Pregabalin Sandoz GmbH

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-10-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-10-2023
Public Assessment Report Public Assessment Report (PAR)
12-10-2023

Active ingredient:

pregabaliin

Available from:

Sandoz GmbH

ATC code:

N03AX16

INN (International Name):

pregabalin

Therapeutic group:

Antiepileptics,

Therapeutic area:

Anxiety Disorders; Epilepsy

Therapeutic indications:

EpilepsyPregabalin Sandoz GmbH on näidustatud adjunctive ravi täiskasvanutel, osaline krambid koos või ilma sekundaarse üldistada. Generaliseerunud Ärevus DisorderPregabalin Sandoz GmbH on näidustatud ravi Generaliseerunud Ärevushäire (GAD) täiskasvanutel.

Product summary:

Revision: 16

Authorization status:

Endassetõmbunud

Authorization date:

2015-06-19

Patient Information leaflet

                                70
B. PAKENDI INFOLEHT
Ravimil on müügiluba lõppenud
71
PAKENDI INFOLEHT: TEAVE KASUTAJALE
PREGABALIN SANDOZ GMBH 25 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 50 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 75 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 100 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 150 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 200 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 225 MG KÕVAKAPSLID
PREGABALIN SANDOZ GMBH 300 MG KÕVAKAPSLID
pregabaliin
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 Pregabalin Sandoz GmbH ja milleks seda kasutatakse
2.
Mida on vaja teada enne Pregabalin Sandoz GmbH võtmist
3.
Kuidas Pregabalin Sandoz GmbH’d võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Pregabalin Sandoz GmbH’d säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON PREGABALIN SANDOZ GMBH JA MILLEKS SEDA KASUTATAKSE
Pregabalin Sandoz GmbH kuulub ravimite rühma, mida kasutatakse
epilepsia ja generaliseerunud
ärevushäire raviks täiskasvanutel.
EPILEPSIA:
Pregabalin Sandoz GmbH’d kasutatakse täiskasvanutel teatud
epilepsia vormide (osalised
ehk partsiaalsed krambihood koos või ilma sekundaarse
generaliseerumiseta) raviks. Arst määrab teile
Pregabalin Sandoz GmbH epilepsia raviks juhul, kui senise raviga ei
õnnestu haigust kontrolli all
hoida. Te peate Pregabalin Sandoz GmbH’d võtma lisaks senisele
ravile. Pregabalin Sandoz GmbH ei
ole ette nähtud kasutamiseks eraldi, vaid alati kombinatsioonis
teiste epilepsiavastaste ravimitega.
GENERALISEERUNUD ÄREVUSHÄIRE:
Pregabalin Sandoz GmbH’d kasut
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
Ravimil on müügiluba lõppenud
2
1.
RAVIMPREPARAADI NIMETUS
Pregabalin Sandoz GmbH 25 mg kõvakapslid
Pregabalin Sandoz GmbH 50 mg kõvakapslid
Pregabalin Sandoz GmbH 75 mg kõvakapslid
Pregabalin Sandoz GmbH 100 mg kõvakapslid
Pregabalin Sandoz GmbH 150 mg kõvakapslid
Pregabalin Sandoz GmbH 200 mg kõvakapslid
Pregabalin Sandoz GmbH 225 mg kõvakapslid
Pregabalin Sandoz GmbH 300 mg kõvakapslid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Pregabalin Sandoz GmbH 25 mg kõvakapslid
Iga kõvakapsel sisaldab 25 mg pregabaliini.
Pregabalin Sandoz GmbH 50 mg kõvakapslid
Iga kõvakapsel sisaldab 50 mg pregabaliini.
Pregabalin Sandoz GmbH 75 mg kõvakapslid
Iga kõvakapsel sisaldab 75 mg pregabaliini.
Pregabalin Sandoz GmbH 100 mg kõvakapslid
Iga kõvakapsel sisaldab 100 mg pregabaliini.
Pregabalin Sandoz GmbH 150 mg kõvakapslid
Iga kõvakapsel sisaldab 150 mg pregabaliini.
Pregabalin Sandoz GmbH 200 mg kõvakapslid
Iga kõvakapsel sisaldab 200 mg pregabaliini.
Pregabalin Sandoz GmbH 225 mg kõvakapslid
Iga kõvakapsel sisaldab 225 mg pregabaliini.
Pregabalin Sandoz GmbH 300 mg kõvakapslid
Iga kõvakapsel sisaldab 300 mg pregabaliini.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Kõvakapsel
Pregabalin Sandoz GmbH 25 mg kõvakapslid
Kahvatu kollakaspruun läbipaistmatu kapslikaas ja kapslikorpus,
kapsli suurus 4 (14,3 mm x 5,3 mm),
täidetud valge kuni peaaegu valge pulbriga
Pregabalin Sandoz GmbH 50 mg kõvakapslid
Helekollane läbipaistmatu kapslikaas ja kapslikorpus, kapsli suurus 3
(15,9 mm x 5,8 mm), täidetud
valge kuni peaaegu valge pulbriga.
Pregabalin Sandoz GmbH 75 mg kõvakapslid
Punane läbipaistmatu kapslikaas ja valge läbipaistmatu kapslikorpus,
kapsli suurus 4
(14,3 mm x 5,3 mm), täidetud valge kuni peaaegu valge pulbriga.
Ravimil on müügiluba lõppenud
3
Pregabalin Sandoz GmbH 100 mg kõvakapslid
Punane läbipaistmatu kapslikaas ja kapslikorpus, kapsli suurus 3
(15,9 mm x 5,8 mm), täidetud valge
kuni peaaegu valge pulbriga.
Pregabalin Sandoz GmbH 150
                                
                                Read the complete document

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Patient Information leaflet Patient Information leaflet Bulgarian 12-10-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 12-10-2023
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