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ZOLEDRONIC ACID SANDOZ 4 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Zoledronic acid 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, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zoledronic acid is and what
it is used for
2. What you need to know before
you are given Zoledronic acid
3. How Zoledronic acid is given
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other
information

1

may cause the calcium level in the
blood to become too low.
• Thalidomide (a medicine used to
treat a certain type of blood cancer
involving the bone) or any other
medicines which may harm your
kidneys.
• Other medicines that also contain
zoledronic acid and which are
used to treat osteoporosis and
other non-cancer diseases of the
bone, or any other
bisphosphonate, since the
combined effects of these
medicines taken together with
Zoledronic acid are unknown.
• Anti-angiogenic medicines (used to
treat cancer), since the
combination of these medicines
with zoledronic acid has been
associated with an increased risk
of osteonecrosis of the jaw (ONJ).

What Zoledronic acid is
and what it is used for

The active substance in Zoledronic
acid solution for infusion 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

Pregnancy and breast-feeding
You should not be given Zoledronic
acid if you are pregnant. Tell your
doctor if you are or think that you
may be pregnant.
You must not be given Zoledronic
acid if you are breast-feeding.

What you need to know
before you are given
Zoledronic acid

Ask your doctor for advice before
taking any medicine while you are
pregnant or breast-feeding.

Follow carefully all instructions given
to you by your doctor.

Driving and using machines
There have been very rare cases of
drowsiness and sleepiness with the
use of zoledronic acid. You should
therefore be careful when driving,
using machinery or performing other
tasks that need full attention.

Your doctor will carry out blood tests
before you start treatment with
Zoledronic acid and will check your
response to treatment at regular
intervals.

Zoledronic acid solution for
infusion contains sodium.
This medicinal product contains less
than 1 mmol sodium (23 mg) per
dose, i.e. essentially ‘sodium- free’.

You should not be given
Zoledronic acid
• if you are allergic to zoledronic
acid, another bisphosphonate (the
group of substances to which
Zoledronic acid belongs), or any of
the other ingredients of this
medicine (listed in section 6).
• if you are breast-feeding.

3

Warnings and precautions
Talk to your doctor before you are
given Zoledronic acid
• if you have or have had a kidney
problem.
• if you have or have had pain,
swelling or numbness of the jaw,
a feeling of heaviness in the jaw or
loosening of a tooth.
• if you are having dental treatment
or are due to undergo dental
surgery, tell your dentist that you
are being treated with Zoledronic
acid.

How Zoledronic acid is
given

• Zoledronic acid must only be given
by healthcare professionals trained
in administering bisphosphonates
intravenously, i.e. through a vein.
• Your doctor will recommend that
you drink enough water before
each treatment to help prevent
dehydration.
• Carefully follow all the other
instructions given to you by your
doctor, nurse or pharmacist.
How much Zoledronic acid is
given
The usual single dose given is 4 mg
zoledronic acid.
If you have a kidney problem, your
doctor will give you a lower dose
depending on the severity of your
kidney problem.

Reduced levels of calcium in the
blood (hypocalcaemia), sometimes
leading to muscle cramps, dry skin,
burning sensation, have been
reported in patients treated with
Zoledronic acid. Irregular heart beat
(cardiac arrhythmia), seizures,
spasm and twitching (tetany) have
been reported as secondary to
severe hypocalcaemia. In some
instances the hypocalcaemia may be
life-threatening. If any of these apply
to you, tell your doctor straight away.
If you have pre-existing
hypocalcaemia, it must be corrected
before initiating the first dose of
Zoledronic acid. You will be given
adequate calcium and vitamin D
supplements.

How often Zoledronic acid is
given
• If you are being treated for the
prevention of bone complications
due to bone metastases, you will
be given one infusion of Zoledronic
acid every three to four weeks.
• If you are being treated to reduce
the amount of calcium in your
blood, you will normally only be
given one infusion of Zoledronic
acid.

Patients aged 65 years and over
Zoledronic acid can be given to
people aged 65 years and over.
There is no evidence to suggest that
any extra precautions are needed.

How Zoledronic acid is given
Zoledronic acid is given as a drip
(infusion) into a vein which should
take at least 15 minutes and should
be administered as a single
intravenous solution in a separate
infusion line.

Children and adolescents
Zoledronic acid is not recommended
for use in children and adolescents
below the age of 18 years.

Patients whose blood calcium levels
are not too high will also be
prescribed calcium and vitamin D
supplements to be taken each day.

