FrancophonIA/ELRC3.0 huggingface dataset:
English: 2000mg twice in one day 1000 mg twice in one day 500 mg twice in one day 500 mg single dose
Maltese: 2000mg darbtejn f'jum wieħed 1000 mg darbtejn f'jum wieħed 500 mg darbtejn f'jum wieħed 500 mg doża waħda
English: Values for Tmax denote median and range.
Maltese: Valuri għat-Tmax jindikaw medjan u medda.
English: The Wellcome Foundation Ltd. Greenford, Middlesex, United Kingdom
Maltese: Greenford, Middlesex,
English: Herpes Simplex Virus (HSV) Infections Treatment of HSV infections - immunocompetent adults and adolescents
Maltese: Soppressjoni ta' infezzjonijiet b'HSV - adulti u adoloxxenti immunokompetenti
English: France, Belgium, Denmark, Italy, Luxembourg, Netherlands: Zelitrex This leaflet was last approved in {MM/YYYY}.
Maltese: Valtrex Franza, Il-Belġju, Id-Danimarka, L-Italja, Il-Lussemburgu, L-Olanda:
English: Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.
Maltese: Terapija antivirali minn ġol-vini għandha tiġi kkunsidrata meta r-rispons għal terapija orali jitqies bħala insuffiċjenti.
English: They are white and marked with “GX CF2” on one side.
Maltese: Huma ta' lewn abjad u mmarkati b'“GX CF2” fuq naħa waħda.
English: • The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
Maltese: • Id-doża tas-soltu hija 2000 mg (żewġ pilloli ta' 1000 mg jew erba' pilloli ta' 500 mg) darbtejn kuljum.
English: White, biconvex, elongated tablet with a white to off-white core, marked “GX CE7” in blue ink on one side.
Maltese: Pilolla bajda, konvessa miż-żewġ naħat, tawwalija b'qalba minn bajda sa bajda tagħti fl-isfar, immarkata “GX CE7” b'linka blu fuq naħa waħda.
English: 250 mg tablets
Maltese: Pilloli ta' 250 mg Pakketti ta' 60 pillola
English: • unconsciousness (coma)
Maltese: • telf ta' koxjenza (koma)
English: Valtrex and associated names (see Annex I) 250 mg film-coated tablets Valtrex and associated names (see Annex I) 500 mg film-coated tablets Valtrex and associated names (see Annex I) 1000 mg film-coated tablets
Maltese: Valtrex u ismijiet assoċjati (ara Anness I) pilloli ta' 250 mg miksijin b'rita Valtrex u ismijiet assoċjati (ara Anness I) pilloli ta' 500 mg miksijin b'rita Valtrex u ismijiet assoċjati (ara Anness I) pilloli ta' 1000 mg miksijin b'rita
English: The success of chemotherapy or transplantation is often compromise by infection during the period of immunosuppression after treatment or surgery reactivation of latent viruses is particularly common (Bustamante, 1991: Houglund, 2001).
Maltese: Is-suċċess tal-kimoterapija jew trapjant huwa spiss kompromess mill-infezzjonijiet matul il-perjodu ta' immunosoppressjoni wara t-trattament jew kirurġija riattivazzjoni ta' viruses moħbija hija partikolarment komuni (Bustamante, 1991:
English: The authors of Winston study concluded that oral valaciclovir can be an effective alternative to IV ganciclovir for prophylaxis of CMV disease after bone marrow transplant.
Maltese: L-awturi tal-istudju Winston ikkonkludew li valaciclovir orali jista' jkun alternattiva effettiva għal ganciclovir IV għall-profilassi ta' mard CMV wara trapjant tal-mudullun.
English: The elimination of aciclovir is correlated to renal function, and exposure to aciclovir will increase with increased renal impairment.
Maltese: L-eliminazzjoni ta' aciclovir hija korrelatata mal-funzjoni tal-kliewi, u esponiment għal aciclovir jiżdied b'żieda fl-indeboliment tal-kliewi.
English: If cutaneous lesions are extensive or if visceral involvement is suspected, IV aciclovir should be initiated and continued until clinical improvement is evident [Balfour, 1983].
Maltese: Jekk illeżjonijiet tal-ġilda jkunu estensivi jew jekk ikun hemm suspett ta' involviment vixxerali, għandu jinbeda aciclovir IV u jitkompla sakemm titjib kliniku ikun evidenti [Balfour, 1983].
