Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID; CODEINE PHOSPHATE
TEVA CANADA LIMITED
N02AA79
CODEIN, COMBINATIONS WITH PSYCHOLEPTICS
50MG; 40MG; 330MG; 30MG
CAPSULE
BUTALBITAL 50MG; CAFFEINE 40MG; ACETYLSALICYLIC ACID 330MG; CODEINE PHOSPHATE 30MG
ORAL
100/500
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0401238001; AHFS:
APPROVED
2013-04-15
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TEVA-TECNAL C1/4 Butalbital, Acetylsalicylic Acid, Caffeine, and Codeine Phosphate Capsules 50 mg / 330 mg / 40 mg / 15 mg USP N TEVA-TECNAL C1/2 Butalbital, Acetylsalicylic Acid, Caffeine, and Codeine Phosphate Capsules 50 mg / 330 mg / 40 mg / 30 mg USP COMBINATION ANALGESIC Teva Canada Limited Date of Revision: 30 Novopharm Court November 13, 2018 Toronto, Ontario Canada, M1B 2K9 www.tevacanada.com Control #: 220040 PAGE 2 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 ................................................................................................. 14 DRUG INTERACTIONS .................................................................................................. 17 DOSAGE AND ADMINISTRATION .............................................................................. 18 OVERDOSAGE ................................................................................................................ 20 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 23 STORAGE AND STABILITY .......................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 26 PART II: SCIENTIFIC INFORMATION ................................................................................ 27 PHARMACEUTICAL INFORMATION ......................................................................... 27 Belgenin tamamını okuyun