FrancophonIA/ELRC3.0 huggingface dataset:
English: Recurrent genital herpes in immunocompromised adults Episodic treatment of recurrent genital herpes: 500 mg twice daily for seven days.
Maltese: Każijiet ripetuti ta' erpete ġenitali f'adulti b'immunodefiċjenza Kura episodika ta' infezzjonijiet ripetuti b'erpete ġenitali: 500 mg darbtejn kuljum għal sebat ijiem.
English: − the treatment of herpes zoster in immunocompromised adults (see section 4.4)
Maltese: − it-trattament tal-ħerpes żoster fl-adulti immunokompremssi (ara sezzjoni 4.4)
English: 500 mg three times daily for 7 days
Maltese: 500 mg darbtejn kuljum għal 7 ijiem
English: Studies 035 and 036 were randomised, double-blind, placebo-controlled multicentre trials designed to compare the efficacy and safety of 3 doses of famciclovir (125mg, 250mg, 500mg) with that of placebo for acute treatment of a recurrent episode of genital herpes.
Maltese: Studji 035 u 036 kienu studji b'aktar minn ċentru wieħed, li saru b'mod randomizzat, double blind, u kkontrollati bi plaċebo, imfasslin biex jikkumparaw l-effikaċja u s-sigurtà ta' 3 dożi ta' farmciclovir (125mg, 250mg, 500mg) ma' dawk ta' plaċebo għat-trattament akut ta' episodju rikorrenti ta' ħerpes ġenitali.
English: Study 008 was a randomised, double-blind, placebo-controlled study.
Maltese: Studju 008 kien studju li sar b'mod randomizzat, double-blind u kkontrollat bi plaċebo.
English: The section was also updated to reflect drug interactions due to aldehyde oxidase involvement.
Maltese: Is-sezzjoni ġiet ukoll aġġornata sabiex tirrifletti l-interazzjonijiet tal-mediċini minħabba l-involviment tal-aldehyde oxidase.
English: Herpes zoster in immunocompromised adults 500 mg three times daily for 10 days
Maltese: Herpes zoster f'adulti b'immunodefiċjenza 500 mg tliet darbiet kuljum għal 10 ijiem
English: Adjusted dose regimen
Maltese: Tfal u adoloxxenti
English: 500 mg once daily for 10 days 250 mg once daily for 10 days Haemodialysis patients 250 mg following each dialysis during 10 days
Maltese: 500 mg darba kuljum għal 10 ijiem 250 mg darba kuljum għal 10 ijiem Pazjenti bl-emodijaliżi 250 mg wara kull dijaliżi matul 10 ijiem
English: Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2.
Maltese: L-erpete ġenitali hija infezzjoni virali kkawżata mill-virus tal-herpes simplex tat-tip 1 jew 2.
English: Section 4.2: Posology and Method of Administration
Maltese: Sezzjoni 4.2: Pożoloġija u Metodu ta' Kif Jingħata
English: In the acute treatment of herpes zoster famciclovir 750mg tid resulted in a shorter time to full crusting than placebo, and both 750mg and 500mg tid resulted in shortened time to loss of vesicles and time to loss of ulcers.
Maltese: Fittrattament akut tal-ħerpes żoster, farmciclovir 750mg tid irriżulta fi żmien iqsar għall-formazzjoni ta' qoxra sħiħa miż-żmien meħud mill-plaċebo, u s-750mg u l-500mg tid it-tnejn irriżultaw fi żmien imqassar għat-tneħħija ta' nuffati u ta' żmien għat-tneħħija tal-ulċeri.
English: Famvir and associated names (see Annex I) 125 mg film-coated tablets Famvir and associated names (see Annex I) 250 mg film-coated tablets Famvir and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Famvir u ismijiet assoċjati (Ara Anness I) tal-125 mg pilloli miksija b'rita Famvir u ismijiet assoċjati (Ara Anness I) tal-250 mg pilloli miksija b'rita Famvir u ismijiet assoċjati (Ara Anness I) tal-500 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: 500 mg three times daily for 10 days
Maltese: 500 mg tliet darbiet kuljum għal 10 ijiem
English: The approved daily dose regimen for either episodic or suppressive therapy of recurrent genital herpes in HIV-infected patients is 500mg bid.
