ZOLEDRONIC ACID INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

M05BA08

INN (Διεθνής Όνομα):

ZOLEDRONIC ACID

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0141761003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2019-08-08

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
(zoledronic acid injection)
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
DATE OF REVISION:
July 10, 2017
CONTROL NUMBER: 205639
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
25
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
.......................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.................................................................................
34
CLINICAL TRIALS
.......