Zoledronic acid Hospira: detailed information

Package leaflet: Information for the user

Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion

Zoledronic Acid
Please read all of this leaflet carefully before this medicine is administered to you 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What Zoledronic Acid Hospira is and what it is used for
What you need to know before you are given Zoledronic Acid Hospira
How Zoledronic Acid Hospira is used
Possible side effects
How to store Zoledronic Acid Hospira
Contents of the pack and other information

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

The active substance of Acido Zoledronico Hospira is zoledronic acid, which belongs to a group of
substances called bisphosphonates. Zoledronic acid works by binding to 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 tumour from the primary tumour site to the bones)
* to reduce the amount of calcium in the blood in adult patients in whom it is too high due to the
presence of a tumour. Tumours can accelerate normal bone metabolism, leading to increased release of calcium from bone.
This condition is known as tumour-induced hypercalcaemia (TIH).

2. What you need to know before you are given Acido Zoledronico Hospira

Follow carefully all instructions given to you by your doctor.
Before starting treatment with Acido Zoledronico Hospira, your doctor will carry out blood tests and will monitor your response to treatment at regular intervals.
Acido Zoledronico Hospira must not be given to you

if you are breastfeeding
if you are allergic (hypersensitive) to zoledronic acid, to any other bisphosphonate (the group of substances to which Acido Zoledronico Hospira belongs) or to 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 Hospira:

if you have or have had kidney problems
if you have or have had pain, swelling or numbness in the jaw or a feeling of heaviness in the jaw, or if a tooth is loose. Your doctor may recommend that you have a dental examination before starting treatment with Acido Zoledronico Hospira
if you are currently undergoing dental treatments or need to undergo dental surgery; inform your dentist that you are being treated with Acido Zoledronico Hospira and inform your doctor about your dental treatments.

During treatment with Acido Zoledronico Hospira, you must maintain good oral hygiene (including regular tooth cleaning) and have 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 wounds to heal, or discharge, as these may be signs of a condition called osteonecrosis of the jaw.
Patients receiving chemotherapy and/or radiotherapy, those taking steroids, those undergoing dental surgery, those not receiving routine dental care, those with gum disease, smokers, or those previously treated with bisphosphonates (used to treat or prevent bone disorders) have a higher risk of developing osteonecrosis of the jaw.
Low levels of calcium in the blood (hypocalcaemia) have been reported in patients treated with zoledronic acid, which may sometimes cause muscle cramps, dry skin, or a burning sensation. Cases of irregular heartbeat (cardiac arrhythmia), seizures, muscle spasms and contractions (tetany) secondary to severe hypocalcaemia have also been reported. In some circumstances, hypocalcaemia can be life-threatening. If any of these conditions apply to you, inform your doctor immediately.
If you have pre-existing hypocalcaemia, it must be treated before the first dose of Acido Zoledronico Hospira is administered. You will be given adequate supplementation of calcium and vitamin D.
Patients aged 65 years and older
Acido Zoledronico Hospira can be administered to patients aged 65 years and older.
There is no evidence suggesting the need for additional precautions.
Children and adolescents
Acido Zoledronico Hospira is not recommended for use in adolescents and children under 18 years of age.
Other medicines and Acido Zoledronico Hospira
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is particularly important that you inform your doctor if you are also taking:

Aminoglycosides (medicines used to treat serious infections), calcitonin (a type of medicine used to treat postmenopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine used to treat high blood pressure or oedema), or other medicines that lower calcium levels, as the combination of these substances
with bisphosphonates could cause an excessive decrease in blood calcium concentration.
Thalidomide (a medicine used to treat certain types of blood cancers involving the bones) or any other medicine that may be harmful to the kidneys.
Other medicines containing zoledronic acid used in the treatment of osteoporosis and other non-tumour bone diseases, or any other bisphosphonate, since the combined effects of these medicines when taken together with Acido Zoledronico Hospira are unknown.
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 (ONJ).

Pregnancy and breastfeeding
Acido Zoledronico Hospira must not be given to you if you are pregnant. Inform your doctor if you are pregnant or suspect you may be pregnant.
Acido Zoledronico Hospira must not be given to you if you are breastfeeding.
If you are pregnant or breastfeeding, ask your doctor for advice before taking any medicine.
Driving and using machines
Somnolence and drowsiness have been reported very rarely with the use of Acido Zoledronico Hospira.
Therefore, you should exercise extreme caution when driving, operating machinery or performing other activities requiring special attention.
Acido Zoledronico Hospira contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically “sodium-free”.

3. How Acido Zoledronico Hospira is used

Acido Zoledronico Hospira must be administered only by healthcare professionals trained in the use of intravenous bisphosphonates, that is, through a vein (also referred to as I.V. administration).
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, pharmacist, or nurse.

