Land: Canada
Språk: engelsk
Kilde: Health Canada
DOXORUBICIN HYDROCHLORIDE
PFIZER CANADA ULC
L01DB01
DOXORUBICIN
150MG
POWDER FOR SOLUTION
DOXORUBICIN HYDROCHLORIDE 150MG
INTRAVENOUS
75ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0110825004; AHFS:
APPROVED
2007-06-05
_Pr_ _Doxorubicin Hydrochloride for Injection USP (doxorubicin hydrochloride)_ _ _ _Page 1 of 31_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr DOXOrubicin Hydrochloride for Injection USP Doxorubicin Hydrochloride for Injection sterile powder for solution, 10 mg / vial, 50 mg / vial and 150 mg / vial, for intravenous and intravesical use Antineoplastic agent Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: November 17, 1995 Date of Revision: March 16, 2023 Submission Control Number: 268408 _ _ _Pr_ _Doxorubicin Hydrochloride for Injection USP (doxorubicin hydrochloride)_ _ _ _Page 2 of 31_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 03/2023 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations 03/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 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................................................................................. 6 4.2 Recommended Dose and Dos read_full_document