Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Estonian

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:

rivastigmiin

Available from:

3M Health Care Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics, , Anticholinesterases

Therapeutic area:

Alzheimeri tõbi

Therapeutic indications:

Kerge kuni mõõdukalt raskekujulise Alzheimeri tõve sümptomaatiline ravi.

Product summary:

Revision: 1

Authorization status:

Endassetõmbunud

Authorization date:

2014-04-03

Patient Information leaflet

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B. PAKENDI INFOLEHT
Ravimil on müügiluba lõppenud
42
PAKENDI INFOLEHT: TEAVE KASUTAJALE
RIVASTIGMINE 3M HEALTH CARE LTD. 4,6 MG/24 H TRANSDERMAALNE PLAASTER
RIVASTIGMINE 3M HEALTH CARE LTD. 9,5 MG/24 H TRANSDERMAALNE PLAASTER
Rivastigmiin
ENNE RAVIMI KASUTAMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti, apteekri või
meditsiiniõega.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.

Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti,
apteekri või meditsiiniõega.
Kõrvaltoime võib olla ka selline, mida selles infolehes ei ole
nimetatud. Vt lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Rivastigmine 3M Health Care Ltd. ja milleks seda
kasutatakse
2.
Mida on vaja teada enne Rivastigmine 3M Health Care Ltd.’e
kasutamist
3.
Kuidas Rivastigmine 3M Health Care Ltd.’t kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Rivastigmine 3M Health Care Ltd.’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON RIVASTIGMINE 3M HEALTH CARE LTD. JA MILLEKS SEDA
KASUTATAKSE
Rivastigmine 3M Health Care Ltd.’e toimeaine on rivastigmiin.
Rivastigmiin kuulub koliinesteraasi inhibiitoriteks nimetatavate
ainete rühma. Alzheimeri tõvest
põhjustatud dementsusega patsientidel surevad ajus teatud
närvirakud, mille tulemuseks on
atsetüülkoliiniks nimetatud neurotransmitteri (aine, mis võimaldab
närvirakkudel üksteisega suhelda)
madal tase. Rivastigmiin toimib atsetüülkoliini lõhustavaid
ensüüme: atsetüülkoliinesteraasi ja
butürüülkoliinesteraasi blokeerivalt. Nende ensüümide
blokeerimisega võimaldab Rivastigmine 3M
Health Care Ltd. atsetüülkoliini tasemel ajus suureneda, aidates
seega vähendada Alzheimeri tõve
sümptomeid.
Rivastigmine 3M Health Care Ltd.’t kasutatakse täiskasvanud
patsientide ravis, kellel on kerge kuni
mõõdu
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
Ravimil on müügiluba lõppenud
2
1.
RAVIMPREPARAADI NIMETUS
Rivastigmine 3M Health Care Ltd. 4,6 mg/24 h transdermaalne plaaster
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks transdermaalne plaaster vabastab 24 tunni vältel 4,6 mg
rivastigmiini. Üks 4,15 cm
2
plaaster
sisaldab 7,17 mg rivastigmiini.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Transdermaalne plaaster.
Ristkülikukujulised plaastrid, ümmarguste nurkadega, mõõtmetega
ligikaudu 2,5 x 1,8 cm. Iga plaaster
koosneb kombineeritud eemaldatavast läbipaistvast poolitatavast
kilest, funktsionaalsest adhesiivsest
matriitsikihist, mis sisaldab ravimit ja tagumisest kaitsekihist.
Tagumine kaitsekiht on läbipaistev kuni
poolläbipaistev, korduvas mustris märgistus „R5“.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Kerge kuni keskmise raskusega Alzheimeri tõve sümptomaatiline ravi.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Ravi peaks alustama ja selle käiku kontrollima Alzheimeri tõve
(dementsuse) diagnoosimise ja ravi
kogemusega arst. Diagnoos tuleb panna kehtivatest ravijuhistest
lähtuvalt. Sarnaselt iga dementsusega
patsientidel alustatava raviga, tohib ravi rivastigmiiniga alustada
ainult juhul, kui on olemas hooldaja,
kes regulaarselt manustab ravimit ja jälgib ravi käiku.
Annustamine
TRANSDERMAALSED PLAASTID
24 TUNNI JOOKSUL _IN VIVO _
VABANEV RIVASTIGMIINI ANNUS
Rivastigmine 3M Health Care Ltd.
4,6 mg/24 h
4,6 mg
Rivastigmine 3M Health Care Ltd.
9,5 mg/24 h
9,5 mg
Rivastigmine 3M Health Care Ltd.
13,3 mg/24 h*
13,3 mg
*Rivastigmine 3M Health Care Ltd. 13,3 mg/24 h transdermaalsele
plaastrile hetkel müügiluba ei ole,
kuid teistel müügiloa hoidjatel võib see olemas olla.
Algannus
Ravi alustatakse 4,6 mg/24 h-ga.
Säilitusannus
Ravimil on müügiluba lõppenud
3
Pärast vähemalt neli nädalat kestnud ravi ja kui see on raviarsti
hinnangul hästi talutav, tuleb annust
4.6 mg/24 h suurendada 9,5 mg/24 h-ni, mis on ööpäevane soovitatav
efektiivne annus, mille
kasutamist tuleb jätkata senikaua, kui 
                                
                                Read the complete document

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Active ingredient rivastigmiin

rivastigmiin

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 Danish 18-09-2014
Summary of Product characteristics Summary of Product characteristics Danish 18-09-2014
Public Assessment Report Public Assessment Report Danish 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 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
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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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