국가: 캐나다
언어: 영어
출처: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
PHARMASCIENCE INC
N06BA04
METHYLPHENIDATE
27MG
TABLET (EXTENDED-RELEASE)
METHYLPHENIDATE HYDROCHLORIDE 27MG
ORAL
100
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548007; AHFS:
CANCELLED POST MARKET
2019-11-29
PRODUCT MONOGRAPH PMS-METHYLPHENIDATE ER Methylphenidate Hydrochloride Extended-Release Tablets, House Standard 18 mg, 27 mg, 36 mg, and 54 mg CNS STIMULANT PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Ave., Suite 100 June 20, 2019 Montréal, Canada H4P 2T4 www.pharmascience.com SUBMISSION CONTROL NO: 228697 _pms-METHYLPHENIDATE ER Product Monograph _ _Page 2 of 50 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 12 DRUG INTERACTIONS ......................................................................................................... 20 DOSAGE AND ADMINISTRATION ..................................................................................... 22 OVERDOSAGE ....................................................................................................................... 24 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 25 STORAGE AND STABILITY ................................................................................................. 29 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 29 PART II: SCIENTIFIC INFORMATION ............................................................................... 31 PHARMACEUTICAL INFORMATION ................................................................................. 31 CLINICAL TRIALS ............ 전체 문서 읽기