ZOLEDRONIC ACID 4/5 Mg/Ml Concentrate for Soln for Inf

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

ZOLEDRONIC ACID

Dostupné s:

Fresenius Kabi Limited

ATC kód:

M05BA08

INN (Mezinárodní Name):

ZOLEDRONIC ACID

Dávkování:

4/5 Mg/Ml

Léková forma:

Concentrate for Soln for Inf

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Biphosphonates

Stav Autorizace:

Authorised

Datum autorizace:

2012-10-12

Informace pro uživatele

Zoledronic acid 4 mg/5 ml
concentrate for solution for infusion
Zoledronic acid
Package leaflet: Information for the user
V006
M087454/04 UK/IE
The following information is intended for healthcare
professionals only
How to prepare and administer Zoledronic acid
−
To
prepare
an
infusion
solution
containing
4
mg
zoledronic acid, further dilute the Zoledronic acid concentrate
(5.0 ml) with 100 ml of calcium-free or other divalent cation-free
infusion solution. If a lower dose of Zoledronic acid is
required,
first
withdraw
the
appropriate
volume
as
indicated below and then dilute it further with 100 ml of
infusion solution. To avoid potential incompatibilities, the
infusion solution used for dilution must be either 0.9% w/v
sodium chloride or 5% w/v glucose solution.
Do
not
mix
Zoledronic
acid
concentrate
with
calcium-containing
or
other
divalent
cation
containing solutions such as lactated Ringer’s solution.
Instructions for preparing reduced doses of Zoledronic acid:
Withdraw the appropriate volume of the liquid concentrate,
as follows:
- 4.4 ml for 3.5 mg dose
- 4.1 ml for 3.3 mg dose
- 3.8 ml for 3.0 mg dose
-
For
single
use
only.
Any
unused
solution
should
be
discarded.
Only
clear
solution
free
from
particles
and
discolouration should be used. Aseptic techniques must be
followed during the preparation of the infusion.
-
Shelf
life
after
dilution:
chemical
and
physical
in-use
stability has been demonstrated for 24 hours at 2°C-8ºC.
From
a
microbiological
point
of
view,
the
diluted
solution for infusion should be used immediately. If not used
immediately, in-use storage times and conditions prior to use
are the responsibility of the user and would normally not be
longer than 24 hours at 2°C – 8°C. The refrigerated solution
should then be equilibrated to room temperature prior to
administration.
V006
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 quest

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg of zoledronic acid (as
monohydrate).
One ml concentrate contains 0.8 mg of 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 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_
_Adults and elderly_
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_
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 the risks and benefits of treatment.
In the clinical studies, patients with serum creatinine > 400 µmol/l
or > 4.5 mg/dl were excluded. N