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ZOLEDRONIC ACID MEDIMPEX 4 MG / 5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

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Package leaflet: Information for the user
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion
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, 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.
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 to use Zoledronic acid
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:

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

Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zoledronic acid and will check
your response to treatment at regular intervals.
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 this medicine
(listed in section 6).

if you are breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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.

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Children and adolescents
Zoledronic acid is not recommended for use in adolescents and children below the age of 18 years.
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.
Other medicines and Zoledronic acid
Tell your doctor or pharmacist 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.

Other medicines that also contain zoledronic acid and is 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).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
You should not be given Zoledronic acid if you are pregnant.
You must not be given Zoledronic acid if you are breast-feeding.
Fertility data are not available on Zoledronic acid.
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 potassium
This medicine contains potassium, less than 1 mmol (39 mg) per 5 ml, i.e. essentially potassium-free .

3.

How to use Zoledronic acid

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 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.

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Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D
supplements to be taken each day.
How often you will be given Zoledronic acid

If you are being treated for the prevention of 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.
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.

4.

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:
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 and vomiting as well as loss of appetite.

Conjunctivitis.

Low level of red blood cells (anaemia).
Uncommon (may affect up to 1 in 100 people):

Hypersensitivity reactions.

Low blood pressure.

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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.

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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.

5.

How to store Zoledronic acid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton,
This medicinal product does not require any special storage conditions.
Do not freeze.

6.

Contents of the pack and other information

What Zoledronic acid contains

The active substance is zoledronic acid. One vial contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic acid monohydrate.

The other ingredients are: mannitol (E421), dipotassium hydrogen phosphate, water for
injections, potassium hydroxide (for pH adjustment), phosphoric acid (for pH adjustment).
What Zoledronic acid looks like and contents of the pack
Zoledronic acid concentrate for solution for infusion is a clear, colourless, sterile solution, with pH
6.0-6.5.
One vial with 5 ml concentrate contains 4 mg of zoledronic acid.
One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic
acid.

4

Zoledronic acid is supplied as packs containing:
1 vial
4 vials
10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medimpex UK Ltd.
127 Shirland Road, London W9 2 EP
United Kingdom
Manufacturer
Gedeon Richter Plc.
Gy mr i t 19-21,
1103 Budapest
Hungary

This medicinal product is authorised in the Member States of the EEA under the following
names
Norway: Zoledronsyre Medimpex
Germany: Zoledronic acid Medimpex
Spain: Zoledronic acid Medimpex
France: Zoledronic acid Medimpex
Italy: Acido Zoledronico Medimpex
United Kingdom: Zoledronic acid Medimpex
This leaflet was last revised in {05/2012}
-----------------------------------------------------------------------------------------------------------------------INFORMATION FOR THE HEALTHCARE PROFESSIONAL
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 cationcontaining 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.

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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.

-

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 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 reach and sight 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.
The diluted Zoledronic acid infusion solution should be used immediately in order to avoid
microbial contamination.

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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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