Zoledronic Acid 4mg/100ml Solution for Infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Zoledronic acid

Disponible des:

Wockhardt UK Limited

Codi ATC:

M05BA; M05BA08

Designació comuna internacional (DCI):

Zoledronic acid

Dosis:

4mg/100 millilitre(s)

formulario farmacéutico:

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:

2013-05-17

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 4MG/100ML SOLUTION FOR INFUSION
(Referred to as Zoledronic Acid Solution for Infusion in the remainder
of this leaflet)
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 Zoledronic Acid Solution for Infusion is used
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 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 ZOL

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 4mg/100ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg
zoledronic acid monohydrate.
Each ml of the solution contains 0.04 mg zoledronic acid anhydrous,
corresponding to 0.04264 mg zoledronic acid
monohydrate.
This medicinal product contains less than 1 mmol sodium (23mg) per
dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution; free from visible foreign matter.
The pH of the solution is between 6.0 – 7.0 and the osmolality is
between 260 – 340 mOsm.
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 should be given
the package leaflet and 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_
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