4 mg/5 ml concentrate for infusion solution,
zoledronic acid solution
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 substances called bisphosphonates. Zoledronic acid works by binding to bone tissue and slowing the rate of bone turnover. It is used to:
- prevent bone complications, e.g. fractures in adult patients with bone metastases (cancer that has spread from the primary cancer site to bone tissue).
- reduce the amount of calcium in the blood in adult patients in cases where it is too high due to a tumor. Tumors can speed up the normal rate of bone turnover in such a way that the release of calcium from the bone tissue increases. This condition is called tumor-induced hypercalcemia (TIH).
Zoledronic acid contained in Zoledronic Acid Fresenius Kabi may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Zoledronic Acid Fresenius Kabi
You should not receive Zoledronic Acid Fresenius Kabi:
Carefully follow the instructions given to you by your doctor.
Your doctor will take blood tests before you start treatment with Zoledronic Acid Fresenius Kabi and will regularly monitor how you respond to treatment.
- if you are allergic to zoledronic acid, other bisphosphonates (the group of substances to which Zoledronic Acid Fresenius Kabi belongs), or any other ingredient in this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor before receiving Zoledronic Acid Fresenius Kabi
- if you have or have had any kidney disease.
- if you or have had pain, swelling, or numbness in the jaw, a feeling of “heavy jaw” or that a tooth has become loose. Your doctor may recommend that you undergo a dental examination before starting treatment with Zoledronic Acid Fresenius Kabi.
- if you are undergoing dental treatment or will undergo dental surgery, inform your dentist that you are being treated with Zoledronic Acid Fresenius Kabi and inform your doctor about your dental treatment.
While you are being treated with Zoledronic Acid Fresenius Kabi, you should maintain good oral hygiene (including regular tooth brushing) and have regular 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 sores that do not heal or drain, as these may be signs of a condition called osteonecrosis of the jaw.
Patients who are undergoing chemotherapy and/or radiation therapy, who are taking steroids, who are undergoing dental surgery, who do not receive regular dental care, who have gum problems, who are smokers, or who have previously been treated with a bisphosphonate (used to treat or prevent bone disease) may have a higher risk of developing osteonecrosis of the jaw.
Decreased levels of calcium in the blood (hypocalcemia) which can sometimes lead to muscle cramps, dry skin, and a burning sensation have been reported in patients treated with zoledronic acid. Irregular heart rhythm ( cardiac arrhythmia ), convulsions, spasms, and twitching ( tetany ) have been reported as a result of severe hypocalcemia. In some cases, hypocalcemia can be life-threatening. If any of these occur, talk to your doctor immediately. If you have pre-existing hypocalcemia, it must be corrected before starting the first dose of Zoledronic Acid Fresenius Kabi. You will be given adequate supplements of calcium and vitamin D.
Patients who are 65 years of age and older
Zoledronic Acid Fresenius Kabi can be given to people aged 65 and over. There is nothing to suggest that any extra precautions would be necessary.
Children and young people
Zoledronic Acid Fresenius Kabi is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Zoledronic Acid Fresenius Kabi
Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. You must tell your doctor if you are also taking:
- Aminoglycosides (medicines used to treat serious infections ), calcitonin (a type of medicine used to treat osteoporosis in postmenopausal women and hypercalcemia ), loop diuretics (a type of medicine used to treat high blood pressure or swelling caused by fluid retention (edema)) or other medicines that lower calcium levels, as these in combination with bisphosphonates can lower the level of calcium in the blood to an excessively low level.
- Thalidomide (a medicine used to treat a certain type of blood cancer involving bone tissue) or any other medicine that can damage the kidneys.
- Medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancerous diseases of bone tissue, or any other bisphosphonate, as the effects of combining these medicines with zoledronic acid are unknown.
- Anti-angiogenic medicines (used to treat cancer), as the combination of these with zoledronic acid, have been associated with an increased risk of osteonecrosis of the jaw.
Pregnancy and breastfeeding
You should not be treated with Zoledronic Acid Fresenius Kabi if you are pregnant. Inform your doctor if you are or think you are pregnant.
