VANCOMYCIN 1G POWDER FOR SOLUTION FOR INFUSION

Active substance: VANCOMYCIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER

Vancomycin 500 mg
Powder for Solution for Infusion
Vancomycin 1 g
Powder for Solution for Infusion
(vancomycin)
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 further questions, please ask your doctor or your 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 gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist





In this leaflet:

1. WHAT VANCOMYCIN IS AND
WHAT IT IS USED FOR
2. BEFORE YOU TAKE VANCOMYCIN
3. HOW TO TAKE VANCOMYCIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VANCOMYCIN
6. FURTHER INFORMATION

1. WHAT IS VANCOMYCIN AND
WHAT IS IT USED FOR?
Vancomycin belongs to a group of medicines
called antibiotics. Antibiotics help your body
fight infections. Vancomycin works by
destroying certain bacteria that cause
infection.
Vancomycin infusion is often used to treat
infections caused by bacteria called
‘staphylococci’ which may be difficult to cure
using more common antibiotics like penicillin.
Some of the infections it is used to treat are:






Bone infections
Pneumonia
Septicaemia (blood poisoning)
Soft tissue infections

Vancomycin is sometimes used during
operations or dental procedures to prevent
infections.
Vancomycin can also be given as a solution
to drink to kill bacteria which cause severe
diarrhoea.
If your doctor gives you this medicine for
anything else, ask him or her if you have any
questions about it.

2. BEFORE YOU USE VANCOMYCIN
Vancomycin is not suitable for everyone.
Do not take Vancomycin:
• If you are allergic to Vancomycin or any
other ingredient of this medicine or if
you have ever had an allergic reaction to
any other antibiotic. Symptoms of an
allergic reaction are rash, itching,
swelling or breathing difficulties.
(See section 6 of this leaflet for a full list
of ingredients).
• If you have difficulty hearing.
• If you have ever had kidney trouble.
Take special care with Vancomycin:
If you are about to have a general
anaesthetic





If you are taking other antibiotics that
can affect your kidneys e.g. amphotericin B,
aminoglycosides, bacitracin, polymyxin B,
colistin, viomycin or cisplatin

If any of the above apply to you, please talk
to your doctor or pharmacist for advice if you
have not already done so.
Taking other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. This is extremely important, as
using more than one medicine at the same
time can strengthen or weaken the effect of
the medicines. In particular tell your doctor if
you are taking any other antibiotics.
Taking Vancomycin with food and drink:
Vancomycin can be given as an infusion or
taken as a solution before, with or after food.
If Vancomycin is being taken as a solution to
drink, a common flavouring syrup may be
added to the solution to improve the taste.
Pregnancy and breast – feeding:
You should tell your doctor if you are
pregnant or if you intend to become
pregnant. Your doctor will then decide
whether you should receive Vancomycin.
Mothers who wish to breast-feed should
discuss this with their doctor who will then
advise you on what to do.
Driving or using machines:
Vancomycin has no known affect on your
ability to drive and operate machinery.

3. HOW TO TAKE VANCOMYCIN
The dose of medicine given to you will
depend on your age, the infection you have,
how well your kidneys are working, if you
have poor hearing and any other medicines
you may be taking.
Usual doses – as infusion
Adults: 500mg every 6 hours or 1000mg
every 12 hours.
Children: 10mg for every kilogram of their
body weight every 6 hours.
The Vancomycin solution must slowly go
through a tube and needle from a bag or
pump and into one of your veins. This is
called an ‘intravenous infusion’. This will
usually take at least one hour each time you
get a dose.
Usual doses – orally by mouth
Adults: 500mg a day, divided into more
than one dose, for 7 to 10 days.
Children: 40mg for every kilogram of their
body weight each day. This will be divided
into 3 or 4 doses and given for 7 to 10
days.

