SODIUM FUSIDATE 500 MG FOR INTRAVENOUS INFUSION

Active substance: SODIUM FUSIDATE

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into consideration if you are on a controlled
sodium diet.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Fusidate 500 mg for Intravenous Infusion
sodium fusidate
Please read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects become serious, or you notice any side effects not listed in this leaflet
please tell your doctor or pharmacist.
• In this leaflet Sodium Fusidate 500 mg for Intravenous Infusion will be called sodium fusidate
infusion.
In this leaflet:
1. What sodium fusidate infusion is and what it
is used for
2. Before you have sodium fusidate infusion
3. How to use sodium fusidate infusion
4. Possible side effects
5. How to store sodium fusidate infusion
6. Further information

1. WHAT SODIUM FUSIDATE INFUSION IS
AND WHAT IT IS USED FOR
This medicine contains sodium fusidate. It is a
type of antibiotic.
Sodium fusidate infusion works by killing germs
(bacteria) that cause infections.
Sodium fusidate infusion is used to treat
infections such as:
• Infections of the skin and wounds
• Infections of the blood such as septicaemia
• Infections of the bone and heart tissue
• Infections of the lungs such as pneumonia
• Infections connected with the condition cystic
fibrosis.

2. BEFORE YOU HAVE SODIUM FUSIDATE
INFUSION
Do not have sodium fusidate infusion
• If you are allergic (hypersensitive) to fusidic acid
or its salts.
• If you are allergic (hypersensitive) to any of the
other ingredients in your medicine. You can find
a list of these ingredients in section 6 of this
leaflet.
Take special care with sodium fusidate infusion
Before you have sodium fusidate infusion, tell
your doctor:
• If you are taking statins (medicines
to lower blood cholesterol).
• If you have problems with your liver
• If you have recently been jaundiced.
When you are having sodium fusidate infusion
your doctor may take regular blood tests in
patients on high doses, with liver or bile problems,
taking the medicine for a long time or taking other
medicines that affect the liver.

If you are concerned that your treatment is not as
effective as it should be, tell your doctor. As with
any antibiotic treatment, long term or repeated
use may increase the risk of developing antibiotic
resistance.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking, or have recently taken any other
medicines. This includes any medicines which
you have bought without a prescription.
• Do not take statins (medicines to lower blood
cholesterol) while using this medicine.

How much sodium fusidate infusion to have
Your doctor will prescribe the right dose for you.
If you have received more sodium fusidate
infusion than you should
Your doctor or nurse will give you this medicine.
If you think you may have been given too much,
tell your doctor or nurse straight away.
If you have missed a dose of sodium fusidate
infusion
Your doctor or nurse will give you this medicine.
If you think that you have missed a dose then tell
your doctor or nurse.
If you have any further questions about using
this medicine, please ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, sodium fusidate infusion can
cause side effects, although not everybody gets
them.
Approximately 3 out of 10 people may
experience side effects with sodium fusidate
infusion, but many of these are where the
medicine is given into the vein.

Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice
before having sodium fusidate infusion:
• If you are pregnant, or think you are pregnant
• If you are breast-feeding.
Tell your doctor if you become pregnant while
having this medicine.

Number of people affected not known: You must
get urgent medical help if you have any of the
following symptoms. You may be developing a
condition called rhabdomyolysis:
• You develop muscle weakness
• You develop muscle pain
• You develop muscle tenderness.

Driving and using machines
Usually your medicine will have very little effect
on your ability to drive or use machines. Check
with your doctor if you feel any side effect that
may stop you from driving or using machines.

Common: affects less than 1 in 10 people:
problems with your liver.
You should tell your doctor straight away if you
have the following symptoms:
• Your skin or the whites of your eyes appear
yellow.

Important information about some of the
ingredients of sodium fusidate infusion
Sodium fusidate infusion contains:
• Sodium. Each reconstituted vial contains 73
milligrams (mg) sodium. You should take this
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PLEASE TEAR ALONG THE PERFORATIONS AND RETAIN THIS PORTION
BEFORE GIVING THE REMAINING LEAFLET TO THE PATIENT.

Serious side effects:
Rare (affects less than 1 in 1,000 people): allergic
reaction. You must get urgent medical help if
you have any of the following symptoms:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash.

Number of people affected not known: problems
with your kidneys.
You should tell your doctor straight away if you
have the following symptoms:
• You are not passing water.

Other possible side effects:
Common (affect less than 1 in 10 people):
Pain or inflammation of the vein where sodium
fusidate infusion is given, dizziness, drowsiness.
Uncommon (affect less than 1 in 100 people):
Headache, rash, itchy rash, itching, loss of appetite,
feeling tired, weak or unwell.
Number of people affected not known:
Pale stools
Dark urine
Upper right hand side stomach pain.
If any of the side effects become serious or you
notice any side effects not listed in this leaflet, tell
your doctor or pharmacist.

5. HOW TO STORE SODIUM FUSIDATE
INFUSION
• Keep out of the reach and the sight of children.
• Do not use sodium fusidate infusion after the
expiry date on the carton. The expiry date is the
last day of that month.

