FIORINAL-C 1/2 CAPSULE

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ACETYLSALICYLIC ACID; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL

Prieinama:

ARALEZ PHARMACEUTICALS CANADA INC

ATC kodas:

N02AA79

INN (Tarptautinis Pavadinimas):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Dozė:

330MG; 40MG; 30MG; 50MG

Vaisto forma:

CAPSULE

Sudėtis:

ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG; BUTALBITAL 50MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/500

Recepto tipas:

Narcotic (CDSA I)

Gydymo sritis:

OPIATE AGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0401238001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2015-12-01

Prekės savybės

Page 1 of 47
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.
6733 Mississauga Rd., Suite 800
Mississauga, Ontario
L5N 6J5
www.miravohealthcare.com
Date of Revision:
July 18, 2023
Submission Control No: 270298
Page 2 of 47
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
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
................................................................................31
PHARMACEUTICAL INFORMATION
...............................................