How much Acido Zoledronico Hospira is administered

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

How often Acido Zoledronico Hospira is administered

If you are being treated to prevent bone complications caused by bone metastases, you will receive an infusion of Acido Zoledronico Hospira every three to four weeks.
If you are being treated to reduce the level of calcium in your blood, you will normally receive a single infusion of Acido Zoledronico Hospira.

How Acido Zoledronico Hospira is administered

Acido Zoledronico Hospira is administered intravenously as an infusion lasting at least 15 minutes and must be given as a single intravenous solution through a separate infusion line.

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

If you have been administered more Acido Zoledronico Hospira than you should have If doses higher than those recommended have been administered, you must be monitored particularly closely by your doctor. This is because you may develop serum electrolyte abnormalities (e.g., abnormal levels of calcium, phosphate, and magnesium) and/or changes in renal function, including severe kidney impairment. If calcium levels drop too low, you may require 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 ones are usually mild and may disappear in a short time.
Inform your doctor immediately if you experience any of the following serious side effects:

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

Severe kidney failure (this will normally be detected by your 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, swelling or failure of sores in the mouth or jaw to heal, discharge, numbness or a feeling of heaviness in the jaw, or a loose tooth. These may be signs of jaw damage (osteonecrosis). If you experience any of these symptoms, inform your doctor and dentist immediately during or after treatment with Zoledronic Acid Hospira.
Irregular heart rhythm (atrial fibrillation) has been observed in patients treated with zoledronic acid for postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular heart rhythm, but you must inform your doctor if you develop such symptoms after receiving zoledronic acid.
Severe allergic reactions: difficulty breathing, swelling, particularly 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 hypocalcaemia).
A kidney function disorder called Fanconi syndrome (this will normally be diagnosed by your doctor through certain urine tests).

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

As a consequence of low calcium levels: seizures, numbness, and tetany (secondary to hypocalcaemia).
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be signs of bone damage in the ear.
Osteonecrosis has very rarely occurred in other bones besides the jaw, particularly in the hip or thigh. If you experience symptoms such as onset or worsening of pain, pain or stiffness during or after stopping treatment with Zoledronic Acid Hospira, inform your doctor immediately.

Inform your doctor as soon as possible if any of the following side effects occur:

Very common (may affect more than 1 in 10 people): Low levels of phosphate in the blood.

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

Headache and a flu-like syndrome with fever, fatigue, weakness, drowsiness, chills, and bone, joint, and/or muscle pain. In most cases, no specific treatment is needed and symptoms disappear within a short time (a few hours or days).
Gastrointestinal reactions such as nausea and vomiting, as well as loss of appetite.
Conjunctivitis.
Low levels of red blood cells in the blood (anaemia).

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 disturbances, taste disturbances, tremor, tingling or numbness of the hands or feet, diarrhoea, 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. Your doctor will monitor these and take necessary measures.
Weight gain.
Increased sweating.
Drowsiness.
Blurred vision, eye lesions, eye sensitivity to light.
Sudden chills with fainting, weakness, or collapse.
Difficulty breathing with wheezing or cough.
Hives.

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

Slow heart rate.
Confusion.
Rarely, an unusual femur fracture may occur, particularly 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 could be an early sign of a possible femur fracture.
Pulmonary interstitial disease (inflammation of the tissue surrounding the air sacs, alveoli, in the lungs). 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 bone, joint, and/or muscle pain, occasionally disabling.

Reporting of side effects
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed 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 Hospira

Your doctor, pharmacist or nurse knows how to appropriately store Acido Zoledronico Hospira (see section 6).

6. Package contents and other information

What Acido Zoledronico Hospira contains

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

Description of the appearance of Acido Zoledronico Hospira and package contents
Acido Zoledronico Hospira is supplied as a concentrated liquid (referred to as "concentrate for solution for infusion" or "sterile concentrate") in a vial. One vial contains 4 mg of zoledronic acid.
Each pack contains one vial of concentrate.

Marketing Authorization Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
1930 Zaventem
Belgium

For further information about this medicinal product, please contact the representative of the Marketing Authorization Holder:

BE/LU LT
Pfizer NV/SA Pfizer Luxembourg SARL filialas Lietuvoje
Tél/Tel: +32 (0) 2 554 62 11 Tel. + 370 52 51 4000

BG
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

CZ HU
Pfizer, spol. s r.o. Pfizer Kft.
Tel: +420-283-004-111 Tel: + 36 1 488 37 00

DK MT
Pfizer ApS Drugsales Ltd
Tlf: + 45 44 20 11 00 Tel: +356 21 419 070/1/2

DE NL
PFIZER PHARMA GmbH Pfizer bv
Tel: +49 (0)30 550055-51000 Tel: +31 (0)10 406 43 01

EE NO
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00

EL AT
Pfizer ΕΛΛΑΣ A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ.: +30 210 6785 800 Tel: +43 (0)1 521 15-0

ES PL
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: +34 91 490 99 00 Tel: +48 22 335 61 00

