FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: HBeAg Seroconversion
Maltese: IU/mLa serokonverżjonia HBeAg normalizzazzjonia ALT
English: Baseline HBV
Maltese: IU/mLa Linja Bażi HBV
English: (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
Maltese: (Sena 3), wara ġimgħa 156 sa ġimgħa 204 (Sena 4), jew wara ġimgħa 204 sa ġimgħa 252 (Sena 5).
English: HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Maltese: Negattivi għal HBeAg (studju 027): trattament b'entecavir sa 96 ġimgħa (n= 325) irriżulta f'rati ta' titjib kumulattiv ta' 94% għal DNA ta' HBV < 300 kopja/ml skont il-PCR u 89% għal normalizzazzjoni ta' l-ALT meta mqabbel ma' 77% għal DNA ta' HBV < 300 kopja/ml skont il-PCR
English: Periodic monitoring of hepatic function is recommended during treatment.
Maltese: Monitoraġġ perjodiku tal-funzjoni talfwied huwa rrakkomandat waqt it-trattament.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048).
Maltese: Esperjenza f'pazjenti b'mard tal-fwied mhux stabbli: il-profil tas-sigurezza ta' entecavir f'pazjenti b'mard tal-fwied mhux stabbli ġie evalwat fi studju komparattiv open-label li fih il-pazjenti ntagħżlu b'mod każwali, li fih, pazjenti rċivew kura b'entecavir 1 mg/kuljum (n=102) jew adefovir dipivoxil 10 mg/kuljum (n = 89) (studju 048).
English: Periodic Safety Update Reports
Maltese: Sommarju tal-profil tas-sigurtà
English: Baraclude 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate).
Maltese: Kull pillola fiha 1 mg entecavir (bħala monoidrat).
English: They are marked with “BMS” on one side and “1612” on the other.
Maltese: Huma mmarkati b'“BMS” fuq naħa u “1612” fuq in-naħa l-oħra.
English: Contents of the pack and other information What Baraclude contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Baraclude
English: Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Maltese: Lista f'għamla ta' tabella ta' reazzjonijiet avversi, ġiet osservata reazzjoni avversa addizzjonali waħda [tnaqqis tal-bikarbonat fid-demm (2%)] f'pazjenti kkurati b'entecavir sa ġimgħa 48.
English: Assessment of adverse reactions is based on experience from postmarketing surveillance and four clinical studies in which 1,720 patients with chronic hepatitis B infection and compensated liver disease received double-blind treatment with entecavir (n = 862) or lamivudine (n = 858) for up to 107 weeks (see section 5.1).
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi hija bbażata fuq esperjenza minn sorveljanza ta' wara ttqegħid fis-suq u fuq erba' studji kliniċi fejn 1,720 pazjent b'infezzjoni kronika tal-epatite B u mard tal-fwied stabbli irċivew trattament double blind b'entecavir (n= 862), jew lamivudine (n= 858) sa
English: Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM.
Maltese: 0.0012 µM. Entecavir-TP ifixkel polymerases tad-DNA α, β u δ fiċ-ċelloli b'valuri ta' Ki ta' 18 sa 40 µM.
English: At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count < 200 cells/mm3).
Maltese: Fil-linja bażi, pazjenti ttrattati b'entecavir kellhom terapija preċedenti b'lamivudine għal medja ta' 4.8 snin u ammont medju ta' CD4 ta' 494 ċelloli/mm3 (b'5 pazjenti biss li kellhom ammont ta' CD4 < 200 ċellola/mm3).
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
Maltese: Il-popolazzjoni tal-istudju kienu 82% irġiel, 39% Kawkasi, u 39% Asjatiċi, b'età medja ta' 49 sena; 89% tal-pazjenti kellhom il-marda negattiva għal HBeAg meta sar it-trapjant.
English: 1.1%e 10.7% e 27% e 41.3% e
Maltese: 1.1%e 10.
English: Baraclude 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate).
Maltese: Kull pillola fiha 0.5 mg entecavir (bħala monoidrat).
