Country: Канада
Језик: Енглески
Извор: Health Canada
ACETYLSALICYLIC ACID; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE
ARALEZ PHARMACEUTICALS CANADA INC
N02AA79
CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
330MG; 40MG; 50MG; 15MG
CAPSULE
ACETYLSALICYLIC ACID 330MG; CAFFEINE 40MG; BUTALBITAL 50MG; CODEINE PHOSPHATE 15MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0401238002; AHFS:
APPROVED
2015-12-01
Page 1 of 44 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 2 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 ..................................................................... Прочитајте комплетан документ