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ZOLEDRONIC ACID MYLAN 5 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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Package leaflet: Information for the user

Zoledronic acid 5mg/100ml
solution for infusion
(zoledronic acid)

Read all of 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 further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Zoledronic acid 5 mg/100 ml solution for infusion is and what it is used for
2. What you need to know before you are given Zoledronic acid 5 mg/100 ml solution for
infusion
3. How Zoledronic acid 5 mg/100 ml solution for infusion is given
4. Possible side effects
5. How to store Zoledronic acid 5 mg/100 ml solution for infusion
6. Contents of the pack and other information
1. What Zoledronic acid 5 mg/100 ml solution for infusion is and what it is used for
Zoledronic acid 5 mg/100 ml solution for infusion contains the active substance zoledronic
acid. It belongs to a group of medicines called bisphosphonates and is used to treat postmenopausal women and adult men with osteoporosis or osteoporosis caused by treatment
with steroids, and Paget's disease of the bone in adults.
Osteoporosis
Osteoporosis is a disease that involves the thinning and weakening of the bones and is
common in women after the menopause, but can also occur in men. At the menopause, a
woman's ovaries stop producing the female hormone oestrogen, which helps keep bones
healthy. Following the menopause bone loss occurs, bones become weaker and break more
easily. Osteoporosis could also occur in men and women because of the long term use of
steroids, which can affect the strength of bones. Many patients with osteoporosis have no
symptoms but they are still at risk of breaking bones because osteoporosis has made their
bones weaker. Decreased circulating levels of sex hormones, mainly oestrogens converted
from androgens, also play a role in the more gradual bone loss observed in men. In both
women and men, zoledronic acid strengthens the bone and therefore makes it less likely to
break. Zoledronic acid is also used in patients who have recently broken their hip in a minor
trauma such as a fall and therefore are at risk of subsequent bone breaks.
Paget's disease of the bone
It is normal that old bone is removed and is replaced with new bone material. This process is
called remodelling. In Paget's disease, bone remodelling is too rapid and new bone is formed
in a disordered fashion, which makes it weaker than normal. If the disease is not treated,
bones may become deformed and painful, and may break. Zoledronic acid works by returning
the bone remodelling process to normal, securing formation of normal bone, thus restoring
strength to the bone.
2. What you need to know before you are given Zoledronic acid 5 mg/100 ml solution for
infusion
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you
are given Zoledronic acid 5 mg/100 ml solution for infusion.
You must not be given Zoledronic acid 5 mg/100 ml solution for infusion:
• if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients
of this medicine (listed in section 6).
• if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
• if you have severe kidney problems.
• if you are pregnant.
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor before you are given Zoledronic acid 5 mg/100 ml solution for infusion:
• if you are being treated with zoledronic acid 4mg/100ml solution for infusion or zoledronic
acid 4mg/5ml concentrate for solution for infusion, which contain the same active substance
as Zoledronic acid 5 mg/100 ml solution for infusion and are used in adult patients with
certain types of cancer to prevent bone complications or to reduce the amount of calcium.
• if you have a kidney problem, or used to have one.
• if you are unable to take daily calcium supplements.
• if you have had some or all of the parathyroid glands in your neck surgically removed.
• if you have had sections of your intestine removed.
Monitoring test
Your doctor should do a blood test to check your kidney function (levels of creatinine) before
each dose of zoledronic acid. It is important for you to drink at least 2 glasses of fluid (such
as water), within a few hours before receiving zoledronic acid, as directed by your healthcare
provider.
Before you receive treatment with Zoledronic acid 5 mg/100 ml solution for infusion, tell your
doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your
jaw feels heavy, or if you have lost a tooth. Before you receive dental treatment or undergo
dental surgery, tell your dentist you are receiving treatment with Zoledronic acid 5 mg/100 ml
solution for infusion.
Children and adolescents
Zoledronic acid 5 mg/100 ml solution for infusion is not recommended for anyone under 18
years of age. The use of Zoledronic acid 5 mg/100 ml solution for infusion in children and
adolescents has not been studied.
Other medicines and Zoledronic acid 5 mg/100 ml solution for infusion
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any
other medicines.
It is especially important for your doctor to know all the medicines you are taking, especially if
you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or
diuretics ('water pills') that may cause dehydration.
Pregnancy and breast-feeding
You must not be given Zoledronic acid 5 mg/100 ml solution for infusion if you are pregnant
or breast-feeding, think you may be pregnant or are planning to have a baby.
Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Driving and using machines
Zoledronic acid 5 mg/100 ml solution for infusion has no or negligible influence on the ability
to drive and use machines. If you feel dizzy while taking Zoledronic acid 5 mg/100 ml solution
for infusion, do not drive or use machines until you feel better.
Zoledronic acid 5 mg/100 ml solution for infusion contains sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per infusion, i.e. essentially
'sodium-free'.
3. How to use Zoledronic acid 5 mg/100 ml solution for infusion
Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor
or nurse if you are not sure.
Osteoporosis
The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The
infusion will take at least 15 minutes.
In case you recently broke your hip, it is recommended that Zoledronic acid 5 mg/100 ml
solution for infusion is administered two or more weeks after your hip repair surgery.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by
your doctor.
For osteoporosis, Zoledronic acid 5 mg/100 ml solution for infusion works for one year. Your
doctor will let you know when to return for your next dose.
Paget's disease
The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse.
The infusion will take at least 15 minutes. Zoledronic acid 5 mg/100 ml solution for infusion
may work for longer than one year, and your doctor will let you know if you need to be treated
again.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at