English: How to store Baraclude
Maltese: Doża ta' Baraclude *
English: Mean change from baselinec,e HBsAg lossb
Maltese: Bidla medja mil-linja bażi c,e Telf HBsAgb
English: The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Maltese: IsCmax, l-AUC (0-24), u s-Cmin għal dawn l-individwi kienu 6.31 ng/ml, 18.33 ng h/ml, u 0.28 ng/ml, rispettivament.
English: Skin and subcutaneous tissue disorders: uncommon: rash, alopecia General disorders and administration site conditions:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda mhux komuni: raxx, alopeċja
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Maltese: Tnaqqis fil-viral load (log10 kopji/ml)c DNA ta' HBV ma jistax jiġi osservat (< 300 kopja/ml skont PCR)c Normalizzazzjoni ta' l-ALT (≤ 1 x ULN)
English: Biotransformation: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Maltese: Bijotrasformazzjoni: entecavir mhuwiex sottostrat, inibitur jew inducer tas-sistema ta' enżimi CYP450.
English: The Baraclude oral solution is recommended for patients weighing from 10 kg to 32.5 kg.Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablet.
Maltese: Is-soluzzjoni ta' Baraclude hija rrakkomandata għal pazjenti li jiżnu minn 10 kg sa 32.5 kg.Tfal li jiżnu tal-inqas 32.6 kg jistgħu jieħdu s-soluzzjoni orali jew il-pillola ta' 0.5 mg.
English: Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
Maltese: Popolazzjoni pedjatrika: il-farmakokinetika fi stat fiss ta' entecavir ġiet evalwata (studju 028) f'24 individwu pedjatriku pożittiv għal HBeAg li qatt ma ħadu nucleoside qabel u 19 li esperjenzaw lamivudine minn sentejn sa <18-il sena b'mard tal-fwied kumpensat.
English: Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Maltese: Baraclude 0.5 mg pilloli miksijin b'rita jiġu f'kaxex tal-kartun li kull kaxxa fiha 30 x 1 jew 90 x 1 pillola miksijin b'rita (f'folji ta' doża waħda) u fi fliexken li fihom 30 pillola miksijin b'rita.
English: Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets
Maltese: Baraclude 0.5 mg pilloli miksijin b'rita Baraclude 1 mg pilloli miksijin b'rita
English: Bottle pack:
Maltese: Maltitol:
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Maltese: entecavir ġew evalwati wkoll fi prova klinika kkontrollata b'mod attiv ta' 191 pazjent infettati b'HBV b'mard tal-fwied mhux stabbli u fi prova klinika ta' 68 pazjent ko-infettati b'HBV u b'HIV.
English: In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during posttreatment follow-up.
Maltese: Fi studji f'pazjenti refrattarji għal lamivudine, b'numru limitat ta' pazjenti li kienu qegħdin jiġu osservati, 11% tal-pazjenti ttrattati b'entecavir u ebda pazjenti ttrattat b'lamivudine ma żviluppaw żjidiet fl-ALT waqt follow-up li sar wara t-trattament.
English: For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR at end of dosing.
Maltese: Għal 26 pazjent li ġew ittrattati b'entecavir u 28 pazjent li ġew ittrattati għal iktar minn 52 ġimgħa (medja ta' 96 ġimgħa), 96% ta' dawk il-pazjenti ittrattati b'entecavir u 64% ta' dawk il-pazjenti ttrattati b'lamivudine kellhom DNA ta' HBV < 300 kopja/ml skont il-PCR fl-aħħar tad-dożi.
English: The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Maltese: Il-farmakokinetika ta' entecavir wara doża waħda ta' 1 mg f'pazjenti mingħajr infezzjoni kronika ta' l-epatite B jidhru fittabella:
English: Each ml oral solution contains 0.05 mg entecavir (as monohydrate).
Maltese: Kull ml tas-soluzzjoni orali fih 0.05 mg entecavir (bħala monoidrat).
