HYALGAN

Active substance: SODIUM HYALURONATE

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HYALGAN

®

(Sodium hyaluronate)
Solution for intra-articular injection,
20mg/2ml, prefilled syringe
Please read this leaflet carefully. It tells
you about your medicine. Keep the
leaflet in a safe place because you may
want to read it again. If you have any
questions or are unsure about anything,
please ask your doctor.
If any of the side effects gets serious,
or if you notice any side effects not listed
in the leaflet, please tell your doctor.
In this leaflet:
1. What Hyalgan is and what it’s used for
2. Things to consider before you have
Hyalgan injection
3. How you will be given the injection
4. Possible side effects
5. How Hyalgan should be stored
6. Further information
1 What Hyalgan is and what it’s used for
Hyalgan is an injection. It is a sterile
solution which provides 20mg of the
active ingredient, sodium hyaluronate,
in 2ml of liquid. Each pre-filled syringe
is used only once.
Hyalgan is used to treat people who
have painful knees because they have
osteoarthritis. Hyalgan injections help
to reduce the pain and make it easier
to move.
Osteoarthritis is a disease which affects
the joints making them painful and
difficult to move. The joints may swell up
and change shape.
Sodium hyaluronate is found naturally
in the joints. It acts as a lubricant and
shock absorber. It also plays a number
of other important roles in normal joint
function. In people with osteoarthritis in
their knees the hyaluronic acid in the
knee joints has broken down making
the knees painful and difficult to move.
2 Things to consider before you have
Hyalgan injection

Are there any reasons why I shouldn’t
have the Hyalgan injection?

Some people must not have this
injection. You should tell your doctor
before you are given Hyalgan injection if:
• You think that you may be allergic to
sodium hyaluronate or to any or the
other ingredients in the product listed
in Section 6.
• You know that you are allergic to any
other avian (bird) proteins such as in
feathers or droppings (sodium hyaluronate is of avian origin).
• You have any infection in the knee joint.
• You have any infection or disease in
the area of skin around the joint being
treated.
You should also ask yourself these
questions before having the injection.
Are you pregnant or breast-feeding?
Is your knee joint swollen or inflamed?
If the answer to any of the questions is
YES, tell your doctor or nurse because
the injection may not be suitable for you.
Other special warnings
Try to rest, with as little exercise as
possible, for the first 48 hours after the
injection into your knee. You should
certainly try to avoid any strenuous or
prolonged activity, and you should even
try to avoid standing for too long. You
can then start to return to normal activity
after this 48 hour rest.

Hyalgan should not affect your ability to
drive or operate machinery.
3 How you will be given the injection

Your doctor will give you the injection
of Hyalgan directly into the affected
knee. Before you have the injection he
or she will examine the knee carefully
and will remove any excess fluid from
the joint if necessary. The excess fluid
is usually removed by inserting a
needle into the knee joint and drawing
it off using a syringe. This syringe is
then disconnected from the needle,
leaving the needle in place.
The syringe containing the Hyalgan is
then connected to the needle and the
Hyalgan injected into the knee joint.
A usual course of treatment is to have
an injection into the knee once a week
for five weeks. Your doctor will tell you
when you should have your injections.

The course of injections can be
repeated, but only after an interval of at
least 6 months.
Hyalgan is intended to be given to adults,
including the elderly. It is not recommended for children.
Information for the doctor or nurse
Hyalgan is supplied ready to use. The
syringe is for single use only and the
contents must be administered
immediately once the container is
opened. The solution may only be
used if it is clear. Hyalgan should not
be mixed with, or given at the same
time as, any other medicines that are
to be injected into the knee and must
not be diluted. It must not be used
with disinfectants called quaternary
ammonium salts.

5 How Hyalgan should be stored

All medicines should be kept out of the
reach and sight of children.
Hyalgan should be stored in its original
packaging in order to protect from light.
Store below 25ºC.
Do not freeze. Hyalgan should not be
used if the package has been opened or
damaged.
Hyalgan should not be used after the
expiry date which is printed on the
package.
Medicines should not be disposed of via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.
6 Further information

4 Possible side effects

Although Hyalgan is suitable for most
people like all medicines it can sometimes cause side effects.
There is very slight risk of an allergic
reaction to Hyalgan, particularly in
those people who have an allergy to
bird proteins. In a very few cases
Hyalgan may cause a severe shock-like
reaction.
Tell the doctor or nurse straightaway if
you get any allergic reactions such as
• skin rashes or itching,
• swelling of the face, lips or tongue,
• coughing, wheezing or breathlessness,
either while you are having the injection
or any time later.

With Hyalgan you may experience
some pain, swelling, fluid in the knee,
heat or redness after injection. This
does not usually last very long and can
be treated by resting the affected knee
and cooling it with an ice pack.
If any of these symptoms do not disappear or do not improve within 1 to 4
days, go back to your doctor.
If any of the symptoms become troublesome, or if you notice anything else not
mentioned here, please go and see your
doctor.

Each pre-filled syringe contains 20 mg
of the active ingredient sodium hyaluronate in 2 ml of liquid. The liquid also
contains other ingredients sodium
chloride, disodium hydrogen phosphate
dodecahydrate, sodium dihydrogen
phosphate dihydrate and water for
injections.
The syringes are for single use only.
A pack contains 1 prefilled syringe.
The product licence holder and manufacturer is
Fidia Farmaceutici S.p.A.,
Via Ponte della Fabbrica 3/A,
35031 Abano Terme (Padova), Italy.
Hyalgan is distributed in the UK and in
Ireland by
A1 Pharmaceuticals Plc,
Unit 20/21 Easter Park,
Ferry Lane, Rainham,
Essex RM13 9BP.
This leaflet was last approved in
03/2012
If you would like any more information,
or would like the leaflet in a different
format, please contact 0044 (0) 1708
528900

682370/6

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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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