TEVA-HYDROMORPHONE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

HYDROMORPHONE HYDROCHLORIDE

Доступна з:

TEVA CANADA LIMITED

Код атс:

N02AA03

ІПН (Міжнародна Ім'я):

HYDROMORPHONE

Дозування:

1MG

Фармацевтична форма:

TABLET

Склад:

HYDROMORPHONE HYDROCHLORIDE 1MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Narcotic (CDSA I)

Терапевтична области:

OPIATE AGONISTS

Огляд продуктів:

Active ingredient group (AIG) number: 0108698004; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2021-07-30

Характеристики продукта

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