LEO PHARMA - TACROLIMUS OINTMENT

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TACROLIMUS

Доступно од:

LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.

АТЦ код:

D11AH01

INN (Међународно име):

TACROLIMUS

Дозирање:

0.03%

Фармацеутски облик:

OINTMENT

Састав:

TACROLIMUS 0.03%

Пут администрације:

TOPICAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-09-29

Карактеристике производа

_LEO Pharma - Tacrolimus_
_®_
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_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
..................................................................................