natgillin/translations-raw huggingface dataset:
Hvis du vil have yderligere oplysninger om EVRA, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
36 Česká republika JANSSEN- CILAG s. r. o.
Česká republika JANSSEN-CILAG s.r.o.
Deutschland Janssen- Cilag GmbH Raiffeisenstr.
Deutschland JANSSEN-CILAG GmbH
JANSSEN- CILAG AB c/ o Vistor hf.
Ísland JANSSEN-CILAG AB c/o Vistor hf.
Johnson & Johnson s. r. o.
Slovenská republika Johnson & Johnson s.r.o.
Det leveres som kapsler 1, 5 mg (gule), 3 mg (orange), 4, 5 mg (røde), 6 mg (røde og orange), som oral opløsning, 2 mg/ ml og som depotplastre, der afgiver enten 4, 6 eller 9, 5 mg rivastigmin gennem huden i løbet af 24 timer.
6 mg), as an oral solution (2 mg/ ml), and as transdermal patches, which release either 4.6 mg or 9.5 mg rivastigmine across the skin over 24 hours.
Exelon kapsler, oral opløsning og depotplastre anvendes ved let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
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.
Kapslerne og den orale opløsning kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson’ s disease.
Behandling med Exelon bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom og demens hos patienter med Parkinsons sygdom.
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.
Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Exelon.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Exelon by the patient.
Exelon kapsler eller oral opløsning gives to gange dagligt sammen med morgen - og aftensmaden.
Exelon capsules or oral solution should be given twice a day, with morning and evening meals.
Startdosis er 1, 5 mg to gange dagligt.
The starting dose is 1.5 mg twice a day.
Hos patienter, der tåler denne dosis, kan dosis øges i trin på 1, 5 mg med mindst to uger mellem hvert trin, indtil en fast dosis på 3 til 6 mg to gange dagligt er nået.
In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Anvendes depotplastre, bør behandlingen begynde med det plaster, der afgiver 4, 6 mg pr.
The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Tåles denne dosis godt, kan der efter mindst fire uger skiftes til 9, 5 mg pr.
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.
Plasteret sættes på tør, ren, ubehåret, sund hud på maven, ryggen, overarmen eller brystkassen og skal skiftes hver 24 timer.
The patches are stuck onto clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
De nærmere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
See the Summary of Product Characteristics (also part of the EPAR) for detailed information.
Det aktive stof i Exelon, rivastigmin, er et middel til behandling af demens.
The active substance in Exelon, rivastigmine, is an antidementia medicine.
Det medfører for lavt indhold af neurotransmitteren acetylcholin (et signalstof, som anvendes af nervecellerne til indbyrdes kommunikation).
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).
Derved mindskes symptomerne på Alzheimers sygdom og på demens ved Parkinsons sygdom.
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.
Exelon blev undersøgt ved let til middelsvær Alzheimers sygdom.
Exelon has been studied in mild to moderately severe Alzheimer’ s disease.
Depotplastrene blev anvendt hos 1 195 patienter i én hovedundersøgelse.
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.
Exelon kapsler blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
Exelon capsules have also been studied in 541 patients with dementia due to Parkinson’ s disease.
Dels kognitive funktioner (evnen til at tænke, lære og huske), dels overordnede funktioner (en kombination af flere områder bestående af generel funktionsevne, kognitive symptomer, adfærd og evne til at udføre daglige aktiviteter).
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).
I endnu en undersøgelse hos 27 patienter blev det vist, at Exelon kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
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.
Hos de patienter, der fik Exelon, 6 til 9 mg dagligt, øgedes de kognitive symptomer med 0, 2 points fra et udgangspunkt på 22, 9 points ved undersøgelsens start (lavere score = bedre præstationer).
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.
Hos de patienter, der fik placebo, var der en stigning på 2, 6 points fra et udgangspunkt på 22, 5.
This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Hos patienterne på placebo var stigningen 4, 4 points.
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.
Også som depotplaster var Exelon mere effektivt end placebo til at forhindre forværring af demens.
The Exelon transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Udgangspunktet var omkring 24 points.
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.
Også i score vedrørende overordnede funktioner var der større bedring hos de patienter, der fik Exelon.
The global symptom score also improved more in the patients taking Exelon.
Bivirkningerne af Exelon afhænger af den form for demens, patienten har, og om patienten får kapsler, oral opløsning eller depotplastre.
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.
Som helhed er de almindeligste bivirkninger (ses hos flere end 1 patient ud af 10) kvalme og opkastning, især i den fase, hvor dosis af Exelon øges.
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.
Den fuldstændige liste over alle de indberettede bivirkninger ved Exelon fremgår af indlægssedlen.
For the full list of all side effects reported with Exelon, see the Package Leaflet.
Exelon bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rivastigmin, andre stoffer afledt af carbamat eller andre af indholdsstofferne.
Exelon should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Det bør ikke anvendes hos patienter med svær leversygdom.
It should not be used in patients with severe liver problems.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Exelon på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Exelon has a modest effectiveness in treating the symptoms of Alzheimer’ s dementia, although this does reflect an important benefit in some patients.
