qanastek/EMEA-V3 huggingface dataset:
Exelon capsules, oral solution and transdermal patches are used for the treatment of patients with mild to moderately severe Alzheimer’ s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Dan it- tip ta 'demenza huwa disturb tal- moħħ progressiv li jolqot gradwalment il- memorja, l- abilità intellettiva u l- imġiba.
The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson’ s disease.
Il- kapsuli u s- soluzzjoni orali jistgħu wkoll jintużaw għat- trattament tad- demenza minn ħafifa għal moderatament gravi f' pazjenti bil- marda ta 'Parkinson.
How is Exelon used?
Kif jintuża Exelon?
Treatment with Exelon should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’ s disease or dementia in patients with Parkinson’ s disease.
It- trattament b' Exelon għandu jibda u jiġi mmonitorjat minn tabib li għandu l- esperjenza fid- dijanjożi u fit- trattament tal- marda ta 'Alzheimer jew fid- demenza f' pazjenti bil- marda ta' Parkinson.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Exelon by the patient.
It - trattament għandu jinbeda biss jekk hija disponibbli persuna li tieħu ħsieb il- pazjent, li tista 'tikkontrolla regolarment l- użu ta' Exelon mill- pazjent.
Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
It- trattament għandu jitkompla sa meta l - mediċina turi benefiċċju terapewtiku, iżda d- doża tista 'titnaqqas jew it- trattament imwaqqaf fil - preżenza ta' effetti sekondarji.
Exelon capsules or oral solution should be given twice a day, with morning and evening meals.
Exelon kapsuli jew soluzzjoni orali għandhom jingħataw darbtejn kuljum, ma 'l- ikla ta' filgħodu jew ma 'dik ta' filgħaxija.
The capsules should be swallowed whole.
Il- kapsuli għandhom jinbelgħu sħaħ.
The starting dose is 1.5 mg twice a day.
Id- doża inizjali hija 1. 5 mg darbtejn kuljum.
The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Jekk din id- doża tirriżulta tollerata sew, tista 'tiżdied b' 1. 5 mg kull doża waħda, iżda mhux iktar frekwenti minn ġimagħtejn bejn żieda u oħra, sakemm tintlaħaq doża regolari ta' 3- 6 mg darbtejn kuljum.
If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/ 24 h patch after at least four weeks if the lower dose is well tolerated.
Biex jintlaħaq l- ogħla benefiċċju terapewtiku l- pazjenti għandhom jieħdu l- ogħla dożaġġ tollerat sew.
The patches are stuck onto clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Id- doża massima rakkomandata hija 6 mg darbtejn kuljum.
They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Fil- każ ta 'stikk transdermiku, għall- ewwel għandu jitwaħħal l- istikk ta' 4. 6 mg għal 24 siegħa.
The patches can be worn during bathing and hot weather.
Sussegwentement, wara talanqas erba 'ġimgħat ta' trattament jekk id- doża l- aktar baxxa tkun ġiet tollerata sew, jista 'jintuża l- istikk ta' 9. 5 mg/ 24 siegħa.
Patients can be switched from the capsules or oral solution to the patches.
L- istikk jitwaħħal fuq il- ġilda nadifa, xotta, mingħajr xagħar u intatta tad- dahar, tal- parti ta 'fuq tad- driegħ jew tas- sider, u għandu jitbiddel kull 24 siegħa.
See the Summary of Product Characteristics (also part of the EPAR) for detailed information.
L- istikk ma għandux jitwaħħal fuq il- ġilda bi ħmura jew irritata, fuq il- koxxa jew fuq iż- żaqq
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. jew f' pożizzjoni fejn jista 'jitherra meta jħokk ma' ħwejjeġ issikkati.
How does Exelon work?
Kif jaħdem Exelon?
The active substance in Exelon, rivastigmine, is an antidementia medicine.
Is- sustanza attiva f' Exelon, rivastigmina, hija mediċina kontra d- demenza.
In patients with Alzheimer’ s dementia or dementia due to Parkinson’ s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Fil- pazjenti b' demenza tat - tip Alzheimer jew b' demenza dovuta għall- marda ta 'Parkinson, ċerti ċelluli nervużi tal- moħħ imutu, b' hekk dan jirriżulta f' livelli baxxi tan- newrotrasmettitur aċetilkolina (acetylcholine - sustanza kimika li tħalli ċ- ċelluli nervużi jikkomunikaw ma' xulxin).
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Rivastigmina taħdem billi timblokka l- enzimi li jkissru l- aċetilkolina: aċetilkolinesterażi (acetylcholinesterase) u butirilkolinesterażi (butyrylcholinesterase).
By blocking these enzymes, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’ s dementia and dementia due to Parkinson’ s disease.
Billi jimblokka dawn l- enzimi, Exelon jippermetti żieda fil- livelli ta 'aċetilkolina fil- moħħ u b' dan il- mod jgħin biex inaqqas is- sintomi tad- demenza tat- tip Alzheimer u tad- demenza dovuta għall- marda ta' Parkinson.
How has Exelon been studied?
Kif ġie studjat Exelon?
Exelon has been studied in mild to moderately severe Alzheimer’ s disease.
Exelon ġie studjat fil- marda ta 'Alzheimer minn ħafifa għal moderatament gravi.
The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Il- kapsuli ġew studjati fuq 2, 126 pazjent fi tliet studji ewlenin, filwaqt li l- istikk transdermiku ġie eżaminat fi studju ewlieni li involva 1, 195 pazjent.
Exelon capsules have also been studied in 541 patients with dementia due to Parkinson’ s disease.
Exelon kapsuli ġew studjati fuq 541 pazjent b' demenza dovuta għall - marda ta 'Parkinson.
All of the studies lasted six months and compared the effects of Exelon with those of placebo (a dummy treatment).
L- istudji kollha damu sitt xhur u qabblu l- effetti ta 'Exelon ma' dawk tal- plaċebo (trattament finta).
