JAMP ALPRAZOLAM TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
12-08-2021

Viambatanisho vya kazi:

ALPRAZOLAM

Inapatikana kutoka:

JAMP PHARMA CORPORATION

ATC kanuni:

N05BA12

INN (Jina la Kimataifa):

ALPRAZOLAM

Kipimo:

1MG

Dawa fomu:

TABLET

Tungo:

ALPRAZOLAM 1MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100/500/1000

Dawa ya aina:

Targeted (CDSA IV)

Eneo la matibabu:

BENZODIAZEPINES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0115008003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-09-15

Tabia za bidhaa

                                JAMP-Alprazolam (alprazolam)-Product Monograph Page 1 of 43
PRODUCT MONOGRAPH JAMP ALPRAZOLAM
Alprazolam Tablets, USP
0.25 mg, 0.5 mg, 1 mg and 2 mg
ANXIOLYTIC
– ANTIPANIC
JAMP Pharma Corporation Date of Revision:
1310 rue Nobel August 12, 2021
Boucherville,
Quebec
J4B 5H3
Submission
Control No.: 253380
JAMP-Alprazolam (alprazolam)-Product Monograph Page 2 of 43
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
.............................................................................................
13
DRUG INTERACTIONS
.............................................................................................
17
DOSAGE AND ADMINISTRATION
............................................................................
20
OVERDOSAGE
.........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 23
STORAGE AND STABILITY
......................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
................................................................. 26
PHARMACEUTICAL INFORMATION
........................................................................
26
CLINICAL TRIALS
....................................................................................................
26
DETAILED PHARMACOLOGY
........................................
                                
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