FrancophonIA/ELRC3.0 huggingface dataset:
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 oħra 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: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Maltese: Polyvinyl alcohol, Titanium dioxide (E 171), Talc, Macrogol 3350, Iron oxide isfar (E 172)
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Maltese: jgħodd ukoll għal ketamine u dextromethorphan (ara wkoll sezzjoni 4.4).
English: Estonia Tel: + 372 6652405
Maltese: Sandoz d.d. Estonia Tel: + 372 6652405
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Komuni (jaffettwa minn 1 sa 10 utenti f'100):
English: Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Maltese: Qalba tal-pillola: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica u magnesium stearate.
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' tneħħija renali ta' memantine taħt kondizzjonijiet ta' awrina alkalina tista' titnaqqas b'fattur ta' 7 għal 9 (ara sezzjoni 4.4).
English: organizacna zlozka Tel: + 421-2/48 200 600
Maltese: Slovenská republika Sandoz d.d. organizacna zlozka Tel: + 421-2/48 200 600
English: • The other ingredients are:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
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 100 film-coated tablets 112 film-coated tablets
Maltese: 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 60 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Maltese: Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Il-Greċja Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
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: The recommended maintenance dose is 20 mg per day.
Maltese: Id-doża ta' manteniment rakkomandata hi ta' 20 mg kuljum.
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: 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: 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 m u parti mit-tneħħija renali totali tinkiseb bi tnixxija tubulari.
English: Pharmacotherapeutic group: Psychoanaleptics; Other Anti-dementia drugs, ATC code: N06DX01.
Maltese: Psikoanalettiċi; Mediċini oħra ta' kontra d-dimenzja, Kodiċi ATC:
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered 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: EU/1/13/826 /007 EU/1/13/826 /008 EU/1/13/826 /009 EU/1/13/826 /010 EU/1/13/826 /011 EU/1/13/826 /015
Maltese: EU/1/13/826 /007 EU/1/13/826 /008 EU/1/13/826 /009 EU/1/13/826 /010
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Maltese: Data ta' l-ewwel awtorizzazzjoni: 22 ta' April 2013
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: 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: EXPIRY DATE EXP
Maltese: Reazzjoni avversa
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: 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 ketajoniċi.
English: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Maltese: Pilloli miksija b'rita. 28 pillola miksija b'rita 30 pillola miksija b'rita 42 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Maltese: Memantine Lek 10 mg pilloli miksija b'rita huma disponibbli f'folji PVC / PVDC-Aluminju ta '28, 30, 42, 50, 56, 60, 98, 100 u 112 pillola.
English: Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Maltese: Memantine Lek 20 mg pilloli miksija b'rita huma disponibbli fil-PVC / PVDC-aluminju f'pakketti ta 'folji ta' 28, 30, 42, 56, 98 u 100 pillola.
English: Do not take Memantine LEK
Maltese: Tieħux Memantine LEK:
English: EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
Maltese: EU/1/13/826 /007 28 pillola miksija b'rita EU/1/13/826 /008 30 pillola miksija b'rita EU/1/13/826 /009 42 pillola miksija b'rita EU/1/13/826 /010 56 pillola miksija b'rita EU/1/13/826 /011 98 pillola miksija b'rita EU/1/13/826 /015 100 pillola miksija b'rita
English: Psychotic reactions2
Maltese: Alluċinazzjonijiet1 Mhux magħruf Reazzjonijiet psikotiċi2
English: Manufacturers Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Maltese: Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greċja Manifattur:
English: Tablet coat
Maltese: Kisja tal-pillola
English: From the fourth week on, the usual dose is 2 tablets once a day (1 x 20 mg).
Maltese: Mill-raba' ġimgħa ‘l quddiem id-doża normali hija ta' 2 pilloli darba kuljum (1 x 20 mg).
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: Common Common Uncommon Very rare
Maltese: Rari ħafna
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà <Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.>
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Pharmathen S.A.
English: Common Uncommon
Maltese: Mixja anormali
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 20 mg memantine hydrochloride ekwivalenti għal 16.62 mg memantine.
English: half 10 mg tablet week 2
Maltese: nofs pillola ta' 10 mg ġimgħa 2
English: Each 20 mg tablet contains 20 mg of 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: Both active substances are chemically related NMDA-antagonists.
Maltese: Iż-żewġ sustanzi attivi huma antagonsiti-NMDA kimikament relatati.
English: representative office Latvia.
Maltese: Sandoz d.d. representative office Latvia.
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: • 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) Rari ħafna (jaffettwa anqas minn 1 f'10,000 persuna):
English: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini, Attiki Greece
Maltese: 6, Dervenakion str. 15351 Pallini, Attiki
English: Fatigue
Maltese: Konfużjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg 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: EU/1/13/826 /001 EU/1/13/826 /002 EU/1/13/826 /003 EU/1/13/826 /004 EU/1/13/826 /005 EU/1/13/826 /006 EU/1/13/826 /012 EU/1/13/826 /013 EU/1/13/826 /014
Maltese: EU/1/13/826 /006 EU/1/13/826 /012 EU/1/13/826 /013 EU/1/13/826 /014
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride li hi ekwivalenti għal 8.31 mg memantine.
