qanastek/EMEA-V3 huggingface dataset:
Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Għalkemm ma ġietx stabilita r- relazzjoni mal- kawża, monitoraġġ tal- ħin ta ’ protrombin jew INR ikun aħjar għal pazjenti li jkunu qed jiġu kkurati b’ mediċini kontra l- koagulazzjoni orali.
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.
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.
In a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Fi studju kliniku li sar fuq pazjenti żgħażagħ b’ saħħithom ma dehrx effett rilevanti ta ’ memantine fuq il- farmakokinetika ta ’ galantamine.
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Memantine m’ għamilx impediment fuq CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monoxygenase li fih flavin, epoxide hydrolase jew sulfejxin in vitro.
For memantine, no clinical data on exposed pregnancies are available.
Għal memantine, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Studji fl- annimali jindikaw li jista ’ jeffettwa kemm jikber fl- utru b’ livelli ta ’ esponiment, li huma identiċi jew ikunu ħarira ogħla mill- esponiment fil- bniedem (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista ’ jkun hemm fuq in- nies, mhux magħruf.
Memantine should not be used during pregnancy unless clearly necessary.
Memantine m’ għandux jintuża waqt it- tqala sakemm ma jkunx hemm bżonn ċar.
It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Mhux magħruf jekk memantine joħroġx mal- ħalib tas- sider tal- mara, iżda meta tqies kemm hija lipofilika s- sustanza, probabbli li dan iseħħ.
Women taking memantine should not breast-feed.
Nisa li jkunu qed jieħdu memantine m’ għandhomx ireddgħu.
Moderate to severe Alzheimer’ s disease usually causes impairment of driving performance and compromises the ability to use machinery.
Il- marda ta ’ Alzheimer moderata għal severa normalment ma tħallix persuna ssuq tajjeb u l- ħila ta ’ l- użu ta ’ makkinarji tiġi kompromessa.
Furthermore, Ebixa has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Minbarra hekk, Ebixa għandha effett minn minuri sa moderata fuq il- ħila biex issuq u tuża magni u għalhekk pazjenti outpatients għandhom ikunu mwissija biex joqgħodu aktar attenti.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal moderata, b’ 1, 784 pazjent ikkurat b’ Ebixa u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Ebixa ma kinitx
The most frequently occurring adverse events with a higher incidence in the Ebixa 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%).
L- aktar każijiet reazzjonijiet avversi li seħħew ta ’ spiss fil- grupp ta ’ Ebixa 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%).
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa and since its introduction in the market.
Ir- Reazzjonijiet Avversi tal- Mediċina li ġejjin elenkati fit- Tabella hawn taħt kienu miġbura fi studji kliniċi b’ Ebixa u minn meta tpoggiet fis- suq.
4 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).
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).
Cardiac disorders Nervous system disorders
Disturbi fil- qalb Disturbi fis- sistema nervuża
Uncommon Common Uncommon Very rare
Mhux komuni Komuni Mhux komuni Rari ħafna
Cardiac failure Dizziness Gait abnormal Seizures
Insuffiċjenza kardijaka Sturdament Mixja anormali Aċċessjonijiet
Common Uncommon Not known
Komuni Mhux komuni Mhux magħruf
Constipation Vomiting Pancreatitis2
Stitkezza Rimettar Pankrejatite2
Infections and infestations Vascular disorders
Infezzjonijet u infestazzjonijiet Disturbi vaskulari
Common Uncommon
Mhux komuni Komuni Mhux komuni
Fungal infections Hypertension Venous thrombosis/ thromboembolism
Infezzjonijiet tal- moffa Pressjoni għolja Trombożi fil- vini/ trombo - emboliżmu
Fatigue
Għeja
Psychiatric disorders 1
Disturbi psikjatriċi 1
Common Uncommon Uncommon Not known
Komuni Mhux komuni Mhux komuni Mhux magħruf
Somnolence Confusion Hallucinations1 Psychotic reactions2
Ngħas Konfużjoni Alluċinazzjonijiet1 Reazzjonijiet psikotiċi2
Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Alluċinazzjonijiet dehru l- aktar f’ pazjenti bil- marda ta ’ Alzheimer severa.
2 Isolated cases reported in post-marketing experience.
2 Każijiet iżolati rrappurtati f’ esperjenza wara t- tqegħid fis- suq
Alzheimer’ s disease has been associated with depression, suicidal ideation and suicide.
