REMERON RD TABLET (ORALLY DISINTEGRATING)

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 (ORALLY DISINTEGRATING)

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:

2021-05-11

Ürün özellikleri

_REMERON RD_
®
_ (mirtazapine)_
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REMERON RD
®
mirtazapine orally disintegrating tablets
15, 30 and 45 mg
ANTI-DEPRESSANT
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Initial Approval:
December 19, 2003
Date of Revision:
May 10, 2021
Submission Control No. 250922
_REMERON RD_
®
_ (mirtazapine)_
_ _
_Page 2 of 39_
TABLE OF CONTENTS
Warnings and Precautions, Skin (7)
12/2020
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
5
OVERDOSAGE
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 7
7. WARNINGS