Država: Kanada
Jezik: engleski
Izvor: Health Canada
MIRTAZAPINE
ORGANON CANADA INC.
N06AX11
MIRTAZAPINE
30MG
TABLET (ORALLY DISINTEGRATING)
MIRTAZAPINE 30MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0143928002; AHFS:
APPROVED
2021-05-11
_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 Pročitajte cijeli dokument