Il- marda ta ’ Alzheimer kienet assoċjata ma ’ dipressjoni, ħsibijiet ta ’ suwiċidju u suwiċidju.
In post- marketing experience these events have been reported in patients treated with Ebixa.
Fl- esperjenza ta ’ wara t- tqegħid fis- suq dawn il- każijiet kienu rrappurtati f’ pazjenti ikkurati b’ Ebixa.
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Hemm biss esperjenza limitata b’ doża eċċessiva minn studji kliniċi u esperjenza wara t- tqegħid fis- suq.
Relative large overdoses (200 mg and 105 mg/ day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/ or diarrhoea or no symptoms.
Dożi eċċessivi relattivament għoljin (200 mg u 105 mg/ jum għal 3- ijiem, rispettivament) kienu assoċjati ma ’ sintomi ta ’ għeja biss, dgħjufija u/ jew dijarea jew ma ebda sintomu.
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)
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, u disturbi fil- qagħda tal- mixi) u/ jew ta ’ natura gastro- intestinali (rimettar u dijarea).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
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 ijiem, u wara kellu diplopja u aġitazzjoni).
The patient received symptomatic treatment and plasmapheresis.
Il- pazjent irċieva kura għas- sintomi u plażmafereżi.
The patient recovered without permanent sequelae.
Il- pazjent irkupra mingħajr ma kellu konsegwenzi permanenti.
In another case of a large overdose, the patient also survived and recovered.
5 F’ każ ieħor ta ’ doża eċċessiva kbira, il- pazjent ukoll baqa ħaj u rkupra.
The patient had received 400 mg memantine orally.
Il- pazjent kien irċieva 400 mg memantine b’ mod orali.
The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Il- pazjent kellu sintomi fuq is- sistema nervuża ċentrali fosthom, irrikwitezza, psikożi, alluċinazzjonijiet tal- vista, pro- aċċessjonijiet, ngħas, sturdament u telf mis- sensi.
Treatment:
Kura:
In the event of overdose, treatment should be symptomatic.
F’ każ ta ’ doża eċċessiva, għandha tingħata kura għas- sintomi.
No specific antidote for intoxication or overdose is available.
M’ hemmx antidotu speċifiku għal intossikazzjoni jew doża eċċessiva.
Standard clinical procedures to remove active substance material, e. g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Proċeduri standard kliniċi biex titneħħa s- sustanza attiva, eż. tlaħliħ ta ’ l- istonku, mediċinali- karbo (li ma jħallux ir- riċirkolazzjoni entero- epatika), l- aċidifikazzjoni ta ’ l- awrina, id- dijureżi forzata għandhom jintużaw kif ikun jixraq.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
F’ każ ta ’ sinjali u sintomi ta ’ simulazzjoni eċċessiva tas- Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas- sintomi bir- reqqa.
Other Anti-dementia drugs, ATC code:
Mediċini oħra ta ’ kontra d- dimenzja, Kodiċi ATC:
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Aktar evidenza qed tindika li l- funzjoni ħażina ta ’ newrotrasmissjoni glutamaterġika, b’ mod partikolari fir- riċetturi- NMDA, jagħtu kontribut kemm għall- espressjoni tas- sintomi kif ukoll għall - avvanz ta ’ dimenzja newrodiġenerattiva.
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist.
Memantine huwa anatagonist mhux kompetittiv b’ affinità moderata għar- riċettur- NMDA li jiddipendi mill- vultaġġ.
It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Jibdel l- effetti ta ’ livelli toniċi għoljin b’ mod patoloġiku ta ’ glutamate li jistgħu jwasslu għal funzjoni ħażin tan- newroni.
Clinical studies:
Studji kliniċi:
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.
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 fil - linja bażi ta ’ 3- 14) kien jinkludi 252 outpatient.
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).
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).
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.
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.
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints:
Pazjenti kkurati b’ memantine wrew effett statistikament aħjar mill- pazjenti ikkurati bi plaċebo fuq il- fini primarji:
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
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).
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.
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.
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
Fl- ewwel analiżi li kienet definita minn qabel, sinifikat statistiku ma ntlaħaqx mal- fini ewlieni ta ’ l- effikaċja f ’ ġimgħa 24.
