Zoledronic acid Actavis

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

zoledronic acid monohydrate

Saatavilla:

Actavis Group PTC ehf  

ATC-koodi:

M05BA08

INN (Kansainvälinen yleisnimi):

zoledronic acid

Terapeuttinen ryhmä:

Drugs for treatment of bone diseases

Terapeuttinen alue:

Fractures, Bone

Käyttöaiheet:

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.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-04-20

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ZOLEDRONIC ACID ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you are given Zoledronic acid Actavis
3.
How Zoledronic acid Actavis is used
4.
Possible side effects
5.
How to store Zoledronic acid Actavis
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID ACTAVIS IS AND WHAT IT IS USED FOR
The active substance in Zoledronic acid Actavis 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 ACTAVIS
_ _
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid Actavis and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID ACTAVIS
-
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zoledr

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Actavis 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 (sterile concentrate).
Clear and colourless concentrate for solution for infusion.
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 Actavis must only be prescribed and administered to
patients by healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients treated with
Zoledronic acid Actavis 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 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.
3
_Renal impairment _
_TIH: _
Zoledronic acid Actavis treatment in TIH patients who also have