APO-MIRTAZAPINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MIRTAZAPINE

Dostupno od:

APOTEX INC

ATC koda:

N06AX11

INN (International ime):

MIRTAZAPINE

Doziranje:

45MG

Farmaceutski oblik:

TABLET

Sastav:

MIRTAZAPINE 45MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTIDEPRESSANTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0143928003; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2006-10-03

Svojstava lijeka

_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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_Page 1 of 44 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
USP
Antidepressant
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 03, 2006
Date of Revision:
January 31, 2022
Submission Control Number: 257508
_APO-MIRTAZAPINE (Mirtazapine Tablets) _
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_Page 2 of 44 _
_ _
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
01/2022
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
................................................................................................................
6
5
OVERDOSAGE
.....................................................