Maltese: Il-kors tad-doża ta' kuljum approvata għat-terapija episodika jew suppressiva tal-ħerpres ġenitali rikorrenti fil-pazjenti infettati bl-HIV huwa ta' 500mg bid.
English: For the primary efficacy parameter, confidence intervals for the difference in proportions (famciclovir minus aciclovir) were used to assess treatment effects.
Maltese: Għall-parametru primarju ta' effikaċja, intużaw intervalli ta' fiduċja għad-differenza fil-proporzjonijiet (farmciclovir mingħajr aciclovir) biex jiġu vvalutati l-effetti tattrattament.
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.
Maltese: Sommarju tal-istudji kkumbinati 102 u 195 juri l-benefiċċji ta' farmciclovir fit-trażżin tar-rikorrenza tal-HSV fil-pazjenti immunokompetenti għall-pazjenti infettati bl-HIV.
English: Novartis Pharma GmbH Brunner Strasse 59 1235 Wien
Maltese: L-Awstrija Novartis Pharma GmbH Brunner Strasse 59
English: 250 mg twice daily for 5 days 250 mg once daily for 5 days Haemodialysis patients 250 mg following each dialysis during 5 days
Maltese: 250 mg darbtejn kuljum għal 5 ijiem 250 mg darba kuljum għal 5 ijiem Pazjenti bl-emodijaliżi 250 mg wara kull dijalizi matul 5 ijiem
English: Other
Maltese: MEMBRI
English: The CHMP agreed that patients treated with 500mg tid co-administered with probenecid should be monitored for toxicity.
Maltese: Is-CHMP qabel li l-pazjenti ttrattati b'500mg tid koamministrata ma' probenecid għandha tiġi mmonitorata għat-tossiċità.
English: Cholestatic jaundice.
Maltese: Suffejra kolestatika.
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.
Maltese: • Probenecid (użat sabiex tikkura l-livelli għoljin ta' uric acid fid-demm assoċjati mal-gotta u biex iżżid il-livelli ta' antibijotici tat-tip ta' penicillin fid-demm), jew kwalunkwe mediċina oħra li tista' taffettwalek il-kliewi.
English: Study 007 was a randomised, double-blind, double-dummy, active-controlled study.
Maltese: Studju 007 kien studju li sar b'mod randomizzat, double-blind, b'dummy doppju u kkontrollat b'mod attiv.
English: Study 083 was presented to show efficacy in immunocompromised patients with herpes simplex virus infections.
Maltese: Studju 083 kien ippreżentat sabiex juri l-effikaċja fil-pazjenti immunokompromessi bl-infezzjonijiet tal-virus tal-ħerpes simplex.
English: Dizziness, somnolence.
Maltese: Nawżea, rimettar.
English: Study 102 was a randomised, double-blind, placebo-controlled, crossover study to assess the safety and efficacy of oral famciclovir in the suppression of symptomatic and asymptomatic recurrent genital herpes in HIV-infected patients.
Maltese: Studju 102 kien studju intersezzjonali li sar b'mod każwali, double blind u kkontrollat mill-plaċebo sabiex jivvaluta s-sigurtà u l-effikaċja ta' farmciclovir orali fis-soppressjoni tal-ħerpes ġenitali rikorrenti sintomatiku jew asintomatiku fil-pazjenti infettati bl-HIV.
English: Famvir and associated names (see Annex I) 125 mg film-coated tablets Famvir and associated names (see Annex I) 250 mg film-coated tablets Famvir and associated names (see Annex I) 500 mg film-coated tablets
Maltese: Famvir u ismijiet assoċjati (Ara Anness I) tal-125 mg pilloli miksija b'rita Famvir u ismijiet assoċjati (Ara Anness I) tal-250 mg pilloli miksija b'rita Famvir u ismijiet assoċjati (Ara Anness I) tal-500 mg pilloli miksija b'rita
English: − the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section
Maltese: − kura ta' herpes zoster u zoster oftalmiku f'adulti immunokompetenti (ara sezzjoni 4.4)
English: Suppressive therapy should be discontinued after a maximum of 12 months of continuous antiviral therapy to reassess recurrence frequency and severity.
Maltese: Il-kura għandha titwaqqaf wara massimu ta' 12-il xahar ta' kura antivirali kontinwa sabiex tiġi evalwata mill-ġdid il-frekwenza u s-severità.
English: Study 086 was a randomised, double-blind, double-dummy, active-controlled multicentre study.
Maltese: Studju 086 kien studju b'aktar minn ċentru wieħed li sar b'mod randomizzat, double-blind, b'dummy doppju u kkontrollat b'mod attiv.
English: Moreover, famciclovir 500 mg bid was found in clinical trials to be effective, safe and well tolerated in this group of patients.
Maltese: Barra minn hekk, farmciclovir ta' 500mg bid instab, fi provi kliniċi, li kien effettiv, sigur u ttollerat sew f'dan il-grupp ta' pazjenti.
English: 500 mg once daily for 7 days 250 mg once daily for 7 days Haemodialysis patients 250 mg following each dialysis during 7 days
Maltese: 500 mg darba kuljum għal 7 ijiem 250 mg darba kuljum għal 7 ijiem Pazjenti bl-emodijaliżi 250 mg wara kull dijaliżi matul 7 ijiem
English: Subjects with hepatic impairment
Maltese: Disturbi gastro-intestinali
English: Based on the available data, the CHMP agreed that the indication treatment of herpes zoster in immunocompetent and immunocompromised patients was recommended.
Maltese: Abbażi tad-dejta disponibbli, is-CHMP qabel li t-trattament ta' indikazzjoni għall-ħerpes żoster filpazjenti immunokompetenti u immunokompromessi jkun rakkomandat.
English: 125 mg twice daily for 5 days
Maltese: 125 mg darbtejn kuljum għal 5 ijiem
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.
Maltese: Il-parametri sekondarji ta' effikaċja ewlenin kienu n-numru (%) ta' jiem ta' tixrid virali minn kwalunkwe sit u n-numru (%) ta' jiem ta' tixrid virali speċifiku għas-sit matul kull perijodu ta' trattament.
English: Mild and moderate hepatic impairment had no effect on the extent of systemic availability of penciclovir following oral administration of famciclovir.
Maltese: Indeboliment epatiku ħafif għal moderat ma kellu l-ebda effett fuq il-firxa tad-disponibbiltà sistemika tal-penciclovir wara li l-famciclovir ingħata oralment.
English: − the treatment of first and recurrent episodes of genital herpes in immunocompetent adults
Maltese: − it-trattament tal-ewwel episodju u ta' episodji rikorrenti ta' ħerpes ġenitali fl-adulti immunokompetenti
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.
Maltese: Il-konverżjoni in vivo tal-farmciclovir għal penciclovir tinvolvi żewġ stadji: iddeaċetilazzjoni tal-farmciclovir għal 6-deoxy penciclovir u l-ossidazzjoni ta' 6-deoxy penciclovir għal penciclovir.
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.
Maltese: Għalkemm l-istudju pivotali għal dan il-grupp/indikazzjoni (083) ippreżenta xi nuqqasijiet, li meħudin flimkien jipprekludu konklużjoni affidabbli dwar in-nuqqas ta' inferjorità tal-kors ta' 500mg ta' farmciclovir bid fir-rigward ta' aciclovir 5 x 400mg, ġie rrikonoxxut li dan il-kors huwa approvat għall-biċċa l-kbira tal-SM tal-UE.
English: * Never reported in clinical trials; category is based on the “rule of three”
Maltese: *Qatt ma ġie rrapurtat fi provi kliniċi, il-kategorija hija bbażata fuq ir-“regola ta' tlieta”
English: Impaired fertility (including histopathological changes in the testis, altered sperm morphology, reduced sperm concentration and motility, and reduced fertility) was observed in male rats given 500 mg/kg/day.
Maltese: Kien osservat li l-firien li ngħataw 500 mg/kg/jum kellhom problemi ta' fertilità (inklużi tibdil istopatoloġiċi, tibdil fit-testis, morfoloġija alterata tal-isperma, konċentrazzjoni mnaqqsa tal-isperma u motilità, u fertilità imnaqqsa.
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).