Udvalget konkluderede først, at fordelene ved Exelon ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’ s disease, Exelon’ s benefits did not outweigh its risks.
Efter fornyet overvejelse af denne opfattelse konkluderede udvalget imidlertid, at lægemidlets beskedne virkning kan være en fordel for nogle patienter.
However, following a re-examination of this opinion, the Committee concluded that the medicine’ s modest effectiveness could also be of benefit to some patients.
Udvalget afgjorde derfor, at fordelene ved Exelon opvejer risiciene til behandling af let til middelsvær Alzheimers sygdom og let til middelsvær demens ved idiopatisk Parkinsons sygdom.
Therefore, the Committee decided that Exelon’ s benefits are greater than its risks for the treatment of mild to moderately severe Alzheimer’ s dementia and mild to moderately severe dementia in patients with idiopathic Parkinson ’ s disease.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Exelon.
The Committee recommended that Exelon be given marketing authorisation.
2/ 3 Andre oplysninger om Exelon:
2/ 3 Other information about Exelon:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exelon til Novartis Europharm Limited den 12. maj 1998.
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Exelon on 12 May 1998.
Markedsføringstilladelsen blev fornyet den 12. maj 2003 og den 12. maj 2008.
The marketing authorisation was renewed on 12 May 2003 and on 12 May 2008.
Den fuldstændige EPAR for Exelon findes her.
The full EPAR for Exelon can be found here.
EU- nummer 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
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
Navn Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
Invented name Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon Exelon
Styrke 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
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
Lægemiddelform Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsel, hårde Kapsel, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde
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
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
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
Emballage 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)
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)
Paknings- størrelse 28 56 112 28 56 112 28 56 112 28 56 112
Package size 28 56 112 28 56 112 28 56 112 28 56 112
Oral opløsning Kapsler, hårde Kapsler, hårde Kapsel, hårde Kapsler, hårde
Oral solution Capsule, hard Capsule, hard Capsule, hard Capsule, hard
flaske (brunt glas) flaske (HDPE) flaske (HDPE) flaske (HDPE) flaske (HDPE)
bottle (amber glass) bottle (HDPE) bottle (HDPE) bottle (HDPE) bottle (HDPE)
1 flaske 250 250 250 250
1 bottle 250 250 250 250
EU/ 1/ 98/ 066/ 018 EU/ 1/ 98/ 066/ 019
EU/ 1/ 98/ 066/ 018
Exelon Exelon
Exelon
2 mg/ ml 4, 6 mg/ 24 timer
2 mg/ ml
Oral opløsning Depotplaster
Oral solution
Oral anvendelse Transdermal anvendelse
Oral use
flaske (brunt glas) brev (papir/ polyester/ alu/ polyacrylonitril)
bottle (amber glass)
1 flaske 7 breve
7 sachets
4, 6 mg/ 24 timer
4.6 mg/ 24 h
brev (papir/ polyester/ alu/ polyacrylonitril)
sachet (paper/ polyester/ alu/ polyacrylonitrile)
60 breve (30x2 breve)
60 sachets (30x2 sachets)
90 breve (30x3 breve)
90 sachets (30x3 sachets)
9, 5 mg/ 24 timer
9.5 mg/ 24 h
Exelon 1, 5 mg hårde kapsler
Exelon 1.5 mg hard capsules
Hver kapsel indeholder rivastigminhydrogentartrat svarende til 1, 5 mg rivastigmin.
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg.
Råhvidt til svagt gulligt pulver i en kapsel med gul hætte og gul skal, med ” EXELON 1, 5 mg ” præget med rødt på kapselskallen.
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ EXELON 1,5 mg ” on body.
Symptomatisk behandling af let til moderat svær Alzheimers demens.
Symptomatic treatment of mild to moderately severe Alzheimer’ s dementia.
Symptomatisk behandling af let til moderat svær demens hos patienter med idiopatisk Parkinsons sygdom.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’ s disease.
Behandlingen bør indledes og overvåges af en læge, der har erfaring med diagnosticering og behandling af Alzheimers demens eller demens, der er associeret med Parkinsons sygdom.
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.
Rivastigmin skal indtages to gange daglig sammen med henholdsvis morgen - og aftensmåltid.
Rivastigmine should be administered twice a day, with morning and evening meals.
Initialdosis 1, 5 mg to gange daglig.
Initial dose 1.5 mg twice a day.
Dosistitrering Startdosis er 1, 5 mg to gange daglig.
Dose titration The starting dose is 1.5 mg twice a day.
Efterfølgende øgninger til 4, 5 mg og dernæst 6 mg to gange daglig skal også være baseret på god tolerance af den aktuelle dosis og kan overvejes efter mindst to ugers behandling på det pågældende dosisniveau.
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.
Hvis der observeres bivirkninger (f. eks. kvalme, opkastning, mavesmerter, appetitløshed), vægttab eller forværring af ekstrapyramidale symptomer (f. eks. tremor) hos patienter med demens, der er associeret med Parkinsons sygdom, i løbet af behandlingen, vil disse muligvis kunne undgås ved udeladelse af en eller flere doser.
