PMS-BUPRENORPHINE-NALOXONE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

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

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

N07BC51

INN (nume internaţional):

BUPRENORPHINE, COMBINATIONS

Dozare:

2MG; 0.5MG

Forma farmaceutică:

TABLET

Compoziție:

BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 2MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.5MG

Calea de administrare:

SUBLINGUAL

Unități în pachet:

30

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE PARTIAL AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0252216001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-05-07

Caracteristicilor produsului

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
...............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX................................................................ 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.1
Dosing Considerations
..............................................................