The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Il- kejl ewlieni ta 'l- effikaċja kien il- bidla tas- sintomi fi tliet oqsma prinċipali: konjittiv (kapaċità li dak li jkun jaħseb, jitgħallem u jiftakar) u globali (tagħqid ta' bosta oqsma fosthom il- funzjonament ġenerali, is- sintomi konjittivi, l- imġiba u l- kapaċità li dak li jkun jagħmel l - attivitajiet ta 'kuljum).
An additional study in 27 patients was used to show that Exelon capsules and oral solution produced similar levels of the active substance in the blood.
Intuża studju ieħor fuq 27 pazjent biex juri li Exelon kapsuli u soluzzjoni orali pproduċew livelli simili tas- sustanza attiva fid- demm.
What benefit has Exelon shown during the studies?
X' benefiċċji wera Exelon f' dawn l- istudji?
Exelon was more effective than placebo at controlling symptoms.
Exelon irriżulta aktar effikaċi mill- plaċebo biex jikkontrolla s- sintomi.
In the three studies of Exelon capsules in patients with Alzheimer’ s dementia, patients taking doses of Exelon between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Fit- tliet studji li saru fuq Exelon kapsuli fil- pazjenti bid- demenza ta 'Alzheimer, il- pazjenti li ħadu dożi ta' Exelon bejn 6 u 9 mg kuljum esperjenzaw żieda medja tas- sintomi konjittivi ta '0. 2 punti, mill- valur inizjali ta' 22. 9 punti fil - bidu ta 'l- istudju; aktar baxx ikun il- punteġġ, aħjar ikun ir- riżultat li t- terapija tilħaq.
This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Dan tqabbel ma 'żieda ta' 2. 6 punti osservata fil- pazjenti ttrattati bil- plaċebo minn valur inizjali ta '22. 5.
For the global score, patients taking Exelon capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Għal dak li għandu x' jaqsam mal- punteġġ globali, il- pazjenti ttrattati b' Exelon kapsuli esperjenzaw żieda tas - sintomi ta '4. 1 punti meta mqabbla ma' 4. 4 punti rreġistrati fil- pazjenti ttrattati bil- plaċebo.
The Exelon transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Exelon stikk transdermiku wkoll wera ruħu aktar effikaċi mill- plaċebo biex iwaqqaf l- aggravar tad- demenza.
The patients with dementia due to Parkinson’ s disease taking Exelon capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Il- pazjenti li jbatu minn demenza dovuta għall- marda ta 'Parkinson ittrattati b' Exelon kapsuli wrew titjib tas- sintomi konjittivi ta' 2. 1 punti meta mqabbla ma 'l- aggravar ta' 0. 7 punti osservat fil- pazjenti li ħadu l- plaċebo, minn valur inizjali ta '24 punt.
The global symptom score also improved more in the patients taking Exelon.
Il- punteġġ globali tas- sintomi wkoll tjieb iktar fil - pazjenti ttrattati b' Exelon.
What is the risk associated with Exelon?
X' inhu r- riskju assoċjat ma 'Exelon?
The types of side effects seen with Exelon depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
It- tipi ta 'effetti sekondarji osservati b' Exelon jiddependu mit- tip ta' demenza li qiegħda tiġi ttrattata u mill- format meħud (kapsuli, soluzzjoni orali jew stikk transdermiku).
Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Exelon is being increased.
Kumplessivament, l- effetti sekondarji l- aktar komuni (li dehru f' aktar minn pazjent 1 minn 10) jinkludu nawżea (dardir) u remettar, partikolarment matul il- fażi li fiha d- dożaġġ ta 'Exelon żdied.
For the full list of all side effects reported with Exelon, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtata b' Exelon, ara l- Fuljett ta' Tagħrif.
Exelon should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Exelon ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal rivastigmina jew għal derivati tal- karbamati (carbamates) oħra jew għal kwalunkwe mill- ingredjenti l- oħra.
It should not be used in patients with severe liver problems.
Il - mediċina ma għandhiex tintuża f' pazjenti bi problemi gravi tal- kliewi.
Why has Exelon been approved?
Għaliex ġie approvat Exelon?
The Committee initially concluded that for the treatment of dementia due to Parkinson’ s disease, Exelon’ s benefits did not outweigh its risks.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Exelon għandu effikaċja modesta fit- trattament tas- sintomi tad- demenza ta 'Alzheimer, minkejja li dan jirrifletti benefiċċju importanti għal uħud mill- pazjenti.
The Committee recommended that Exelon be given marketing authorisation.
Għall- ewwel, il- Kumitat ikkonkluda li, għat- trattament tad- demenza dovuta għall- marda ta 'Parkinson, il- benefiċċji ta' Exelon ma kinux ogħla mir- riskji
2/ 3 Other information about Exelon:
2/ 3 tiegħu.
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Exelon on 12 May 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Exelon lil Novartis Europharm Limited fit- 12 ta 'Mejju 1998.
The marketing authorisation was renewed on 12 May 2003 and on 12 May 2008.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 12 ta 'Mejju 2003 u fit- 12 ta' Mejju 2008.
The full EPAR for Exelon can be found here.
L- EPAR sħiħ għal Exelin jista 'jiġi kkonsulat hawn.
