País: Canadá
Língua: inglês
Origem: Health Canada
PIZOTIFEN (PIZOTIFEN MALATE)
PALADIN LABS INC.
N02CX01
PIZOTIFEN
1MG
TABLET
PIZOTIFEN (PIZOTIFEN MALATE) 1MG
ORAL
100
Prescription
ANTIMIGRAINE AGENTS, MISCELLANEOUS
Active ingredient group (AIG) number: 0110877001; AHFS:
APPROVED
2009-06-02
_Product Monograph _ _ _ SANDOMIGRAN DS (_pizotifen tablets)_ _ _ _ Page 1 of 21_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOMIGRAN DS Pizotifen tablets Tablets, 1 mg pizotifen (as pizotifen malate), oral Serotonin and Tryptamine Antagonist Migraine Prophylaxis ATC code: N02CX Paladin Labs Inc. 100 Alexis Nihon Blvd., Suite 600 Saint-Laurent, Quebec, Canada H4M 2P2 Date of Initial Authorization: December 31, 1980 Date of Revision: August 23, 2023 Version 5.0 Submission Control Number: 272965 _Product Monograph _ _ _ SANDOMIGRAN DS (_pizotifen tablets)_ _ _ _ Page 2 of 21_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 08/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED._ _ RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations .............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 5 4.5 Missed Dose .............................................. Leia o documento completo