PROGRAF SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TACROLIMUS

Beschikbaar vanaf:

ASTELLAS PHARMA CANADA INC

ATC-code:

L04AD02

INN (Algemene Internationale Benaming):

TACROLIMUS

Dosering:

5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

TACROLIMUS 5MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

1ML

Prescription-type:

Prescription

Therapeutisch gebied:

IMMUNOSUPPRESSIVE AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0127857001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2005-04-12

Productkenmerken

_Product Monograph Master Template _
_Template Date: September 2020 _
_Prograf_
_®_
_ (tacrolimus) _
_Page 1 of 95 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROGRAF
®
Tacrolimus
tacrolimus for injection
5 mg/mL, for intravenous use
tacrolimus immediate release capsules, USP
0.5 mg, 1 mg and 5 mg, for oral use
IMMUNOSUPPRESSANT
Astellas Pharma Canada, Inc.
Markham, ON
L3R 0B8
Prograf® and Advagraf® are registered trademarks of Astellas
Pharma Inc. All other trademarks or registered trademarks are the
property of their respective owners.
Date of Initial Authorization:
NOV 15, 2011
Date of Revision:
December 1, 2022
Submission Control Number: 263332
334198-PRG-CAN
_Product Monograph Master Template _
_Template Date: September 2020 _
_Prograf_
_®_
_ (tacrolimus) _
_Page 2 of 95 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
12/2022
7 WARNINGS AND PRECAUTIONS, Immune
12/2022
7 WARNINGS AND PRECAUTIONS, Renal
12/2022
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
...............................................................................................................
5
2
CONTRAINDICATIONS
.............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
6
4.