FrancophonIA/ELRC3.0 huggingface dataset:
English: The first one was a pivotal trial (Study 123-012) in renal transplant patients and the second one was a smaller trial (Study 123-031) in adult heart transplant recipients.
Maltese: L-ewwel wieħed kien prova pivotali (Studju 123-012) f'pazjenti b'trapjant tal-kliewi u t-tieni wieħed kien prova iżgħar (Studju 123-031) fir-reċipjenti adulti ta' trapjant tal-qalb.
English: However, the modelled data presented indicated that the Cmax (suggested to be important for the short-term treatment of herpes labialis) and the AUC will still be sufficient in the group with CLcrea 30-49 ml/min.
Maltese: Madankollu, iddejta mfassla ppreżentata indikat li s-Cmax (ssuġġerit li huwa importanti għat-trattament fuq żmien qasir ta' herpes labialis) u l-AUC xorta sejrin ikunu biżżejjed fil-grupp bi CLcrea 30-49 ml/min.
English: The safety and efficacy of valaciclovir for the treatment of HSV in immunocompromised patients was evaluated in Study 123-008 but there are limited data available to demonstrate the efficacy and the optimal dosage of VACV for treating HSV in immunocompromised patients.
Maltese: Is-sigurtà u l-effikaċja ta' valaciclovir għat-trattament ta' HSV f'pazjenti immunokompromessi ġiet evalwata fl-Istudju 123-008 iżda hemm dejta limitata disponibbli biex turu l-effikaċja u d-dożaġġ ottimali ta' VACV għat-trattament ta
English: Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)
Maltese: Profilassi għal infezzjoni u mard b'cytomegalovirus (CMV) f'adulti u adoloxxenti (≥12-il sena)
English: How to store Valtrex
Maltese: Tiħux Valtrex
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, i.e. dawk b'involviment tal-vixxri, zoster mifrux, newropatiji motorji, enċefalite u kumplikazzjoijiet ċerebrovaskulari għandhom jiġu kkurati b'terapija antivirali minn ġol-vini.
English: The CHMP considered that only studies of limited size and unknown quality have been reported.
Maltese: Is-CHMP ikkunsidra li studji ta' daqs limitat u ta' kwalità mhux magħrufa biss ġew irrapportati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains valaciclovir hydrochloride equivalent to 250 mg valaciclovir Each tablet contains valaciclovir hydrochloride equivalent to 500 mg valaciclovir Each tablet contains valaciclovir hydrochloride equivalent to 1000 mg valaciclovir
Maltese: Kull pillola fiha valaciclovir hydrochloride ekwivalenti għal 250 mg valaciclovir Kull pillola fiha valaciclovir hydrochloride ekwivalenti għal 500 mg valaciclovir Kull pillola fiha valaciclovir hydrochloride ekwivalenti għal 1000 mg valaciclovir Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Herpes simplex virus (HSV) infections
Maltese: Infezzjonijiet bil-Virus tal-Herpes Simplex (HSV)
English: Immunocompetent Adults and Adolescents (≥12 years) The dose is 500 mg of Valtrex to be taken once daily.
Maltese: Adulti u Adoloxxenti Immunokompetenti (≥12-il sena) Id-doża hija 500 mg ta' Valtrex li għandha tittieħed darba kuljum.
English: Other uncommon side effects:
Maltese: Effetti sekondarji oħra mhux komuni:
English: A significant proportion of the congenital anomalies described in the articles were consistent with the known foetal adverse effects of intra-uterine infection with CMV.
Maltese: Proporzjon sinifikanti tal-anomaliji konġenitali deskritti flartikoli kienu konsistenti mal-effetti avvrsi tal-fetu magħrufa ta' infezzjoni intra-uterina b'CMV.
English: Treatment of herpes labialis (cold sores) in immunocompetent adults and adolescents (alternative 1-day regimen)
Maltese: Kura ta' herpes labialis (ponot qrib ixxofftejn wara riħ) f'adulti u adoloxxenti immunokompetenti (skeda alternattiva ta' jum wieħed)
English: • The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
Maltese: • Id-doża tas-soltu hija ta' 500 mg (pillola waħda ta' 500 mg jew żewġ pilloli ta' 250 mg) darbtejn kuljum.
