JAMP-ZOLEDRONIC ACID SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)

Beszerezhető a:

JAMP PHARMA CORPORATION

ATC-kód:

M05BA08

INN (nemzetközi neve):

ZOLEDRONIC ACID

Adagolás:

4MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 4MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

5 ML

Recept típusa:

Prescription

Terápiás terület:

BONE RESORPTION INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2018-11-07

Termékjellemzők

PRODUCT MONOGRAPH
Pr
JAMP-ZOLEDRONIC ACID
(Zoledronic Acid for Injection)
4 mg Zoledronic acid/5 mL incorporated as the monohydrate
Sterile liquid concentrate must be diluted before use
Bone Metabolism Regulator
JAMP Pharma Corporation
Date of Preparation:
1310 Rue Nobel
November 7, 2018
Boucherville, Québec
J4B 5H3
Control # 220781
_Page 2 of 52_
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..................................................................................................11
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STAB
IL
I
T
Y
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC
INFORMATION
...............................................................................30
PHARMACEUTICAL
INFORMATION..........................................................................30
CLINICAL
TR
IA
L
S
..........................................................................................................31
DETAILED PHARMACOLOGY
..