FR PT
Pfizer Laboratórios Pfizer, Lda.
Tél: + 33 (0)1 58 07 34 40 Tel: +351 21 423 55 00

HR RO
Pfizer Croatia d.o.o. Pfizer România S.R.L.
Tel: +385 1 3908 777 Tel: +40 (0)21 207 28 00

IE SI
Pfizer Healthcare Ireland Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0) 1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

IS SK
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: +354 540 8000 Tel: +421–2–3355 5500

IT FI
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 430 040

CY SE
Pharmaceutical Trading Co Ltd Pfizer AB
Τηλ: 24656165 Tel: +46 (0)8 550 520 00

LV UK(Northern Ireland)
Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited
Tel.: + 371 670 35 775 Tel: + 44 (0) 1304 616161

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

INFORMATION FOR HEALTHCARE PROFESSIONALS
How to prepare and administer Acido Zoledronico Hospira

To prepare an infusion solution containing 4 mg of Acido Zoledronico Hospira, further dilute Acido Zoledronico Hospira concentrate (5.0 ml) with 100 ml of a calcium-free infusion solution or other bivalent cations. If a reduced dose of Acido Zoledronico Hospira is required, withdraw the appropriate volume as indicated below and then further dilute it in 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride injection solution or 5% w/v glucose solution.

Acido Zoledronico Hospira concentrate must not be mixed with calcium-containing solutions
or other bivalent cations such as lactated Ringer's solution.

Instructions for preparing reduced doses of Acido Zoledronico Hospira
Withdraw the appropriate volume of solution required 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 residue must be discarded. Only clear, particle-free, colorless solution should be used. Aseptic techniques must be followed during the preparation of the infusion.
From a microbiological standpoint, the diluted infusion solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C. Refrigerated solution must be brought to room temperature before administration.
The solution containing Acido Zoledronico Hospira must be administered as a single 15-minute intravenous infusion through a separate infusion line. The patient's hydration status should be assessed before and after administration of zoledronic acid to ensure adequate hydration.
Numerous studies using polyvinyl chloride, polyethylene, and polypropylene infusion lines have shown no incompatibility with zoledronic acid.
Since compatibility data with other substances administered intravenously are not available, Acido Zoledronico Hospira must not be mixed with other medicinal products and/or substances and must always be administered through a separate infusion line.

How to store Acido Zoledronico Hospira

Keep Acido Zoledronico Hospira out of the reach and sight of children.
Do not use Acido Zoledronico Hospira after the expiry date stated on the packaging.
The unopened, intact vial does not require any special storage conditions.
The diluted infusion solution of Acido Zoledronico Hospira should preferably be used immediately to avoid microbial contamination.

Package leaflet: information for the user

Zoledronic Acid Hospira 4 mg/100 ml infusion solution

Zoledronic acid
Please 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Zoledronic Acid Hospira is and what it is used for
What you need to know before you are given Zoledronic Acid Hospira
How Zoledronic Acid Hospira is used
Possible side effects
How to store Zoledronic Acid Hospira
Contents of the pack and other information

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

The active substance of Acido Zoledronico Hospira is zoledronic acid, which belongs to a group of
substances called bisphosphonates. Zoledronic acid works by binding to 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 the tumour from the primary tumour site to the bones)
* To reduce the amount of calcium in the blood in adult patients in whom it is too high due to the
presence of a tumour. Tumours can accelerate normal bone metabolism so that the release of calcium from bone is increased.
This condition is known as tumour-induced hypercalcaemia (TIH).

2. What you need to know before you are given Acido Zoledronico Hospira

if you are breastfeeding
if you are allergic (hypersensitive) to zoledronic acid, to any other bisphosphonate (the group of substances to which zoledronic acid belongs), or to any of the other ingredients of Acido Zoledronico Hospira.

Warnings and precautions
Talk to your doctor before you are given Acido Zoledronico Hospira:

if you have or have had kidney problems
if you have or have had pain, swelling or numbness in the jaw/mandible or a feeling of heaviness in the jaw/mandible or loosening of a tooth. Your doctor may recommend that you undergo a dental examination before starting treatment with Acido Zoledronico Hospira.
if you are currently undergoing dental treatments or need to have dental surgery; inform your dentist that you are being treated with Acido Zoledronico Hospira and inform your doctor about your dental treatments.

