TEVA-BUPRENORPHINE/NALOXONE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

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

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

N07BC51

INN (Jina la Kimataifa):

BUPRENORPHINE, COMBINATIONS

Kipimo:

8MG; 2MG

Dawa fomu:

TABLET

Tungo:

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

Njia ya uendeshaji:

SUBLINGUAL

Vitengo katika mfuko:

30

Dawa ya aina:

Narcotic (CDSA I)

Eneo la matibabu:

OPIATE PARTIAL AGONISTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-12-17

Tabia za bidhaa

TEVA-BUPRENORPHINE/NALOXONE
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N TEVA-BUPRENORPHINE/NALOXONE
Buprenorphine and Naloxone Sublingual Tablets
Tablets, Buprenorphine (as Buprenorphine Hydrochloride) and Naloxone
(as
Naloxone Hydrochloride Dihydrate),
2 mg/0.5 mg and 8 mg/2 mg, sublingual
Teva Standard
Partial Opioid Agonist
and
Opioid Antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
April 18, 2016
Date of Revision:
January 25, 2022
Submission Control No.: 254725
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TEVA-BUPRENORPHINE/NALOXONE
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_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
3 Serious Warning and Precautions
01/2022
4 Dosage and Administration
01/2022
7 Warning and Precautions
01/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
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4
1.1
P
EDIATRICS
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4
1.2
G
ERIATRICS
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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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