TIROCAP CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LEVOTHYROXINE SODIUM

제공처:

IBSA INSTITUT BIOCHIMIQUE SA

ATC 코드:

H03AA01

INN (International Name):

LEVOTHYROXINE SODIUM

복용량:

125MCG

약제 형태:

CAPSULE

구성:

LEVOTHYROXINE SODIUM 125MCG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

THYROID AGENTS

제품 요약:

Active ingredient group (AIG) number: 0107794013; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-06-21

제품 특성 요약

_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