ACIDO 4 mg /5 Ml Infusion Solution

Зміст інструкції

1. Acido Zoledronico Teva 4 mg/5 ml concentrate for solution for infusion
   1. What is Acido Zoledronico Teva and what is it used for
   2. What you need to know before you are given Acido zoledronico Teva
   3. How Acido Zoledronico Teva is administered
   4. Possible side effects
   5. How to store Acido Zoledronico Teva
   6. Contents of the pack and other information

Acido Zoledronico Teva 4 mg/5 ml concentrate for solution for infusion

acido zoledronico

Read 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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Acido Zoledronico Teva is and what it is used for
• 2. What you need to know before you are given Acido Zoledronico Teva
• 3. How Acido Zoledronico Teva is given
• 4. Possible side effects
• 5. How to store Acido Zoledronico Teva
• 6. Contents of the pack and other information

1. What is Acido Zoledronico Teva and what is it used for

The active ingredient of this medicine is zoledronic acid, belonging to a group of substances
called bisphosphonates. Zoledronic acid works by binding to the bone and slowing down its rate of
metabolism. It is used:

• To prevent bone complications,such as fractures, in adult patients with bone metastases (spread of cancer from the primary tumor site to the bones).
• To reduce the amount of calciumin the blood in adult patients in whom it is too high following the presence of a tumor. Tumors can accelerate normal bone metabolism in such a way that the release of calcium from the bone is increased. This condition is known as neoplastic hypercalcemia (TIH).

2. What you need to know before you are given Acido zoledronico Teva

Follow all instructions given to you by your doctor carefully.
Before starting treatment with Acido Zoledronico Teva, your doctor will perform blood tests and check your response to treatment at regular intervals.

Acido Zoledronico Teva must not be given to you:

• if you are breastfeeding.
• if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid 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 Acido Zoledronico Teva:

• if you have or have had kidney problems.
• if you have or have had pain, swelling or numbnessin the jaw/lower jaw or a feeling of heaviness in the jaw/lower jaw or loss of a tooth. Your doctor may recommend that you have a dental examination before starting treatment with Acido Zoledronico Teva.
• if you are undergoing dental treatmentsor need to undergo dental surgery, inform your dentist that you are being treated with Acido Zoledronico Teva and inform your doctor about your dental treatments.

During treatment with Acido Zoledronico Teva, you must maintain good oral hygiene (which
includes regular teeth cleaning) and must receive routine dental check-ups.
Immediately inform your doctor and dentist if you experience any problems with your mouth or teeth
such as tooth loss, pain, swelling or failure of sores to heal or discharge, as
these may be signs of a condition called osteonecrosis of the jaw/lower jaw.
Patients undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are
undergoing dental surgery, who are not receiving routine dental care, who have gum disease,
who are smokers, or who have been previously treated with bisphosphonates (used to treat or
prevent bone diseases) have a higher risk of developing osteonecrosis of the
jaw/lower jaw.
Decreased levels of calcium in the blood (hypocalcemia) have been reported in patients treated with Acido Zoledronico Teva,
which can sometimes cause muscle cramps, dry skin, a burning sensation. Cases of irregular heartbeat (cardiac arrhythmia), convulsions, spasms and
muscle contractions (tetany) secondary to severe hypocalcemia have been reported. In some circumstances, hypocalcemia can
be life-threatening. If any of these conditions affect you, tell your doctor immediately.
If a pre-existing hypocalcemia condition exists, it must be treated before starting the first dose
of Acido Zoledronico Teva. You will be given adequate calcium and vitamin D supplementation.

Patients aged 65 years and over
Acido Zoledronico Teva can be given to people aged 65 years and over. There
is no evidence that additional precautions are necessary.

Children and adolescents
Acido Zoledronico Teva is not recommended for use in adolescents and children under the age
of 18 years.

Other medicines and Acido Zoledronico Teva
Tell your doctor if you are taking, have recently taken or might take any other
medicines. It is particularly important to tell your doctor if you are also taking:

• Aminoglycosides (medicines used to treat serious infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcemia), loop diuretics (a type of medicine used to treat high blood pressure or edema) or other medicines that lower calcium levels, as the combination of these substances with bisphosphonates may cause a significant decrease in blood calcium concentration.
• Thalidomide (a medicine used to treat some types of blood cancers involving the bones) or any other medicine that may be harmful to the kidneys.
• Other medicines containing zoledronic acid and used for the treatment of osteoporosis and other non-cancerous bone diseases, or any other bisphosphonate, as the combined effects of these medicines when taken with Acido Zoledronico Teva are not known.
• Anti-angiogenic medicines (used to treat cancer), as the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw.

