PMS-METHYLPHENIDATE ER TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

METHYLPHENIDATE HYDROCHLORIDE

제공처:

PHARMASCIENCE INC

ATC 코드:

N06BA04

INN (국제 이름):

METHYLPHENIDATE

복용량:

36MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

METHYLPHENIDATE HYDROCHLORIDE 36MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Schedule G (CDSA III)

치료 영역:

Respiratory and CNS Stimulants

제품 요약:

Active ingredient group (AIG) number: 0107548005; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-11-29

제품 특성 요약

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
............