ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

זמין מ:

STRIDES PHARMA CANADA INC

קוד ATC:

M05BA08

INN (שם בינלאומי):

ZOLEDRONIC ACID

כמות:

4MG

טופס פרצבטיות:

SOLUTION

הרכב:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

BONE RESORPTION INHIBITORS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2014-06-24

מאפייני מוצר

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PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID FOR INJECTION CONCENTRATE
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
BONE METABOLISM REGULATOR
Strides Pharma Canada Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 11, 2020
Varennes, Quebec
Canada, J3X 1P7
Submission Control No.: 241322
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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
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
.....................................................................................
23
OVERDOSAGE
.......................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 28
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.................................................................................
34
CLINICAL TRIALS
.........................................