FrancophonIA/ELRC3.0 huggingface dataset:
English: A double blind, placebo controlled study was conducted in 1,484 heterosexual, immunocompetent adult couples discordant for HSV-2 infection.
Maltese: Studju double blind, ikkontrollat bi plaċebo sar f'1,484 koppja adulta eterosesswali immunokompetenti fejn persuna waħda biss mill-koppja kellha infezzjoni b'HSV-2.
English: Valtrex belongs to a group of medicines called antivirals.
Maltese: Valtrex jagħmel parti minn grupp ta' mediċini msejħa antivirali.
English: Cytomegalovirus (CMV) infections:
Maltese: Infezzjonijiet b'cytomegalovirus (CMV):
English: Pharmacokinetic variability (% CV) in Cmax and AUC are expected to be similar for different doses and degrees of renal impairment.
Maltese: Il-varjabilità farmakokinetika (% CV) fis-Cmax u l-AUC huma mistennija li jkunu simili għal dożi u gradi differenti ta' indeboliment renali.
English: Exposure to aciclovir and its metabolites CMMG and 8-OH-ACV in plasma and cerebrospinal fluid (CSF) was evaluated at steady-state after multiple-dose valaciclovir administration in 6 subjects with normal renal function (mean creatinine clearance 111 mL/min, range 91-144 mL/min) receiving 2000 mg every 6 hours and 3 subjects with severe renal impairment (mean CLcr 26 mL/min, range 17-31 mL/min) receiving 1500 mg every 12 hours.
Maltese: Esponiment għal aciclovir u l-metaboliti tiegħu CMMG u 8-OH-ACV fil-plażma u fil-fluwidu ċerebrospinali (CSF) kien stmat fl-istat fiss wara għoti ta' dożi multipli ta' valaciclovir f'6 individwi b'funzjoni normali tal-kliewi (medja tat-tneħħija tal-krejatinina 111 mL/min, medda 91-144 mL/min) li kienu qed jirċievu 2000 mg kull 6 sigħat u 3 individwi b'indeboliment qawwi tal-kliewi (medja ta'
English: Reversible increases in liver function tests (e.g. bilirubin, liver enzymes).
Maltese: Żidiet riversibbli f'testijiet tal-funzjoni tal-fwied (eż. bilirubin, enzimi tal-fwied).
English: The CHMP recommended a cut-off at 10 ml/min in this case (resulting in an estimated exposure of 39-63 at <10 ml/min and 43-77 at CLcr 10-30 ml/min).
Maltese: Is-CHMP irrakkomanda cut-off ta' 10 ml/min f'dan il-każ (li jirriżulta f'espożizzjoni stmata ta' 39-63 f'<10 ml/min u 43-77 fi CLcr 10-30 ml/min).
English: A-1140 Wien Austria
Maltese: A-1140
English: Clinical Trial Data Nervous system disorders Very common:
Maltese: Dejta minn Provi Kliniċi Disturbi fis-sistema nervuża Komuni ħafna:
English: United Kingdom The Wellcome Foundation Ltd Glaxo Wellcome House
Maltese: Ir-Renju Unit The Wellcome Foundation Ltd Glaxo Wellcome House
English: Other rare side effects: • kidney problems where you pass little or no urine.
Maltese: Effetti sekondarji rari oħra: • problemi fil-kliewi fejn inti tgħaddi ftit li xejn jew ma tgħaddix awrina.
English: The dose is reduced by 50% already at CLcrea 30-49 ml/min, while for varicella-zoster infections, which have a normal dose in about the same range as that proposed for herpes labialis, the dose is reduced by 33% at CLcrea 30-49 ml/min.
Maltese: Id-doża titnaqqas b'50% diġà fi CLcrea 30-49 ml/min, filwaqt li għal infezzjonijiet ta' varicella-zoster, li għandhom doża normali f'madwar listess firxa bħal dik proposta għal herpes labialis, id-doża titnaqqas bi 33% fi CLcrea 30-49 ml/min.
