ACIDO 4 mg /5 Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. Acido Zoledronico Fresenius Kabi 4 mg/5 ml
   1. What is Acido Zoledronico Fresenius Kabi and what is it used for
   2. What you need to know before you are given Zoledronic Acid
   3. How Acido Zoledronico Fresenius Kabi is used
   4. Possible side effects
   5. How to store Acido Zoledronico Fresenius Kabi
   6. Contents of the pack and other information

Acido Zoledronico Fresenius Kabi 4 mg/5 ml

concentrate for solution for infusion
Generic medicine

Read this leaflet carefully before you are given this medicine because it contains important information.

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

1. What is Acido Zoledronico Fresenius Kabi and what is it used for

The active ingredient of Acido Zoledronico Fresenius Kabi 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 Zoledronic Acid

Fresenius Kabi
Follow all instructions given to you by your doctor carefully.
Before starting treatment with Zoledronic Acid Fresenius Kabi, your doctor will
perform blood tests and check your response to treatment at
regular intervals.

Zoledronic Acid Fresenius Kabi must not be given to you:

• if you are allergic to zoledronic acid, another bisphosphonate (the group of substances 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
Speak to your doctor before you are given Zoledronic Acid Fresenius
Kabi

• if you have or have had kidney problems.
• if you have or have had pain, swelling or numbnessof the jaw/lower jaw or a feeling of heaviness in the jaw/lower jaw or the loss of a tooth. Your doctor may recommend that you have a dental check-up before starting treatment with Zoledronic Acid Fresenius Kabi. if you are undergoing dental treatmentsor need to undergo dental surgery, inform your dentist that you are being treated with Zoledronic Acid Fresenius Kabi and inform your doctor about your dental treatments.

During treatment with Zoledronic Acid Fresenius Kabi, you must maintain
good oral hygiene (including regular teeth cleaning) and you 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.
In patients treated with zoledronic acid, reduced levels of calcium in the
blood (hypocalcemia) have been reported, 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 apply to you, inform your doctor
immediately. If a pre-existing condition of hypocalcemia is present, it must be
treated before starting the first dose of Zoledronic Acid Fresenius Kabi. You will be
given adequate calcium and vitamin D supplementation.

Patients aged 65 years and over
Zoledronic Acid Fresenius Kabi can be given to people aged 65 years and
over. There is no evidence that additional precautions are necessary.

Children and adolescents
Zoledronic Acid Fresenius Kabi is not recommended for use in children and
adolescents under the age of 18 years.

Other medicines and Zoledronic Acid Fresenius Kabi
Tell your doctor if you are taking, have recently taken or might take
any other medicine. It is particularly important that you 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 and 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.
• Medicines containing zoledronic acid 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 together with zoledronic acid are not known.
• Anti-angiogenic medicines (used to treat cancer), as the association of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw/lower jaw.

Pregnancy and breastfeeding
Zoledronic Acid Fresenius Kabi must not be given to you if you are pregnant.
Tell your doctor if you are pregnant or think you might be.
Do not take Zoledronic Acid Fresenius Kabi if you are breastfeeding.
Ask your doctor for advice before taking any medicine during
pregnancy or breastfeeding.

Driving and operating machinery
Very rarely, drowsiness and lethargy have been reported with the use of Zoledronic
Acid. You should therefore be very careful when driving, operating machinery or performing other activities that require complete
attention.

Zoledronic Acid Fresenius Kabi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is
essentially “sodium-free”.

3. How Acido Zoledronico Fresenius Kabi is used

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

How much Acido Zoledronico Fresenius Kabi is administered

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

How often is Acido Zoledronico Fresenius Kabi administered

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

How Acido Zoledronico Fresenius Kabi is administered
Acido Zoledronico Fresenius Kabi is administered into a vein in the form of an infusion
(infusion) lasting at least 20 minutes and must be administered as a
single intravenous solution in a separate infusion line.
Patients with not too 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 Fresenius Kabi
If you have been given doses higher than those recommended, you must be
closely monitored by your 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
decrease too much, you may need to be given a calcium supplement for infusion.
If you have any doubts about the use of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects

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

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

• Severe kidney impairment (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 to heal sores inside the mouth or jaw/mandible, discharge, numbness or feeling of heaviness in the jaw/mandible or tooth loss. These may be signs of damage to the jaw (osteonecrosis). If you experience such symptoms during or after stopping treatment with Acido Zoledronico Fresenius Kabi, 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 unclear whether zoledronic acid causes this irregular heartbeat, but you should report it to your doctor if you experience such 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 result of low calcium levels: irregular heartbeat (cardiac arrhythmia secondary to hypocalcemia).
• A kidney function disorder 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 result 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 symptoms of bone damage to the ear.
• Osteonecrosis has occurred very rarely also 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 Fresenius Kabi, tell your doctor immediately.

