Zoledronic acid Fresenius Kabi

Package Leaflet: Information for the User

Zoledronic Acid Fresenius Kabi, 4 mg/5 ml, Concentrate for Solution for Infusion

Zoledronic Acid

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should 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.

Contents of the Pack

• 1. What Zoledronic Acid Fresenius Kabi is and What it is Used For
• 2. Before You Use Zoledronic Acid Fresenius Kabi
• 3. How to Use Zoledronic Acid Fresenius Kabi
• 4. Possible Side Effects
• 5. How to Store Zoledronic Acid Fresenius Kabi
• 6. Contents of the Pack and Other Information

1. What Zoledronic Acid Fresenius Kabi is and What it is Used For

The active substance in Zoledronic Acid Fresenius Kabi is zoledronic acid, which belongs to a group of medicines called bisphosphonates. Zoledronic acid works by binding to bone tissue and slowing down the rate of bone change. It is used:

• -to prevent bone complications,e.g. fractures in adult patients with bone metastases from solid tumors (spread of cancer from the original site to the bone);
• -to reduce high levels of calcium in the bloodin adult patients when this is caused by the presence of a tumor. Tumors can speed up bone breakdown, leading to high levels of calcium in the blood. This condition is called tumor-induced hypercalcemia (TIH).

2. Before You Use Zoledronic Acid Fresenius Kabi

Follow all instructions given by your doctor carefully.

Your doctor will order blood tests before you start using Zoledronic Acid Fresenius Kabi and will regularly check your response to treatment.

When Not to Use Zoledronic Acid Fresenius Kabi:

• if you are allergic to zoledronic acid, other bisphosphonates (the group of medicines to which Zoledronic Acid Fresenius Kabi belongs), or any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding.

Warnings and Precautions

Before You Start Using Zoledronic Acid Fresenius Kabi, Tell Your Doctor:

• if you have or have had kidney problems;
• if you have or have had pain, swelling, or numbnessin your jaw, a feeling of heaviness in your jaw, or a loose tooth. Your doctor may recommend that you have a dental check-up before starting treatment;
• if you are having or are going to have dental treatment. You should tell your dentist that you are being treated with Zoledronic Acid Fresenius Kabi, and your doctor should be told about any dental treatment you are having;

While Being Treated with Zoledronic Acid Fresenius Kabi, You Should:

Maintain good oral hygiene by brushing your teeth regularly and having regular dental check-ups. If you experience any problems with your mouth or teeth, tell your doctor and dentist immediately.

Patient Over 65 Years

Zoledronic Acid Fresenius Kabi can be used for patients over 65 years. There are no special warnings or precautions for this age group.

Children and Adolescents

Zoledronic Acid Fresenius Kabi should not be used in children and adolescents under the age of 18 years.

Zoledronic Acid Fresenius Kabi and Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• aminoglycosides (used to treat serious infections), calcitonin (used to treat osteoporosis and hypercalcemia), loop diuretics (used to treat high blood pressure and swelling), and other medicines that lower calcium levels. Using these medicines with bisphosphonates may cause a serious lowering of calcium levels;
• thalidomide (used to treat certain blood cancers) or other medicines that can harm the kidneys;
• medicines containing zoledronic acid used to treat osteoporosis and other non-cancerous bone diseases, or other bisphosphonates. The combined effects of these medicines with zoledronic acid are not known;
• anti-angiogenic medicines (used to treat cancer), as using them with zoledronic acid has been associated with an increased risk of jaw problems (osteonecrosis of the jaw, ONJ).

Pregnancy and Breastfeeding

Zoledronic Acid Fresenius Kabi must not be used during pregnancy. If you are pregnant or think you may be pregnant, tell your doctor.

Zoledronic Acid Fresenius Kabi must not be used during breastfeeding.

Driving and Using Machines

Very rare cases of drowsiness have been reported with zoledronic acid. Therefore, caution is advised when driving, operating machinery, or performing other tasks that require concentration.

Zoledronic Acid Fresenius Kabi Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to Use Zoledronic Acid Fresenius Kabi

Zoledronic Acid Fresenius Kabi is Administered by a Healthcare Professional Only

Your doctor will advise you to drink plenty of water before each dose to avoid dehydration.

Follow all other instructions given by your doctor, nurse, or pharmacist.

What Dose of Zoledronic Acid Fresenius Kabi Will You Receive

• The usual single dose is 4 mg.
• If you have kidney problems, your doctor will give you a lower dose depending on how well your kidneys are working.

How Often Will You Receive Zoledronic Acid Fresenius Kabi

• For preventing bone complications caused by bone metastases, one infusion of Zoledronic Acid Fresenius Kabi is given every 3 to 4 weeks.
• For treating high levels of calcium in the blood, one infusion of Zoledronic Acid Fresenius Kabi is usually given.