English: Aciclovir inhibits herpes virus DNA polymerase.
Maltese: Aciclovir jinibixxi l-polymerase tad-DNA tal-virus tal-herpes.
English: Valtrex is an oral tablet containing valaciclovir (VACV), the esterified prodrug of the antiherpetic compound Aciclovir (ACV).
Maltese: Valtrex hija pillola orali li fiha valaciclovir (VACV), il-promediċina esterifikata tal-kompost antierpetiku Aciclovir (ACV).
English: The CHMP concluded that the MAH has provided a comprehensive account for the frequency of resistance in immunocompetent and immunocompromised individuals across the clinical trials.
Maltese: Is-CHMP ikkonkluda li l-MAH ipprovda rendikont komprensiv għall-frekwenza tar-reżistenza f'individwi immunokompetenti u immunokompromessi fil-provi kliniċi.
English: Glaxo Wellcome Operations Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
Maltese: Glaxo Wellcome Operations Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Ir-Renju Unit
English: Varicella zoster virus (VZV) infections - herpes zoster and ophthalmic zoster
Maltese: Infezzjonijiet bil-virus tal-varicella zoster (VZV) - herpes zoster
English: HSV Suppression for Outbreak Reduction (recurrent episodes of genital herpes simples) The MAH in order to demonstrate efficacy in the suppression of genital herpes recurrences presented two Studies (123-026 and 123-037).
Maltese: L-MAH sabiex juri l-effikaċja fis-soppressjoni ta' rikorrenzi ta' herpes ġenitali ppreżenta żewġ Studji (123-026 u 123-037).
English: Indication 1 Varicella zoster virus (VZV) infections - herpes zoster The following indication was agreed: “Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults.
Maltese: Indikazzjoni 1 Infezzjonijiet tal-Varicella zoster virus (VZV) - herpes zoster L-indikazzjoni li ġejja ġiet miftiehma: “Valtrex huwa indikat għat-trattament ta' herpes zoster (ħruq ta' Sant'Antnin) u zoster oftalmiku fladulti immunokompetenti.
English: CSF penetration, determined by CSF/plasma AUC ratio, is independent of renal function and was about 25% for aciclovir and the metabolite 8-OH-ACV, and about 2.5% for the metabolite CMMG.
Maltese: Il-penetrazzjoni ġos-CSF, stabbilita mill-proporzjon ta' CSF/AUC fil-plażma, hija indipendenti mill-funzjoni tal-kliewi u kienet madwar 25% għal aciclovir u l-metabolit 8-OH-ACV, u madwar 2.5% għall-metabolit CMMG.
English: A switch from IV aciclovir to oral antiviral therapy (to complete a 10-14 day treatment course) is reasonable when formation of new cutaneous lesions has ceased and the signs and symptoms of visceral VZV infection are improving [CDC, 2009].
Maltese: Bidla minn aciclovir IV għal terapija antivirali orali (sabiex jitlesta kors ta' trattament ta' 10-14-il jum) huwa raġjonevoli meta l-formazzjoni ta' leżjonijiet tal-ġilda ġodda tkun waqfet u s-sinjali u sintomi ta' infezzjoni VZV vixxerali jkun qegħdin jitjiebu [CDC, 2009].
English: Valaciclovir pharmacokinetics is not dose-proportional.
Maltese: Il-farmakokinetika ta' valaciclovir mhijiex fi proporzjon mad-doża.
English: For higher doses (4000 mg or more per day), see section 4.4.
Maltese: Għal dożi ogħla (4000 mg jew aktar kuljum), ara sezzjoni 4.4.
English: Table 1: DOSAGE ADJUSTMENT FOR RENAL IMPAIRMENT Therapeutic Indication
Maltese: Tabella 1: AĠĠUSTAMENT FID-DOŻA GĦAL INDEBOLIMENT
English: This information is included in section 4.4 of the SPC.
