NUBAIN INJECTION 10MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NALBUPHINE HYDROCHLORIDE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N02AF02

INN (International Name):

NALBUFINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

NALBUPHINE HYDROCHLORIDE 10MG

Administration route:

INTRAMUSCULAR

Units in package:

5X1ML

Prescription type:

Schedule G (CDSA IV)

Therapeutic area:

OPIATE PARTIAL AGONISTS

Product summary:

Active ingredient group (AIG) number: 0114464001; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-12-04

Summary of Product characteristics

_Nubain _
_ _
_Page 1 of 34 _
PRODUCT MONOGRAPH
©
NUBAIN
(NALBUPHINE HYDROCHLORIDE)
INJECTION, 10 MG/ML
OPIOID ANALGESIC
ADJUNCT ANESTHETIC
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec, J4B 7K8
Date of Revision:
April 3, 2018
Submission Control No: 213120
_Nubain _
_ _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
.............................................................................................
12
DRUG INTERACTIONS
.............................................................................................
14
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
CLINICAL TRIALS
.....................................................................................................
23
TOXICOLOGY
...........................................