You must not be treated with Zoledronic Acid Fresenius Kabi if you are breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
There have been very rare cases of lethargy and sleepiness associated with the use of zoledronic acid. You should therefore be careful when driving a car, using machines, or performing other activities that require your full concentration.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure
Zoledronic Acid Fresenius Kabi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost “sodium-free”.
How to use Zoledronic Acid Fresenius Kabi
Zoledronic Acid Fresenius Kabi should only be given by healthcare professionals who have experience in administering bisphosphonates intravenously, i.e. through a vein.
Your doctor will recommend that you drink water before each treatment to prevent dehydration.
Follow all other instructions from your doctor, nurse, or pharmacist carefully.
What dose of Zoledronic Acid Fresenius Kabi is given?
- The single dose that is usually given is 4 mg.
- If you have reduced kidney function, your doctor will give you a lower dose, which depends on the severity of your kidney problems.
How often will you be treated with Zoledronic Acid Fresenius Kabi?
- If you are being treated for the prevention of bone tissue complications due to metastases in the bone tissue, you will receive an infusion of Zoledronic Acid Fresenius Kabi every three to four weeks.
- If you are being treated to reduce the amount of calcium in your blood, you will usually only receive one infusion of Zoledronic Acid Fresenius Kabi.
How is Zoledronic Acid Fresenius Kabi
given Zoledronic Acid Fresenius Kabi is given as a drip ( infusion ) into a vein for at least 20 minutes and must be given intravenously as a separate infusion in a special infusion tube.
Patients who do not have too much calcium in their blood will also receive a prescription for calcium and vitamin D supplements, which must be taken daily.
If you have been given too much Zoledronic Acid Fresenius Kabi
If you have received doses higher than those recommended, you must be closely monitored by your doctor. This is because you may have abnormal levels of electrolytes in your blood (eg abnormal amounts of calcium, phosphorus, and magnesium ) and/or changes in kidney function, including severely impaired kidney function. If your level of calcium is too low, you may need to receive additional calcium by infusion.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common of these are usually mild and likely to disappear after a short time.
Tell your doctor right away if you experience any of the following serious side effects:
Common (may affect up to 1 in 10 users):
- Severe kidney impairment (normally determined by your doctor using some specific blood tests).
- Low levels of calcium in the blood.
Uncommon (may affect up to 1 in 100 users):
- Pain in the mouth, teeth, and/or jaw, swelling or sores that do not heal on the inside of the mouth or jaw, warts, numbness, or a feeling of the heavy jaw or tooth loss. These may be signs of bone damage in the jaw ( osteonecrosis ). Tell your doctor and dentist immediately if you experience such symptoms while you are being treated with Zoledronic Acid Fresenius Kabi or after stopping treatment.
- Irregular heart rhythm ( atrial fibrillation ) has been observed in patients receiving zoledronic acid for postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular heart rhythm, but you should report to your doctor if you experience such symptoms after receiving zoledronic acid.
- Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Rare (may affect up to 1 in 1,000 users):
- As a result of low calcium levels: irregular heart rhythm ( cardiac arrhythmia due to hypocalcemia )
- A kidney function disorder called Fanconi syndrome (normally diagnosed by your doctor with urine samples)
Very rare (may affect up to 1 in 10,000 users):
- As a result of low calcium levels: convulsions, numbness, and twitching (as a result of hypocalcemia)
- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. This could be a sign of a bone injury in the ear.
- Osteonecrosis has, in very rare cases, also been observed in bones other than the jaw, especially in the hip or thigh. Tell your doctor immediately if you experience symptoms such as new or worsening aches, pains, or stiffness during treatment with Zoledronic Acid Fresenius Kabi or after stopping treatment.
Tell your doctor as soon as possible if you experience any of the following side effects:
Very common (may affect more than 1 in 10 users):
- Low level of phosphate in the blood.
Common (may affect up to 1 in 10 users):
- Headache and a flu-like condition consisting of fever, fatigue, weakness, drowsiness, chills, and aches in bones, joints, and/or muscles. In most cases, no treatment is required and the symptoms disappear after a short time (a few hours or days).
- Reactions from the gastrointestinal tract, e.g. nausea and vomiting, as well as loss of appetite.
- Inflammation in the conjunctiva of the eye.
- Low level of red blood cells ( anemia ).
Uncommon (may affect up to 1 in 100 users):
- Hypersensitivity reaction.
