PRO-MIRTAZAPINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MIRTAZAPINE

זמין מ:

PRO DOC LIMITEE

קוד ATC:

N06AX11

INN (שם בינלאומי):

MIRTAZAPINE

כמות:

30MG

טופס פרצבטיות:

TABLET

הרכב:

MIRTAZAPINE 30MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTIDEPRESSANTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2008-07-02

מאפייני מוצר

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 ...........