ZOLEDRONIC ACID CONCENTRATE FOR INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Διαθέσιμο από:

GENERIC MEDICAL PARTNERS INC

Φαρμακολογική κατηγορία (ATC):

M05BA08

INN (Διεθνής Όνομα):

ZOLEDRONIC ACID

Δοσολογία:

4MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-05-08

Αρχείο Π.Χ.Π.

_Page 1 of 54_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID CONCENTRATE FOR INJECTION
(Zoledronic Acid for Injection)
4 mg zoledronic acid/5 mL incorporated as the monohydrate for
intravenous infusion
Concentrate – must be diluted before use
Bone Metabolism Regulator
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200,
Toronto, Ontario, Canada
M2J 4R3
DATE OF REVISION:
August 14, 2017
Control No.: 207383
_Page 2 of 54_
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
................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY............................................................
25
STORAGE AND STABILITY
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
..............................................................