Maltese: Din l-informazzjoni hija inkluża fis-sezzjoni 4.4 talSPC.
English: Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr
Maltese: Aciclovir huwa impeditur speċifiku tal-virusis tal-herpes b'attività in vitro kontra l-virusis tal-herpes simplex (HSV) tat-tip 1 u tat-tip 2, l-virus tal-varicella zoster (VZV), is-cytomegalovirus (CMV), ilVirus ta' Epstein-Barr (EBV), u l-virus tal-herpes 6 umana (HHV-6).
English: Psychiatric and nervous system disorders Common:
Maltese: Disturbi psikjatriċi u fis-sistema nervuża Komuni:
English: This applies to concomitant administration with aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, and tacrolimus.
Maltese: Dan japplika għal għoti konkomitanti ma' aminoglycosides, sustanzi organoplatinum, sustanzi ta' kuntrast li fihom l-iodine, methotrexate, pentamidine, foscarnet, ciclosporin, u tacrolimus.
English: Vomiting, diarrhoea.
Maltese: Rimettar, dijarea
English: Valtrex Tablets 500 mg are supplied in cartons containing 10, 30, 42, 90 or 112 film-coated tablets.
Maltese: Il-Pilloli Valtrex 500 mg huma fornuti f'kaxxi tal-kartun li fihom 10, 30, 42, 90 jew 112-il pillola miksijin b'rita.
English: Among subjects participating in a viral shedding sub-study, valaciclovir significantly reduced shedding by 73 % compared to placebo (see section 4.4 for additional information on transmission reduction).
Maltese: Fost individwi li ħadu sehem f'sotto studju dwar it-tixrid tal-virus, valaciclovir naqqas it-tixrid b'mod sinifikanti b'73 % meta tqabbel ma' plaċebo (ara sezzjoni 4.4 għal aktar informazzjoni dwar it-tnaqqis ta' tixrid).
English: The safety profile of prophylactic IV treatment with ganciclovir and oral treatment with VACV were comparable and were both similar to that of the placebo group.
Maltese: Il-profil tas-sigurtà tat-trattament profilattiku IV bi ganciclovir u t-trattament orali bi VACV kienu komparabbli u kienu t-tnejn simili għal dak tal-grupp plaċebo.
English: Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4)
Maltese: Valtrex huwa indikat għall-profilassi ta' infezzjoni u mard b'CMV wara trapjant ta' organi solidi f'adulti u adoloxxenti (ara sezzjoni 4.4).
English: Valaciclovir is rapidly and almost completely converted to acyclovir and L-valine via intestinal and hepatic first-pass metabolism.
Maltese: Valaciclovir jiġi konvertit f'acyclovir u L-valine malajr u kważi kompletament permezz tal-metaboliżmu intestinali u epatiku first-pass.
English: Aciclovir is a potent and selective inhibitor of a number of herpes viruses, including the human pathogens herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).
Maltese: Aciclovir huwa inibitur qawwi u selettiv ta' numru ta' viruses tal-herpes, inkluż il-patoġeni talbniedem herpes simplex virus (HSV), varicella zoster virus (VZV), u cytomegalovirus (CMV).
English: The CHMP endorsed the following: “For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Maltese: Is-CHMP approva dan li ġej: “Għal herpes labialis (ħżiża), valaciclovir 2000 mg darbtejn kuljum għal jum wieħed huwa trattament effettiv fl-adulti u l-adolexxenti.
English: 250 mg tablets, 1000 mg tablets Two years
Maltese: Pilloli ta' 250 mg, pilloli ta' 1000 mg Sentejn
English: This conversion is probably mediated by an enzyme isolated from human liver referred to as valaciclovir hydrolase.
Maltese: Dan it-tibdil huwa wisq probabbli medjat minn enzima iżolata mill-fwied uman imsejħa valaciclovir hydrolase.