English: Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011
Maltese: Data ta' l-aħħar tiġdid: 26 Ġunju 2011
English: Patients treated with Baraclude have reported the following side effects: common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Maltese: komuni (għallinqas pazjent 1 minn kull 100): uġigħ ta' ras, insomnja (diffikultà biex wieħed jorqod), għeja (għeja kbira), sturdament, ngħas (ħedla), rimettar, dijarea, dardir, dispepsja (indiġestjoni), u livelli ogħla ta' enzimi tal-fwied fid-demm.
English: Titanium dioxide Hypromellose Macrogol 400
Maltese: Titanium dioxide
English: ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Maltese: Innormalizzazzjoni ta' l-ALT (≤ 1 x ULN) instabet f'27% tal-pazjenti ttrattati b'entecavir u f'21% tal pazjenti ttrattati b'lamivudine fl-aħħar tad-dożi.
English: Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Maltese: Baraclude 1 mg pilloli miksijin b'rita jiġu f'kaxex talkartun li kull kaxxa fiha 30 x 1 jew 90 x 1 pillola miksijin b'rita (f'folji ta' doża waħda) u fi fliexken li fihom 30 pillola miksijin b'rita.
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)c
Maltese: Proporzjon ma setax jiġi osservat (< 300 kopja/ml)b
English: Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
Maltese: Anormalitajiet fit-testijiet tal-laboratorju: fi studji kliniċi b'pazjenti li qatt ma kienu kkurati fil-passat b'nukleoside, 5% kellhom livelli għoljin ta' ALT ta' > 3 darbiet tal-linja bażi, u < 1% kellhom livelli ta' ALT għoli ta' > darbtejn tal-linja bażi flimkien ma' bilirubina totali ta' > darbtejn tal-limitu ta' fuq tan-normal (ULN) u ta' > darbtejn tal-linja bażi. Livelli ta' albumina ta' < 2.5 g/dl seħħew f'< 1 % talpazjenti, livelli ta' amylase ta' > 3 darbiet tal-linja bażi fi 2% , livelli ta' lipase ta' > 3 darbiet tal-linja bażi fi 11% u plejtlits ta' < 50,000/mm3 f'< 1%.
English: For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
Maltese: Għall-adulti, id-doża rakkomandata hija jew ta' 0.5 mg (10 ml) jew 1 mg (20 ml) darba kuljum li tittieħed oralment (mill-ħalq).
English: Package leaflet: Information for the user Baraclude 0.05 mg/ml oral solution
Maltese: Informazzjoni għall-utent Baraclude 0.05 mg/ml soluzzjoni orali
English: They are marked with “BMS” on one side and “1611” on the other.
Maltese: Huma mmarkati b'“BMS” fuq naħa u “1611” fuq in-naħa l-oħra.
English: Patients were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Maltese: Ilpazjenti kienu randomizzati (2:1) biex jirċievu kura blinded b'entevacir 0.015 mg/kg sa 0.5 mg/jum
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Maltese: Minn dawn il-pazjenti, 55/57 (96%) kellhom titjib istoloġiku kif definit qabel (ara hawn fuq), u 50/57 (88%) kellhom tnaqqis ta' ≥ 1 punt fil-punteġġ tal-fibrożi ta' Ishak.
English: Blister pack: 30 x 1 film-coated tablet 90 x 1 film-coated tablet
Maltese: 90 x 1 pillola miksija b'rita
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Maltese: e ETVr li sseħħ fi kwalunkwe sena; breakthrough viroloġiku f'sena speċifika.
English: How to store BARACLUDE
Maltese: Doża ta' Baraclude
English: 210 ml oral solution with a measuring spoon.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 210 ml ta' soluzzjoni orali b'mgħarfa tal-kejl.
English: Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Maltese: Il-funzjoni tal-kliewi trid tiġi evalwata b'attenzjoni kbira qabel u waqt it-terapija b'entecavir f'riċevituri ta' trapjant tal-fwied li jkunu qed jirċievu cyclosporine jew tacrolimus (ara sezzjoni 5.2).
