FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali li għalihom id-data ta' bijoekwivalenza jew il-ġustifikazzjoni ma ġewx sottomessi jew ġew ikkunsidrati bħala mhux biżżejjed mis-CHMP sabiex tiġi stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE għandhom jiġu sospiżi, billi d-dettalji li jappoġġjaw l-awtorizzazzjonijiet għattqegħid fis-suq mhumiex korretti u li l-bilanċ bejn il-benefiċċju u r-riskju ta' dawn lawtorizzazzjonijiet għat-tqegħid fis-suq mhuwiex meqjus favorevoli skont l-Artikolu 116 tadDirettiva 2001/83/KE.
English: Ergates Industrial Area, 2643 Nicosia Cyprus
Maltese: Ergates Industrial Area, 2643 Nicosia Ċipru
English: Date of latest renewal: 3rd August 2018
Maltese: Data tal-aħħar tiġdid: 3 ta 'Awissu 2018
English: 20days, more than 99 % being excreted renally.
Maltese: 20 jum, aktar minn 99 % tneħħiet mal-awrina.
English: Iron oxide yellow and red (E 172)
Maltese: Iron oxide isfar u aħmar (E 172)
English: 319 Pinner Road North Harrow Middlesex, HA1 4HF United Kingdom
Maltese: 319 Pinner Road North Harrow HA1 4HF
English: Memantine Accord 5 mg, 10 mg, 15 mg; 20 mg film-coated tablets
Maltese: Memantine Accord 5 mg, 10 mg, 15 mg; 20 mg
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: PVC/PE/PVDC-aluminium blister
Maltese: Folja tal-aluminju-PVC/PE/PVDC
English: About 45 % of memantine is bound to plasma-proteins.
Maltese: Madwar 45 % ta' memantine jeħel mal-proteini tal-plażma.
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 ta' Alzheimer (ADAS-cog) (p = 0.003) u CIBIC-plus (p = 0.004) f'Ġimgħa 24 bl-aħħar osservazzjoni miġjuba 'l quddiem (LOCF).
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 3rd August 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 04-12-2013 Data tal-aħħar tiġdid: 3 ta 'Awissu 2018
English: Do not take Memantine Accord:
Maltese: Tiħux Memantine Accord:
English: Very Rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa wieħed minn kull 10,000 persuna):
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60-100hours.
Maltese: Memantine jitneħħa b'mod mono-esponenzjali b' t½ terminali ta' 60 sa 100 siegħa.
English: Not known Psychotic reactions2
Maltese: Alluċinazzjonijiet1 Reazzjonijiet psikotiċi2
English: Week 2 (day 8-14):
Maltese: It-2 ġimgħa (jum 8-14):
English: Week 3 (day 15-21):
Maltese: It-3 ġimgħat (jum 15-21):
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10-40 mg.
Maltese: Studji f'voluntiera wrew farmakokinetika linjari f'medda ta' dożi minn 10 sa 40 mg.
English: BLISTER FOR TABLETS
Maltese: FOLJA GĦAL PILLOLI
English: Week 1 Week 2 Week 3 Week 4
Maltese: Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 Ġimgħa 4
English: MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Maltese: FIS-SUQ Accord Healthcare S.L.U.
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: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxymemantine, 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: Memantine Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminium blister) of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets and 112 tablets.
Maltese: Il-pilloli miksija b'rita ta Memantine Accord huma disponibbli f'pakketti b'folji ta' 14 pillola, 28 pillola, 30 pillola, 42 pillola, 50 pillola, 56 pillola, 98 pillola, 100 pillola u 112 pillola (folja talaluminju-PVC/PE/PVDC).
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 skont il-klassi tas-sistema tal-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 jistax ikun stmat mit-tagħrif li hemm).
English: CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE
Maltese: KARTUNA GĦAL 28 PILLOLA - PAKKETT GĦALL-BIDU TAT-TRATTAMENTTRATTAMENT SKEDAT FUQ 4 ĠIMGĦAT
English: Memantine Accord contains the active substance memantine hydrochloride.
Maltese: Memantine Accord fih is-sustanza attiva memantine hydrochloride.
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7-9 (see section 4.4).
Maltese: Ir-rata ta' eliminazzjoni renali ta' memantine taħt kondizzjonijiet ta' awrina alkalina tista' titnaqqas b'fattur ta' 7 għal 9 (ara sezzjoni 4.4).
