Zoledronic Acid Accord zoledronic acid 4mg/5mL concentrated injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

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

Prieinama:

Accord Healthcare Pty Ltd

INN (Tarptautinis Pavadinimas):

zoledronic acid monohydrate

Vaisto forma:

Injection, concentrated

Sudėtis:

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

Vartojimo būdas:

Intravenous Infusion

Vienetai pakuotėje:

1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Zoledronic Acid Accord 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.,For treatment of tumour-induced hypercalcaemia.,As an adjunct to adjuvant treatment for women with early breast cancer who are in established menopause.

Produkto santrauka:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2015-05-28

Pakuotės lapelis

Zoledronic Acid Accord - version 3
1
ZOLEDRONIC ACID ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ZOLEDRONIC ACID ACCORD?
Zoledronic Acid Accord contains the active ingredient zoledronic acid.
Zoledronic Acid Accord 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.
For more information, see Section 1. Why am I using Zoledronic Acid
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZOLEDRONIC ACID ACCORD?
Do not use if you are allergic to zoledronic acid, any of the
ingredients listed at the end of this leaflet or any other
bisphosphonate medicine.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I’m
given Zoledronic Acid Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Zoledronic Acid Accord and affect
how it works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I USE ZOLEDRONIC ACID ACCORD?
Zoledronic Acid Accord is an injection and will be given to you by
your doctor.
More instructions can be found in Section 4. How is Zoledronic Acid
Accord given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZOLEDRONIC ACID ACCORD?
THINGS YOU
SHOULD DO
•
Tell any other doctors, nurses or pharmacists who treat you that you
are taking this medicine
•
Tell your doctor immediately If you become pregnant while taking this
medicine
•
Tell your doctor if you experience any of the side effects listed in
the CMI
THINGS YOU
SHOULD NOT DO
Do not receive Zoledronic Acid Accord if you are allergic to
zoledronic acid, any of the ingredients listed
at the end of this leaflet

Prekės savybės

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
ZOLEDRONIC ACID ACCORD CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Zoledronic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 0.8 mg zoledronic acid.
1 vial of 5 mL concentrated injection contains 4 mg zoledronic acid
(calculated as the anhydrous form,
corresponding to 4.264 mg zoledronic acid monohydrate).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Zoledronic Acid Accord is a clear, colourless solution, practically
free from visible particles and is
available as a sterile liquid concentrate for injection.
After further dilution, Zoledronic Acid Accord is administered by
intravenous (IV) infusion (see
SECTION
4.2 DOSE AND METHOD OF ADMINISTRATION
). The concentrate for injection is for single use in one patient
on one occasion only.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Zoledronic Acid Accord 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For information on the dilution of Zoledronic Acid Accord, 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. Zoledronic Acid Accord should be further diluted
with 100 mL 0.9% w/v sodium
chloride or 5% w/v glucose injection. Patients should also be
administered an oral calcium supplement
of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.
TREATMENT OF TUMOUR-INDUCED HYPERCALCAEMIA (TIH)
DOSAGE REGIMEN FOR ADULTS (INCLUDING ELDERLY PATIENTS):
The recommended dos