OSTEOVAN zoledronic acid 5mg/100mL injection solution vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

zoledronic acid monohydrate, Quantity: 5.33 mg (Equivalent: zoledronic acid, Qty 5 mg)

Dostępny od:

Sandoz Pty Ltd

INN (International Nazwa):

zoledronic acid monohydrate

Forma farmaceutyczna:

Injection, solution

Skład:

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

Droga podania:

Intravenous

Sztuk w opakowaniu:

3 Vials, 6 Vials, 1 Vial

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

- 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 glucocorticiod-induced bone mineral density loss. - Treatment of Paget's disease of bone.

Podsumowanie produktu:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

2008-06-23

Ulotka dla pacjenta

OSTEOVAN
®
_Zoledronic acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Osteovan.
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.NOVARTIS.COM.AU.
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 Osteovan
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 OSTEOVAN IS
USED FOR
The active ingredient in Osteovan is
zoledronic acid, which belongs to a
group of medicines called
bisphosphonates.
Osteovan 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.
Osteovan 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 at the
h

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION - OSTEOVAN

(ZOLEDRONIC ACID) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Zoledronic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Osteovan 5 mg/100 mL solution for infusion contains 5 mg zoledronic
acid (anhydrous),
corresponding to 5.330 mg zoledronic acid monohydrate.
Contains sodium and sulfites.
For the full list of excipients, section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for intravenous infusion
Osteovan 5 mg/100 mL solution for infusion 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.
•
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 DOSE AND METHOD OF ADMINISTRATION
General
The
incidence
of
post-dose
symptoms
occurring
within
the
first
three
days
after
administration of Osteovan can be reduced with the administration of
paracetamol shortly
following Osteovan administration.
Patients must be appropriately hydrated prior to administration of
Osteovan. 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).
Treatment of Postmenopausal Osteoporosis
For the treatment of postmenopausal osteoporosis the recommended