TIROCAP CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LEVOTHYROXINE SODIUM

Tersedia dari:

IBSA INSTITUT BIOCHIMIQUE SA

Kode ATC:

H03AA01

INN (Nama Internasional):

LEVOTHYROXINE SODIUM

Dosis:

88MCG

Bentuk farmasi:

CAPSULE

Komposisi:

LEVOTHYROXINE SODIUM 88MCG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

THYROID AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0107794006; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-06-21

Karakteristik produk

_TIROCAP™ (levothyroxine sodium capsules) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TIROCAP™
Levothyroxine Sodium capsule
Capsules,13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125
mcg,
137 mcg, 150 mcg, 175 mcg and 200 mcg, oral
Thyroid Hormone
ATC Code: H03AA01
Institut Biochimique SA (IBSA)
Via del Piano 266
CH-6915 Pambio-Noranco,
Switzerland
Imported by:
Progress Therapeutics Inc.
14-320 Harry Walker Parkway North
Newmarket ON
Canada, L3Y 7B4
Date of Initial Authorization:
November 25, 2020
Date of Revision:
June 17, 2021
Submission Control No: 248553
_ _
_TIROCAP™ (levothyroxine sodium capsules) _
_Page 2 of 32_
TABLE OF CONTENTS
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
.............................................. 5
4
DOSAGE AND ADMINISTRATION
.........................................................................
5
4.1
Dosing
Considerations.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................. 6
4.3
Administration...................................................................................................
9
4.4
Missed
Dose.....................................................................................................
9
5
OVER