Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
DOXORUBICIN HYDROCHLORIDE
PANDA PHARMACEUTICALS INC.
L01DB01
DOXORUBICIN
50MG
POWDER FOR SOLUTION
DOXORUBICIN HYDROCHLORIDE 50MG
INTRAVENOUS
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0110825003; AHFS:
APPROVED
2017-08-16
_Doxorubicin Hydrochloride for Injection USP _ _ _ _ _ _ _ _Page 1_ _ of 43_ _ _ PRODUCT MONOGRAPH PR DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP 50 MG / VIAL Sterile Powder for Solution - Intravenous THERAPEUTIC CLASSIFICATION Antineoplastic Agent PANDA PHARMACEUTICALS INC. 35 Nixon Road Unit 10 Caledon, ON L7E 1K1 Control # 195868 Date of Preparation: August 11, 2017 _Doxorubicin Hydrochloride for Injection USP _ _ _ _ _ _ _ _Page 2_ _ of 43_ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ......................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ............................................................................................... 10 DRUG INTERACTIONS ................................................................................................ 11 DOSAGE AND ADMINISTRATION .............................................................................. 12 OVERDOSAGE ............................................................................................................ 16 STORAGE AND STABILITY ......................................................................................... 16 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 17 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 18 PART II: SCIENTIFIC INFORMATION ........................................................................... 18 PHARMACEUTICAL INFORMATION ........................................................................... 18 CLINICAL TRIALS ......................... Baca dokumen lengkapnya