Zoledronic acid Sandoz, Solution for Infusion 5mg/100ml

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

ZOLEDRONIC ACID, MONOHYDRATE

Boleh didapati daripada:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Kod ATC:

M05BA08

INN (Nama Antarabangsa):

ZOLEDRONIC ACID MONOHYDRATE 5 mg

Borang farmaseutikal:

SOLUTION FOR INFUSION

Komposisi:

ZOLEDRONIC ACID MONOHYDRATE 5 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

DRUGS FOR TREATMENT OF BONE DISEASES

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2013-07-16

Risalah maklumat

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID SANDOZ 5 MG/100 ML SOLUTION FOR INFUSION
Zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoledronic acid Sandoz is and what it is used for
2.
What you need to know before you are given Zoledronic acid Sandoz
3.
How Zoledronic acid Sandoz is given
4.
Possible side effects
5.
How to store Zoledronic acid Sandoz
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR
Zoledronic acid Sandoz contains the active substance zoledronic acid.
It belongs to a group of
medicines called bisphosphonates and is used to treat post-menopausal
women and men with
osteoporosis or osteoporosis caused by treatment with steroids, and
Paget’s disease of the bone.
OSTEOPOROSIS
Osteoporosis is a disease that involves the thinning and weakening of
the bones and is common in
women after the menopause, but can also occur in men. At the
menopause, a woman’s ovaries stop
producing the female hormone oestrogen, which helps keep bones
healthy. Following the
menopause bone loss occurs, bones become weaker and break more easily.
Osteoporosis could also
occur in men and women because of the long term use of steroids, which
can affect the strength of
bones.
Many patients with osteoporosis have no symptoms but they are still at
risk of breaking bones
because osteoporosis has made their bones weaker. Decreased
circulating levels of sex hormones,
mainly oestrogens converted

Ciri produk

Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Sandoz 5 mg/100ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of 100 ml solution for infusion contains 5 mg zoledronic
acid.
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous,
corresponding to 0.0533 mg
zoledronic acid monohydrate.
Excipient with known effect: This medicinal product contains 0.306
mmol (or 7.04 mg) sodium per
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution (isotonic, pH between 6.0 – 7.0).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis
•
in post-menopausal women
•
in men
at increased risk of fracture, including those with a recent
low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic
glucocorticoid therapy
•
in post-menopausal women
•
in men
at increased risk of fracture.
Treatment of Paget’s disease of the bone in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients must be appropriately hydrated prior to administration of
Zoledronic acid. This is especially
important for the elderly and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with Zoledronic acid
administration.
Page 2 of 19
For the treatment of post-menopausal osteoporosis, osteoporosis in men
and the treatment of
osteoporosis associated with long-term systemic glucocorticoid
therapy, the recommended dose is a
single intravenous infusion of 5 mg zoledronic acid administered once
a year.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The
need for continued treatment should be re-evaluated periodically based
on the benefits and potential
risks of zoledronic acid on an individual patient basis, particularly
after 5 or more years of use.
In patients with a recent low-trauma hip fracture, it is recommended
to give the Zoledronic acid
Sandoz infusion at le