Zoledronic Acid 4 mg / 5 mL Concentrate for solution for infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Zoledronic acid

Disponible des:

Noridem Enterprises Limited

Codi ATC:

M05BA; M05BA08

Designació comuna internacional (DCI):

Zoledronic acid

Dosis:

4 mg/5ml

formulario farmacéutico:

Concentrate for solution for infusion

tipo de receta:

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

Área terapéutica:

Bisphosphonates; zoledronic acid

Estat d'Autorització:

Not marketed

Data d'autorització:

2013-02-22

Informació per a l'usuari

PACKAGE LEAFLET
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.
THE NAME OF YOUR MEDICINE IS ZOLEDRONIC ACID 4 MG / 5 ML CONCENTRATE
FOR SOLUTION FOR
INFUSION
_In the rest of this leaflet Zoledronic Acid 4 mg / 5 mL Concentrate
for solution for infusion is _
_called Zoledronic Acid. _
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 N

Fitxa tècnica

Health Products Regulatory Authority
13 January 2021
CRN009YKT
Page 1 of 15
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 zoledronic acid
(anhydrous).
One mL concentrate contains zoledronic acid (as monohydrate)
corresponding to 0.8 mg zoledronic acid (anhydrous).
Excipient with known effect
One mL concentrate for solution for infusion contains 1.13 mg of
sodium as sodium citrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution free from visible particles with pH of 5.5 to 7.0 and
osmolality of 290-320 mOsm/Kg.
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. Patients treated with
Zoledronic Acid 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 hypercalc