Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
CALCITRIOL
PHARMASCIENCE INC
A11CC04
CALCITRIOL
0.25MCG
CAPSULE
CALCITRIOL 0.25MCG
ORAL
15G/50G
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0113628001; AHFS:
APPROVED
2023-03-14
_pms-CALCITRIOL Product Monograph _ _ _ _Page 1 of 26_ PRODUCT MONOGRAPH PR PMS-CALCITRIOL Calcitriol Capsules Capsules 0.25 mcg and 0.5 mcg House Standard Vitamin D 3 Metabolite Pharmascience Inc. Date of Preparation: 6111 Royalmount Ave., Suite 100 MAR 13, 2023 Montréal, Canada H4P 2T4 www.pharmascience.com Submission Control No: 272415 _pms-CALCITRIOL Product Monograph _ _ _ _Page 2 of 26_ 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 ........................................................................ 8 OVERDOSAGE ........................................................................................................ 10 ACTION AND CLINICAL PHARMACOLOGY .................................................... 10 STORAGE AND STABILITY .................................................................................. 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................... 12 PART II: SCIENTIFIC INFORMATION ................................................................ 14 PHARMACEUTICAL INFORMATION ................................................................. 14 CLINICAL TRIALS .................................................................................................. 15 DETAILED PHARMACOLOGY ............................................................................. Přečtěte si celý dokument