PMS-BUPRENORPHINE-NALOXONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)

Available from:

PHARMASCIENCE INC

ATC code:

N07BC51

INN (International Name):

BUPRENORPHINE, COMBINATIONS

Dosage:

8MG; 2MG

Pharmaceutical form:

TABLET

Composition:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2MG

Administration route:

SUBLINGUAL

Units in package:

30

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE PARTIAL AGONISTS

Product summary:

Active ingredient group (AIG) number: 0252216002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-05-07

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-BUPRENORPHINE-NALOXONE
Buprenorphine and Naloxone Sublingual Tablet
Sublingual Tablet; buprenorphine (as buprenorphine hydrochloride) /
naloxone (as naloxone
hydrochloride dihydrate), 2 mg / 0.5 mg and 8 mg / 2 mg
USP
Partial Opioid Agonist
and
Opioid Antagonist
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
May 7, 2014
Date of Revision:
September 25, 2023
Submission Control No:
_pms-BUPRENORPHINE-NALOXONE Product Monograph _
_ _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
7 WARNINGS AND PRECAUTIONS, Gastro-intestinal
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX................................................................ 5
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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