FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 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: Ir-reazzjonijiet avversi huma mniżżla skond il-klassi tas-sistema ta' l-organi, bil-konvenzjoni li ġejja: 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 jistgħax ikun stmat mit-tagħrif li hemm).
English: C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
Maltese: C-memantine mogħti b'mod orali, medja ta' 84% tad-doża kienet irkuprata fi żmien 20 jum, aktar minn 99% tneħħiet ma' l-awrina.
English: Multipack containing 980 (10 packs of 98) and 1000 (20 packs of 50) film-coated tablets.
Maltese: Pakkett multiplu fih 980 (10 pakketti ta' 98) u 1000 (20 pakkett ta' 50) pillola miksijin b'rita.
English: Linearity Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Maltese: Linjarità Studji f'voluntiera wrew farmakokinetika linejari f'medda ta' dożi minn 10 sa 40 mg.
English: Tablet cores for 10/20 mg film-coated tablets: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Maltese: Il-qalba tal-pilloli miksijin b'rita ta' 5/10/15/20 mg Microcrystalline cellulose Croscacarmellose sodium Colloidal anhydrous silica Magnesium stearate
English: Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 49 x 1 tablets, 50 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 tablets, 100 x 1 tablets, 112 tablets, 980 (10 x 98) tablets or 1000 (20 x 50) tablets.
Maltese: Il-pilloli miksijin b'rita ta' Ebixa jiġu f'pakketti ta' folji b' 14-il pillola, 28 pillola, 30 pillola, 42 pillola, 49 x 1 pillola, 50 pillola, 56 pillola, 56 x 1 pillola, 70 pillola, 84 pillola, 98 pillola, 98 x 1 pillola, 100 pillola, 100 x 1 pillola, 112-il pillola, 980 (10 x 98) pillola jew 1000 (20 x 50) pillola.
English: Before you take Ebixa
Maltese: Tiħux Ebixa
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Maltese: • Għeja, infezzjonijiet tal-moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, Insufiċjenza kardijaka u emboli tad-demm fil-vini (trombożi/tromboemboliżmu)
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, m'għandux jinbiegħ separatament.
English: EU/1/02/219/035 840 (20 packs of 42) film-coated tablets EU/1/02/219/049 840 (20 packs of 42) film-coated tablets
Maltese: EU/1/02/219/035 840 (20 pakkett ta' 42) pillola miksijin b'rita EU/1/02/219/049 840 (20 pakkett ta' 42) pillola miksijin b'rita
English: - The other ingredients for Ebixa 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Ebixa 10 mg film-coated tablets is iron oxide yellow (E172) and for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Maltese: - Is-sustanzi l-oħra f'Ebixa 5/10/15 u 20 mg huma microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, li lkoll jinsabu filqalba tal-pillola; u hypromellose, macrogol 400, titanium dioxide (E 171) u kif ukoll, iron oxide isfar (E172) għall-pilloli miksijin b'rita ta' Ebixa 10 mg u iron oxide isfar u aħmar (E 172) għall-pilloli miksijin b'rita ta' Ebixa 15 mg u Ebixa 20 mg, li lkoll jinsabu fil-kisja talpilloli.
English: • The active substance is memantine hydrochloride.
Maltese: • Is-sustanza attiva hi memantine hydrochloride.
English: The pack sizes 49 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Maltese: Il-paketti bid-daqsijiet ta' 49 x 1, 56 x 1, 98 x 1 u 100 x 1 pilloli miksijin b'rita huma preżentati f'folji ta' dożi individwali.
