TAPAZOLE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

METHIMAZOLE

Tilgjengelig fra:

PALADIN LABS INC.

ATC-kode:

H03BB02

INN (International Name):

THIAMAZOLE

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

METHIMAZOLE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANTITHYROID AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0104552003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2007-06-04

Preparatomtale

_ _
_TAPAZOLE_
_®_
_ (methimazole tablets) Product Monograph _
_Page 1 of 19_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TAPAZOLE®
Methimazole
Tablets, 5 mg and 10 mg, oral
Manufacturer’s Standard
Antithyroid Agent
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
paladinlabs.com
_ _
Date of Initial Authorization:
DEC 31, 1951
Date of Revision:
APR 13, 2023
Version 8.0
Submission Control Number: 270311
_ _
_TAPAZOLE_
_®_
_ (methimazole tablets) Product Monograph _
_Page 2 of 19_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
06/2021
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
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..............................................