MYLAN-BUPRENORPHINE/NALOXONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

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

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

N07BC51

Designación común internacional (DCI):

BUPRENORPHINE, COMBINATIONS

Dosis:

8MG; 2MG

formulario farmacéutico:

TABLET

Composición:

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

Vía de administración:

SUBLINGUAL

Unidades en paquete:

7/100

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE PARTIAL AGONISTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2019-09-17

Ficha técnica

_ _
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
_Page 2 of 60 _
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