ZOMETA zoledronic acid 4 mg/100 mL injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zoledronic acid, Quantity: 4 mg (Equivalent: zoledronic acid monohydrate, Qty 4.264 mg)

Available from:

SciGen Australia Pty Ltd

INN (International Name):

Zoledronic acid

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; mannitol; nitrogen; sodium citrate dihydrate

Administration route:

Intravenous Infusion

Units in package:

5, 1, 4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Clear, colourless solution in a 100 mL colourless plastic vial, grey rubber stopper, aluminium cap with flip-off lid; Container Type: Vial; Container Material: Plastic; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-08-15

Patient Information leaflet

ZOMETA
®
1
ZOMETA
®
_zoledronic acid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zometa.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ (NEW
ZEALAND).
Those updates may contain important
information about the medicine and
its use of which you should be aware.
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 having Zometa
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZOMETA IS USED
FOR
•
Zometa is used to lower the
amount of calcium in the blood
when it becomes too high, as may
happen in some forms of cancer.
Some cancers can speed up normal
changes in bone so that the amount
of calcium released from the bones
into the blood is increased. Zometa
belongs to a group of medicines
called bisphosphonates, which
strongly bind to bone. These
medicines slow down the rate of
bone change and help to restore the
amount of calcium in the blood to
normal.
•
Zometa is also used to slow down
the spread of cancers in bone,
helping to prevent changes to the
bones that may cause them to
weaken.
It is used in people with advanced
cancer of the bone marrow (called
multiple myeloma) and other
advanced cancers that have spread to
the bone. This medicine is used in
addition to other standard cancer
treatments.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Zometa is only available with a
docto

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - ZOMETA

(ZOLEDRONIC ACID)
1.
NAME OF THE MEDICINE
Zoledronic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zometa powder for injection contains 4mg zoledronic acid (calculated
as the anhydrous form,
corresponding to 4.264 mg zoledronic acid monohydrate) as a
lyophilised powder.
Zometa concentrated injection contains 4mg zoledronic acid (calculated
as the anhydrous
form, corresponding to 4.264 mg zoledronic acid monohydrate) as a
liquid concentrate.
Zometa injection solution contains 4 mg zoledronic acid (calculated as
the anhydrous form,
corresponding to 4.264 mg zoledronic acid monohydrate) as a ready to
use injection solution.
Contains sodium and sulfites.
For the full list of excipients, section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Zometa powder for injection: White to off white lyophilised powder in
glass vials. Diluent:
Clear, colourless liquid in glass ampoules.
Zometa concentrated injection: Clear, colourless solution in plastic
vials.
Zometa injection solution: Clear, colourless solution in plastic
vials.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
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 hypercalcemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
For information on the reconstitution and dilution of Zometa, see
“Instructions for Use and
Handling”.
Prevention of skeletal-related events in patients with advanced
malignancies involving bone
DOSAGE REGIMEN FOR ADULTS (INCLUDING ELDERLY PATIENTS):
The recommended dose for the prevention of skeletal-related events in
patients with advanced
malignancies involving bone is 4 mg, given as an intravenous infusion
lasting no less than 15-
minutes every 3 to 4 weeks. The Zometa 4 mg/5 mL concentrate should be
reconstituted and
further diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v glucose
solution. The 4
mg/100 mL injection solution