SANDOZ TACROLIMUS CAPSULE (IMMEDIATE RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TACROLIMUS (TACROLIMUS MONOHYDRATE)

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

L04AD02

INN (Nama Internasional):

TACROLIMUS

Dosis:

1MG

Bentuk farmasi:

CAPSULE (IMMEDIATE RELEASE)

Komposisi:

TACROLIMUS (TACROLIMUS MONOHYDRATE) 1MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

IMMUNOSUPPRESSIVE AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-11-22

Karakteristik produk

_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
....................................................