English: In additional studies in rats, foetal abnormalities and maternal toxicity were observed at subcutaneous doses that produced plasma aciclovir levels of 100 micrograms/mL (>10-fold higher than 2000 mg single dose valaciclovir in humans with normal renal function).
Maltese: Fi studji addizzjonali fil-firien, anormalitajiet fil-fetu u tossiċità tal-omm kienu osservati f'dożi mogħtija taħt il-ġilda li pproduċew livelli ta' 100 mikrogramma/mL ta' aciclovir (>10 darbiet ogħla minn doża waħda ta' 2000 mg valaciclovir fil-bnedmin b'funzjoni normali tal-kliewi).
English: Use in ocular HSV infections
Maltese: Disturbi gastro-intestinali
English: 1000 mg tablets
Maltese: Pillola ta' 1000 mg
English: Pharmacokinetic data in adult patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dose adjustment; however, clinical experience is limited.
Maltese: Dejta farmakokinetika f'pazjenti adulti b'ċirrożi avanzata (funzjoni sintetika tal-fwied tkun indebolita u jkun hemm evidenza ta' mogħdija alternattiva sistemika flok dik portali) ma tindikax il-bżonn għal aġġustament fid-doża; madankollu, l-esperjenza klinika hija limitata.
English: Suppression of recurrences of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years)
Maltese: Kura ta' infezzjonijiet bil-virus tal-herpes simplex (HSV) f'adulti u adoloxxenti (≥12-il sena)
English: • you have kidney problems.
Maltese: • jekk inti għandek problemi bil-kliewi.
English: Rare (affects up to 1 in 1,000 people)
Maltese: Rari (jaffettwaw sa persuna waħda minn kull 1,000)
English: The CHMP discussed the wording for the following indications taking into account the Marketing Authorisation Holder (MAH) proposals, the current national SPCs and scientific knowledge: 1- Varicella zoster virus (VZV) infections - herpes zoster, 2- Herpes simplex virus (HSV) infections
Maltese: Is-CHMP iddiskuta l-kliem għad-indikazzjonijiet li ġejjin filwaqt li kkunsidra l-proposti tad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH), l-SPCs nazzjonali attwali u l-għarfien xjentifiku: 1- Infezzjonijiet tal-Varicella zoster virus (VZV)- herpes zoster, 2- Infezzjonijiet tal-Herpes simplex virus (HSV)
English: The dose in immunocompetent patients is 1000 mg three times daily for seven days (3000 mg total daily dose).
Maltese: Id-doża f'pazjenti immunokompetenti hija ta' 1000 mg tliet darbiet kuljum għal sebat ijiem (doża totali ta' 3000 mg kuljum).
English: The CHMP considered Herpes labialis covered by the indication “Treatment and suppression of HSV infections of the skin and mucous membranes”, and concluded that does not deserve to be specified in section 4.1 of the SPC although the short course dosage shall be mentioned in Section 4.2.
Maltese: Is-CHMP kkunsidra li Herpes labialis hija koperta bl-indikazzjoni “Trattament u soppressjoni ta' infezzjonijiet HSV tal-ġilda u l-membrani mukużi”, u kkonkluda li ma jixraqx li tkun speċifikata fisSezzjoni 4.1 tal-SPC għalkemm il-dożaġġ ta' kors qasir ser jiġi msemmi fis-Sezzjoni 4.2.
English: Monitoring of clinical HSV and VZV isolates from patients receiving aciclovir therapy or prophylaxis has revealed that virus with reduced sensitivity to aciclovir is extremely rare in the immunocompetent host and is found infrequently in severely immunocompromised individuals e.g. organ or bone marrow transplant recipients, patients receiving chemotherapy for malignant disease and people infected with the human immunodeficiency virus (HIV).
Maltese: Monitoraġġ ta' iżolati kliniċi tal-HSV u l-VZV minn pazjenti li kienu qed jirċievu terapija jew profilassi b'aciclovir uriet li virus b'sensittività mnaqqsa għal aciclovir huwa rari ħafna fil-pazjenti immunokompetenti u jinstab b'mod infrekwenti f'individwi immunokompromessi b'mod sever eż. f'pazjenti li rċivew trapjanti ta' organi jew tal-mudullun tal-għadam, pazjenti li qed jirċievu kimoterapija għal mard malinn u persuni infettati bil-virus tal-immunodefiċjenza umana (HIV).
English: Section 4.1 Therapeutic Indications
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi
English: - suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adults
Maltese: - soppressjoni tal-erpete ġenitali rikorrenti f'adulti u adolexxenti immunokompetenti u f'adulti immunokompromessi
English: In the case of HSV, VZV and EBV this enzyme is the viral thymidine kinase (TK), which is only present in virus-infected cells.
Maltese: Fil-każ tal-HSV, lVZV u l-EBV din l-enzima hija t-thymidine kinase (TK) virali, li hija preżenti biss f'ċelluli infettati bil-virus.
English: Data on the efficacy of valaciclovir from transplant patients (~200) at high risk of CMV disease (e.g. donor CMV-positive/recipient CMV negative or use of anti-thymocyte globulin induction therapy) indicate that valaciclovir should only be used in these patients when safety concerns preclude the use of valganciclovir or ganciclovir.
Maltese: Dejta dwar l-effikaċja ta' valaciclovir minn pazjenti li rċivew trapjanti (~200) u li kellhom riskju kbir ta' mard b'CMV (eż. donatur pożittiv għal CMV/reċipjent negattiv għal CMV jew użu ta' terapija ta' induzzjoni bi globulina anti-thymocyte) tindika li valaciclovir għandu jintuża biss f'dawn il-pazjenti meta tħassib dwar sigurtà ma jippermettix l-użu ta' valganciclovir jew ganciclovir.
English: However, the primary safety concerns with aciclovir pertain primarily to reversible acute effects on renal function due to the potential for crystallization in renal tubules.
Maltese: Madankollu, it-tħassib ta' sigurtà primarju b'aciclovir jirrigwardjaw primarjament l-effetti akuti riversibbli fuq il-funzjoni renali minħabba l-potenzjal għall-kristallizzazzjoni fit-tubi renali.
English: The CHMP agreed that for herpes labialis, valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Maltese: Is-CHMP qabel li għal herpes labialis, valaciclovir 2000 mg darbtejn kuljum għal jum wieħed huwa trattament effettiv fl-adulti u l-adolexxenti.
English: Peak plasma concentrations of unchanged valaciclovir are only about 4% of peak aciclovir levels, occur at a median time of 30 to 100 min post-dose, and are at or below the limit of quantification 3 h after dosing.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma ta' valaciclovir mhux mibdul huma biss madwar 4% tal-ogħla livelli ta' aciclovir, jseħħu f'ħin medjan minn 30 sa 100 min wara li tingħta d-doża, u huma fil-limiti jew anqas mill-limiti ta' kwantifikazzjoni 3 sigħat wara li tingħata d-doża.
English: Increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate motefil, an immunosuppressant agent used in transplant patients, have been shown when the drugs are co-administered.
Maltese: Intwerew żidiet fl-AUCs ta' aciclovir u tal-metabolit inattiv ta' mycophenolate mofetil, sustanza immunosoppressiva li tintuża f'pazjenti bi trapjanti, fil-plażma meta dawn il-mediċini ngħataw flimkien.
English: • prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old)
Maltese: • jilqa' kontra infezzjoni minn CMV wara trapjanti tal-organi (f'adulti u adoloxxenti li għandhom aktar minn 12-il sena)
English: 500 mg tablets
Maltese: Pilloli ta' 500 mg
English: Renal pain
Maltese: Ir-Renju Unit
English: The MAH stated that higher doses of valaciclovir usually are recommended for dosing in immunocompromised subjects relative to immunocompetent subjects for a common indication.
Maltese: L-MAH iddikjara li dożi ogħla ta' valaciclovir normalment huma rakkomandati għal dożaġġ f'suġġetti immunokompromessi b'mod relattiv ma' suġġetti immunokompetenti għal indikazzjoni komuni.
English: They are white and marked with “GX CF1” on one side.
Maltese: Huma ta' lewn abjad u mmarkati b'“GX CF1” fuq naħa waħda.
English: The CHMP noted that the suggested dose reductions for renal impairment at treatment of herpes labialis are somewhat different from that for other indications, since the dose is halved already at CLcrea 30-49 ml/min, despite the relatively low dose.
