Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
18-09-2014
Public Assessment Report Public Assessment Report (PAR)
18-09-2014

Active ingredient:

rivastigmin

Available from:

3M Health Care Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics, , Anticholinesterases

Therapeutic area:

Alzheimers sygdom

Therapeutic indications:

Symptomatisk behandling af mild til moderat alvorlig Alzheimers demens.

Product summary:

Revision: 1

Authorization status:

Trukket tilbage

Authorization date:

2014-04-03

Patient Information leaflet

                                40
B. INDLÆGSSEDDEL
Lægemidlet er ikke længere autoriseret til salg
41
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
RIVASTIGMINE3M HEALTH CARE LTD. 4,6 MG/24 TIMER DEPOTPLASTER
RIVASTIGMINE 3M HEALTH CARE LTD. 9,5 MG/24 TIMER DEPOTPLASTER
rivastigmin
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT BRUGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er
mere, du vil vide.
-
Lægen har ordineret Rivastigmine 3M Health Care Ltd. til dig
personligt. Lad derfor være med
at give det til andre. Det kan være skadeligt for andre, selvom de
har de samme symptomer, som
du har.

Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en
bivirkning bliver værre,
eller du får bivirkninger, som ikke er nævnt her. Se punkt 4.
-
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at bruge Rivastigmine 3M Health
Care Ltd.
3.
Sådan skal du bruge Rivastigmine 3M Health Care Ltd.
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Det aktive lægemiddel i Rivastigmine 3M Health Care Ltd. er
rivastigmin.
Rivastigmin tilhører en medicingruppe, der kaldes
kolinesterasehæmmere. Hos patienter med
Alzheimers demens dør visse nerveceller i hjernen, hvilket resulterer
i lave niveauer af
neurotransmitteren acetylcholin (et stof, som bruges af nervecellerne
til at kommunikere med
hinanden). Rivastigmin virker ved at blokere de enzymer, der nedbryder
acetylcholin:
acetylcholinesterase og butyrylcholinesterase. Ved at blokere disse
enzymer kan Rivastigmine 3M
Health Care Ltd. medvirke til, at acetylcholin-indholdet øges i
hjernen, hvilket hjælper med at
reducere symptomerne på Alzheimers sygdom.
Rivastigmine 3M Health Care Ltd. anvendes til behandling af voksne
patienter med mild til moderat
svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis
påvirker hukommelse,

                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
_ _
BILAG I
PRODUKTRESUME
Lægemidlet er ikke længere autoriseret til salg
2
1.
LÆGEMIDLETS NAVN
Rivastigmine 3M Health Care Ltd. 4,6 mg/24 timer depotplaster
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hvert depotplaster frigiver 4,6 mg rivastigmin pr. 24 timer. Hvert
depotplaster på 4,15 cm
2
indeholder
7,17 mg rivastigmin.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Depotplaster
Rektangulære plastre, cirka 2,5 cm x 1,8 cm med afrundede hjørner.
Hvert plaster består af en
kombination af et aftageligt, gennemsigtigt dæklag, et funktionslag
bestående af DIA-matrix og et
beskyttelseslag på bagsiden. Bagsidelaget er gennemsigtigt til
gennemskinneligt, mærket med "R5" i et
gentagelsesmønster.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Symptomatisk behandling af let til moderat svær Alzheimers demens.
4.2
DOSERING OG ADMINISTRATION
Behandlingen bør indledes og overvåges af en læge, der har erfaring
med diagnosticering og behandling
af Alzheimers demens. Diagnosen bør stilles i henhold til de
gældende retningslinjer. Som ved al
behandling af patienter med demens bør rivastigminterapi kun
påbegyndes, hvis der er en
omsorgsgivende person, som løbende vil administrere og holde øje med
behandlingen hos patienten.
Posologi
DEPOTPLASTRE
RIVASTIGMINFRIGIVELSE
PR. 24 TIMER_ IN VIVO_
Rivastigmin 4,6 mg/24 timer
4,6 mg
Rivastigmin 9,5 mg/24 timer
9,5 mg
Rivastigmin 9,5 mg/24 timer*
13,3 mg
*En marknadsføringstilladelse for Rivastigmine 3M Health Care Ltd.
13,3 mg/24 timer depotplaster
er i øjeblikket ikke til rådighed, denne styrke kan være
tillgængelig fra andre marknadsføringtilladelse
indehavere.
Initialdosis
Behandlingen indledes med 4,6 mg/24 timer.
Vedligeholdelsesdosis
Efter mindst fire ugers behandling, og hvis denne dosis ifølge den
behandlende læge tåles godt, bør dosis
med 4,6 mg/24 timer øges til 9,5 mg/24 timer, som er den anbefalede
virksomme dosis, anvendes så
længe der er terapeutisk effekt for patienten.
Lægemidlet er ikke længere autori
                                
