RIVA-ALPRAZOLAM TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
29-06-2018
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Aktivní složka:
ALPRAZOLAM
Dostupné s:
LABORATOIRE RIVA INC.
ATC kód:
N05BA12
INN (Mezinárodní Name):
ALPRAZOLAM
Dávkování:
1MG
Léková forma:
TABLET
Složení:
ALPRAZOLAM 1MG
Podání:
ORAL
Jednotky v balení:
100/500/1000
Druh předpisu:
Targeted (CDSA IV)
Terapeutické oblasti:
BENZODIAZEPINES
Přehled produktů:
Active ingredient group (AIG) number: 0115008003; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2018-09-04
Charakteristika produktu
PRODUCT MONOGRAPH
RIVA-ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
LABORATOIRE RIVA INC
. Date of Revision:
660 Boul. Industriel June 29, 2018
Blainville, Québec
J7C 3V4
www.labriva.com
CONTROL# 216392
_Product Monograph – Riva-Alprazolam _
_ _
_Page 2 of 39 _
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
.........................................................
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