How Zoledronic Acid Fresenius Kabi is Given

Zoledronic Acid Fresenius Kabi is given as an intravenous infusion (drip into a vein) over at least 20 minutes and as a single intravenous solution through a separate infusion line.

If your blood calcium levels are not too high, your doctor may also prescribe calcium and vitamin D supplements for you to take each day.

Overdose of Zoledronic Acid Fresenius Kabi

If you have been given more Zoledronic Acid Fresenius Kabi than you should, you will be closely monitored by your doctor. This is because you may experience changes in the levels of certain minerals in the blood (such as calcium, phosphorus, and magnesium) and/or kidney problems, including severe kidney problems. If you have low calcium levels, you may need to be given calcium supplements.

4. Possible Side Effects

Like all medicines, Zoledronic Acid Fresenius Kabi can cause side effects, although not everybody gets them.

Tell Your Doctor Immediately if You Notice Any of the Following Serious Side Effects:

Common (May Affect Up to 1 in 10 People):

• severe kidney problems (usually detected by your doctor through blood tests);
• low levels of calcium in the blood.

Uncommon (May Affect Up to 1 in 100 People):

• mouth sores, toothache, jaw swelling or numbness, a feeling of heaviness in the jaw, or loose teeth; these may be signs of bone damage in the jaw (osteonecrosis); if you get any of these symptoms, tell your doctor and dentist;
• irregular heartbeat (atrial fibrillation) in patients with osteoporosis treated with zoledronic acid; it is not known whether zoledronic acid causes irregular heartbeat;
• severe allergic reactions: difficulty breathing, swelling mainly of the face and throat.

Rare (May Affect Up to 1 in 1,000 People):

• as a result of low calcium levels: irregular heartbeat (arrhythmia), seizures, numbness, and muscle cramps (due to hypocalcemia);
• kidney problems called Fanconi syndrome (confirmed by your doctor through urine tests).

Very Rare (May Affect Up to 1 in 10,000 People):

• as a result of low calcium levels: seizures, numbness, and muscle cramps (due to hypocalcemia);
• if you experience ear pain, discharge from the ear, or ear infection, tell your doctor. These may be signs of bone damage in the ear;
• very rare cases of bone damage in the hip and thigh have been reported. If you experience symptoms such as pain, weakness, or discomfort in the hip, thigh, or groin, tell your doctor immediately.

Not Known (Frequency Cannot be Estimated from the Available Data):

• kidney inflammation (interstitial nephritis): symptoms may include decreased urine output, blood in the urine, nausea, general feeling of being unwell.

Tell Your Doctor if You Notice Any of the Following Side Effects:

Very Common (May Affect More Than 1 in 10 People):

• low levels of phosphorus in the blood.

Common (May Affect Up to 1 in 10 People):

• headache and flu-like symptoms including fever, fatigue, weakness, sleepiness, chills, and pain in the bones, joints, and/or muscles; in most cases, no specific treatment is needed, and these symptoms disappear within a short time (a few hours or days);
• gastrointestinal symptoms such as nausea, vomiting, and loss of appetite;
• conjunctivitis;
• low red blood cell count (anemia).

Uncommon (May Affect Up to 1 in 100 People):

• allergic 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;
• tremors;
• tingling or numbness in the hands or feet;
• diarrhea;
• constipation;
• abdominal pain;
• dry mouth;
• low levels of magnesium and potassium in the blood; your doctor will monitor this and order necessary tests;
• weight gain;
• increased sweating;
• drowsiness;
• blurred vision, tearing, sensitivity to light;
• sudden feeling of cold with fainting, collapse, or loss of consciousness;
• difficulty breathing with wheezing or coughing;
• hives.

Rare (May Affect Up to 1 in 1,000 People):

• slow heartbeat;
• confusion;
• rare cases of unusual fractures of the thigh bone, especially in patients treated long-term for osteoporosis; if you experience pain, weakness, or discomfort in the thigh, hip, or groin, tell your doctor, as this may be an early sign of a fracture;
• interstitial lung disease (inflammation of the tissue around the air sacs in the lungs);
• flu-like symptoms, including joint and muscle pain;
• 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 the bones, joints, and/or muscles, sometimes causing immobilization.

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.

5. How to Store Zoledronic Acid Fresenius Kabi

Your doctor, pharmacist, or nurse is informed about how to store Zoledronic Acid Fresenius Kabi (see section 6).

6. Contents of the Pack and Other Information

What Zoledronic Acid Fresenius Kabi Contains

• The active substance is zoledronic acid. One vial contains 4 mg of zoledronic acid (monohydrate).
• The other ingredients are mannitol, disodium edetate, and water for injections.

What Zoledronic Acid Fresenius Kabi Looks Like and Contents of the Pack

Zoledronic Acid Fresenius Kabi is a clear and colorless solution for infusion in transparent and colorless plastic vials.