During treatment with Acido Zoledronico Hospira, you must maintain good oral hygiene (including regular tooth cleaning) and undergo 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, failure of wounds to heal, or discharge, as these may be signs of a condition called osteonecrosis of the jaw/mandible.
Patients receiving chemotherapy and/or radiotherapy, those taking steroids, those undergoing dental surgery, those not receiving routine dental care, those with gum disease, smokers, or those previously treated with bisphosphonates (used to treat or prevent bone diseases) have a higher risk of developing osteonecrosis of the jaw/mandible.
In patients treated with zoledronic acid, reduced levels of calcium in the blood (hypocalcaemia) have been reported, which may sometimes cause muscle cramps, dry skin, or a burning sensation. Cases of irregular heartbeat (cardiac arrhythmia), seizures, muscle spasms and contractions (tetany) secondary to severe hypocalcaemia have also been reported. In some cases, hypocalcaemia may be life-threatening. If any of these conditions apply to you, inform your doctor immediately.
If you have pre-existing hypocalcaemia, it must be treated before starting the first dose of Acido Zoledronico Hospira. You will be given adequate calcium and vitamin D supplementation.
Patients aged 65 years and older
Acido Zoledronico Hospira for infusion can be administered to people aged 65 years and older. There is no evidence suggesting the need for additional precautions.
Children and adolescents
Acido Zoledronico Hospira is not recommended for use in adolescents and children under 18 years of age.
Other medicines and Acido Zoledronico Hospira
Inform your doctor if you are taking, have recently taken, or might take any other medicines. It is particularly important that you inform your doctor if you are also taking:

Aminoglycosides (medicines used to treat serious infections), calcitonin (a type of medicine used to treat postmenopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine used to treat high blood pressure or oedema), or other medicines that lower calcium levels, as the combination of these substances
with bisphosphonates may cause an excessive decrease in blood calcium concentration.
Thalidomide (a medicine used to treat certain types of blood cancers involving the bones) or any other medicine that may be harmful to the kidneys.
Other medicines containing zoledronic acid used in the treatment of osteoporosis and other non-tumour bone diseases, or any other bisphosphonate, since the combined effects of these medicines when taken together with Acido Zoledronico Hospira are unknown.
Anti-angiogenic medicines (used to treat cancer), as the combination of these with Acido Zoledronico Hospira has been associated with an increased risk of osteonecrosis of the jaw (ONJ).

Pregnancy and breastfeeding
If you are pregnant, Acido Zoledronico Hospira must not be administered to you. Inform your doctor if you are pregnant or suspect you may be pregnant.
If you are breastfeeding, Acido Zoledronico Hospira must not be administered to you.
If you are pregnant or breastfeeding, ask your doctor for advice before taking any medicine.
Driving and using machines
Somnolence and numbness have very rarely occurred with the use of Acido Zoledronico Hospira.
Therefore, you should exercise maximum caution when driving, operating machinery, or performing other activities requiring special attention.
Acido Zoledronico Hospira contains sodium
This medicine contains 360 mg of sodium (the main component of table salt) in each dosage unit. This corresponds to 18% of the maximum recommended daily intake of sodium for an adult.

3. How Acido Zoledronico Hospira is used

Acido Zoledronico Hospira must be administered only by healthcare personnel trained in the use of intravenous bisphosphonates, 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, pharmacist, or nurse.

How much Acido Zoledronico Hospira is administered

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

How often Acido Zoledronico Hospira is administered

If you are being treated to prevent bone complications due to bone metastases, you will receive an infusion of Acido Zoledronico Hospira every three to four weeks.
If you are being treated to reduce the amount of calcium in your blood, you will normally receive a single infusion of Acido Zoledronico Hospira.

How Acido Zoledronico Hospira is administered

Acido Zoledronico Hospira is administered intravenously as an infusion lasting at least 15 minutes and must be given as a single intravenous solution via a separate infusion line.

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

If you have been given more Acido Zoledronico Hospira than you should have received
If doses higher than recommended have been administered, you must be closely monitored by your doctor. This is because you could develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphate, and magnesium) and/or changes in renal function, including severe kidney impairment. If your calcium levels drop too low, you may need to receive intravenous calcium supplementation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common ones are usually mild and may disappear in a short time.
Contact your doctor immediately if you experience any of the following serious side effects:

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

Severe kidney failure (this will normally be detected by your 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, swelling or failure of healing of sores in the mouth or jaw, discharge, numbness or heaviness in the jaw or loosening of a tooth. These may be signs of jaw bone damage (osteonecrosis). If you experience any of these symptoms, inform your doctor and dentist immediately, both during or after stopping treatment with Zoledronic Acid Hospira.
In patients treated with zoledronic acid for postmenopausal osteoporosis, an irregular heart rhythm (atrial fibrillation) has been observed. It is currently unclear whether zoledronic acid causes this irregular heart rhythm, but you should report such symptoms to your doctor if they occur after receiving zoledronic acid.
Severe allergic reactions: difficulty breathing, swelling, particularly 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 hypocalcaemia).
A kidney function disorder called Fanconi syndrome (this will normally be diagnosed by your doctor through certain urine tests).

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

As a consequence of low calcium levels: seizures, numbness and tetany (secondary to hypocalcaemia).
Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.
Osteonecrosis has very rarely occurred in other bones besides the jaw, particularly in the hip or thigh. If you experience symptoms such as onset or worsening of pain, pain or stiffness during or after stopping treatment with Zoledronic Acid Hospira, inform your doctor immediately.

