Rivastigmine 3M Health Care Ltd

Country: European Union

Language: Croatian

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, , Антихолинэстеразных

Therapeutic area:

Alzheimerova bolest

Therapeutic indications:

Simptomatsko liječenje blage do umjereno teške Alzheimerove demencije.

Product summary:

Revision: 1

Authorization status:

povučen

Authorization date:

2014-04-03

Patient Information leaflet

                                41
B. UPUTA O LIJEKU
Lijek više nema odobrenje za stavljanje u promet
42
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
RIVASTIGMIN 3M HEALTH CARE LTD. 4,6 MG/24 H TRANSDERMALNI FLASTER
RIVASTIGMIN 3M HEALTH CARE LTD. 9,5 MG/24 H TRANSDERMALNI FLASTER
rivastigmin
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA
VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku
ili medicinskoj sestri.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte dio
4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Rivastigmin 3M Health Care Ltd. i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Rivastigmin 3M
Health Care Ltd.
3.
Kako primjenjivati Rivastigmin 3M Health Care Ltd.
4.
Moguće nuspojave
5.
Kako čuvati Rivastigmin 3M Health Care Ltd.
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE RIVASTIGMIN 3M HEALTH CARE LTD. I ZA ŠTO SE KORISTI
Djelatna tvar Rivastigmina 3M Health Care Ltd. je rivastigmin.
Rivastigmin pripada skupini tvari koje se nazivaju inhibitori
kolinesteraze. U bolesnika s
Alzheimerovom demencijom, određene živčane stanice u mozgu odumiru,
što ima za posljedicu nisku
koncentraciju neurotransmitera acetilkolina (tvari koja omogućuje
živčanim stanicama da međusobno
komuniciraju). Rivastigmin djeluje tako da blokira enzime koji
razgrađuju acetilkolin:
acetilkolinesterazu i butirilkolinesterazu. Blokiranjem tih enzima
Rivastigmin 3M Health Care Ltd.
omogućava povećavanje koncentracije acetilkolina u mozgu te tako
pomaže u smanjivanju simptoma
Alzheimerove bolesti.
Rivastigmin 3M Health Care Ltd. se primjenjuje u liječenju
poremećaja pamćenja u odraslih bolesnika
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek više nema odobrenje za stavljanje u promet
2
1.
NAZIV LIJEKA
Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni flaster
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan transdermalni flaster oslobađa 4,6 mg rivastigmina u 24 sata.
Jadan transdermalni flaster površine
4,15 cm
2
sadrži 7,17 mg rivastigmina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Transdermalni flaster
Pravokutni flasteri zaobljenih kuteva, približnih dimenzija 2,5 cm s
1,8 cm. Jedan transdermalni flaster
sastoji se od sljedeće kombinacije: odvojive, transparentne zaštitne
folije koja se može skinuti,
funkcionalnog sloja koji sadrži lijek u adhezivnom matriksu i
zaštitnog potpornog sloja. Potporni sloj je
transparentan do proziran s oznakom „R5“ u ponavljajućem uzorku.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Simptomatsko liječenje blage do umjereno teške Alzheimerove
demencije.
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje treba započeti i nadgledati liječnik s iskustvom u
dijagnosticiranju i liječenju Alzheimerove
demencije. Dijagnozu treba postaviti u skladu s trenutnim smjernicama.
Kao što je slučaj s bilo kojim
liječenjem koje se započinje u bolesnika s demencijom, liječenje
rivastigminom treba započeti jedino
ako postoji njegovatelj koji će redovito pratiti uzimanje lijeka.
Doziranje
TRANSDERMALNI FLASTERI
_IN VIVO_ STOPE OSLOBAĐANJA
RIVASTIGMINA U 24 H
Rivastigmin 4,6 mg/24 h
4,6 mg
Rivastigmin 9,5 mg/24 h
9,5 mg
Rivastigmin 13,3 mg/24 h
*
13,3 mg
*
Odobrenje za stavljanje u promet
transdermalnog flastera Rivastigmin 3M Health Care Ltd.
13,3 mg/24 h trenutno nije dostupno, iako ova doza može biti dostupna
od drugih nositelja odobrenja.
Početna doza
Liječenje se započinje dozom od 4,6 mg/24 h.
Doza održavanja
Nakon najmanje četiri tjedna liječenja te ako se lijek prema
mišljenju liječnika dobro podnosi, dozu od
4,6 mg/24 h potrebno je povećati na 9,5 mg/24 h, dnevnu preporučenu
djelotvornu dozu, s kojom treba
nastavit
                                
                                Read the complete document

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Active ingredient rivastigmin

rivastigmin

ATC code N06DA03

N06DA03

Marketed by 3M Health Care Limited

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INN (International Name) rivastigmine

rivastigmine

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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
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Patient Information leaflet Patient Information leaflet Danish 18-09-2014
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Public Assessment Report Public Assessment Report German 18-09-2014
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