qanastek/EMEA-V3 huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Axura’ s benefits are greater than its risks for the treatment of patients with moderate to severe Alzheimer’ s disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Axura jgħaddu r- riskji tiegħu għat- trattament ta' pazjenti li jbatu mill- marda ta 'Alzheimer minn moderata għal gravi.
The Committee recommended that Axura be given marketing authorisation.
Il- Kumitat irrakkomanda li Axura jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Axura:
Informazzjoni oħra dwar Axura:
The European Commission granted a marketing authorisation valid throughout the European Union to Merz Pharmaceuticals GmbH for Axura on 17 May 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha lil Merz Pharmaceuticals GmbH għal Axura fis- 17 ta 'Mejju 2002.
The marketing authorisation was renewed on 17 May 2007.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fis- 17 ta 'Mejju 2007.
The full EPAR for Axura can be found here.
L- EPAR sħiħ għal Axura jista 'jiġi kkonsultat hawn.
Oral drops solution Oral drops solution Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Soluzzjoni ta ’ qtar orali Soluzzjoni ta ’ qtar orali Soluzzjoni ta ’ qtar orali Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
bottle (glass) bottle (glass) bottle (glass) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja r (alu/ PP)
1 bottle 1 bottle 1 bottle 28 tablets 56 tablets 112 tablets 1000 tablets (20 x 50 tablets)
1 x flixkun 1 x flixkun 1 x flixkun 28 pillola 56 pillola 112- il pillola 1000 pillola (20 x 50 pillola)
Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
bottle (glass) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
flixkun (ħġieġ) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP)
10 bottles 14 tablets 42 tablets 98 tablets 980 (10 x 98) tablets 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
10 fliexken 14- il pillola 42 pillola 98 pillola 980 (10 x 98) pillola 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg pillola
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) PVDC/ PE/ PVC/ AL
folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) folja (alu/ PP) PVDC/ PE/ PVC/ AL
14 tablets 28 tablets 42 tablets 56 tablets 98 tablets 840 tablets (20 x 42 tablets) 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
14 pillola 28 pillola 42 pillola 56 pillola 98 pillola 840 (20 x 42) pillola 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg pillola
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
14 tablets 28 tablets 42 tablets 56 tablets 98 tablets 840 tablets (20 x 42 tablets)
14 pillola 28 pillola 42 pillola 56 pillola 98 pillola 840 (20 x 42) pillola
Axura 10 mg film-coated tablets
Axura 10 mg pilloli miksijin b’ rita.
White to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
Pilloli miksijin b’ rita bojod jagħtu fl- offwajt, oblong u ippuntati fin- nofs, imbuzzati miż- żewġ naħat, b’ xaqq minn fejn taqsam fuq iż- żewġ naħat.
Axura should be administered once a day and should be taken at the same time every day.
Axura għandha tingħata darba kuljum u għandha tittieħed fl- istess ħin kuljum.
The film-coated tablets can be taken with or without food.
Il- pilloli miksija b’ rita jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
Dose titration The maximum daily dose is 20 mg per day.
Titrazzjoni tad- doża Id- doża massima ta ’ kuljum hija ta ’ 20 mg kuljum.
The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Il- pazjent għandu jieħu nofs pillola miksija b’ rita ta ’ 10 mg kuljum għal 7 t’ ijiem
The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Il- pazjent għandu jieħu pillola miksija b’ rita (ta ’ 10 mg) kuljum għal 7 t’ ijiem
The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
It- 3 ġimgħa (jum 15- 21) Il- pazjent għandu jieħu pillola u nofs miksija b’ rita ta ’ 10 mg (15 mg) kuljum għal 7 t’ ijiem.
The patient should take two 10 mg film-coated tablets (20 mg) per day.
Il- pazjent għandu jieħu żewġ pilloli miksija b’ rita ta ’ 10 mg (20 mg) kuljum.
2 Maintenance dose The recommended maintenance dose is 20 mg per day.
2 Doża ta ’ manteniment Id- doża 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 (two 10 mg tablets 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 (żewġ pilloli ta ’ 10 mg darba kuljum) kif spjegat hawn fuq.
