ZOLEDRONIC ACID FOR INJECTION SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

มีจำหน่ายจาก:

PFIZER CANADA ULC

รหัส ATC:

M05BA08

INN (ชื่อสากล):

ZOLEDRONIC ACID

ปริมาณ:

4MG

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

เส้นทางการบริหาร:

INTRAVENOUS

หน่วยในแพ็คเกจ:

5ML

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

BONE RESORPTION INHIBITORS

สรุปสินค้า:

Active ingredient group (AIG) number: 0141761002; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2021-04-08

สรุปลักษณะสินค้า

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA