NU-OLANZAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

OLANZAPINE

Tersedia dari:

NU-PHARM INC

Kode ATC:

N05AH03

INN (Nama Internasional):

OLANZAPINE

Dosis:

7.5MG

Bentuk farmasi:

TABLET

Komposisi:

OLANZAPINE 7.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

Active ingredient group (AIG) number: 0128783004; AHFS:

Status otorisasi:

CANCELLED (UNRETURNED ANNUAL)

Tanggal Otorisasi:

2018-03-28

Karakteristik produk

PRODUCT MONOGRAPH
PR
NU-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
Antipsychotic Agent
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
OCTOBER 8, 2009
Richmond Hill, Ontario
L4B 1E4
Control No.: 121691
Page 2 of 57
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........................................................................................................
25
DOSAGE AND ADMINISTRATION
...................................................................................
27
OVERDOSAGE......................................................................................................................
28
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
29
STORAGE AND STABILITY
..............................................................................................
31
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................... 31
PART II: SCIENTIFIC INFORMATION
.............................................................................
33
PHARMACEUTICAL INFORMATION
...............................................................................
33
CLINICAL TRIALS
...............................................................................................................
33
DETAILED PHARMACOLOGY
................................