Axura is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Axura mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/ min) no dose adjustment is required.
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.
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 (rata ta ’ 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 t’ ijiem ta ’ kura, id- doża tista ’ tiġi miżjuda 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 (rata ta ’ tneħħija tal - kreatinina 5- 29 ml/ min) id- doża ta ’ kuljum għandha tkun 10 mg kuljum.
Administration of Axura is not recommended in patients with severe hepatic impairment.
It- teħid ta ’ Axura mhux rakkomandat f’ pazjenti li għandhom indeboliment epatiku sever.
The film-coated tablets contain lactose monohydrate.
Il- pilloli miksijin b’ rita fihom lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi rari li jintirtu ta ’ intolleranza għal galactose, nuqqas ta ’ Lapp lactase jew mal assorbiment ta ’ glucose - galactose 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.
3 • 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.
3 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 ’ mediċini antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn ta ’ 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 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. • 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 a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Fi studju kliniku ma dehrx effett rilevanti ta ’ memantine fuq il- farmakokinetika ta ’ galantamine.
Furthermore, Axura has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Minbarrahekk, Axura 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 Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1784 pazjent ikkurat b’ Axura u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Axura ma kinitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
The most frequently occurring adverse reactions with a higher incidence in the Axura 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 ’ Axura 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 Axura 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’ Axura u minn meta tpoggiet fis- suq.
4 Cardiac disorders
4 għandhom jitniżżlu skond is- serjetà tagħhom.
Uncommon
Ir- reazzjonijiet avversi huma mniżżla skond il- klassi tas- sistema ta ’ l- organi, bil- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10) komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax ikun stmat mit- tagħrif li hemm).
Cardiac failure
Disturbi fil- qalb Disturbi fis- sistema nervuża
Nervous system
Mhux komuni Komuni Mhux komuni Rari ħafna
Common
Insuffiċjenza kardijaka Sturdament Mixja anormali Aċċessjonijiet
Common
Komuni Mhux komuni Mhux magħruf
Infections and infestations
Stitkezza Rimettar Pankrejatite2
Vascular disorders
Infezzjonijet u infestazzjonijiet Disturbi vaskulari
Common
Mhux komuni Komuni Mhux komuni
Venous thrombosis/ thromboembolism
Infezzjonijiet tal- moffa Pressjoni għolja Trombożi fil- vini/ trombo - emboliżmu
Common
Komuni Mhux komuni Mhux komuni Mhux magħruf
Psychotic reactions2
Ngħas Konfużjoni Alluċinazzjonijiet1 Reazzjonijiet psikotiċi2
1 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 Alzheimer ’ s disease has been associated with depression, suicidal ideation and suicide.
2 Każijiet iżolati rrappurtati f’ esperjenza wara t- tqegħid fis- suq 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 Axura.
Fl- esperjenza ta ’ wara t- tqegħid fis- suq dawn il- każijiet kienu rrappurtati f’ pazjenti ikkurati b’ Axura.
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 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).
5 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.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
5 F’ każ ta ’ sinjali u sintomi ta ’ simulazzjoni eċċessiva tas- sistema nervuża ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas- sintomi bir- reqqa.
6 Absorption:
Assorbiment:
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.
6 N- 3, 5- dimethyl- gludantan, it- taħlita ta ’ 4 - u 6- hydroxy- memantine, u 1- nitroso- 3, 5- dimethyl- adamantane.
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.
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 ketajoniċi.
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 ’ tneħħija renali ta ’ memantine taħt kondizzjonijiet ta ’ awrina alkalina tista ’ titnaqqas b’ fattur ta ’ 7 għal 9 (ara sezzjoni 4. 4).
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Studji f’ voluntiera wrew farmakokinetika linjari f’ medda ta ’ dożi minn 10 sa 40 mg.
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 ta ’ quddiem tal- bniedem.
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
7 Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talkum Magnesium stearate
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/ PP).
Pakketti b’ folji li fihom jew 7, 10, 14 jew 20 pillola f’ kull strixxa (Alu/ PP).
