Zoledronic Acid 4mg/5ml Concentrate For Solution For Infusion
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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 start taking 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, pharmacist and nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Zoledronic Acid 4 mg/5 ml Concentrate for Solution for Infusion
In the rest of this leaflet Zoledronic Acid 4 mg /5 ml Concentrate for Solution for Infusion is called Zoledronic Acid.
In this leaflet:
1. What Zoledronic Acid is and what it is used for
2. What you need to know before you take Zoledronic Acid
3. How to use 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
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 compliance, 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 take 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.
Do not use Zoledronic Acid if you:
• are breast-feeding.
• 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 (listed in section 6).
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Zoledronic Acid.
Talk to your doctor before taking Zoledronic Acid, if you:
• have or have had a kidney problem.
• have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
• are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid.
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 are not sure if any of the above applies to you, talk to your doctor or nurse, before having 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.
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, 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.
• Other zoledronic acid products (sometimes used to treat osteoporosis and other noncancer diseases of the bone), or any other bisphosphonate, since the combined effects of these medicines taken with Zoledronic Acid is unknown.
• Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
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 breastfeeding.
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.
Zoledronic Acid contains sodium
One ml concentrate for solution for infusion contains 1.13 mg of sodium as sodium citrate.
3. How to use Zoledronic Acid
• 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 take more 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, 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 serious side effects straight away:
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.
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 fro postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
• Severe allergic reactions: shortness of breath, swelling mainly of the face and throat.
Very rare (may affect up to 1 in 10,000 people):
- As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary
to hypocalcaemia), seizures, numbness and tetany (secondary to hypocalcaemia).
Tell your doctor about any of the following serious 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 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, 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.
• 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 (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.
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.
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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zoledronic Acid
Your doctor, pharmacist or nurse knows how to store Zoledronic Acid properly (see section 6).
6. Contents of the pack and other information
What Zoledronic Acid contains
The active substance is zoledronic acid. One vial contains 4 mg of zoledronic acid and each ml corresponding to 1.126 mg sodium ion.
The other ingredients are mannitol (E421), sodium citrate (E331) and water for injections.
What Zoledronic Acid looks like and contents of pack
Zoledronic Acid is a clear, colourless solution free from visible particles.
One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous).
One ml concentrate for solution for infusion contains 1.13 mg of sodium as sodium citrate. Each pack contains the vial with concentrate. Zoledronic Acid is supplied as packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Zoledronic Acid 4 mg/5 ml Concentrate for Solution for Infusion
IE: Zoledronic Acid 4 mg/5 ml Concentrate for Solution for Infusion
AT: Zoledronsaure Noridem 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslosung
DE: Zoledronsaure Noridem 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslosung
ES: Acido Zoledronico Kern Pharma 4 mg/5ml concentrado para solution para perfusion
EFG
PL: Zoledronic Acid Noridem
EL: ZOXALON 4 mg/5 ml tcukvo Sra^upa yra napaoKeu^ SraAtiparog npog sy%uan This leaflet was last revised in April 2014.
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
- Aseptic techniques must be followed during the preparation of the infusion. For single use only. Only clear solution free from particles and discolouration should be used.
-After aseptic dilution, it is preferable to use the diluted product immediately. If not used
immediately, the duration and conditions of storage prior to use are the user's responsibility. The total time between dilution, storage in a refrigerator at 2°C - 8°C and end of administration must not exceed 24 hours.
- The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
- 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.
- The readily prepared Zoledronic Acid infusion solution should preferably be used immediately. If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C - 8°C.
- The total time between dilution, storage in the refrigerator and end of administration must not
exceed 24 hours.
If this leaflet is difficult to see or read please contact the following address for help: Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland Tel +353-1-2907000
Confidential 6 06/02/2014