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

Active substance(s): ZOLEDRONIC ACID / ZOLEDRONIC ACID MONOHYDRATE

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Claris Injectables Limited
Artwork Code : 1400005650

Artwork Req. No: 15121

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Barcode Information:

Barcode Scan Report:
Packing: 5ml Tubular Vial

Plant Location : Injectable

Country: United Kingdom

Language : English

Ref. Code Creation/Blockage Note:

Artwork Control Key No.:

“Controlled Copy” Holder (1)

(2)

(3)

(4)

(5)

Package leaflet: Information for the user
Zoledronic Acid 4mg/5ml concentrate for solution for infusion
Zoledronic acid
The name of your medicine is Zoledronic acid 4mg/5ml
concentrate for solution for infusion, which will be referred to as
Zoledronic acid throughout this leaflet.
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 or
pharmacist or nurse.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.






Aminoglycosides (medicines used to treat 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.
Aclasta (a medicine that also contains 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).

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 you will be given 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

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.

The active substance 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

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.
This medicinal product contains less than 1 mmol sodium (23 mg)
per vial, i.e. essentially 'sodium- free'.
3. How you will be given Zoledronic acid

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



Zoledronic acid should not be used
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).

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.
Your doctor may recommend a dental examination before you
start treatment with Zoledronic acid.
– if you are having dental treatment or are due to undergo
dental surgery, tell your dentist that you are being treated with
Zoledronic acid and inform your doctor about your dental
treatment.
While being treated with Zoledronic acid, you should maintain
good oral hygiene (including regular teeth brushing) and receive
routine dental check-ups.
Contact your doctor and dentist immediately if you experience
any problems with your mouth or teeth such as loose teeth,
pain or swelling, or non-healing of sores or discharge, as these
could be signs of a condition called osteonecrosis of the jaw.
Patients who are undergoing chemotherapy and/or radiotherapy,
who are taking steroids, who are undergoing dental surgery, who
do not receive routine dental care, who have gum disease, who
are smokers, or who were previously treated with a
bisphosphonate (used to treat or prevent bone disorders) may
have a higher risk of developing osteonecrosis of the jaw.
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.





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, pharmacist or nurse.

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 take more than Zoledronic acid than you should
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.
Side effects are classified according to their frequency into the
following categories:

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.
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:

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 (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.

Tell your doctor about any of the following serious side
effects straight away:
Common:
− Severe kidney impairment (will normally be determined by
your doctor with certain specific blood tests).

Do not mix Zoledronic acid 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.

Claris Injectables Limited
Artwork Code : 1400005650

Artwork Req. No: 15121

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Barcode Information:

Barcode Scan Report:
Packing: 5ml Tubular Vial

Plant Location : Injectable

Country: United Kingdom

Language : English

Ref. Code Creation/Blockage Note:

Artwork Control Key No.:

“Controlled Copy” Holder (1)



(2)

Low level of calcium in the blood.

Uncommon:
− Pain in the mouth, teeth and/or jaw, swelling or non-healing
sores inside the mouth or jaw, discharge, 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 while being treated with Zoledronic Acid or
after stopping treatment.
− 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.
Rare:
-

As a consequence of low calcium values: irregular heart beat
(cardiac arrhythmia; secondary to hypocalcaemia).

Very rare:
- As a consequence of low calcium values: seizures, numbness
and tetany (secondary to hypocalcaemia).
Tell your doctor about any of the following side effects as
soon as possible:
Very common:
− Low level of phosphate in the blood.
Common:
− 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:
− 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, anxiety,
sleep disturbances, taste disturbance, trembling, tingling or
numbness of the hands or feet, diarrhea, constipation,
abdominal pain, dry mouth.
− 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.
− Weight increase
− Increased sweating
− Sleepiness.
− Blurred vision, tearing of the eye, eye sensitivity to light.
− Sudden coldness with fainting, limpness or collapse.
− Difficulty in breathing with wheezing or coughing.
− Urticaria.

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The diluted Zoledronic acid solution should be used
immediately in order to avoid microbial contamination.
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.
After dilution: Chemical and physical in-use stability has been
demonstrated for 24 hours at 20° to 25°C and to 2° to 8°C. 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.
6. Contents of the pack and other information
What Zoledronic acid contains
− The active substance is Zoledronic acid.
One ml concentrate contains 0.8 mg zoledronic acid
corresponding to 0.8523 mg zoledronic acid monohydrate.
One vial with 5 ml concentrate solution contains 4 mg
zoledronic acid, corresponding to 4.264 mg zoledronic acid
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 liquid, clear and colourless
concentrate in a vial.
Each pack contains the vial with concentrate. Zoledronic acid is
supplied in 5 ml clear glass vial with bromobutyl rubber stopper
and aluminium cap with plastic flip-off seal.
Pack of 5 vials.
Marketing Authorisation Holder
Claris Lifesciences UK Limited
Crewe Hall, Crewe, Cheshire, CW16UL,
United Kingdom.
Manufacturer
Peckforton Pharmaceuticals Limited
Crewe Hall, Crewe, Cheshire, CW16UL,
United Kingdom
This Leaflet was last revised in 11/2015.
Other sources of Information
Detailed information on this medicine is available on the
European Medicines Agency website:

1400005650

Rare:
− 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.
− Painful redness and/or swelling of the eye.
Very rare:
− Fainting due to low blood pressure.
− Severe bone, joint and/or muscle pain, occasionally
incapacitating.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report any side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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 pack. The expiry date refers to the last day of that month.
The unopened vial does not require any special storage
conditions.



Chemical and physical in-use stability has been
demonstrated for 24 hours at 20° to 25°C and to 2° to 8°C.
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.



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.



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.

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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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