English: The MAH provided several key documents describing Study HS230027 and Study HS230028, and data analysis supporting short-course, high-dose therapy in immunocompetent adolescents and adults.
Maltese: L-MAH pprovda bosta dokumenti ewlenin li jiddeskrivu l-Istudju HS230027 u l-Istudju HS230028, u analiżi tad-dejta li tappoġġa terapija b'kors qasir u doża għolja fl-adolexxenti u l-adulti immunokompetenti.
English: Middlesex UB6 0NN United Kingdom
Maltese: Middlesex UB6 0NN
English: Symptoms and Signs
Maltese: Sinjali u Sintomi
English: For AEs identified from clinical trials, a frequency category was assigned based on the overall frequency observed in clinical trials.
Maltese: Għall-AA identifikati minn provi kliniċi, kategorija ta' frekwenza ġiet assenjata fuq il-bażi tal-frekwenza globali osservata fi provi kliniċi.
English: Animal studies do not show reproductive toxicity for valaciclovir (see section 5.3).
Maltese: Studji fl-annimali ma jurux tossiċità riproduttiva għal valaciclovir (ara sezzjoni 5.3).
English: Genital Herpes Suppression for Transmission Risk Reduction The MAH presented the Study HS2AB3009 to demonstrate the efficacy of valaciclovir suppressive therapy (500 mg once daily).
Maltese: L-MAH ippreżenta l-Istudju HS2AB3009 biex juri l-effikaċja tat-terapija soppressiva bi valaciclovir (500 mg darba kuljum).
English: Pharmacotherapeutic group: Nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB11.
Maltese: Nucleosides u nucleotides li ma jinkludux impedituri ta' reverse transcriptase, Kodiċi ATC:
English: • Treatment and suppression of recurrent ocular HSV infections (see section 4.4)
Maltese: • Kura u soppressjoni ta' infezzjonijiet rikorrenti fl-għajnejn b'HSV (ara sezzjoni 4.4)
English: • Do not use Valtrex after the expiry date which is stated on the carton.
Maltese: • Tużax Valtrex wara d-data ta' skadenza li tidher fuq il-kartuna.
English: Estimations of relationships between aciclovir pharmacokinetics and renal function are obtained from subjects in Studies P66-01, P66-02, P66-09 and P66-10 who received valaciclovir 1000mg doses.
Maltese: L-istimi tar-relazzjonijiet bejn il-farmakokinetiċi ta' aciclovir u l-funzjoni renali huma miksuba minn suġġetti fl-Istudji P66-01, P66-02, P66-09 u P66-10 li rċevew dożi ta' valaciclovir ta' 1000 mg.
English: The CHMP endorsed also contraindications regarding hypersensitivity to ACV, VACV or formulations of VACV.
Maltese: Is-CHMP approva wkoll kontraindikazzjonijiet rigward sensittività eċċessiva għal ACV, VACV jew formulazzjonijiet ta' VACV.
English: Cimetidine and probenecid taken together with valaciclovir increased aciclovir AUC by about 65%.
Maltese: Cimetidine u probenecid li ttieħdu flimkien ma' valaciclovir żiedu l-AUC ta' aciclovir b'madwar 65%.
English: Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form.
Maltese: Aciclovir jimpedixxi s-sintesi tad-DNA tal-virus tal-herpes ladarba jiġi fosforilat għal forma triphosphate attiva.
English: The MAH presented two studies in order to support the safety use of VACV (Study 123-016 and Study 123-039).
Maltese: L-MAH ippreżenta żewġ studji sabiex jappoġġa l-użu tas-sigurtà ta' VACV (Studju 123-016 u Studju 123-039).
English: The criteria varied among studies, but excluded subjects with either serum creatinine greater than the upper limit of normal (Scr > ULN), Scr > 1.5 mg/dL (~133 uM), or with creatinine clearance less than 35 mL/min.