English: The rate and extent of absorption decreases with increasing dose, resulting in a less than proportional increase in Cmax over the therapeutic dose range and a reduced bioavailability at doses above 500 mg. Aciclovir pharmacokinetic (PK) parameter estimates following single doses of 250 to 2000 mg valaciclovir to healthy subjects with normal renal function are shown below.
Maltese: Listimi tal-parametru ta' farmakokinetika (PK) ta' aciclovir wara għoti ta' dożi waħdiet ta' 250 sa 2000 mg valaciclovir lil individwi b'saħħithom b'funzjoni normali tal-kliewi qed jintwerew hawn taħt.
English: These data give confidence that the potential for development of resistance has not diminished the established benefit/risk profile of valaciclovir.
Maltese: Din id-dejta tagħti fiduċja li l-potenzjal għall-iżvilupp ta' reżistenza ma naqqasx il-profil stabbilit tal-benefiċċji/riskji ta' valaciclovir.
English: The MAH did a proposal for the harmonisation of valaciclovir SPCs taking into account the whole pharmaceutical presentations and all the dosages currently approved in at least one European MSs.
Maltese: Il-MAH għamel proposta għall-armonizzazzjoni tal-SPCs ta' valaciclovir filwaqt li jiġu kkunsidrati lpreżentazzjonijiet farmaċewtiċi kollha u d-dożaġġi kollha attwalment approvati f'mill-inqas SM Ewropew wieħed.
English: For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
Maltese: Għal herpes labialis (ponot qrib ix-xofftejn meta wieħed ikollu riħ), 2000 mg ta' valaciclovir darbtejn kuljum għal jum wieħed hija kura effettiva fl-adulti u fl-adoloxxenti.
English: • shortness of breath (dyspnoea)
Maltese: • qtugħ ta' nifs (dispnea)
English: In study 123-012 the results indicate that prophylaxis with oral VACV in renal transplant patients reduced the incidence or delayed the onset of CMV disease in both the seropositive and the seronegative recipients.
Maltese: Fl-istudju 123-012 ir-riżultati jindikaw li profilassi bi VACV orali f'pazjenti b'trapjant tal-kliewi inaqqas l-inċidenza jew jittardja l-bidu ta' mard CMV kemm fir-reċipjenti seropożittivi kif ukoll dawk seronegattivi.
English: It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).
Maltese: Huwa jaħdem billi joqtol jew iwaqqaf it-tkabbir tal-virusis msejħa herpes simplex (HSV), varicella zoster (VZV) u cytomegalovirus (CMV).
English: Selectivity is maintained in CMV with phosphorylation, at least in part, being mediated through the phosphotransferase gene product of UL97.
Maltese: Is-selettività tinżamm f'CMV b'fosforilazzjoni, tal-anqas f'parti, li hija medjata permezz talprodott tal-ġene phosphotransferase ta' UL97.
English: The MAH provided the dosage adjustment rationale for the treatment of herpes labialis in subjects with renal impairment.
Maltese: L-MAH ipprovda r-raġunament tal-aġġustament tad-dożaġġ għat-trattament ta' herpes labialis f'suġġetti b'indeboliment renali.
English: 1000 mg twice daily 1000 mg once daily
Maltese: 1000 mg darbtejn kuljum 1000 mg darba kuljum
English: - the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Valtrex and associated names (see Annex I).
Maltese: - is-Sommarju tal-Karatteristiċi tal-Prodotti, it-tikkettjar u l-fuljett ta' tagħrif proposti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ġew evalwati fuq il-bażi tad-dokumentazzjoni sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat,
English: The MAH, to show the safety and efficacy of valaciclovir for the prophylaxis of CMV disease in transplant recipients, presented four randomized, controlled clinical trials: Lowance, 1999; Egan, 2002; Ljungman, 2002; Winston, 2003.
Maltese: Lowance, 1999; Egan, 2002; Ljungman, 2002;
English: Indication 2 - Herpes simplex virus (HSV) infections Regarding herpes simplex there were differences between Member States regarding site of infection and recommendations for treatment, suppression or prevention.
Maltese: Rigward herpes simplex kien hemm differenzi bejn Stati Membri rigward is-sit ta' infezzjoni u rrakkomandazzjonijiet għat-trattament, is-soppressjoni jew il-prevenzjoni.
English: Tablet core
Maltese: darbiet kuljum.
English: • altered brain function (encephalopathy)
Maltese: • funzjoni tal-moħħ mibdula (enċefalopatija)
English: The CHMP requested the MAH to further discuss the proposed dose adjustment for renal impairment at one-day treatment of herpes labialis.
Maltese: Is-CHMP talab lill-MAH sabiex jiddiskuti ulterjorment l-aġġustament tad-doża propost għal indeboliment renali għat-trattament ta' jum ta' herpes labialis.
English: Valaciclovir did not affect fertility in rats dosed by the oral route.
Maltese: Valaciclovir m'affetwax il-fertilità fil-firien li ngħataw dożi mir-rotta orali.
English: GlaxoSmithKline Oy Piispansilta 9 A, 02230 Espoo, Finland
Maltese: Il-Finlandja GlaxoSmithKline Oy Piispansilta 9 A,
English: Valaciclovir has shown efficacy in the treatment of herpes labialis (cold sores), mucositis due to chemotherapy or radiotherapy, HSV reactivation from facial resurfacing, and herpes gladiatorum.
Maltese: Madankollu, valaciclovir wera effikaċja fit-trattament ta' herpes labialis (ħżiża), mukożites minħabba kimoterapija jew radjoterapija, riattivazzjoni tal-HSV minn risurġenza tal-wiċċ, u herpes gladiatorum.
English: Abdominal discomfort Hepato-biliary disorders Uncommon:
Maltese: Disturbi fil-fwied u fil-marrara Mhux komuni:
English: More serious ARs such as thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome, acute renal failure and neurological disorders are discussed in greater detail in other sections of the label.
Maltese: Effetti mhux mixtieqa huma mniżżlin hawn taħt skont il-klassi tas-sistemi u tal-organi u skont ilfrekwenza.
English: Based on results from study P66-09, estimates of relative bioavailability of aciclovir from different valaciclovir dose levels were assumed to be independent of renal function.
Maltese: Fuq il-bażi tar-riżultati mill-istudju P66-09, l-istimi tal-bijodisponibbiltà relattiva ta' aciclovir minn livelli differenti ta' doża ta' valaciclovir ġew preżunti li huma indipendenti mill-funzjoni renali.
English: • severe allergic reactions (anaphylaxis).
Maltese: • reazzjonijiet allerġiċi qawwija (anafilassi).
English: The MAH, in order to prove the safety and efficacy of valaciclovir for the treatment of HSV, evaluated the product in a clinical development programme of six studies focusing on genital herpes (HSV-2) infection.
Maltese: L-MAH, sabiex jagħti prova tas-sigurtà u l-effikaċja ta' valaciclovir għat-trattament ta' HSV, evalwa l-prodott fi programm ta' żvilupp kliniku ta' sitt studji li jiffokaw fuq infezzjoni tal-herpes ġenitali (HSV-2).
English: Valtrex can be used to:
Maltese: Valtrex jista' jintuża biex:
English: The first stage of phosphorylation requires the activity of a virus-specific enzyme.
Maltese: L-ewwel stadju tal-fosforilazzjoni jeħtieġ l-attività ta' enzima speċifika għall-virus.
English: Binding of valaciclovir to plasma proteins is very low (15%).
Maltese: L-irbit ta' valaciclovir mal-proteini tal-plażma huwa baxx ħafna (15%).
English: Don't take Valtrex
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' VALTREX
English: Valaciclovir is eliminated in the urine principally as aciclovir (greater than 80% of the recovered dose) and the aciclovir metabolite CMMG (about 14% of the recovered dose).
Maltese: Valaciclovir jitneħha mal-awrina l-biċċa l-kbira bħala aciclovir (aktar minn 80% tad-doża rkuprata) u l-metabolit ta' aciclovir CMMG (madwar 14% tad-doża rkuprata).
English: The CHMP endorsed the MAH's proposal to delete “Valtrex accelerates the resolution of pain….and postherpetic neuralgia” and the information was moved under section 5.1.