                                Read the complete document

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Active ingredient rivastigmin

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ATC code N06DA03

N06DA03

Marketed by 3M Health Care Limited

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INN (International Name) rivastigmine

rivastigmine

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 18-09-2014
Public Assessment Report Public Assessment Report Bulgarian 18-09-2014
Patient Information leaflet Patient Information leaflet Spanish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Spanish 18-09-2014
Public Assessment Report Public Assessment Report Spanish 18-09-2014
Patient Information leaflet Patient Information leaflet Czech 18-09-2014
Summary of Product characteristics Summary of Product characteristics Czech 18-09-2014
Public Assessment Report Public Assessment Report Czech 18-09-2014
Patient Information leaflet Patient Information leaflet German 18-09-2014
Summary of Product characteristics Summary of Product characteristics German 18-09-2014
Public Assessment Report Public Assessment Report German 18-09-2014
Patient Information leaflet Patient Information leaflet Estonian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Estonian 18-09-2014
Public Assessment Report Public Assessment Report Estonian 18-09-2014
Patient Information leaflet Patient Information leaflet Greek 18-09-2014
Summary of Product characteristics Summary of Product characteristics Greek 18-09-2014
Public Assessment Report Public Assessment Report Greek 18-09-2014
Patient Information leaflet Patient Information leaflet English 18-09-2014
Summary of Product characteristics Summary of Product characteristics English 18-09-2014
Public Assessment Report Public Assessment Report English 18-09-2014
Patient Information leaflet Patient Information leaflet French 18-09-2014
Summary of Product characteristics Summary of Product characteristics French 18-09-2014
Public Assessment Report Public Assessment Report French 18-09-2014
Patient Information leaflet Patient Information leaflet Italian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Italian 18-09-2014
Public Assessment Report Public Assessment Report Italian 18-09-2014
Patient Information leaflet Patient Information leaflet Latvian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Latvian 18-09-2014
Public Assessment Report Public Assessment Report Latvian 18-09-2014
Patient Information leaflet Patient Information leaflet Lithuanian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Lithuanian 18-09-2014
Public Assessment Report Public Assessment Report Lithuanian 18-09-2014
Patient Information leaflet Patient Information leaflet Hungarian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Hungarian 18-09-2014
Public Assessment Report Public Assessment Report Hungarian 18-09-2014
Patient Information leaflet Patient Information leaflet Maltese 18-09-2014
Summary of Product characteristics Summary of Product characteristics Maltese 18-09-2014
Public Assessment Report Public Assessment Report Maltese 18-09-2014
Patient Information leaflet Patient Information leaflet Dutch 18-09-2014
Summary of Product characteristics Summary of Product characteristics Dutch 18-09-2014
Public Assessment Report Public Assessment Report Dutch 18-09-2014
Patient Information leaflet Patient Information leaflet Polish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Polish 18-09-2014
Public Assessment Report Public Assessment Report Polish 18-09-2014
Patient Information leaflet Patient Information leaflet Portuguese 18-09-2014
Summary of Product characteristics Summary of Product characteristics Portuguese 18-09-2014
Public Assessment Report Public Assessment Report Portuguese 18-09-2014
Patient Information leaflet Patient Information leaflet Romanian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Romanian 18-09-2014
Public Assessment Report Public Assessment Report Romanian 18-09-2014
Patient Information leaflet Patient Information leaflet Slovak 18-09-2014
Summary of Product characteristics Summary of Product characteristics Slovak 18-09-2014
Public Assessment Report Public Assessment Report Slovak 18-09-2014
Patient Information leaflet Patient Information leaflet Slovenian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 18-09-2014
Public Assessment Report Public Assessment Report Slovenian 18-09-2014
Patient Information leaflet Patient Information leaflet Finnish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Finnish 18-09-2014
Public Assessment Report Public Assessment Report Finnish 18-09-2014
Patient Information leaflet Patient Information leaflet Swedish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Swedish 18-09-2014
Public Assessment Report Public Assessment Report Swedish 18-09-2014
Patient Information leaflet Patient Information leaflet Norwegian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 18-09-2014
Patient Information leaflet Patient Information leaflet Icelandic 18-09-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 18-09-2014
Patient Information leaflet Patient Information leaflet Croatian 18-09-2014
Summary of Product characteristics Summary of Product characteristics Croatian 18-09-2014
Public Assessment Report Public Assessment Report Croatian 18-09-2014

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