English: From Week 4 on (day 22-28):
Maltese: Mir-4 ġimgħa 'l quddiem (jum 22-28):
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) oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine LEK 20 mg pilloli miksijin b'rita memantine hydrochloride
English: 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: Skala ta' assessjar tal-marda ta' Alzheimer (ADAS-cog) (p=0.003) u CIBIC-plus (p=0.004)
English: Concomitant administration of memantine with the antispasmodic medicinal products, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Maltese: Meta memantine jingħata flimkien prodotti mediċinali antispasmodiċi, dantolene jew baclofen, jista' jibdlilhom l-effetti tagħhom u jista' jkun hemm bżonn ta' bidla fid-doża.
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
Maltese: Din tiżdied għal pillola ta 10mg waħda darba kuljum (1 x10 mg) fit-tieni ġimgħa u għal pillola 1 u nofs ta
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Maltese: Memantine LEK 10 mg pilloli miksijin b'rita memantine hydrochloride
English: EU/1/13/826 /005 56 film-coated tablets
Maltese: EU/1/13/826 /005
English: No adverse reactions of memantine were noted on male and female fertility.
Maltese: Fertilità L-ebda reazzjonijiet avversi ta' memantine ma ġew innutati fuq il-fertilità maskili u femminili.
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 tal kreatinina 30 - 49 mL/min) id-doża għandha tkun 10 mg kuljum.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
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: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Maltese: Folji Aluminium-PVC/PVDC impoġġijin f'kaxex tal-kartun li fihom 28, 30, 42, 50, 56, 60, 98, 100 u 112 pillola miksija b'rita.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-immaniġġar tar-riskju (RMP) Mhux applikabbli
English: Other medicines and Memantine LEK
Maltese: Mediċini oħra u Memantine
English: Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Memantine LEK jaħdem fuq dawn ir riċetturi-NMDA u jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Maltese: Memantine LEK 10 mg pilloli miksijin b'rita Memantine LEK 20 mg pilloli miksijin b'rita memantine hydrochloride
English: Hepatic impairment
Maltese: Mhux magħruf Epatite
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: Il-pazjent kellu sintomi fuq is-sistema nervuża ċentrali fosthom, ma setgħax joqod bi kwietu, psikożi, alluċinazzjonijiet tal-vista, pro-aċċessjonijiet, ngħas, sturdament u telf mis-sensi.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Maltese: Fl-aktar każ estrem ta' doża eċċessiva, il-pazjent irnexxielu jibqa ħaj meta ħa b'mod orali 2000 mg memantine b'effetti fuq is-sistema nervuża ċentrali (koma għal 10 t'ijiem, u wara kellu diplopja u aġitazzjoni).
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi tal bilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini.
English: Headache Fatigue 1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Maltese: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: Drug hypersensitivity
Maltese: GĦAMLA KWALITATTIVA
English: Memantine LEK is for oral use.
Maltese: Memantine LEK huwa għall-użu orali.
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.
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Maltese: Folji Aluminium-PVC/PVDC impoġġijin f'kaxex tal-kartun li fihom 28, 30, 42, 56, 98 u 100 pilloli miksija b'rita.
English: Somnolence Confusion Hallucinations1
Maltese: .8 Effetti mhux mixtieqa Sommarju tal-profil tas-sigurtà
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 ta' quddiem tal-bniedem.
English: How to store Memantine LEK
Maltese: Kif jaħdem Memantine LEK
English: one 10 mg tablet week 3
Maltese: pillola waħda ta' 10 mg ġimgħa 3
English: Constipation Vomiting Pancreatitis2
Maltese: Infezzjonijiet tal-moffa
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 (rata ta' tneħħija tal-kreatinina 50-80 mL/min) m'hemmx bżonn li tinbidel id-doża.
English: • In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Maltese: • Fl-esperjenza wara t-tqegħid fis-suq, każijiet iżolati b'żidiet fil-proporzjon internazzjonali normalizzat (INR) kienu rrappurtati f'pazjenti li kienu qed jingħataw fl-istess waqt warfarin.
English: EU/1/13/826 /013 100 film-coated tablets
Maltese: EU/1/13/826 /011 EU/1/13/826 /015
English: Elevated liver function test Hepatitis
Maltese: DATA TA' REVIŻJONI TAT-TEST
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: 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: Film-coated tablet.
Maltese: Kisja tal-pillola:
English: Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Maltese: Tfal u adolexxenti Memantine LEK mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Maltese: (punteġġ totali ta' MMSE mal-linja bażi ta' 10 sa 22) kien jinkludi 403 pazjent.
English: If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Maltese: Jekk il-pazjent ikun jittollerha sew wara mill-anqas 7 t'ijiem ta' kura, id-doża tista' tiġi miżjuda sa 20 mg/jum skond l-iskema standard ta'
English: 08 October 2012
Maltese: 08 ta' Ottubru 2012
English: Mometasone Furoate Sandoz is a ‘hybrid medicine'.
Maltese: Mometasone Furoate Sandoz huwa ‘mediċina ibrida'.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ il-Pajjiżi l-Baxxi) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ il-Belġju, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Italja, il-Lussemburgu, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit, kif ukoll in-Norveġja).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks, and that the marketing authorisation can be granted in the Netherlands and in the following Member States of the EU: Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Mometasone Furoate Sandoz huma akbar mir-riskji tiegħu, u li lawtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fil-Pajjiżi l-Baxxi u fl-Istati Membri tal-UE li ġejjin: ilBelġju, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, lUngerija, l-Italja, il-Lussemburgu, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit, kif ukoll in-Norveġja.
English: The active substance, mometasone furoate, belongs to the group ‘glucocorticoids'.
Maltese: Is-sustanza attiva, mometasone furoate, tagħmel parti mill-grupp ta' ‘glukokortikojdi'.