Maltese: Il-kriterji varjaw fost l-istudji, iżda eskludu s-suġġetti jew bil-krejatinina fis-serum akbar mil-limitu massimu tan-normal (Scr > ULN), Scr > 1.5 mg/dL (~133 uM), jew bit-tneħħija ta' kreatinina ta' inqas minn 35 mL/min.
English: Neither valaciclovir nor aciclovir is metabolized by cytochrome P450 enzymes.
Maltese: La valaciclovir u lanqas aciclovir ma huma mmetabolizzati minn enzimi taċ-ċitokroma P450.
English: Specific documentation was submitted taking into account updated data.
Maltese: Dokumentazzjoni speċifika ġiet sottomessa li tikkunsidra d-dejta aġġornata.
English: In plasma as well as CSF, concentrations of aciclovir, CMMG and 8-OH-ACV were on average 2, 4 and 5-6 times higher, respectively, at severe renal impairment compared with normal renal function.
Maltese: Fil-plażma kif ukoll fis-CSF, konċentrazzjonijiet ta' aciclovir, CMMG u 8-OH-ACV kienu f'medja ta' 2, 4 u 5-6 drabi ogħla, rispettivament, f'indeboliment qawwi tal-kliewi meta mqabbel ma' funzjoni normali talkliewi.
English: 500 mg once daily b 250 mg once daily
Maltese: 500 mg darba kuljum b 250 mg darba kuljum
English: Following 1000 mg valaciclovir, cimetidine and probenecid reduce aciclovir renal clearance and increase the AUC of aciclovir by about 25% and 45%, respectively, by inhibition of the active renal secretion of aciclovir.
Maltese: Wara li jingħata 1000 mg valaciclovir, cimetidine u probenecid inaqqsu t-tneħħija ta' aciclovir mill-kliewi u jżidu l-AUC ta' aciclovir b'madwar 25% u 45%, rispettivament, permezz ta' inibizzjoni ta' sekrezzjoni attiva ta' aciclovir mill-kilwa.
English: The sample size of the clinical trial database is based on pooled data from valaciclovir pivotal studies for 4 different indications.
Maltese: Id-daqs tal-kampjun tad-database tal-provi kliniċi huwa bbażat fuq dejta miġbura minn studji pivotali bi valaciclovir għal 4 indikazzjonijiet differenti.
English: Each tablet contains 250 mg, 500 mg or 1000 mg of valaciclovir (as valaciclovir hydrochloride).
Maltese: Kull pillola fiha 250 mg, 500 mg jew 1000 mg ta' valaciclovir
English: Leucopenia, thrombocytopenia Leucopenia is mainly reported in immunocompromised patients.
Maltese: Lewkopenija hija l-biċċa l-kbira rrappurtata f'pazjenti immunokompromessi.
English: 1000 mg three times daily 1000 mg twice daily 1000 mg once daily 500 mg once daily
Maltese: 1000 mg tliet darbiet kuljum 1000 mg darbtejn kuljum 1000 mg darba kuljum 500 mg darba kuljum
English: Varicella Zoster Virus Infection
Maltese: Infezzjoni bil-Virus tal-Varicella Zoster
English: CMV prophylaxis with valaciclovir in subjects receiving solid organ transplantation (kidney, heart) reduces the occurrence of acute graft rejection, opportunistic infections and other herpes virus infections (HSV, VZV).
Maltese: Profilassi kontra CMV b'valaciclovir f'individwi li rċivew trapjanti ta' organi solidi (kilwa, qalb) tnaqqas il-frekwenza ta' rifjut akut tal-graft, ta' infezzjonijiet opportunistiċi u ta' infezzjonijiet oħra bil-virus tal-herpes (HSV, VZV).
English: There have been reports of renal insufficiency, microangiopathic haemolytic anaemia and thrombocytopenia (sometimes in combination) in severely immunocompromised adult patients, particularly those with advanced HIV disease, receiving high doses (8000 mg daily) of valaciclovir for prolonged periods in clinical trials.