Contact your doctor as soon as possible if any of the following side effects occur:

Very common (may affect more than 1 in 10 people):

Low levels of phosphate in the blood.

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

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

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 disturbances, taste disturbances, tremor, tingling or numbness in the hands or feet, diarrhoea, 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. Your doctor will monitor these and take necessary measures.
Weight gain.
Increased sweating.
Drowsiness.
Blurred vision, eye lesions, light sensitivity.
Sudden chills with fainting, weakness or collapse.
Breathing difficulties with wheezing or cough.
Hives.
Rare (may affect up to 1 in 1,000 people):
Slow heart rate.
Confusion.
Rarely, an unusual fracture of the femur may occur, particularly 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 could be an early sign of a possible femur fracture.
Interstitial lung disease (inflammation of the tissue surrounding the air sacs, alveoli, of the lungs).
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 bone, joint and/or muscle pain, occasionally disabling.

Reporting of side effects
If you experience any adverse events, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed 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 Hospira

Your doctor, pharmacist or nurse knows how to store Acido Zoledronico Hospira
appropriately (see section 6).

6. Package contents and other information

What Acido Zoledronico Hospira contains

The active substance of Acido Zoledronico Hospira 4 mg/100 ml infusion solution is zoledronic acid. One 100 ml bag contains 4 mg of zoledronic acid (as monohydrate). One ml of solution contains 0.04 mg of zoledronic acid (as monohydrate).
The other components are: mannitol, sodium citrate, sodium chloride, and water for injections.
(see section 2, Acido Zoledronico Hospira 4 mg/100 ml infusion solution contains sodium).

Description of the appearance of Acido Zoledronico Hospira and contents of the pack
Acido Zoledronico Hospira is a clear, colourless solution. It is supplied in 100 ml plastic bags as ready-to-use infusion solution. Each pack contains one bag with 4 mg of zoledronic acid.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
1930 Zaventem
Belgium
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
BE/LU LT
Pfizer NV/SA Pfizer Luxembourg SARL filialas Lietuvoje
Tél/Tel: +32 (0) 2 554 62 11 Tel. + 370 52 51 4000
BG
Пфайзер Люксембург САРЛ, Клон България
Tel.: +359 2 970 4333
CZ HU
Pfizer, spol. s r.o. Pfizer Kft.
Tel: +420-283-004-111 Tel: + 36 1 488 37 00
DK MT
Pfizer ApS Drugsales Ltd
Tlf: + 45 44 20 11 00 Tel: +356 21 419 070/1/2
DE NL
PFIZER PHARMA GmbH Pfizer bv
Tel: +49 (0)30 550055-51000 Tel: +31 (0)10 406 43 01
EE NO
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00
EL AT
Pfizer ΕΛΛΑΣ A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ.: +30 210 6785 800 Tel: +43 (0)1 521 15-0
ES PL
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: +34 91 490 99 00 Tel: +48 22 335 61 00
FR PT
Pfizer Laboratórios Pfizer, Lda.
Tél: + 33 (0)1 58 07 34 40 Tel: +351 21 423 55 00
HR RO
Pfizer Croatia d.o.o. Pfizer România S.R.L.
Tel: +385 1 3908 777 Tel: +40 (0)21 207 28 00
IE SI
Pfizer Healthcare Ireland Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0) 1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400
IS SK
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: +354 540 8000 Tel: +421–2–3355 5500
IT FI
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 430 040
CY SE
Pharmaceutical Trading Co Ltd Pfizer AB
Tel: 24656165 Tel: +46 (0)8 550 520 00
LV UK (Northern Ireland)
Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited
Tel.: + 371 670 35 775 Tel: + 44 (0) 1304 616161
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
INFORMATION FOR HEALTHCARE PROFESSIONALS
How to prepare and administer Acido Zoledronico Hospira

Acido Zoledronico Hospira 4 mg/100 ml infusion solution contains 4 mg of zoledronic acid in 100 ml of ready-to-use infusion solution for patients with normal renal function.
For single use only. Any unused solution should be discarded. Only use solution that is clear, free from visible particles and without discoloration. Aseptic techniques must be followed during preparation of the infusion.
From a microbiological standpoint, the infusion solution should be used immediately after first opening. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, provided that dilution is performed under controlled and validated aseptic conditions. Refrigerated solution should be brought to room temperature before administration.
The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions. It should be administered as a single intravenous infusion via a separate infusion line over 15 minutes. The hydration status of

patients must be assessed before and after administration of zoledronic acid to ensure they are adequately hydrated.

In patients with normal renal function, Acido Zoledronico Hospira 4 mg/100 ml infusion solution should be administered immediately without any further preparation. In patients with mild to moderate renal impairment, a reduced dose should be prepared according to the instructions below.

