital herpes: 125 mg twice daily for five days.
Maltese: Kura episodika f'każijiet ripetuti ta' erpete ġenitali: 125 mg darbtejn kuljum għal ħamest ijiem.
English: In study 004 the 750mg tid famciclovir dose was not superior to either the 250mg tid or 500mg tid dose on the primary efficacy endpoints and was not included in subsequent studies.
Maltese: 750mg tid ma kinitx superjuri għad-doża ta' 250mg tid jew għad-doża ta' 500mg tid fuq il-punti tattmiem primarji tal-effikaċja u ma ġietx inkluża fi studji sussegwenti.
English: The posology was thus endorsed by the CHMP.
Maltese: Għalhekk, il-pożoloġija ġiet approvata mis-CHMP.
English: Study 098 was a multicentre randomised, double-blind, double-dummy study, comparing famciclovir 500mg tid with aciclovir 800mg 5 times daily.
Maltese: Studju 098 kien studju b'aktar minn ċentru wieħed li sar b'mod każwali, double-blind, b'dummy doppju, li jqabbel farmciclovir 500mg tid ma' aciclovir 800mg, 5 darbiet kuljum.
English: Section 4.8: Undesirable effects
Maltese: Sezzjoni 4.8: Effetti mhux mixtieqa
English: GENITAL HERPES IMMUNOCOMPETENT ADULTS INITIAL (FIRST) EPISODE
Maltese: IMMUNOKOMPETENTI EPISODJU INIZJALI (TAL-EWWEL)
English: Novartis (Hellas) S.A.C.I.
Maltese: Novartis (Hellas) S.A.C.I. 12th Km National Road No.
English: − the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults
Maltese: − is-suppressjoni tal-ħerpes ġenitali rikorrenti fl-adulti immunokompetenti u immunokompromessi
English: The proposed regimen (500mg bid) is also in line with current recommendations and with the SPCs in the vast majority of the MSs.
Maltese: Il-kors propost (500mg bid) huwa wkoll konformi marrakkomandazzjoni attwali u mal-SPCs fil-biċċa l-kbira tal-SM.
English: The study was a randomised, aciclovir-controlled, double-blind, double-dummy multicentre study of famciclovir vs. aciclovir in clinic-initiated episodic treatment of recurrent mucocutaneous herpes simplex virus infections in HIV-infected patients.
Maltese: aciclovir fit-trattament tal-episodji mibdijin mill-klinika ta' infezzjonijiet rikorrenti mukokutanji tal-virus tal-ħerpes simplex fil-pazjenti infettati bl-HIV.