Maltese: Is-CHMP innota li t-tnaqqis tad-doża suġġerit għall-indeboliment renali fit-trattament ta' herpes labialis huma kemmxejn differenti minn dak ta' indikazzjonijiet oħra, peress li d-doża diġà tinqasam fin-nofs fi CLcrea 30-49 ml/min, minkejja d-doża relattivament baxxa.
English: Cytomegalovirus is a leading cause of virus-associated birth defects, including mental retardation and deafness and may cause severe and fatal diseases in immunocompromised individuals, particularly bone marrow transplant (BMT), solid organ transplantation recipients, and immunosuppressed patients as those with HIV.
Maltese: Cytomegalovirus huwa kaġun ewlieni ta' difetti tat-twelid assoċjati ma' virus, inklużi l-ritardazzjoni mentali u t-truxija u jista' jikkawża mard serju u fatali f'individwi immunokompromessi, partikolarment riċevituri tat-trapjant tal-mudullun (bone marrow transplant - BMT), u trapjenti ta' organi solidi, u pazjenti immunosopprimiti bħal dawk bl-HIV.
English: Accordingly, evaluation of valaciclovir dosage regimens for patients with renal impairment were primarily derived such that peak acyclovir concentrations (Cmax) would approximate those from 2000mg bid one-day dosing in subjects with CLcr from 50 to 120 mL/min.
Maltese: Għaldaqstant, l-evalwazzjoni tal-iskedi ta' dożaġġ ta' valaciclovir għal pazjenti b'indeboliment renali kienu primarjament derivati b'tali mod li l-konċentrazzjonijiet tal-quċċata ta' acyclovir (Cmax) kienu jkunu madwar dawk tal-proposta ta' doża ta' jum ta' 2000mg f'suġġetti bi CLcr minn 50 sa 120 mL/min.
English: The clinical trial safety database is based on 5855 subjects exposed to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster, treatment/suppression of genital herpes & treatment of cold sores).
Maltese: Id-database ta' sigurtà minn provi kliniċi hija bbażata fuq 5855 individwu esposti għal valaciclovir fi provi kliniċi għal indikazzjonijiet multipli (kura ta' herpes zoster, kura/soppressjoni ta' erpete ġenitali u kura ta' ponot qrib ix-xofftejn wara riħ)
English: 250 mg tablet
Maltese: Pillola ta' 250 mg
English: Valtrex and associated names (see Annex 1) 250 mg film-coated tablets Valtrex and associated names (see Annex 1) 500 mg film-coated tablets Valtrex and associated names (see Annex 1) 1000 mg film-coated tablets [See Annex I - To be completed nationally] Valaciclovir
Maltese: Valtrex u ismijiet assoċjati (ara Anness 1) pilloli ta' 250 mg miksijin b'rita Valtrex u ismijiet assoċjati (ara Anness 1) pilloli ta' 500 mg miksijin b'rita Valtrex u ismijiet assoċjati (ara Anness 1) pilloli ta' 1000 mg miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Valaciclovir
English: Some Member States have an additional contraindication for virus resistant to aciclovir.
Maltese: Xi Stati Membri għandhom kontraindikazzjoni addizzjonali għal virus reżistenti għall aciclovir.
English: • The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
Maltese: • Id-doża tas-soltu hija 1000 mg (pillola waħda ta' 1000 mg kew żewġ pilloli ta' 500 mg) tliet darbiet kuljum.
English: Belgium GlaxoSmithKline s.a.
Maltese: GlaxoSmithKline s.a.
English: A limited amount of data on the use of valaciclovir and a moderate amount of data on the use of aciclovir in pregnancy is available from pregnancy registries (which have documented the pregnancy outcomes in women exposed to valaciclovir or to oral or intravenous aciclovir (the active metabolite of valaciclovir); 111 and 1246 outcomes (29 and 756 exposed during the first trimester of pregnancy, respectively) and postmarketing experience indicate no malformative or foeto/neonatal toxicity.
Maltese: Ammont limitat ta' dejta dwar l-użu ta' valaciclovir u ammont moderat ta' dejta dwar l-użu ta' aciclovir fit-tqala huwa disponibbli minn reġistri tat-tqala (li ddokumentaw ir-riżultati ta' tqaliet f'nisa esposti għal valaciclovir jew għal aciclovir (il-metabolit attiv ta' valaciclovir) mill-ħalq jew minn ġolvini; 111 u 1246 riżultat (29 u 756 minnhom esposti fl-ewwel trimestru tat-tqala rispettivament) u esperjenza ta' wara t-tqegħid fis-suq ma jindikaw l-ebda tossiċità ta' malformazzjoni jew tossiċita għal fetu jew għat-tarbija tat-twelid.
