Zoledronic Acid 5mg/100ml Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ZOLEDRONIC ACID, MONOHYDRATE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID MONOHYDRATE 5 mg

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

ZOLEDRONIC ACID MONOHYDRATE 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR TREATMENT OF BONE DISEASES

Authorization status:

Withdrawn

Authorization date:

2012-12-14

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ZOLEDRONIC ACID 5MG/100ML SOLUTION FOR INFUSION
(Referred to as Zoledronic Acid Infusion in the remainder of this
leaflet)
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.
- If you get any 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 Infusion is and what it is used for
2. What you need to know before you are given Zoledronic Acid Infusion
3. How Zoledronic Acid Infusion is given
4. Possible side effects
5. How to store Zoledronic Acid Infusion
6. Contents of the pack and other information
1. WHAT ZOLEDRONIC ACID INFUSION IS AND WHAT IT IS USED FOR
Zoledronic Acid Infusion contains the active substance zoledronic
acid. It belongs to a group of
medicines called bisphosphonates and is used to treat Paget’s
disease of the bone in adults.
PAGET’S DISEASE OF THE BONE
It is normal that old bone is removed and is replaced with new bone
material. This process is called
remodelling. In Paget’s disease, bone remodelling is too rapid and
new bone is formed in a disordered
fashion, which makes it weaker than normal. If the disease is not
treated, bones may become deformed
and painful, and may break. Zoledronic Acid Infusion works by
returning the bone remodelling process
to normal, securing formation of normal bone, thus restoring strength
to the bone.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID INFUSION
Follow carefully all instructions given to you by your doctor or nurse
carefully before you are given
Zoledronic Acid Infusion.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID INFUSION:
• if you are allergic to zoledronic acid, other bisphosphonates or
any of the other ingredients of this
medicine (listed in section 6).
- if you hav

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 5mg/100ml Solution for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as
monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous (as
monohydrate).
This medicinal product contains less than 1 mmol sodium (23mg) per
dose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution; free from visible foreign matter.
The pH of the solution is 6.0 – 7.0 and the osmolarity is 260 –
340 mOsm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Paget's disease of the bone in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the treatment of Paget's disease, zoledronic acid infusion should
be
prescribed only by physicians with experience in the treatment of
Paget's
disease of the bone. The recommended dose is a single intravenous
infusion of
5 mg zoledronic acid.
Re-treatment of Paget's disease: After initial treatment with
zoledronic acid
infusion in Paget's disease an extended remission period is observed
in
responding patients. Re-treatment consists of an additional
intravenous
infusion of 5mg zoledronic acid after an interval of one year or
longer from
initial treatment in patients who have relapsed. Limited data on
re-treatment of
Paget’s disease are available (see section 5.1).
Patients must be appropriately hydrated prior to administration of
zoledronic
acid infusion. This is especially important for the elderly and for
patients
receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with
administration of zoledronic acid infusion. In addition, in patients
with Paget's
disease, it is strongly advised that adequate supplemental calcium
corresponding to at least 500 mg elemental calcium twice daily is
ensured for
at least 10 days following administration of zoledronic acid infusion
(see
section 4.4).
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