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ZOLEDRONIC ACID SUN 4 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

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If you are given more Zoledronic acid 4 mg/100 ml 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 blood 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 extra calcium by infusion.

Patients aged 65 years and over
Zoledronic acid 4 mg/100 ml can be given to people aged 65 years and over. There is no
evidence to suggest that any extra precautions are needed.

Package leaflet: Information for the user

Zoledronic acid 4 mg/100 ml 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. See section 4.

What is in this leaflet
1. What Zoledronic acid 4 mg/100 ml is and what it is used for
2. What you need to know before you are given Zoledronic acid 4 mg/100 ml
3. How Zoledronic acid 4 mg/100 ml is used
4. Possible side effects
5. How to store Zoledronic acid 4 mg/100 ml
6. Contents of the pack and other information

Children and adolescents
Zoledronic acid 4 mg/100 ml is not recommended for use in adolescents and children
below the age of 18 years.
Other medicines and Zoledronic acid 4 mg/100 ml
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), 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 calciumlowering 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
- 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 4 mg/100 ml are
unknown
- anti-angiogenic medicines (used to treat cancer), since the combination of these with
Zoledronic acid 4 mg/100 ml has been associated with an increased risk of
osteonecrosis of the jaw (ONJ).
Pregnancy and breast-feeding
You should not be given Zoledronic acid 4 mg/100 ml if you are pregnant. Tell your doctor if
you are or think that you may be pregnant.

1. What Zoledronic acid 4 mg/100 ml is and what it is used for
The active substance in Zoledronic acid 4 mg/100 ml 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 tumourinduced hypercalcaemia (TIH).

2. What you need to know before you are given Zoledronic acid 4 mg/100 ml
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zoledronic acid 4 mg/100 ml and will check your response to treatment at regular
intervals.
You should not be given Zoledronic acid 4 mg/100 ml
- if you are breast-feeding
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances
to which Zoledronic acid 4 mg/100 ml belongs), or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before you are given Zoledronic acid 4 mg/100 ml:
- 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 4 mg/100 ml.
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 4 mg/100 ml. 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 4 mg/100 ml. You will be given adequate calcium and
vitamin D supplements.

You must not be given Zoledronic acid 4 mg/100 ml if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breastfeeding.
Driving and using machines
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic
acid 4 mg/100 ml. You should therefore be careful when driving, using machinery or
performing other tasks that need full attention.
Zoledronic acid 4 mg/100 ml contains sodium
Zoledronic acid 4 mg/100 ml contains less than 1 mmol sodium (23 mg) per its single
maximum dose, i.e. it is essentially “sodium-free”.

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 immediately about any of the following serious side effects
Serious side effects
Common (may affect up to 1 in 10 people)
- severe kidney impairment (this 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.
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).
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).
Tell your doctor about any of the following side effects as soon as possible
Other side effects

3. How Zoledronic acid 4 mg/100 ml is used
Zoledronic acid 4 mg/100 ml must only be given by healthcare professionals trained in
giving bisphosphonates intravenously, i.e. into 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 Zoledronic acid 4 mg/100 ml is given
Zoledronic acid 4 mg/100 ml is given as a drip (infusion) into a vein which should take at
least 15 minutes and should be given 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.
How much Zoledronic acid 4 mg/100 ml 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 4 mg/100 ml 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 4 mg/100 ml 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 4 mg/100 ml.

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
- 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, 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.

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

After opening the vial, the product should be used immediately in order to avoid microbial
contamination.

Store the unopened vial below 30°C.

How to store Zoledronic acid 4 mg/100 ml
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after
EXP.

- Since no data are available on the compatibility of Zoledronic acid 4 mg/100 ml solution
for infusion with other intravenously administered substances,
Zoledronic acid 4 mg/100 ml solution for infusion must not be mixed with other
medications/substances and should always be given through a separate infusion line.

- Studies with several types of infusion lines made from polyvinylchloride, polyethylene
and polypropylene showed no incompatibility with Zoledronic acid 4 mg/100 ml solution
for infusion.

12.0
18.0
25.0
50-60
40-49
30-39

*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
The reduced doses for patients with renal impairment are expected to achieve the same
AUC as that seen in patients with creatinine clearance of 75 ml/min.