EU Number EU/ 1/ 98/ 066/ 001 EU/ 1/ 98/ 066/ 002 EU/ 1/ 98/ 066/ 003 EU/ 1/ 98/ 066/ 004 EU/ 1/ 98/ 066/ 005 EU/ 1/ 98/ 066/ 006 EU/ 1/ 98/ 066/ 007 EU/ 1/ 98/ 066/ 008 EU/ 1/ 98/ 066/ 009 EU/ 1/ 98/ 066/ 010 EU/ 1/ 98/ 066/ 011 EU/ 1/ 98/ 066/ 012
Numru ta ’ l- UE EU/ 1/ 98/ 066/ 001 EU/ 1/ 98/ 066/ 002 EU/ 1/ 98/ 066/ 003 EU/ 1/ 98/ 066/ 004 EU/ 1/ 98/ 066/ 005 EU/ 1/ 98/ 066/ 006 EU/ 1/ 98/ 066/ 007 EU/ 1/ 98/ 066/ 008 EU/ 1/ 98/ 066/ 009 EU/ 1/ 98/ 066/ 010 EU/ 1/ 98/ 066/ 011 EU/ 1/ 98/ 066/ 012
Invented name Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
Isem ivvintat Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
Strength 1.5 mg 1.5 mg 1.5 mg 3 mg 3 mg 3 mg 4.5 mg 4.5 mg 4.5 mg 6 mg 6 mg 6 mg
Qawwa 1. 5 mg 1. 5 mg 1. 5 mg 3 mg 3 mg 3 mg 4. 5 mg 4. 5 mg 4. 5 mg 6 mg 6 mg 6 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Għamla Farmaċewtika Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn Jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu)
Il- pakkett folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu) folja (PVC/ alu)
Package size 28 56 112 28 56 112 28 56 112 28 56 112
Daqs tal- Pakkett 28 56 112 28 56 112 28 56 112 28 56 112
2 mg/ ml 1.5 mg 3 mg 4.5 mg 6 mg
2 mg/ ml 1. 5 mg 3 mg 4. 5 mg
Oral solution Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Soluzzjoni orali Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali
bottle (amber glass) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE)
flixkun (ħġieġ kannella) flixkun (HDPE) flixkun (HDPE) flixkun (HDPE)
1 bottle 250 250 250 250
flixkun wieħed 250 250 250 250
Oral solution
Kapsula, iebsa
bottle (amber glass)
flixkun (HDPE)
4.6 mg/ 24 h
2 mg/ ml 4. 6 mg/ 24 h
Transdermal patch
Soluzzjoni orali Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Transdermal use
Użu orali Użu transdermali
sachet (paper/ polyester/ alu/ polyacrylonitrile)
flixkun (ħġieġ kannella) qartas (karta/ polyester/ alu/ polyacrylonitrile)
7 sachets
flixkun wieħed 7 qratas
4.6 mg/ 24 h
4. 6 mg/ 24 h
Transdermal patch
Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
sachet (paper/ polyester/ alu/ polyacrylonitrile)
qartas (karta/ polyester/ alu/ polyacrylonitrile)
30 sachets
30 qartas
Transdermal patch
tgħaddi minn ġol- ġilda
sachet (paper/ polyester/ alu/ polyacrylonitrile)
(karta/ polyester/ alu/ polyacrylonitrile)
60 sachets (30x2 sachets)
60 qartas (30 qartas x2)
90 sachets (30x3 sachets)
90 qartas (30 qartas x3)
9.5 mg/ 24 h
9. 5 mg/ 24 h
7 sachets
7 qratas
Exelon 1.5 mg hard capsules
Exelon 1. 5 mg kapsuli ibsin
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg.
Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għall- 1. 5 mg rivastigmine.
Hard capsules
Kapsuli ibsin
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ EXELON 1,5 mg ” on body.
Trab abjad li jagħti fl- offwajt jew ħarira fl- isfar, f’ kapsula b’ kappa safra u b’ għatu isfar, u stampata bl - aħmar “ EXELON 1. 5 mg ” fuq il- kappa.
Symptomatic treatment of mild to moderately severe Alzheimer’ s dementia.
Trattament ta ’ sintomi ta ’ dimenzja ta ’ Alzheimer li jkunu ħfief għal severi b’ mod moderat.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’ s disease.
Trattament ta ’ sintomi ta ’ dimenzja li jkunu ħfief għal severi b’ mod moderat f’ pazjenti bil- marda ta ’ Parkinson idjopatika.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia or dementia associated with Parkinson’ s disease.
Il- kura għandha tinbeda u tkun segwita minn tabib li għandu esperjenza fid- dijanjożi u l- kura ta ’ dimenzja ta ’ Alzheimer jew dimenzja assoċjata mal- marda ta ’ Parkinson.
Diagnosis should be made according to current guidelines.
Id- dijanjożi għandha tiġi magħmula skond il- linji gwida kurrenti.
Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
It- terapija b’ rivastigmine għandha tinbeda biss jekk persuna li tista ’ tagħti l- kura tkun disponibbli biex timmonitorja regolarment it- teħid tal- prodott mediċinali mill - pazjent.
Rivastigmine should be administered twice a day, with morning and evening meals.
Rivastigmine għandu jingħata darbtejn kuljum, ma ’ l- ikliet ta ’ filgħodu u ta ’ filgħaxija.
Initial dose 1.5 mg twice a day.
Doża tal- bidu 1. 5 mg darbtejn kuljum.
Dose titration The starting dose is 1.5 mg twice a day.
Titration tad- doża Id- doża tal- bidu hija ta ’ 1. 5 mg darbtejn kuljum.
If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day.
Jekk din id- doża tiġi ttollerata sew wara minimu ta ’ ġimgħatejn ta ’ kura, id- doża tista ’ tiġi miżjuda għal 3 mg darbtejn kuljum.
Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Dawn jistgħu jiġu kkunsidrati wara minimu ta ’ ġimgħatejn ta ’ kura b’ dak il- livell ta ’ doża.
If adverse reactions (e. g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e. g. tremor) in patients with dementia associated with Parkinson’ s disease are observed during treatment, these may respond to omitting one or more doses.
Jekk jiġu osservati reazzjonijiet avversi (eż. dardir, rimettar, uġigħ fl- addome jew nuqqas ta ’ aptit) jew tnaqqis fil- piż jew sintomi ekstrapiramidali jmorru għall- agħar (eż. tregħid) f’ pazjenti b’ dimenzja assoċjata mal- marda ta ’ Parkinson waqt il- kura, dawn jistgħu jitnaqqsu billi tiġi maqbuża doża waħda jew aktar.