The following information is intented for healthcare professionals only:
How to prepare and administer Zoledronic acid 5 mg/100 ml solution for infusion
• Zoledronic acid 5 mg/100 ml solution for infusion is ready for use.
For single use only. Any unused solution should be discarded. Only clear solution free from
particles and discoloration should be used. Zoledronic acid 5 mg/100 ml solution for infusion
must not be mixed or given intravenously with any other medicinal product and must be
given through a separate vented infusion line at a constant infusion rate. The infusion time
must not be less than 15 minutes. Zoledronic acid 5 mg/100 ml solution for infusion must
not be allowed to come into contact with any calcium-containing solutions. If refrigerated,
allow the refrigerated solution to reach room temperature before administration. Aseptic
techniques must be followed during preparation of the infusion. The infusion must be
conducted according to standard medical practice.

Date: 27 Feb 2014
Description Zoledronic Acid 5mg/100ml
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 381380

SAP No. N/A

Superceded Affiliate Item Code 304899
TrackWise PR No. 381380
MA No. 04569/1448

Vendor Job No. 225172
Proof No. 2
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 11:49
Page Count

Black

1/2

PMS
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Non-Print
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Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 560mm

Body Text Size 9pt

least the first ten days after being given Zoledronic acid 5 mg/100 ml solution for infusion. It is
important that you follow this advice carefully so that the level of calcium in your blood does
not become too low in the period after the infusion. Your doctor will inform you regarding the
symptoms associated with hypocalcaemia.
Zoledronic acid 5 mg/100 ml solution for infusion with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment
with zoledronic acid, as directed by your doctor. This will help to prevent dehydration. You
may eat normally on the day you are treated with zoledronic acid. This is especially important
in patients who take diuretics ('water pills') and in elderly patients.
If you missed a dose of Zoledronic acid 5 mg/100 ml solution for infusion
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Before stopping Zoledronic acid 5 mg/100 ml solution for infusion therapy
If you are considering stopping Zoledronic acid 5 mg/100 ml solution for infusion treatment,
please go to your next appointment and discuss this with your doctor. Your doctor will advise
you and decide how long you should be treated with Zoledronic acid 5 mg/100 ml solution
for infusion.
If you have any further questions on 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 everybody gets them.
Side effects related to the first infusion are very common (occurring in more than 30% of
patients) but are less common following subsequent infusions. The majority of the side
effects, such as fever and chills, pain in the muscles or joints, and headache, occur within
the first three days following the dose of Zoledronic acid 5 mg/100 ml solution for infusion.
The symptoms are usually mild to moderate and go away within three days. Your doctor can
recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects.
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic
acid 5 mg/100 ml solution for infusion.
Some side effects could be serious
Common (may affect up to 1 in 10 people)
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic
acid 5 mg/100 ml solution for infusion for the treatment of postmenopausal osteoporosis.
It is currently unclear whether Zoledronic acid 5 mg/100 ml solution for infusion causes
this irregular heart rhythm but you should report it to your doctor if you experience such
symptoms after you have received Zoledronic acid 5 mg/100 ml solution for infusion.
Swelling and/or pain at the infusion site may occur.
Uncommon (may affect up to 1 in 100 people)
Skin reactions such as redness.
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Not known (frequency cannot be estimated from the available data)
Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw
(osteonecrosis). Tell your dentist immediately if you experience such symptoms.
Kidney disorders (e.g. decreased urine output) may occur. Your doctor should do a blood test
to check your kidney function before each dose of Zoledronic acid 5 mg/100 ml solution for
infusion. It is important for you to drink at least 2 glasses of fluid (such as water), within a few
