Land: Canada
Språk: engelsk
Kilde: Health Canada
LEUCOVORIN (LEUCOVORIN CALCIUM)
PFIZER CANADA ULC
V03AF03
CALCIUM FOLINATE
10MG
SOLUTION
LEUCOVORIN (LEUCOVORIN CALCIUM) 10MG
INTRAVENOUS
50ML
Prescription
ANTIDOTES
Active ingredient group (AIG) number: 0108436002; AHFS:
APPROVED
2017-08-01
_Pr_ _Leucovorin Calcium Injection USP - Product Monograph _ _Page 1 of 24_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR LEUCOVORIN CALCIUM INJECTION USP Leucovorin calcium Solution, 10 mg/mL, intravenous and intramuscular USP Folic Acid Derivative Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: MAY 09, 1997 Date of Revision: DEC 13, 2022 Submission Control Number: 267164 _ _ _Pr_ _Leucovorin Calcium Injection USP - Product Monograph _ _Page 2 of 24_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential; 7.1.1 Pregnant Women 12/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.3 Reconstitution ................................................................................................... 7 4.4 Administration................................................................................................... 7 5 OVERDOSAGE ............................................................................... read_full_document