If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
Jekk ir- reazzjonijiet avversi jippersistu, id- doża ta ’ kuljum għandha tiġi mnaqqsa temporanjament għal dik id- doża preċedenti li kienet ittollerata sew.
Maintenance dose The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
2 Doża ta ’ manteniment Id- doża effettiva hija ta ’ bejn 3 u 6 mg darbtejn kuljum; biex jinkiseb il- benefiċċju massimu mill- kura, il- pazjenti għandhom jinżammu fuq l- aktar doża għolja li jittoleraw.
The recommended maximum daily dose is 6 mg twice a day.
Id- doża massima rrikkmandata ta ’ kuljum hija ta ’ 6 mg darbtejn kuljum.
2 Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Il- kura ta ’ manteniment tista ’ titkompla sakemm tkun ta ’ benefiċċju terapewtiku għall- pazjent.
Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Għalhekk, il- benefiċċju kliniku ta ’ rivastigmine għandu jerġa ’ jiġi vvalutat fuq bażi regolari, speċjalment għal dawk il- pazjenti li jkunu qed jiġu kkurati b’ dożi ta ’ anqas minn 3 mg darbtejn kuljum.
If after 3 months of maintenance dose treatment the patient’ s rate of decline in dementia symptoms is not altered favourably, the treatment should be discontinued.
Jekk wara 3 xhur ta ’ kura bid- doża ta ’ manteniment ir- rata li biha s- sintomi ta ’ dimenzja ma jurux bidla favorevoli, il- kura għandha titwaqqaf.
Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Għandu jiġi kkunsidrat it- twaqqif jekk ikun jidher li l- effett terapewtiku jkun intilef.
Individual response to rivastigmine cannot be predicted.
Ir- rispons individwali għal rivastigmine ma jistax jiġi mbassar.
However, a greater treatment effect was seen in Parkinson’ s disease patients with moderate dementia.
Madankollu, effett akbar mill- kura deher f’ pazjenti bil- Parkinson b’ dimenzja moderata.
Similarly a larger effect was observed in Parkinson’ s disease patients with visual hallucinations (see section 5.1).
B’ mod simili, effett akbar deher f’ pazjenti bil - marda ta ’ Parkinson li kellhom alluċinazzjonijiet viżivi (ara sezzjoni 5. 1).
Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
L- effett tal- kura ma ġiex studjat fi provi, kkontrollati bi plaċebo għal aktar minn 6 xhur.
Re-initiation of therapy If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily.
Meta terġa ’ tinbeda t- terapija Jekk il- kura tiġi mwaqqfa għal aktar minn ħafna jiem, din għandha terġa ’ tinbeda b’ doża ta ’ 1. 5 mg darbtejn kuljum.
Dose titration should then be carried out as described above.
Iż- żieda fid- doża mbagħad għandha tiġi magħmula hekk kif spjegat hawn fuq.
Renal and hepatic impairment Due to increased exposure in moderate renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed (see section 5.2).
Indeboliment renali u epatiku Minħabba żieda fl- esponiment meta jkun hemm indeboliment renali ħafif u indeboliment epatiku ħafif għal moderat, ir- rakkomandazzjonijiet sabiex id- doża tkun miżjuda skond it- tolleranza ta ’ l- individwu għandhom jiġu segwiti bir- reqqa (ara sezzjoni 5. 2).
Patients with severe liver impairment have not been studied (see section 4.3).
Pazjenti b’ indeboliment epatiku sever ma kinux studjati (ara sezzjoni 4. 3).
Children Rivastigmine is not recommended for use in children.
Tfal Rivastigmine mhux irrakkomandat għall- użu fit- tfal.
The use of this medicinal product is contraindicated in patients with
L- użu ta ’ dan il- prodott mediċinali huwa kontra- indikat għal pazjenti
- hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients
- b’ sensittività eċċessiva għas- sustanza attiva, għal derivattivi tat- tip carbamate jew għal xi
used in the formulation,
sustanzi mhux attivi użati fil- formulazzjoni,
- severe liver impairment, as it has not been studied in this population.
- b’ indeboliment sever tal- fwied, minħabba li ma kienx hemm studji f’ din il- popolazzjoni.
The incidence and severity of adverse reactions generally increase with higher doses.
L- inċidenza u s- severità tar- reazzjonijiet avversi ġeneralment jiżdiedu b’ dożi aktar għoljin.
If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e. g. vomiting).
Jekk il - kura tiġi mwaqqfa għal aktar minn bosta jiem, din għandha terġa ’ tiġi mibdija b’ 1. 5 mg darbtejn kuljum, sabiex titnaqqas il- possibbiltà ta ’ reazzjonijiet avversi (eż. rimettar).
Dose titration:
Żieda tad- doża:
Adverse reactions (e. g. hypertension and hallucinations in patients with Alzheimer’ s dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson’ s disease) have been observed shortly after dose increase.
Ġew osservati reazzjonijiet avversi (eż. pressjoni għolja u alluċinazzjonijiet f’ pazjenti b’ dimenzja ta ’ Alzheimer u sintomi ekstrapiramidali marru għall- agħar, l- aktar tregħid, f’ pazjenti b’ dimenzja assoċjata mal- marda ta ’ Parkinson) ftit wara li ġiet miżjuda d- doża.
They may respond to a dose reduction.
Dawn jistgħu jitnaqqsu bi tnaqqis fid- doża.
In other cases, Exelon has been discontinued (see section 4.8).
F’ każijiet oħra, Exelon ġie mwaqqaf (ara sezzjoni 4. 8).
Gastrointestinal disorders such as nausea and vomiting may occur particularly when initiating treatment and/ or increasing the dose.
