ENDOCET TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Διαθέσιμο από:

BRISTOL-MYERS SQUIBB CANADA

Φαρμακολογική κατηγορία (ATC):

N02AJ17

INN (Διεθνής Όνομα):

OXYCODONE AND PARACETAMOL

Δοσολογία:

5MG; 325MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

OXYCODONE HYDROCHLORIDE 5MG; ACETAMINOPHEN 325MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0215596001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-10-13

Αρχείο Π.Χ.Π.

ENDOCET
®
(oxycodone hydrochloride 5 mg and acetaminophen 325 mg)
Page 1 of 33
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ENDOCET
®
(OXYCODONE HYDROCHLORIDE 5 MG AND ACETAMINOPHEN 325 MG)
TABLETS, USP
OPIOID ANALGESIC
Bristol-Myers Squibb Canada
Montreal, Canada
Date of Revision:
October 13, 2016
Registered trademark of Endo Pharmaceuticals Inc.
used under licence by Bristol-Myers Squibb Canada
Submission Control No: 194808
ENDOCET
®
(oxycodone hydrochloride 5 mg and acetaminophen 325 mg)
Page 2 of 33
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
..............................................................................................
12
DRUG INTERACTIONS
..............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 19
STORAGE AND STABILITY
......................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
....................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 21
PART II: SCIENTIFIC INFORMATION
............................................................................
22