ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Διαθέσιμο από:

OMEGA LABORATORIES LIMITED

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:

1VIAL*5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-02-26

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
Z
OLEDRONIC
A
CID
F
OR
I
NJECTION
C
ONCENTRATE
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
Omega Laboratories Limited
Date of Preparation: February 18, 2014
11 177 Hamon
Montreal, Quebec
H3M 3E4
Control No. 158614, 171670
_ _
_Page 2 of 58 _
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
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 27
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
..................................................