Jista ’ jkun hemm problemi fis- sistema gastro- intestinali, bħal dardir jew rimettar, l- aktar meta tinbeda l- kura u/ jew meta tiżdied id- doża.
These adverse reactions occur more commonly in women.
Dawn ir- reazzjonijiet avversi jseħħu b’ mod aktar komuni fin- nisa.
Patients with Alzheimer’ s disease may lose weight.
Pazjenti li jbatu bil- marda ta ’ Alzheimer jistgħu jonqsu fil- piż.
Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Inibituri tat- tip cholinesterase, inkluż rivastigmine, kienu assoċjati ma ’ tnaqqis fil- piż f’ dawn il- pazjenti.
During therapy patient’ s weight should be monitored.
Waqt it- terapija, il- piż tal- pazjent għandu jiġi mmonitorjat.
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
3 F’ każ li l- pazjent jibda ’ jirremetti ħafna meta jingħata kura b’ rivastigmine, id- doża għandha tiġi aġġustata hekk kif irrikkmandat f’ sezzjoni 4. 2.
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Xi każijiet ta ’ rimettar sever kienu assoċjati ma ’ tiċrit ta ’ l- esofagu (ara sezzjoni 4. 8).
Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Dawn il- każijiet dehru li jseħħu l- aktar wara żiediet fid- dożi jew b’ dożi għoljin ta ’ rivostigmine.
3 Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Għandha tingħata attenzjoni meta jintuża rivastigmine f’ pazjenti bis- sindrome tas- sinus marid jew b’ difetti tal- konduttività fil- qalb (imblukkar sino- atrijali, imblukkar atrijo- ventrikulari) (ara sezzjoni 4. 8).
Rivastigmine may cause increased gastric acid secretions.
Rivastigmine jista ’ jikkawża żieda ta ’ aċidu fl- istonku.
Care should be exercised in treating patients with active gastric or duodenal ulcers or patients predisposed to these conditions.
Għandha tingħata attenzjoni meta jkunu qed jiġu kkurati pazjenti b’ ulċeri attivi fl- istonku jew duwodenali, jew pazjenti predisposti għal dawn il - kondizzjonjiet.
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Għandha tingħata attenzjoni meta inibituri ta ’ cholinesterase jingħataw lill- pazjenti li fil- passat kellhom attakki ta ’ l- ażżma jew mard ostruttiv tal- pulmun.
Cholinomimetics may induce or exacerbate urinary obstruction and seizures.
Il- kolinomimetiċi jistgħu jikkaġunaw jew jaggravaw ostruzzjoni awrinarja, u aċċessjonijiet.
Caution is recommended in treating patients predisposed to such diseases.
L - attenzjoni hija rrikkmandata meta jkunu qed jiġu kkurati pazjenti predisposti għal dan il- mard.
The use of rivastigmine in patients with severe dementia of Alzheimer’ s disease or associated with Parkinson’ s disease, other types of dementia or other types of memory impairment (e. g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
L- użu ta ’ rivastigmine f’ pazjenti li jbatu b’ dimenzja severa ta ’ Alzheimer jew dik assoċjata mal- marda ta ’ Parkinson, b’ tipi oħra ta ’ dimenzja jew b’ tipi oħra ta ’ mard li jxekklu l- memorja (eż. tnaqqis fl - għarfien relatat ma ’ l- età) għadu ma ġiex investigat u għalhekk l- użu tiegħu f’ dawn il- pazjenti m’ huwiex rakkomandat.
Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Bħal kolinomimetiċi oħrajn, rivastigmine jista ’ jħarrax jew jikkaġuna sintomi ekstrapiramidali.
Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson’ s disease (see section 4.8).
Aggravar (inkluż bradikajniżja, diskajniżja, mixja mhux normali) u żieda fil- każijiet jew severità tat - tregħid dehru f’ pazjenti li jbatu b’ dimenzja assoċjata mal- marda ta ’ Parkinson (ara sezzjoni 4. 8).
These events led to the discontinuation of rivastigmine in some cases (e. g. discontinuations due to tremor 1.7% on rivastigmine vs 0% on placebo).
Dawn il- każijiet wasslu għat- twaqqif ta ’ rivastigmine f’ xi pazjenti (eż. twaqqif minħabba t- tregħid 1. 7% fuq rivastigmine kontra 0% fuq plaċebo).
Clinical monitoring is recommended for these adverse reactions.
Huwa rrikkmandat monitoraġġ kliniku għall- dawn ir - reazzjonijiet avversi.
As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Bħala sustanza li tinibixxi cholinesterase, rivastigmine jista ’ jeżaġera l- effetti rilassanti tal- muskoli tat - tip succinylcholine waqt il- loppju.
Caution is recommended when selecting anaesthetic agents.
Hija rakkomandata attenzjoni fl- għażla ta ’ sustanzi tal- loppju.
Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Tista ’ tiġi kkunsidrata l- possibiltà ta ’ aġġustamenti tad- doża jew twaqqif temporanju tal- kura jekk meħtieġa.
In view of its pharmacodynamic effects, rivastigmine should not be given concomitantly with other cholinomimetic substances and might interfere with the activity of anticholinergic medicinal products.
Minħabba l- effetti farmakodinamiċi tiegħu, rivastigmine m’ għandux jingħata fl- istess ħin ma ’ sustanzi oħrajn tat- tip kolinomimetiċi, u jista ’ jfixkel l- attività ta ’ prodotti mediċinali tat- tip antikolinerġiċi.
No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Fi studji fuq voluntiera b’ saħħithom, ma dehret l- ebda interazzjoni farmakokinetika bejn rivastigmine u digoxin, warfarin, diazepam, jew fluoxetine.
The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Iż- żieda fil- ħin tal- protrombin li hija kkaġunata minn warfarin mhix affettwata meta jingħata rivastigmine.