Maltese: Is-CHMP approva l-proposta tal-MAH biex jiġi mħassar “Valtrex jaċċelera r-riżoluzzjoni tal-uġigħ ….u n-nevralġija posterpetika” u l-informazzjoni tressqet taħt is-sezzjoni 5
English: Other medicinal products (including e.g. tenofovir) administered concurrently that compete with or inhibit active tubular secretion may increase aciclovir concentrations by this mechanism.
Maltese: Prodotti mediċinali oħra (inkluż eż. tenofovir) li ingħataw fl-istess ħin u jikkompetu ma' sekrezzjoni attiva tat-tubuli jew jimpeduha jistgħu jżidu lkonċentrazzjonijiet ta' aciclovir permezz ta' dan il-mekkaniżmu.
English: Valaciclovir has not been studied in patients with severe immune deficiency.
Maltese: Valaciclovir ma ġiex studjat f'pazjenti b'defiċjenza immuni qawwija.
English: Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1).
Maltese: Ma sarux studji kliniċi f'pazjenti infettati b'HSV li kienu immunokompromessi minħabba kawżi oħra ħlief b'infezzjoni tal-HIV (ara sezzjoni 5.1).
English: • rash, sometimes itchy, hive-like rash (urticaria)
Maltese: • jikkura l-ħruq ta' Sant'Antnin (fl-adulti)
English: The metabolite 8-OH-ACV is detected only in small amounts in urine (< 2% of the recovered dose).
Maltese: Il-metabolit 8-OH-ACV fl-awrina jidher biss f'ammonti żgħar (< 2% tad-doża rkuprata).
English: Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was evidence of an association with valaciclovir.
Maltese: Dejta minn provi kliniċi intużat biex jiġu assenjati kategoriji ta' frekwenza għal ARs jekk, fil-provi kliniċi, kien hemm evidenza ta' assoċjazzjoni ma' valaciclovir.
English: The CHMP asked for the rationale behind the proposed doses in herpes labialis due to a concern that a dose reduction already at CLcrea 49 ml/min might possibly lead to underexposure.
Maltese: Is-CHMP talab għar-raġunament wara d-dożi proposti f'herpes labialis minħabba tħassib li tnaqqis fiddoża diġà f'CLcrea 49 ml/min jista' possibbilment iwassal għal espożizzjoni nieqsa.
English: The CHMP agreed to include a reference to ocular HSV in section 5.1.
Maltese: Is-CHMP qabel li tiġi inkluża referenza għal HSV okulari fis-sezzjoni 5.1. “Valtrex inaqqas ir-riskju ta' komplikazzjonijiet okulari ta' zoster oftalmiku”.
English: • vomiting
Maltese: • sturdament
English: The valaciclovir and aciclovir pharmacokinetic profiles are similar after single and repeat dosing.
Maltese: Il-profili farmakokinetiċi ta' valaciclovir u aciclovir jixxiebhu wara għoti ta' dożi waħdiet u ripetuti .
English: 1000 mg tablet
Maltese: 1500 mg darbtejn kuljum
English: 500 mg twice daily 500 mg once daily
Maltese: 500 mg darbtejn kuljum 500 mg darba kuljum
English: A study of the pharmacokinetics of valaciclovir and aciclovir during late pregnancy indicates that pregnancy does not affect the pharmacokinetics of valaciclovir.
Maltese: Studju tal-farmakokinetika ta' valaciclovir u aciclovir mogħtija għall-aħħar tat-tqala juri li t-tqala ma taffettwax il-farmakokinetika ta' valaciclovir.
English: The dose is 500 mg of Valtrex twice daily.
Maltese: Id-doża hija 500 mg ta' Valtrex darbtejn kuljum.
English: During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced.
Maltese: Waqt kura ta' soppressjoni b'sustanzi antivirali, il-frekwenza ta' tixrid tal-virus tonqos b'mod sinifikanti.
English: Less than 1% of the administered dose of valaciclovir is recovered in the urine as unchanged drug.
Maltese: Anqas minn 1% tad-doża ta' valciclovir mogħtija hija rkuprata fl-awrina bħala mediċina mhux mibdula.
English: For other indications where the normal dose is in the lower range, dose reductions in renal impairment are not made until CLcrea is below 30 ml/min, since at these exposure levels, the expected increase in exposure at CLcrea 30-49 ml/min is not considered a great safety risk.
