FrancophonIA/ELRC3.0 huggingface dataset:
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Maltese: Memantine jitneħħa b'mod mono-esponenzjali b' t½ terminali ta' 60 sa 100 siegħa.
English: Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Maltese: U KONTENUT Pakketti multipli ta' 500 ml, li jinkludu 10 pakketti, kull wieħed fih flixkun b'50 ml soluzzjoni orali.
English: Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP).
Maltese: Pakketti b'folji li fihom jew 7, 10, 14 jew 20 pillola f'kull strixxa (Alu/PP).
English: MM/YYYY
Maltese: ġimgħa
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: Memantine Merz 10 mg tablets
Maltese: Memantine Merz 10 mg pilloli
English: The active substance is memantine hydrochloride.
Maltese: Is-sustanza attiva hi memantine hydrochloride.
English: EU/1/12/799/018 840 film-coated tablets (20 packs of 42) EU/1/12/799/024 840 film-coated tablets (20 packs of 42)
Maltese: EU/1/12/799/018 840 pilloli miksijin b'rita (20 x 42) EU/1/12/799/024 840 pilloli miksijin b'rita (20 x 42)
English: Gait abnormal
Maltese: Mixja anormali
English: Titanium dioxide (E 171) Iron oxide yellow (E 172)
Maltese: Titanium dioxide (E 171) Iron oxide isfar (E 172)
English: The most frequently occurring adverse reactions with a higher incidence in the Memantine Merz 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 Merz milli filgrupp 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: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 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: • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Maltese: • Sustanzi attivi bħal cimetidine, ranitidine, procainamide, quinidine, quinine u nicotine li jużaw l-istess sistema ta' trasport ketajoniku renali bħal amantadine jistgħu ukoll jinteraġixxu ma' memantine u b'hekk jista' jkun hemm riskju ta' livelli ogħla fil-plażma.
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Maltese: Hemm rapport wieħed ta' każ li kien publikat dwar riskju li jista' jkun hemm meta memantine jingħata ma' phenytoin.
English: The volume of distribution is around 10 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa madwar 10 l/kg.
English: Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pakketti b'folji li fihom 14-il pillola miksija b'rita għal PVDC/PE/PVC/Al jew folja strixxa ta' PP/Al.
English: The other ingredients for Memantine Merz 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 Memantine Merz 10 mg film-coated tablets is iron oxide yellow (E172) and for Memantine Merz 15 mg and Memantine Merz 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Maltese: Is-sustanzi l-oħra f'Memantine Merz 5/10/15 u 20 mg microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, li lkoll jinsabu fil-qalba tal-pillola; u hypromellose, macrogol 400, titanium dioxide (E 171) u kif ukoll, iron oxide isfar (E 172) għall-pilloli miksijin b'rita ta' Memantine Merz 10 mg u iron oxide isfar u aħmar (E 172) għall-pilloli miksijin b'rita ta' Memantine Merz 15 mg u Memantine Merz 20 mg, li lkoll jinsabu fil-kisja tal-pilloli.
English: Hallucinations1
Maltese: Alluċinazzjonijiet1
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 bi tnixxija tubulari.
English: Memantine Merz 5 mg, 10 mg, 15 mg, 20 mg tablets
Maltese: Memantine Merz pilloli ta' 5 mg, 10 mg, 15 mg, 20 mg
English: 98 film-coated tablets
Maltese: U 98 PILLOLA BHALA
English: Memantine Merz contains the active substance memantine hydrochloride.
Maltese: Memantine Merzfih is-sustanza attiva memantine hydrochloride.
English: When daily doses of 5 to 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: Excipients: The oral solution contains sorbitol.
Maltese: Is-soluzzjoni orali fiha sorbitol.
English: Memantine Merz 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Maltese: Memantine Merz 5 mg, 10 mg, 15 mg, 20 mg pilloli miksija b'rita Memantine hydrochloride
English: Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Maltese: Xi fatturi li jistgħu jgħollu l-pH ta' l-awrina (ara sezzjoni 5.2 “Eliminazzjoni”) jistgħu jeħtieġu monitoraġġ bir-reqqa tal-pazjent.
