REMERON TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

MIRTAZAPINE

Mevcut itibaren:

ORGANON CANADA INC.

ATC kodu:

N06AX11

INN (International Adı):

MIRTAZAPINE

Doz:

30MG

Farmasötik formu:

TABLET

Kompozisyon:

MIRTAZAPINE 30MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTIDEPRESSANTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2011-03-03

Ürün özellikleri

_REMERON_
®
_ (mirtazapine)_
_ _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REMERON
®
mirtazapine tablets
30 mg
ANTI-DEPRESSANT
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.Organon.ca
Date of Initial Approval:
May 18, 2001
Date of Revision:
May 4, 2021
Submission Control No.: 250721
_REMERON_
®
_ (mirtazapine)_
_ _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
12/2020
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
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS