4 mg/100 ml infusion solution
zoledronic acid
What Zerlinda is and what it is used for
The active substance in Zerlinda is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by binding to bone tissue and reducing the rate of bone turnover. It is used for:
- To prevent bone complications, e.g. fracture er, in adult patients with bone metastases (spread cancer from primary cancer site to bone tissue).
- To reduce the amount of calcium in the blood in adult patients when this is too high due to a tumor. Tumors can accelerate 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 Zerlinda may also be approved to treat other conditions not mentioned in this leaflet. 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 Zerlinda
Carefully follow the instructions given to you by your doctor.
Your doctor will take blood tests before you start treatment with Zerlinda and will regularly monitor how you respond to treatment.
You shall not get Zerlinda
- If you are breastfeeding.
- If you are allergic to zoledronic acid, other bisphosphonates (the group of substances to which Zerlinda belongs), or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before receiving Zerlinda:
- If you have or have had any kidney disease.
- If you or have had pain, swelling, or numbness in the jaw, a feeling of the heavy jaw, or that a tooth has become loose. Your doctor may recommend that you undergo a dental examination before starting treatment with Zerlinda.
- If you are undergoing dental treatment or will undergo dental surgery, inform your dentist that you are being treated with Zerlinda and inform your doctor about your dental treatment.
While you are being treated with Zerlinda, 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 Zerlinda. You will be given adequate supplements of calcium and vitamin D.
Patients who are 65 years of age and older
Zoledronic acid can be given to people who are 65 years of age and older. There is nothing to suggest that any extra precautions would be necessary.
Children and young people
Zoledronic acid is not recommended for use in adolescents and children under 18 years of age.
Other medicines and Zerlinda
Tell the doctor if you are taking/using, have recently taken/used, or maybe taking/using other medicines. 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 have the effect of lowering the calcium level 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.
- Other medicines contain zoledronic acid or other bisphosphonates, as the combined effect of these medicines together with Zerlinda is not known.
- Anti-angiogenic medicines (used to treat cancer), as combining these with Zerlinda have been associated with an increased risk of bone damage ( osteonecrosis ) of the jaw (ONJ).
Pregnancy and breastfeeding
You should not be treated with zoledronic acid if you are pregnant. Inform your doctor if you think you are pregnant.
You must not be treated with zoledronic acid 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.
Zerlinda contains sodium
This medicine contains 356 mg of sodium (the main ingredient in common/table salt) per 100 ml sachet. This corresponds to 17.8% of the maximum recommended daily intake of sodium for adults.
How to use Zerlinda
- Zerlinda 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 enough water before each treatment to help prevent dehydration.
- Follow all other instructions from your doctor, pharmacist, or nurse carefully.
What dose of Zerlinda is given?
- The single dose that is usually given is 4 mg.
- If you have impaired 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 Zerlinda?
- 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 Zerlinda every three to four weeks.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only receive one infusion of Zerlinda.
How is Zerlinda given?
- Zerlinda is given as a drip ( infusion ) into a vein over at least 15 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 Zerlinda
If you have received doses higher than those recommended, you must be carefully examined by your doctor. This is because you may have abnormal amounts 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.
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 will most likely disappear after a short time.
Tell your doctor immediately 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 Zerlinda 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 it 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; as a result of 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 Zerlinda 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.
- Conjunctivitis.
- Low level of red blood cells ( anemia ).
Uncommon (may affect up to 1 in 100 users):
- Hypersensitivity reaction.
- Low blood pressure.
- Chest pains.
- Skin reactions ( redness and swelling) at the infusion site, rash, itching.
- High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, changes in taste, tremors, tingling or numbness in the hands and feet, diarrhea, constipation, stomach pain, and dry mouth.
- A low number of white blood cells and platelets.
- The low blood level of magnesium and potassium. 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):
- Low heart rate.
- Confusion.
- Unusual femur fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases. 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 swollen joints.
- 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 Zerlinda
Your doctor, pharmacist, or nurse knows how to store Zerlinda correctly (see section 6).
Keep this medicine out of the sight and reach of children
Use before the expiry date which is stated on the carton and bag after EXP. The expiration date is the last day of the specified month.
After the first opening, Zerlinda solution for infusion should preferably be used immediately. If the solution is not used immediately, it should be stored in a refrigerator at 2°C – 8°C.
Contents of the packaging and other information
Contents declaration
- The active substance in Zerlinda is zoledronic acid. Each 100 ml infusion bag contains 4 mg zoledronic acid (as monohydrate).
- Other ingredients are sodium chloride, mannitol (E421), sodium citrate dihydrate (E331), and water for injections.
Appearance and package sizes of the medicine
Zerlinda 4 mg/100 ml is a clear and colorless solution without visible particles, which is supplied in a plastic infusion bag with outer packaging, as well as two hose valves with a tip valve nozzle and an injection tip with a cap that can be broken off.
Package sizes:
1 x 100 ml infusion bag
10 x 100 ml infusion bag
Not all pack sizes may be marketed.
Holder of a permit for sale
Actavis Group PTC EHF.
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland
Manufacturer
SC Informed Fluids SRL
Str. Theodor Pallady no.50, Sector 3, 032266 Bucharest
Romania