English: When daily doses of 5-30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Maltese: Meta ngħataw dożi ta' 5 sa 30 mg kuljum, il-proporzjon tal-medja ta' fluwidu ċerebrospinali (CSF)/serum kien kalkolat 0.52.
English: EU/1/13/880/013 28 film-coated tablets
Maltese: EU/1/13/880/013 28 pillola miksija b'rita
English: Other medicines and Memantine Accord
Maltese: Mediċini oħra u Memantine Accord
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 skont 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: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Memantine Accord 5 mg, 7 tablets of Memantine Accord 10 mg, 7 tablets of Memantine Accord 15 mg and 7 tablets of Memantine Accord 20 mg.
Maltese: Pakkett ta' bidu tal-kura fih 28 pillola f'4 folji b'7 pilloli ta' 5 mg ta' Memantine Accord, 7 pilloli ta' 10 mg ta' Memantine Accord, 7 pilloli ta' 15 mg ta' memanine u 7 pilloli ta' 20 mg ta' Memantine Accord.
English: Blister packs containing 28 tablets with 7 tablets of 5 mg, 7 tablets of 10 mg, 7 tablets of 15 mg and 7 tablets of 20 mg.
Maltese: Folji tal-aluminju li fihom 28 pillola b'7 pilloli ta' 5 mg, 7 pilloli ta' 10 mg, 7 pilloli ta' 15 mg u 7 pilloli ta' 20 mg.
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, insuffiċjenza tal-qalb u emboli tad-demm fil-vini (trombożi/tromboemboliżmu)
English: Week 1 (day 1-7):
Maltese: L-1 ġimgħa (jum 1-7):
English: Film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 56 x 1 film-coated tablets 98 x 1 film-coated tablets
Maltese: Pilloli miksijin b'rita. 14 x 1 pilloli miksijin b'rita 28 x 1 pilloli miksijin b'rita 56 x 1 pilloli miksijin b'rita 98 x 1 pilloli miksijin b'rita
English: Excipientwith known effect: each film-coated tablet contains 73.80 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita fiha 73.80 mg lactose (bħala monohydrate).
English: Memantine Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminium blister) of 14 tablets, 28 tablets, 42 tablets, 56 tablets and 98 tablets.
Maltese: Il-pilloli miksija b'rita ta' memantine jiġu f'pakketti ta' folji bi 14 pillola, 28 pillola, 42 pillola, 56 pillola u 98 pillola (folji tal-aluminju-PVC/PE/PVDC).
English: Balance disorders Uncommon Gait abnormal Very rare
Maltese: Komuni Komuni Mhux komuni Rari ħafna
English: United Kingdom
Maltese: Ngħas
English: How to store Memantine Accord 6.
Maltese: Kif taħżen Memantine Accord 6.
English: Date of first authorisation: 04 December 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 04-12-2013
English: EU/1/13/880/009 EU/1/13/880/010 EU/1/13/880/011 EU/1/13/880/012 EU/1/13/880/015 EU/1/13/880/020 EU/1/13/880/021 EU/1/13/880/022 EU/1/13/880/023
Maltese: EU/1/13/880/009 EU/1/13/880/010 EU/1/13/880/011 EU/1/13/880/012 EU/1/13/880/015
English: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine - The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), all in the tablet coating
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, kollha fil-qalba tal-pillola; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), kollha fil-kisja tal-pillola.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa wieħed minn kull 100 persuna):
English: Memantine Accord 10 mg tablets are also available in perforated unit dose calendar blister in pack-sizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Maltese: Memantine Accord 10 mg pilloli huma disponibbli wkoll f'folja perforata ta' doża waħda b'kalendarju f'daqsijiet tal-pakkett ta' 14x1, 28x1, 56x1 jew 98x1 pillola.
English: Memantine Accord 20 mg tablets are also available in perforated unit dose calendar blister in packsizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Maltese: Memantine Accord 20 mg pilloli huma disponibbli wkoll f'folja perforata ta' doża waħda b'kalendarju f'daqsijiet tal-pakkett ta' 14x1, 28x1, 56x1 jew 98x1 pillola.