English: BLISTER FOR TABLETS
Maltese: FOLJA GĦALL-PILLOLI
English: EU/1/02/219/021 980 (10 packs of 98) film-coated tablets EU/1/02/219/012 1000 (20 packs of 50) film-coated tablets
Maltese: EU/1/02/219/021 980 (10 pakketti ta'98) pillola miksija b'rita EU/1/02/219/012 1000 (20 pakkett ta'50) pillola miksija b'rita
English: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (or any combination with hydrochlorothiazide) - anticholinergics (substances generally used to treat movement disorders or intestinal cramps) - anticonvulsants (substances used to prevent and relieve seizures) - barbiturates (substances generally used to induce sleep) - dopaminergic agonists (substances such as L-dopa, bromocriptine) - neuroleptics (substances used in the treatment of mental disorders) - oral anticoagulants
Maltese: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma' hydrochlorothiazide) - antikolinerġiċi (sustanzi li ġeneralment jintużaw għall-kura ta' disturbi fil-movimenti jew spażmi fl-imsaren) - mediċini kontra l-aċċessjonijiet (mediċini li jintużaw biex ikunu evitati jew iserrħu l-aċċessjonijiet) - barbiturati (sustanzi li ġeneralment jintużaw biex jgħinuk torqod) - agonisti dopaminerġiċi ( sustanzi bħal L-dopa, bromocriptine) - newrolettiċi (sustanzi li jintużaw għall-kura ta' disturbi tal-moħħ) - mediċini orali kontra l-koagulazzjoni tad-demm
English: - The active substance is memantine hydrochloride.
Maltese: - Is-sustanza attiva hi memantine hydrochloride.
English: Film-coated tablets Multipack: 840 (20 packs of 42) film-coated tablets.
Maltese: Pilloli miksijin b'rita Pakkett multiplu: 840 (20 pakkett ta' 42) pillola miksija b'rita.
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substanceactive substance interaction of memantine with glyburide/metformin or donepezil was observed.
Maltese: Fi studji farmakokinetiċi b'doża waħda (PK) f'żgħażagħ b'saħħithom, ma dehrietx interazzjoni bejn sustanza attiva u oħra ta'memantine ma' glyburide/metformin jew donepezil.
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Maltese: F'voluntiera b'funzjoni tal-kliewi normali, it-tneħħija totali (Cltot) kienet 170 ml/min/1.73 m2 u parti mit-tneħħija renali totali tinkiseb b'sekrezzjoni tubulari.
English: CARTON AND LABEL FOR BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: KARTUNA GĦAL PAKKETT INTERMEDJU / KOMPONENT TA' MULTIPAKK (MINGĦAJR IL-KAXXA BLU)
English: • The other ingredients are potassium sorbate, sorbitol E420 and purified water.
Maltese: • Is-sustanzi l-oħra huma potassium sorbate, sorbitol E420 u ilma purifikat.
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Maltese: Id-doża ta' manteniment Id-doża ta' manteniment rakkomandata hi ta' 20 mg kuljum.
English: CARTON FOR BLISTER PACK
Maltese: KARTUNA U TIKKETTA GĦAL FLIXKUN BĦALA
English: Multipack containing 840 (20 x 42) film-coated tablets
Maltese: Pakkett multiplu fih 840 (20 x 42) pillola miksijin b'rita.
English: Memantine hydrochloride Week 4, Day 22 23 24 25 26 27 28 7 Film-coated tablets Ebixa 20 mg
Maltese: Memantine hydrochloride Ġimgħa 4, Jum 22 23 24 25 26 27 28 7 Pilloli miksijin b'rita Ebixa 20 mg
English: Memantine hydrochloride Week 3, Day 15 16 17 18 19 20 21 7 Film-coated tablets Ebixa 15 mg
Maltese: Memantine hydrochloride Ġimgħa 3, Jum 15 16 17 18 19 20 21 7 Pilloli miksijin b'rita Ebixa 15 mg
English: Ebixa oral solution is available in bottles of 50 ml, 100 ml or 10 x 50 ml.
Maltese: Is-soluzzjoni orali Ebixa tiġi fi fliexken ta' 50 ml, 100 ml jew 10 x 50 ml.
English: Ebixa contains the active substance memantine hydrochloride.
Maltese: Ebixa fih is-sustanza attiva memantine hydrochloride.
English: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Maltese: Pakkett wieħed li jintuża biex tinbeda l-kura fih 28 pillola f'4 folji b'7 pilloli ta' Ebixa 5 mg, 7 pilloli ta' Ebixa 10 mg, 7 pilloli ta' Ebixa 15 mg u 7 pilloli ta' Ebixa 20 mg.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, colloidal anhydrous silica, talc u magnesium stearate, kollha fil-qalbha tal-pillola; u hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow u red (E172), kollha fil-kisja tal-pillola.
