Zoledronic Acid SUN zoledronic acid 5 mg / 100 mL injection solution vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-01-2022
Summary of Product characteristics
(SPC)
21-01-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
zoledronic acid monohydrate, Quantity: 5.33 mg (Equivalent: zoledronic acid, Qty 5 mg)
Available from:
Sun Pharma ANZ Pty Ltd
INN (International Name):
zoledronic acid monohydrate
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sodium citrate dihydrate; mannitol; water for injections
Administration route:
Intravenous Infusion
Units in package:
1 Vial, 6 Vials, 3 Vials
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Treatment of Paget?s disease of bone.
Product summary:
Visual Identification: Clear colourless solution in 100 ml colourless Type - I glass vial with flurotec coated chlorobutyl grey rubber stopper and golden red alu seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-05-15
Patient Information leaflet
Zoledronic Acid SUN
1
ZOLEDRONIC ACID SUN
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 SUN?
Zoledronic Acid SUN contains the active ingredient zoledronic acid.
Zoledronic Acid SUN is used to treat osteoporosis in
postmenopausal women and in men and also used to treat Paget's disease
of bone.
For more information, see Section 1. Why am I using Zoledronic Acid
SUN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZOLEDRONIC ACID SUN?
Do not use if you have ever had an allergic reaction to zoledronic
acid or any of the ingredients listed at the end of the CMI or
any other bisphosphonate medicine. TALK TO YOUR DOCTOR OR PHARMACIST
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 use
Zoledronic Acid SUN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Zoledronic Acid medicine and affect
how it works. These include: medicines that may
affect your kidneys such as fluid tablets or aminoglycoside medicines
used to treat severe infections. A list of these medicines
is in Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I USE ZOLEDRONIC ACID SUN?
Zoledronic Acid SUN will be given to you by infusion into a vein by
your doctor or nurse once a year. The infusion will take at
least 15 minutes. More instructions can be found in Section 4. How do
I use Zoledronic Acid SUN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING THIS MEDICINE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Zoledronic Acid SUN.
•
If you get a headache, fever or other flu-like symptoms in the first
three days after you are given
Zoledronic Acid SUN, take paracetamol if your doctor has told you to.
THINGS YOU
SHOULD NOT DO
•
Do
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – ZOLEDRONIC ACID SUN
(ZOLEDRONIC ACID MONOHYDRATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Zoledronic acid monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zoledronic
Acid
SUN
5
mg/100
mL
solution
for
injection
contains
5
mg
zoledronic
acid
(anhydrous), corresponding to 5.330 mg zoledronic acid monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Zoledronic Acid SUN 5 mg/100 mL solution for injection is sterile,
clear and colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Treatment of osteoporosis in postmenopausal women to reduce the
incidence of hip,
vertebral and non-vertebral fractures.
•
Treatment of osteoporosis in patients over 50 years of age with a
history of at least one low
trauma hip fracture, to reduce the incidence of further fractures.
•
To increase bone mineral density in men with osteoporosis.
•
To increase bone mineral density in patients with osteoporosis
associated with long term
glucocorticoid use.
•
To prevent glucocorticoid-induced bone mineral density loss.
•
Treatment of Paget’s disease of bone.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
The incidence of post-dose symptoms occurring within the first three
days after administration
of Zoledronic Acid SUN can be reduced with the administration of
paracetamol shortly
following Zoledronic Acid SUN administration.
Patients must be appropriately hydrated prior to administration of
Zoledronic Acid SUN. This is
especially important in the elderly and for patients receiving
diuretic therapy (see SECTION 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Adequate hydration can be
achieved by the
patient drinking two glasses of fluid (such as water) before and after
the infusion.
The inclusion and exclusion criteria of the clinical trials should be
used as a basis for patient
selection (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL
TRIALS).
2
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
For
the
Read the complete document
