TEVA-HYDROMORPHONE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

HYDROMORPHONE HYDROCHLORIDE

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

N02AA03

INN (International Nazwa):

HYDROMORPHONE

Dawkowanie:

4MG

Forma farmaceutyczna:

TABLET

Skład:

HYDROMORPHONE HYDROCHLORIDE 4MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Narcotic (CDSA I)

Dziedzina terapeutyczna:

OPIATE AGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2011-01-18

Charakterystyka produktu

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
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