JAMP-ZOLEDRONIC ACID SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-11-2018
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Active ingredient:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Available from:
JAMP PHARMA CORPORATION
ATC code:
M05BA08
INN (International Name):
ZOLEDRONIC ACID
Dosage:
4MG
Pharmaceutical form:
SOLUTION
Composition:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG
Administration route:
INTRAVENOUS
Units in package:
5 ML
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0141761002; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-11-07
Summary of Product characteristics
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
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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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