Pregnancy and breastfeeding
If you are pregnant, you must not be given Acido Zoledronico Teva. Tell your doctor if you are
pregnant or suspect you may be pregnant.
If you are breastfeeding, you must not be given Acido Zoledronico Teva.
Ask your doctor for advice before taking any medicine during pregnancy or if you are
breastfeeding.

Driving and using machines
Very rarely, drowsiness and lethargy have been reported with the use of Acido Zoledronico Teva. You should
therefore be very careful when driving, using machines or performing other activities that require full attention.

Acido Zoledronico Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially
‘sodium-free’.

3. How Acido Zoledronico Teva is administered

• Acido Zoledronico Teva must be administered only by healthcare professionals trained in the use of bisphosphonates via the intravenous route, i.e., through a vein.
• The doctor will recommend that you drink sufficient water before each treatment to help prevent dehydration.
• Carefully follow all other instructions given by the doctor, pharmacist or nurse.

How much is administered

• The usual single dose is 4 mg.
• If you have kidney problems, the doctor will administer a reduced dose based on the severity of the kidney problem.

How often is Acido Zoledronico Teva administered

• If you are being treated for the prevention of bone complications caused by bone metastases, you will be given an infusion of Acido Zoledronico Teva every three or four weeks.
• If you are being treated to reduce the amount of calcium in the blood, you will normally be given a single infusion of Acido Zoledronico Teva.

How Acido Zoledronico Teva is administered

• Acido Zoledronico Teva is administered intravenously as an infusion lasting at least 15 minutes and must be administered as a single intravenous solution in a separate infusion line.

Patients with not excessively high blood calcium levels will also be prescribed
calcium and vitamin D supplements to be taken daily.

If you have been given too much Acido Zoledronico Teva
If you have been given doses higher than those recommended, you must be monitored with
particular attention by the doctor. This is because you may develop abnormalities in serum electrolytes (e.g.
abnormal levels of calcium, phosphorus and magnesium) and/or changes in renal function, including
severe renal impairment. If calcium levels drop too low, you may need to
receive calcium supplementation by infusion.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common are usually mild and, probably, will disappear in a short time.

Tell your doctor immediately if any of these side effects should occur:
Common (may affect up to 1 in 10 people):

• Severe kidney failure (will be ascertained by the doctor through specific blood tests).
• Low levels of calcium in the blood.

Uncommon (may affect up to 1 in 100 people):

• Pain in the mouth, teeth and/or jaw/mandible, swelling or failure of sores inside the mouth or jaw/mandible to heal, secretion, numbness or feeling of heaviness in the jaw/mandible or loss of a tooth. These may be signs of damage to the jaw/mandible (osteonecrosis). If you experience these symptoms during or after stopping treatment with Acido Zoledronico Teva, tell your doctor and dentist immediately.
• In patients treated with zoledronic acid for postmenopausal osteoporosis, an irregular heartbeat (atrial fibrillation) has been observed. It is currently unknown whether zoledronic acid causes this irregular heartbeat, but you should report it to your doctor if you have these symptoms after being given zoledronic acid.
• Severe allergic reactions: shortness of breath, swelling, especially of the face and throat.

Rare (may affect up to 1 in 1,000 people):

• As a consequence of low calcium levels: irregular heartbeat (cardiac arrhythmia secondary to hypocalcemia).
• A disorder of kidney function called Fanconi syndrome (will normally be established by the doctor with some urine tests).

Very rare (may affect up to 1 in 10,000 people):

• As a consequence of low calcium levels: convulsions, numbness and tetany (secondary to hypocalcemia).
• Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.
• Osteonecrosis has very rarely occurred in other bones besides the jaw/mandible, in particular in the hip or thigh. If you experience symptoms such as the onset or worsening of pain, pain or stiffness during or after stopping treatment with Acido Zoledronico Teva, tell your doctor immediately.

Tell your doctor as soon as possible if any of the following side effects should occur:
Very common (may affect more than 1 in 10 people):

• Low levels of phosphates in the blood.

Common (may affect up to 1 in 10 people):

• Headache and flu-like syndrome with fever, fatigue, weakness, drowsiness, chills and pain in bones, joints and/or muscles. In most cases, no specific treatment is necessary and the symptoms disappear after a short time (a couple of hours or days).
• Gastrointestinal reactions, such as nausea and vomiting, as well as loss of appetite.
• Low levels of red blood cells in the blood (anemia).
• Conjunctivitis.