No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Ma ġew osservati l- ebda effetti ħżiena fuq il - konduttività kardijaka, meta ngħataw digoxin u rivastigmine fl- istess ħin.
According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Minħabba l- metaboliżmu tiegħu, mhux mistenni li jkun hemm interazzjonijiet metaboliċi ma ’ prodotti mediċinali oħrajn, għalkemm rivastigmine jista ’ jinibixxi l- metaboliżmu medjat minn butyrylcholinesterase ta ’ sustanzi oħrajn.
For rivastigmine no clinical data on exposed pregnancies are available.
Għal rivostigmine m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
No effects on fertility or embryofoetal development were observed in rats and rabbits, except at doses related to maternal toxicity.
Ma ġew osservati l- ebda effetti fuq il- fertilità jew fuq l- iżvilupp ta ’ l- embriju/ fetu fil- firien u l- fniek, ħlief meta d- dożi kienu relatati ma ’ tossiċità fl- omm.
In peri/ postnatal studies in rats, an increased gestation time was observed.
Fi studji ta ’ madwar/ wara t- twelid li saru fuq il- firien, ġiet osservata żieda fiż - żmien ta ’ ġestazzjoni.
Rivastigmine should not be used during pregnancy unless clearly necessary.
Rivastigmine m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
In animals, rivastigmine is excreted into milk.
4 Fl- annimali rivastigmine joħroġ mal- ħalib.
It is not known if rivastigmine is excreted into human milk.
Mhux magħruf jekk rivastigmine joħroġx mal- ħalib tas - sider tal- bniedem.
Therefore, women on rivastigmine should not breast-feed.
Għalhekk, in- nisa li jkunu qed jieħdu rivastigmine m’ għandhomx ireddgħu.
Alzheimer’ s disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Il- marda ta ’ Alzheimer tista ’ tikkawża tnaqqis gradwali fil- ħila tas- sewqan jew tikkomprometti l- ħila biex jitħaddem makkinarju.
Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Barra dan, rivastigmine jista ’ jikkaġuna sturdament jew ngħas, l- aktar fil - bidu tal- kura jew meta tkun qed tiżdied id- doża.
As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Bħala konsegwenza, rivastigmine għandu influwenza żgħira jew moderata fuq il- ħila biex issuq u tħaddem magni.
4 continue driving or operating complex machines should be routinely evaluated by the treating physician.
Għalhekk, il- ħila li jkomplu jsuqu jew li jħaddmu magni kumplessi, ta ’ pazjenti li jbatu mill- marda ta ’ Alzheimer u li jkunu qed jieħdu rivastigmine, għandha tiġi evalwata bħala rutina mit- tabib li jkun qed jagħtihom il- kura.
The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Ir- reazzjonijiet avversi l- aktar komuni huma dawk fis- sistema gastro- intestinali, u dawn jikludu dardir (38%) u rimettar (23%), speċjalment waqt li tkun qed tiġi miżjuda d- doża.
Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Waqt studji kliniċi, il - pazjenti nisa kienu aktar suxxettibbli mill- irġiel li jkollhom reazzjonijiet avversi fis- sistema gastro - intestinali, u tnaqqis fil- piż.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’ s dementia treated with Exelon.
Ir- reazzjonijiet avversi li ġejjin, elenkati hawn taħt f’ Tabella 1, kienu miġbura minn pazjenti ikkurati b’ Exelon għal dimenzja t’ Alzheimer.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
Ir- reazzjonijiet avversi huma kklassifikati skond il- frekwenza, bl- aktar frekwenti l- ewwel, u billi tintuża l- konvenzjoni li ġejja:
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000) and not known (cannot be estimated from the available data).
Komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000) u mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Urinary infection
Infezzjoni fis- sistema ta ’ l- awrina
Agitation Confusion Insomnia Depression Hallucinations Dizziness Headache Somnolence Tremor Syncope Seizures Extrapyramidal symptoms (including worsening of Parkinson’ s disease)
Disturbi psikjatriċi Aġitazzjoni Komuni Konfużjoni Komuni Nuqqas ta ’ rqad Mhux komuni Dipressjoni Mhux komuni Alluċinazzjonijiet Rari ħafna Disturbi fis- sistema nervuża Sturdament Komuni ħafna Uġigħ ta ’ ras Komuni Ngħas Komuni Tregħid Komuni Sinkope Mhux komuni Aċċessjonijiet Rari Sintomi ekstrapiramidali (li jinkludu aggravar tal- marda ta ’ Rari ħafna Parkinson) Disturbi fil- qalb
disorders Rare Very rare
Rari Rari ħafna
Angina pectoris Cardiac arrhythmia (e. g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Angina pectoris Problemi fir- ritmu tat- tħabbit tal- qalb (eż. bradikardja, imblukkar atrijo- ventrikulari, fibrillazzjoni ta ’ l- atrija u takikardija)
Very common Very common Very common Common Rare Very rare Very rare Not known
Disturbi gastro- intestinali Dardir Komuni ħafna Rimettar Komuni ħafna
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
5 Dijarea Komuni ħafna Uġigħ addominali u dispepsja Komuni Ulċeri gastriċi u duwodenali Rari Emorraġiji gastro- intestinali Rari ħafna Pankrejatite Rari ħafna Xi każijiet ta ’ rimettar sever kienu assoċjati ma ’ tiċrit ta ’ l - Mhux magħruf esofagu (ara sezzjoni 4. 4).
Metabolism and nutritional disorders
Disturbi fil- metaboliżmu u n - nutrizzjoni Anoressija Komuni ħafna Disturbi fil- fwied u fil- marrara Disturbi il- ġilda
Very common
Mhux komuni fil- ġilda u fit- tessuti ta ’ taħt Komuni Rari
Elevated liver function tests
Livelli għolja tat- testijiet tal- funzjoni tal- fwied Żieda fl- għaraq Raxxijiet
Common Rare disorders and administration
Disturbi
Sweating increased Rashes
ġenerali u kondizzjonijiet ta '
Common Common Uncommon
mnejn jingħata Għeja kbira u astenja Komuni Tħossok ma tiflaħx Komuni Waqgħat aċċidentali Mhux komuni Investigazzjonijiet
Weight loss
Tnaqqis fil- piż
The following additional adverse reactions have been observed with Exelon transdermal patches: anxiety, delirium, pyrexia (common).
