Zoledronic acid Actavis
zoledronic acid
zoledronic acid
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 Zoledronic acid Actavis is and what it is used for
What you need to know before you are given Zoledronic acid Actavis
How Zoledronic acid Actavis is used
Possible side effects
How to store Zoledronic acid Actavis
Contents of the pack and other information
The active substance in Zoledronic acid Actavis 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:
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).
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals.
if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
Zoledronic acid Actavis belongs), or any of the other ingredients of this medicine (listed in section 6).
if you are breast-feeding.
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 Actavis.
if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Actavis and inform your doctor about your dental treatment.
While being treated with Zoledronic acid Actavis, 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 Actavis. You will be given adequate calcium and vitamin D supplements.
Zoledronic acid Actavis can be given to people aged 65 years and over. There is no evidence to
suggest that any extra precautions are needed.
Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
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 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.
Other medicines that contain zoledronic acid which are 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 Actavis are 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).
You should not be given Zoledronic acid Actavis if you are pregnant. Tell your doctor if you are or think that you may be pregnant.
You must not be given Zoledronic acid Actavis if you are breast-feeding.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
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 medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-
free’.
Zoledronic acid Actavis 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.
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.
If you are being treated for the prevention of bone complications due to bone metastases, you
will be given one infusion of Zoledronic acid Actavis 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 Actavis.
Zoledronic acid Actavis 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 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.
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.
Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Low level of calcium in the blood.
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 Actavis 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.
As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
A kidney function disorder called Fanconi syndrome (will normally be determined by your
doctor with certain urine tests).
As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These
could be signs of bone damage in the ear.
Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh. Tell your doctor immediately if you experience symptoms such as new onset or
worsening of aches, pain or stiffness while being treated with Zoledronic acid Actavis or after
stopping treatment.
Low level of phosphate in the blood.
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).
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, diarrhoea, 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.
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.
Fainting due to low blood pressure.
Severe bone, joint and/or muscle pain, occasionally incapacitating.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Your doctor, pharmacist or nurse knows how to store Zoledronic acid Actavis properly.
The active substance is zoledronic acid. One vial contains 4 mg zoledronic acid (as monohydrate).
The other ingredients are: mannitol, sodium citrate and water for injections.
Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial. One vial contains 5 ml of solution.
Zoledronic acid Actavis is supplied as packs containing 1, 4 or 10 vials. Not all pack sizes may be marketed.
220 Hafnarfjörður Iceland
20014 Nerviano (MI) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Тел: +359 24899585
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V.
Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U.
Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf.
Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117
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To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution. If a lower dose of Zoledronic acid Actavis 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.
Instructions for preparing reduced doses of Zoledronic acid Actavis: 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.
Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for
24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose. From a microbiological point of view, the solution for infusion should
be used immediately after dilution. 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. If refrigerated, the solution must be allowed to reach room temperature before
administration.
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 Actavis to ensure that they are adequately hydrated.
Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis must not be mixed with other medications/substances and should always be given through a separate infusion line.
Keep Zoledronic acid Actavis out of the sight and reach of children.
Do not use Zoledronic acid Actavis after the expiry date stated on the vial and carton after EXP.
This medicinal product does not require any specific storage conditions.
For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution” above.