APO-METHYLPHENIDATE ER TABLET (EXTENDED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

METHYLPHENIDATE HYDROCHLORIDE

Tilgængelig fra:

APOTEX INC

ATC-kode:

N06BA04

INN (International Name):

METHYLPHENIDATE

Dosering:

36MG

Lægemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensætning:

METHYLPHENIDATE HYDROCHLORIDE 36MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Schedule G (CDSA III)

Terapeutisk område:

Respiratory and CNS Stimulants

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2016-03-07

Produktets egenskaber

_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
.........................................................................