MYLAN-BUPRENORPHINE/NALOXONE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

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

Доступно од:

MYLAN PHARMACEUTICALS ULC

АТЦ код:

N07BC51

INN (Међународно име):

BUPRENORPHINE, COMBINATIONS

Дозирање:

8MG; 2MG

Фармацеутски облик:

TABLET

Састав:

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

Пут администрације:

SUBLINGUAL

Јединице у пакету:

7/100

Тип рецептора:

Narcotic (CDSA I)

Терапеутска област:

OPIATE PARTIAL AGONISTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2019-09-17

Карактеристике производа

_ _
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