Zoledroninezuur CF 4 mg/100 ml, oplossing voor infusie

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

ZOLEDRONINEZUUR 1-WATER SAMENSTELLING overeenkomend met ; ZOLEDRONINEZUUR 0-WATER

Available from:

Centrafarm B.V.

ATC code:

M05BA08

INN (International Name):

Zoledronic acid 1-WATER COMPOSITION corresponding to ; zoledronic acid 0-WATER

Pharmaceutical form:

Oplossing voor infusie

Composition:

MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Administration route:

Intraveneus gebruik

Therapeutic area:

Zoledronic Acid

Product summary:

Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Authorization date:

2013-07-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledroninezuur CF 4 mg/100 ml, oplossing voor infusie
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 is and what it is used for
2. What you need to know before you are given
3. How is used
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
The active substance in 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
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
and will
check your response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN :

if you are breast-feeding.

if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to
which belongs), or any of the other ingredients of this
medicine (listed in
section 6).
WARN

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zoledroninezuur CF 4 mg/100 ml, oplossing voor infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One
vial
contains
4 mg
zoledronic
acid,
corresponding
to
4.26 mg
zoledronic
acid
monohydrate.
This
medicinal
product
contains
less
than
1
mmol
sodium
(23 mg)
per
infusion,
i.e.
essentially ’sodium-free’.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless solution
pH:
5.5-7.0
Osmolarity:
0.27-0.33 Osmol/kg
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
must only be prescribed and administered to patients by
healthcare
professionals experienced in the administration of intravenous
bisphosphonates. Patients
treated with 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 _
2
_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: _
treatment in TIH patients who also have severe renal
imp