ZOLEDRONIC ACID INJECTION SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Tilgængelig fra:

MARCAN PHARMACEUTICALS INC

ATC-kode:

M05BA08

INN (International Name):

ZOLEDRONIC ACID

Dosering:

5MG

Lægemiddelform:

SOLUTION

Sammensætning:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

100ML

Recept type:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2018-07-25

Produktets egenskaber

_Page 1 of 68_
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Marcan Pharmaceuticals Inc.,
Date of Preparation:
2 Gurdwara Road, Suite #112,
July 24, 2018
Ottawa, ON, K2E 1A2
CONTROL NUMBER: 203800
_Page 2 of 68_
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..................................................................................................10
DRUG INTERACTIONS
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STAB
IL
I
T
Y
..........................................................................................33
SPECIAL HANDLING INSTRUCTIONS
.......................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II: SCIENTIFIC
INFORMATION
...............................................................................35
PHARMACEUTICAL
INFORMATION..........................................................................35
CLINICAL
TR
IA
L
S
..............................................................................................