Riik: Kanada
keel: inglise
Allikas: Health Canada
CALCITRIOL
STERIMAX INC
A11CC04
CALCITRIOL
2MCG
SOLUTION
CALCITRIOL 2MCG
INTRAVENOUS
1ML
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0113628003; AHFS:
APPROVED
2013-01-29
_ _ _Calcitriol Injection USP Product Monograph _ _Page 1 of 24 _ _ _ PRODUCT MONOGRAPH PR CALCITRIOL INJECTION USP 1 mcg/mL and 2 mcg/mL Vitamin D 3 Metabolite Sterile SteriMax Inc. 2770 Portland Drive Oakville, ON Canada L6H 6R4 Date of Revision: March 10, 2016 Control No : 192651 _ _ _Calcitriol Injection USP Product Monograph _ _Page 2 of 24_ 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 ............................................................11 STORAGE AND STABILITY ..........................................................................................13 SPECIAL HANDLING INSTRUCTIONS .......................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................13 PART II: SCIENTIFIC INFORMATION ...............................................................................14 PHARMACEUTICAL INFORMATION ..........................................................................14 CLINICAL TRIALS ................................ Lugege kogu dokumenti