English: Venous thrombosis/thromboembolism
Maltese: Trombożi fil-vini/trombo emboliżmu
English: Multipack 840 (20 packs of 42) film-coated tablets Multipack 980 (10 packs of 98) film-coated tablets Multipack 1000 (20 packs of 50) film-coated tablets
Maltese: Pakketti multipli ta' 840 (20 pakkett ta' 42) pillola miksija b'rita Pakketti multipli ta' 980 (10 pakkett ta' 98) pillola miksija b'rita Pakketti multipli ta' 1000 (20 pakkett ta' 50) pillola miksija b'rita
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Maltese: • Jista' jkun hemm possibilità ta' livelli ta' hydrochlorthiazide (HCT) imnaqqsa fis-serum meta memantine jingħata ma' HCT jew kwalunkwe taħlita ma' HCT.
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)
English: EU/1/12/799/010 840 film-coated tablets (20 packs of 42) EU/1/12/799/011 980 film-coated tablets (10 packs of 98) EU/1/12/799/012 1000 film-coated tablets (20 packs of 50)
Maltese: EU/1/12/799/010 840 pillola miksija b'rita (20 x 42) EU/1/12/799/011 980 pillola miksija b'rita (10 x 98) EU/1/12/799/012 1000 pillola miksija b'rita (20 x 50)
English: 5 mg tablet week 2
Maltese: pillola ta' 5 mg ġimgħa 2
English: H. Lundbeck AB
Maltese: Oy H. Lundbeck Ab Puh/Tel:
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Maltese: Dan jista' jgħodd ukoll għal ketamine u dextromethorphan (ara wkoll sezzjoni 4.4).
English: How the dosing pump works:
Maltese: Sustanzi mhux attivi:
English: Multipack 840 (20 packs of 42) film-coated tablets
Maltese: Pakketti multipli ta' 840 (20 pakketti ta' 42) pillola miksija b'rita
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).
Maltese: Meta ras il-pompa terġa' tingħafas l-isfel kompletament(ekwivalenti għal għafsa waħda tal-pompa), toħroġ id-doża korretta (għafsa waħda hija ekwivalenti għal 0.5 ml ta' soluzzjoni orali, u fiha madwar 5 mg tas-sustanza attiva memantine hydrochloride; fig. 6).
English: EU/1/12/799/001 EU/1/12/799/002 EU/1/12/799/003 EU/1/12/799/004 EU/1/12/799/005 EU/1/12/799/006 EU/1/12/799/007 EU/1/12/799/008 EU/1/12/799/009 EU/1/12/799/010 EU/1/12/799/011 EU/1/12/799/012
Maltese: EU/1/12/799/005 EU/1/12/799/006 EU/1/12/799/007 EU/1/12/799/008 EU/1/12/799/009 EU/1/12/799/010
English: week 1
Maltese: ġimgħa 1
English: CARTON AND LABEL FOR 50 ml BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: PAKKETT INTERMEDJU / KOMPONENT TA' MULTIPAKK (MINGĦAJR IL-KAXXA BLU)
English: 50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III).
Maltese: 50 ml (u 10 x 50 ml) fi fliexken tal-ħġieġ kannella (Idrolitiċi Klassi
English: Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins.
Maltese: Proċess renali ieħor jinvolvi ri-assorbiment tubulari, probabbli permezz ta' proteini ta' trasport katajoniċi.
English: EU/1/12/799/013 14 film-coated tablets EU/1/12/799/014 28 film-coated tablets EU/1/12/799/015 42 film-coated tablets EU/1/12/799/016 56 film-coated tablets EU/1/12/799/017 98 film-coated tablets EU/1/12/799/019 14 film-coated tablets EU/1/12/799/020 28 film-coated tablets EU/1/12/799/021 42 film-coated tablets EU/1/12/799/022 56 film-coated tablets EU/1/12/799/023 98 film-coated tablets
Maltese: EU/1/12/799/013 14 pilloli miksijin b'rita EU/1/12/799/014 28 pilloli miksijin b'rita EU/1/12/799/015 42 pilloli miksijin b'rita EU/1/12/799/016 56 pilloli miksijin b'rita EU/1/12/799/017 98 pilloli miksijin b'rita EU/1/12/799/019 14 pilloli miksijin b'rita EU/1/12/799/020 28 pilloli miksijin b'rita EU/1/12/799/021 42 pilloli miksijin b'rita EU/1/12/799/022 56 pilloli miksijin b'rita EU/1/12/799/023 98 pilloli miksijin b'rita
English: 1 g of solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: U KWANTITATTIVA 1 g tas-soluzzjoni fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
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 film-coated 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, 7 pilloli miksijin b'rita ta' 20 mg.
English: Other medicines and Memantine Merz
Maltese: Mediċini oħra u Memantine Merz
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance-active 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: 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-il 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: Memantine Merz film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipscks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Maltese: Il-pilloli Memantine Merz jiġu f'pakketti ta' folji b'14-il pillola, 28 pillola, 30 pillola, 42 pillola, 50 pillola, 56 pillola, 98 pillola, 100 pillola, 112 pillola.
English: Fungal infections
Maltese: Infezzjonijiet u infestazzjonijiet
English: Balance disorder
Maltese: Komuni disturbi tal-bilanċ
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 (E 172), kollha fil-kisja tal-pillola.
English: There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Maltese: Hemm relazzjoni possibbli bejn din l-akkumulazzjoni u l-vakwolizzazzjoni osservata fil-pulmun.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
Maltese: Fi studju b' 14C-memantine mogħti b'mod orali, medja ta' 84% tad-doża kienet irkuprata fi żmien 20 jum, aktar minn 99% tneħħiet ma' l-awrina.
English: The solution also contains potassium sorbate and sorbitol (E 420).
Maltese: Is-soluzzjoni fiha wkoll potassium sorbate u sorbitol (E 420).
English: EU/1/12/799/001 14 film-coated tablets EU/1/12/799/002 28 film-coated tablets EU/1/12/799/003 30 film-coated tablets EU/1/12/799/004 42 film-coated tablets EU/1/12/799/005 50 film-coated tablets EU/1/12/799/006 56 film-coated tablets EU/1/12/799/007 98 film-coated tablets EU/1/12/799/008 100 film-coated tablets EU/1/12/799/009 112 film-coated tablets
Maltese: EU/1/12/799/001 14-il pillola miksija b'rita EU/1/12/799/002 28 pillola miksija b'rita EU/1/12/799/003 30 pillola miksija b'rita EU/1/12/799/004 42 pillola miksija b'rita EU/1/12/799/005 50 pillola miksija b'rita EU/1/12/799/006 56 pillola miksija b'rita EU/1/12/799/007 98 pillola miksija b'rita EU/1/12/799/008 100 pillola miksija b'rita EU/1/12/799/009 112-il pillola miksija b'rita
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Maltese: Doża ta' manteniment Id-doża ta' manteniment rakkomandata hi ta' 20 mg kuljum.
English: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Memantine Merz 5 mg, 7 tablets of Memantine Merz 10 mg, 7 tablets of Memantine Merz 15 mg and 7 tablets of Memantine Merz 20 mg.
Maltese: Pakkett wieħed li jintuża biex tinbeda l-kura fih 28 pillola f'4 folji b'7 pilloli ta' Memantine Merz 5 mg, 7 pilloli ta' Memantine Merz 10 mg, 7 pilloli ta' Memantine Merz 15 mg u 7 pilloli ta' Memantine Merz 20 mg.
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: Both compounds are chemically related NMDA-antagonists.
Maltese: Iż-żewġ sustanzi huma antagonsiti-NMDA kimikament relatati.
