Zoledronic acid medac

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

zoledronic acid monohydrate

Dostupné z:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC kód:

M05BA08

INN (Medzinárodný Name):

zoledronic acid

Terapeutické skupiny:

Drugs for treatment of bone diseases

Terapeutické oblasti:

Fractures, Bone; Cancer

Terapeutické indikácie:

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).

Prehľad produktov:

Revision: 13

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2012-08-03

Príbalový leták

32
B. PACKAGE LEAFLET
33 PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID MEDAC 4 MG/100 ML 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 medac is and what it is used for
2.
What you need to know before you are given Zoledronic acid medac
3.
How Zoledronic acid medac is used
4.
Possible side effects
5.
How to store Zoledronic acid medac
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID MEDAC IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid medac 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 MEDAC
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid medac and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID MEDAC
-
if you are breast-feeding.
-
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zoledronic acid medac bel

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid medac 4 mg/100 ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One bottle with 100 ml solution contains 4 mg zoledronic acid (as
monohydrate).
One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, 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 medac must only be prescribed and administered to
patients by healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated with
Zoledronic acid medac 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.
3
_Renal impairment _
_TIH: _
Zoledronic acid treatment in TIH patients who also have severe renal
impairment should be considered
only after evaluating the risks and benefits of treatme