Skip to Content

UK Edition. Click here for US version.

ZOLEDRONIC ACID FAIR-MED 5 MG/100ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Zoledronic acid 5mg/100ml solution for infusion

Read all of this leaflet carefully
before you are given this
medicine, because it contains
inportant 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 is and what it
is used for
2. What you need to know before you
are given Zoledronic acid
3. How Zoledronic acid is given
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other
information
1. What Zoledronic acid is and what
it is used for
Zoledronic acid contains the active
substance zoledronic acid. It belongs
to a group of medicines called
bisphosphonates and is used to treat
Paget’s disease of the bone in adults.
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
Follow all instructions given to
you by your doctor, pharmacist or
nurse carefully before you are given
Zoledronic acid.
You must not be given Zoledronic
acid:
• if you are allergic to zoledronic acid,
other bisphosponates 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:
• if you are being treated with
zoledronic acid 5mg/100ml solution
for infusion or zoledronic acid
4mg/5ml concentrate for solution for
infusion, which contains the same
active substance as Zoledronic acid
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.
Before you receive treatment with
Zoledronic acid, 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.
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.
Children and adolescents
Zoledronic acid is not recommended
for anyone under 18 years of age. The
use of Zoledronic acid in children and
adolescents has not been studied.
Other medicines and Zoledronic
acid
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 (“waterpills”) that may
cause dehydration.
Pregnancy and breast-feeding
You must not be given Zoledronic acid
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 has no or negligible
influence on the ability to drive and
use machines. If you feel dizzy while
taking Zoledronic acid, do not drive or
use machines until you feel better.
Zoledronic acid contains sodium.
This medicinal product contains less
than 1 mmol sodium (23 mg) per
infusion, i.e. essentially ’sodium-free’.
3. How Zoledronic acid is given
Follow carefully all instructions given
to you by your doctor or nurse. Check
with your doctor or nurse if you are not
sure.
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 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 least the first ten
days after being given Zoledronic
acid. 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 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
Contact your doctor or hospital as
soon as possible to re-schedule your
appointment.
Before stopping Zoledronic acid
therapy
If you are considering stopping
Zoledronic acid 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.
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. 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.
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. 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.
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. 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.
If you experience any of the above
side effects, you should contact your
doctor immediately.
Zoledronic acid 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 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 to:
Yellow Card Scheme
Website: 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
Your doctor, pharmacist or nurse
knows how to store Zoledronic acid
properly
• 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
carton and vial after EXP. The expiry
date refers to the last day of that
month.
• The unopened vial does not require
any special storage conditions.
• After opening the bottle, the product
should be used immediately in order
to avoid microbial contamination. If
not used immediately, in-use storage
times and conditions prior to use are
the responsibility of the user. Allow
the refrigerated solution to reach room
temperature before administration.
• Do not throw away any medicines
via wastewater. Ask your pharmacist
how to throw away medicines you no
longer use. These measures will help
protect the environment.
6. Contents of the pack and other
information
What Zoledronic acid contains
• The active substance is zoledronic
acid.
Each vial with 100 ml of solution
contains 5 mg of zoledronic acid (as
monohydrate)
Each ml of the solution contains 0.05
mg of zoledronic acid anhydrous (as
monohydrate).
• The other ingredients are mannitol
(E421), sodium citrate (E331) and
water for injections.
What Zoledronic acid looks like
and contents of the pack
Zoledronic acid 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 5mg/100ml solution
for infusions is supplied in:
1 vial
4 vials
10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fair-Med Healthcare GmbH
Planckstrasse 13
Hamburg, 22765
Germany
Manufacturer
Agila Specialties Polska Sp. Zo.o.
10, Daniszewska Str., Warsaw
03-230
Poland
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
Neufeld an der Leitha, 2491
Austria
This leaflet was last approved in
12/2014.

300000097 1

Information for the healthcare professional:
Zoledronic acid 5mg/100ml solution for infusion

The following information is intended for medical or healthcare professionals only
(see section 3 of the package leaflet or 4.2 of the summary of product characteristics):
How to prepare and administer Zoledronic acid
- 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 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 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.
How to store Zoledronic acid
- 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 carton and
vial after EXP.
- The unopened vial does not require any special storage conditions.
After opening the vial, the product should be used immediately in order to avoid
microbial contamination. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user. Allow the refrigerated
solution to reach room temperature before administration.
Contents of the pack and other information
What Zoledronic acid contains
• The active substance is zoledronic acid. Each vial with 100 ml of solution contains
5 mg of zoledronic acid (as monohydrate) Each ml of the solution contains 0.05
mg of zoledronic acid anhydrous (as monohydrate).
• The other ingredients are mannitol (E421), sodium citrate (E331) and water for
injections.
What Zoledronic acid looks like and contents of the pack
Zoledronic acid 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 5mg/100ml solution for infusions is supplied in:
1 vial
4 vials
10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fair-Med Healthcare GmbH Planckstrasse 13
Hamburg, 22765
Germany
For further information please refer to the summary of product characteristics.
This leaflet was last approved in 12/2014.

300000097 1

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.

Hide