Zoledronic Acid 4mg/5ml Concentrate for Solution for Infusion

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

ZOLEDRONIC ACID, MONOHYDRATE

Disponibbli minn:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

Kodiċi ATC:

M05BA08

INN (Isem Internazzjonali):

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

Għamla farmaċewtika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompożizzjoni:

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

DRUGS FOR TREATMENT OF BONE DISEASES

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2012-12-14

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid 4mg/5ml 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).
This medicinal product contains less than 1 mmol sodium (23mg) per
dose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution; free from visible foreign matter.
The pH of the concentrate is 6.0 – 7.0 and the osmolarity is 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 concentrate for 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 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 (albumin-corrected serum
calciu