FrancophonIA/ELRC3.0 huggingface dataset:
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: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 98 film-coated tablets 112 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 42 pilloli miksija b'rita 50 pilloli miksija b'rita 56 pillola miksija b'rita 60 pilloli miksija b'rita 98 pilloli miksija b'rita 112 pillola miksija b'rita
English: EU/1/13/824/003 28 film-coated tablets EU/1/13/824/004 30 film-coated tablets EU/1/13/824/005 42 film-coated tablets EU/1/13/824/006 50 film-coated tablets EU/1/13/824/007 56 film-coated tablets EU/1/13/824/008 60 film-coated tablets EU/1/13/824/009 98 film-coated tablets EU/1/13/824/010 112 film-coated tablets
Maltese: EU/1/13/824/003 28 pilloli miksijin b' rita EU/1/13/824/004 30 pilloli miksijin b' rita EU/1/13/824/005 42 pilloli miksijin b' rita EU/1/13/824/006 50 pilloli miksijin b' rita EU/1/13/824/007 56 pilloli miksijin b' rita EU/1/13/824/008 60 pilloli miksijin b' rita EU/1/13/824/009 98 pilloli miksijin b' rita EU/1/13/824/010 112 pilloli miksijin b' rita
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 randomizzati.
English: Nemdatine contains the active substance memantine hydrochloride.
Maltese: Nemdatine fih is-sustanza attiva memantine hydrochloride.
English: Iron oxide red and yellow (E172)
Maltese: Iron oxide aħmar u isfar (E172)
English: STATEMENT OF ACTIVE SUBSTANCE(S) memantine hydrochloride
Maltese: ATTIVA memantine hydrochloride
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 ħafifa għal severa, b'1,784 pazjent ikkurat b'memantine u 1,595 pazjent ikkurati 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: The 20 mg tablets furthermore contain iron oxide red and yellow (E172).
Maltese: Ilpilloli ta '20 mg minbarra dan li fihom iron oxide aħmar u isfar (E172).
English: Pharmacotherapeutic group: Psychoanaleptics, other Anti-dementia drugs, ATC code: N06DX01.
Maltese: Psikoanalettiċi, mediċini oħra ta' kontra d-dimenzja, Kodiċi ATC:
English: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg pilloli miksijin b' rita memantine hydrochloride
English: Each tablet contains 5, 10, 15 or 20 mg of memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine.
Maltese: Kull pillola fiha 5, 10, 15, jew 20 mg memantine hydrochloride li hi ekwivalenti għal 4.15, 8.31, 12.46 jew 16.62 mg memantine.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: 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)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini (EMA) http://www.ema.europa.eu/
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 linejari f'medda ta' dożi minn 10 sa 40 mg.
English: engraved on one side.
Maltese: fuq naħa waħda.
English: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Maltese: L-użu fl-istess ħin ta' antagonisti-N-methyl-D-aspartate (NMDA)- antagonisti oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
English: Elevated liver function test Not known Hepatitis
Maltese: Test tal-funzjoni tal-fwied għoli Mhux magħruf Epatite
English: INFORMATION IN BRAILLE Nemdatine 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nemdatine 15 mg
English: INFORMATION IN BRAILLE Nemdatine 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nemdatine 5 mg
English: - The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate.
Maltese: Qalba tal-pillola: Microcrystalline cellulose, crospovidone tip A talc, u magnesium stearate.
English: Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Maltese: HypromelloseH 6cP Titanium dioxide (E171) Lactose monohydrate MacrogolM 3350
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: 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: ANNEX II
Maltese: Ħadd
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 - 1 µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Maltese: Pillola kisja (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 u triacetin.
English: INFORMATION IN BRAILLE Nemdatine 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nemdatine 10 mg
English: You may experience increased symptoms as described in section 4 ‘Possible side effects'.
Maltese: Jista' jkollok aktar sintomi li hemm imsemmija f'sezzjoni 4. “Effetti sekondarji li jista' jkollu”.
English: Two 5 mg tablets
Maltese: 2 pilloli ta' 5 mg
English: Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Maltese: Pillola kisja: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 u triacetin.
English: 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Maltese: 28 pillola miksija b'rita 42 pilloli miksija b'rita 56 pillola miksija b'rita 98 pilloli miksija b'rita
English: From Week 4 on:
Maltese: It-tieni ġimgħa:
English: HDPE bottle: 100 film-coated tablets.
Maltese: Flixkun tal-HDPE: 100 pillola miksija b'rita.
