ZOLEDRONIC ACID FOR INJECTION SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Dostupno od:

PFIZER CANADA ULC

ATC koda:

M05BA08

INN (International ime):

ZOLEDRONIC ACID

Doziranje:

4MG

Farmaceutski oblik:

SOLUTION

Sastav:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

5ML

Tip recepta:

Prescription

Područje terapije:

BONE RESORPTION INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2021-04-08

Svojstava lijeka

PRODUCT MONOGRAPH
Pr
ZOLEDRONIC ACID FOR INJECTION
4 MG/5 ML (0.8 MG/ML)
ZOLEDRONIC ACID (AS ZOLEDRONIC ACID MONOHYDRATE)
STERILE SOLUTION
BONE METABOLISM REGULATOR
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision: April
30, 2018
Control No.: 210700
_Product Monograph - _
_Pr_
_Zoledronic Acid for Injection _
_Page 2 of 54 _
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
..........................................................................................................34
DETAILED PHA