TRIANAL C½ CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CAFFEINE; ACETYLSALICYLIC ACID; CODEINE PHOSPHATE; BUTALBITAL

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

N02AA79

INN (국제 이름):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

복용량:

40MG; 330MG; 30MG; 50MG

약제 형태:

CAPSULE

구성:

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

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Narcotic (CDSA I)

치료 영역:

OPIATE AGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2015-10-28

제품 특성 요약

_TRIANAL C¼ and TRIANAL C½ _
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_Page 1 of 45 _
PRODUCT INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N TRIANAL C¼
N TRIANAL C½
Butalbital, Acetylsalicylic Acid, Caffeine and Codeine Phosphate
Capsules USP
50-330-40-15- mg
50-330-40-30- mg
Combination Analgesic
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec, Canada.
J7C 3V4
www.labriva.com
Submission Control No: 220042
DATE OF REVISION:
October 22, 2018
_TRIANAL C¼ and TRIANAL C½ _
_ _
_Page 2 of 45 _
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
................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
........................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
................................................................................
30
PHARMACEUTICAL INF