ABSTRAL TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

FENTANYL (FENTANYL CITRATE)

Inapatikana kutoka:

PALADIN LABS INC.

ATC kanuni:

N02AB03

INN (Jina la Kimataifa):

FENTANYL

Kipimo:

200MCG

Dawa fomu:

TABLET

Tungo:

FENTANYL (FENTANYL CITRATE) 200MCG

Njia ya uendeshaji:

SUBLINGUAL

Vitengo katika mfuko:

10/30

Dawa ya aina:

Narcotic (CDSA I)

Eneo la matibabu:

OPIATE AGONISTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0123302017; AHFS:

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2018-06-29

Tabia za bidhaa

_ _
_ABSTRAL Product Monograph _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
N
ABSTRAL
®
Fentanyl citrate sublingual tablets
100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg fentanyl as
fentanyl citrate
Opioid Analgesic
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, Quebec H4M 2P2
Date of Preparation:
March 8, 2018
Version 7.0
Submission Control No: 210630
_ _
®
Registered trademark of Strakan International Limited
_ _
_ _
_ABSTRAL Product Monograph Page 2 of 64_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................36
PART II: SCIENTIFIC INFORMATION
...........................................................