TEVA-HYDROMORPHONE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

HYDROMORPHONE HYDROCHLORIDE

Saadav alates:

TEVA CANADA LIMITED

ATC kood:

N02AA03

INN (Rahvusvaheline Nimetus):

HYDROMORPHONE

Annus:

4MG

Ravimvorm:

TABLET

Koostis:

HYDROMORPHONE HYDROCHLORIDE 4MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Narcotic (CDSA I)

Terapeutiline ala:

OPIATE AGONISTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2011-01-18

Toote omadused

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