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STEOZOL 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

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Package leaflet: Information for the user
STEOZOL 4 mg/5 ml concentrate for 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, 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.
2.
3.
4.
5.
6.

What STEOZOL is and what it is used for
What you need to know before you are given STEOZOL
How STEOZOL is used
Possible side effects
How to store STEOZOL
Contents of the pack and other information

1.

What STEOZOL is and what it used for

The active substance in STEOZOL 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 adults 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 STEOZOL
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with STEOZOL and will check your
response to treatment at regular intervals.
You should not be given STEOZOL:

if you are breast-feeding.

if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
STEOZOL belongs), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given STEOZOL:




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
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are being treated with STEOZOL.
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.
Patients aged 65 years and over
STEOZOL can be given to people aged 65 years and over. There is no evidence to suggest that any extra
precautions are needed.
Children and adolescent
STEOZOL is not recommended for use in adolescents and children below the age of 18 years.
Other medicines and STEOZOL
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 containing zoledronic acid or any other bisphosphonate, since the combined effects of
these medicines taken together with STEOZOL are unknown.
• Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic
acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Pregnancy and breast-feeding
You should not be given STEOZOL if you are pregnant. Tell your doctor if you are or think that you
may be pregnant.
You must not be given STEOZOL 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.
STEOZOL contains less than 1 mmol (23 mg) of sodium per ml of solution, which means it is
essentially sodium free (that is, salt free).

3. How STEOZOL is used




STEOZOL 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, pharmacist, or nurse.

Always use this medicine exactly your doctor has told you. Check with your doctor if you are not sure.
How much STEOZOL is given

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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 STEOZOL is given
• If you are being treated for the prevention of bone complications, due to bone metastases, you
will be given one infusion of STEOZOL 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 STEOZOL.
How STEOZOL is given
• STEOZOL 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 STEOZOL 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 additional 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.

Very rare (may affect up to 1 in 10,000 people):
• As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to
hypocalcaemia), seizures, numbness and tetany (secondary to hypocalcaemia).
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.
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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.
• 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
• Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs).
• Flu-like symptoms including arthritis and joint swelling
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.
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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store STEOZOL
Your doctor, pharmacist or nurse knows how to store STEOZOL properly (see section 6 “Information
for the healthcare professional”).
6. Contents of the pack and other information
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What STEOZOL contains
− The active substance of Steozol is zoledronic acid.
One prefilled syringe with 5 ml concentrate contains 4 mg zoledronic acid as zoledronic acid
hemipentahydrate 4.66 mg.
1 ml of concentrate contains 0.8 mg zoledronic acid.
− The other ingredients are: mannitol (E421), sodium citrate, (E331), water for injections.
What STEOZOL looks like and contents of the pack
STEOZOL is supplied as a concentrate for solution for infusion. The solution is clear.
The syringes are made of crystal clear polymer (polycycloolefin) barrel with plastic tip cap and crystal
clear polymer (styrene-butadiene) rubber stopper.
Each pack contains 1, 3, 4 or 10 prefilled syringe of 5 ml with 1, 3, 4 or 10 needles for the
reconstitution of the solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
To be completed nationally
Manufacturer
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milano - IT

This medicinal product is authorised in the Member States of the EEA under the following
names:
IT
Steozol 4 mg/5 ml concentrato per soluzione per infusione
AT
Steozol
CZ
Steozol 4 mg/5 ml koncentrát pro infuzní roztok
DK
Steozol
FI
Steozol 4 mg/5 ml infuusiokonsentraatti, liuosta varten
HU
Steozol 4 mg/5 ml koncentrátum oldatos infúzióhoz
NO
Steozol 4 mg/5 ml konsentrat til infusjonsvæske
SK
STEOZOL 4 mg/5 ml koncentrát na prípravu infúzneho roztoku
SE
Steozol
UK
Steozol 4 mg/5 ml concentrate for solution for infusion
BG
Steozol 4 mg/5 ml concentrate for solution for infusion
RO
Steozol 4 mg/5 ml concentrat pentru soluție perfuzabilă
DE
Steozol 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
ES
STEOZOL 4 mg/5 ml concentrado para solución para perfusión
FR
STEOZOL 4 mg/5 ml solution à diluer pour perfusion
EL
STEOZOL 4 mg/5 πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση

This leaflet was last approved in 05/2014

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer STEOZOL


Turn the syringe upside down, keeping the plunger down. Tap the syringe gently to let any air
bubbles rise to the top. Push the plunger rod slowly until all air bubbles are gone. Steozol is now
ready to inject into the solution for diultion. In case you only need part of the entire dose, use the
scale on the syringe to see how much concentrate you withdraw.



To prepare an infusion solution containing 4 mg STEOZOL, further dilute the STEOZOL
concentrate (5.0 ml) with 100 ml of 0.9 g/100 ml sodium chloride solution or 5 g/100 ml glucose
solution. If a lower dose of STEOZOL 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 g/100 ml sodium
chloride or 5 g/100 ml glucose solution.
Do not mix STEOZOL concentrate with calcium-containing or other divalent cationcontaining
solutions such as lactated Ringer’s solution.
Instructions for preparing reduced doses of STEOZOL:
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

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For single use only. Any unused solution should be discarded. Only clear solution free from
particles should be used. Aseptic techniques must be followed during the preparation of the
infusion.



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 or at
25°C. The refrigerated solution should then be equilibrated to room temperature prior to
administration.



The total time between dilution, storage in the refrigerator or at 25°C and end of administration
must not exceed 24 hours.



The solution containing STEOZOL 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 STEOZOL to ensure that they are adequately hydrated.



Studies with glass bottles, several types of infusion bags and infusion lines made from
polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9 g/100 ml sodium chloride
solution or 5 g/100 ml glucose solution) showed no incompatibility with STEOZOL.



Since no data are available on the compatibility of STEOZOL with other intravenously
administered substances, STEOZOL must not be mixed with other medications/substances
and should always be given through a separate infusion line.

How to store STEOZOL

Keep STEOZOL out of the sight and reach of children.

Do not use STEOZOL after the expiry date which is stated on the pack after “EXP”. The expiry
date refers to the last day of that month.

This medicine does not require any special storage conditions

The diluted STEOZOL infusion solution should be used immediately in order to avoid microbial
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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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