APO-TAPENTADOL TABLET (IMMEDIATE RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE)

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

N02AX06

INN (Διεθνής Όνομα):

TAPENTADOL

Δοσολογία:

75MG

Φαρμακοτεχνική μορφή:

TABLET (IMMEDIATE RELEASE)

Σύνθεση:

TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 75MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Narcotic (CDSA I)

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0152846006; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-02-17

Αρχείο Π.Χ.Π.

N
APO-TAPENTADOL (tapentadol)
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
APO-TAPENTADOL
Tapentadol Tablets
Tablets, 50 mg, 75 mg, and 100 mg Tapentadol (as tapentadol
hydrochloride), oral
Opioid Analgesic
APOTEX INC.
150 Signet Drive
Toronto (Ontario)
M9L 1T9
Date of Initial Authorization:
January 15, 2018
Date of Revision:
February 16, 2022
Submission Control No: 259139
N
APO-TAPENTADOL (tapentadol)
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Opioid induced hyperalgesia
02/2022
7 Warnings and Precautions, Serotonin toxicity / Serotonin syndrome
02/2022
7 Warnings and Precautions, Reproductive Health: Female and Male
Potential, Fertility
02/2022
7 Warnings and Precautions, Sleep apnea
02/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................................................
2
TABLE OF CONTENTS
................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 4
1.
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics (<18 years)
.........................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
..............................................................................
4
2.
CONTRAINDICATIONS
.............................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................... 5
4.
DOSAGE AND ADMINISTRATION
...........................................................................
6
4.1
Dosing Considerations
........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................... 7
4.4
Administration
..................................