Pack sizes of 14, 28, 30, 42, 50, 56, 98, 100, 112, 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
Il- pakketti jiġu f’ daqsijiet ta ’, 14, 28, 30, 42, 50, 56, 98, 100, 112, 980 (10 x 98) jew 1000 (20 x 50) pillola.
100 D-60318 Frankfurt/ Main Germany
100 D- 60318 Frankfurt/ Main Il- Ġermanja
8 EU/ 1/ 02/ 218/ 008 EU/ 1/ 02/ 218/ 009 EU/ 1/ 02/ 218/ 010 EU/ 1/ 02/ 218/ 012 EU/ 1/ 02/ 218/ 013 EU/ 1/ 02/ 218/ 014 EU/ 1/ 02/ 218/ 015
EU/ 1/ 02/ 218/ 001 EU/ 1/ 02/ 218/ 002 EU/ 1/ 02/ 218/ 003 EU/ 1/ 02/ 218/ 007 EU/ 1/ 02/ 218/ 008 EU/ 1/ 02/ 218/ 009 EU/ 1/ 02/ 218/ 010 EU/ 1/ 02/ 218/ 012 EU/ 1/ 02/ 218/ 013 8 EU/ 1/ 02/ 218/ 014 EU/ 1/ 02/ 218/ 015
17/ 05/ 2002 Date of latest renewal:
17/ 05/ 2002 Data ta ’ l- aħħar tiġdid:
Axura 10 mg/ g oral drops, solution.
Axura 10 mg/ g qtar orali, soluzzjoni.
1 g of solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
1 g 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 sorbitol E420 and 0.5 mg potassium, see section 4.4.
1 g ta ’ soluzzjoni fiha 100 mg sorbitol E420 u 0. 5 mg potassju, ara sezzjoni 4. 4.
The drops can be taken with or without food.
Il- qtar jistgħu jistgħu jittieħdu fuq l- ikel jew fuq stonku vojt.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Sabiex jitnaqqas ir- riskju ta ’ effetti mhux mixtieqa id- doża ta ’ manteniment tinkiseb billi tittella ’ bil- mod minn doża ta ’ 5 mg fil- ġimgħa għall- ewwel 3 ġimgħat kif ġej:
The patient should take 10 drops (5 mg) per day for 7 days.
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 taqtira (10 mg) kuljum għal 7 t’ ijiem.
The patient should take 30 drops (15 mg) per day for 7 days.
Il- pazjent għandu jieħu 30 taqtira kuljum (15 mg) kuljum għal 7 t’ ijiem.
10 Maintenance dose 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 (rata ta ’ tneħħija tal- kreatinina 30 – 49 ml/ min) id- doża għandha tkun ta ’ 10 mg kuljum.
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 (rata ta ’ 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.
Indeboliment epatiku: F’ pazjenti b’ indeboliment epatiku ħafif jew moderat (Child- Pugh A u Child- Pugh B) m’ hemmx bżonn ta ’ tibdil fid- doża.
Administration of Axura in patients with severe hepatic impairment is not recommended.
It- teħid ta ’ Axura mhux rakkomandat f’ pazjenti li għandhom indeboliment epatiku sever.
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.
These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related may be more frequent or more pronounced (see also section 4.5).
Dawn is- sustanzi jaħdmu fuq l- istess sistema ta ’ riċettur bħal memantine, u għalhekk effetti avversi (l- aktar relatati mas- sistema nervuża ċentrali SNĊ) jistgħu jseħħu b’ mod aktar frekwenti jew aktar bil- qawwa (ara wkoll sezzjoni 4. 5).
The effects of barbiturates and neuroleptics may be reduced.
• 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
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 (PK) f’ żgħażagħ b’ saħħithom, ma dehrietx interazzjoni bejn sustanza attiva u oħra ta’ memantine ma ’ glyburide/ metformin jew donepezil.
Furthermore, Axura has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Minbarrahekk, Axura għandha influwenza 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 Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1, 784 pazjent ikkurat b’ Axura u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Axura ma kienitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Axura and since its introduction in the market.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
12 Cardiac disorders
12 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).
Nervous system disorders
Mhux komuni Komuni Mhux komuni Rari ħafna
2 Isolated cases reported in post-marketing experience
2 Każijiet iżolati rrappurtati f’ esperjenza wara t- tqegħid fis- suq
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 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).