English: Elevated liver function test
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Memantine hydrochloride Week 1, Day 1 2 3 4 5 6 7 7 Film-coated tablets Ebixa 5 mg
Maltese: Memantine hydrochloride Ġimgħa 1, Jum 1 2 3 4 5 6 7 7 Pilloli miksijin b'rita Ebixa 5 mg
English: Memantine hydrochloride Week 2, Day 8 9 10 11 12 13 14 7 Film-coated tablets Ebixa 10 mg
Maltese: Memantine hydrochloride Ġimgħa 2, Jum 8 9 10 11 12 13 14 7 Pilloli miksijin b'rita Ebixa 10 mg
English: The solution also contains potassium sorbate and sorbitol E420.
Maltese: Is-soluzzjoni fiha wkoll potassium sorbate u sorbitol E420.
English: Ebixa 5 mg/pump actuation oral solution.
Maltese: Ebixa 5 mg/attwazzjoni bil-pompa, soluzzjoni orali.
English: Each tablet contains 5/10/15/20 mg ofmemantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
Maltese: Kull pillola fiha 5/10/15/20 mg memantine hydrochloride li hi ekwivalenti għal 4.15/8.31/12.
English: Ebixa 20 mg tablets
Maltese: Ebixa pilloli ta' 20 mg
English: Week 3 (day 15-21) The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Maltese: Il-pazjent għandu jieħu 1.5 ml ta' soluzzjoni (15 mg) ekwivalenti għal tliet attwazzjonijiet bil-pompa kuljum għal 7 t' ijiem.
English: Alzheimer's disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Maltese: Skala ta' assessjar tal-marda Alzheimer ADAS-cog (p=0.003) u CIBIC-plus (p=0.004) f'Ġimgħa 24 bl-aħħar osservazzjonijiet miġjuba 'l quddiem (LOCF).
English: One pump actuation contains 5 mg memantine hydrochloride.
Maltese: Attwazzjoni bil-pompa waħda fiha 5 mg ta' memantine hydrochloride.
English: Ebixa 5 mg film-coated tablets Ebixa 10 mg film-coated tablets Ebixa 15 mg film-coated tablets Ebixa 20 mg film-coated tablets
Maltese: Ebixa 5 mg pilloli miksijin b'rita Ebixa 10 mg pilloli miksijin b'rita Ebixa 15 mg pilloli miksijin b'rita Ebixa 20 mg pilloli miksijin b'rita
English: Ebixa 10 mg film-coated tablets: Pack sizes of 14, 28, 30, 42, 50, 56, 70, 84, 98, 100,112 film-coated tablets.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, 30, 42, 50, 56, 70, 84, 98, 100,112-il pillola miksijin b'rita.
English: Blister: PVDC/PE/PVC/Al-blister or PP/Al-blister
Maltese: Folja: folja-PVDC/PE/PVC/Al jew folja-PP/Al Ebixa 10 mg pilloli miksijin b'rita:
English: Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Maltese: Kull attwazzjoni bil-pompa tagħti 0.5 ml ta' soluzzjoni li fiha 5 mg ta' memantine hydrochloride li hija ekwivalenti għal 4.16 mg memantine.
English: Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free.
Maltese: Minbarra hekk, din il-mediċina fiha potassium, anqas minn 1 mmol (39 mg) kull doża, i.e. tista' titqies li ma fihiex potassju.
English: In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina 3049 ml/min) id-doża għandha tkun ta' 10 mg (1 ml ta' soluzzjoni, ekwivalenti għal żewġ attwazzjonijiet bil-pompa).
English: 7 film-coated tablets of Ebixa 20 mg
Maltese: 7 pilloli miksijin b'rita ta' Ebixa 20 mg
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171) and iron oxide yellow (E172), all in the tablet coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, u magnesium stearate, kollha fil-qalba tal-pillola u hypromellose, macrogol 400, titanium dioxide (E171) u iron oxide isfar (E172), kollha fil-kisja tal-pillola.
English: Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 filmcoated tablets of 20 mg.
