MYLAN-BUPRENORPHINE/NALOXONE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-03-2019
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Active ingredient:
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)
Available from:
MYLAN PHARMACEUTICALS ULC
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:
7/100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE PARTIAL AGONISTS
Product summary:
Active ingredient group (AIG) number: 0252216002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-09-17
Summary of Product characteristics
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MYLAN-BUPRENORPHINE/NALOXONE
Buprenorphine (as Buprenorphine Hydrochloride)
and
Naloxone (as Naloxone Hydrochloride Dihydrate)
Sublingual Tablets 2 mg / 0.5 mg and 8 mg / 2 mg
Partial Opioid Agonist
and
Opioid Antagonist
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: March 29, 2019
Submission Control No: 225699
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
5
ADVERSE REACTIONS
............................................................................................................
17
DRUG INTERACTIONS
............................................................................................................
24
DOSAGE AND ADMINISTRATION
........................................................................................
27
DRUG ABUSE AND DEPENDENCE
.......................................................................................
32
OVERDOSAGE
..........................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
34
STORAGE AND STABILITY
....................................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKA
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