- 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 changes
- Tremors
- Tingling or numbness in the hands and feet.
- Diarrhea.
- Constipation
- Stomach ache
- Dry mouth
- A low number of white blood cells and platelets.
- Low levels of magnesium and potassium in the blood. Your doctor will check this and take the necessary measures.
- Weight gain
- Increased sweating
- Somnolence.
- Blurred vision, watery eyes, eye sensitivity to light.
- A sudden feeling of coldness with fainting, weakness, or collapse.
- Difficulty breathing with wheezing or coughing.
- Hives.
Rare (may affect up to 1 in 1,000 users):
- Slow pulse.
- Confusion.
- Unusual femur fractures may occur in rare cases, especially in patients receiving long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femur fracture.
- Interstitial lung disease ( inflammation of the tissue around the alveoli)
- Flu-like symptoms include arthritis and joint swelling.
- Painful red and/or swollen eyes.
Very rare (may affect up to 1 in 10,000 users):
- Fainting due to low blood pressure.
- Severe pain in bones, joints, and/or muscles, which in some cases can be disabling.
How to store Zoledronic Acid Fresenius Kabi
Keep this medicine out of the sight and reach of children
Use before the expiry date stated on the bottle after the date of issue. The expiration date is the last day of the specified month.
Your doctor, pharmacist, or nurse knows how to store Zoledronic Acid Fresenius Kabi correctly (see section 6).
Contents of the packaging and other information
Contents declaration
- The active substance in Zoledronic Acid Fresenius Kabi is zoledronic acid. One vial contains 4 mg of zoledronic acid (as a monohydrate).
- Other ingredients are mannitol, sodium citrate, and water for injections.
Appearance and package sizes of the medicine
Zoledronic Acid Fresenius Kabi is supplied as a concentrate in a clear, colorless plastic vial.
Zoledronic Acid Fresenius Kabi is supplied in packs of 1, 4, or 10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Austria GmbH
Hafnerstrasse 36, A-8055 Graz
Austria
This medicine is approved in the European Economic Area under the names:
| AT | Zoledronsäure Fresenius Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung |
| ASK | Zoledroninezuur Fresenius Kabi 4 mg/5 ml concentrate for solution for infusion |
| BG | Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate for infusion solution |
| CZ | Zoledronic acid Fresenius Kabi 4 mg/5 ml |
| THE | Zoledronsäure Fresenius Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung |
| DK | Zoledronic Acid Fresenius Kabi |
| EE | Zoledronic acid Fresenius Kabi 4 mg/5 ml |
| EL | Zoledronic acid / Fresenius Kabi, πύκνό πρόμενος για πρόμενος προς προστέρων, 4mg/5ml. |
| ES | Ácido Zoledrónico Fresenius Kabi 4 mg / 5 ml concentrado para solución para perfusión |
| FI | Zoledronic Acid Fresenius Kabi 4 mg/5 ml infusion concentrate, liuosta värten |
| FR | Acide Zolédronique Fresenius Kabi 4mg/5ml, solution à diluter pour perfusion |
| HU | Zoledronsav Fresenius Kabi 4 mg/5ml koncentrátum oldatos infúzióhoz |
| IE | Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate for solution for infusion |
| IT | Acido zoledronico Fresenius Kabi |
| LU | Zoledronsäure Fresenius Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung |
| LT | Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentratas infuziniam tirpalui |
| LV | Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentrāts infūziju įlišų pagaļųšāani |
| NL | Zoledroninezuur FreseniusKabi 4 mg/5 ml concentrate for solution for infusion |
| NO | Zoledronic Acid Fresenius Kabi |
| PL | Zoledronic acid Fresenius Kabi |
| PT | Ácido zoledrónico Fresenius Kabi |
| ROCK | Acid zoledronic Fresenius Kabi 4 mg/5 ml concentrat pentru soluşti perfuzabilă |
| SEE | Zoledronic Acid Fresenius Kabi |
| SI | Zoledronska skill Fresenius Kabi 4 mg/5 ml concentrate za logo za infundiranje |
| SK | Zoledronic acid Fresenius Kabi 4 mg/5ml |
| UK | Zoledronic acid Fresenius Kabi 4 mg/5 ml concentrate for solution for infusion |