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ZOLEDRONIC ACID STRIDES 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 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. 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:
 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 breast-feeding.
 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).

Dimension: 350 x 230 mm

Warnings and precautions
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.
Reduced levels of calcium in the blood (hypocalcaemia),
sometimes leading to muscle cramps, dry skin, burning sensation,
have been reported in patients treated with Zometa. 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.

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 (as sodium citrate
anhydrous) per dose of Zoledronic acid, being essentially sodium
free.

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.

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.

 Carefully follow all the other instructions given to you by your
doctor, pharmacist or nurse.

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

 If you have a kidney problem, your doctor will give you a lower
dose depending on the severity of your kidney problem.

 Thalidomide (a medicine used to treat a certain type of blood
cancer involving the bone) or any other medicines which may
harm your kidneys.

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.

 Other medicines that also contain zoledronic acid and 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 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 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.

Font: Times New Roman ; Font Size: 9 Pt.

How much Zoledronic acid is given
 The usual single dose given is 4 mg.

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 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.

The following information is intended for
medical or 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.
 From a microbiological point of view, the
diluted solution for infusion should be used
immediately. If not used immediately, inuse 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.

 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 vial does not require any
specific storage conditions.
 The diluted Zoledronic acid infusion
solution should be used immediately in
order to avoid microbial contamination.

4. Possible side effects

 Low blood pressure.

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:

 Chest pain.

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.
Common (may affect up to 1 in 10 people):
 Headache and 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.

 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.

Manufacturer
Agila Specialties Polska Sp.z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland

 Interstitial lung disease (inflammation of the tissue around the
air sacks of the lungs)
Very rare (may affect up to 1 in 10,000 people):
 Fainting due to low blood pressure.
 Severe bone,
incapacitating.

joint

and/or

muscle

pain,

occasionally

 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
Your doctor, pharmacist or nurse knows how to store Zoledronic
acid properly (see section 6).

6. Contents of the pack and other information

Uncommon (may affect up to 1 in 100 people):
 Hypersensitivity reactions.

 The other ingredients are: Sodium citrate (E331), mannitol
(E421) and water for injections.

Font: Times New Roman ; Font Size: 9 Pt.

Marketing Authorisation Holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire WD 189SS
United Kingdom

 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.

 Low level of red blood cells (anaemia).

Dimension: 350 x 230 mm

Marketing Authorisation Holder and Manufacturer

The leaflet was last revised in October 2013

 Confusion.

What Zoledronic acid contains
 The active substance of Zoledronic acid is zoledronic acid. One
vial contains 4 mg zoledronic acid, corresponding to 4.264 mg
zoledronic acid monohydrate.

 Conjunctivitis.

What Zoledronic acid looks like and contents of the pack
Zoledronic acid is clear, colourless solution filled into colourless
glass vial with rubber stopper and aluminium seal.
It is available in packs containing 1, 4 or 10 vials. Each vial
contains 5 ml of solution.
Not all pack sizes may be marketed.

1xxxxxx

The hydration status of patients must
be assessed prior to and following
administration of Zoledronic acid to ensure
that they are adequately hydrated.

Expand Transcript

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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