13 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.
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.
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 total ta ’ 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 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).
14 Absorption:
Assorbiment:
Biotransformation:
Bijotransformazzjoni:
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 ta ’ quddiem tal- bniedem.
Brown glass bottles (Hydrolytic Class III) with dropper containing either 20, 50, 100 g or 10 x 50 g solution.
Fliexken tal- ħġieġ (Idrolitiku Klassi III) kannella b’ qattara li jkun fihom 20, 50, 100 g jew 10 x 50 g ta ’ soluzzjoni.
16 MM/ YYYY
XX/ SSSS
Axura 5 mg film-coated tablets.
Axura 5 mg pilloli miksijin b’ rita.
Axura 20 mg film-coated tablets.
Axura 10 mg pilloli miksijin b’ rita Axura 15 mg pilloli miksijin b’ rita Axura 20 mg pilloli miksijin b’ rita
Axura should be administered once a day and should be taken at the same time every day.
Axura għandha tingħata darba kuljumu għandha tittieħed fl- istess ħin kuljum.
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.
Dose titration 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:
Tittrazzjoni tad- doża 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
18 The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
L- 1 ġimgħa (jum 1- 7) 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.
17 It- 2 ġimgħa (jum 8- 14) Il- pazjent għandu jieħu pillola miksija b’ rita 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 (greyorange, oval-oblong film) for 7 days.
It- 3 ġimgħa (jum 15- 21) Il- pazjent għandu jieħu pillola miksija b’ rita 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.
Ir- 4 ġimgħa (jum 22- 28) Il- pazjent għandu jieħu pillola miksija b’ rita kuljum ta ’ 20 mg (ħamra- griża ovali- oblong b’ rita) għal 7 t’ ijiem
Maintenance dose The recommended maintenance dose is 20 mg per day.
Id- doża ta ’ manteniment Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg kuljum.
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/ min) no dose adjustment is required.
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.
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 (rata ta ’ tneħħija tal- kreatinina 30 - 49 ml/ min) id- doża għandha tkun 10 mg kuljum.
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 (rata ta ’ tneħħija tal - kreatinina 5 – 29 ml/ min) id- doża ta ’ kuljum għandha tkun 10 mg kuljum.
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
18 Minħabba f’ hekk hemm tagħrif limitat u pazjenti b’ dawn il- kondizzjonijiet għandhom jinżammu taħt superviżjoni mill- qrib.
19 Excipients:
Sustanzi mhux attivi:
Furthermore, Axura has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
19 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 Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ 20 from those with placebo; the adverse reactions were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja ħafifa għal severa, b’ 1, 784 pazjent ikkurat b’ Axura u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Axura ma kinitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
Cardiac disorders
Insuffiċjenza kardijaka Disturbi fil- qalb
Cardiac failure
Disturbi fis- sistema nervuża
Nervous system
Komuni Mhux komuni Rari ħafna
Gait abnormal
Sturdament Mixja anormali Aċċessjonijiet
21 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.
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 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
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.
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).
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).
22 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.
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.
21 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.
23 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.
No genotoxicity has been observed following testing of memantine in standard assays.
22 Ma ġiet osservata l- ebda tossiċità għal ġeni wara testijiet b’ memantine f’ assaġġi standard.
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
Il- qalba tal- pillola miksija b’ rita ta ’ 10 mg Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talkum Magnesium stearate
Methacrylic acid - ethyl acrylate copolymer (1:1) Sodium lauryl sulphate Polysorbate 80 Talc Triacetin Simethicone emulsion
Il- qoxra tal- pillola miksija b’ rita ta ’ 10 mg Methacrylic acid - ethyl acrylate copolymer (1: 1) Sodium lauryl sulphate Polysorbate 80 Talkum Triacetin Simethicone emulsion
24 This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ħażna speċjali.
Each pack contains 28 film-coated tablets in 4 PVDC/ PE/ PVC/ Al-blister or PP/ Al-blisters with 7 film-coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film- coated tablets of 20 mg.