To prepare reduced doses for patients with baseline CLcr ≤60 ml/min, refer to Table 1 below. Remove the volume of Acido Zoledronico Hospira solution indicated from the bag and replace it with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution for injection.
Table 1: Preparation of reduced doses of Acido Zoledronico Hospira 4 mg/100 ml infusion solution

Basal creatinine clearance (ml/min)	Remove the following amount of Acido Zoledronico Hospira 4 mg/100 ml solution for infusion (ml)	Dose adjustment (mg of zoledronic acid in 100 ml)*
50-60	12.0	3.5
40-49	18.0	3.3
30-39	25.0	3.0

*The doses were calculated assuming a target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min). Administration of the reduced dose in patients with renal impairment is expected to achieve an AUC value equal to that observed in patients with a creatinine clearance of 75 ml/min.

Numerous studies conducted using infusion lines made of polyvinyl chloride, polyethylene, and polypropylene have shown no incompatibility with zoledronic acid.
Since compatibility data of Acido Zoledronico Hospira with other substances administered intravenously are not available, Acido Zoledronico Hospira must not be mixed with other medicinal products and/or substances and should always be administered through a separate infusion line.

How to store Acido Zoledronico Hospira

Keep Acido Zoledronico Hospira out of the sight and reach of children.
Do not use Acido Zoledronico Hospira after the expiry date stated on the packaging.
The bag does not require any special storage conditions.
After opening the vial, the product must be used immediately to avoid microbial contamination.

Package leaflet: Information for the user

Zoledronic Acid Hospira 5 mg/100 ml infusion solution

Zoledronic acid
Please read this leaflet carefully before you are given this medicine, as 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 experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Zoledronic Acid Hospira is and what it is used for
What you need to know before you are given Zoledronic Acid Hospira
How Zoledronic Acid Hospira is administered
Possible side effects
How to store Zoledronic Acid Hospira
Contents of the pack and other information

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

Acido Zoledronico Hospira contains the active substance acido zoledronico. It belongs to a group of medicines called bisphosphonates and is used to treat Paget’s disease of bone in adults.

Normally, old bone is removed and replaced by new bone tissue. This process is called bone remodelling. In Paget’s disease, bone remodelling occurs too rapidly, and the new bone forms in a disorganised way, making it weaker than normal. If left untreated, bones may become deformed, painful, and may fracture. Acido Zoledronico Hospira works by restoring normal bone remodelling, ensuring normal bone formation and thereby re-establishing bone strength.

2. What you should know before being given Zoledronic Acid Hospira

Carefully follow all instructions provided by your doctor, pharmacist, or nurse before
you are given Zoledronic Acid Hospira.
Zoledronic Acid Hospira must not be given to you:

if you are allergic to zoledronic acid, other bisphosphonates, or any of the excipients of this medicine (listed in section 6).
if you have hypocalcemia (that is, if your blood calcium levels are too low).
if you have severe kidney problems.
if you are pregnant.
if you are breastfeeding.

Warnings and precautions
Talk to your doctor before you are given Zoledronic Acid Hospira:

if you are already being treated with other medicines containing zoledronic acid, the active substance in Zoledronic Acid Hospira (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce calcium levels).
if you have kidney problems or have had them in the past.
if you cannot take a daily calcium supplement.
if you have had part or all of your parathyroid glands in the neck surgically removed.
if sections of your intestine have been surgically removed.

An adverse effect called osteonecrosis of the jaw/mandible (bone damage in the jaw/mandible) has been reported in post-marketing experience in patients treated with zoledronic acid for the treatment of osteoporosis. Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the onset of osteonecrosis of the jaw/mandible, as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, there are several precautions you should take.
Before receiving treatment with Zoledronic Acid Hospira, talk to your doctor, pharmacist, or nurse if:

you have any mouth or dental problems such as poor dental health, gum disease, or if you have planned a dental extraction;
you do not receive routine dental care or have not had a dental check-up for a long time;
you are a smoker (as this may increase the risk of dental problems);
you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders);
you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with Zoledronic Acid Hospira.
During treatment with Zoledronic Acid Hospira, you must maintain good oral hygiene (including regular tooth cleaning) and receive routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or need dental surgery (e.g., tooth extractions), inform your doctor and tell your dentist that you are being treated with Zoledronic Acid Hospira. Immediately inform your doctor and dentist if you experience any mouth or dental problems such as tooth loss, pain, swelling, failure of wounds to heal, or discharge, as these may be signs of osteonecrosis of the jaw/mandible.
Monitoring tests
Your doctor should take a blood sample to check your kidney function (creatinine levels) before each infusion of Zoledronic Acid Hospira. It is important that you drink at least two glasses of fluid (for example, water) within a few hours before treatment with Zoledronic Acid Hospira, as instructed by your healthcare provider.
Children and adolescents
Zoledronic Acid Hospira is not recommended for use in individuals under 18 years of age.
Other medicines and Zoledronic Acid Hospira
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
It is important for your doctor to know about all medicines you are taking, especially if you are already taking other medicines that may potentially harm the kidneys (e.g., aminoglycosides) or diuretics (“water pills”) that may cause dehydration.
Pregnancy and breastfeeding
Zoledronic Acid Hospira must not be given to you if you are pregnant or breastfeeding, or if you suspect you are pregnant or are planning to become pregnant.
Ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Driving and using machines
If you feel dizzy while taking Zoledronic Acid Hospira, do not drive or operate machinery until you feel better.
Zoledronic Acid Hospira contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How Acido Zoledronico Hospira is administered