English: The MAH gained approval in some Member States for the use of valaciclovir at a higher dose and shorter course (2g twice daily for one day) for the treatment of herpes labialis (Clinical practice recommendation of the International Herpes management Forum (IHMF) [Gilbert, 2007]).
Maltese: L-MAH kiseb approvazzjoni f'ċerti Stati Membri għall-użu ta valaciclovir f'doża ogħla u kors iqsar (2g darbtejn kuljum għal jum wieħed) għat-trattament ta' herpes labialis (Rakkomandazzjoni talprattika klinika tal-Forum Internazzjonali tal-Ġestjoni tal-Herpes (IHMF)
English: • tremors
Maltese: • rimettar
English: Studies 123-007 and HS230018 were conducted to evaluate the safety and efficacy of valaciclovir in the suppression of recurrent ano-genital HSV episodes in HIV-infected subjects (Conant, 2002).
Maltese: Is-Soppressjoni ta' HSV f'Pazjenti infettati bl-HIV L-Istudji 123-007 u HS230018 twettqu biex jevalwaw is-sigurtà u l-effikaċja ta' valaciclovir fissoppressjoni ta' episodji rikorrenti ta' HSV ano-ġenitali f'suġġetti infettati bl-HIV (Conant, 2002).
English: NAME OF THE MEDICINAL PRODUCT Valtrex and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Valaciclovir STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains valaciclovir hydrochloride equivalent to 250 mg valaciclovir.
Maltese: Valtrex u ismijiet assoċjati (ara Anness I) 250 mg pilloli miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Valaciclovir DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha valaciclovir hydrochloride ekwivalenti għal 250 mg valaciclovir.
English: Valtrex can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.
Maltese: Valtrex jista' jilqa' kontra l-iżvilupp ta' ġrieħi meta jittieħed mal-ewwel sinjali u sintomi ta' rikorrenza ta' HSV.
English: Middlesex UB6 0NN, United Kingdom
Maltese: Middlesex UB6 0NN,
English: The CHMP endorses the following wording: “Valtrex is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents”
Maltese: Is-CHMP japprova l-kliem li ġej: “Valtrex huwa indikat għall-profilassi ta' infezzjoni u mard CMV wara trapjant ta' organu solidu fladulti u l-adolexxenti”
English: • fall in blood pressure leading to collapse.
Maltese: • il-pressjoni tad-demm taqa' li twassal għal kollass.
English: AUC h.micrograms/mL 5.50 ± 0.82 11.1 ± 1.75 18.9 ± 4.51 29.5 ± 6.36 Cmax = peak concentration; Tmax = time to peak concentration; AUC = area under the concentrationtime curve.
Maltese: mikrogramm a/mL Cmax = l-ogħla konċentrazzjoni; Tmax = ħin biex tintlaħaq l-ogħla konċentrazzjoni; AUC = l-erja taħt ilkurva ta' konċentrazzjoni mal-ħin.
English: Valaciclovir 500 mg twice daily was superior to 1000 mg once daily for suppression of symptomatic recurrences Valaciclovir 1000 mg twice daily for treatment of recurrences was comparable to oral aciclovir 200 mg five times daily on herpes episode duration.
Maltese: Valaciclovir 1000 mg mogħti darbtejn kuljum għal kura ta' rikorrenzi kien kumparabbli ma' aciclovir 200 mg mogħti mill-ħalq ħames darbiet kuljum fir-rigward tat-tul ta' żmien tal-episodju tal-herpes.
English: Herpes Simplex Virus Infection
Maltese: Infezzjoni bil-Virus tal-Herpes Simplex
English: The bioavailability of aciclovir from valaciclovir is about 3.3 to 5.5-fold greater than that historically observed for oral aciclovir.
Maltese: Il-bijodisponibiltà ta' aciclovir minn valaciclovir hija madwar 3.3 sa 5.5 drabi ogħla minn dik li ġiet osservata b'mod storiku għal aciclovir mill-ħalq.
English: After oral administration, valaciclovir is converted to aciclovir and L-valine by first-pass intestinal and/or hepatic metabolism.