Maltese: Għalhekk is-CHMP approva r-restrizzjoni tal-ħerpres ġenitali rikorrenti fil-pazjenti infettati bl-HIV li jirrifletti r-riżultat tal-istudju kliniku rispettiv (083).
English: Two placebo-controlled studies in immunocompetent patients and one-active controlled study in HIV-infected patients with recurrent genital herpes showed that famciclovir was effective.
Maltese: Żewġ studji kkontrollati bil-plaċebo f'pazjenti immunokompetenti u studju wieħed attivament ikkontrollat f'pazjenti infettati bl-HIV b'erpete ġenitali ripetuta wera li famciclovir kien effettiv.
English: In uninfected cells treated with penciclovir, concentrations of penciclovir-triphosphate are only barely detectable.
Maltese: F'ċelloli mhux infettati kkurati bil-penciclovir, ilkonċentrazzjonijiet tal-penciclovir-trifosfat bilkemm jidhru.
English: Penciclovir is dialysable; plasma concentrations are reduced by approximately 75% following 4 h haemodialysis.
Maltese: Il-penciclovir huwa dijalisibbli; ilkonċentrazzjonijiet tal-plażma jitnaqqsu b'madwar 75% wara erba' sigħat dijalisi tad-demm.
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).
Maltese: - Shingles (herpes zoster), li hija infezzjoni kkawżata minn virus imsejjaħ variċella zoster (listess virus li jikkawża l-ġidri r-riħ).
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.
Maltese: Studji kkontrollati bil-plaċebo u studji mhux ikkontrollati li damu sa 16 -il ġimgħa wrew li famciclovir kien effettiv fit-trażżin ta' erpete ġenitali ripetuta f'pazjenti infettati bl-HIV; l-istudju kkontrollat bil-plaċebo wera li famciclovir naqqas b'mod sinnifikanti lproporzjoni ta' ġranet ta' tneħħija tal-HSV kemm dik sintomatika kif ukoll dik mhux sintomatika.
English: On this endpoint the 250mg bid dose was superior to the 125mg bid dose.
Maltese: F'dan il-punt tat-tmiem, id-doża ta' 250mg bid kienet superjuri għad-doża ta' 125mg bid.
English: The doses selected for episodic treatment and suppression of recurrent genital herpes in the immunocompetent patient were determined in replicate, multiple-dose, placebo-controlled trials.
Maltese: Id-dożi magħżulin għat-trattament episodiku u s-suppressjoni tal-ħerpes ġenitali rikorrenti fil-pazjent immunokompetenti ġew stabbiliti fi provi ta' replika, b'dożi multipli u kkontrollati mill-plaċebo.
English: When raloxifen is coadministered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.
Maltese: Meta raloxifen jingħata flimkien ma' famciclovir, l-effikaċja klinika tal-kura antivirali għandha tiġi ssorveljata.
English: Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir.
Maltese: Ilkonverżjoni ta' famciclovir għall-metabolit attiv penciclovir jista' jkun indebbolit f'dawn il-pazjenti li jirriżulta f'konċentrazzjonijiet imnaqqsa tal-plażma fil-penciclovir, u b'hekk jista' jkun hemm possibilment tnaqqis fl-effikaċja ta' famciclovir.
English: The CHMP agreed that famciclovir resulted in a significant reduction in time to resolution of cutaneous signs of herpes zoster.
Maltese: Il-kura għandha tingħata kemm jista' jkun malajr wara dijanjozi tal-herpes zoster.
English: Like aciclovir, the most common form of resistance encountered among HSV strains is a deficiency in the production of the thymidine kinase (TK) enzyme.
Maltese: Bħal aciclovor l-aktar forma komuni ta' reżistenza li kien hemm fost ir-razez bil-virus tal-herpes simplex (HSV) hija d-defiċjenza fil-produzzjoni tal-enzima tat-timidina kinasa (TK).
English: Genital herpes in immunocompetent adults
Maltese: IMMUNOKOMPETENTI
English: Gender
Maltese: Sessi
English: All doses of famciclovir were well tolerated with no differences in either the nature or frequency of adverse events among the different doses of famciclovir.
