País: Canadá
Língua: inglês
Origem: Health Canada
DACTINOMYCIN
RECORDATI RARE DISEASES CANADA INC
L01DA01
DACTINOMYCIN
0.5MG
POWDER FOR SOLUTION
DACTINOMYCIN 0.5MG
INTRAVENOUS
0.5MG/VIAL
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0105865001; AHFS:
APPROVED
2006-09-06
_ _ _ _ _Page 1 of 23_ PRODUCT MONOGRAPH PR COSMEGEN® DACTINOMYCIN FOR INJECTION LYOPHILIZED POWDER FOR INJECTION CONTAINING 500 MCG DACTINOMYCIN/VIAL ACTINOMYCIN ANTIBIOTIC; ANTINEOPLASTIC Recordati Rare Diseases Canada Inc. 3080 Yonge Street, Suite 6060 Toronto, ON M4N 3N1 Control # 217570 Date of Revision: August 29, 2018 _ _ _ _ _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 ....................................................................................................7 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................13 SPECIAL HANDLING INSTRUCTIONS .......................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................15 PHARMACEUTICAL INFORMATION ..........................................................................15 CLINICAL TRIALS .............................. Leia o documento completo