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.
Analiżi- meta ta ’ pazjenti bil- marda ta ’ Alzheimer moderata għal severa (total tal- punteġġi MMSE < 20) minn sitt studji ta ’ fażi 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.
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.
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).
11%, p < 0. 0001).
Memantine has an absolute bioavailability of approximately 100%. tmax is between 3 and 8 hours.
Memantine għandu bijodisponibilità assoluta ta ’ madwar 100%. tmax hija bejn 3 u 8 sigħat.
There is no indication that food influences the absorption of memantine.
M’ hemmx indikazzjoni li l- ikel jeffettwa l- assorbiment ta ’ memantine.
Distribution:
6 Distribuzzjoni:
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.
Dożi ta ’ 20 mg kuljum jwasslu għal konċentrazzjonijiet ta ’ memantine fil- plażma fi stat fiss f’ medda ta ’ bejn 70 sa 150 ng/ ml (0. 5 – 1µmol) b’ varjazzjonijiet kbar bejn individwu. u ieħor.
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/ serum ratio of 0.52 was calculated.
Meta ngħataw dożi ta ’ 5 sa 30 mg kuljum, il- proporzjon tal- medja ta ’ fluwidu ċerebrospinali CSF/ serum kien kalkolat 0. 52.
The volume of distribution is around 10 l/ kg.
Il- volum ta ’ distribuzzjoni huwa madwar 10 l/ kg.
About 45% of memantine is bound to plasma-proteins.
Madwar 45% ta ’ memantine jeħel mal- proteini tal- plażma.
In man, about 80% of the circulating memantine-related material is present as the parent compound.
Fil- bniedem, madwar 80% tal- materjal li għandu x’ jaqsam ma ’ memantine li jkun fiċ- ċirkolazzjoni jinsab bħala s- sustanza mhux mibdula.
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.
Il- metaboli ewlenin fil- bniedem huma N- 3, 5- dimethyl- gludantan, it- taħlita ta ’ 4 - u 6- hydroxy- memantine, u 1- nitroso- 3, 5- dimethyl- adamantane.
None of these metabolites exhibit NMDA-antagonistic activity.
L- ebda wieħed minn dawn il- metaboli m’ għandu attività antagonista għal NMDA.
No cytochrome P 450 catalysed metabolism has been detected in vitro.
Ma nstab l- ebda metaboliżmu katalizzat minn cytochrome P 450 in vitro.
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.
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.
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Eliminazzjoni: Memantine jitneħħa b’ mod mono- esponenzjali b ’ t½ terminali ta ’ 60 sa 100 siegħa.
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.
F’ voluntiera b’ funzjoni tal- kliewi normali, it- tneħħija totali (Cltot) kienet 170 ml/ min/ 1. 73 m2 u parti mit- tneħħija renali totali tinkiseb b’ sekrezzjoni tubulari.
Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins.
Proċess renali ieħor jinvolvi ri- assorbiment tubulari, probabbli permezz ta ’ proteini ta ’ trasport katajoniċi.
The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Ir- rata ta ’ eliminazzjoni renali ta ’ memantine taħt kondizzjonijiet ta ’ awrina alkalina tista ’ titnaqqas b’ fattur ta ’ 7 għal 9 (ara sezzjoni 4. 4).
Alkalisation of urine may result from drastic changes in diet, e. g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
L- awrina tista ’ ssir alkalina minn bidliet drastiċi fid- dieta, eż. minn dieta li tinkludi l- laħam għal waħda veġetarjana, jew it- teħid ta ’ ammonti kbar ta ’ buffers gastriċi alkalini.
Linearity:
Linjarità:
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Studji f’ voluntiera wrew farmakokinetika linejari f’ medda ta ’ dożi minn 10 sa 40 mg.
Pharmacokinetic/ pharmacodynamic relationship:
Relazzjoni farmaokinetika/ farmakodinamika:
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.
B’ doża ta ’ 20 mg memantine kuljum il- livelli ta ’ CSF qablu mal- valur- ki (ki = kostanti ta ’ l- impediment) ta ’ memantine, li hija 0. 5µmol fil- kortiċi anterjuri tal- bniedem.
