TEVA-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
19-12-2019
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Aktiv bestanddel:
METHYLPHENIDATE HYDROCHLORIDE
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
N06BA04
INN (International Name):
METHYLPHENIDATE
Dosering:
18MG
Lægemiddelform:
TABLET (EXTENDED-RELEASE)
Sammensætning:
METHYLPHENIDATE HYDROCHLORIDE 18MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500
Recept type:
Schedule G (CDSA III)
Terapeutisk område:
Respiratory and CNS Stimulants
Produkt oversigt:
Active ingredient group (AIG) number: 0107548004; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2023-03-21
Produktets egenskaber
_ _
PRODUCT MONOGRAPH
TEVA-METHYLPHENIDATE ER-C
(Methylphenidate Hydrochloride)
Extended-release Tablets 18 mg, 27 mg, 36 mg, and 54 mg
Teva Standard
CNS Stimulant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 19, 2019
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 233639
C
_Teva-Methylphenidate ER-C_
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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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 28
PART II: SCIENTIFIC INFORMATION
....................................................................................
30
PHARMACEUTICAL INFORMATION
.................................................................................
30
CLINICAL TRIALS
.....................
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