English: In a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Maltese: Fi studju kliniku ma dehrx effett rilevanti ta' memantine fuq il-farmakokinetika ta' galantamine.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
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: The patient had received 400 mg memantine orally.
Maltese: Il-pazjent kien irċieva 400 mg memantine b'mod orali.
English: The other ingredients are: potassium sorbate, sorbitol (E 420) and purified water.
Maltese: Is-sustanzi l-oħra huma: potassium sorbate, sorbitol (E 420) u ilma purifikat.
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Maltese: Fi studju ieħor b'terapija waħda għal marda ta' Alzheimer ħafifa għal moderata, total ta' 470 pazjent (punteġġi totali MMSE mal-linja bażi ta' 11-23) kienu randomizzat.
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
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: 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
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 jistax ikun stmat mit-tagħrif li hemm).
English: Each tablet contains 5/10/15/20 mg of memantine 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: Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 5 mg memantine hydrochloride ekwivalenti għal 4.15 mg memantine.
English: Administration
Maltese: SISTEMA
English: 15 mg tablet week 4 and beyond
Maltese: pillola ta' 15 mg minn ġimgħa 4
English: EU/1/12/799/025 28 film-coated tablets EU/1/12/799/026 28 film-coated tablets
Maltese: EU/1/12/799/025 28 pilloli miksijin b'rita EU/1/12/799/026 28 pilloli miksijin b'rita
English: For detailed instructions on the preparation and handling of the product see section 6.6.
Maltese: Għal istruzzjonijiet dettaljati dwar il-preparazzjoni u l-immaniġġjar tal-prodott ara sezzjoni 6.6.
English: Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 20 mg memantine hydrochloride li hi ekwivalenti għal 16.62 mg memantine.
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. Pharmacokinetic/pharmacodynamic relationship
Maltese: Studji f'voluntiera wrew farmakokinetika linjari f'medda ta' dożi minn 10 sa 40 mg.
English: Lot {number} See embossed stamp.
Maltese: Jista' jkun li mhux il-pakketti kollha jkunu għal skop kummerċjali.
English: How to store Memantine Merz
Maltese: Tieħux Memantine Merz
English: Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 15 mg memantine hydrochloride ekwivalenti għal 12.46 mg memantine.
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Maltese: Fil-parti l-kbira tal-provi kliniċi, pazjenti li ftit qabel kellhom infart mijokardijaku, insuffiċjenza mhux kompensata tal-qalb konġestiva (NYHA III-IV), jew pressjoni għolja mhux kontrollata kienu esklużi.
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,
English: Very rare (may affect up to 1 in 10,000 users): • Seizures
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna minn kull 10,000 utenta):
English: • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Maltese: • L-użu ta' memantine u amantadine għandu jkun evitat, minħabba r-riskju ta' psikożi farmakotossika.
English: Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Maltese: Mediċini oħra ta' kontra d-dimenzja, Kodiċi ATC:
English: Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist.
Maltese: Memantine huwa anatagonist mhux kompetittiv b'affinità moderata għar-riċettur-NMDA li jiddipendi mill-vultaġġ.
English: Tél: +352 45 07 07-1
Maltese: Global Health Solutions s.à r.l. Tél: +352 45 07 07-1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20 x 42 TABLETS, 20 x 50 TABLETS AND 10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
Maltese: TIKKETTA TAT-TGEŻWIR TA' BARRA FUQ IL-MULTIPAKKS (20 x 42 PILLOLA, 20 x 50 PILLOLA U 10 x 98 PILLOLA) IMGEŻWRA FIL-FOJL (LI JINKLUDI L-KAXXA BLU)
English: 10 mg tablet week 3
Maltese: pillola ta' 10 mg ġimgħa 3
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: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita
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: 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 ta' l-għarfien, globali u funzjonali.
English: Memantine Merz 5 mg/pump actuation, oral solution
Maltese: Memantine Merz 5 mg/għafsa soluzzjoni orali