TRIANAL C¼ CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUTALBITAL; ACETYLSALICYLIC ACID; CAFFEINE; CODEINE PHOSPHATE

Dostupné s:

LABORATOIRE RIVA INC.

ATC kód:

N02AA79

INN (Mezinárodní Name):

CODEIN, COMBINATIONS WITH PSYCHOLEPTICS

Dávkování:

50MG; 330MG; 40MG; 15MG

Léková forma:

CAPSULE

Složení:

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

Podání:

ORAL

Jednotky v balení:

100/500

Druh předpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

OPIATE AGONISTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2015-10-28

Charakteristika produktu

_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 _
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_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