MINT-METRONIDAZOLE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METRONIDAZOLE

Διαθέσιμο από:

MINT PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

P01AB01

INN (Διεθνής Όνομα):

METRONIDAZOLE

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

METRONIDAZOLE 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0102572001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-02-27

Αρχείο Π.Χ.Π.

_MINT-METRONIDAZOLE (metronidazole tablets) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr MINT-METRONIDAZOLE
Metronidazole Tablets
Tablets, 250 mg, Oral
USP
ANTIBACTERIAL - ANTIPROTOZOAL
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
FEB 27, 2023
Date of Revision:
January 19, 2024
Submission Control Number.: 278986
_MINT-METRONIDAZOLE (metronidazole tablets) _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2024
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis
01/2024
7 WARNINGS AND PRECAUTIONS, Driving and Operating
Machinery
01/2024
7 WARNINGS AND PRECAUTIONS, Genitourinary
01/2024
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
01/2024
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory
Tests
01/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
01/2024
7 WARNINGS AND PRECAUTIONS, Psychiatric
01/2024
7 WARNINGS AND PRECAUTIONS, Renal
01/2024
7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance
01/2024
7 WARNINGS AND PRECAUTIONS, Skin
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1 Pediatrics
..............................................................................................................
4
1.2
GERIATRICS
..........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................