Zoledronic Acid 4 mg/100 ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zoledronic acid

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M05BA; M05BA08

INN (International Name):

Zoledronic acid

Dosage:

4 mg/100 millilitre(s)

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Bisphosphonates; zoledronic acid

Authorization status:

Not marketed

Authorization date:

2018-06-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 4 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.

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 solution for infusion is and what it is used for
2.
What you need to know before you are given Zoledronic Acid solution
for infusion
3.
How to use Zoledronic Acid solution for infusion
4.
Possible side effects
5.
How to store Zoledronic Acid solution for infusion
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
The active substance in Zoledronic Acid solution for infusion 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 cancer 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 SOLUTION
FOR INFUSION
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic Acid solution
for infusion and will check your response to treatment at regular
intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID SOLUTION FOR INFUSION:

if you are breast

Summary of Product characteristics

Health Products Regulatory Authority
16 December 2021
CRN009Y26
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 4 mg/100 ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag with 100 ml solution contains 4 mg zoledronic acid. One ml
solution contains 0.04 mg zoledronic acid.
Each bag with 100 ml solution contains 342.9 mg (14.9 mmol) of sodium
(see Section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear particle free and colourless to slightly yellow 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 Solution for infusion must only be prescribed and
administered to patients by healthcare professionals
experienced in the administration of intravenous bisphosphonates.
Patients treated with Zoledronic Acid Solution for infusion
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_
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
Health Product