Exelon

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-06-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
08-06-2023
Public Assessment Report Public Assessment Report (PAR)
06-02-2013

Active ingredient:

rivastigmine

Available from:

Novartis Europharm Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Dementia; Alzheimer Disease; Parkinson Disease

Therapeutic indications:

Simptomātiska vieglas vai vidēji smaga Alcheimera demences ārstēšana. Simptomātiska ārstēšana vieglas vai vidēji smagas demences pacientiem ar idiopātisko Parkinsona slimība.

Product summary:

Revision: 46

Authorization status:

Autorizēts

Authorization date:

1998-05-11

Patient Information leaflet

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Exelon 1,5 mg cietās kapsulas
Exelon 3,0 mg cietās kapsulas
Exelon 4,5 mg cietās kapsulas
Exelon 6,0 mg cietās kapsulas
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Exelon 1,5 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 1,5 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 3,0 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 3,0 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 4,5 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 4,5 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 6,0 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 6,0 mg rivastigmīna
(
_Rivastigminum_
).
Pilnu palīgvielu sarakstu skatīt 6.1 apakšpunktā.
3.
ZĀĻU FORMA
Cietās kapsulas
Exelon 1,5 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar dzeltenu korpusu
un dzeltenu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 1,5 mg”.
Exelon 3,0 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar oranžu korpusu
un oranžu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 3 mg”.
Exelon 4,5 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar sarkanu korpusu
un sarkanu vāciņu. Uz kapsulas
korpusa ir apdruka baltā krāsā “EXELON 4,5 mg”.
Exelon 6,0 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar oranžu korpusu
un sarkanu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 6 mg”.
3
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
TERAPEITISKĀS INDIKĀCIJAS
Simptomātiska viegli vai vidēji izteiktas Alcheimera slimības
terapija.
Simptomātiska viegli vai vidēji izteiktas demences terapija
pacientiem ar idiopātisku Parkinsona
slimību.
4.2.
DEVAS UN LIETOŠANAS VEIDS
Terapija jāsāk un jākontrolē ārstam ar Alcheimera demences vai ar
Parkinsona slimību saistītas
demenc
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Exelon 1,5 mg cietās kapsulas
Exelon 3,0 mg cietās kapsulas
Exelon 4,5 mg cietās kapsulas
Exelon 6,0 mg cietās kapsulas
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Exelon 1,5 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 1,5 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 3,0 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 3,0 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 4,5 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 4,5 mg rivastigmīna
(
_Rivastigminum_
).
Exelon 6,0 mg cietās kapsulas
Katra kapsula satur rivastigmīna hidrogēntartrātu, kā daudzums
atbilst 6,0 mg rivastigmīna
(
_Rivastigminum_
).
Pilnu palīgvielu sarakstu skatīt 6.1 apakšpunktā.
3.
ZĀĻU FORMA
Cietās kapsulas
Exelon 1,5 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar dzeltenu korpusu
un dzeltenu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 1,5 mg”.
Exelon 3,0 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar oranžu korpusu
un oranžu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 3 mg”.
Exelon 4,5 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar sarkanu korpusu
un sarkanu vāciņu. Uz kapsulas
korpusa ir apdruka baltā krāsā “EXELON 4,5 mg”.
Exelon 6,0 mg cietās kapsulas
Dzeltenbalts vai gaiši dzeltens pulveris kapsulā ar oranžu korpusu
un sarkanu vāciņu. Uz kapsulas
korpusa ir apdruka sarkanā krāsā “EXELON 6 mg”.
3
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
TERAPEITISKĀS INDIKĀCIJAS
Simptomātiska viegli vai vidēji izteiktas Alcheimera slimības
terapija.
Simptomātiska viegli vai vidēji izteiktas demences terapija
pacientiem ar idiopātisku Parkinsona
slimību.
4.2.
DEVAS UN LIETOŠANAS VEIDS
Terapija jāsāk un jākontrolē ārstam ar Alcheimera demences vai ar
Parkinsona slimību saistītas
demenc
                                
