Zoledronic acid Sandoz, Concentrate for solution for Infusion

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

ZOLEDRONIC ACID, MONOHYDRATE

Disponible des:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

Codi ATC:

M05BA08

Designació comuna internacional (DCI):

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ZOLEDRONIC ACID MONOHYDRATE 4 mg/5ml

tipo de receta:

POM

Área terapéutica:

DRUGS FOR TREATMENT OF BONE DISEASES

Estat d'Autorització:

Withdrawn

Data d'autorització:

2013-07-15

Informació per a l'usuari

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID SANDOZ SANDOZ 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Zoledronic acid Sandoz
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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoledronic acid Sandoz is and what it is used for
2.
What you need to know before you are given Zoledronic acid Sandoz
3.
How Zoledronic acid Sandoz is used
4.
Possible side effects
5.
How to store Zoledronic acid Sandoz
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid Sandoz is Zoledronic acid
Sandoz, which belongs to a
group of substances called bisphosphonates. Zoledronic acid Sandoz
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 SANDOZ
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Sandoz and
will check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID SANDOZ_ _

if you are allergic to Zoledronic acid Sandoz, another bisphosphonate
(the group of substances
Pa

Fitxa tècnica

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Sandoz 4 mg/5 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 5 ml concentrate for solution for infusion contains 4 mg
zoledronic acid, corresponding
to 4.264 mg zoledronic acid monohydrate.
1 ml concentrate for solution for infusion contains 0,8 mg zoledronic
acid.
Excipient with known effect: This medicinal product contains 0.245
mmol (or 5.63 mg) sodium per
dose.
For the 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 must only be prescribed and administered to patients
by healthcare professionals
experienced in the administration of intravenous bisphosphonates.
POSOLOGY
Prevention of skeletal related events in patients with advanced
malignancies involving bone
Page 2 of 22
_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
calcium

12.0 mg/dl or
3.0 mmol/l) is a single dose of 4 mg Zoledronic acid.
Renal impairment
_TIH: _
Zoledronic acid treatment in TIH patients who also have severe renal