Adults and children should not have more than
2 grams of Vancomycin by mouth each day.
Your doctor will only inject Vancomycin into
a vein and not into a muscle.
Your doctor or nurse may take samples of
your blood. The hospital’s laboratory will
measure the amount of Vancomycin in your
blood. Your doctor may decide to change
your dose to get the right amount in your
blood. They may count your blood cells.
Your doctor may also test your kidneys and
ears, especially if you are elderly. If you have
difficulty hearing, your doctor may not want
to give you an injection of Vancomycin.
Your doctor or nurse will take great care that
the Vancomycin solution does not leak out of
your vein when they are injecting it. Please
tell then immediately if you have pain or
swelling during the injection or later.
Elderly patients: Your doctor may need to
prescribe a lower dose to those listed above.
Patients with kidney or liver problems: Your
doctor may prescribe a lower dose.
If you take more Vancomycin than you should:
It is most unlikely that you will be given too
much medicine by the nurse or doctor. Your
doctor and nurse will be monitoring your
progress, and checking the medicine that you
are given. Always ask if you are not sure why
you are getting a dose of medicine.
If you forget to take Vancomycin.
Your doctor or nurse know when to give you
your medicine. It is most unlikely that you will
not be given the medicine as it has been
prescribed. If you think that you may have
missed a dose then talk to your nurse or doctor.
If you stop taking Vancomycin
It is important that the course of treatment
your doctor has prescribed is taken. You may
start to feel better but it is important not to
stop taking this medicine, until the doctor
advises, otherwise your condition may get
worse again.
If you have any further questions on the use
of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Vancomycin can have side
effects, although not everybody gets them.
Vancomycin is well tolerated by most patients
and side effects are usually mild and go away.
Tell your doctor and stop taking Vancomycin
immediately if you experience any of the
following rare effects:



severe allergic reaction – you may
experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause
difficulty in swallowing or breathing),
and you may feel you are going to faint.

Other side effects include:
Kidney troubles, but this is rare.
Hearing difficulty – sometimes with
dizziness and ringing in the ears.
Low blood cell count – these may cause
symptoms such as chills and, occasionally,
bruising.
• Feeling sick
• You are less likely to have side effects if
you are given Vancomycin as a solution
to drink because it usually passes
through your stomach and intestines
without getting into the rest of your body.









If the Vancomycin solution is too strong
or if it is injected too quickly it can cause
your blood pressure to drop, difficulty
breathing, rashes and itchiness, flushed
skin and muscle pain.

If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE VANCOMYCIN
Keep out of the reach and sight of children.
The hospital will store the vials of Vancomycin
at not above 25˚C. The hospital should not
use Vancomycin after the ‘Use Before’ date
shown on the carton and vial label. This
product is for single use only and any out of
date or unused vancomcyin should be returned
to your doctor or pharmacist for disposal.
When Vancomycin powder has been
dissolved in sterile diluting solution the
hospital may store the solution in the
refrigerator (2-8˚C) for up to 24 hours.
Solutions of the parenteral powder intended
for oral administration may be stored in a
refrigerator (2˚-8˚C) for 24 hours.
Keep medicine out of reach and sight of
children.
Remember: This medicine is for you. Only a
doctor can prescribe it for you. Never give it
to others. It may harm them even if their
symptoms are the same as yours.
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
What Vancomycin contains
The active ingredient is: Vancomycin
Hydrochloride
A hospital pharmacist, nurse or doctor will
have dissolved the Vancomycin injection
powder, usually in either sterile sodium
chloride solution or sterile dextrose solution.
What Vancomycin look likes and contents of
the pack
Vancomycin Hydrochloride powder which
looks like a whitish, porous cake.
A glass vial supplied to the hospital
containing either 500 milligrams (mg) or
1000 milligrams. Each vial contains
vancomycin 500 mg (equivalent to 500
000IU) or 1 g (equivalent to 1 000 000IU) as
vancomycin hydrochloride.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Laboratorio Reig Jofre, Gran Capitán, 10
08970 Sant Joan Despi, Barcelona, Spain
Manufacturer:
Laboratorio Reig Jofre, Gran Capitán, 10
08970 Sant Joan Despi, Barcelona, Spain
Leaflet revision date: November 2012

B1YYYY-01

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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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