English: Nemdatine 10 mg and 20 mg film-coated tablets:
Maltese: Nemdatine 10 mg u 20 mg pilloli miksija b'rita:
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: Iron oxide yellow, red and black (E172)
Maltese: Iron oxide isfar, aħmar u iswed (E172)
English: No adverse reactions of memantine were noted on male and female fertility.
Maltese: Fertilità Ma dehru l-ebda reazzjonijiet avversi ta' memantine fuq il-fertilità maskili u femminili.
English: EU/1/13/824/014 28 film-coated tablets EU/1/13/824/015 42 film-coated tablets EU/1/13/824/016 56 film-coated tablets EU/1/13/824/017 98 film-coated tablets
Maltese: EU/1/13/824/014 28 pilloli miksijin b' rita EU/1/13/824/015 42 pilloli miksijin b' rita EU/1/13/824/016 56 pilloli miksijin b' rita EU/1/13/824/017 98 pilloli miksijin b' rita
English: Week 4: 7 film-coated tablets of Nemdatine 20 mg
Maltese: Ġimgħa 4: 7 pilloli miksijin b'rita ta '20 mg Nemdatine
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
Maltese: Ġimgħa 3 (jum 15-21) Ħu pillola waħda kuljum ta' 15 mg (oranġjo, ovali) għal 7 t'ijiem.
English: One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg.
Maltese: Pakkett wieħed bidu tal-kura fih 28 pillola f'4 folji f' kartellun jew f' pakkett multiplu li jkun fih 4 folji ġo 4 kartuni immedjati separati u kartuna waħda ta' barra b'7 pilloli ta '5 mg Nemdatine, 7 pilloli ta' 10
English: Treatment initiation pack.
Maltese: Pakkett għall-bidu Trattament.
English: Week 4 (day 22-28): Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.
Maltese: Ġimgħa 4 (jum 22-28) Ħu pillola waħda kuljum ta' 20 mg (roża skur, ovali) għal 7 t'ijiem
English: Hypertension Uncommon Venous thrombosis/thromboembolism
Maltese: Trombożi fil-vini/trombo emboliżmu
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<0.0001).
English: EU/1/13/824/001 EU/1/13/824/002 EU/1/13/824/003 EU/1/13/824/004 EU/1/13/824/005 EU/1/13/824/006 EU/1/13/824/007 EU/1/13/824/008 EU/1/13/824/009 EU/1/13/824/010 EU/1/13/824/019 EU/1/13/824/011 EU/1/13/824/012 EU/1/13/824/013 EU/1/13/824/014 EU/1/13/824/015 EU/1/13/824/016 EU/1/13/824/017 EU/1/13/824/020
Maltese: EU/1/13/824/019 EU/1/13/824/011 EU/1/13/824/012 EU/1/13/824/013 EU/1/13/824/014
English: Blister packs: 28, 42, 56 and 98 film-coated tablets.
Maltese: Pakketti b'folji: 28, 42, 56 u 98 pillola miksija b'rita.
English: Week 2: 7 film-coated tablets of Nemdatine 10 mg
Maltese: Ġimgħa 2: 7 pilloli miksijin b'rita ta '10 mg Nemdatine
English: How to take Nemdatine
Maltese: Tieħux Nemdatine
English: Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.
Maltese: Ġimgħa 2 (jum 8-14) Ħu pillola waħda ta' 10 mg kuljum (bajda, b'forma ta' kapsula) għal 7 t'ijiem.
English: Breast-feeding
Maltese: TAL-BIDU
English: Week 3: 7 film-coated tablets of Nemdatine 15 mg
Maltese: Ġimgħa 3: 7 pilloli miksijin b'rita ta '15 mg Nemdatine
English: In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - 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: Għandek tgħarraf lit-tabib tiegħek jekk dan l-aħħar bdilt id-dieta tiegħek jew bi ħsiebek tibdel id-dieta tiegħek b'mod sostanzjali (eż. minn dieta normali għal waħda veġetarjana stretta) jew jekk qed tbati minn stat ta' aċidożi tubulari renali (RTA, jiżdiedu s-sustanzi li jiffurmaw l-aċidu fid-demm minħabba funzjoni renali batuta (il-kliewi ma jaħdmux tajjeb)) jew infezzjonijiet severi tal-passaġġ awrinarju, (struttura li minnha tgħaddi l-awrina) għax it-tabib tiegħek jista' jkollu bżonn jibdel id-doża tal-mediċina tiegħek.