Carefully follow all instructions provided by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
For the treatment of Paget's disease, Acido Zoledronico Hospira must be prescribed only by physicians experienced in the management of bone Paget's disease.
The usual dose is 5 mg, administered by your doctor or nurse as a single intravenous infusion.
The infusion will last at least 15 minutes. Acido Zoledronico Hospira may remain effective for more than one year, and your doctor will inform you if further treatment is needed.
Your doctor may advise you to take calcium and vitamin D supplements (for example, in tablet form) for at least the first ten days following administration of Acido Zoledronico Hospira. It is important that you follow this advice carefully to prevent blood calcium levels from becoming too low in the period following the infusion. Your doctor will inform you about possible symptoms associated with hypocalcemia.

Acido Zoledronico Hospira with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after treatment with Acido Zoledronico Hospira, as directed by your doctor. This will help prevent dehydration. On the day of treatment with Acido Zoledronico Hospira, you may eat normally.
This is particularly important for patients taking diuretics ("water pills") and for elderly patients (aged 65 years or older).

If you forget to take Acido Zoledronico Hospira
Contact your doctor or hospital as soon as possible to schedule a new appointment.

If you stop treatment with Acido Zoledronico Hospira
If you are considering stopping treatment with Acido Zoledronico Hospira, please attend your next appointment and discuss this with your doctor. Your doctor can advise you and decide how long treatment with Acido Zoledronico Hospira should continue.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects related to the first infusion are very common (occurring in more than 30% of patients), but become less common with subsequent infusions. Most side effects such as fever and chills, muscle or joint pain, and headache occur within the first three days after administration of Acido Zoledronico Hospira. Symptoms are usually mild to moderate and resolve within three days. Your doctor may recommend a mild painkiller such as ibuprofen or paracetamol to reduce these side effects. The likelihood of experiencing side effects decreases with subsequent doses of Acido Zoledronico Hospira.
Some side effects may be serious
Common (may affect up to 1 in 10 people)
In patients treated with zoledronic acid for postmenopausal osteoporosis, irregular heart rhythm (atrial fibrillation) has been observed. It is currently unclear whether zoledronic acid is the cause of this irregular heart rhythm, but you must inform your doctor if you experience such symptoms after receiving zoledronic acid.
Uncommon (may affect up to 1 in 100 people)
Swelling, redness, pain and itching of the eyes or sensitivity of the eyes to light.
Very rare (may affect up to 1 in 10,000 people)
Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear.
Not known (frequency cannot be estimated from available data)
Pain in the mouth and/or jaw, swelling or sores inside the mouth or jaw that do not heal, discharge, numbness or a feeling of heaviness in the jaw, or tooth loss. These could be signs of bone damage in the jaw (osteonecrosis). Inform your doctor and dentist immediately if you experience any of these symptoms while being treated with Acido Zoledronico Hospira or after stopping treatment.
Kidney problems may occur (e.g. reduced urine output). Your doctor will need to take a blood sample to check your kidney function before each infusion of Acido Zoledronico Hospira. It is important that you drink at least one or two glasses of fluid (e.g. water) within a few hours before treatment with Acido Zoledronico Hospira, as advised by your healthcare provider.
If you experience any of these side effects, inform your doctor immediately.
Acido Zoledronico Hospira may also cause other side effects
Very common (affects more than 1 in 10 people)
Fever
Common (affects up to 1 in 10 people)
Headache, dizziness, malaise, vomiting, diarrhoea, muscle pain, bone and/or joint pain, back, arm or leg pain, flu-like symptoms (e.g. fatigue, chills, joint and muscle pain), chills, feeling tired and lacking interest, weakness, pain, feeling unwell. Swelling and/or pain at the injection site may occur.
In patients with Paget’s disease, symptoms due to low calcium levels in the blood have been reported, such as muscle spasms, numbness or tingling, particularly around the mouth.
Uncommon (may affect up to 1 in 100 people)
Influenza, upper respiratory tract infections, decreased red blood cell count, loss of appetite, insomnia, drowsiness which may include reduced alertness and consciousness, tingling or numbness sensations, extreme tiredness, tremors, temporary loss of consciousness, eye infection or irritation and inflammation with pain and redness, dizziness, increased blood pressure, hot flushes, cough, shortness of breath, stomach ache, abdominal pain, constipation, dry mouth, heartburn, rash, excessive sweating, itching, skin redness, neck pain, muscle, bone and/or joint stiffness, joint swelling, muscle spasms, shoulder pain, chest and rib cage muscle pain, joint inflammation, muscle weakness, abnormal kidney function tests, frequent abnormal need to urinate, swelling of the hands, ankles or feet, thirst, toothache, altered taste.
Rare (may affect up to 1 in 1,000 people)
Rarely, particularly in patients receiving long-term treatment for osteoporosis, an unusual fracture of the femur may occur. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this could be an early sign of a possible femur fracture. Low levels of phosphate in the blood.
Not known (frequency cannot be estimated from available data)
Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, low blood pressure, dehydration secondary to acute phase reactions (post-dose symptoms such as fever, vomiting and diarrhoea).
Reporting of side effects
If you experience any adverse events, including those not listed in this leaflet, speak to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed 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 Hospira

