ZOLEDRONIC ACID FOR INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

제공처:

JUNO PHARMACEUTICALS CORP.

ATC 코드:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

복용량:

4MG

약제 형태:

SOLUTION

구성:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

관리 경로:

INTRAVENOUS

패키지 단위:

5ML

처방전 유형:

Prescription

치료 영역:

BONE RESORPTION INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2016-01-04

제품 특성 요약

_Zoledronic Acid for Injection Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION
4 mg / 5 mL zoledronic acid (as zoledronic acid monohydrate)
Sterile Concentrate Solution for Intravenous Infusion
Bone Metabolism Regulator
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
DATE OF REVISION:
September 22, 2020
SUBMISSION CONTROL NO.: 243250
_Zoledronic Acid for Injection Product Monograph _
_Page 2 of 50_
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
.............................................................................................12
DRUG INTERACTIONS
...............................................................................................20
DOSAGE AND ADMINISTRATION
..........................................................................21
OVERDOSAGE
............................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................25
STORAGE AND STABILITY
......................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................29
PART II: SCIENTIFIC INFORMATION
.........................................................................30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...........................................................................