English: (HBV) infection in adults.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti
English: In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Maltese: Fi studji kliniċi b'pazjenti refrattorji b'lamivudin, 4% kellhom livelli ogħla ta' ALT > 3 darbiet tallinja bażi u < 1% kellhom livelli ogħla ta' ALT ta' > darbtejn il-linja bażi b'bilirubina totali ta' > darbtejn tal-ULN u ta' > darbtejn tal-livell tal-linja bażi.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkat fit- taqsima 6.1.
English: These 14 patients had a lower rate of genotypic entecavir resistance (cumulative probability 18.8% through 5 years of follow-up) than the overall study population (see table).
Maltese: Dawn l-14-il pazjent kellhom rata iktar baxxa ta' reżistenza għal entecavir ġenotipiku (probabbiltŕ kumulattiva ta' 18.8% sa 5 snin ta' followup) milli fil-popolazzjoni totali tal-istudju (ara t-tabella).
English: Body Weighta
Maltese: TAGĦRIF
English: Blister packs: do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Recommended Once Daily Dose of Oral Solutionb
Maltese: Doża ta' Darba Kuljum Rakkomandata ta' Soluzzjoni Oralib
English: 10.0 ml a Body weight should be rounded to the nearest 0.1 kg. b Children with body weight at least 32.6 kg should receive 10.0 ml (0.5 mg) of oral solution or one 0.5 mg tablet once daily.
Maltese: Il--pazjenti pedjatriċi b'piż tal-ġisem ta' anqas minn 32.6 kg, għandhom jingħataw 10 ml (0.5 mg) tas--soluzzjoni orali jew pillola ta' 0.5 mg darba kuljum.
English: The entecavir-TP Ki for HBV DNA
Maltese: Kienet osservata rata aktar baxxa ta' rispons viroloġiku (HBV DNA <50
English: Baraclude 1 mg film-coated tablets Tablet core:
Maltese: Baraclude 1 mg pilloli miksijin b'rita Qalba tal-pillola:
English: For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Maltese: Għal dożaġġ xieraq fil-popolazzjoni pedjatrika, hemm disponibbli Baraclude soluzzjoni orali jew Baraclude 0.5 mg pilloli miksijin b'rita.
English: Oral solution Clear, colourless to pale yellow solution
Maltese: Doża ta' Darba Kuljum Rakkomandata ta' Soluzzjoni Orali
English: Normalization of:f
Maltese: CLT/F
English: Baraclude 0.5 mg film-coated tablets Tablet core:
Maltese: Baraclude 0.5 mg pilloli miksijin b'rita Qalba tal-pillola:
English: rare: anaphylactoid reaction
Maltese: rari: reazzjoni anafilattojdi
English: Bristol-Myers Squibb Polska Sp. z o.o.
Maltese: N.V. Bristol-Myers Squibb Belgium S.A.
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Maltese: Id-doża rakkomandata hija jew 0.5 mg (10 ml) jew 1 mg (20 ml) darba kuljum li tittieħed oralment (mill-ħalq).
English: Baraclude oral solution is also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Maltese: Is-soluzzjoni orali Baraclude tintuża wkoll biex tikkura infezzjoni HBV kronika (fit-tul) fi tfal u adolexxenti li għandhom sentejn sa anqas minn 18-il sena.
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.The population pharmacokinetic analysis covering patients in the age range 1675 years did not identify age as significantly influencing entecavir pharmacokinetics.
Maltese: Wara aġġustament għad-differenzi fil-clearance tal-kreatinina u l-piż tal-ġisem, is-suġġetti anzjani kellhom AUC 12.5% ogħla minn suġġetti żgħar.
English: Severe Managed with CAPD
Maltese: Immaniġġj at b'CAPD
English: Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies
Maltese: Reżistenza Ġenotipika Ġdida għal Entecavir Sa Sena 5, Studji dwar Pazjenti li Qatt ma Ħadu Nukleoside
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Maltese: Għal pazjenti li oriġinarjament ġew assenjati għal trattament b'entecavir, it-tnaqqis fid-DNA ta' HBV wara 48 ġimgħa kien -4.20 log10 kopji/ml, normalizzazzjoni ta' l-ALT seħħet f'37% tal-pazjenti b'ALT ta' linja bażi anormali u ħadd minnhom ma' laħaq sirokonversjoni ta' HBeAg.