6. FURTHER INFORMATION
What sodium fusidate infusion contains
• The active ingredient is sodium fusidate. A vial of
powder contains 500 mg of sodium fusidate.
• The other ingredients are citric acid, disodium
edetate, disodium hydrogen phosphate and water
for injections.
You can find important information about some of
the ingredients in your medicine near the end of
section 2 of this leaflet.
What sodium fusidate infusion looks like and
contents of the pack
Sodium fusidate infusion comes in packs of 2 vials.
One vial contains sodium fusidate (powder) and the
other vial the solution for the infusion.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Essential Pharma Ltd, 7 Egham Business
Village, Crabtree Road, Egham, Surrey,
TW20 8RB, UK.
Manufacturer:
LEO Pharma A/S,
DK 2750 Ballerup, Denmark.

This leaflet was last revised in
April 2013

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11503890-00

This product should be administered intravenously into a wide bore vein with a good blood flow. Excessive
doses may cause venospasm, thrombophlebitis and haemolysis of erythrocytes. Both oral and intravenous
presentations have been given concurrently with other antibiotics, e.g. cloxacillin, flucloxacillin, ampicillin,
methicillin and erythromycin.

FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY

Sodium Fusidate 500 mg for Intravenous Infusion

Sodium Fusidate Ph.Eur. 500 mg (equivalent to 480 mg fusidic acid) contained in one vial. (The second
vial contains buffer solution).
Powder for reconstitution and use as an intravenous infusion.
The vial of 10 ml sterile phosphate-citrate buffer solution (pH 7.4 - 7.6) contains disodium hydrogen
phosphate, citric acid, disodium edetate and water for injections. (When reconstituted with powder vial
contains 3.1 mMol sodium and 1.1 mMol phosphate).
Shelf-life and storage conditions: The sodium fusidate dry powder is stable for 3 years when stored at
room temperature (below 25°C) and protected from light.
After the sodium fusidate dry powder is dissolved in the buffer solution provided and added to 500 ml
of infusion fluid , the shelf-life of this solution is 24 hours.
When the buffer solution is transferred to the powder vial, this vial should be regarded as a unit dose.
The required amount of solution should be used once only and any unused portion discarded.
Recommended procedure for reconstitution and administration:
To reconstitute, dissolve the contents of one vial containing 500 mg sodium fusidate powder (equivalent
to 480 mg of fusidic acid) in the 10 ml buffer provided.
For adults weighing more than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid.
For children and adults weighing less than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of
infusion fluid. Each dose corresponds to 6-7 ml of the resulting solution per kg bodyweight.
The diluted fluid should be infused via a central venous line over 2 hours. If a superficial vein is
employed a more prolonged period of at least 6 hours is advisable.
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ANVERSO / FRONT

Sodium fusidate infusion will be given to you
into your vein by a doctor or nurse.

You must tell your doctor or pharmacist if you
are taking any of the following medicines:
• Other antibiotics, such as lincomycin and
rifampicin.
• Oral anti-coagulants (medicines to "thin" your
blood). You may be likely to bleed more easily.
Your doctor may need to change your dose.
• Medicines to lower blood cholesterol, such as
statins. This may lead to muscle weakness,
tenderness or pain. Also see section 4 of this
leaflet.
• Ritonavir or saquinavir, medicines used to
treat HIV.
• Ciclosporin. This medicine is used to reduce
the body's immune reactions.

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3. HOW TO USE SODIUM FUSIDATE
INFUSION

Number of people affected not known: the level of
some cells in your blood may change. You should
tell your doctor straight away if you have any of the
following symptoms:
• You develop any unexplained bruising or bleeding
• You develop persistent or repeated mouth ulcers,
sore throats or other infections.

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If additional antibacterial therapy is to be employed, it is recommended that for parenteral administration,
separate infusion fluids be used.
This product should not be infused with amino acid solutions or in whole blood.
In vitro compatibility studies of Sodium Fusidate 500 mg for Intravenous Infusion with commonly used
infusion solutions have been carried out.
The results showed that sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically and
chemically compatible for at least 24 hours at room temperature with the following infusion solutions (the
figure in parenthesis shows the concentration of sodium fusidate in the final admixture):
Sodium Chloride Intravenous Infusion BP 0.9% (1-2 mg/ml)
Dextrose Intravenous Infusion BP 5% (1-2 mg/ml)
Compound Sodium Lactate Intravenous Infusion ("Ringer-Lactate Solution") (1 mg/ml)
Sodium Lactate Intravenous Infusion BP (1 mg/ml)
Sodium Chloride (0.18%) and Dextrose (4%) Intravenous Infusion BP (1 mg/ml)
Potassium Chloride (0.3%) and Dextrose (5%) Intravenous Infusion BP (1 mg/ml).
Sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically incompatible with infusion fluids
containing 20% or more of dextrose, lipid infusions and peritoneal dialysis fluids. Precipitation may occur
at dilutions which result in a pH of less than 7.4.
Further information can be found in the Summary of Product Characteristics or from:
Essential Pharma Ltd, 7 Egham Business Village,
Crabtree Road, Egham, Surrey, TW20 8RB, UK.
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REVERSO / BACK

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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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