Zoledronic acid Mylan

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

zoledronic acid

Saadav alates:

Mylan Pharmaceuticals Limited

ATC kood:

M05BA08

INN (Rahvusvaheline Nimetus):

zoledronic acid

Terapeutiline rühm:

Drugs for treatment of bone diseases

Terapeutiline ala:

Fractures, Bone

Näidustused:

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).

Toote kokkuvõte:

Revision: 14

Volitamisolek:

Authorised

Loa andmise kuupäev:

2012-08-23

Infovoldik

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ZOLEDRONIC ACID MYLAN 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, 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 Mylan is and what it is used for
2.
What you need to know before you are given Zoledronic acid Mylan
3.
How Zoledronic acid Mylan is used
4.
Possible side effects
5.
How to store Zoledronic acid Mylan
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID MYLAN IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid Mylan 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 MYLAN
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Mylan and will
check your response to treatment at regular intervals.
YOU MUST NOT BE GIVEN ZOLEDRONIC ACID MYLAN:
-
if you are breast-feeding.
-
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
zoledronic acid be

Toote omadused

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Mylan 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 (as
monohydrate).
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
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 Mylan must only be prescribed and administered to
patients by healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated with
Zoledronic acid Mylan 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 elderly 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 elderly 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
impairment should be considered
only after evaluating th