Maltese: Kull pakkett fih 28 pillola miksija b'rita f'4 folji ta' PVDC/PE/PVC/Al jew folji ta' PP/Al għal 7 pilloli miksijin b'rita ta' 5 mg, 7 pilloli miksijin b'rita ta' 10 mg, 7 pilloli miksijin b'rita ta' 15 mg u 7 pilloli miksijin b'rita ta' 20 mg,
English: Ebixa 10 mg tablets
Maltese: Ebixa pilloli ta' 10 mg
English: Film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 49 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 84 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 49 x 1 pillola miksija b'rita 56 pillola miksija b'rita 56 x 1 pillola miksija b'rita 70 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita 98 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita 112 pillola miksija b'rita
English: Ebixa 20 mg film-coated tablets Memantine hydrochloride
Maltese: Ebixa 20 mg pilloli miksijin b'rita Memantine hydrochloride
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 µmol) with large interindividual variations.
Maltese: Dożi ta' 20 mg kuljum jwasslu għal konċentrazzjonijiet ta' memantine fil-plażma fi stat fiss f'medda ta' bejn 70 sa 150 ng/ml (0.5 - 1µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: Ebixa 5 mg/pump actuation oral solution
Maltese: Ebixa 5 mg/attwazzjoni bil-pompa, soluzzjoni orali
English: Other medicines and Ebixa
Maltese: Mediċini oħra u Ebixa
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5 - 29 ml/min) id-doża ta' kuljum għandha tkun 10 mg kuljum.
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (fig. 6).
Maltese: Meta ras il-pompa terġa' tingħafas l-isfel kompletament (ekwivalenti għal attwazzjoni bil-pompa waħda), toħroġ id-doża korretta (fig. 6).
English: Children and adolescents Ebixa is not recommended for children and adolescents under the age of 18 years.
Maltese: Tfal u adolexxenti Ebixa mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: 7 film-coated tablets of Ebixa 15 mg
Maltese: 7 pilloli miksijin b'rita ta' Ebixa 15 mg
English: Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Ebixa jaħdem fuq dawn ir-riċetturi-NMDA u jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: Ebixa 20 mg film-coated tablets: Pack sizes of 14, 28, 42, 56, 70, 84, 98, 112 film-coated tablets.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, 42, 56, 70, 84, 98, 112-il pillola miksijin b'rita.
English: 7 film-coated tablets of Ebixa 10 mg
Maltese: 7 pilloli miksijin b'rita ta' Ebixa 10 mg
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Maltese: L-istudju wera effetti tajbin tal-kura b'memantine meta mqabbla ma' plaċebo mas-6 xahar (analiżi tal-każijiet għall-impressjoni ta' bidla skond intervista tat-tabib (CIBIC-plus): p=0.025; studju kooperattiv tal-marda Alzheimer (ADCS-ADLsev): p=0.003; Batterija ta' indeboliment sever (SIB): p=0.002).
English: Detailed information on this medicine is available on the the European Medicines Agency web site:http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Film-coated tablets 50 film-coated tablets 98 film-coated tablets
Maltese: Pilloli miksijin b'rita. 50 pillola miksijin b'rita 98 pillola miksijin b'rita
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (2 ml solution, equivalent to four pump actuations) as described above.
Maltese: Minn studji kliniċi, id-doża rakkomandata għal pazjenti li għandhom 'l fuq minn 65 sena hija 20 mg kuljum (2 ml ta' soluzzjoni, ekwivalenti għal erba' attwazzjonijiet bil-pompa) kif spjegat hawn fuq.
English: Hepatic impairment
Maltese: Indeboliment epatiku:
English: In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina 3049 ml/min) id-doża għandha tkun 10 mg kuljum.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Maltese: L-istudju wera effetti tajbin tal-kura b'memantine meta mqabbla ma' plaċebo mas-6 xahar (analiżi tal-każijiet għall-impressjoni ta' bidla skond l-intervista tat-tabib (CIBIC-plus): p=0.025; studju kooperattiv tal-marda ta' Alzheimer (ADCS-ADLsev): p=0.003; Batterija ta' indeboliment sever (SIB): p=0.002).
English: Ebixa 10 mg film-coated tablets Memantine hydrochloride
Maltese: Ebixa 10 mg pilloli miksijin b'rita memantine hydrochloride
English: Ebixa 15 mg film-coated tablets.
