APO-HYDROMORPHONE CR CAPSULE (EXTENDED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

HYDROMORPHONE HYDROCHLORIDE

Disponibil de la:

APOTEX INC

Codul ATC:

N02AA03

INN (nume internaţional):

HYDROMORPHONE

Dozare:

3MG

Forma farmaceutică:

CAPSULE (EXTENDED RELEASE)

Compoziție:

HYDROMORPHONE HYDROCHLORIDE 3MG

Calea de administrare:

ORAL

Unități în pachet:

60/100

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0108698002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-05-31

Caracteristicilor produsului

_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
APO-HYDROMORPHONE CR
HYDROmorphone* Hydrochloride Controlled Release Capsules
3 mg, 4.5 mg, 6 mg, 9 mg, 12 mg, 18 mg, 24 mg and 30 mg
Opioid Analgesic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
April 9, 2021
Control No: 246549
*HYDROmorphone is the name of the active chemical ingredient
(hydromorphone) and is not a
brandname/tradename.
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal
Syndrome (NOWS), April 2021
7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, April 2021
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES..............................................................................................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
.........................................................7
4.3
Administration
.........................................................................................................9
4.4
Missed Dose
........................................................................