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ZOLEDRONIC ACID MYLAN 4 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

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Package leaflet: Information for the user

Zoledronic acid Mylan
4 mg/100 ml solution for
infusion

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
What Zoledronic acid Mylan 4 mg/100 ml
1. 
solution for infusion is and what it is used for
2. What you need to know before you are
given Zoledronic acid Mylan 4 mg/100 ml
solution for infusion
3. How Zoledronic acid Mylan 4 mg/100 ml
solution for infusion is used
4. Possible side effects
5. How to store Zoledronic acid Mylan
4 mg/100 ml solution for infusion
6. Contents of the pack and other information
1. What Zoledronic acid Mylan 4 mg/100 ml
solution for infusion is and what it is
used for
The active substance in Zoledronic acid Mylan
4 mg/100 ml solution for infusion is zoledronic
acid, which belongs to a group of substances
called bisphosphonates. Zoledronic acid works
by attaching itself to the bone and slowing
down the rate of bone change. It is used:
• To prevent bone complications, e.g.
fractures, in adult patients with bone
metastases (spread of cancer from
primary site to the bone).
• To reduce the amount of calcium in the
blood in adult patients where it is too
high due to the presence of a tumour.
Tumours can accelerate normal bone
change in such a way that the release
of calcium from bone is increased. This
condition is known as tumour-induced
hypercalcaemia (TIH).
The product will be referred to Zoledronic
acid for the remaining portion of this leaflet.
2. What you need to know before you are
given Zoledronic acid Mylan 4 mg/100 ml
solution for infusion
Follow carefully all instructions given to you
by your doctor.
Your doctor will carry out blood tests before
you start treatment with Zoledronic acid
and will check your response to treatment at
regular intervals.
You should not be given Zoledronic acid:
• if you are breast-feeding.
• if you are allergic to zoledronic acid,
another bisphosphonate (the group of
substances to which Zoledronic acid
belongs), or any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before you are given Zoledronic acid:
• if you have or have had a kidney problem.
• if you have or have had pain, swelling or
numbness of the jaw, a feeling of heaviness
in the jaw or loosening of a tooth.
• if you are having dental treatment or are
due to undergo dental surgery, tell your
dentist that you are being treated with
zoledronic acid.
Reduced levels of calcium in the blood
(hypocalcaemia), sometimes leading to
muscle cramps, dry skin, burning sensation,
have been reported in patients treated with
zoledronic acid. Irregular heart beat (cardiac
arrhythmia), seizures, spasm and twitching
(tetany) have been reported as secondary to
severe hypocalcaemia. In some instances the
hypocalcaemia may be life-threatening. If any
of these apply to you, tell your doctor straight
away. If you have pre-existing hypocalcaemia,
it must be corrected before initiating the first
dose of zoledronic acid. You will be given
adequate calcium and vitamin D supplements.
Patients aged 65 years and over
Zoledronic acid can be given to people aged
65 years and over. There is no evidence to
suggest that any extra precautions are needed.
Children and adolescents
Zoledronic acid is not recommended for use
in adolescents and children below the age of
18 years.
Other medicines and Zoledronic acid
Tell your doctor if you are taking, have
recently taken or might take any other
medicines. It is especially important that you
tell your doctor if you are also taking:
• Aminoglycosides (medicines used
to treat severe infections), calcitonin
(a type of medicine used to treat
post-menopausal osteoporosis and
hypercalcaemia), loop diuretics (a type
of medicine to treat high blood pressure
or oedema) or other calcium‑lowering
medicines, since the combination

