FIORINAL-C 1/2 CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-07-2023
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ACETYLSALICYLIC ACID; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL
Fáanlegur frá:
ARALEZ PHARMACEUTICALS CANADA INC
ATC númer:
N02AA79
INN (Alþjóðlegt nafn):
CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
Skammtar:
330MG; 40MG; 30MG; 50MG
Lyfjaform:
CAPSULE
Samsetning:
ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG; BUTALBITAL 50MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100/500
Gerð lyfseðils:
Narcotic (CDSA I)
Lækningarsvæði:
OPIATE AGONISTS
Vörulýsing:
Active ingredient group (AIG) number: 0401238001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2015-12-01
Vara einkenni
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
...............................................
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