STATEX SUPPOSITORIES 20MG SUPPOSITORY

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

MORPHINE SULFATE

Saadav alates:

PALADIN LABS INC.

ATC kood:

N02AA01

INN (Rahvusvaheline Nimetus):

MORPHINE

Annus:

20MG

Ravimvorm:

SUPPOSITORY

Koostis:

MORPHINE SULFATE 20MG

Manustamisviis:

RECTAL

Ühikuid pakis:

10

Retsepti tüüp:

Narcotic (CDSA I)

Terapeutiline ala:

OPIATE AGONISTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0104545002; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2021-12-23

Toote omadused

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
STATEX
®
morphine sulfate
Oral Drops –50 mg/mL
Suppositories – 5, 10, 20 and 30 mg
Oral Syrup – 1 and 5 mg/mL
Tablets – 5, 10, 25 and 50 mg
Opioid Analgesic
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
St-Laurent, Quebec
H4M 2P2
Date of Preparation:
December 4, 1985
Date of Revision:
August 2, 2019
Version: 6.0
Submission Control No: 229677
_ _
_Product monograph STATEX_
_®_
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_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
DETAILED PHARMACOLOGY
.........................