ZOLEDRONIC ACID INJECTION SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
27-07-2017
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
Tilgængelig fra:
TEVA CANADA LIMITED
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:
CANCELLED POST MARKET
Autorisation dato:
2019-08-08
Produktets egenskaber
1
PRODUCT MONOGRAPH
PR
ZOLEDRONIC ACID INJECTION
(zoledronic acid injection)
5 mg/100 mL solution for intravenous infusion
Bone Metabolism Regulator
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
DATE OF REVISION:
July 10, 2017
CONTROL NUMBER: 205639
2
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
25
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
.......................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 33
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.................................................................................
34
CLINICAL TRIALS
.......
Læs hele dokumentet