Other medicines and Zoledronic
acid
Tell your doctor if you are taking
have recently taken or might take
any other medicines. It is especially
important that you tell your doctor if
you are also taking:
• Aminoglycosides (medicines used
to treat severe infections),
calcitonin (a type of medicine used
to treat post-menopausal
osteoporosis and hypercalcaemia),
loop diuretics (a type of medicine
to treat high blood pressure or
oedema) or other calcium lowering
medicines, since the combination
of these with bisphosphonates

If you are given more Zoledronic
acid than you should be
If you have received doses higher
than those recommended, you must
be carefully monitored by your
doctor. This is because you may
develop serum electrolyte
abnormalities (e.g. abnormal levels
of calcium, phosphorus and
magnesium) and/or changes in
kidney function, including severe
kidney impairment. If your level of
calcium falls too low, you may have
to be given supplemental calcium by
infusion.
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INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zoledronic acid
• Zoledronic acid 4 mg/100 ml solution for infusion contains 4 mg zoledronic
acid in 100 ml of infusion solution for immediate use in patients with
normal renal function.
• 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.
- The solution containing zoledronic acid must not be further diluted or
mixed with other infusion solutions. It is given as a single intravenous
infusion in a separate infusion line in no less than 15 minutes. The
hydration status of patients must be assessed prior to and following
administration of Zoledronic acid to ensure that they are adequately
hydrated.
- Zoledronic acid 4 mg/100 ml solution for infusion can be used
immediately without further preparation for patients with normal renal
function. In patients with mild to moderate renal impairment, reduced
doses should be prepared as instructed below.
• To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min,
refer to Table 1 below. Remove the volume of Zoledronic acid solution
indicated from the bottle and replace with an equal volume of sterile
sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose
solution for injection.

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4

experience pain, weakness or
discomfort in your thigh, hip or
groin as this may be an early
indication of a possible fracture of
the thigh bone.
• Interstitial lung disease
(inflammation of the tissue around
the air sacks of the lungs)
• Flu-like symptoms including
arthritis and joint swelling.
• Painful redness and/or swelling of
the eye.

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them. The most
common ones are usually mild and
will probably disappear after a short
time.
Tell your doctor about any of the
following serious side effects
straight away:

Very rare (may affect up to 1 in
10,000 people):
• Severe bone, joint and/or muscle
pain, occasionally incapacitating.

Common (may affect up to 1 in 10
people):
• Severe kidney impairment (will
normally be determined by your
doctor with certain specific blood
tests).
• Low level of calcium in the blood.

Reporting of side effects
If you get any side effects talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard).
By reporting side effects you can
help provide more information on the
safety of this medicine

Uncommon (may affect up to 1 in
100 people):
• Pain in the mouth, teeth and/or
jaw, swelling or sores inside the
mouth, numbness or a feeling of
heaviness in the jaw, or loosening
of a tooth. These could be signs of
bone damage in the jaw
(osteonecrosis). Tell your doctor
and dentist immediately if you
experience such symptoms.
• Irregular heart rhythm (atrial
fibrillation) has been seen in
patients receiving zoledronic acid
for postmenopausal osteoporosis.
It is currently unclear whether
zoledronic acid causes this
irregular heart rhythm but you
should report it to your doctor if
you experience such symptoms
after you have received zoledronic
acid.
• Severe allergic reaction: shortness
of breath, swelling mainly of the
face and throat.

5

How to store Zoledronic
acid

Keep this medicine out of the sight
and reach of children.
Your doctor, nurse or pharmacist
knows how to store this medicine
properly.
Do not use this medicine after the
expiry date which is stated on the
carton and on the bottle. The expiry
date refers to the last days of that
month.
This medicinal product does not
require any special storage
conditions.

Rare (may affect up to 1 in 1,000
people):
• As a consequence of low calcium
values: irregular heart beat
(cardiac arrhythmia; secondary to
hypocalcaemia).

After first opening, the product
should be used immediately. Discard
any unused contents.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

Very rare (may affect up to 1 in
10,000 people):
• As a consequence of low calcium
values: seizures,
numbness and tetany (secondary
to hypocalcaemia).

6

Tell your doctor about any of the
following side effects as soon as
possible:

Contents of the pack
and other information

What Zoledronic acid solution for
infusion contains
The active substance is zoledronic
acid. One bottle of 100 ml solution
for infusion contains 4 mg zoledronic
acid, corresponding to 4.264 mg
zoledronic acid monohydrate.
1 ml solution contains 0.04 mg
zoledronic acid.