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 disorders, taste disturbances, tremor, tingling or numbness in the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
• Low levels of white blood cells and platelets in the blood.
• Low levels of magnesium and potassium in the blood. The doctor will monitor them and take the necessary measures.
• Weight gain.
• Increased sweating.
• Drowsiness.
• Blurred vision, eye injury, sensitivity to light.
• Sudden chills with fainting, weakness or collapse.
• Difficulty breathing with wheezing or coughing.
• Urticaria.

Rare (may affect up to 1 in 1,000 people):

• Slow heartbeat.
• Confusion.
• Rarely, an unusual fracture of the femur may occur, particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early indication of a possible femur fracture.
• Interstitial lung disease (inflammation of the lung tissue).
• Flu-like symptoms including arthritis and joint swelling.
• Painful redness and/or swelling of the eyes.

Very rare (may affect up to 1 in 10,000 people):

• Fainting due to low blood pressure.
• Severe pain in bones, joints and/or muscles, 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 through the national reporting system indicated in Annex V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Acido Zoledronico Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the
vial label after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After dilution, it is preferable to use the diluted medicine immediately. If not used
immediately, the storage times and conditions before use are the responsibility
of the user. The total time between dilution, storage in a refrigerator at 2°C – 8°C and the end
of administration must not exceed 24 hours.
Do not use this medicine if you notice particles or a change in color or in the solution.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Zoledronico Teva contains

• The active substance is zoledronic acid. One vial contains 4 mg of zoledronic acid (as monohydrate).
• The other ingredients are: mannitol, sodium citrate, water for injections.

Description of the appearance of Acido Zoledronico Teva and contents of the pack
Acido Zoledronico Teva is supplied as concentrate for infusion solution. Each vial of
transparent plastic or glass contains 5 ml of clear and colourless concentrate.
Acido Zoledronico Teva is supplied in packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
PLIVA Croatia Ltd
Prilaz baruna Filipovića 25
10 000 Zagreb
Croatia
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Актавис ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +353 19127700

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +353 19127700

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Finland Oy
Finnland
Sími: +358 201805900

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom
Teva UK Limited
Tel: +44 1977628500

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu
---------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

How to prepare and administer Acido Zoledronico Teva

• To prepare an infusion solution containing 4 mg of zoledronic acid, further dilute Acido Zoledronico Teva concentrate (5 ml) with 100 ml of calcium-free or other bivalent cation-free infusion solution. If a reduced dose of zoledronic acid is required, initially withdraw the appropriate volume as follows and then further dilute in 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must be 0.9% w/v sodium chloride solution or 5% w/v glucose solution.

Acido Zoledronico Teva concentrate must not be mixed with solutions containing calcium or
other bivalent cations such as Ringer's lactate solution.
Instructions for preparing Acido Zoledronico Teva at reduced dosages:
Withdraw the appropriate volume of concentrate, as follows:

• 4.4 ml for the 3.5 mg dose
• 4.1 ml for the 3.3 mg dose
• 3.8 ml for the 3.0 mg dose
• For single use only. Any unused solution should be discarded. Only clear, particle-free and colourless solution should be used. Aseptic techniques must be followed during the preparation of the infusion.
• From a microbiological point of view, the diluted infusion solution must be used immediately. See below for maximum storage times during use.
• The solution containing zoledronic acid must be administered as a single infusion over a period of 15 minutes via a separate infusion line. The hydration status of patients must be assessed before and after the administration of Acido Zoledronico Teva to ensure they are adequately hydrated.
• Studies conducted on various infusion lines made of polyvinyl chloride, polyethylene and polypropylene have not shown incompatibility with zoledronic acid.
• Since there are no data on the compatibility of zoledronic acid with other substances administered intravenously, zoledronic acid must not be mixed with other medicines and/or substances and must always be administered through a separate infusion line.

How to store Acido Zoledronico Teva
Unopened vial

• Keep Acido Zoledronico Teva out of the sight and reach of children.
• Do not use Acido Zoledronico Teva after the expiry date which is stated on the vial and the carton after Exp.

Diluted solution

• The infusion solution of Acido Zoledronico Teva, freshly prepared, should preferably be used immediately. If the solution is not used immediately, storage before use is the responsibility of the user and must be refrigerated at 2°C - 8°C.
• The total time between dilution, refrigerated storage and the end of administration must not exceed 24 hours.