FIORINAL-C 1/4 CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ACETYLSALICYLIC ACID; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE

Disponibil de la:

ARALEZ PHARMACEUTICALS CANADA INC

Codul ATC:

N02AA79

INN (nume internaţional):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Dozare:

330MG; 40MG; 50MG; 15MG

Forma farmaceutică:

CAPSULE

Compoziție:

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

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

OPIATE AGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-12-01

Caracteristicilor produsului

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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
.....................................................................