Your doctor, pharmacist or nurse will know how to properly store
Acido Zoledronico Hospira.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bag after Exp.
The unopened bag does not require any special storage conditions.
After opening the bag, the product must be used immediately to avoid microbial contamination. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C. Allow the solution removed from the refrigerator to reach room temperature before use.

6. Package contents and other information

What Acido Zoledronico Hospira 5 mg/100 ml infusion solution contains

The active substance is zoledronic acid. One 100 ml bag of solution contains 5 mg of anhydrous zoledronic acid (as monohydrate). One ml of solution contains 0.05 mg of zoledronic acid (as monohydrate).
The excipients are mannitol, sodium citrate, and water for injections.

Description of the appearance of Acido Zoledronico Hospira and contents of the pack
Acido Zoledronico Hospira is a clear, colourless solution. It is supplied in 100 ml plastic bags containing ready-to-use solution for infusion. Each pack contains one bag.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
1930 Zaventem
Belgium
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
BE/LU LT
Pfizer NV/SA Pfizer Luxembourg SARL filialas Lietuvoje
Tél/Tel: +32 (0) 2 554 62 11 Tel. + 370 52 51 4000
BG
Пфайзер Люксембург САРЛ, Клон България
Tel.: +359 2 970 4333
CZ HU
Pfizer, spol. s r.o. Pfizer Kft.
Tel: +420-283-004-111 Tel: + 36 1 488 37 00
DK MT
Pfizer ApS Drugsales Ltd
Tlf: + 45 44 20 11 00 Tel: +356 21 419 070/1/2
DE NL
PFIZER PHARMA GmbH Pfizer bv
Tel: +49 (0)30 550055-51000 Tel: +31 (0)10 406 43 01
EE NO
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 52 61 00
EL AT
Pfizer ΕΛΛΑΣ A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ.: +30 210 6785 800 Tel: +43 (0)1 521 15-0
ES PL
Pfizer, S.L. Pfizer Polska Sp. z o.o.
Tel: +34 91 490 99 00 Tel: +48 22 335 61 00
FR PT
Pfizer Laboratórios Pfizer, Lda.
Tél: + 33 (0)1 58 07 34 40 Tel: +351 21 423 55 00
HR RO
Pfizer Croatia d.o.o. Pfizer România S.R.L.
Tel: +385 1 3908 777 Tel: +40 (0)21 207 28 00
IE SI
Pfizer Healthcare Ireland Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0) 1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400
IS SK
Icepharma hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: +354 540 8000 Tel: +421–2–3355 5500
IT FI
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 430 040
CY SE
Pharmaceutical Trading Co Ltd Pfizer AB
Tel: 24656165 Tel: +46 (0)8 550 520 00
LV UK (Northern Ireland)
Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited
Tel.: + 371 670 35 775 Tel: + 44 (0) 1304 616161
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

INFORMATION FOR HEALTHCARE PROFESSIONALS
How to prepare and administer Acido Zoledronico Hospira

Acido Zoledronico Hospira is ready to use.

For single use only. Any unused solution should be discarded. Only use solution that is clear, particle-free, and without discoloration. Acido Zoledronico Hospira must not be mixed or administered intravenously with other medicinal products and must be administered via a dedicated vented infusion line at a constant rate. The infusion time must be longer than 15 minutes. Acido Zoledronico Hospira must not come into contact with calcium-containing solutions. If refrigerated, the solution must reach room temperature before administration. Aseptic techniques must be followed during preparation of the infusion. The infusion must be administered according to standard medical practice.

How to store Acido Zoledronico Hospira

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging and bag after EXP.
The bag, in its intact packaging, requires no special storage conditions.
After opening the bag, the medicinal product must be used immediately to avoid microbial contamination. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally do not exceed 24 hours at 2°C - 8°C. If refrigerated, the solution must reach room temperature before administration.