Zoledronic acid Sandoz 4mg/5ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zoledronic acid

Available from:

Rowex Ltd

ATC code:

M05BA; M05BA08

INN (International Name):

Zoledronic acid

Dosage:

4 mg/5 millilitre(s)

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Bisphosphonates; zoledronic acid

Authorization status:

Marketed

Authorization date:

2012-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID SANDOZ 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, nurse or
pharmacist.

If you get any side effects, talk to your doctor, nurse or pharmacist.
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 used
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
The active substance in Zoledronic acid Sandoz 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 SANDOZ
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Sandoz and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID SANDOZ_ _

if you are breast-feeding

if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zoledronic

Summary of Product characteristics

Health Products Regulatory Authority
20 May 2020
CRN008HGL
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Sandoz 4mg/5ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 5 ml concentrate for solution for infusion contains 4 mg
zoledronic acid, corresponding to 4.264 mg zoledronic acid
monohydrate.
1 ml concentrate for solution for infusion contains 0.8 mg zoledronic
acid.
Excipients with known effect:
This medicinal product contains 0.245 mmol sodium (5.63 mg) per 5 ml
concentrate for solution for infusion.
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 Sandoz must only be prescribed and administered to
patients by healthcare professionals experienced in the
administration of intravenous bisphosphonates.
Patients treated with Zoledronic acid Sandoz 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 older 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 older people_
The recommended dose in hypercalcaemia (al