Maltese: Wara għoti mill-ħalq, valaciclovir jinbidel f'aciclovir u L-valine permezz ta' metaboliżmu intestinali u/ jew epatiku first-pass.
English: NAME OF THE MEDICINAL PRODUCT Valtrex and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Valaciclovir STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains valaciclovir hydrochloride equivalent to 500 mg valaciclovir LIST OF EXCIPIENTS
Maltese: Valtrex u ismijiet assoċjati (ara Anness I) 500 mg pilloli miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Valaciclovir DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha valaciclovir hydrochloride ekwivalenti għal 500 mg valaciclovir.
English: The MAH, as requested, included an introductory statement in Section 4.8 to clarify the sample size/exposure from clinical trials.
Maltese: L-MAH, kif mitlub, inkluda dikjarazzjoni introduttorja fis-Sezzjoni 4.8 biex jiġi ċċarat id-daqs /lespożizzjoni tal-kampjun minn provi kliniċi.
English: Two randomized, double-blind, placebo-controlled safety and efficacy studies were described to support the use of valaciclovir in the treatment of cold sores (herpes labialis).
Maltese: sigurtà u effikaċja ġew deskritti biex jiġi appoġġat l-użu ta' valaciclovir fit-trattament ta' ħżiża (herpes labialis).
English: White, biconvex, elongated tablet with a white to off-white core, engraved “GX CF1” on one side.
Maltese: Pillola bajda, konvessa miż-żewġ naħat, tawwalija b'qalba minn bajda sa bajda tagħti fl-isfar, imnaqqxa b'“GX CF1” fuq naħa waħda.
English: What Valtrex tablets look like and contents of the pack Valtrex tablets are contained in polyvinyl chloride/aluminium foil blister packs.
Maltese: Il-pilloli Valtrex huma magħluqa ġo folji tal- polyvinyl chloride/fojl tal-aluminju.
English: Herpes zoster, herpes simplex and HIV infection do not significantly alter the pharmacokinetics of valaciclovir and aciclovir after oral administration of valaciclovir compared with healthy adults.
Maltese: Herpes zoster, herpes simplex u infezzjoni bl-HIV ma bidlitx b'mod sinifikanti l-farmakokinetika ta' valaciclovir u aciclovir wara għoti mill-ħalq ta' valaciclovir meta mqabbel ma' adulti f'saħħithom.
English: For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at least 5 days, following assessment of the severity of the clinical condition and immunological status of the patient.
Maltese: Għall-kura ta' HSV f'adulti immunokompromessi, id-dożaġġ huwa ta' 1000 mg darbtejn kuljum għal mill-anqas 5 ijiem, wara li ssir stima tal-qawwa tal-kundizzjoni klinika tal-pazjent u l-istat immunoloġiku tal-pazjent.
English: Aciclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and thus blocking virus replication.
Maltese: Aciclovir triphosphate jimpedixxi b'mod kompetittiv il-polmerase tad-DNA tal-virus u linkorporazzjoni ta' dan l-analogu tan-nucleoside jġiegħel il-katina tinqata', jwaqqaf is-sintesi tadDNA tal-virus u b'hekk jimblokka r-replikazzjoni tal-virus.
English: Reduced sensitivity to aciclovir has been described as a result of subtle alterations in either the virus thymidine kinase or DNA polymerase.
Maltese: Tnaqqis fis-sensittività għal aciclovir ġiet imfissra bħala riżultat ta' tibdiliet żgħar jew fit-thymidine kinase jew inkella fid-DNA polymerase tal-virus.
English: Following oral administration of a 500 mg dose of valaciclovir, peak aciclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times the corresponding maternal aciclovir serum concentrations.
Maltese: Wara għoti ta' doża ta' 500 mg ta' valaciclovir mill-ħalq, l-ogħla konċentrazzjonijiet ta' aciclovir (Cmax) fil-ħalib tas-sider kienu fuq medda minn 0.5 sa 2.3 drabi aktar mill-konċentrazzjonijiet li jaqblu magħhom ta' aciclovir fis-serum tal-omm.
English: • treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old).
Maltese: • jikkura infezzjonijiet ta' HSV fil-ġilda u erpete ġenitali (f'adulti u adoloxxenti li għandhom aktar minn 12-il sena).