País: Canadá
Língua: inglês
Origem: Health Canada
AFLIBERCEPT
SANOFI-AVENTIS CANADA INC
L01XX44
AFLIBERCEPT
100MG
SOLUTION
AFLIBERCEPT 100MG
INTRAVENOUS
4ML/3X4ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0154950002; AHFS:
CANCELLED POST MARKET
2020-07-13
PRODUCT MONOGRAPH Pr ZALTRAP ™ Aflibercept Concentrate for solution for infusion, 25 mg/mL 100 mg and 200 mg vials Antineoplastic agent ATC code: L01XX44 sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Québec H7V 0A3 Date of Preparation: August 3, 2016 Submission Control No.: 196179 Date of Approval: August 5, 2016 _ _ _ _ _Page 2 of 42_ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................23 ACTION AND CLINICAL PHARMACOLOGY ............................................................23 STORAGE AND STABILITY ..........................................................................................26 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................26 PART II: SCIENTIFIC INFORMATION ...............................................................................27 PHARMACEUTICAL INFORMATION ..........................................................................27 CLINICAL TRIALS ..........................................................................................................28 TOXICOLOGY ............ Leia o documento completo