TEVA-HYDROMORPHONE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

HYDROMORPHONE HYDROCHLORIDE

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

N02AA03

INN (Algemene Internationale Benaming):

HYDROMORPHONE

Dosering:

4MG

farmaceutische vorm:

TABLET

Samenstelling:

HYDROMORPHONE HYDROCHLORIDE 4MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Narcotic (CDSA I)

Therapeutisch gebied:

OPIATE AGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0108698006; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-01-18

Productkenmerken

Teva-HYDROmorphone
Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TEVA-HYDROMORPHONE
(HYDROMORPHONE HYDROCHLORIDE TABLETS, USP)
Tablets: 1 mg, 2 mg, 4 mg and 8 mg, Oral
Opioid Analgesic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No.: 244765
Date of Revision: Nov 13, 2020
Teva-HYDROmorphone
Page 2 of 37
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS Neurologic, Serotonin toxicity / Serotonin
syndrome
NOV, 2020
7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea
NOV, 2020
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
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 5
4
DOSAGE AND ADMINISTRATION
...................................................................................
6
4.1 Dosing Considerations
.................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................. 6
4.3 Administration
.....................