                                Read the complete document

Similar products

Active ingredient rivastigmine

rivastigmine

ATC code N06DA03

N06DA03

Marketed by Novartis Europharm Limited

Novartis Europharm Limited

INN (International Name) rivastigmine

rivastigmine

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Patient Information leaflet Patient Information leaflet Bulgarian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-06-2023
Public Assessment Report Public Assessment Report Bulgarian 06-02-2013
Patient Information leaflet Patient Information leaflet Spanish 08-06-2023
Summary of Product characteristics Summary of Product characteristics Spanish 08-06-2023
Public Assessment Report Public Assessment Report Spanish 06-02-2013
Patient Information leaflet Patient Information leaflet Czech 08-06-2023
Summary of Product characteristics Summary of Product characteristics Czech 08-06-2023
Public Assessment Report Public Assessment Report Czech 06-02-2013
Patient Information leaflet Patient Information leaflet Danish 08-06-2023
Summary of Product characteristics Summary of Product characteristics Danish 08-06-2023
Public Assessment Report Public Assessment Report Danish 06-02-2013
Patient Information leaflet Patient Information leaflet German 08-06-2023
Summary of Product characteristics Summary of Product characteristics German 08-06-2023
Public Assessment Report Public Assessment Report German 06-02-2013
Patient Information leaflet Patient Information leaflet Estonian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Estonian 08-06-2023
Public Assessment Report Public Assessment Report Estonian 06-02-2013
Patient Information leaflet Patient Information leaflet Greek 08-06-2023
Summary of Product characteristics Summary of Product characteristics Greek 08-06-2023
Public Assessment Report Public Assessment Report Greek 06-02-2013
Patient Information leaflet Patient Information leaflet English 08-06-2023
Summary of Product characteristics Summary of Product characteristics English 08-06-2023
Public Assessment Report Public Assessment Report English 06-02-2013
Patient Information leaflet Patient Information leaflet French 08-06-2023
Summary of Product characteristics Summary of Product characteristics French 08-06-2023
Public Assessment Report Public Assessment Report French 06-02-2013
Patient Information leaflet Patient Information leaflet Italian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Italian 08-06-2023
Public Assessment Report Public Assessment Report Italian 06-02-2013
Patient Information leaflet Patient Information leaflet Lithuanian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-06-2023
Public Assessment Report Public Assessment Report Lithuanian 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Hungarian 08-06-2023
Public Assessment Report Public Assessment Report Hungarian 06-02-2013
Patient Information leaflet Patient Information leaflet Maltese 08-06-2023
Summary of Product characteristics Summary of Product characteristics Maltese 08-06-2023
Public Assessment Report Public Assessment Report Maltese 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Dutch 08-06-2023
Public Assessment Report Public Assessment Report Dutch 06-02-2013
Patient Information leaflet Patient Information leaflet Polish 08-06-2023
Summary of Product characteristics Summary of Product characteristics Polish 08-06-2023
Public Assessment Report Public Assessment Report Polish 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Portuguese 08-06-2023
Public Assessment Report Public Assessment Report Portuguese 06-02-2013
Patient Information leaflet Patient Information leaflet Romanian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Romanian 08-06-2023
Public Assessment Report Public Assessment Report Romanian 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Slovak 08-06-2023
Public Assessment Report Public Assessment Report Slovak 06-02-2013
Patient Information leaflet Patient Information leaflet Slovenian 08-06-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 08-06-2023
Public Assessment Report Public Assessment Report Slovenian 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Finnish 08-06-2023
Public Assessment Report Public Assessment Report Finnish 06-02-2013
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Summary of Product characteristics Summary of Product characteristics Swedish 08-06-2023
Public Assessment Report Public Assessment Report Swedish 06-02-2013
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