Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CALCITRIOL
GALDERMA CANADA INC
D05AX03
CALCITRIOL
3MCG
OINTMENT
CALCITRIOL 3MCG
TOPICAL
5G/30G/60G/100G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0113628006; AHFS:
APPROVED
2009-12-01
PRODUCT MONOGRAPH Pr SILKIS ® (Calcitriol) Ointment 3 µg/g Topical Non-Steroidal Antipsoriatic Agent GALDERMA CANADA INC. 55 Commerce Valley Drive W., Suite 400 Thornhill, ON L3T 7V9 www.galderma.ca DATE OF PREPARATION: November 30, 2009 DATE OF REVISION: October 17, 2017 SUBMISSION CONTROL NO: 206311 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 5 DRUG INTERACTIONS ................................................................................................... 7 DOSAGE AND ADMINISTRATION ............................................................................... 7 OVERDOSAGE .................................................................................................................. 8 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 8 STORAGE AND STABILITY ........................................................................................... 9 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 9 PART II: SCIENTIFIC INFORMATION ................................................................................10 PHARMACEUTICAL INFORMATION ..........................................................................10 CLINICAL TRIALS .......................................................................................................... 10 DETAILED PHARMACOLOGY ...................................... Baca dokumen lengkap