PMS-METHYLPHENIDATE ER TABLET (EXTENDED-RELEASE)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

METHYLPHENIDATE HYDROCHLORIDE

Dostupné s:

PHARMASCIENCE INC

ATC kód:

N06BA04

INN (Mezinárodní Name):

METHYLPHENIDATE

Dávkování:

54MG

Léková forma:

TABLET (EXTENDED-RELEASE)

Složení:

METHYLPHENIDATE HYDROCHLORIDE 54MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Schedule G (CDSA III)

Terapeutické oblasti:

Respiratory and CNS Stimulants

Přehled produktů:

Active ingredient group (AIG) number: 0107548006; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2019-11-29

Charakteristika produktu

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