JAMP-ALPRAZOLAM TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
24-07-2018
Nekateri dokumenti za ta izdelek trenutno niso na voljo, pošljete lahko zahtevo v našo stranko in obvestili vas bomo takoj, ko jih bomo lahko pridobili.
Pošlji zahtevo.
Pošlji zahtevo.
Aktivna sestavina:
ALPRAZOLAM
Dostopno od:
JAMP PHARMA CORPORATION
Koda artikla:
N05BA12
INN (mednarodno ime):
ALPRAZOLAM
Odmerek:
0.5MG
Farmacevtska oblika:
TABLET
Sestava:
ALPRAZOLAM 0.5MG
Pot uporabe:
ORAL
Enote v paketu:
100/500
Tip zastaranja:
Targeted (CDSA IV)
Terapevtsko območje:
BENZODIAZEPINES
Povzetek izdelek:
Active ingredient group (AIG) number: 0115008002; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2020-04-01
Lastnosti izdelka
Page 1 of 37
PRODUCT MONOGRAPH
JAMP-ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
JAMP Pharma Corporation
Date of Revision: July 24, 2018
1310 rue Nobel
Boucherville, Québec
J4B 5H3
CONTROL# 217423
Page 2 of 37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................................
3
CONTRAINDICATIONS
...................................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................................
5
ADVERSE REACTIONS
.................................................................................................................
12
DRUG INTERACTIONS
..................................................................................................................
16
DOSAGE AND ADMINISTRATION
...........................................................................................
19
OVERDOSAGE
................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
21
STORAGE AND STABILITY
.......................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 22
PART II: SCIENTIFIC INFORMATION
..........................................................................
24
PHARMACEUTICAL INFORMATION
........................................................................................
24
CLINICAL TRIALS
....................................................
Preberite celoten dokument