English: Compensated liver disease
Maltese: TAL-PRODOTT MEDIĊINALI
English: What BARACLUDE is and what it is used for Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B
Maltese: Is-soluzzjoni orali Baraclude hija mediċina kontra virusijiet, użata sabiex tittratta infezzjoni kronika (fit-tul) bil-virus ta' l-epatite B (HBV) fl-adulti.
English: Film-coated tablet (tablet)
Maltese: Kull kartuna tinkludi mgħarfa tad-dożaġġ (polypropylene)
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Maltese: Fl-aħħar tad-dożi, fost pazjenti li komplew it-trattament b'entecavir għal aktar minn 52 ġimgħa (medja ta' 96 ġimgħa), 81% mill-243 pazjent ttrattat b'entecavir u 39% mill-164 pazjent ttrattat b'lamivudine kellhom DNA ta' HBV < 300 kopja/ml skont il-PCR waqt li normalizzazzjoni fl-ALT (≤ 1 x ULN)
English: * for doses < 0.5 mg Baraclude oral solution is recommended.
Maltese: ml (0.5 mg) ta' soluzzjoni orali jew pillola ta' 0.5 mg waħda kuljum.
English: 43.6% e a Results reflect use of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 13 weeks for 48 of 80 patients in Year 3, a median of 38 weeks for 10 of 52 patients in Year 4, and for 16 weeks for 1 of 33 patients in Year 5 in a rollover study.
Maltese: għal medjan ta' 13-il ġimgħa għal 48 minn 80 pazjent f'Sena 3, medjan ta' 38 ġimgħa għal 10 minn 52 pazjent f'Sena 4, u għal 16-il ġimgħa għal 1 minn 33 pazjent f'Sena 5 fi studju rollover.
English: 0.3 mg once daily OR 0.5 mg every 48 hours
Maltese: 0.5 mg kull 48 siegħa
English: Hrvatska
Maltese: LVD
English: System organ class
Maltese: Klassi ta 'organi tas-sistema
English: The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Maltese: L-aktar reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' memantine milli fil-grupp tal-plaċebo kienu sturdament (6.3% vs 5.6%, rispettivament), uġigħ ta' ras (5.2% vs 3.9%), stitikezza (4.6% vs 2.6%), ngħas (3.4% vs 2.2%) u pressjoni għolja (4.1% vs 2.8%).
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Maltese: Memantine m'għamilx impediment fuq CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monoxygenase li fih flavin, epoxide hydrolase jew sulfejxin in vitro.
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Maltese: Il-metaboli ewlenin fil-bniedem huma N-3,5-dimethylgludantan, it-taħlita ta' 4- u 6-hydroxy-memantine, u 1-nitroso-3,5-dimethyl-adamantane.
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta 'reazzjonijiet avversi
English: Verovškova 57, 1526 Ljubljana Slovenia
Maltese: Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana Slovenja
English: INFORMATION IN BRAILLE Memantine LEK 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine LEK 10 mg
English: EL-69300 Rodopi Greece
Maltese: EL-69300
English: INFORMATION IN BRAILLE Memantine LEK 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine LEK 20 mg
English: Iron oxide yellow (E 172)
Maltese: Iron oxide isfar (E 172)
English: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Maltese: Polyvinyl alcohol, Titanium dioxide (E 171), Talc, Macrogol 3350, Iron oxide isfar (E 172), Iron oxide red (E 172)
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Maltese: Studji f'voluntiera wrew farmakokinetika linjari f'medda ta' dożi minn 10 sa 40 mg.
English: (≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: komuni ħafna (≥ 1/10) komuni (≥1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma jistax ikun stmat mit-tagħrif li hemm).
English: Memantine LEK contains the active substance memantine hydrochloride.
Maltese: Memantine LEK fih is-sustanza attiva memantine hydrochloride.
English: The volume of distribution is around 10 L/kg.
Maltese: Il-volum ta' distribuzzjoni huwa madwar 10 L/kg.