SANDOZ TACROLIMUS CAPSULE (IMMEDIATE RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TACROLIMUS (TACROLIMUS MONOHYDRATE)

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

L04AD02

INN (Internationale Bezeichnung):

TACROLIMUS

Dosierung:

1MG

Darreichungsform:

CAPSULE (IMMEDIATE RELEASE)

Zusammensetzung:

TACROLIMUS (TACROLIMUS MONOHYDRATE) 1MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

IMMUNOSUPPRESSIVE AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-11-22

Fachinformation

_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
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
..........................................................................................................
4
1.1
Pediatrics
..........................................................................................................................
5
1.2
Geriatrics
..........................................................................................................................
5
2
CONTRAINDICATIONS.............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
............................................................................
6
4.1
Dosing Considerations
......................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................