LEO PHARMA - TACROLIMUS OINTMENT
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-09-2022
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
TACROLIMUS
Fáanlegur frá:
LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.
ATC númer:
D11AH01
INN (Alþjóðlegt nafn):
TACROLIMUS
Skammtar:
0.1%
Lyfjaform:
OINTMENT
Samsetning:
TACROLIMUS 0.1%
Stjórnsýsluleið:
TOPICAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0127857004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2022-09-29
Vara einkenni
_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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_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
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