TEVA-HYDROMORPHONE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

HYDROMORPHONE HYDROCHLORIDE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

N02AA03

INN (International ime):

HYDROMORPHONE

Doziranje:

8MG

Farmaceutski oblik:

TABLET

Sastav:

HYDROMORPHONE HYDROCHLORIDE 8MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Narcotic (CDSA I)

Područje terapije:

OPIATE AGONISTS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2021-07-30

Svojstava lijeka

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
....................................................................................................................
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
...................................................................................
6
4.1 Dosing Considerations
.................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................................. 6
4.3 Administration
.....................