Ország: Kanada
Nyelv: angol
Forrás: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
APOTEX INC
N06BA04
METHYLPHENIDATE
36MG
TABLET (EXTENDED-RELEASE)
METHYLPHENIDATE HYDROCHLORIDE 36MG
ORAL
100
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548005; AHFS:
APPROVED
2016-03-07
_APO-METHYLPHENIDATE ER (Methylphenidate Hydrochloride Extended-Release Tablets) _ _Page 1 of 58_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION APO-METHYLPHENIDATE ER Methylphenidate Hydrochloride Extended-Release Tablets Extended-Release Tablets, 18 mg, 27 mg, 36 mg and 54 mg, Oral Apotex Standard Central Nervous System Stimulant Apotex Inc. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: FEB 03, 2010 Date of Revision: JUL 28, 2023 Submission Control Number : 272953 _APO-METHYLPHENIDATE ER (Methylphenidate Hydrochloride Extended-Release Tablets) _ _Page 2 of 58_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 07/2023 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin toxicity/Serotonin syndrome 07/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 07/2023 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 ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ......................................................................... Olvassa el a teljes dokumentumot