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 ekwivalenti għal 16.62 mg memantine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Maltese: Nemdatine jaħdem fuq dawn ir-riċetturi-NMDA u jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: Uncommon (affects 1 to 10 users in 1,000) - 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 abnormali, Insufiċjenza kardijaka u tagħqid tad-demm fil-vini (trombożi/tromboemboliżmu) Rari ħafna (jaffettwa anqas minn 1 f'10,000 persuna)
English: Nemdatine 20 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 20 mg pilloli memantine hydrochloride
English: Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Maltese: Pillola coat (Opadry II roża 33G240000): Hypromellose 6cP-dijossidu tat-titanju (E171), lactose monohydrate, macrogol 3350, triacetin u iron oxide aħmar u isfar (E172).
English: Reykjavíkurvegi 78 220 Hafnarfjörður
Maltese: Reykjavíkurvegi 78 220
English: 7 film-coated tablets of Nemdatine 20 mg
Maltese: 7 pilloli miksijin b'rita ta' 20 mg Nemdatine
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 15 mg memantine hydrochloride ekwivalenti għal 12.46 mg memantine.
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
Maltese: Ġimgħa 1 (jum 1-7) Ħu pillola waħda ta' 5 mg kuljum (bajda, ovali) għal 7 t'ijiem.
English: Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Maltese: Il-pilloli Nemdatine miksijin b'rita ta' 10 mg huma bojod, f'għamla ta' kapsula bi konvessi ta' daqs ta' 9,8 mm x 4.9 mm, b'qasma u b'marka ta' ‘M10' fuq naħa waħda.
English: CARTON FOR BLISTER PACK
Maltese: Daqsijiet tal-pakkett
English: Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.
Maltese: Daqsijiet tal-pakkett Pakketti b'folji: 7, 42 u 98 pillola miksija b'rita.
English: The tablet can be divided into equal doses.
Maltese: mediċini magħrufa bħala mediċini kontra d-dimenzja.
English: Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Maltese: Kull pillola fiha 5 mg memantine hydrochloride ekwivalenti għal 4.15 mg memantine.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Maltese: Tużax Nemdatine wara d-data ta' skadenza li tidher fuq il-kartuna u l-folja wara EXP.
English: Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Maltese: Pillola miksija b'rita, oranġjo, għamla ovali, ibbuzzata fuq iż-żewġ naħat, b'daqs ta' 11.4 mm x 6.4 mm, bil-marka “M15” imnaqqxa fuq naħa waħda.
English: Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 film-coated tablets of Nemdatine 5 mg 7 film-coated tablets of Nemdatine 10 mg 7 film-coated tablets of Nemdatine 15 mg 7 film-coated tablets of Nemdatine 20 mg
Maltese: Kull pakkett fih 28 pillola miksija b'rita (7 pilloli miksija b'rita ta '5 mg, 7 pilloli miksijin b'rita ta' 10 mg, 7 pilloli miksijin b'rita ta '15 mg u 7 pilloli miksija b'rita ta' 20 mg).
English: Nemdatine 5 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 5 mg pilloli memantine hydrochloride
English: Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Maltese: Il-pilloli Nemdatine miksijin b'rita ta' 20 mg huma roża skur, pilloli miksijin b'rita li huma ovali, bi konvessi, ta' daqs ta' 12.6 mm x 7 mm, b'marka ta' ‘M20' fuq naħa waħda.
English: Blister packs: 7, 42 and 98 film-coated tablets.
Maltese: Pakketti b'folji: 7, 42 u 98 pillola miksija b'rita.
English: Additional for 15 mg film-coated tablets Iron oxide yellow, red and black (E172) Additional for 20 mg film-coated tablets Iron oxide red and yellow (E172)
Maltese: Il-pilloli 15 mg minbarra dan li fihom iron oxide isfar, aħmar u iswed (E172).
English: What Nemdatine looks like and contents of the pack Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Maltese: Il-pilloli Nemdatine miksijin b'rita ta' 15 mg huma oranġjo, pilloli miksijin b'rita li huma ovali, bi konvessi, ta' daqs ta' 11.4 mm x 6.4 mm, b'marka ta' ‘M15' fuq naħa waħda.
English: Nemdatine 20 mg film-coated tablets:
Maltese: Nemdatine 20 mg pilloli miksija b'rita:
English: Excipient(s) with known effect:
Maltese: Eċċipjent (i) b'effett magħruf:
English: Nemdatine 15 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 15 mg pilloli memantine hydrochloride
English: Nemdatine 10 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 10 mg pilloli memantine hydrochloride
English: Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets memantine hydrochloride
Maltese: Nemdatine 5 mg pilloli miksijin b'rita Nemdatine 10 mg pilloli miksijin b'rita Nemdatine 15 mg pilloli miksijin b'rita Nemdatine 20 mg pilloli miksijin b'rita memantine hydrochloride
English: Uncommon Fatigue
Maltese: Mixja anormali
English: White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Maltese: Pilloli miksijin b'rita, bojod, f'għamla ta' kapsula bi konvessi ta' daqs ta' 9,8 mm x 4.9 mm, b'qasma u b'marka ta' ‘M10' fuq naħa waħda.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) once a day) as described above.
