Zoledronic Acid Ibigen 4 Mg/5 Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
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Zoledronic Acid 4 mg/5 ml concentrate 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 get 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
The active substance in this medicine 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).
• 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 non-cancer 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.
• 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 this medicine (see section 6, "Further Information").
Before you are given Zoledronic Acid, tell your doctor:
• if you have or have had any liver problems
• 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
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 when driving and operating machinery or performing other tasks that need full attention.
• 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 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 product should preferably be used immediately. If not used immediately, in-use storage times and conditions
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 will be carefully monitored by your doctor. This is because you may develop abnormal levels of calcium, phosphorus and magnesium in your blood and/or changes in kidney function, including severe kidney problems. If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
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.
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 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 problems such as nausea and vomiting as well as loss of appetite
• Conjunctivitis
• Blood tests indicating changes in kidney function (higher levels of creatinine), including severe kidney problems. Such changes are also known to occur with other medicines 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 (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
• 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 this medicine
• Severe allergic reaction: shortness of breath, swelling mainly of the face and throat
• Sleepiness
• Weeping of the eye, eye sensitivity to light
• Sudden coldness with fainting, limpness or collapse
• Difficulty in breathing with wheezing or coughing
• Urticaria ('nettle rash’).
Rare (may affect up to 1 in 1,000 people):
• Slow heartbeat
• Confusion
• Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis. 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 (may affect up to 1 in 10,000 people):
• 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 get 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.
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid properly (see section 6).
What Zoledronic Acid contains
• The active substance is zoledronic acid.
• One vial contains 4 mg zoledronic acid corresponding to 4.66 mg zoledronic acid hemipentahydrate.
• The other ingredients are mannitol, sodium citrate, water for injection.
What Zoledronic Acid looks like and contents of the pack
Zoledronic Acid is supplied as a liquid concentrate in a vial. One vial contains 4 mg of zoledronic acid. Each pack contains the vial with concentrate.
Zoledronic Acid is supplied as packs containing 1 vial.
Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano, 2 - 04011 - Aprilia (LT) - Italy Manufacturer
Istituto Biochimico Italiano S.p.A.
Via Fossignano, 2 - 04011 - Aprilia (LT) - Italy
Date of last revision 02/2013
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prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C
- 8°C, unless 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 ensure 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, in-use storage times and conditions prior to use are the responsibility of the user.