Страна: Канада
Език: английски
Източник: Health Canada
CALCITRIOL
FRESENIUS KABI CANADA LTD
A11CC04
CALCITRIOL
1MCG
SOLUTION
CALCITRIOL 1MCG
INTRAVENOUS
1ML
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0113628002; AHFS:
CANCELLED POST MARKET
2023-03-10
PRODUCT MONOGRAPH PR CALCITRIOL INJECTION 1 MCG/ML AND 2 MCG/ML Vitamin D 3 metabolite FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Date of Revision: Toronto, ON, M9W 0C8 November 16, 2017 Submission Control No.: 199558 Calcitriol Injection – Product Monograph _ _ Page 2 of 23 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 ................................................................................................................. 6 DRUG INTERACTIONS ................................................................................................................. 8 DOSAGE AND ADMINISTRATION ............................................................................................. 9 OVERDOSAGE ............................................................................................................................. 10 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 10 STORAGE AND STABILITY ....................................................................................................... 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING........................................................... 12 PART II: SCIENTIFIC INFORMATION ................................................................................... 13 PHARMACEUTICAL INFORMATION ...... Прочетете целия документ