Maltese: Kien hemm rapporti ta' insuffiċjenza tal-kliewi, anemija emolitika mikroanġjopatika u tromboċitopenija (xi kultant flimkien) f'pazjenti adulti immunokompromessi b'mod sever, l-aktar dawk bil-marda tal-HIV avvanzata, li jirċievu dożi għoljin (8000 mg kuljum) ta' valaciclovir għal perjodi twal fi provi kliniċi.
English: • slow, slurred speech (dysarthria)
Maltese: • uġigħ fil-fond tad-dahar (uġigħ tal-kliewi)
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression”.
Maltese: Valtrex huwa indikat għat-trattament ta' herpes zoster f'pazjenti adulti b'immunosoppressjoni ħafifa jew moderata”.
English: Immunocompetent Adults and Adolescents (≥12 years) The dose is 500 mg of Valtrex to be taken twice daily (1000 mg total daily dose).
Maltese: Adulti u Adoloxxenti Immunokompetenti (≥12-il sena) Id-doża hija 500 mg ta' Valtrex li għandha tittieħed darbejn kuljum (doża totali ta' 1000 mg kuljum).
English: Section 4.6 Pregnancy
Maltese: Sezzjoni 4.6 Tqala
English: Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of valaciclovir.
Maltese: Insuffiċjenza akuta tal-kliewi u sintomi newroloġiċi, li jinkludu konfużjoni, alluċinazzjonijiet, aġitazzjoni, koxjenza mnaqqsa u koma, kienu rrappurtati f'pazjenti li kienu qed jirċievu dożi eċċessivi ta' valaciclovir.
English: Netherlands GlaxoSmithKline BV Huis ter Heideweg 62
Maltese: GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist, L-Olanda
English: 6.5 Nature and contents of container Polyvinyl chloride / aluminium foil blister packs.
Maltese: Pakketti ta' folji tal-polyvinyl chloride / fojl tal-aluminju.
English: Varicella zoster virus (VZV) infections - herpes zoster Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4).
Maltese: Valtrex huwa indikat għall-kura tal-herpes zoster (ħruq ta' Sant'Antnin) u zoster oftalmika f'adulti immunokompetenti (ara sezzjoni 4.4).
English: Nevertheless, given the relatively benign indication, a conservative approach might be appropriate to reduce the potential safety risk.
Maltese: Madankollu, minħabba l-indikazzjoni relattivament beninni, approċċ konservattiv jista' jkun xieraq biex jitnaqqas ir-riskju potenzjali ta' sikurezza.
English: The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford,
Maltese: Ir-Rumanija The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford,
English: Suppression of HSV infections - immunocompetent adults and adolescents
Maltese: Kura ta' infezzjonijiet b'HSV - adulti u adoloxxenti immunokompetenti
English: The included study reports have shown that no additional clinical benefit was found with 2-day vs. 1-day treatment (Spruance, 2003).
Maltese: Ir-rapporti tal-istudji inklużi wrew li l-ebda benefiċċju kliniku addizzjonali ma nsab b'trattament ta' jumejn kontra trattament ta' jum (Spruance, 2003).
English: Intravenous therapy generally is considered standard for zoster treatment in immunocompromised patients; however, limited data indicate a clinical benefit of valaciclovir in the treatment of VZV infection (herpes zoster) in certain immunocompromised patients, including those with solid organ cancer, HIV, autoimmune diseases, lymphoma, leukaemia and stem cell transplants.
Maltese: Terapija minn ġol-vini ġeneralment hija kkunsidrata standard għal kura ta' zoster f'pazjenti immunokompromessi; madankollu, dejta limitata tindika benefiċċju kliniku ta' valaciclovir fil-kura ta' infezzjoni bil-VZV (herpes zoster) f'ċerti pazjenti immunokompromessi, li jinkludu dawk b'kanċer ta' organu solidu, bl-HIV, b'mard awtoimmuni, b'limfoma, b'lewkimja u bi trapjanti tal-istem cells.