In short term studies in rats memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
Fi studji fuq perijodu qasir f’ firien, memantine bħal antagonisti NMDA oħrajn, stimola il- formazzjoni ta ’ vacuoles fin- newroni u nekrożi (leżjonijiet Olney) biss wara dożi li wasslu għal konċentrazzjonijiet li kellhom quċċata għolja ħafna.
Ataxia and other preclinical signs have preceded the vacuolisation and necrosis.
Atassja u sinjali ta ’ qabel l- użu kliniku oħrajn seħħew qabel ma ffurmaw il- vacuoles fin- newroni u n- nekrożi.
As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Peress li l- effetti la dehru fi studji fit- tul f’ annimali gerriema u lanqas f’ annimali mhux gerriema, ir- relevanza ta ’ dawn ir- riżultati mhumiex magħrufa.
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Bidliet fl- għajnejn dehru b’ mod mhux konsistenti fi studji dwar tossiċità b’ dożi ripetuti f’ annimali gerriema u klieb, iżda mhux fix- xadini.
Specific ophthalmoscopic examinations in clinical studies with memantine did not disclose any ocular changes.
Studji speċifiċi oftalmoskopiċi fl- istudji kliniċi b’ memantine ma wrew l- ebda bidliet fl- għajnejn.
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Fosfolipidożi f’ makrofaġi fil- pulmun minħabba l- akkumulazzjoni ta ’ memantine f’ lisożomi ġiet osservata f’ annimali ġerriema.
This effect is known from other active substances with cationic amphiphilic properties.
Dan l- effett hu magħruf minn sustanzi attivi oħra b’ karatteristiċi amfifiliċi katajoniċi.
There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Hemm relazzjoni possibbli bejn din l- akkumulazzjoni u l- vakwolizzazzjoni osservata fil- pulmun.
This effect was only observed at high doses in rodents.
Dan l- effett deher biss f’ dożi għoljin f’ annimali gerriema.
The clinical relevance of these findings is unknown.
Ir- rilevanza klinika ta ’ dawn ir- riżultati m’ humiex magħrufa.
No genotoxicity has been observed following testing of memantine in standard assays.
Ma ġietx osservata l- ebda tossiċità għal ġeni wara testijiet b’ memantine f’ assaġġi standard.
There was no evidence of any carcinogenicity in life long studies in mice and rats.
Ma kienx hemm evidenza ta ’ riskju ta ’ tumuri fi studji fi ġrieden u firien tul ħajjithom kollha.
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Memantine ma kienx teratoġeniku fil- firien u fniek, anki meta d- dożi kienu tossiċi għall- omm, u l- ebda effetti avversi ma dehru b’ memantine fuq il- fertilità.
In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
Fil- firien, tnaqqis fit- tkabbir tal- fetu deher b’ livelli ta ’ esponiment, li huma daqs jew ħarira ogħla mill- esponiment fil- bniedem.
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talkum Magnesium stearate
7 Tablet coat:
Kisja tal- pillola:
Methacrylic acid - ethyl acrylate copolymer (1:1) Sodium lauryl sulphate Polysorbate 80 Talc Triacetin Simethicone emulsion
Methacrylic acid - ethyl acrylate copolymer (1: 1) Sodium lauryl sulphate Polysorbate 80 Talkum Triacetin Simethicone emulsjoni
4 years.
4 snin.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ħażna speċjali.
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip.
Pakketti b’ folji li fihom jew 7, 10, 14 jew 20 pillola f’ kull strixxa ta ’ folja.
Pack sizes of 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
Il- pakketti jiġu f’ daqsijiet ta ’ 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) jew 1000 (20 x 50) pillola.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Il- pakketti jiġu f’ daqsijiet ta ’ 49 x 1, 56 x 1, 98 x 1 u 100 x 1 pillola miksija b’ rita disponibbli f’ folji ta ’ doża waħda.
Lundbeck A/ S Ottiliavej 9, DK-2500 Valby Denmark
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Id- Danimarka
EU/ 1/ 02/ 219/ 001-3 EU/ 1/ 02/ 219/ 007-012 EU/ 1/ 02/ 219/ 014-021
EU/ 1/ 02/ 219/ 001- 3 EU/ 1/ 02/ 219/ 007- 012 EU/ 1/ 02/ 219/ 021
15/ 05/ 2002 Date of latest renewal:
15/ 05/ 2002 Data ta ’ l- aħħar tiġdid:
8 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Ebixa 10 mg/ g oral drops, solution.