hours before receiving Zoledronic acid 5 mg/100 ml solution for infusion, as directed by your
healthcare provider.
If you experience any of the above side effects, you should contact your doctor immediately.
Zoledronic acid 5 mg/100 ml solution for infusion may also cause other side effects
Very common (may affect more than 1 in 10 people)
Fever
Common (may affect up to 1 in 10 people)
Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones
and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and
muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell.
In patients with Paget's disease: symptoms due to low blood calcium, such as muscle spasms,
or numbness, or a tingling sensation especially in the area around the mouth have been
reported.
Uncommon (may affect up to 1 in 100 people)
Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness,
sleepiness which may include reduced alertness and awareness, tingling sensation or
numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection
or irritation or inflammation with pain and redness, spinning sensation, increased blood
pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation,
dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain,
stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain
in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney
test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache,
taste disturbances.
Rare (may affect up to 1 in 1,000 people)
Unusual fracture of the thigh bone particularly in patients on long-term treatment for
osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture
of the thigh bone.
Not known (frequency cannot be estimated from the available data)
Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the
face and throat, decreased blood pressure, dehydration secondary to post-dose symptoms
such as fever, vomiting and diarrhoea.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Zoledronic acid 5 mg/100 ml solution for infusion
Your doctor, pharmacist or nurse knows how to store Zoledronic acid 5 mg/100 ml solution for
infusion properly.
6. Contents of the pack and other information
What Zoledronic acid 5 mg/100 ml solution for infusion contains
• The active substance is zoledronic acid. Each vial with 100 ml of solution contains 5 mg
zoledronic acid (as monohydrate).
One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
• The other ingredients are mannitol (E421), sodium citrate (E331) and water for injections.
What Zoledronic acid 5 mg/100 ml solution for infusion looks like and contents of the pack
Zoledronic acid 5 mg/100 ml solution for infusion is a clear and colourless solution.
It comes in 100 ml clear Type I silicon dioxide inner coated glass vials, capped with Type I
bromobutyl rubber stoppers and sealed with aluminum polypropylene flip off seals, as a
ready-to-use solution for infusion.
Zoledronic acid 5 mg/100 ml solution for infusion is supplied as packs containing 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Manufacturer
Agila Specialties Polska Sp. Zo.o., 10, Daniszewska Str., 03-230 Warsaw, Poland
Sanochemia Pharmazeutica AG, Landeggerstrasse 7, A - 2491 Neufeld an der Leitha, Austria
This leaflet was last revised in
02/2014

How to store Zoledronic acid 5 mg/100 ml solution for infusion
• Keep this medicine out of the sight and reach of children.
• Do not use Zoledronic acid 5 mg/100 ml solution for infusion after the expiry date which is
stated on the carton and vial. The expiry date refers to the last day of that month.
• The unopened vial does not require any special storage conditions.
After first opening: chemical and physical stability has been demonstrated for 24 hours at
2°C - 8°C and at 25°C. From a microbiological point of view, the solution for infusion should be
used immediately. If not used immediately, in-use storage times and conditions prior to use
are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Do not throw away any medicines via wastewater. These measures will help protect the
environment.
381380

Date: 27 Feb 2014
Description Zoledronic Acid 5mg/100ml
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 381380

SAP No. N/A

Superceded Affiliate Item Code 304899
TrackWise PR No. 381380
MA No. 04569/1448

Vendor Job No. 225172
Proof No. 2
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 11:49
Page Count

Black

2/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 560mm

Body Text Size 9pt

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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