Maltese: Għal indikazzjonijiet oħra fejn id-doża normali hija fil-firxa t'isfel, it-tnaqqis fid-doża fl-indeboliment renali ma jsirx sakemm isCLcrea tkun inqas minn 30 ml/min, peress li f'dawn il-livelli ta' espożizzjoni, iż-żieda mistennija flespożizzjoni fi CLcrea 30-49 ml/min mhijiex ikkunsidrata bħala riskju għas-sigurtà kbir.
English: • skin reaction after exposure to sunlight (photosensitivity).
Maltese: • reazzjonijiet fil-ġilda wara esponiment għax-xemx (fotosensittività)
English: 4.1 Therapeutic indications
Maltese: Indikazzjoni Terapewtika
English: Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4).
Maltese: Valtrex huwa indikat għall-kura tal-herpes zoster f'pazjenti adulti b'immunosoppressjoni ħafifa jew moderata (ara sezzjoni 4.4).
English: Valaciclovir has been proven to reduce the risk of transmission of genital herpes in immunocompetent adults when taken as suppressive therapy and combined with safer sex practices.
Maltese: Valaciclovir ġie ppruvat li jnaqqas ir-riskju ta' trasmissjoni tal-erpte ġenitali f'adulti immunokompetenti meta jittieħed bħala terapija ta' soppressjoni u kien msiebaħ ma' prattika ta' sess protett.
English: The level of information differs across Members States.
Maltese: Il-livell ta' informazzjoni huwa differenti bejn l-Istati Membri.
English: The dose in immunocompromised patients is 1000 mg three times daily for at least seven days (3000 mg total daily dose) and for 2 days following crusting of lesions.
Maltese: Id-doża f'pazjenti immunokompromessi hija ta' 1000 mg tliet darbiet kuljum għal mill-anqas sebat ijiem (doża totali ta' 3000 mg kuljum) u għal jumejn wara li l-ġrieħi jiffurmaw qoxra.
English: For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately upon appearance of the first signs or symptoms.
Maltese: Għal episodji rikorrenti ta' herpes simplex, dan idealment għandu jkun waqt il-perjodu ta' prodromu jew minnufih mad-dehra tal-ewwel sinjali jew sintomi.
English: The following frequency categories are used for classification of adverse effects: Very common ≥ 1/10,
Maltese: Il-kategoriji ta' frekwenzi li ġejjin huma wżati għall-klassifikazzjoni tal-effetti avversi:
English: - Keep this leaflet.
Maltese: Stat ta' idratazzjoni
English: The MAH stated that valaciclovir offered proven efficacy for prophylaxis of CMV infection and disease and influenced positively other outcomes such as graft rejection and opportunistic infections.
Maltese: L-MAH iddikjara li valaciclovir offra effikaċja ppruvata għall-profilassi ta' infezzjoni u mard CMV u influwenza b'mod pożittiv eżiti oħra bħar-rifjut tat-trapjant u infezzjonijiet opportunistiċi.
English: The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases.
Maltese: Il-proċess ta' fosforilazzjoni jintemm (bidla minn mono għal triphosphate) permezz ta' kinases taċċelluli.
English: However, at therapeutic doses of valaciclovir, no effects on the breastfed newborns/infants are anticipated since the dose ingested by the child is less than 2% of the therapeutic dose of intravenous aciclovir for treatment of neonatal herpes (see Section 5.2).
Maltese: Madankollu, bid-dożi terapewtiċi ta' valaciclovir, ma huma mistennija l-ebda effetti fuq it-trabi/trabi tat-twelid minħabba li d-doża li tieħu t-tarbija hija anqas minn 2% tad-doża terapewtika ta' aciclovir minn ġol-vini għall-kura ta' herpes wara t-twelid (ara sezzjoni 5.2).
English: NAME OF THE MEDICINAL PRODUCT Valtrex and associated names (see Annex I) 1000 mg film-coated tablets [See Annex I - To be completed nationally] Valaciclovir
Maltese: Valtrex u ismijiet assoċjati (ara Anness I) 1000 mg pilloli miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Valaciclovir ISEM
English: Some Member States have revised the dose recommendations in patients with renal impairment in treatment of herpes zoster based on safety signals.
Maltese: Xi Stati Membri rrevedu r-rakkomandazzjonijiet tad-doża f'pazjenti b'indeboliment renali fittrattament ta' herpes zoster fuq il-bażi ta' sinjali tas-sigurtà.
