Skip to Content

UK Edition. Click here for US version.

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

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

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, 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

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 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 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
concentrate for 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.

What you need to know
before you are given
Zoledronic acid

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.

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.

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.

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.

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

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.

3

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.

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 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.

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 children and adolescents below the age
of 18 years.

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 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

Patients whose blood calcium levels are not
too high will also be prescribed calcium and
Continued on the next page >>

INFORMATION FOR THE HEALTHCARE
PROFESSIONAL

Do not mix Zoledronic acid
concentrate with calcium-containing
or other divalent cation-containing
solutions such as lactated Ringer’s
solution.

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.

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.
Continued on the next page >>

SZ00000LT000

Artwork Proof Box
Ref: V006 - CDS update + National phase
Proof no.
004.1

Date prepared:
28/05/2015

Colours:
Black
Dimensions: 148 x 594 mm

Font size:
7pt
Fonts:
Helvetica

vitamin D supplements to be taken each day.

• Increased or reduced sense of touch or
sensation.
• Muscle cramps.
• Weight increase.

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

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
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, nurse or pharmacist. This includes
any possible side effect 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.

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).

This medicinal product does not require any
special storage conditions.
After first opening, the product should be
used immediately. Discard any unused
contents.
Do not use this medicine if you notice any
visible signs of deterioration such as
particles and discoloration.

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).

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.

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.

6

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).

Contents of the pack and
other information

What Zoledronic acid concentrate for
solution for infusion contains
The active substance is zoledronic acid.
One vial of 5 ml concentrate for solution for
infusion contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic acid
monohydrate. 1 ml concentrate for solution
for infusion contains 0.8 mg zoledronic acid
The other ingredients are mannitol (E421),
sodium citrate (E331), water for injections.

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, abdominal pain.
• Blood in urine

What Zoledronic acid concentrate for
solution for infusion looks like and
contents of the pack
Zoledronic acid concentrate for solution for
infusion is supplied as a clear and
colourless liquid concentrate in a vial. One
vial contains 4 mg of zoledronic acid.
Each pack contains the vial with
concentrate. Zoledronic acid concentrate for
solution for infusion is supplied as packs
containing 1, 4 or 10 vials.
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.
SZ00000LT000

• Zoledronic acid 4 mg concentrate for
solution for infusion, further diluted in
100 ml, should be given as a single
intravenous infusion in no less than 15
minutes 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.

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.

• 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

SZ00000LT000

Artwork Proof Box
Ref: V006 - CDS update + National phase
Proof no.
004.1

Date prepared:
28/05/2015

Colours:
Black
Dimensions: 148 x 594 mm

Font size:
7pt
Fonts:
Helvetica

Expand view ⇕

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.

Hide