Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DASATINIB
TARO PHARMACEUTICALS INC
L01EA02
DASATINIB
70MG
TABLET
DASATINIB 70MG
ORAL
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152198003; AHFS:
APPROVED
2020-05-21
Page 1 of 65 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TARO-DASATINIB Dasatinib Tablets 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib Protein-tyrosine kinase inhibitor TARO PHARMACEUTICALS INC. 130 East Drive, Brampton, Ontario Canada L6T 1C1 Date of Revision: March 19, 2021 Submission Control No: 245318 Page 2 of 65 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 ............................................................................................. 14 DRUG INTERACTIONS ............................................................................................. 28 DOSAGE AND ADMINISTRATION .......................................................................... 30 OVERDOSAGE ........................................................................................................... 33 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 33 STORAGE AND STABILITY ..................................................................................... 35 SPECIAL HANDLING INSTRUCTIONS ................................................................... 35 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 35 PART II: SCIENTIFIC INFORMATION .......................................................................... 37 PHARMACEUTICAL INFORMATION ...................................................................... 37 CLINICAL TRIALS ......................................................................................... Přečtěte si celý dokument