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ZOLEDRONIC ACID IBIGEN 4 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): NO ACTIVES PRESENT / ZOLEDRONIC ACID HEMIPENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledronic Acid 4 mg powder and solvent for solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given Zoledronic Acid
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor, nurse or pharmacist
 If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist
In this leaflet
1. What Zoledronic Acid is and what it is used for
2. Before you are given Zoledronic Acid
3. How Zoledronic Acid is used
4. Possible side effects
5. How to store Zoledronic Acid
6. Further 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 cases where it is too high due to the presence of a
tumour in adult patients. 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. 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 (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to
which Zoledronic Acid belongs), or any of the other ingredients of Zoledronic Acid (see section
“FURTHER INFORMATION”

Before you are given Zoledronic Acid, tell your doctor:
 if you have or have had a liver problem
 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
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. 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 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 noncancer diseases of the bone), or any other bisphosphonate, since the combined effects of these medicines
taken together with Zoledronic Acid are unknown.  

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.
Use in children
Zoledronic Acid is not recommended for use in adolescents and children below the age of 18 years.
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.
Driving and using machines
The effects of Zoledronic Acid on driving, using machines and performing other tasks that need your full
attention have not been studied. However, adverse reactions, such as dizziness and somnolence, may affect
the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic Acid
along with driving and operating of machinery or performing other tasks that need full attention.
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
Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.
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 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.
How often you will be given Zoledronic Acid
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
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. POSSIBLE SIDE EFFECTS
Like all medicines, Zoledronic Acid can cause side effects, although not everybody gets them. The most
common ones are usually mild and will probably disappear after a short time.

The frequency of possible side effects listed below is defined using the following convention:
 very common: affects more than 1 user in 10
 common: affects 1 to 10 users in 100
 uncommon: affects 1 to 10 users in 1,000
 rare: affects 1 to 10 users in 10,000
 very rare: affects less than 1 user in 10,000
 not known: frequency cannot be estimated from the available data
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, as reported with other bisphosphonates (the group of substances to which Zoledronic acid
belongs)
 Blood tests indicating changes in kidney function (higher levels of creatinine), including severe kidney
impairment. Such changes are also known to occur with other medicinal products of this kind. In
addition, some cases of kidney disease have been reported
 Low level of red blood cells (anaemia)
 Low level of calcium in the blood
Uncommon:
 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
 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
 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
 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:
 Slow heartbeat
 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
Very rare:
 Fainting due to low blood pressure
 Severe bone, joint and/or muscle pain, occasionally incapacitating
 Painful redness and/or swelling of the eye
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100
3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local
pharmacy.”

5. HOW TO STORE ZOLEDRONIC ACID
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid properly (see section 6).
6. FURTHER INFORMATION
What Zoledronic Acid contains
 The active substance of Zoledronic Acid is zoledronic acid One vial contains 4 mg zoledronic acid,
corresponding to 4.66 mg zoledronic acid hemypentahydrate.
 The other ingredients are: mannitol, sodium citrate
What Zoledronic Acid looks like and contents of the pack
Zoledronic Acid is supplied as a White to off-white powder in a vial
One vial contains 4 mg of zoledronic acid. Each pack contains the vial with powder, together with
a 5 ml ampoule containing clear, colourless water for injections, which is used to dissolve the powder.
Zoledronic Acid is supplied as packs containing 1 vial and 1 ampoule.
Marketing Authorisation Holder
Ibigen S.r.l. - Via Fossignano, 2
04011 Aprilia (LT) - Italy
Telefono: +39 (0)6 921501
Fax: +39 (0)6 92150500
e-mail: info@ibigen.it
Manufacturer
Istituto Biochimico Italiano S.p.A.
Via Fossignano, 2
04011 – Aprilia
Italy
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zoledronic Acid
 To prepare an infusion solution containing 4 mg Zoledronic Acid, add 5 ml of water for injections from
the ampoule supplied in the pack to the vial containing the zoledronic acid powder under aseptic
conditions. Shake the vial gently to dissolve the powder
 Further dilute the Zoledronic Acid reconstituted solution (5 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 of the reconstituted solution (4 mg/5 ml) 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 reconstituted solution with calcium-containing or other divalent cationcontaining solutions such as lactated Ringer’s solution
Instructions for preparing reduced doses of Zoledronic Acid:
Withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml), 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 product 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 to 8°C, unless reconstitution/dilution has
taken place in controlled and validated aseptic conditions
 The solution containing Zoledronic Acid is given as a single 15-minute intravenous infusion. The
hydration status of patients must be assessed prior to and following administration of Zoledronic Acid to
assure 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% w/v sodium chloride solution or 5% w/v glucose
solution) 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 reach and sight of children
 Do not use Zoledronic Acid after the expiry date stated on the pack
 After dilution: 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.

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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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