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.
Vedligeholdelsesdosis Den effektive dosis er 3 til 6 mg to gange daglig; for at opnå maksimal terapeutisk fordel skal patienterne holdes på den højeste dosis, som de tåler godt.
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 Der kan foregå vedligeholdelsesbehandling så længe, der er terapeutisk effekt for patienten.
2 Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Hvis der ikke er en positiv ændring i patientens tilbagefaldsrate af demenssymptomer efter 3 måneders vedligeholdelsesbehandling, bør behandlingen afbrydes.
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.
Dog blev der set en bedre effekt hos Parkinsons patienter med moderat demens.
However, a greater treatment effect was seen in Parkinson’ s disease patients with moderate dementia.
5. 1).
Similarly a larger effect was observed in Parkinson’ s disease patients with visual hallucinations (see section 5.1).
Behandlingens effekt er ikke blevet undersøgt i placebo- kontrollerede undersøgelser ud over 6 måneder.
Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Genoptagelse af terapi Hvis behandlingen afbrydes i mere end nogle dage, skal behandlingen genoptages med 1, 5 mg 2 gange daglig.
Re-initiation of therapy If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily.
5. 2).
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).
4. 3).
Patients with severe liver impairment have not been studied (see section 4.3).
- overfølsomhed over for det aktive stof, andre carbamatderivater eller over for et eller flere af
- hypersensitivity to the active substance, other carbamate derivatives or to any of the excipients
hjælpestofferne.
used in the formulation,
- alvorligt nedsat leverfunktion, da det ikke har været afprøvet i denne patientgruppe.
- severe liver impairment, as it has not been studied in this population.
Hvis behandlingen afbrydes i mere end nogle dage, må behandlingen genoptages med 1, 5 mg 2 gange daglig for at formindske muligheden for bivirkninger (f. eks. opkastninger).
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).
Dosistitrering:
Dose titration:
Bivirkninger (f. eks. hypertension og hallucinationer hos patienter med Alzheimers demens og forværring af ekstrapyramidale symptomer, specielt tremor hos patienter med demens, der er associeret med Parkinsons sygdom) er observeret kort efter dosisøgning.
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.
4. 8).
In other cases, Exelon has been discontinued (see section 4.8).
Gastrointestinale gener som kvalme og opkastning kan specielt forekomme, når behandlingen påbegyndes, og/ eller når dosis øges.
Gastrointestinal disorders such as nausea and vomiting may occur particularly when initiating treatment and/ or increasing the dose.
Patienter med Alzheimers sygdom kan tabe sig.
Patients with Alzheimer’ s disease may lose weight.
Patienters vægt bør monitoreres gennem behandlingen.
During therapy patient’ s weight should be monitored.
I tilfælde af alvorlig opkastning, der er associeret med rivastigmin- behandling, skal der foretages passende dosisjustering som anbefalet i afsnit 4. 2.
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Nogle tilfælde af alvorlig opkastning blev associeret med esophagusruptur (jævnfør afsnit 4. 8).
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
3 overledningsdefekter (sino- atrialt blok, atrio- ventrikulært blok) (jævnfør afsnit 4. 8).
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).
Brugen af rivastigmin til patienter med svær demens af Alzheimers sygdom eller associeret med Parkinsons sygdom, andre typer demens eller andre typer hukommelsessvækkelse (f. eks. aldersrelateret kognitiv tilbagegang) er ikke blevet undersøgt, og anvendelse hos disse patientpopulationer kan derfor ikke anbefales.
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.
4. 8).
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).
Disse hændelser førte til seponering af rivastigmin i nogle tilfælde (f. eks. seponering grundet tremor 1, 7% på rivastigmin versus 0% på placebo).
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).
Den warfarin- inducerede stigning i protrombin- tid påvirkes ikke af indgift af rivastigmin.
The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.
Ifølge dets metabolisme forekommer metaboliske interaktioner med andre lægemidler højst sandsynligt ikke, selvom rivastigmin kan hæmme den butylkolinesterase- medierede metabolisme hos andre stoffer.
According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
I peri - / postnatale undersøgelser på rotter blev der observeret en forlænget drægtighedsperiode.
In peri/ postnatal studies in rats, an increased gestation time was observed.
Alzheimers sygdom kan medføre gradvis forringelse af køreegenskaber eller nedsætte evnen til at betjene maskiner.
Alzheimer’ s disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Som følge heraf har rivastigmin en mild eller moderat indvirkning på evnen til at føre motorkøretøj og betjene maskiner.
Therefore, the ability of patients with dementia on rivastigmine to
Derfor bør rivastigmin- behandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
4 continue driving or operating complex machines should be routinely evaluated by the treating physician.
De mest almindeligt rapporterede bivirkninger er gastrointestinale, inklusive kvalme (38%) og opkastning (23%), særligt under dosistitrering.
The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration.
Bivirkningerne i tabel 1 er blevet akkumuleret hos patienter med Alzheimers demens, som har modtaget behandlng med Exelon.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’ s dementia treated with Exelon.