Skip to Content

UK Edition. Click here for US version.

OSATE 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
Osate 4 mg/5 ml

concentrate for solution for infusion

Zoledronic acid
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
Osate 4 mg/5 ml concentrate for
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 or
nurse.
• If you get any side effects,
talk to your doctor or nurse.
This includes any possible
side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Osate is and what it is
used for
2. What you need to know before
you are given Osate
3. How to use Osate
4. Possible side effects
5. How to store Osate
6. Contents of the pack and other
information
1. WHAT IS OSATE AND
WHAT IS IT USED FOR
The active substance of Osate 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).
Osate will always be given to you
by a doctor or a nurse as an
infusion in a vein.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN OSATE
Follow carefully all instructions
given to you by your doctor.
Your doctor will carry out blood
tests before you start treatment
with Osate and will check your
response to treatment at regular
intervals.
You should not be given Osate:
• if you are allergic to zoledronic
acid, another bisphosphonate
(the group of substances to
which Osate belongs), or any of
the other ingredients of this
medicine (listed in section 6.1)
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor or nurse before
you are given Osate:
• 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
Osate
• if you have any pain in your
thigh, hip or groin. It is also
important that you tell your
doctor if you experience this
after starting treatment with
Osate (see section 4).
Children and adolescents
Osate is not recommended for use
in children and adolescents below
the age of 18 years.
Patients aged 65 years and over
Osate can be given to people aged
65 years and over. There is no

evidence to suggest that any
extra precautions are needed.
Other medicines and Osate
Tell your doctor if you are taking
or have recently taken any other
medicines. It is especially
important that you tell your doctor
if you are also taking:
• Aminoglycosides (medicines
used to treat severe infections),
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
contains zoledronic acid and is
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
Osate are unknown
• Anti-angiogenic medicines
(used to treat cancer), since the
combination of these with
Osate has been associated with
reports of osteonecrosis of the
jaw (ONJ).
Pregnancy, breast-feeding and
fertility
You should not be given Osate if
you are pregnant. Tell your doctor
if you are or think that you may be
pregnant.
You must not be given Osate if you
are breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby,
ask your doctor for advice before
taking this medicine.
Driving and using machines
There have been very rare cases
of drowsiness and sleepiness
with the use of Osate. You should
therefore be careful when driving,
using machinery or performing
other tasks that need full
attention.
Important information about
some of the ingredients in Osate
This medicine contains less than
1 mmol sodium (23 mg) per vial,
i.e. essentially sodium-free.
3. HOW OSATE IS GIVEN
• Osate 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, nurse or
pharmacist.
How much Osate 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 Osate is given
• If you are being treated for the
prevention of bone
complications due to bone
metastases, you will be given
one infusion of Osate 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
Osate.
How Osate is given
• Osate 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.
.../...

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY:
How to prepare and administer Instructions for preparing reduced
Osate
doses of Osate:
To prepare an infusion solution Withdraw the appropriate volume
containing 4 mg zoledronic acid, of the liquid concentrate, as
further
dilute
the
Osate follows:
concentrate (5.0 ml) with 100 ml of • 4.4 ml for 3.5 mg dose
calcium-free or other divalent • 4.1 ml for 3.3 mg dose
cation-free infusion solution. If a • 3.8 ml for 3.0 mg dose
lower dose of Osate is required, For single use only. Any unused
first withdraw the appropriate solution should be discarded.
volume as indicated below and Only clear solution free from
then dilute it further with 100 ml of particles and discolouration should
infusion solution. To avoid be used. Aseptic techniques must
potential incompatibilities, the be followed during the prepainfusion solution used for dilution ration of the infusion.
must be either 0.9% w/v sodium Chemical and physical in-use
chloride or 5% w/v glucose stability has been demonstrated
solution.
for 24 hours at 2°C – 8°C;
Do not mix Osate concentrate however from a microbiological
with calcium-containing or other point of view, the diluted solution
divalent cation-containing solu- for infusion should be used
tions such as lactated Ringer’s immediately. If not used immediasolution.
tely, in-use storage times and

If you are given more Osate than
you should
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;
If you have any further questions
on the use of this medicine, ask
your doctor or nurse.
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 side effects
(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 side effects
(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
• 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.
Tell your doctor about any of the
following side effects as soon as
possible:
Very common side effects
(may affect more than 1 in 10
people):
• Low level of phosphate in the
blood.
Common side effects
(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 side effects
(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, sleep
disturbances, tingling or
numbness of the hands or feet,
diarrhoea
• 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
• Sleepiness
• Tearing of the eye, eye
sensitivity to light

conditions prior to use are the
responsibility of the user and
would normally not be longer than
24 hours at 2°C – 8°C.
The refrigerated solution should
then be equilibrated to room
temperature prior to administration.
The solution containing zoledronic
acid is given as a single 15-minute
intravenous infusion in a separate
infusion line. The hydration status
of patients must be assessed
prior to and following administration of Osate to ensure that
they are adequately hydrated.
Studies with several types of
infusion lines made from
polyvinylchloride, polyethylene
and polypropylene showed no
incompatibility with Osate.

• Sudden coldness with fainting,
limpness or collapse
• Difficulty in breathing with
wheezing or coughing
• Urticaria.
Rare side effects
(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)
Very rare side effects (may affect
up to 1 in 10.000 people):
• Fainting due to low blood
pressure
• Severe bone, joint and/or
muscle pain, occasionally
incapacitating
• Painful redness and/or swelling
of the eye.
If you get any side effects, talk to
your doctor or nurse. This
includes any possible side
effects not listed in this leaflet.
You can also report side effects
directly via Yellow Card Scheme,
Tel: Freephone 0808 100 3352
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 OSATE
Your doctor, nurse or pharmacist
knows how to store Osate
properly.
Keep this medicine out of the
sight and reach of children.
Do not throw away any medicines
via wastewater. Ask you
pharmacist how to throw away
medicines you no longer use.
These measures will help protect
the environment.
Do not use this medicine after the
expiry date which is stated on the
carton and vial label after EXP.
The expiry date refers to the last
day of that month.
This medicine does not require
any special storage conditions
until the vial has been opened and
the concentrate is diluted.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Osate contains
• The active substance of Osate
is zoledronic acid. One vial
contains 4 mg zoledronic acid,
corresponding to 4.264 mg
zoledronic acid monohydrate
(as monohydrate),
corresponding to 4.264 mg
zoledronic acid monohydrate.
• The other ingredients are:
mannitol, sodium citrate, water
for injections.
What Osate looks like and
contents of the pack
Osate is supplied as a liquid
concentrate in a vial. One vial
contains 4 mg of zoledronic acid.
Each pack contains the vial with
concentrate. Osate is supplied as
packs containing 1, 4 or 10 vials.
Not all pack sizes may be
marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd
Castle Court, 41 London Road
Reigate, Surrey RH2 9RJ
Phone: +44 (0)870 351 87 44
Email: info@stragenuk.com
Manufacturer
Lisa Pharma
Via Licinio 11, 22036 ERBA (Como)
Italy
This leaflet was last revised in
04/2013

Since no data are available on the
compatibility of Osate with other
intravenously administered substances, Osate must not be mixed with
other medications/substances and
should always be given through a
separate infusion line.
How to store Osate
• Keep Osate out of the sight and
reach of children
• Do not use Osate after the
expiry date stated on the pack
• The unopened vial does not
require any specific storage
conditions
• The diluted Osate infusion
solution should be used
immediately in order to avoid
microbial contamination.

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