ZOLEDRONIC ACID FOR INJECTION CONCENTRATE SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Tilgængelig fra:

DR REDDY'S LABORATORIES LTD

ATC-kode:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

Dosering:

4MG

Lægemiddelform:

SOLUTION

Sammensætning:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

5ML(1 VIAL)

Recept type:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-03-21

Produktets egenskaber

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
...........................................................