Ebixa 10 mg/ g qtar orali, soluzzjoni.
1 g of solution contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
Gramma 1 tas- soluzzjoni fiha 10 mg memantine hydrochloride ekwivalenti għal 8. 31 mg memantine.
One drop of solution is equivalent to 0,5 mg memantine hydrochloride.
Qatra waħda ta ’ soluzzjoni hi ekwivalenti għal 0. 5 mg memantine hydrochloride.
1 g of solution contains 100 mg of sorbitol E420 and 0.5 mg potassium, see section 4.4.
1 g tas- soluzzjoni fiha 100 mg sorbitol E420 u 0. 5 mg potassju, ara sezzjoni 4. 4.
Oral drops, solution.
Qtar orali, soluzzjoni.
The solution is clear and colourless to light yellowish.
Is- soluzzjoni hija ċara u bla kulur tagħti fl- isfar ċar.
Treatment of patients with moderate to severe Alzheimer’ s disease.
Kura ta ’ pazjenti bil- marda ta ’ Alzheimer minn moderata għal severa.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia.
Il- kura għandha tibda tingħata u tibqa taħt superviżjoni ta ’ tabib li jkollu esperjenza bid- dijanjożi u l- kura tad- dimenzja ta ’ Alzheimer.
Ebixa should be administered once a day and should be taken at the same time every day.
Ebixa għandha tingħata darba kuljum u għandha tittieħed fl- istess ħin kuljum.
The drops can be taken with or without food.
Il- qtar jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
Dose titration
Titrazzjoni tad- doża
The patient should take 10 drops (5 mg) per day for 7 days.
L- 1 ġimgħa (jum 1- 7) Il- pazjent għandu jieħu 10 taqtiriet (5 mg) kuljum għal 7 t’ ijiem.
Week 2 (day 8-14):
It- 2 ġimgħa (jum 8- 14):
The patient should take 20 drops (10 mg) per day for 7 days.
Il- pazjent għandu jieħu 20 taqtiriet (1 mg) kuljum għal 7 t’ ijiem.
The patient should take 30 drops (15 mg) per day for 7 days.
It- 3 ġimgħa (jum 15- 21) Il- pazjent għandu jieħu 30 taqtira kuljum (15 mg) kuljum għal 7 t ’ ijiem.
The patient should take 40 drops (20 mg) once a day.
Il- pazjent għandu jieħu 40 taqtira (20 mg) darba kuljum.
The recommended maintenance dose is 20 mg per day.
10 Doża ta ’ manteniment Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg kuljum
On the basis of the clinical studies the recommended dose for patients over the age of 65 years is 20 mg per day (40 drops once a day) as described above.
Minn studji kliniċi, id- doża rakkomandata għal pazjenti li għandhom ’ l fuq minn 65 sena hija 20 mg kuljum (40 taqtira darba kuljum) kif spjegat hawn fuq.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment renali moderat (tneħħija tal- kreatinina 30 – 49 ml/ min) id- doża għandha tkun ta ’ 10 mg kuljum.
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.
Jekk il- pazjent ikun jiflaħ għaliha sew wara mill- anqas 7 t’ ijiem ta ’ kura, id- doża tista ’ tiġi mużjuda sa 20 mg/ jum skond l - iskema standard ta ’ kif għandha tiżdied.
In patients with severe renal impairment (creatinine clearance 5 – 29 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment sever renali (tneħħija tal- kreatinina 5- 29 ml/ min) id- doża għandha tkun 10 mg kuljum.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
F’ pazjenti b’ indeboliment epatiku ħafif għal moderat (Child- Pugh A u Child- Pugh B) m’ hemmx bżonn ta ’ tibdil fid- doża.
Administration of Ebixa is not recommended in patients with severe hepatic impairment.
It- teħid ta ’ Axura mhux rakkomandat f’ pazjenti li għandhom indeboliment epatiku sever.
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Hija rakkomandata l- attenzjoni f’ pazjenti li jbatu b’ epilessija, għandhom passat ta ’ aċċessjonijiet jew pazjenti li għandhom fatturi li minħabba fihom ikollhom tendenza għall- epilessija.
