PRO-MIRTAZAPINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MIRTAZAPINE

Saatavilla:

PRO DOC LIMITEE

ATC-koodi:

N06AX11

INN (Kansainvälinen yleisnimi):

MIRTAZAPINE

Annos:

30MG

Lääkemuoto:

TABLET

Koostumus:

MIRTAZAPINE 30MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTIDEPRESSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0143928002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2008-07-02

Valmisteyhteenveto

PRO-MIRTAZAPINE
Page 1 of 43
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
House Standard
ANTI-DEPRESSANT
Pro Doc Ltée.
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control No.: 279376
Date of Initial
Approval:
July 02,2008
Date of Revision:
October 20, 2023
PRO-MIRTAZAPINE
Page 2 of 43
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS, Skin 08/2021
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
......................................................................................................................
6
5 OVERDOSAGE ...........