L- effetti avversi li ġejjin dehru bil- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Exelon: ansjetà, tgħewdin, deni (komuni).
Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson’ s disease treated with Exelon.
Tabella 2 turi reazzjonijiet avversi rrappurtati f’ pazjenti b’ dimenzja assoċjata mal- marda ta ’ Parkinson ikkurati b’ Exelon.
Psychiatric disorders Nervous Cardiac
Disturbi psikjatriċi
Common Common Common system disorders Very common Common Common Common Common Common Common Uncommon disorders Common Uncommon Uncommon
Komuni Komuni Komuni
Insomnia Anxiety Restlessness Tremor Dizziness Somnolence Headache Worsening of Parkinson’ s disease Bradykinesia Dyskinesia Dystonia Bradycardia Atrial Fibrillation Atrioventricular block
Disturbi fis- sistema nervuża Tregħid Komuni ħafna Sturdament Komuni Ħedla tan- ngħas Komuni Uġigħ ta ’ ras Komuni Aggravar tal- marda ta ’ Parkinson Komuni Bradikajneżja Komuni Diskajneżja Komuni Distonja Mhux komuni Disturbi fil- qalb
Gastrointestinal disorders
Komuni Mhux komuni Mhux komuni
Very common Very common Common Common Common
Bradikardija Fibrillazzjoni ta ’ l- atriju Blokk atrijo- ventrikulari
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Salivary hypersecretion
Disturbi gastro- intestinali Dardir Komuni ħafna Rimettar Komuni ħafna Dijarea Komuni Uġigħ fl- addome u dispepsja Komuni Tnixxija ta ’ bżiq Komuni
Skin and subcutaneous tissue disorders
6 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi
Common
Komuni muskolu- skeletrali u tal -
Musculoskeletal and connective tissue disorders
connective tissue Disturbi
Common
Komuni fil- metaboliżmu u n -
Muscle rigidity
Riġidità fil- muskoli
Common Common disorders and administration
nutrizzjoni Anoressija Komuni Deidratazzjoni Komuni Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Għeja kbira u astenja Komuni Mixi mhux normali Komuni
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted 6 with Exelon in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Tabella 3 telenka n- numru u l- perċentwali ta ’ pazjenti b’ każijiet minn prova klinika speċifika ta 24 - gimgha kondotta b’ Exelon f’ pazjenti b’ dimenzja assoċjata mal- marda ta Parkinson b’ avversi li kienu definiti minn qabel li jistgħu jirriflettu aggravar tas- sintomi ta ’ Parkinson.
Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson’ s disease
Każijiet avversi definiti minn qabel li jistgħu jirriflettu aggravar tas- sintomi ta ’ Parkinson f’ pazjenti b’ dimenzja assoċjata mal- marda ta ’ Parkinson
Placebo n (%)
Plaċebo n (%)
Total patients studied Total patients with pre-defined AE(s) Tremor Fall Parkinson’ s disease (worsening) Salivary hypersecretion Dyskinesia Parkinsonism Hypokinesia Movement disorder Bradykinesia Dystonia Gait abnormality Muscle rigidity Balance disorder Musculoskeletal stiffness Rigors Motor dysfunction
Total tal- pazjenti studjati Total tal- pazjenti b’ effetti avversi Tregħid Waqa ’ Marda ta ’ Parkinson (tmur għall- agħar) Sekrezzjoni eċċessiva ta ’ bżieq Diskineżja Sintomi tal- Parkinson Ipokineżja Disturbi fil- moviment Bradikineżja Distonja Mixi mhux normali Ebusija fil- muskoli Disturbi fl- ekwilibriju Riġidità muskolu- skeletrali Tregħid Funzjoni motorja ħażina
362 (100) 99 (27.3) 37 (10.2) 21 (5.8) 12 (3.3) 5 (1.4) 5 (1.4) 8 (2.2) 1 (0.3) 1 (0.3) 9 (2.5) 3 (0.8) 5 (1.4) 1 (0.3) 3 (0.8) 3 (0.8) 1 (0.3) 1 (0.3)
362 (100) 99 (27. 3) 37 (10. 2) 21 (5. 8) 12 (3. 3) 5 (1. 4) 5 (1. 4) 8 (2. 2) 1 (0. 3) 1 (0. 3) 9 (2. 5) 3 (0. 8) 5 (1. 4) 1 (0. 3) 3 (0. 8) 3 (0. 8) 1 (0. 3) 1 (0. 3)
179 (100) 28 (15.6) 7 (3.9) 11 (6.1) 2 (1.1) 0 1 (0.6) 1 (0.6) 0 0 3 (1.7) 1 (0.6) 0 0 2 (1.1) 0 0 0
179 (100) 28 (15. 6) 7 (3. 9) 11 (6. 1) 2 (1. 1) 0 1 (0. 6) 1 (0. 6) 0 0 3 (1. 7) 1 (0. 6) 0 0 2 (1. 1) 0 0 0
Symptoms Most cases of accidental overdose have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment.
Sintomi Il- maġġoranza tal- każijiet aċċidentali ta ’ doża eċċessiva ma kienux assoċjati ma ’ sinjali jew sintomi kliniċi, u kważi l- pazjenti kollha li kienu nvoluti komplew il- kura b’ rivastigmine.
Where symptoms have occurred, they have included nausea, vomiting and diarrhoea, hypertension or hallucinations.
