Zoledronic Acid Ibigen 4 mg powder and solvent for solution for infusion

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

ZOLEDRONIC ACID, MONOHYDRATE

Saatavilla:

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

ATC-koodi:

M05BA08

INN (Kansainvälinen yleisnimi):

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

Lääkemuoto:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Koostumus:

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

Prescription tyyppi:

POM

Terapeuttinen alue:

DRUGS FOR TREATMENT OF BONE DISEASES

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2013-01-16

Pakkausseloste

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID IBIGEN 4 MG POWDER AND SOLVENT 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 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 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 ingredients

Valmisteyhteenveto

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic Acid Ibigen 4 mg powder and solvent for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 4 mg zoledronic acid (anhydrous), corresponding to
4.66 mg zoledronic acid
hemypentahydrate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion
White to off-white powder and clear, colourless solvent
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 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
calcium ≥ 12.0 mg/dl or
3.0 mmol/l) is 4 mg Zoledronic Acid Ibigen solution for infusion.
Page 2 of 21
Renal impairment
_TIH: _
Zoledronic Acid Ibigen treatment in TIH patients who also have severe
renal impairment
should be considered only
_ _
after evalu