PAT-TRAMADOL/ACET TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Διαθέσιμο από:

PATRIOT A DIVISION OF JANSSEN INC

Φαρμακολογική κατηγορία (ATC):

N02AJ13

INN (Διεθνής Όνομα):

TRAMADOL AND PARACETAMOL

Δοσολογία:

325MG; 37.5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-11-11

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
PR
PAT-TRAMADOL/ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.patriot-canada.ca
Date of Preparation:
July 9, 2012
Date of Revision:
September 5, 2014
SUBMISSION CONTROL NO: 177222
© 2014 Patriot, a Division of Janssen Inc.
_ _
_Page 2 of 40 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG ABUSE, ADDICTION AND DEPENDENCE
............................................................ 12
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
.........................................