HALYCIL TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PROPYLTHIOURACIL

Verfügbar ab:

HALEWOOD CHEMICALS LIMITED

ATC-Code:

H03BA02

INN (Internationale Bezeichnung):

PROPYLTHIOURACIL

Dosierung:

50MG

Darreichungsform:

TABLET

Zusammensetzung:

PROPYLTHIOURACIL 50MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTITHYROID AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2021-10-06

Fachinformation

_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.................................................................................