282 TABLETS

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACETYLSALICYLIC ACID; CAFFEINE (CAFFEINE CITRATE); CODEINE PHOSPHATE

Tersedia dari:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kode ATC:

N02AJ07

INN (Nama Internasional):

CODEINE AND ACETYLSALICYLIC ACID

Dosis:

375MG; 30MG; 15MG

Bentuk farmasi:

TABLET

Komposisi:

ACETYLSALICYLIC ACID 375MG; CAFFEINE (CAFFEINE CITRATE) 30MG; CODEINE PHOSPHATE 15MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Narcotic (CDSA I)

Area terapi:

SALICYLATES

Ringkasan produk:

Active ingredient group (AIG) number: 0301235008; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2021-05-11

Karakteristik produk

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N.
282
®
ACETYLSALICYLIC ACID (375 MG), CODEINE PHOSPHATE (15 MG),
CAFFEINE (15 MG*) TABLETS
*
equivalent to 30 mg caffeine citrate
N.
292
®
ACETYLSALICYLIC ACID (375 MG), CODEINE PHOSPHATE (30 MG),
CAFFEINE (15 MG*) TABLETS
*
equivalent to 30 mg caffeine citrate
ANALGESIC
ANTIPYRETIC
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
June 22, 2018
SUBMISSION CONTROL NO.:
214268
282

and 292

are registered trademarks of Pharmascience Inc.
_282_
_®_
_ and 292_
_®_
_ Prescribing Information _
_Page 2 of 33_
_ _
TABLE OF CONTENT
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
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION
.......................