NU-QUETIAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

QUETIAPINE (QUETIAPINE FUMARATE)

Tersedia dari:

NU-PHARM INC

Kode ATC:

N05AH04

INN (Nama Internasional):

QUETIAPINE

Dosis:

25MG

Bentuk farmasi:

TABLET

Komposisi:

QUETIAPINE (QUETIAPINE FUMARATE) 25MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/500

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

Active ingredient group (AIG) number: 0131858001; AHFS:

Status otorisasi:

CANCELLED (UNRETURNED ANNUAL)

Tanggal Otorisasi:

2018-03-28

Karakteristik produk

Page 1 of 42
PRODUCT MONOGRAPH
Pr
NU-QUETIAPINE
QUETIAPINE AS QUETIAPINE FUMARATE
TABLETS 25 MG, 100 MG, 200 MG AND 300 MG
ANTIPSYCHOTIC AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
RICHMOND HILL, ON
SEPTEMBER 2, 2009
L4B 1E4
Control#: 132324
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
4
ADVERSE
REACTIONS.......................................................................................................
11
DRUG INTERACTIONS
.......................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................
20
OVERDOSAGE......................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
22
STORAGE AND
STABILITY...............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 24
PART II: SCIENTIFIC INFORMATION
.............................................................................
25
PHARMACEUTICAL
INFORMATION...............................................................................
25
CLINICAL TRIALS
...............................................................................................................
26
DETAILED PHARMACOLOGY
.....