DBL ZOLEDRONIC ACID IV INFUSION zoledronic acid solution for infusion 4 mg/100 mL bag

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

zoledronic acid monohydrate

Saadav alates:

Pfizer Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

zoledronic acid monohydrate

Volitamisolek:

Registered

Infovoldik

DBL™ ZOLEDRONIC ACID IV INFUSION
_contains the active ingredient zoledronic acid_
_ _
DBL™ Zoledronic Acid IV Infusion CMI
1 of 3
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL™ Zoledronic
Acid IV Infusion.
It does not contain all the available
information. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using DBL™ Zoledronic Acid IV
Infusion against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL™
ZOLEDRONIC ACID IV
INFUSION IS USED FOR
DBL™ Zoledronic Acid IV Infusion
contains the active ingredient
zoledronic acid. It belongs to a group
of medicines called bisphosphonates
which work by stopping the
breakdown of bone which can occur in
some forms of cancer.
In people with advanced cancer
involving the bone, DBL™
Zoledronic Acid IV Infusion is used
prevent unwanted bone-related events
such as fractures, severe back pain and
the need for radiation or surgery to the
bones.
DBL™ Zoledronic Acid IV Infusion
can also be used to lower high levels
of calcium in the blood due to cancer.
Your doctor may have prescribed
DBL™ Zoledronic Acid IV Infusion
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS REGARDING WHY DBL™
ZOLEDRONIC ACID IV INFUSION HAS
BEEN PRESCRIBED FOR YOU.
DBL™ Zoledronic Acid IV Infusion
is not addictive.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL™ ZOLEDRONIC ACID
IV INFUSION
_WHEN YOU MUST NOT HAVE IT _
DO NOT TAKE OR RECEIVE DBL™
ZOLEDRONIC ACID IV INFUSION IF:
YOU HAVE HAD AN ALLERGIC REACTION TO:
-
zoledronic acid or any of the
ingredients listed at the end of
this leaflet
-
any other bisphosphonate
medicine
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; s

Toote omadused

Version: pfpzolai11120
Superceded: v.3.0 of DBL Zoledronic Acid Concentrated Injection
and V 4.0 of DBL Zoledronic acid IV Infusion
Page 1 of 23
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
ZOLEDRONIC
ACID
(ZOLEDRONIC
ACID)
1.
NAME OF THE MEDICINE
Zoledronic acid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL Zoledronic Acid Concentrated Injection contains 4 mg
anhydrous zoledronic
acid/5 mL, equivalent to 4.264 mg zoledronic acid monohydrate. Each
vial contains an overfill
to permit withdrawal of the labelled amount of zoledronic acid from
the vial.
Each bag of DBL Zoledronic Acid IV Infusion contains 4 mg anhydrous
zoledronic acid/100
mL, equivalent to 4.264 mg zoledronic acid monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
CONCENTRATED INJECTION
DBL Zoledronic Acid Concentrated Injection is a sterile, colourless
solution.
SOLUTION FOR INFUSION
DBL Zoledronic Acid IV Infusion is a clear to colourless solution free
from visible particulates.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Zoledronic Acid is indicated for the:
•
Prevention of skeletal-related events (pathological fracture, spinal
cord compression,
radiation to bone or surgery to bone) in patients with advanced
malignancies involving
bone.
•
Treatment of tumour-induced hypercalcaemia.
Version: pfpzolai11120
Superceded: v.3.0 of DBL Zoledronic Acid Concentrated Injection
and V 4.0 of DBL Zoledronic acid IV Infusion
Page 2 of 23
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
PREVENTION OF SKELETAL-RELATED EVENTS IN PATIENTS WITH ADVANCED
MALIGNANCIES INVOLVING
BONE
_Dosage regimen for adults (including elderly patients) _
The recommended dose is 4 mg given as an intravenous infusion lasting
no less than 15
minutes, every 3 to 4 weeks.
DBL Zoledronic Acid Concentrated Injection must be reconstituted and
further diluted with
100 mL 0.9% w/v sodium chloride or 5% w/v glucose solution prior to
administration. See
Method of administration, Instructions for use and handling.
DB