3.5
3.3
3.0

Adjusted dose
(mg zoledronic
acid in 100 ml)

Replace with the
following volume
of sterile sodium
chloride 9 mg/ml
(0.9%) or 5%
glucose solution for
injection (ml)
12.0
18.0
25.0
Remove the
following amount
of Zoledronic
acid solution
for infusion (ml)
Baseline creatinine
clearance (ml/min)

Table 1: Preparation of reduced doses of Zoledronic acid 4 mg/100 ml solution for infusion

Remove the volume of Zoledronic acid 4 mg/100 ml solution for infusion indicated from the
vial and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution
for injection, or 5% glucose solution for injection.

To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table1
below.

- Zoledronic acid 4 mg/100 ml solution for infusion can be used immediately without
further preparation for patients with normal renal function. In patients with mild to
moderate renal impairment, reduced doses should be prepared as instructed below.

- The solution containing zoledronic acid must not be further diluted or mixed with other
infusion solutions. It 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 4 mg/100 ml to assure that they are adequately
hydrated.

- From a microbiological point of view, the solution for infusion should be used
immediately, after first opening. 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.

- Zoledronic acid 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in
100 ml of infusion solution for immediate use in patients with normal renal function.
- 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.

How to prepare and administer Zoledronic acid 4 mg/100 ml

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

zoledronic acid

Zoledronic acid 4 mg/100 ml solution for infusion

Please turn over

044BP2231A

350 mm
EUUK- UNITED KINGDOM
Size: 350x430 mm

100

95

75

25

5

0

Zoledronic acid 4mg-100ml-EUUK-PIL-350x430mm-21-01-15
21 January 2015 14:54:24

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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
- painful redness and/or swelling of the eye.
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.
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.

This medicinal product is authorised in the Member states of the EEA under the
following names
Belgium:
Zoledroninezuur SUN 4 mg/100 ml oplossing voor infusie
Acide zolédronique SUN 4 mg/100 ml Solution pour perfusion
Zoledronsäure SUN 4 mg/100 ml Infusionslösung
Denmark:
Zoledronsyre SUN 4 mg/100 ml infusionsvæske, opløsning
Finland:
Tsoledronihappo SUN 4 mg/100 ml infuusioneste, liuos
France:
Acide zolédronique SUN 4 mg/100 ml solution pour perfusion
Germany:
Zoledronsäure SUN 4 mg/100 ml Infusionslösung
Italy:
Acido Zoledronico SUN Pharma 4 mg/100 ml soluzione per infusione
The Netherlands:
Zoledroninezuur SUN 4 mg/100 ml oplossing voor infusie
Norway:
Zoledronsyre SUN 4 mg/100 ml infusjonsvæske, oppløsning
Spain:
Ácido zoledrónico SUN 4 mg/100 ml solución para perfusión EFG
Sweden:
Zoledronsyra SUN 4 mg/100 ml infusionsvätska, lösning
United Kingdom:
Zoledronic acid 4 mg/100 ml solution for infusion
This leaflet was last revised in 12/2014

5. How to store Zoledronic acid 4 mg/100 ml
Your doctor, pharmacist or nurse knows how to store Zoledronic acid 4 mg/100 ml
properly (see section 6).
Keep this medicine out of the sight and reach of children.

044BP2231A

This medicine must not be used after the expiry date which is stated on the carton and vial
after EXP. The expiry date refers to the last day of that month.
Store the unopened vial below 30°C.
After first opening:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C.
From a microbiological point of view, the 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 for infusion should then be equilibrated to room temperature prior to
administration.

6. Contents of the pack and other information
What Zoledronic acid 4 mg/100 ml contains
- The active substance is zoledronic acid. Each vial contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic acid monohydrate.
- The other ingredients are mannitol (E421), sodium citrate (E331) and water for
injections.
What Zoledronic acid 4 mg/100 ml looks like and contents of the pack
Zoledronic acid 4 mg/100 ml is a clear and colourless solution.
It comes in 100 ml glass vials as a ready-to-use solution for infusion. The vial label has a
built in edge that can be peeled and used as a hanger.
Zoledronic acid 4 mg/100 ml is supplied in packs containing one vial as unit pack or in
multi-packs comprising 4 or 5 packs, each containing 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Suppliers LOGO / Id here

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

350 mm
EUUK- UNITED KINGDOM
Size: 350x430 mm

100

95

75

25

5

0

Zoledronic acid 4mg-100ml-EUUK-PIL-350x430mm-21-01-15
21 January 2015 14:54:25

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.

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