TIROCAP CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
17-06-2021

有效成分:

LEVOTHYROXINE SODIUM

可用日期:

IBSA INSTITUT BIOCHIMIQUE SA

ATC代码:

H03AA01

INN(国际名称):

LEVOTHYROXINE SODIUM

剂量:

137MCG

药物剂型:

CAPSULE

组成:

LEVOTHYROXINE SODIUM 137MCG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

THYROID AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2021-06-21

产品特点

                                _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
                                
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产品特点 产品特点 法文 17-06-2021