Maltese: Id-dożi kollha ta' farmciclovir kienu ttollerati tajjeb mingħajr differenza la fin-natura u lanqas fil-frekwenza tal-avvenimenti avversi fost id-dożi differenti ta' farmciclovir.
English: The CHMP acknowledged that no comparative study with aciclovir was conducted.
Maltese: Is-CHMP irrikonoxxa li ma twettaqxstudju komparattiv b'aciclovir.
English: The proportion of patients with severe ocular manifestations was also similar in both treatment groups.
Maltese: Il-proporzjon ta' pazjenti b'manifestazzjonijiet okulari serji kien ukoll simili fiż-żewġ gruppi ta' trattament.
English: Studies 004, 011, and 040 were randomised, multicentre studies.
Maltese: Studji 004, 011, u 040 kienu studji b'aktar minn ċentru wieħed li saru b'mod każwali.
English: A dose ranging study (024) found that both 125mg and 250mg bid regimens were significantly better than placebo.
Maltese: Studju ta' firxa tad-doża (024) sab li kemm korsijiet ta' 125mg kif ukoll ta' 250mg bid kienu ferm aħjar mill-plaċebo.
English: EPISODIC TREATMENT OF RECURRENT HERPES AND SUPPRESSION OF RECURRENT HERPESNo inconsistencies were observed with regards to episodic treatment across MSs therefore 125mg twice bid for five days was considered as the acceptable posology for this indication.
Maltese: Ma ġewx osservati inkonsistenzi rigward it-trattament episodiku bejn l-SM, għalhekk 125mg doppja bid għal ħamest ijiem ġiet kkunsidrata bħala l-pożoloġija aċċettabbli għal din l-indikazzjoni.
English: The CHMP thus endorsed the 500mg bid for seven days as the approved posology in this indication.
Maltese: Is-CHMP għalhekk approva l-500mg bid għal sebat ijiem bħala l-pożoloġija approvata għal din l-indikazzjoni.
English: Famvir (famciclovir) was included in the list of products for SPC harmonisation and a referral was triggered in order to resolve divergences and harmonise the nationally authorised SPCs across Europe.
Maltese: Famvir (farmciclovir) ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tal-SPC u ngħata bidu għal referenza sabiex jiġu solvuti d-diverġenzi u jiġu armonizzati l-SPCs awtorizzati fuq livell nazzjonali madwar l-Ewropa.
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.
Maltese: Pazjenti b'herpes zoster ikkumplikata, jiġifieri dawk b'involviment tal-vixxri, b'zoster li tinxtered, b'newropatiji motoriċi, b'enċefalite u kumplikazzjonijiet ċerebrovaskulari għandhom jingħataw kura antivirali minn ġol-vini.
English: IMMUNOCOMPROMISED ADULTS EPISODIC TREATMENT OF RECURRENT HERPES
Maltese: TRATTAMENT EPISODIKU TAL-ĦERPES RIKORRENTI
English: Within the EEA, the 750mg tablet strength is currently approved only in Ireland, UK and Spain.
Maltese: Fi ħdan iż-ŻEE, il-pillola b'qawwa ta' 750mg hija attwalment approvata biss fl-Irlanda, fir-Renju Unit u fi Spanja.
English: Very common side effects - Headache
Maltese: Effetti sekondarji komuni ħafna - Uġigħ ta' ras
English: Creatinine clearance [ml/min]
Maltese: .2 Inkompatibilitajiet [Biex timtela mill-pajjiż partikolari]
English: The CHMP agreed that the active treatments lead to a reduction in the rate of complications of ophthalmic zoster; the extent of which however remains disputable.
Maltese: Is-CHMP qabel li t-trattamenti attivi jwasslu għal tnaqqis fir-rata tal-kumplikazzjonijiet taż-żoster oftalmiku; madankollu l-limitu tiegħu jibqa' diskutibbli.
English: 500 mg twice daily
Maltese: 500 mg darba kuljum250 mg darba kuljum
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of famciclovir in pregnant women.
Maltese: Hemm ammont limitat ta' data (anqas minn 300 riżultat ta' tqala) mill-użu ta' famciclovir f'nisa tqal.
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.