of these with bisphosphonates may
cause the calcium level in the blood to
become too low.
• Thalidomide (a medicine used to treat
a certain type of blood cancer involving
the bone) or any other medicines which
may harm your kidneys.
• Other medicines that also contain
zoledronic acid and which are used to
treat osteoporosis and other non-cancer
diseases of the bone, or any other
bisphosphonate, since the combined
effects of these medicines taken together
with Zoledronic acid are unknown.
• Anti-angiogenic medicines (used to
treat cancer), since the combination
of these with zoledronic acid has been
associated with an increased risk of
osteonecrosis of the jaw (ONJ).
Pregnancy and breast-feeding
You should not be given Zoledronic acid if
you are pregnant. Tell your doctor if you are
or think that you may be pregnant.
You must not be given Zoledronic acid if you
are breast-feeding.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking any medicine
Driving and using machines
There have been very rare cases of drowsiness
and sleepiness with the use of zoledronic acid.
You should therefore be careful when driving,
using machinery or performing other tasks
that need full attention.
Zoledronic acid contains sodium
This medicinal product contains less than
1 mmol sodium (23 mg) per dose (100ml), i.e.
essentially ‘sodium-free’.
3. How Zoledronic acid Mylan 4 mg/100 ml
solution for infusion is used
• Zoledronic acid must only be given
by healthcare professionals trained
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.
• Carefully follow all the other instructions
given to you by your doctor, pharmacist
or nurse.
How much Zoledronic acid is given
• The usual single dose given is 4 mg.
If you have a kidney problem, your doctor
will give you a lower dose depending on the
severity of your kidney problem.
How often Zoledronic acid is given
• If you are being treated for the
prevention of bone complications due
to bone metastases, you will be given
one infusion of Zoledronic acid every
three to four weeks.
• If you are being treated to reduce the
amount of calcium in your blood, you
will normally only be given one infusion
of Zoledronic acid.
How Zoledronic acid is given
• Zoledronic acid is given as a drip
(infusion) into a vein which should
take at least 15 minutes and should be
administered as a single intravenous
solution in a separate infusion line.
Patients whose blood calcium levels are not
too high will also be prescribed calcium and
vitamin D supplements to be taken each day.
If you are given more Zoledronic acid than
you should be
If you have received doses higher than
those recommended, you must be carefully
monitored by your doctor. This is because
you may develop serum electrolyte
abnormalities (e.g. abnormal levels of
calcium, phosphorus and magnesium) and/
or changes in kidney function, including
severe kidney impairment. If your level of
calcium falls too low, you may have to be
given supplemental calcium 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 will probably disappear after a
short time.
Tell your doctor about any of the following
serious side effects straight away:
Common (may affect up to 1 in 10 people):
• Severe kidney impairment (will normally
be determined by your doctor with
certain specific blood tests).
• Low level of calcium in the blood.
Uncommon (may affect up to 1 in
100 people):
• Pain in the mouth, teeth and/or 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 doctor and
dentist immediately if you experience
such symptoms.

The following information is intended for healthcare professionals only:
How to prepare and administer Zoledronic acid
• For single use only. Any unused solution should be discarded. Only clear solution free from
particles and discolouration should be used. Aseptic techniques must be followed during
the preparation of the infusion.
• If refrigerated, allow the refrigerated solution to reach room temperature before
administration.
• It is given as a single 15-minute intravenous infusion. Since no data are available on
the compatibility of zoledronic acid with other intravenously administered substances,
Zoledronic acid must not be mixed with other medications/substances and should always
be given through a separate infusion line.The hydration status of patients must be assessed
prior to and following administration of Zoledronic acid to ensure that they are adequately
hydrated.
• Zoledronic acid can be used immediately without further preparation for patients with
normal renal function. In patients with mild to moderate renal impairment, reduced doses
should be prepared as instructed below.
To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Remove the volume of Zoledronic acid solution indicated from the vial and replace with an
equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose
solution for injection.
542398

• Irregular heart rhythm (atrial fibrillation) has
been seen 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 you have
received zoledronic acid.
• Severe allergic reaction: shortness of breath,
swelling mainly of the face and throat.
Rare (may affect up to 1 in 1,000 people):

As a consequence of low calcium values:
irregular heart beat (cardiac arrhythmia;
secondary to hypocalcaemia).
Very rare (may affect up to 1 in
10,000 people):
• As a consequence of low calcium
values: seizures, numbness and tetany
(secondary to hypocalcaemia).
Tell your doctor about any of the following
side effects as soon as possible:
Very common (may affect more than 1 in
10 people):
• Low level of phosphate in the blood.
Common (may affect up to 1 in 10 people):
• Headache and a flu-like syndrome
consisting of fever, fatigue, weakness,
drowsiness, chills and bone, joint and/or
muscle ache. In most cases no specific
treatment is required and the symptoms
disappear after a short time (couple of
hours or days).
• Gastrointestinal reactions such as
nausea and vomiting as well as loss of
appetite.
• Conjunctivitis.
• Low level of red blood cells (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,
trembling, tingling or numbness of the
hands or feet, diarrhoea, constipation,
abdominal pain, dry mouth.
• Low counts of white blood cells and
blood platelets.
• Low level of magnesium and potassium
in the blood. Your doctor will monitor
this and take any necessary measures.
• Weight increase.
• Increased sweating.
• Sleepiness.
• Blurred vision, tearing of the eye, eye
sensitivity to light.
• Sudden coldness with fainting, limpness
or collapse.
• Difficulty in breathing with wheezing or
coughing.
• Urticaria.
Rare (may affect up to 1 in 1,000 people):
• Slow heartbeat.
• Confusion.
• 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.
• Interstitial lung disease (inflammation
of the tissue around the air sacks of the
lungs).
• Flu-like symptoms including arthritis
and joint swelling.
• Painful redness and/or swelling of the
eye.
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 incapacitating.
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 national reporting system:
UK
The Yellow Card Scheme, at
www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
E-mail: imbpharmacovigilance@imb.ie

