TIROCAP CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
17-06-2021
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Aktiva substanser:
LEVOTHYROXINE SODIUM
Tillgänglig från:
IBSA INSTITUT BIOCHIMIQUE SA
ATC-kod:
H03AA01
INN (International namn):
LEVOTHYROXINE SODIUM
Dos:
125MCG
Läkemedelsform:
CAPSULE
Sammansättning:
LEVOTHYROXINE SODIUM 125MCG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
THYROID AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0107794013; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2021-06-21
Produktens egenskaper
_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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