English: • flushing, itchy skin rash
Maltese: • fwawar, raxx bil-ħakk fil-ġilda
English: The MAH to support this proposed indication presented two randomised, placebo controlled studies (HS230027 and HS0028) [Spruance, 2003] evaluating the efficacy and safety of one dosing regimen of VACV, 2000 mg twice daily for 1 day, compared to placebo.
Maltese: L-MAH biex jappoġġa din l-indikazzjoni proposta ppreżenta żewġ studji fortuwiti, kkontrollati bi plaċebo (HS230027 u HS0028)
English: Uncommon (affects up to 1 in 100 people)
Maltese: Mhux komuni (jaffettwaw sa persuna waħda minn kull 100)
English: The CHMP also asked the MAH to give reassurance that the benefit/risk of valaciclovir can be regarded as similar to that of valganciclovir, currently widely used in clinical practice.
Maltese: Is-CHMP talab ukoll lill-MAH jagħti riassigurazzjoni li l-benefiċċju/riskju ta' valaciclovir jista' jiġi kkunsidrat bħala simili għal dik ta' valganciclovir, li attwalment jintuża ħafna fil-prattika klinika.
English: There are no data on treatment started more than 72 hours after onset of the zoster rash.
Maltese: M'hemmx dejta dwar kura li nbdiet aktar minn 72 siegħa wara li fiġġ irraxx taż-zoster.
English: Dosage selection for treatment of cold sores was based on administration of high-dose valaciclovir during prodrome, targeting plasma concentrations to exceed the in vitro IC99, based on the hypothesis that optimal antiviral effect would be obtained from high systemic exposure during the time that viral replication dominates temporarily over the host immune response.
Maltese: L-għażla tad-dożaġġ għat-trattament ta' ħżiża kienet ibbażata fuq l-amministrazzjoni ta' doża għolja ta' valaciclovir matul il-prodromu, bil-mira li l-konċentrazzjonijiet fil-plażma jeċċedu l-in vitro IC99, fuq il-bażi tal-ipoteżi li effett antivirali ottimali jinkiseb minn espożizzjoni sistemika għolja matul iżżmien meta ir-replikazzjoni virali tiddomina temporanjament fuq ir-reazzjoni immunitarja tal-ospitant.
English: The Lowance study demonstrated that prophylactic treatment with valaciclovir is a safe and effective way to prevent CMV disease after renal transplantation.
Maltese: L-istudju Lowance wera li t-trattament profilattiku bi valaciclovir huwa mod sikur u effettiv għallprevenzjoni ta' mard CMV wara t-trapjant tal-kliewi.
English: To stop you being infected with CMV (Cytomegalovirus)
Maltese: Biex ma' tħallix li inti tiġi infettat/a b'CMV (Cytomegalovirus)
English: 20 mg/ml Oral solution
Maltese: EU/1/07/388/003 Sebivo 20 mg/m Soluzzjoni orali
English: 300 ml (20 mg/ml)
Maltese: Flixkun (tal-ħġieġ) 300 ml (20 mg/ml) Flixkun wieħed + tazza waħda + siringa tal-ħalq waħda
English: EU Number
Maltese: Numru tal-UE Isem inventat
English: Bottle (glass)
Maltese: Użu orali
English: Abilify aripiprazole
Maltese: Abilify aripiprażolu
English: The full EPAR for Abilify can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, the most common side effects when taking Abilify by mouth (occurring in up to 10 patients in 100) are restlessness, difficulty sleeping, anxiety, extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (a constant urge to move), tremor (shaking), dizziness, sleepiness, headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva), tiredness and diabetes.
Maltese: F'adulti, l-effetti sekondarji l-aktar komuni meta Abilify jittieħed mill-ħalq (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma nuqqas ta' serħan, diffikultà fl-irqad, ansjetà, disturbi ekstrapiramidali (ċaqliq spasmodiku bla kontroll), akatisja (urġenza kostanti biex persuna tiċċaqlaq), rogħda, sturdament, ħedla tan-ngħas, uġigħ ta' ras, viżta mċajpra, dispepsja (ħruq ta' stonku), remettar, nawżja (tħossok ma tiflaħx), kostipazzjoni, produzzjoni eċċessiva ta' bżieq, telqa u dijabete.
English: Bipolar I disorder
Maltese: Disturb bipolari I