JAMP-ZOLEDRONIC ACID SOLUTION
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
07-11-2018
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
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유효 성분:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
제공처:
JAMP PHARMA CORPORATION
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:
5 ML
처방전 유형:
Prescription
치료 영역:
BONE RESORPTION INHIBITORS
제품 요약:
Active ingredient group (AIG) number: 0141761002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2018-11-07
제품 특성 요약
PRODUCT MONOGRAPH
Pr
JAMP-ZOLEDRONIC ACID
(Zoledronic Acid for Injection)
4 mg Zoledronic acid/5 mL incorporated as the monohydrate
Sterile liquid concentrate must be diluted before use
Bone Metabolism Regulator
JAMP Pharma Corporation
Date of Preparation:
1310 Rue Nobel
November 7, 2018
Boucherville, Québec
J4B 5H3
Control # 220781
_Page 2 of 52_
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..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STAB
IL
I
T
Y
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC
INFORMATION
...............................................................................30
PHARMACEUTICAL
INFORMATION..........................................................................30
CLINICAL
TR
IA
L
S
..........................................................................................................31
DETAILED PHARMACOLOGY
..
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