English: 7 film-coated tablets, Memantine Accord 5 mg 7 film-coated tablets, Memantine Accord 10 mg 7 film-coated tablets, Memantine Accord 15 mg 7 film-coated tablets, Memantine Accord 20 mg
Maltese: 7 pilloli miksijin b'rita, Memantine Accord 5 mg 7 pilloli miksijin b'rita, Memantine Accord 10 mg 7 pilloli miksijin b'rita, Memantine Accord 15 mg 7 pilloli miksijin b'rita, Memantine Accord 20 mg
English: Hypertension Uncommon Venous thrombosis/thromboembolism
Maltese: Pressjoni għolja Trombożi fil-vini/tromboemboliżmu
English: Each film-coated tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine - The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), and additional for Memantine Accord 15 mg and Memantine Accord 20 mg film-coated tablets iron oxide yellow and red (E 172), all in the tablet coating
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, li lkoll jinsabu fil-qalba tal-pillola; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171) u kif ukoll għal Memantine Accord 15 mg u Memantine Accord 20 mg pilloli miksija b'rita iron oxide isfar u aħmar (E 172), li lkoll jinsabu fil-kisja tal-pilloli.
English: Excipientwith known effect: each film coated tablet contains 183.13 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita fiha 183.13 mg lactose (bħala monohydrate).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji ta' intolleranza rari għal galattożju, defiċjenza ta' lattożju Lapp jew malassorbiment ta' galattożju tal-glukożju ma għandhomx jieħdu dan il-prodott.
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 (rata ta' tneħħija tal-kreatinina 5-29 ml/min) id-doża ta' kuljum għandha tkun 10 mg kuljum.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Maltese: Fil-każijiet ta' doża eċċessiva taħt il-140 mg jew doża mhux magħrufa l-pazjenti wrew sintomi li kienu ġejjin mis-sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni, u disturbi fil-qagħda tal-mixi) u/jew ta' natura gastro-intestinali (rimettar u dijarea).
English: In man, about 80 % of the circulating memantine-related material is present as the parent compound.
Maltese: Fil-bniedem, madwar 80 % tal-materjal li għandu x'jaqsam ma' memantine li jkun fiċ-ċirkolazzjoni jinsab bħala s-sustanza mhux mibdula.
English: Dizziness
Maltese: Konfużjoni
English: Silica, colloidal anhydrous
Maltese: Microcrystalline cellulose Silica, colloidal anhydrous Crospovidone Magnesium stearate
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Maltese: 14 pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 42 pillola miksija b'rita 50 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita
English: EU/1/13/880/001 28 film-coated tablets EU/1/13/880/002 30 film-coated tablets EU/1/13/880/003 42 film-coated tablets EU/1/13/880/004 50 film-coated tablets EU/1/13/880/005 56 film-coated tablets EU/1/13/880/006 98 film-coated tablets EU/1/13/880/007 100 film-coated tablets EU/1/13/880/008 112 film-coated tablets EU/1/13/880/014 14 film-coated tablets
Maltese: EU/1/13/880/001 28 pillola miksija b'rita EU/1/13/880/002 30 pillola miksija b'rita EU/1/13/880/003 42 pillola miksija b'rita EU/1/13/880/004 50 pillola miksija b'rita EU/1/13/880/005 56 pillola miksija b'rita EU/1/13/880/006 98 pillola miksija b'rita EU/1/13/880/007 100 pillola miksija b'rita EU/1/13/880/008 112-il pillola miksija b'rita EU/1/13/880/014 14 pillola miksija b'rita
English: • Inflammation of the pancreas, inflammation of the liver and psychotic reactions
Maltese: • Infjammazzjoni tal-frixa, infjammazzjoni tal-fwied u reazzjonijiet psikotiċi
English: EU/1/13/880/020 14 x 1 film-coated tablets EU/1/13/880/021 28 x 1 film-coated tablets EU/1/13/880/022 56 x 1 film-coated tablets EU/1/13/880/023 98 x 1 film-coated tablets
Maltese: EU/1/13/880/020 14 x 1 pilloli EU/1/13/880/021 28 x 1 pilloli EU/1/13/880/022 56 x 1 pilloli EU/1/13/880/023 98 x 1 pilloli
English: Memantine Accord film-coated tablets are also available in perforated unit dose calendar blister in pack-sizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Maltese: Memantine Accord pilloli miksijin b'rita huma disponibbli wkoll f'folji perforati ta' doża waħda b'kalendarju f'daqsijiet tal-pakkett ta' 14x1, 28x1, 56x1 jew 98x1 pillola.
English: Memantine Accord belongs to a group of medicines known as anti-dementia medicines.
Maltese: Memantine Accord jagħmel parti minn grupp ta' mediċini magħrufa bħala mediċini kontra ddimenzja.
English: Excipientwith known effect: each film-coated tablet contains 295.18 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita fiha 221.39 mg lactose (bħala monohydrate).
English: From the fourth week on, the usual dose is 2tablets once a day (1 x 20 mg).
Maltese: Mir-4 ġimgħa 'l quddiem, id-doża li ġeneralment tingħata hija ta' 2 pilloli 1 darba kuljum (1 x 20 mg).
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10-22) included 403 patients.
Maltese: Studju pivitali b'terapija waħda ta' memantine fil-kura tal-marda ta' Alzheimer ħafifa għal moderata (punteġġ totali ta' MMSE mal-linja bażi ta' 10 sa 22) kien jinkludi 403 pazjent.
English: Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: 7 x Memantine Accord 5 mg
Maltese: Kull pakkett ta' 28 pillola miksija b'rita għal trattament skedat ta' 4 ġimgħat fih: 7 x Memantine Accord 5 mg
English: Memantine Accord is not recommended for children and adolescents under the age of 18 years.
Maltese: Memantine Accord mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70-150 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 - 1 µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (orange to grey-orange) for 7 days.
Maltese: Ġimgħa 3 (jum 15-21) Ħu pillola miksija b'rita waħda kuljum ta' 15 mg (oranġjo għal oranġjo griża) għal 7 t'ijiem.
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine 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 severa għal moderata, b'1,784 pazjent ikkurat b'memantine u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'memantine ma kinitx differenti min dik tal-plaċebo; ir-reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil-qawwa.
English: Memantine Accord 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine Accord 20 mg pilloli miksijin b'rita memantine hydrochloride
English: The 20 mg film-coated tablets are pale red to grey-red, oblong, scored, coated tablets, debossed with "MT" divided by the score on one side and "20" divided by the score on the other side.
Maltese: Pillola ħamra ċara għal ħamra griża, tawwalija, immarkata u miksija, imnaqqxa bl-ittri “MT”, maqsuma biċ-ċifra fuq naħa u "20" maqsuma miċ-ċifra fuq in-naħa l-oħra.
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores <20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Maltese: III kontrollati bi plaċebo li damu 6-xhur (inklużi studji b'monoterapija u studji b'pazjenti fuq doża stabbli ta' inibituri ta' acetylcholinesterase) wriet li kien hemm effett statistikament sinifikanti favur il-kura b'memantine fil-qasam tal-għarfien, globali u funzjonali.
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali moderat (rata ta' tneħħija talkreatinina 30-49 ml/min) id-doża għandha tkun 10 mg kuljum.
English: • Seizures
Maltese: • Aċċessjonijiet.
English: EU/1/13/880/016 14 x 1 film-coated tablets EU/1/13/880/017 28 x 1 film-coated tablets EU/1/13/880/018 56 x 1film-coated tablets EU/1/13/880/019 98 x 1film-coated tablets
Maltese: EU/1/13/880/016 14 x 1 pilloli miksijin b'rita EU/1/13/880/017 28 x 1 pilloli miksijin b'rita EU/1/13/880/018 56 x 1 pilloli miksijin b'rita EU/1/13/880/019 98 x 1 pilloli miksijin b'rita
English: Memantine Accord 5 mg film-coated tablets Memantine Accord 10 mg film-coated tablets Memantine Accord 15 mg film-coated tablets Memantine Accord 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine Accord 5 mg pilloli miksijin b'rita Memantine Accord 10 mg pilloli miksijin b'rita Memantine Accord 15 mg pilloli miksijin b'rita Memantine Accord 20 mg pilloli miksijin b'rita memantine hydrochloride
English: Film-coated tablets.
Maltese: Pillola waħda kuljum.
English: INNER CARTON FOR BLISTER PACK
Maltese: KARTUNA GĦAL PAKKETT TA' FOLJI
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 tal-istat mentali (MMSE) punteġġ totali fil-linja bażi ta' 3 - 14) kien jinkludi total ta' 252 outpatient.
English: Memantine Accord 10 mg film-coated tablets memantine hydrochloride
Maltese: Memantine Accord 10 mg pilloli miksijin b'rita memantine hydrochloride
English: 15 mg tablet week 4 and beyond 20 mg tablets once a day Maintenance dose
Maltese: pillola ta' 15 mg minn ġimgħa 4 'l quddiem pillola ta' 20 mg darba kuljum
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Memantine Accord acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Memantine Accord jaħdem fuq dawn irriċetturi-NMDA u jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.