LEO PHARMA - TACROLIMUS OINTMENT

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

TACROLIMUS

Inapatikana kutoka:

LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.

ATC kanuni:

D11AH01

INN (Jina la Kimataifa):

TACROLIMUS

Kipimo:

0.03%

Dawa fomu:

OINTMENT

Tungo:

TACROLIMUS 0.03%

Njia ya uendeshaji:

TOPICAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-09-29

Tabia za bidhaa

_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
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_Pr_
_LEO Pharma - Tacrolimus _
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_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
..................................................................................