Maltese: Ebixa 15 mg pilloli miksijin b'rita.
English: The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Maltese: L-użu ta' prodotti mediċinali msejjħa amantadine (għat-trattament tal-marda ta' Parkinson), ketamine (sustanza li ġeneralment tingħatabħala loppju), dextromethorphan (ġeneralment użata għas-sogħla) u antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p0.0001).
Maltese: Meta pazjenti deher li marru għall-agħar fit-tlett oqsma, ir-riżultati wrew effett statistikament sinifikanti ta' memantine biex jevita li jmorru għall-agħar, darbtejn aktar mill-pazjenti ikkurati bi plaċebo hekk kif pazjenti kkurati b'memantine marru għall-agħar fit-tlett oqsma (21% vs. 11%, p0.
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Maltese: Studju pivitali b'terapija waħda f'popolazzjoni ta' pazjenti li kienu qed ibatu mill-marda ta' Alzheimer moderata għal severa (eżami żgħir ħafna ta' l-istat mentali (MMSE) punteġġ totali ta' MMSE fil-linja bażi ta' 3-14) kien jinkludi total ta' 252 outpatient.
English: Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Maltese: Il-pilloli miksijin b'rita ta' 15 mg huma oranġjo għal oranġjo griżi, pilloli miksijin b'rita li huma ovalioblong b'intaljar ta' ‘15' fuq naħa u ‘MEM' fuq naħa oħra.
English: Additional for 10 mg film-coated tablets: Iron oxide yellow
Maltese: Sustanza addizzjonali għall pilloli miksijin b'rita ta' 10 mg Iron oxide isfar
English: From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).
Maltese: Mir-4 ġimgħa 'l quddiem, id-doża li ġeneralment tingħata hija ta' 2 pilloli darba kuljum (1x20 mg).
English: Ebixa 5 mg/pump actuation oral solution Memantine hydrochloride
Maltese: Ebixa 5 mg/attwazzjoni bil-pompa, soluzzjoni orali memantine hydrochloride
English: In patients with severe renal impairment (creatinine clearance 529 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Maltese: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5-29 ml/min) id-doża għandha tkun 10 mg (1 ml ta' soluzzjoni, ekwivalenti għal żewġ attwazzjonijiet bil-pompa) kuljum.
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Maltese: Fi provi kliniċi f'pazjenti b'dimenzja ħafifa għal severa, b'1,784 pazjent ikkurat b'Ebixa u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'Ebixa ma kienitx differenti min dik tal-plaċebo; ir-reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil-qawwa.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints:
Maltese: Pazjenti kkurati b'memantine wrew effett statistikament aħjar mill-pazjenti ikkurati bi plaċebo fuq il-fini primarji:
English: Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red
Maltese: Sustanza addizzjonali għall-pilloli miksijin b'rita ta' 15 mg u 20 mg Iron oxide isfar u aħmar
English: Tablet coat for 5/10/15/20 mg film-coated tablets: Hypromellose
Maltese: Il-kisja tal-pilloli miksijin b'rita ta' 5/10/15/20 mg Hypromellose
English: From the fourth week the recommended dose is four pump actuations once daily (1x 20 mg).
Maltese: Mir-raba' ġimgħa d-doża rakkomandata hija ta' erba' attwazzjonijiet bil-pompa darba kuljum (1 x 20 mg).
English: Ebixa 5 mg film-coated tablets.
Maltese: Ebixa 5 mg pilloli miksijin b'rita.
English: Ebixa 20 mg film-coated tablets.
Maltese: Ebixa 20 mg pilloli miksijin b'rita.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli ta' CSF qablu mal-valur-ki (ki = kostanti ta' limpediment) ta' memantine, li hija 0.5µmol fil-kortiċi anterjuri tal-bniedem.
English: Tablet coat for 10/20 mg film-coated tablets: Hypromellose
Maltese: Qlub tal-pilloli għal 10/20 mg pilloli miksijin b'rita:
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Maltese: F'pazjenti b'indeboliment epatiku ħafif għal moderat (Child-Pugh A u Child-Pugh B) m'hemmx bżonn ta' tibdil fid-doża.