HALYCIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PROPYLTHIOURACIL

Beschikbaar vanaf:

HALEWOOD CHEMICALS LIMITED

ATC-code:

H03BA02

INN (Algemene Internationale Benaming):

PROPYLTHIOURACIL

Dosering:

50MG

farmaceutische vorm:

TABLET

Samenstelling:

PROPYLTHIOURACIL 50MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

ANTITHYROID AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0103603001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2021-10-06

Productkenmerken

_Product Monograph Master Template _
_Template date: September 2020 _
_HALYCIL™ (propylthiouracil) _
_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
HALYCIL™
Propylthiouracil
Tablets, 50 mg, Oral
BP
ATC Code: H03BA02
Thyroid therapy
Halewood Chemicals Ltd.
Staines, Middlesex, TW19 6BJ
United Kingdom
www.halewoodchemicals.com
Distributed by: Accelera Pharma Canada Inc.
Mississauga, ON L5L 5Z9
http://apcipharma.com/
Date of Initial Authorization:
OCT 06, 2021
Submission Control Number: 244881
_ _
_Product Monograph Master Template _
_Template date: September 2020 _
_HALYCIL™ (propylthiouracil) _
_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
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
.............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.4
Administration.................................................................................