STATEX TABLET 25MG

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MORPHINE SULFATE

Disponibil de la:

PALADIN LABS INC.

Codul ATC:

N02AA01

INN (nume internaţional):

MORPHINE

Dozare:

25MG

Forma farmaceutică:

TABLET

Compoziție:

MORPHINE SULFATE 25MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0104545005; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2023-02-20

Caracteristicilor produsului

_Product Monograph _
_ _
_STATEX_
_®_
_ (morphine sulfate tablets) _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
STATEX®
Morphine sulfate tablets
Tablets, 5 mg, 10 mg, 25 mg, 50 mg, Oral
Opioid Analgesic
N02AA01
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec
H4M 2P2
Date of Initial Authorization:
December 04, 1985
Date of Revision:
June 28, 2023
Version: 7.0
Submission Control Number: 271305
_ _
_Product Monograph _
_ _
_STATEX_
_®_
_ (morphine sulfate tablets) _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Abuse and Misuse
06/2023
7 WARNINGS AND PRECAUTIONS, Neurologic
06/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
06/2023
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
..............................................................................................................
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
Rec