Concomitant use of other N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
L- użu fl- istess ħin ta ’ antagonisti- N- methyl- D- aspartate (NMDA) oħra bħal amantadine, ketamine jew dextromethorphan għandu jkun evitat.
The oral drops contain sorbitol.
It- taqtir orali fihom sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fruttosju m’ għandhomx jieħdu din il- mediċina.
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
11 • Il- mod kif jaħdem jindika li l- effeti ta ’ L- Dopa, agonisti dopaminerġiċi, u antikolinerġiċi jistgħu jkunu aktar qawwija meta jingħataw flimkien ma ’ antaginisti ta ’ NMDA bħal memantine.
Concomitant
L- effetti ta ’ barbiturati u newrolettiċi jistgħu jiddgħajjfu.
11 administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Meta memantine jingħata flimkien ma ’ aġenti antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn bidla fid- doża. • L- użu ta ’ memantine u amantadine għandu jkun evitat, minħabba r- riskju ta ’ psikożi farmakotossika.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • 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. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Hemm rapport wieħed ta ’ każ li kien publikat dwar riskju li jista ’ jkun hemm meta memantine jingħata ma ’ phenytoin. • 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. • Jista ’ jkun hemm possibilità ta ’ livelli ta ’ hydrochlorthiazide (HCT) imnaqqsa fis- serum meta memantine jingħata ma ’ HCT jew kwalunkwe taħlita ma ’ HCT. • 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.
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.
Fi studji farmakokinetiċi b’ doża waħda f’ żgħażagħ b’ saħħithom, ma dehrietx interazzjoni bejn sustanza attiva u oħra ta’ memantine ma ’ glyburide/ metformin jew donepezil.
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Studji fl- annimali jindikaw li jista ’ jeffettwa kemm jikber fl- utru b’ livelli ta ’ esponiment, li jixbħu jew ikunu ħarira ogħla mill - esponiment fil- bniedem (ara sezzjoni 5. 3).
Furthermore, Ebixa has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Minbarrahekk, Ebixa għandha effett minn minuri sa moderat fuq il- ħila biex issuq u tuża magni u għalhekk pazjenti outpatients għandhom ikunu mwissija biex joqgħodu aktar attenti.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1, 784 pazjent ikkurat b’ Ebixa u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Ebixa ma kienitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
The most frequently occurring adverse events with a higher incidence in the Ebixa 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%).
L- aktar reazzjonijiet avversi li seħħew ta ’ spiss fil- grupp ta ’ Ebixa 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%).
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa and since its introduction in the market.
Ir- Reazzjonijiet Avversi tal- Mediċina li ġejjin elenkati fit- Tabella hawn taħt kienu miġbura fi studji kliniċi b’ Ebixa u minn meta tpoġġiet fis- suq.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa
12 Cardiac disorders Nervous system disorders
12 għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
Uncommon Common Uncommon Very rare
Komuni Mhux komuni Rari ħafna
Cardiac failure Dizziness Gait abnormal Seizures
Sturdament Mixja anormali Aċċessjonijiet
Relative large overdoses (200 mg and 105 mg/ day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/ or diarrhoea or no symptoms.
Dożi eċċessivi relattivament għoljin (200 mg u 105 mg/ jum għal 3 ijiem, rispettivament) kienu assoċjati ma ’ sintomi ta ’ għeja biss, dgħjufija u/ jew dijarea jew ma ebda sintomu.
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).
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, u disturbi fil- qagħda tal- mixi) u/ jew ta ’ natura gastro- intestinali (rimettar u dijarea).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
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).
In another case of a large overdose, the patient also survived and recovered.
F’ każ ieħor ta ’ doża eċċessiva kbira, il- pazjent ukoll baqa ħaj u rkupra.
Standard clinical procedures to remove active substance material, e. g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Proċeduri standard kliniċi biex titneħħa s- sustanza attiva eż. tlaħliħ ta ’ l- istonku, mediċinali- karbo (li ma jħallux ir- riċirkolazzjoni entero- epatika), l- aċidifikazzjoni ta ’ l- awrina, id- dijureżi forzata għandhom jintużaw kif ikun jixraq.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
13 F’ każ ta ’ sinjali u sintomi ta ’ simulazzjoni eċċessiva tas- Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas- sintomi bir- reqqa.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Aktar evidenza qed tindika li l- funzjoni ħażina ta ’ newrotrasmissjoni glutamaterġika, l- aktar fir- riċetturi- NMDA, jagħtu kontribut kemm għall- espressjoni tas- sintomi kif ukoll għall- avvanz ta ’ dimenzja newrodiġenerattiva.