23 Kull pakkett fih 28 pillola miksija b’ rita f’ 4 folji ta ’ PVDC/ PE/ PVC/ Al jew folji ta ’ PP/ Al għal 7 pilloli miksijin b’ rita ta ’ 5 mg, 7 pilloli miksijin b’ rita ta ’ 10 mg, 7 pilloli miksijin b’ rita ta ’ 15 mg, 7 pilloli miksijin b’ rita ta ’ 20 mg,
Axura 20 mg film-coated tablets.
Axura 20 mg pilloli miksijin b’ rita.
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 miksija b’ rita huma ħomor ċari għal ħomor griżi, pilloli miksija b’ rita li huma ovali- oblong b’ intaljar ta ’ ‘ 20 ’ fuq naħa u ‘ MEM ’ fuq naħa oħra.
Week 1 (day 1-7):
L- 1 ġimgħa (jum 1 - 7):
The patient should take one 5 mg film-coated tablet per day for 7 days.
Il- pazjent għandu jieħu pillola waħda miksija b’ rita ta ’ 5 mg kuljum għal 7 t’ ijiem.
Week 3 (day 15-21):
It- 3 ġimgħat (jum 15- 21):
Maintenance dose The recommended maintenance dose is 20 mg per day.
Doża ta ’ manteniment Id- doża ta ’ manteniment rakkomandata hi ta ’ 20 mg kuljum.
26 Elderly:
25 Anzjani:
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 (rata ta ’ tneħħija tal- kreatinina 30 – 49 ml/ min) id- doża għandha tkun 10 mg kuljum.
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Pazjenti bi problemi rari li jintirtu ta ’ intolleranza għal galactose, nuqqas ta ’ Lapp lactase jew mal assorbiment ta ’ glucose - galactose m’ għandhomx jieħdu din il- mediċina.
The effects of barbiturates and neuroleptics may be reduced.
Meta memantine jingħata flimkien m ’ aġenti
Concomitant 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.
26 antispasmodiċi, dantolene jew baclofen, jista ’ jibdlilhom l- effetti tagħhom u jista ’ jkun hemm bżonn ta ’ bidla fid- doża. • L- użu ta ’ memantine u amantadine għandu jkun evitat, minħabba r- riskju ta ’ psikożi farmakotossika.
27 • 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 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. • 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.
Furthermore, Axura has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Minbarrahekk, Axura 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 Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Fi provi kliniċi f’ pazjenti b’ dimenzja severa għal moderata, b’ 1, 784 pazjent ikkurat b’ Axura u 1, 595 pazjent ikkurat bi plaċebo, ir- rata globali ta ’ reazzjonijiet avversi li seħħew b’ Axura ma kinitx differenti min dik tal- plaċebo; ir- reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil- qawwa.
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).
27 Ir- reazzjonijiet avversi huma mniżżla skond il- klassi tas- sistema ta ’ l- organi, bil- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10) komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax ikun stmat mit- tagħrif li hemm).
Cardiac disorders
Disturbi fil- qalb Disturbi fis- sistema nervuża
28 Nervous system
Mhux komuni Komuni Mhux komuni Rari ħafna
2 Isolated cases reported in post-marketing experience Alzheimer ’ s disease has been associated with depression, suicidal ideation and suicide.
2 Każijiet iżolati rrappurtati f’ esperjenza wara t- tqegħid fis- suq
29 Treatment:
Kura:
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
28 F’ każ ta ’ sinjali u sintomi ta ’ simulazzjoni eċċessiva tas- Sistema Nervuża Ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas- sintomi bir- reqqa.
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).
30 Distribution:
Distribuzzjoni:
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 CSF qablu mal- valur- ki (ki = kostanti ta ’ l- impediment) ta ’ memantine, li hija 0. 5µmol fil- kortiċi ta ’ quddiem tal- bniedem.
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
30 Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Hypromellose Macrogol 400 Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
Hypromellose Macrogol 400 Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
Pack sizes of 14, 28, 42, 56, 98 or 840 (20 x 42) film-coated tablets are presented.
Daqsijiet tal- pakkett ta ’ 14, 28, 42, 56, 98, jew 840 (20 x 42) pillola miksija b’ rita huma disponibbli.
33 ANNEX II
32 ANNESS II
MANUFACTURNG AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 (7 May 2007) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2. 0 (7 ta ’ Mejju 2007) ippreżentata f’ modulu 1. 8. 1 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tinsab f’ postha u qed taħdem, qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (7 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskju Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 4 (7 ta ’ Frar 2008) tal- Pjan ta ’ Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mas- CHMP
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updates RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskju għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess żmien tar- Rapport Perijodiku ta’ Aġġornament dwar is- Sigurtà (PSUR) li jmiss.
LABELLING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA GĦAL PAKKETT TA ’ FOLJI
Axura 10 mg film-coated tablets Memantine hydrochloride
Axura 10 mg pilloli miksijin b’ rita Memantine hydrochloride
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Kull pillola miksija b’ rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8. 31 mg memantine.
112 film-coated tablets.
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 42 pillola miksija b’ rita 50 pillola miksija b’ rita 56 pillola miksija b’ rita 98 pillola miksija b’ rita 100 pillola miksija b’ rita 112- il pillola miksija b’ rita
EU/ 1/ 02/ 218/ 007 28 film-coated tablets.
EU/ 1/ 02/ 218/ 012 14- il pillola miksija b’ rita EU/ 1/ 02/ 218/ 007 28 pillola miksija b’ rita.
EU/ 1/ 02/ 218/ 001 30 film-coated tablets.
EU/ 1/ 02/ 218/ 001 30 pillola miksija b’ rita.
EU/ 1/ 02/ 218/ 002 50 film-coated tablets.
EU/ 1/ 02/ 218/ 013 42 pillola miksija b’ rita EU/ 1/ 02/ 218/ 002 50 pillola miksija b’ rita.
EU/ 1/ 02/ 218/ 008 56 film-coated tablets.
EU/ 1/ 02/ 218/ 008 56 pillola miksija b’ rita.
EU/ 1/ 02/ 218/ 003 100 film-coated tablets.
EU/ 1/ 02/ 218/ 014 98 pillola miksija b’ rita EU/ 1/ 02/ 218/ 003 100 pillola miksija b’ rita.
EU/ 1/ 02/ 218/ 009 112 film-coated tablets.
EU/ 1/ 02/ 218/ 009 112- il pillola miksija b’ rita.
INFORMATION IN BRAILLE Axura 10 mg tablets
INFORMAZZJONI BIL- BRAILLE
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR 50 AND 98 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
KARTUNA GĦAL PILLOLI TA ’ 50 U 98 PILLOLA BHALA PAKKETT INTERMEDJU / KOMPONENT TA ’ MULTIPAKK (MINGĦAJR IL- KAXXA BLU)
50 film-coated tablets.
50 pillola miksija b’ rita.
Not for separate sale Film-coated tablets.
Pilloli miksijin b’ rita.
Component of a multipack comprising 10 packs, each containing 98 film-coated tablets. Not for separate sale.
Mhux biex jinbiegħu separatament
EU/ 1/ 02/ 218/ 010 20 x 50 film-coated tablets EU/ 1/ 02/ 218/ 015 10 x 98 film-coated tablets
EU/ 1/ 02/ 218/ 010 20 x 50 pillola miksija b’ rita EU/ 1/ 02/ 218/ 015 10 x 98 pillola miksija b’ rita
Axura 10 mg tablets
Axura 10 mg pilloli
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER WRAPPER LABEL ON MULTIPACKS (20 x 50 TABLETS AND 10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TAT- TGEŻWIR TA ’ BARRA FUQ IL- MULTIPAKKS (20x50 PILLOLA U 10x98 PILLOLA) IMGEŻWRA FIL- FOJL (LI JINKLUDI L- KAXXA BLU)
Multipack comprising 20 packs, each containing 50 film-coated tablets.
Multipakk li jikkonsisti minn 20 pakkett, kull wieħed minnhom fih 50 pillola miksija b’ rita.
10 packs, each containing 98 film-coated tablets
10 pakketti, kull wieħed minnhom fih 98 pillola miksija b’ rita
42 APPROPRIATE
41 UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Lot {number} See embossed stamp.
LOTT {numru} Ara t- timbru intaljat