Zoledronic Acid Fresenius Kabi is available in packs containing 1, 4, or 10 vials, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134

02-305 Warsaw

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36

8055 Graz

Austria

For more information, contact the marketing authorization holder:

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134

02-305 Warsaw

Phone: +48 22 345 67 89

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria

Zoledronsäure Fresenius Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung

Belgium

Zoledroninezuur Fresenius Kabi 4 mg/5ml concentraat voor oplossing voor infusie

Bulgaria

Zoledronic acid Fresenius Kabi 4 mg/5 ml концентрат за инфузионен разтвор

Czech Republic

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Denmark

Zoledronsyre Fresenius Kabi

Estonia

Zoledronic acid Fresenius Kabi 4 mg/5ml

Finland

Zoledronsyra Fresenius Kabi 4 mg/5 ml infuusiokonsentraatti, liuosta varten

France

Acide Zolédronique Fresenius Kabi 4mg/5ml, solution à diluer pour perfusion

Greece

Zoledronic acid / Fresenius Kabi, πυκνό διάλυμα για διάλυμα προς έγχυση, 4mg/5ml.

Spain

Ácido Zoledrónico Fresenius Kabi 4 mg / 5 ml concentrado para solución para perfusión

Hungary

Zoledronsav Fresenius Kabi 4 mg/5ml koncentrátum oldatos infúzióhoz

Iceland

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Ireland

Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate for solution for infusion

Italy

Acido zoledronico Fresenius Kabi 4 mg/5 ml

Latvia

Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentrāts infūziju šķīduma pagatavošanai

Lithuania

Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentratas infuziniam tirpalui

Luxembourg

Zoledronsäure Fresenius Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung

Malta

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Netherlands

Zoledroninezuur Fresenius Kabi 4 mg/5 ml concentraat voor oplossing voor infusie

Norway

Zoledronsyre Fresenius Kabi 4 mg/5 ml

Poland

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Portugal

Ácido zoledrónico Fresenius Kabi 4 mg/5 ml

Romania

Acid zoledronic Fresenius Kabi 4 mg/5 ml concentrat pentru soluţie perfuzabilă

Slovakia

Zoledronic acid Fresenius Kabi 4 mg/5 ml

Slovenia

Zoledronska kislina Fresenius Kabi 4 mg/5 ml koncentrat za raztopino za infundiranje

Sweden

Zoledronsyra Fresenius Kabi 4 mg/5 ml

United Kingdom

Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate for solution for infusion

Date of Last Revision of the Leaflet: 26.08.2024

Information for Healthcare Professionals Only:

How to Prepare and Administer Zoledronic Acid Fresenius Kabi

• To prepare the infusion solution containing 4 mg of zoledronic acid, Zoledronic Acid Fresenius Kabi (5.0 ml) should be diluted in 100 ml of infusion solution without calcium or other divalent cations. If a dose less than 4 mg is required, the appropriate volume of the solution should be withdrawn and then diluted to 100 ml with infusion solution.

Zoledronic Acid Fresenius Kabi Must Not be Mixed with Solutions Containing Calcium or Other Divalent Cations, Such as Ringer's Solution with Lactate.

Instructions for Preparing Reduced Doses of Zoledronic Acid Fresenius Kabi

• Withdraw the appropriate volume of the concentrate as follows:
• 4.4 ml for a dose of 3.5 mg;
• 4.1 ml for a dose of 3.3 mg;
• 3.8 ml for a dose of 3.0 mg.
• Zoledronic Acid Fresenius Kabi is for single use only. Any unused solution should be discarded. Only clear solutions without visible particles or discoloration should be used. During preparation of the infusion, aseptic techniques should be followed.
• Shelf-life after dilution: Chemical and physical stability of the solution has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the diluted infusion solution should be used immediately. If not used immediately, the responsibility for the storage conditions and the storage time before use lies with the user. This time should not exceed 24 hours at 2°C to 8°C. Before administration, the refrigerated solution should be allowed to reach room temperature.
• The solution containing Zoledronic Acid Fresenius Kabi should be infused over at least 20 minutes and as a single intravenous solution through a separate infusion line.
• Before and after each dose of Zoledronic Acid Fresenius Kabi, your doctor will assess your hydration status to ensure you are properly hydrated.
• No incompatibilities have been observed between Zoledronic Acid Fresenius Kabi and the following infusion materials: glass bottles, and several types of infusion bags made of polyvinyl chloride, polyethylene, and polypropylene (previously filled with 0.9% sodium chloride or 5% glucose solution).
• Because there are no data available on the compatibility of Zoledronic Acid Fresenius Kabi with other intravenously administered drugs, Zoledronic Acid Fresenius Kabi should not be mixed with other drugs and should always be administered through a separate infusion line.

How to Store Zoledronic Acid Fresenius Kabi

• Store in a place where children cannot see or reach it.
• Do not use this medicine after the expiry date stated on the packaging.
• No special precautions for storage of unopened vials.
• Storage conditions after dilution, see section "Shelf-life after dilution".