ZOLEDRONIC ACID CLONMEL 4 MG/5ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZOLEDRONIC ACID MONOHYDRATE

Available from:

Clonmel Healthcare Ltd

ATC code:

M05BA08

INN (International Name):

ZOLEDRONIC ACID MONOHYDRATE

Dosage:

4 MG/5ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Biphosphonates

Authorization status:

Authorised

Authorization date:

2012-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLEDRONIC ACID CLONMEL 4MG/5ML CONCENTRATE FOR 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.

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 Clonmel is and what it is used for
2.
What you need to know before you are given Zoledronic acid Clonmel
3.
How Zoledronic acid Clonmel is used
4.
Possible side effects
5.
How to store Zoledronic acid Clonmel
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID CLONMEL IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid Clonmel is zoledronic acid,
which belongs to a group of
substances called bisphosphonates. Zoledronic acid works by attaching
itself to the bone and
slowing down the rate of bone change. It is used:

TO PREVENT BONE COMPLICATIONS, e.g. fractures, in adult patients with
bone metastases (spread of
cancer from primary site to the bone)

TO REDUCE THE AMOUNT OF CALCIUM in the blood in adult patients where
it is too high due to the
presence of a tumour. Tumours can accelerate normal bone change in
such a way that the release
of calcium from bone is increased. This condition is known as
tumour-induced hypercalcaemia
(TIH).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID CLONMEL
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Clonmel
and will check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID CLONMEL:

if you are breast-feeding.

if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Z

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Clonmel 4mg/5ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg zoledronic acid
(anhydrous).
One ml concentrate contains zoledronic acid (as monohydrate)
corresponding to 0.8 mg zoledronic acid (anhydrous).
Excipients with known effect: Sodium citrate dihydrate
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. is essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Prevention of skeletal related events (pathological fractures,
spinal compression, radiation or surgery to bone, or
tumour-induced hypercalcaemia) in adult patients with advanced
malignancies involving bone.
- Treatment of adult patients with tumour-induced hypercalcaemia
(TIH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zoledronic acid Clonmel must only be prescribed and administered to
patients by healthcare professionals experienced
in the administration of intravenous bisphosphonates. Patients treated
with Zoledronic acid Clonmel should be given
the package leaflet and the patient reminder card.
Posology
Prevention of skeletal related events in patients with advanced
malignancies involving bone
_Adults and elderly people_
The recommended dose in the prevention of skeletal related events in
patients with advanced malignancies involving
bone is 4 mg zoledronic acid every 3 to 4 weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should consider that the
onset of treatment effect is 2-3 months.
Treatment of TIH
_Adults and elderly people_
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium
12.0 mg/dl or 3.0 mmol/l) is a single
do