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.
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.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinican´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of the daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
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).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Skala ta ’ assessjar tal- marda Alzheimer ADAS- cog (p=0. 003) u CIBIC- plus (p=0. 004) f’ Ġimgħa 24 bl- aħħar osservazzjonijiet miġjuba ’ l quddiem (LOCF).
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.
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.
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
Fl- ewwel analiżi li kienet definita minn qabel, sinifikat statistiku ma ntlaħaqx mal- fini ewlieni ta ’ l- effikaċja f’ ġimgħa 24.
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.
Il- metaboli ewlenin fil- bniedem huma N- 3, 5- dimethyl- gludantan, it- taħlita ta ’ 4 - u 6- hydroxy- memantine, u
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.
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.
Alkalisation of urine may result from drastic changes in diet, e. g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
L- awrina tista ’ ssir alkalina minn bidliet drastiċi fid- dieta, eż minn dieta li tinkludi l- laħam għal waħda veġetarjana, jew it- teħid ta ’ ammonti kbar ta ’ buffers gastriċi alkalini.
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.
B’ doża ta ’ 20 mg memantine kuljum il- livelli fil- fluwidu ċerebro- spinali (CSF) qablu mal- valur- ki (ki = kostanti ta ’ l- impediment) ta ’ memantine, li hija 0. 5µmol fil- kortiċi anterjuri al- bniedem.
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Fosfolipidożi f’ makrofaġi fil- pulmun minħabba l- akkumulazzjoni ta ’ memantine f’ lisożomi ġiet osservata f’ annimali gerriema..
No genotoxicity has been observed following testing of memantine in standard assays.
Ma ġiet osservata l- ebda tossiċità għal ġeni wara testijiet b’ memantine f’ assaġġi standard.
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Memantine ma kienx teratoġeniku f’ firien u fniek, anki meta d- dożi kienu tossiċi għall- omm, u l- ebda effetti avversi ma dehru b’ memantine fuq il- fertilità.
In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
F’ firien, tnaqqis fit- tkabbir tal- fetu dehret b’ livelli ta ’ esponiment, li huma daqs jew ħarira ogħla mill- esponiment fil- bniedem.
Potassium sorbate Sorbitol E420 Purified water
Potassium sorbate Sorbitol E420 Ilma purifikat
Not applicable.
15 Ma jgħoddx f’ dan il- każ.
Once opened, the contents of the bottle should be used within 3 months.
La darba jinfetaħ, il- kontenut tal- flixkun għandu jintuża fi żmien 3 xhur.
15 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30ºC.
Taħżinx f’ temperatura ’ l fuq minn 30ºC.
Brown glass bottles (Hydrolytic Class III) with dropper containing either 20, 50, 100 g or 10 x 50 g solution.
Fliexken tal- ħġieġ (Idrolitiċi Klassi III) kannella b’ qattara li jkun fihom 20, 50, 100 g jew 10 x 50 g ta ’ soluzzjoni.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Ebixa 5 mg film-coated tablets.
Ebixa 5 mg pilloli miksijin b’ rita.
Ebixa 10 mg film-coated tablets.
Ebixa 10 mg pilloli miksijin b’ rita.
Ebixa 15 mg film-coated tablets.
Ebixa 15 mg pilloli miksijin b’ rita.
Ebixa 20 mg film-coated tablets.
Ebixa 20 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Kull pillola miksija b’ rita fiha 5 mg memantine hydrochloride ekwivalenti għal 4. 15 mg memantine.
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Kull pillola miksija b’ rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8. 31 mg memantine.
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Kull pillola miksija b’ rita fiha 15 mg memantine hydrochloride ekwivalenti għal 12. 46 mg memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Kull pillola miksija b’ rita fiha 20 mg memantine hydrochloride ekwivalenti għal 16. 62 mg memantine.
The 10 mg film-coated tablet contains 166 mg lactose, see section 4.4.
Il- pillola ta ’ 10 mg miksija b’ rita fiha 166 mg lattosju, ara sezzjoni 4. 4.
