Страна: Канада
мова: англійська
Джерело: Health Canada
SUNITINIB (SUNITINIB MALATE)
TEVA CANADA LIMITED
L01EX01
SUNITINIB
12.5MG
CAPSULE
SUNITINIB (SUNITINIB MALATE) 12.5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0151642001; AHFS:
APPROVED
2023-09-11
_Teva-Sunitinib Capsules _ _Page 1 of 73_ PRODUCT MONOGRAPH Pr TEVA-SUNITINIB Sunitinib Capsules 12.5 mg, 25 mg and 50 mg sunitinib per capsule (as sunitinib malate) Tyrosine Kinase Inhibitor, Anti-Tumour Agent Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Preparation: March 24, 2022 Submission Control No: 233932 _Teva-Sunitinib Capsules _ _Page 2 of 73_ 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 ..................................................................................................17 DRUG INTERACTIONS ..................................................................................................32 DOSAGE AND ADMINISTRATION ..............................................................................34 OVERDOSAGE ................................................................................................................35 ACTION AND CLINICAL PHARMACOLOGY ............................................................35 STORAGE AND STABILITY ..........................................................................................39 SPECIAL HANDLING INSTRUCTIONS .......................................................................39 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................39 PART II: SCIENTIFIC INFORMATION ...............................................................................41 PHARMACEUTICAL INFORMATION ..........................................................................41 CLINICAL TRIALS Прочитайте повний документ