HALYCIL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

PROPYLTHIOURACIL

Dostupno od:

HALEWOOD CHEMICALS LIMITED

ATC koda:

H03BA02

INN (International ime):

PROPYLTHIOURACIL

Doziranje:

50MG

Farmaceutski oblik:

TABLET

Sastav:

PROPYLTHIOURACIL 50MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

ANTITHYROID AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2021-10-06

Svojstava lijeka

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