Fejn kien hemm is - sintomi, dawn kienu jinkludu dardir, rimettar u dijarea, pressjoni għolja jew alluċinazzjonijiet.
Due to the known vagotonic effect of cholinesterase inhibitors on heart rate, bradycardia and/ or syncope may also occur.
Minħabba l- effett vagotoniku magħruf li għandhom l- inibituri ta ’ cholinesterase, dawn jistgħu jirriżultaw f’ bradikardija u/ jew sinkope.
Ingestion of 46 mg occurred in one case; following conservative management the patient fully recovered within 24 hours.
F’ każ wieħed b’ doża ta ’ 46 mg; il- pazjent irkupra għal kollox f’ 24 siegħa b’ trattament konservattiv.
Treatment As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
7 Kura Minħabba li rivastigmine għandu half- life fil- plażma ta ’ xi siegħa, u l- inibizzjoni ta ’ acetylcholinesterase iddum xi 9 sigħat, huwa rrikkmandat li fil- każijiet ta ’ doża eċċessiva bla sintomi, m’ għandu jingħata l- ebda doża oħra ta ’ rivastigmine għall- 24 siegħa wara.
In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Fil- każ ta ’ doża eċċessiva li tkun akkumpanjata b’ dardir sever u rimettar, l- użu ta ’ anti- emetiċi għandu jiġi kkunsidrat.
Symptomatic treatment for other adverse reactions should be given as necessary.
Kura sintomatika għal reazzjonijiet avversi oħrajn għandha tingħata hekk kif ikun hemm bżonn.
In massive overdose, atropine can be used.
Fil- każ ta ’ doża eċċessiva massiva, tista ’ tintuża atropine.
An initial dose of 0.03 mg/ kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Fil- bidu huwa rrikkmandat li tintuża doża ta ’ 0. 03 mg/ kg atropine sulphate minn ġol- vina, bid- dożi ta ’ wara din ibbażati fuq ir- rispons kliniku.
Use of scopolamine as an antidote is not recommended.
L- użu ta ’ scopolamine bħala antidotu mhux irrikkmandat.
Pharmacotherapeutic group: anticholinesterases, ATC code:
Kategorija farmakoterapewtika: anticholinesterases, Kodiċi ATC:
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by
Rivastigmine huwa inibitur ta ’ acetyl - u butyrylcholinesterase tat- tip carbamate, li hu maħsub li jiffaċilita t- trasmissjoni kolinerġika fin- newroni, billi jnaqqas id- degradazzjoni ta ’ acetylcholine li jkun meħlus minn newroni kolinerġiċi li jkollhom il- funzjoni intatta.
Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’ s disease and Parkinson’ s disease.
B’ dan il- mod, rivastigmine jista ’ jkollu effett li jtejjeb id- diffikultajiet ta ’ għarfien li jkunu medjati b’ mod kolinerġiku u li huma assoċjati mal- marda ta ’ Alzheimer u l- marda ta ’ Parkinson.
Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Rivastigmine jinteraġixxi ma ’ l- enżimi speċifiċi tiegħu billi jifforma kumpless marbut b’ mod kovalenti li temporanjament jagħmel l- enżimi inattivi.
In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40% within the first 1.5 hours after administration.
F’ ġuvnotti b’ saħħithom, doża mill- ħalq ta ’ 3 mg tnaqqas l- attività tat- tip acetylcholinesterase (AChE) fis- CSF bejn wieħed u ieħor b’ 40% fi żmien l- ewwel 1. 5 siegħa wara li tkun ingħatat.
Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
L- attività ta ’ l- enżima tiġi lura għall- livelli tal- linja bażi, madwar 9 sigħat wara li l- effett inibitorju massimu jkun intlaħaq.
In patients with Alzheimer’ s disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
F’ pazjenti li jbatu bil- marda ta ’ Alzheimer, l- inibizzjoni ta ’ AChE fis- CSF b’ rivastigmine kienet tiddependi fuq id- doża, meta d- doża kienet sa 6 mg darbtejn kuljum, li hija l- ogħla doża ttestjata.
Inhibition of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar to that of AChE.
L- inibizzjoni ta ’ l- attività tat- tip butyrylcholinesterase fis- CSF ta ’ 14- il pazjent bil- marda ta ’ Alzheimer li kienu kkurati b’ rivastigmine kienet simili għal dik ta ’ AChE.
Clinical studies in Alzheimer’ s dementia The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Studji Kliniċi f’ dimenzja ta ’ Alzheimer L- effikaċja ta ’ rivastigmine kienet stabbilita permezz ta ’ tliet għoddod ta ’ stima indipendenti u speċifiċi għad- dominju, u dawn kienu assesjati f’ intervalli perjodiċi waqt perijodi ta ’ trattament ta ’ 6 xhur.
These include the ADAS-Cog (a performance based measure of cognition), the CIBIC-Plus (a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Dawn jinkludu l- ADAS- Cog (sistema ta ’ kejl tal- konjizzjoni bbażata fuq il- ħila), is- CIBIC - Plus (stima globali komprensiva tal- pazjent mit- tabib, li tinkorpora l- involviment ta ’ min ikun qed jieħu ħsieb il- kura tas- saħħa), u l- PDS (stima magħmula minn min ikun qed jieħu ħsieb il- kura tas - saħħa, ta ’ l- attivitajiet tal- ħajja ta ’ kuljum li jinkludu l- iġene personali, kif jieklu, l- ilbies, il- faċendi tad- dar bħax- xiri, iż- żamma tal- ħila li wieħed jorjenta ruħu fl- ambjent tal- madwar, kif ukoll l - involviment f’ attivitajiet relatati ma ’ finanzi eċċ.).
The patients studied had an MMSE (Mini-Mental State Examination) score of 10– 24.
Il- pazjenti studjati kellhom punteġġ MMSE (Eżami Żgħir ta ’ l- Istat Mentali) ta ’ 10- 24.