The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘ 5 ’ on one side and imprint ‘ MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ 5 mg huma bojod għal offwajt, f’ għamla ovali- oblong u miksijin b’ rita b’ intaljar ta ’ ‘ 5 ’ fuq naħa waħda u intaljar ta ’ ‘ MEM ’ fuq in- naħa l- oħra.
The 10 mg film-coated tablets are white to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
Il- pilloli miksijin b’ rita ta ’ 10 mg huma bojod għal offwajt, miksijin b’ rita, oblong u ġejjin għal ponta fin- nofs, imbuzzati ’ l barra, b’ xaqq wieħed fuq iż- żewġ naħat.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam f’ żewġ biċċiet.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘ 15 ’ on one side and imprint ‘ MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ 15 mg huma oranġjo għal oranġjo griżi, pilloli miksijin b’ rita li huma ovali - oblong b’ intaljar ta ’ ‘ 15 ’ fuq naħa u ‘ MEM ’ fuq naħa oħra.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘ 20 ’ on one side and imprint ‘ MEM’ on the other side.
Il- pilloli miksijin b’ rita ta ’ 20 mg huma ħomor ċari għal ħomor griżi, pilloli miksijin b’ rita li huma ovali- oblong b’ intaljar ta ’ ‘ 20 ’ fuq naħa u ‘ MEM ’ fuq naħa oħra.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia.
Il- kura għandha tibda tingħata u tibqa ’ taħt superviżjoni ta ’ tabib li jkollu esperjenza bid- dijanjożi u l- kura tad- dimenzja ta ’ Alzheimer.
The film- coated tablets can be taken with or without food.
Il- pilloli miksijin b’ rita jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
Adults:
Adult:
The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Id- doża inizjali rakkomandata hija ta ’ 5 mg kuljum li għandha titla fi stadji fuq perijodu ta ’ 4 ġimgħat sabiex tilħaq id- doża ta ’ manteniment kif ġej
17 Week 1 (day 1-7):
Ġimgħa 1 (jum 1- 7)
The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
17 Il- pazjent għandu jieħu pillola miksija b’ rita waħda ta ’ 5 mg kuljum (bajda għal offwajt, ovali- oblong) għal 7 t’ ijiem.
The patient should take one 10 mg film-coated tablet per day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Ġimgħa 2 (jum 8- 14) Il- pazjent għandu jieħu pillola miksija b’ rita waħda ta ’ 10 mg kuljum (bajda għal offwajt, oblong ġejja għal punta fin- nofs, imbuzzata ’ l barra b’ xaqq fuq iż- żewġ naħat,) għal 7 t’ ijiem.
The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong film) for 7 days.
Ġimgħa 3 (jum 15- 21) Il- pazjent għandu jieħu pillola miksija b’ rita waħda kuljum ta ’ 15 mg (oranġjo- griża, ovali- oblong b’ rita) għal 7 t ’ ijiem.
The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong film) for 7 days.
Ġimgħa 4 (jum 22- 28) Il- pazjent għandu jieħu pillola miksija b’ rita waħda kuljum ta ’ 20 mg (ħamra- griża ovali- oblong b’ rita) għal 7 t ’ ijiem
The maximum daily dose is 20 mg per day.
Id- doża massima ta ’ kuljum hi ta ’ 20 mg kuljum.
Maintenance dose
Id- doża ta ’ manteniment
The recommended maintenance dose is 20 mg per day.
Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg kuljum.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Minn studji kliniċi, id- doża rakkomandata għal pazjenti li għandhom ’ l fuq minn 65 sena hija 20 mg kuljum (20 mg darba kuljum) kif spjegat hawn fuq.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment renali moderat (tneħħija tal- kreatinina 30 - 49 ml/ min) id- doża għandha tkun 10 mg kuljum.
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.
Jekk il- pazjent ikun jittollerha sew wara mill- anqas 7 ijiem ta ’ kura, id- doża tista ’ tiġi mużjuda sa 20 mg/ jum skond l- iskema standard ta ’ kif għandha tiżdied.
In patients with severe renal impairment (creatinine clearance 5 – 29 ml/ min) daily dose should be 10 mg per day.
F’ pazjenti b’ indeboliment sever renali (tneħħija tal- kreatinina 5 – 29 ml/ min) id- doża ta ’ kuljum għandha tkun 10 mg kuljum.