Zoledronic Acid Ibigen 4 mg/5 ml concentrate for solution for infusion

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

ZOLEDRONIC ACID, MONOHYDRATE

Commercializzato da:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

Codice ATC:

M05BA08

INN (Nome Internazionale):

ZOLEDRONIC ACID MONOHYDRATE 4 mg/ml

Forma farmaceutica:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composizione:

ZOLEDRONIC ACID MONOHYDRATE 4 mg/ml

Tipo di ricetta:

POM

Area terapeutica:

DRUGS FOR TREATMENT OF BONE DISEASES

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2013-01-16

Foglio illustrativo

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID IBIGEN 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, 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 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 Ibigen 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 cases where it is too high due to the presence
of a tumour in adult patients. 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 NOT BE GIVEN ZOLEDRONIC ACID:
•
if you are breast-feeding
•
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zoledronic Acid belongs), or any of the other ingredi

Scheda tecnica

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid Ibigen 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), corresponding to 4.66
mg zoledronic acid hemypentahydrate.
One ml concentrate contains zoledronic acid (as hemypentahydrate)
corresponding to 0.8 mg
zoledronic acid (anhydrous).
For a 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 Ibigen must only be prescribed and administered to
patients by healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated
with Zoledronic Acid Ibigen 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 Ibigen 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.
Page 2 of 23
Treatment of TIH
_Adults and older people _
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium ≥ 12.0 mg/dl or 3.0
mmol/l) is 4 mg Zoledronic Acid Ibigen.
Renal impairment
_TIH: _
Zoledronic Acid