ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
19-07-2019

ingredients actius:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Disponible des:

DR REDDY'S LABORATORIES LTD

Codi ATC:

M05BA08

Designació comuna internacional (DCI):

ZOLEDRONIC ACID

Dosis:

4MG

formulario farmacéutico:

SOLUTION

Composición:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

5ML(1 VIAL)

tipo de receta:

Prescription

Área terapéutica:

BONE RESORPTION INHIBITORS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2014-03-21

Fitxa tècnica

                                1
PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION CONCENTRATE
4 mg/5 mL zoledronic acid (as zoledronic acid monohydrate)
Bone Metabolism Regulator
DIN Owner:
DR. REDDY’S LABORATORIES LIMITED
Bachupally 500 090 - INDIA
Imported By:
DATE OF REVISION:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga ON L4W 4Y1 Canada
July 19, 2019
Submission Control No: 228529
2
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
..............................................................................................................
21
DOSAGE AND ADMINISTRATION
..........................................................................................
21
OVERDOSAGE
............................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
26
STORAGE AND STABILITY
......................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 30
PART II: SCIENTIFIC INFORMATION
...................................................................................
31
PHARMACEUTICAL INFORMATION
...........................................................
                                
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