PMS-METHYLPHENIDATE ER TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

METHYLPHENIDATE HYDROCHLORIDE

Saatavilla:

PHARMASCIENCE INC

ATC-koodi:

N06BA04

INN (Kansainvälinen yleisnimi):

METHYLPHENIDATE

Annos:

18MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

METHYLPHENIDATE HYDROCHLORIDE 18MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Schedule G (CDSA III)

Terapeuttinen alue:

Respiratory and CNS Stimulants

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0107548004; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2019-11-29

Valmisteyhteenveto

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