Tell your doctor immediately if you experience any of the following side
effects:
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 the bones, joints and/or muscles. In most cases, no specific treatment is necessary and the symptoms disappear after a short time (a few hours or days).
• Gastrointestinal reactions, such as nausea and vomiting and loss of appetite.
• Conjunctivitis.
• Low levels of red blood cells in the blood (anemia).

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 disorders.
• 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, tearing of the eyes, sensitivity to light.
• Sudden chills with fainting, weakness or collapse.
• Difficulty breathing with wheezing or cough.
• 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 tissue around the air sacs in the lungs).
• Flu-like symptoms including arthritis and joint swelling.
• Painful and/or swollen red eyes.

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

• Fainting caused by low blood pressure.
• Severe pain in the bones, joints and/or muscles, occasionally disabling.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Acido Zoledronico Fresenius Kabi

The doctor, pharmacist or nurse knows how to store Acido Zoledronico Fresenius Kabi appropriately (see paragraph 6).

6. Contents of the pack and other information

What Acido Zoledronico Fresenius Kabi contains

• The active ingredient of Acido Zoledronico Fresenius Kabi is zoledronic acid. One vial contains 4 mg of zoledronic acid (as monohydrate).
• The excipients are: mannitol, sodium citrate, water for injections.

Description of the appearance of Acido Zoledronico Fresenius Kabi and contents of the pack
Acido Zoledronico Fresenius Kabi is supplied as a solution in a clear and colourless plastic vial.
Acido Zoledronico Fresenius Kabi is supplied in packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz Austria

This medicinal product is authorised in the Member States of the EEA under the following denominations:

The following information is only for healthcare professionals
How to prepare and administer Acido Zoledronico Fresenius Kabi

• To prepare an infusion solution containing 4 mg of zoledronic acid, further dilute Acido Zoledronico Fresenius Kabi concentrate (5 ml) with 100 ml of an infusion solution free of calcium or other divalent cations. If a reduced dose of Acido Zoledronico Fresenius Kabi 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% p/v sodium chloride solution or 5% p/v glucose solution.

Do not mix Acido Zoledronico Fresenius Kabi with solutions containing calcium or
other divalent cations such as Ringer’s lactate solution.
Instructions for preparing Acido Zoledronico Fresenius Kabi 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 remaining must be discarded. Only clear, particle-free and colourless solution must be used. Aseptic techniques must be followed during the preparation of the infusion.

o Stability after dilution: chemical and physical stability in use has been demonstrated
for 24 hours at 2-8°C. From a microbiological point of view, the diluted infusion
solution must be used immediately. If not used immediately, the storage times
during use and the conditions prior to use are the responsibility of the user and
should not normally exceed 24 hours between 2°C–8°C. The refrigerated solution
must be brought to room temperature before administration.
o The solution containing Acido Zoledronico Fresenius Kabi must be
administered as a single infusion over a period of 20 minutes via a separate
infusion line. The hydration status of patients must be assessed

before and after the administration of Acido Zoledronico Fresenius
Kabi to ensure that they are adequately hydrated.
o Studies with glass bottles, as with different types of container made of
polyvinyl chloride, polyethylene and polypropylene (pre-filled with a solution of
0.9% p/v sodium chloride or 5% p/v glucose), have not demonstrated
incompatibility with Acido Zoledronico Fresenius Kabi.
o Since no compatibility data are available for Acido Zoledronico
Fresenius Kabi with other substances administered intravenously, Acido
Zoledronico Fresenius Kabi must not be mixed with other medicinal products and/or
substances and must always be administered via a separate infusion line.

How to store Acido Zoledronico Fresenius Kabi

• 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 pack.
• The closed vial does not require any special storage conditions.
• For storage conditions after dilution, see “stability after dilution”.