Aclasta
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
20-10-2021
Summary of Product characteristics
(SPC)
20-10-2021
Active ingredient:
Zoledronic acid monohydrate 0.0533 mg/mL equivalent to zoledronic acid 0.05 mg/mL
Available from:
Sandoz New Zealand Limited
INN (International Name):
Zoledronic acid monohydrate 0.0533 mg/mL (= zoledronic acid 0.05 mg/mL)
Dosage:
5 mg/100mL
Pharmaceutical form:
Solution for infusion
Composition:
Active: Zoledronic acid monohydrate 0.0533 mg/mL equivalent to zoledronic acid 0.05 mg/mL Excipient: Mannitol Sodium citrate dihydrate Water for injection
Units in package:
Bottle, plastic, 100 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Novartis Pharma AG
Therapeutic indications:
· Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. · Prevention of postmenopausal osteoporosis.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, - 100 mL - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization date:
2004-10-11
Patient Information leaflet
Aclasta
1
ACLASTA
_Zoledronic acid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aclasta.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
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
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Aclasta
against the benefits they expect it
will have for you.
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 ACLASTA IS USED
FOR
The active ingredient in Aclasta is
zoledronic acid, which belongs to a
group of medicines called
bisphosphonates.
Aclasta is used to treat osteoporosis
in postmenopausal women and in
men, to prevent additional fractures
in men or women who have recently
had a hip fracture, or to treat or
prevent osteoporosis in men and
women caused by treatment with
steroid medicines such as prednisone.
Aclasta is also used to treat Paget’s
disease of bone.
Osteoporosis is a disease which
causes bones to become less dense,
gradually making them weaker, more
brittle and likely to break. This is
common in women after menopause,
when a woman’s ovaries stop
producing the female hormone,
oestrogen, which keeps bones
healthy. It also occurs in men and
women with increasing age. Broken
bones may result from injury or
simple falls. Breaks may occur
during normal everyday activity,
such as lifting, or from minor injury
that would not ordinarily fracture
normal bone. Fractures in people
with osteoporosis usually occur
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ACLASTA
®
zoledronic acid 5 mg/100 mL solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Single-use sterile solution containing 5 mg/100 mL zoledronic acid
(anhydrous),
corresponding to 5.330 mg/100 mL zoledronic acid monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution is sterile, clear and colourless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of osteoporosis in postmenopausal women to reduce the
incidence of hip,
vertebral and non-vertebral fractures and to increase bone mineral
density.
•
Treatment of osteoporosis in men.
•
Treatment of Paget’s disease of bone.
•
Treatment and prevention of glucocorticoid-induced osteoporosis.
•
Prevention of clinical fractures in patients after hip fracture.
•
Prevention of postmenopausal osteoporosis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The incidence of post-dose symptoms occurring within the first three
days after
administration of Aclasta
®
can be reduced with the administration of paracetamol or
ibuprofen shortly following Aclasta administration.
Patients must be appropriately hydrated prior to administration of
Aclasta. This is
especially important in the elderly and for patients receiving
diuretic therapy (see Section
4.4 Special warnings and precautions for use).
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
For the treatment of postmenopausal osteoporosis, the recommended dose
is a single
intravenous infusion of 5 mg infusion of Aclasta administered once a
year.
Adequate supplemental calcium and vitamin D intake is important in
women with
osteoporosis if dietary intake is inadequate (see Section 4.4 Special
warnings and
precautions for use).
PREVENTION OF CLINICAL FRACTURES AFTER A HIP FRACTURE
For the prevention of clinical fractures after a low-trauma hip
fracture, the recommended
dose is a single intravenous infusion of 5 mg Aclasta administered
once a year. In
patients with a recent low-trauma hip fracture,
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