Maltese: Il-parteċipanti ġew assenjati b'mod fortuwitu sabiex jirċievu jew farmciclovir 500mg jew il-plaċebo bid għal 8 ġimgħat, segwiti minn perijodu ta' wash-out ta' 7 ijiem u wara minn tieni perijodu ta' 8 ġimgħat li matulu l-pazjenti kellhom il-kors mhux esperjenzat matul l-ewwel perijodu.
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.
Maltese: Għall-grupp ta' doża ta' farmciclovir ta' 125mg deher li kien hemm tnaqqis fl-effikaċja ta' xi punti tat-tmiem meta kkumparati mal-gruppi ta' doża ogħla li kien konsistenti bejn iż-żewġ provi.
English: Famciclovir is the oral prodrug of the antiviral nucleoside analogue penciclovir, which has activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV).
Maltese: L-iskop tar-referenza inkluda l-qawwiet kollha (125mg, 250mg, 500mg u 750mg) u l-liċenzji kollha. Farmciclovir hija l-prodroga orali ta' penciclovir analogu tan-nukleosid antivirali, li għandu attività kontra l-virus tal-ħerpes simplex tat-tip 1 (HSV-1) u 2 (HSV-2) u l-virus tal-variċellażoster (VZV).
English: No consistent changes were observed in several sperm parameters following long-term treatment with 250mg famciclovir bid.
Maltese: Ma ġewx osservati bidliet konsistenti f'diversi parametri tal-isperma wara trattament fuq medda twila ta' żmien b'250mg ta' farmciclovir bid.
English: Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, the active metabolite of famciclovir, by competing for elimination.
Maltese: L-użu tiegħu flimkien mal-probenecid jista' jwassal għal żieda fil-konċentrazzjonijiet ta' penciclovir fil-plażma ,l-metabolit attiv tal-famciclovir, billi jikkompetu għall-eliminazzjoni.
English: Transmission of genital herpes
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: Subjects with renal impairment
Maltese: DATA TA' META ĠIET IRRIVEDUTA
English: No dose adjustment is recommended for patients with mild and moderate hepatic impairment (see sections 4.2 and 4.4).
Maltese: Mhuwiex irrakkomandat li jsir tibdil fid-doża għal pazjenti b'insuffiċjenza epatika ħafifa jew moderata (ara sezzjonijiet 4.2 u 4.4).
English: OPHTHALMIC ZOSTER IN IMMUNOCOMPETENT ADULTS
Maltese: ŻOSTER OFTALMIKU FL-ADULTI
English: Suppression of recurrent genital herpes in immunocompromised adults 500 mg twice daily.
Maltese: Trażżin ta' erpete ġenitali ripetuta f'adulti b'immunodefiċjenza 500 mg darbtejn kuljum
English: Famvir is indicated for episodic treatment of recurrent herpes simplex infections in the HIV-infected patient where the recommended dose regimen is 500 mg twice daily for seven days.
Maltese: Famvir huwa indikat għat-trattament episodiku tal-infezzjonijiet rikorrenti tal-ħerpes simplex f'pazjenti infettati bl-HIV fejn il-kors tad-doża rrakkomandat huwa ta' 500mg darbtejn kuljum għal sebat ijiem.
English: The suggested dose of 500 mg tid famciclovir for 7 days could be endorsed.
Maltese: Id-doża ssuġġerita ta' 500mg tid ta' farmciclovir għal 7 ijiem tista' tiġi awtorizzata.
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).
Maltese: • Tbenġil mhux spjegat, irqajja' ħomor jew ħomor jagħtu fil-vjola fuq il-ġilda jew tinfaġar (dawn jistgħu jkunu sinjali ta' tnaqqis fl-għadd ta' plejtlits fid-demm, għall-frekwenza ara hawn taħt).
English: If patients experience severe dizziness, somnolence, confusion or other central nervous system disturbances, a dose reduction of famciclovir to 250 mg three times daily may be considered.
Maltese: Jekk il-pazjenti jkollhom sturdament qawwi, ħedla ta' ngħas, konfużjoni jew disturbi oħrajn fis-sistema nervuża ċentrali, jista' jiġi kkunsidrat tnaqqis fid-doża ta' famciclovir għal 250 mg tliet darbiet kuljum.