STATEX DROPS 20MG/ML

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

MORPHINE SULFATE

Verfügbar ab:

PALADIN LABS INC.

ATC-Code:

N02AA01

INN (Internationale Bezeichnung):

MORPHINE

Dosierung:

20MG

Darreichungsform:

DROPS

Zusammensetzung:

MORPHINE SULFATE 20MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

25ML/100ML

Verschreibungstyp:

Narcotic (CDSA I)

Therapiebereich:

OPIATE AGONISTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2018-09-18

Fachinformation

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
STATEX
®
morphine sulfate
Oral Drops – 20 and 50 mg/mL
Suppositories – 5, 10, 20 and 30 mg
Oral Syrup – 1, 5 and 10 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:
April 5, 2018
Version: 5.0
Submission Control No: 211412
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_STATEX_
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_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
DETAILED PHARMACOLOGY
................................