Maltese: Minn studji kliniċi, id-doża rakkomandata għal pazjenti li għandhom 'l fuq minn 65 sena hija 20 mg kuljum (erba' pilloli miksija b'rita ta' 5 mg (20 mg), żewġ pilloli miksija b'rita ta' 10 mg (20 mg) jew pillola waħda miksija b'rita ta' 20 mg (20 mg) darba kuljum) kif spjegat hawn fuq.
English: < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: (≥1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma jistax ikun stmat mit-tagħrif li hemm).
English: Tablet cores for 5, 10, 15 and 20 mg film-coated tablets
Maltese: Il- qalba tal-pilloli għal 5, 10, 15, u 20 mg miksija b'rita
English: Tablet coat for 20 mg film-coated tablets
Maltese: 'l quddiem pillola ta' 20 mg darba kuljum
English: Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Maltese: Pillola miksija b'rita, roża skura, għamla ovali, ibbuzzata fuq iż-żewġ naħat, b'daqs ta' 12.6 mm x 7 mm, bil-marka “M20” imnaqqxa fuq naħa waħda.
English: Pack sizes Blister packs: 42 and 98 film-coated tablets.
Maltese: Daqsijiet tal-pakkett Pakketti b'folji: 42 u 98 pilloli miksija b'rita.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
Maltese: KARTUNA U KARTIERA GĦAL 28 PILLOLA - PAKKETT GĦAL TRATTAMENT TAL
English: Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets
Maltese: Nemdatine 5 mg pilloli miksija b'rita Nemdatine 10 mg pilloli miksija b'rita Nemdatine 15 mg pilloli miksija b'rita Nemdatine 20 mg pilloli miksija b'rita
English: 7 film-coated tablets of Nemdatine 15 mg
Maltese: 7 pilloli miksijin b'rita ta' Nemdatine 5 mg
English: 7 film-coated tablets of Nemdatine 10 mg
Maltese: 7 pilloli miksijin b'rita ta' 10 mg Nemdatine
English: Not known Pancreatitis2
Maltese: Adult Tittrazzjoni tad-doża
English: In patients with mildly impaired renal function (creatinine clearance 50 − 80 ml/min) no dose adjustment is required.
Maltese: F'pazjenti b'funzjoni renali indebolita b'mod ħafif (tneħħija tal-kreatinina 50-80 ml/min) m'hemmx bżonn li tinbidel id-doża.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Maltese: FOLJA GĦALL-PILLOLI - PAKKETT GĦAL TRATTAMENT TAL-BIDU -TRATTAMENT SKEDAT FUQ 4 ĠIMGĦAT
English: Tablet coat for 5 mg and 10 mg film-coated tablets
Maltese: 'l quddiem2 pilloli ta' 10 mg darba kuljum
English: OTHER
Maltese: ħ
English: Film-coated tablet (tablet).
Maltese: Pillola waħda kuljum.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 ° C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/011 7 film-coated tablets EU/1/13/824/012 42 film-coated tablets EU/1/13/824/013 98 film-coated tablets
Maltese: FIS-SUQ EU/1/13/824/001 42 pilloli miksijin b'rita EU/1/13/824/002 98 pilloli miksijin b' rita
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 il-pazjenti wrew sintomi li kienu ġejjin mis-sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni,
English: Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Maltese: Nemdatine 15 mg pilloli miksija b'rita Pilloli miksijin b'rita, oranġjo, ovali, bi konvessi, ta' daqs ta' 11.4 mm x 6.4 mm, b'marka ta' ‘M15'
English: The maximum daily dose is 20 mg per day.
Maltese: Id-doża massima ta' gurnata hi ta' 20 mg kuljum.
English: Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg
Maltese: Bidu tal-kura pakkett ta '28 (4x7) pillola miksija b'rita għal 4 iskeda tat-trattament fil-ġimgħa:
English: Nemdatine 20 mg film-coated tablets
Maltese: Nemdatine 20 mg pilloli miksija b'rita
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: 3 -14) kien jinkludi total ta' 252 outpatient.