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ZOLEDRONIC ACID FRESENIUS KABI 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

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Package leaflet: Information for the user

Zoledronic acid
Read all of this leaflet carefully before you are
given Zoledronic acid 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet.

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 used
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other information
1. What Zoledronic acid is and what it is used for
The active substance in Zoledronic acid 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:

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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).

3. How Zoledronic acid is used
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.
• If you have a kidney problem, your doctor will give you a
lower dose depending on the severity of your kidney
problem.
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.
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.
Patients whose blood calcium levels are not too high will also
be prescribed calcium and vitamin D supplements to be taken
each day.
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.

2. What you need to know before you are given
Zoledronic acid

If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

Follow carefully all instructions given to you by your doctor.

4. Possible side effects

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

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.

You should not be given Zoledronic acid
• if you are allergic (hypersensitive) to zoledronic acid,
another bisphosphonate (the group of substances to
which Zoledronic acid belongs), or any of the other
ingredients of Zoledronic acid (see section 6).
• if you are breast-feeding.
Before you are given Zoledronic acid, tell your doctor
• 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.
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), since the combination of these with
bisphosphonates 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.
• Medicines that also contain zoledronic acid 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 with zoledronic acid has been
associated with reports of osteonecrosis of the jaw (ONJ).
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.
Children and adolescents
Zoledronic acid is not recommended for use in adolescents
and children below the age of 18 years.
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.
Ask your doctor for advice before taking any medicine while
you are pregnant or breast-feeding.
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.
Zoledronic acid contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per
dose, i.e. it is essentially “sodium-free”.

Tell your doctor about any of the following serious
side effects straight away:
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.
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.
Tell your doctor about any of the following side
effects as soon as possible:
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 vomiting as
well as loss of appetite.
• Conjunctivitis
• Low level of red blood cells (anaemia).
Uncommon (may affect up to 1 in 100 people):
• Allergic (hypersensitivity) reactions
• Low blood pressure
• Chest pain
• Skin reactions (redness and swelling) at the infusion site,
rash, itching
• High blood pressure
• Shortness of breath
• Dizziness
• Sleep disturbances
• Tingling or numbness of the hands or feet
• Diarrhoea
• 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.
• Tearing of the eye, eye sensitivity to light.
• Sudden coldness with fainting, limpness or collapse.
• Difficulty in breathing with wheezing or coughing.
• Urticaria.

V001

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.

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V001
M087454/00 UK/IE

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Zoledronic acid 4 mg/5 ml
concentrate for solution for infusion

Rare (may affect up to 1 in 1,000 people):
• Slow heart beat
• Confusion
• Unusual fracture of the thigh bone particularly in patients
on long-term treatment for osteoporosis may occur
rarely. Contact your doctor if you 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.
Very rare (may affect up to 1 in 10,000 people):
• Fainting due to low blood pressure
• Severe bone, joint and/or muscle pain, occasionally
incapacitating
• Painful redness and/or swelling of the eye

Spain







Sweden

Ácido Zoledrónico Fresenius Kabi
4 mg / 5 ml concentrado para solución
para perfusión
Zoledronsyra Fresenius Kabi

United Kingdom
Zoledronic acid 4 mg/5 ml concentrate

for solution for infusion

This leaflet was last revised in 08/2012.


If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
5. How to store Zoledronic acid
Your doctor, nurse or pharmacist knows how to store
Zoledronic acid properly (see section 6).
6. Contents of the pack and other information
What Zoledronic acid contains
• The active substance of Zoledronic acid is zoledronic acid.
One vial contains 4 mg of zoledronic acid (as monohydrate).
• The other ingredients are: mannitol, sodium citrate, water
for injections.
What Zoledronic acid looks like and contents of the
pack
Zoledronic acid is supplied as a solution in a clear and
colourless plastic vial.
Zoledronic acid is supplied as packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT,
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH,
Hafnerstrasse 36,
A-8055 Graz,
Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria




Zoledronsäure Fresenius Kabi 4 mg/5 ml
Konzentrat zur Herstellung einer
Infusionslösung

Belgium



Zoledroninezuur
Fresenius
Kabi
4 mg/5 ml concentraat voor oplossing
voor infusie

Bulgaria


Zoledronic acid Fresenius Kabi 4 mg/5 ml
концентрат за инфузионен разтвор

Czech Republic

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Denmark

Zoledronsyre Fresenius Kabi

Estonia

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Germany




Zoledronsäure Fresenius Kabi 4 mg/5 ml
Konzentrat zur Herstellung einer
Infusionslösung

Greece


Finland



Zoledronic acid / Fresenius Kabi,
πυκνό διάλυμα για διάλυμα προς
έγχυση, 4mg/5ml
Zoledronsyra Fresenius Kabi 4 mg/5 ml
infuusiokonsentraatti, liuosta varten

France


Acide Zolédronique Fresenius Kabi
4mg/5ml, solution à diluer pour perfusion

Hungary



Zoledronsav Fresenius Kabi 4 mg/5ml
koncentrátum oldatos infúzióhoz

Ireland


Zoledronic acid 4 mg/5 ml concentrate
for solution for infusion

Italy

Acido zoledronico Fresenius Kabi



Latvia



Zoledronic acid Fresenius Kabi 4 mg/5 ml
koncentrāts
infūziju
šķīduma
pagatavošanai

Lithuania



Zoledronic acid Fresenius Kabi 4 mg/5 ml
koncentratas infuziniam tirpalui

Luxembourg




Zoledronsäure Fresenius Kabi 4 mg/5 ml
Konzentrat zur Herstellung einer
Infusionslösung

The Netherlands


Zoledroninezuur FreseniusKabi 4 mg/5 ml
concentraat voor oplossing voor infusie

Norway

Zoledronsyre Fresenius Kabi

Poland

Zoledronic acid Fresenius Kabi



Portugal

Ácido zoledrónico Fresenius Kabi

Romania


Acid zoledronic Fresenius Kabi 4 mg/5 ml
concentrat pentru soluţie perfuzabilă

Slovak Republic


Zoledronic
4 mg/5ml

Slovenia




Zoledronska kislina Fresenius Kabi
4 mg/5 ml koncentrat za raztopino za
infundiranje

acid

Fresenius

Kabi

− The solution containing Zoledronic acid is given as a single
15 minute intravenous infusion in a separate infusion line.
The hydration status of patients must be assessed prior to
and following administration of Zoledronic acid to ensure
that they are adequately hydrated.
− Studies with glass bottles, as well as several container types
made from polyvinylchloride, polyethylene and polypropylene
(prefilled with 0.9% w/v sodium chloride solution or 5% w/v
glucose solution) 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 vial does not require any specific storage
conditions.
- For storage conditions after dilution, see “Shelf life after
dilution”

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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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