TEVA-HYDROMORPHONE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

HYDROMORPHONE HYDROCHLORIDE

可用日期:

TEVA CANADA LIMITED

ATC代码:

N02AA03

INN（国际名称）:

HYDROMORPHONE

剂量:

2MG

药物剂型:

TABLET

组成:

HYDROMORPHONE HYDROCHLORIDE 2MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Narcotic (CDSA I)

治疗领域:

OPIATE AGONISTS

產品總結:

Active ingredient group (AIG) number: 0108698003; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2021-07-30

产品特点

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 5
4
DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
.................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................. 6
4.3 Administration
.....................