S.O.S. NALOXONE HYDROCHLORIDE INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

NALOXONE HYDROCHLORIDE

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

V03AB15

INN (Internationale Bezeichnung):

NALOXONE

Dosierung:

1MG

Darreichungsform:

SOLUTION

Zusammensetzung:

NALOXONE HYDROCHLORIDE 1MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

1ML/2ML

Verschreibungstyp:

Ethical

Therapiebereich:

OPIATE ANTAGONISTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108981001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2016-03-22

Fachinformation

_S.O.S. Naloxone Hydrochloride Injection _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
S.O.S. NALOXONE HYDROCHLORIDE INJECTION
Naloxone Hydrochloride
0.4 mg/mL and 1.0 mg/mL solution for injection
USP
Opioid Antagonist
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Québec, Canada
J4B 7K8
Date of Revision:
April 26, 2017
Submission Control No: 203781
_ _
_S.O.S. Naloxone Hydrochloride Injection _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
..........................................................................10
DETAILED PHARMACOLOGY
.....................................................................................10
TOXICOLOGY
.......................................................