Zoledronic acid 4 mg/5 ml concentrate for solution for infusion

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Zoledronic acid

Disponibbli minn:

Fresenius Kabi Deutschland GmbH

Kodiċi ATC:

M05BA; M05BA08

INN (Isem Internazzjonali):

Zoledronic acid

Dożaġġ:

4/5 milligram(s)/millilitre

Għamla farmaċewtika:

Concentrate for solution for infusion

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Bisphosphonates; zoledronic acid

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2012-10-12

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 4 MG/5 ML 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 is and what it is used for
2. What you need to know before you are given Zoledronic acid
3. How Zoledronic acid is used
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other information
1. WHAT ZOLEDRONIC ACID IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid 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
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID

if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to
which Zoledronic acid belongs), or any of the other ingredients of
this medicine ( listed in
section 6).

if you are b

Karatteristiċi tal-prodott

Health Products Regulatory Authority
04 January 2021
CRN00C2FT
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg of zoledronic acid (as
monohydrate).
One ml concentrate contains 0.8 mg of zoledronic acid (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
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 must only be prescribed and administered to patients
by healthcare professionals experienced in the
administration of intravenous bisphosphonates.
Posology
_Prevention of skeletal related events in patients with advanced
malignancies involving bone_
_Adults and elderly_
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_
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4
mg zoledronic acid.
_Renal impairment_
_TIH:_
Zoledronic acid treatment in TIH patients who also have severe renal
impairment should be considered only after evaluating
the risks and benefits of treatment.
In the clinical studie