SANDOZ MIRTAZAPINE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MIRTAZAPINE

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

N06AX11

INN (Algemene Internationale Benaming):

MIRTAZAPINE

Dosering:

15MG

farmaceutische vorm:

TABLET

Samenstelling:

MIRTAZAPINE 15MG

Toedieningsweg:

ORAL

Eenheden in pakket:

50

Prescription-type:

Prescription

Therapeutisch gebied:

MISCELLANEOUS ANTIDEPRESSANTS

Product samenvatting:

Active ingredient group (AIG) number: 0143928001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2006-01-26

Productkenmerken

_Sandoz Mirtazapine _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ MIRTAZAPINE
mirtazapine
Tablets, 15 mg and 30 mg
USP
ANTI-DEPRESSANT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Approval:
JAN 26, 2006
Date of Revision:
JUN 25, 2021
Submission Control No: 249205
_Sandoz Mirtazapine _
_Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7) 06

2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................................
4
1 INDICATIONS
.....................................................................................................................................................
4
1.1 Pediatrics
..............................................................................................................
4
1.2
Geriatrics...............................................................................................................
4
2
CONTRAINDICATIONS ....................................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................................
5
4
DOSAGE AND ADMINISTRATION
...............................................................................................................
5
4.1 Dosing Considerations
..........................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
...................................................... 5
4.3
Administration........................................................................................................
6
4.4 Reconstitution
.......................................................................................................
6
4.5 Missed
Dose................................................................................