English: Luxembourg GlaxoSmithKline s.a.
Maltese: Il-Lussemburgu GlaxoSmithKline s.a.
English: Middlesex , UB6 0NN, United Kingdom
Maltese: Middlesex , UB6 0NN, Ir-Renju Unit
English: GlaxoSmithKline agreed with the European Medicines Agency to harmonise the CMC quality data (Module 3) during this Article 30 referral.
Maltese: GlaxoSmithKline qabel mal-Aġenzija Ewropea għall-Mediċini biex tiġi armonizzata d-dejta talkwalità CSC (Modulu 3) matul din ir-referenza tal-Artikolu 30.
English: The bioavailability of aciclovir from 1000 mg valaciclovir is 54%, and is not reduced by food.
Maltese: Il-bijodisponibiltà ta' aciclovir minn 1000 mg valaciclovir hija 54%, u ma tonqosx bl-ikel.
English: The results of Study 123-031 showed a significant difference in time to development of CMV antigenemia and similar delays of acute rejection and fewer opportunistic or other herpes infections in favour of VACV.
Maltese: Ir-riżultati tal-Istudju 123-031 wrew differenza sinifikanti fil-ħin għall-iżvilupp ta' antigenemia CMV u dewmien simili ta' rifjut akut u anqas infezzjonijiet opportunistiċi jew infezzjonijiet ta' herpes oħra favur VACV.
English: Varicella-Zoster Virus (VZV) Infections Treatment of herpes zoster (shingles) in immunocompetent and immunocompromised adults
Maltese: Kura ta' herpes zoster (ħruq ta' Sant'Antnin) f'adulti immunokompetenti u immunokompromessi
English: HSV resistance to aciclovir, the active metabolite of valaciclovir, as determined by plaque reduction assay has been determined to be less than 1% in immunocompetent subjects and approximately 5-6% in immunocompromised subjects.
Maltese: Ir-reżistenza ta' HSV għal aciclovir, l-metabolit attiv ta' valaciclovir, kif determinata mill-prova tattnaqqis tal-plakka ġiet iddeterminata li hija inqas minn 1% f'suġġetti immunokompetenti u madwar 56% f'suġġetti immunokompromessi.
English: For recurrent episodes, treatment should be for three to five days.
Maltese: Għal infezzjonijiet rikorrenti it-tul ta' żmien ta' kura normalment huwa minn 3-5 ijiem.
English: Czech Republic The Wellcome Foundation Ltd., Glaxo Wellcome House Berkeley Avenue
Maltese: The Wellcome Foundation Ltd., Glaxo Wellcome House Berkeley Avenue Greenford
English: 2007] recommends short course, high dose therapy for treatment of herpes labialis as an alternative to other approved regimens.
Maltese: [Gilbert. 2007] jirrakkomanda terapija b'kors qasir u doża għolja għattrattament ta' herpes labialis bħala alternattiva għal skedi oħra approvati.
English: Valtrex is indicated
Maltese: Valtrex huwa indikat
English: The French guidelines recommend valaciclovir 1000 mg 3 times daily (TID) with close follow-up [Yeni, 2008].
Maltese: Il-linji gwida Franċiż jirrakkomandaw valaciclovir 1000 mg 3 darbiet kuljum (TID) b'segwitu fil-qrib [Yeni, 2008].
English: Valaciclovir was significantly more effective than placebo in delaying the time to first genital herpes recurrence (Patel, 1997; Reitano, 1998).
Maltese: Valaciclovir kien ferm aktar effettiv minn plaċebo fid-dewmien tal-ħin għallewwel rikorrenza tal-herpes ġenitali (Patel, 1997;
English: 2000 mg four times daily
Maltese: 2000 mg erba' darbiet kuljum