ZOLEDRONIC ACID - Z SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

제공처:

SANDOZ CANADA INCORPORATED

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:

2013-02-15

제품 특성 요약

_Zoledronic Acid – Z _
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_Page 1 of 51 _
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID - Z
(Zoledronic acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Bone Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision:
July 21, 2017
Control No. : 206684
_Zoledronic Acid – Z _
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_Page 2 of 51 _
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
.........................................................................................
20
OVERDOSAGE
............................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
25
STORAGE AND STABILITY
.....................................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
..................................................