Olanzapine Teva

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
25-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
25-09-2023
Public Assessment Report Public Assessment Report (PAR)
01-03-2013

Active ingredient:

olansapiin

Available from:

Teva B.V. 

ATC code:

N05AH03

INN (International Name):

olanzapine

Therapeutic group:

Psühhoeptikumid

Therapeutic area:

Schizophrenia; Bipolar Disorder

Therapeutic indications:

AdultsOlanzapine on näidustatud skisofreenia ravi. Olansapiin on efektiivne, säilitades kliinilist paranemist ajal jätkamine ravi patsientidel, kes on näidanud, esialgne ravi vastuseks. Olansapiin on näidustatud ravi mõõduka kuni raske maniakaalse episoodi. Patsientidel, kelle maniakaalne episood on vastanud, et olansapiin-ravi, olansapiin on näidustatud kordumise ennetamiseks patsientidel, kellel on bipolaarne häire.

Product summary:

Revision: 30

Authorization status:

Volitatud

Authorization date:

2007-12-12

Patient Information leaflet

                                75
B. PAKENDI INFOLEHT
76
PAKENDI INFOLEHT: TEAVE KASUTAJALE
OLANZAPINE TEVA 2,5 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
OLANZAPINE TEVA 5 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
OLANZAPINE TEVA 7,5 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
OLANZAPINE TEVA 10 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
OLANZAPINE TEVA 15 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
OLANZAPINE TEVA 20 MG ÕHUKESE POLÜMEERIKATTEGA TABLETID
olansapiin
ENNE RAVIMI VÕTMIST 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 või apteekriga.
-
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
või apteekriga. Kõrvaltoime
võib olla ka selline, mida selles infolehes ei ole nimetatud. Vt
lõik 4.
_ _
INFOLEHE SISUKORD
1.
Mis ravim on Olanzapine Teva ja milleks seda kasutatakse
2.
Mida on vaja teada enne Olanzapine Teva võtmist
3.
Kuidas Olanzapine Teva’t võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Olanzapine Teva’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON OLANZAPINE TEVA JA MILLEKS SEDA KASUTATAKSE
Olanzapine Teva sisaldab toimeainet olansapiini. Olanzapine Teva
kuulub ravimite rühma, mida
nimetatakse antipsühootikumideks ja seda kasutatakse järgmiste
haiguste raviks:
-
Skisofreenia - haigus, mille sümptomiteks on tegelikkusele
mittevastavate asjade kuulmine,
nägemine või tajumine, ekslikud tõekspidamised, ülemäärane
kahtlustamine ning
enesessetõmbumine. Seda haigust põdevad inimesed võivad tunda ka
masendust, ärevust või
pinevust.
-
Mõõdukad kuni rasked maania episoodid - selle seisundi sümptomiteks
on erutusseisund ja
eufooria.
On tõestatud, et Olanzapine Teva hoiab ära nende sümptomite
taastekke bipolaarse häirega
patsientidel, kelle maania episoodid on allunud olansapiinravile.
2.
MIDA ON VAJA TEADA ENNE OLANZAPINE TEV
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Olanzapine Teva 2,5 mg õhukese polümeerikattega tabletid
Olanzapine Teva 5 mg õhukese polümeerikattega tabletid
Olanzapine Teva 7,5 mg õhukese polümeerikattega tabletid
Olanzapine Teva 10 mg õhukese polümeerikattega tabletid
Olanzapine Teva 15 mg õhukese polümeerikattega tabletid
Olanzapine Teva 20 mg õhukese polümeerikattega tabletid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
_ _
Olanzapine Teva 2,5 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 2,5 mg olansapiini.
_Teadaolevat toimet omav abiaine _
Üks õhukese polümeerikattega tablett sisaldab 71,3 mg laktoosi.
Olanzapine Teva 5 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 5 mg olansapiini.
_Teadaolevat toimet omav abiaine _
Üks õhukese polümeerikattega tablett sisaldab 68,9 mg laktoosi.
Olanzapine Teva 7,5 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 7,5 mg olansapiini.
_Teadaolevat toimet omav abiaine _
Üks õhukese polümeerikattega tablett sisaldab 103,3 mg laktoosi.
Olanzapine Teva 10 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 10 mg olansapiini.
_Teadaolevat toimet omav abiaine _
Üks õhukese polümeerikattega tablett sisaldab 137,8 mg laktoosi.
Olanzapine Teva 15 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 15 mg olansapiini.
_Teadaolevat toimet omav abiaine _
Üks õhukese polümeerikattega tablett sisaldab 206,7 mg laktoosi.
Olanzapine Teva 20 mg õhukese polümeerikattega tabletid
Iga õhukese polümeerikattega tablett sisaldab 20 mg olansapiini.
_Teadaolevat toimet omavad abiaine _
Üks õhukese polümeerikattega tablett sisaldab 275,5 mg laktoosi.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Õhukese polümeerikattega tablett
Olanzapine Teva 2,5 mg õhukese polümeerikattega tabletid
Valged kaksikkumerad ümmargused õhukese polümeerikattega tabletid,
                                
                                Read the complete document

Similar products

Active ingredient olansapiin

olansapiin

ATC code N05AH03

N05AH03

Marketed by Teva B.V. 

Teva B.V. 

INN (International Name) olanzapine

olanzapine

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Public Assessment Report Public Assessment Report French 01-03-2013
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