TEVA-HYDROMORPHONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

HYDROMORPHONE HYDROCHLORIDE

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

N02AA03

Designación común internacional (DCI):

HYDROMORPHONE

Dosis:

8MG

formulario farmacéutico:

TABLET

Composición:

HYDROMORPHONE HYDROCHLORIDE 8MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0108698005; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-07-30

Ficha técnica

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