FIORINAL-C 1/4 CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACETYLSALICYLIC ACID; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE

Tersedia dari:

ARALEZ PHARMACEUTICALS CANADA INC

Kode ATC:

N02AA79

INN (Nama Internasional):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Dosis:

330MG; 40MG; 50MG; 15MG

Bentuk farmasi:

CAPSULE

Komposisi:

ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; BUTALBITAL 50MG; CODEINE PHOSPHATE 15MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

OPIATE AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0401238002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-12-01

Karakteristik produk

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PRODUCT INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
FIORINAL
®
-C ¼
N
FIORINAL
®
-C ½
(acetylsalicylic acid-caffeine-codeine-butalbital)
330-40-15-50 mg
330-40-30-50 mg
Capsules
USP
Combination Analgesic
Aralez Pharmaceuticals Canada Inc.
7100 West Credit Avenue, Suite 101
Mississauga, Ontario
L5N 0E4
Date of Revision:
July 16, 2018
Submission Control No: 213743
Page
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of
44
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
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
.....................................................................