SANDOZ TACROLIMUS CAPSULE (IMMEDIATE RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TACROLIMUS (TACROLIMUS MONOHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

L04AD02

INN (International Name):

TACROLIMUS

Dosage:

1MG

Pharmaceutical form:

CAPSULE (IMMEDIATE RELEASE)

Composition:

TACROLIMUS (TACROLIMUS MONOHYDRATE) 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

IMMUNOSUPPRESSIVE AGENTS

Product summary:

Active ingredient group (AIG) number: 0127857002; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-11-22

Summary of Product characteristics

_Sandoz Tacrolimus (tacrolimus) _
_Page 1 of 89_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ
® TACROLIMUS
Tacrolimus
tacrolimus immediate release capsules
0.5 mg, 1 mg and 5 mg, for oral use
USP
IMMUNOSUPPRESSANT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
June 11, 2014
Date of Revision:
April 12, 2023
Submission Control Number: 272173
_Sandoz Tacrolimus (tacrolimus) _
_Page 2 of 89_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
7 WARNINGS AND PRECAUTIONS, Immune
01/2023
7 WARNINGS AND PRECAUTIONS, Renal
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..........................................................................................................
4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS.............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
......................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
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