PMS-TRAMADOL-ACET TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

N02AJ13

INN (mednarodno ime):

TRAMADOL AND PARACETAMOL

Odmerek:

325MG; 37.5MG

Farmacevtska oblika:

TABLET

Sestava:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

OPIATE AGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0250601001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-02-08

Lastnosti izdelka

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-TRAMADOL-ACET
Tramadol Hydrochloride and Acetaminophen Tablets, House Standard
37.5 mg tramadol hydrochloride
/ 325 mg acetaminophen
OPIOD ANALGESIC AND CENTRALLY ACTING ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
September 27, 2022
SUBMISSION CONTROL NO: 264215
_pms-TRAMADOL-ACET Product Monograph _
_Page 2 of 70_
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................................................................................................
19
DRUG INTERACTIONS
................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE
..............................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY...........................................................
33
STORAGE AND STABILITY
........................................................................................
41
SPECIAL HANDLING
INSTRUCTIONS......................................................................
41
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 41
PART II: SCIENTIFIC INFORMATION
..........................................................................
42
PHARMACEUTICAL INFORMATION
...................................