Very common (may affect more
than 1 in 10 people):
• Low level of phosphate in the
blood.
Common (may affect up to 1 in 10
people):
• Headache and a flu-like syndrome
consisting of fever, fatigue,
weakness, drowsiness, chills and
bone, joint and/or muscle ache. In
most cases no specific treatment is
required and the symptoms
disappear after a short time
(couple of hours or days)
• Gastrointestinal reactions such as
nausea and vomiting as well as
loss of appetite.
• Conjunctivitis
• Low level of red blood cells
(anaemia)

The other ingredients are mannitol
(E421), sodium citrate (E331) and
water for injections.
What Zoledronic acid solution for
infusion looks like and contents
of the pack
The medicinal product is presented
as a “ready-to-use” solution for
infusion in a clear, colourless plastic
bottle. The solution for infusion is
clear, colourless.
Zoledronic acid solution for infusion
is supplied as a unit pack containing
1 bottle or as multipacks comprising
3, 4 or 10 cartons, each containing 1
bottle of 100 ml solution for infusion.

Uncommon (may affect up to 1 in
100 people):
• Hypersensitivity reactions.
• Low blood pressure, fainting due to
low blood pressure.
• Weakness.
• Chest pain.
• Skin reactions (redness and
swelling) at the infusion site, rash,
itching.
• High blood pressure, shortness of
breath, dizziness, anxiety, sleep
disturbances, taste disturbances,
tingling or numbness of the hands
or feet, diarrhoea, constipation,
abdominal pain, dry mouth,
trembling.
• Increased sweating.
• Low counts of white blood cells
and blood platelets.
• Low level of magnesium and
potassium in the blood. Your
doctor will monitor this and take
any necessary measures.
• Sleepiness.
• Blurred vision, tearing of the eye,
eye sensitivity to light.
• Sudden coldness with fainting,
limpness or collapse.
• Swelling of hands, ankles or feet.
• Difficulty in breathing with
wheezing or coughing.
• Itchy rash (urticaria).
• Indigestion, inflammation of the
stomach,
• Blood in urine
• Increased or reduced sense of
touch or sensation.
• Muscle cramps.
• Weight increase.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
or
Ebewe Pharma GmbH Nfg. KG,
Mondseestrasse 11,
A-4866 Unterach,
Austria
or
Novartis Pharma GmbH,
Roonstrasse 25 und Obere
Turnstrasse 8; 90429,
Nurnberg,
Germany.
or
Lek S.A.
Podlipie 16
95-010 Strykow, Poland
This leaflet was last revised in
05/2015.

Rare (may affect up to 1 in 1,000
people):
• Slow heartbeat
• Confusion
• High levels of potassium or sodium
in the blood
• Weakness, bruising and frequent
infections due to lack of blood
cells
• Unusual fracture of the thigh bone
particularly in patients on long-term
treatment for osteoporosis may
occur rarely.
Contact your doctor if you

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Table 1: Preparation of reduced doses of Zoledronic acid 4 mg/100 ml
solution for infusion
Baseline
creatinine
clearance
(ml/min)

Remove the
following amount
of Zoledronic acid
solution for
infusion (ml)

Replace with the
following volume
of sterile sodium
chloride 9 mg/ml
(0,9%) or 5%
glucose solution
for injection (ml)

Adjusted dose
(mg zoledronic
acid in 100 ml)

50-60

12.0

12.0

3.5

40-49

18.0

18.0

3.3

30-39

25.0

25.0

3.0

Doses have been calculated assuming target AUC of 0.66 (mg•hr/l)
(CLcr = 75 ml/min). The reduced doses for patients with renal impairment
are expected to achieve the same AUC as that seen in patients with
creatinine clearance of 75 ml/min.
- Studies with several types of infusion lines made from polyvinylchloride,
polyethylene and polypropylene showed no incompatibility with
Zoledronic acid.
- Since no data are available on the compatibility of Zoledronic acid with
other intravenously administered substances, Zoledronic acid must not
be mixed with other medications/substances and should always be given
through a separate infusion line.
How to store Zoledronic acid
• Keep Zoledronic acid out of the sight and reach of children.
• Do not use Zoledronic acid after the expiry date stated on the pack.
• The unopened bottle does not require any special storage conditions.
• After opening the bottle, the product should be used immediately in order
to avoid microbial contamination.
00000000 SZ00000LT000

draft: 44047813
laetus code: 00
mat.no.: 00000000

Artwork Proof Box
Ref: V006 - CDS update + National phase
Proof no.
006.1

Date prepared:
28/05/2015

Colours:
Black
Dimensions: 148 x 810 mm

Font size:
10pt
Fonts:
Helvetica

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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