Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

Buy It Now

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:

rivastigmină

Available from:

3M Health Care Limited

ATC code:

N06DA03

INN (International Name):

rivastigmine

Therapeutic group:

Psychoanaleptics, , Anticolinesterazice

Therapeutic area:

Boala Alzheimer

Therapeutic indications:

Tratamentul simptomatic al demenței Alzheimer ușoară până la moderată.

Product summary:

Revision: 1

Authorization status:

retrasă

Authorization date:

2014-04-03

Patient Information leaflet

                                43
B. PROSPECTUL
Produsul medicinal nu mai este autorizat
44
PROSPECT: INFORMAŢII PENTRU UTILIZATOR
RIVASTIGMINĂ 3M HEALTH CARE LTD. 4,6 MG/24 H PLASTURE TRANSDERMIC
RIVASTIGMINĂ 3M HEALTH CARE LTD. 9,5 MG/24 H PLASTURE TRANSDERMIC
rivastigmină
CITIŢI CU ATENŢIE ŞI ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A
ÎNCEPE SĂ UTILIZAŢI ACEST MEDICAMENT,
DEOARECE CONŢINE INFORMAŢII IMPORTANTE PENTRU DUMNEAVOASTRĂ.
-
Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.
-
Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului
dumneavoastră, farmacistului sau
asistentei medicale.
-
Acest medicament a fost prescris numai pentru dumneavoastră. Nu
trebuie să-l daţi altor
persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală
ca dumneavoastră.
-
Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului
dumneavoastră, farmacistului sau
asistentei medicale. Acestea includ orice posibile reacţii adverse
nemenţionate î
n acest
prospect. Vezi pct. 4.
CE GĂSIŢI ÎN ACEST PROSPECT
1.
Ce
este Rivastigmină 3M Health Care Ltd. şi pentru ce se utilizează
2.
Ce trebuie să ştiţi înainte să utilizaţi Rivastigmină 3M Health
Care Ltd.
3.
Cum să utilizaţi Rivastigmină 3M Health Care Ltd.
4.
Reacţii adverse posibile
5.
Cum se păstrează Rivastigmină 3M Health Care Ltd.
6.
Conţinutul ambalajului şi alte informaţii
1.
CE ESTE RIVASTIGMINĂ 3M HEALTH CARE LTD. ŞI PENTRU CE SE UTILIZEAZĂ
Substanţa activă din Rivastigmină 3M Health Care Ltd. este
rivastigmina.
Rivastigmina aparţine unei clase de substanţe numite inhibitori ai
colinesterazei. La pacienţii cu
demenţă Alzheimer, anumite celule nervoase mor la nivelul
creierului, conducând la niveluri reduse
ale neurotransmiţătorului acetilcolină (o substanţă care permite
celulelor nervoase să comunice între
ele). Rivastigmina acţionează prin blocarea enzimelor care distrug
acetilcolina: acetilcolinesterază şi
butirilcolinesterază. Blocând aceste enzi
me, Rivastigmină 3M Health Care
                                
                                Read the complete document

Summary of Product characteristics

                                1
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
Produsul medicinal nu mai este autorizat
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Rivastigmină 3M Health Care Ltd. 4,6 mg/24 h plasture transdermic
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
Fiecare plasture transdermic eliberează rivastagmină 4,6 mg în 24
de ore. Fiecare plasture transdermic
de 4,15 cm
2
conţine rivastigmină 7,17 mg .
Pentru lista tuturor excipienţilor, vezi pct. 6.1.
3.
FORMA FARMACEUTICĂ
Plasture transdermic
Plasturi de formă dreptunghiulară, de aproximativ 2,5 cm pe 1,8 cm
cu colţuri rotunjite. Fiecare
plasture este alcătuit dintr-o folie de eliberare detaşabilă,
transparentă, un strat funcţional cu matrice
adezivă conţinând medicamentul şi un strat protector de suport.
Stratul de suport este transparent până
la translucid, marcat repetitiv cu “R5”.
4.
DATE CLINICE
4.1
INDICAŢII TERAPEUTICE
Tratamentul simptomatic al formelor uşoare până la moderat severe
ale demenţei Alzheimer.
4.2
DOZE ŞI MOD DE ADMINISTRARE
Tratamentul trebuie iniţiat şi urmărit de un medic cu experienţă
în diagnosticul şi tratamentul demenţei
Alzheimer. Diagnosticul trebuie stabilit pe baza criteriilor actuale.
Similar oricărui tratament iniţiat la
pacienţii cu demenţă, tratamentul cu rivastigmină trebuie început
numai dacă există un însoţitor care va
administra şi monitoriza cu regularitate tratamentul.
Doze
PLASTURI TRANSDERMICI
RATA DE ELIBERARE A
RIVASTIGMINEI _IN VIVO _PE 24
ORE
Rivastigmină 3M Health Care Ltd.
4,6 mg/24 h
4,6 mg
Rivastigmină 3M Health Care Ltd.
9,5 mg/24 h
9,5 mg
Rivastigmină 3M Health Care Ltd.
13,3 mg/24 h*
13,3 mg
*Momentan nu este disponibilă o autorizaţie de punere pe piaţă
pentru Rivastigmină 3M Health Care
Ltd. 13,3 mg/24 h plasture transdermic; această formă de prezentare
poate fi disponibilă la alţi
deţinători de autorizaţie de punere pe piaţă.
Doza iniţială
Tratamentul se începe c
                                
                                Read the complete document

Similar products

Active ingredient rivastigmină

rivastigmină

ATC code N06DA03

N06DA03

Marketed by 3M Health Care Limited

3M Health Care Limited

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 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 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

Search alerts related to this product

Alerts Rivastigmine Health Care Ltd rivastigmină

Rivastigmine Health Care Ltd rivastigmină

View documents history

Documents history Documents history

Rivastigmine 3M Health Care Ltd