ELTROXIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEVOTHYROXINE SODIUM

Disponibil de la:

ASPEN PHARMACARE CANADA INC.

Codul ATC:

H03AA01

INN (nume internaţional):

LEVOTHYROXINE SODIUM

Dozare:

300MCG

Forma farmaceutică:

TABLET

Compoziție:

LEVOTHYROXINE SODIUM 300MCG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THYROID AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0107794002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-09-17

Caracteristicilor produsului

_ELTROXIN_
_®_
_ levothyroxine sodium _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ELTROXIN
®
Levothyroxine sodium
50, 100, 150, 200 and 300 mcg Tablets
BP
Thyroid hormone
ATC Code: H03AA01
Aspen Pharmacare Canada Inc.
111 Queen Street East, Suite 450
Toronto, Ontario, M5C 1S2
Date of Initial Approval:
DEC 30, 1951
Date of Revision:
FEB 8, 2018
Submission Control No: 209764
_ELTROXIN_
_®_
_ levothyroxine sodium _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
Indications, Pediatrics (1.1)
04/2017
Indications, Geriatrics (1.2)
04/2017
Contraindications (2)
04/2017
Dosage and Administration, Dosing Considerations (4.1)
04/2017
Dosage and Administration, Recommended Dose and Dosage Adjustment
(4.2) 04/2017
Overdosage (5)
04/2017
Warnings and Precautions (7)
04/2017
Warnings and Precautions, Pregnant Women (7.1.1)
04/2017
Warnings and Precautions, Breast-feeding (7.1.2)
04/2017
Warnings and Precautions, Pediatrics (7.1.3)
04/2017
Warnings and Precautions, Geriatrics (7.1.4)
04/2017
Adverse Reactions, Adverse Reaction Overview (8.1)
04/2017
Drug Interactions, Overview (9.2)
04/2017
Drug Interactions, Drug-Drug Interactions (9.3)
04/2017
Drug Interactions, Drug-Food Interactions (9.4)
04/2017
Drug Interactions, Drug-Laboratory Interactions (9.6)
04/2017
Action and Clinical Pharmacology, Mechanism of Action (10.1)
04/2017
Action and Clinical Pharmacology, Pharmacokinetics (10.3)
04/2017
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
........................................................................