LEO PHARMA - TACROLIMUS OINTMENT

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TACROLIMUS

Disponible desde:

LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.

Código ATC:

D11AH01

Designación común internacional (DCI):

TACROLIMUS

Dosis:

0.03%

formulario farmacéutico:

OINTMENT

Composición:

TACROLIMUS 0.03%

Vía de administración:

TOPICAL

Unidades en paquete:

100

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0127857005; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2022-09-29

Ficha técnica

_LEO Pharma - Tacrolimus_
_®_
_ _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEO PHARMA - TACROLIMUS
tacrolimus ointment
0.03% and 0.1% (w/w)
Topical Calcineurin Inhibitor
ATC Code: D11AH01
LEO Pharma Gen,
a division of LEO Pharma Inc.
Toronto, Ontario
M2H 3S8
www.leo-pharma.ca
Date of Initial Approval:
September 28, 2022
Submission Control No: 262646
_ _
_Pr_
_LEO Pharma - Tacrolimus _
_ _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
3
DOSAGE AND ADMINISTRATION
..............................................................................
4
3.1
Dosing Considerations
........................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
.................................................... 5
3.3
Administration.....................................................................................................
5
3.4
Missed
Dose.......................................................................................................
5
4
OVERDOSAGE
...........................................................................................................
6
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 6
6
WARNINGS AND PRECAUTIONS
..............................................................................
6
6.1
Special Populations
..................................................................................