Maa: Kanada
Kieli: englanti
Lähde: Health Canada
TACROLIMUS
LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC.
D11AH01
TACROLIMUS
0.1%
OINTMENT
TACROLIMUS 0.1%
TOPICAL
100
Prescription
Active ingredient group (AIG) number: 0127857004; AHFS:
APPROVED
2022-09-29
_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 .................................................................................. Lue koko asiakirja