5. How to store Zoledronic acid Mylan
4 mg/100 ml solution for infusion
Your doctor, pharmacist or nurse knows how
to store Zoledronic acid properly (see
section 6).
6. Contents of the pack and other
information
What Zoledronic acid contains
• The active substance is zoledronic acid.
One vial contains 4 mg zoledronic acid,
corresponding to 4.26 mg zoledronic
acid monohydrate.
• The other ingredients are:
• mannitol (E421)
sodium citrate (E331)
water for injections.
What Zoledronic acid looks like and the
contents of the pack
Zoledronic acid is a clear, colourless solution,
free from visible particles.
Zoledronic acid is supplied as a solution in
a vial. One vial contains 4 mg of zoledronic
acid.
Zoledronic acid is supplied as packs
containing:
1, 4 or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd., 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
12/2014
This medicinal product is authorised in
the Member States of the EEA under the
following names:
NETHERLANDS
BELGIUM
GERMANY

SPAIN

FINLAND
ITALY
SWEDEN

SLOVAKIA
UNITED KINGDOM
AUSTRIA
CZECH REPUBLIC
DENMARK
FRANCE
GREECE
IRELAND

NORWAY
POLAND
PORTUGAL
SLOVENIA

Zoledroninezuur
Mylan 4 mg/100 ml,
oplossing voor infusie
Zoledronic acid
Mylan 4 mg/100 ml
oplossing voor infusie
Zoledronsäure
Mylan 4 mg/100ml
Infusionslösung
Ácido zoledrónico
MYLAN 4 mg/100 ml
concentrado para
solución para
perfusión EFG
Zoledronic acid
Mylan 4 mg/100 ml
infuusioneste, liuos
Acido zoledronico
Mylan
Zoledronic acid
Mylan 4 mg/100
ml infusionsvätska,
lösning
Zoledronic acid Mylan
4 mg/100 ml, infúzny
roztok
Zoledronic acid Mylan
4 mg/100 ml, solution
for infusion
Zoledronsäure
Arcana 4 mg/100 ml
Infusionslösung
Zoledronic acid Mylan
4 mg/100 ml, infuzní
roztok
Zolemyl
Acide Zolédronique
Mylan Pharma
4 mg/100 ml solution
pour perfusion
Zoledronic acid /
Mylan Generics
Zoledronic acid Mylan
4 mg/100 ml solution
for infusion
Zoledronic acid Mylan
4 mg/100 ml
infusjonsvæske,
oppløsning
Zoledronic Acid Mylan
Ácido Zoledrónico
Mylan
Zoledronska kislina
Mylan 4 mg/100 ml
raztopina za
infundiranje

By reporting side effects you can help
provide more information on the safety of
this medicine.

Table 1: Preparation of reduced doses of Zoledronic acid
Baseline creatinine
Remove the following Replace with the
Adjusted dose (mg
clearance (ml/min)
amount of Zoledronic following volume of
zoledronic acid in
acid(ml)
sterile sodium chloride 100 ml)
9 mg/ml (0.9%) or 5%
glucose solution for
injection (ml)
50-60
12.0
12.0
3.5
40-49
18.0
18.0
3.3
30-39
25.0
25.0
3.0
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min). The
reduced doses for patients with renal impairment are expected to achieve the same AUC as
that seen in patients with creatinine clearance of 75 ml/min.
• Studies with several types of infusion lines made from polyvinylchloride, polyethylene and
polypropylene showed no incompatibility with zoledronic acid.
How to store Zoledronic acid
• Keep this medicine out of the sight and reach of children.
• Do not use Zoledronic acid after the expiry date stated on the pack. The expiry date refers
to the last day of that month.
• This medicinal product does not require any special storage conditions.
• After first opening or after preparation of reduced zoledronic acid doses (as described
above): 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.
542398

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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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