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VANCOMYCIN HYDROCHLORIDE 500MG & 1G POWDER FOR CONCENTRATE

Active substance(s): VANCOMYCIN HYDROCHLORIDE

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Taking/using other medicines

Package leaflet:
Information for the user
Vancomycin Hydrochloride
500 mg and 1 g
Powder for Concentrate for Infusion
Vancomycin hydrochloride

read direction (11222211)

Read all of this leaflet carefully
before you start using this medicine.
• 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 Vancomycin Hydrochloride Powder
for Concentrate for Infusion is and what
it is used for
2. What you need to know before you use
Vancomycin Hydrochloride Powder for
Concentrate for Infusion
3. How to use Vancomycin Hydrochloride
Powder for Concentrate for Infusion
4. Possible side effects
5. How to store Vancomycin Hydrochloride
Powder for Concentrate for Infusion
6. Contents of the pack and other
information

1. What Vancomycin Hydrochloride
Powder for Concentrate for
Infusion is and what it is used for
Vancomycin is an antibiotic. It is used
in potentially life-threatening infections,
caused by gram-positive organisms, which
will respond to vancomycin but which would
not respond to other, less toxic antibiotics.

2. What you need to know before you
use Vancomycin Hydrochloride
Powder for Concentrate for Infusion
Do not use Vancomycin Hydrochloride
Powder for Concentrate for Infusion
• if you have shown signs of
hypersensitivity (severe allergy) to
vancomycin in the past
Tell your doctor if the above applies to you
before this medicine is used.

Take special care with Vancomycin
Hydrochloride Powder for Concentrate
for Infusion
• if you have kidney problems
• if you have hearing difficulties
Tell your doctor if either of the above
applies to you before this medicine is used.

Special care is needed if you are
taking/using other medicines as some could
interact with vancomycin, for example:
• other antibiotics that can affect your
kidneys e.g. streptomycin, neomycin,
gentamicin, kanamycin, amikacin,
tobramycin, polymyxin B and colistin
• water tablets e.g. ethacrynic acid and
frusemide
• cholestyramine (a medicine used to
treat high levels of fat in the blood or
diarrhoea in inflammatory diseases of
the gut)
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying
to become pregnant or breast-feeding. Your
doctor will decide if you should receive this
medicine.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Do not drive or use machines if you
experience any side effect (e.g. dizziness)
which may lessen your ability to do so.

3. How to use Vancomycin Hydrochloride
Powder for Concentrate for Infusion
This medicine will be dissolved in Water for
Injections and further diluted in e.g. sodium
chloride intravenous infusion, before it is
given to you. It will usually be given as a
slow infusion via a drip into a vein. The
infusion will last at least 60 minutes and be
repeated during the day or it may be given
as a continuous infusion over 24 hours.
Vancomycin can also be given orally (by
mouth) to treat certain infections of the
bowel. It may also be given via a tube
through the nose. The taste of vancomycin
is extremely unpleasant.

Dose
Your doctor will work out the correct dose of
vancomycin for you and how often it must
be given.
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. Your doctor
will tell how well your kidneys are working
using blood or urine samples.
It will take at least 2 or 3 days for you to
respond to vancomycin. The length of
the course of treatment depends on the
infection being treated and may last a
number of weeks.
During treatment you will undergo blood
tests, be asked to provide urine samples
and possibly have hearing tests to look for
signs of toxic side effects. Blood tests will
also be used during treatment to check the
level of vancomycin in your blood.

Special care will also be taken if you are
elderly or you are due to have a general
anaesthetic.
read direction (11222211)

The following information is intended for
healthcare professionals only:
For single use. Discard any unused contents.

Preparation of Solution:
At the time of use, add 10 ml of sterile
Water for Injections BP to a 500 mg vial of
Vancomycin Hydrochloride 500 mg Powder for
Concentrate for Infusion. Similarly, add 20 ml
of sterile Water for Injections BP to a 1 g vial
of Vancomycin Hydrochloride 1 g Powder for
Concentrate for Infusion. Vials reconstituted
in this manner will give a solution of 50 mg/ml.
Further dilution is required depending on
method of administration:

(i) Intermittent infusion (the preferred
method of administration):
Reconstituted solutions containing 500 mg
vancomycin must be diluted with at least
100 ml diluent. Reconstituted solutions
containing 1 g vancomycin must be diluted with
at least 200 ml diluent.

Sodium Chloride Intravenous Infusion B.P. or
5% Dextrose Intravenous Infusion B.P. are
suitable diluents. The desired dose should be
administered by intravenous infusion over a
period of at least 60 minutes. If administered
over a shorter period of time or in higher
concentrations, there is a possibility of
inducing marked hypotension in addition to
thrombophlebitis. Rapid administration may
also produce flushing and a transient rash over
the neck and shoulders.

(ii) Continuous infusion (should only be
used when intermittent infusion not
feasible):
1 g or 2 g of vancomycin may be added to a
sufficiently large volume of Sodium Chloride
Intravenous Infusion B.P. or 5% Dextrose
Intravenous Infusion B.P. to permit the desired
dose to be infused over twenty-four hours.

(iii) Oral Administration:
The contents of vials for parenteral
administration may be used.

Q79237

W xx-xxxx
Code xxx

Component Specification

Requester

Item number:

Q79237

Request number:

AS5296

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

WB003
4
N/A

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

480 x 160 mm
Vial
Recipharm
N/A
30 x 160 mm
Yes
No

Previous Item Number: Q73120

Pharma code:
Pharma code length:
Supplier Code:

Decimal (Binary)
XX mm
Wxx-xxxx

Version 1
Technician:
Date:

NR
18/Jun/15

Version 2
Technician:
Date:

NR
23/Jun/15

Version 3
Technician:
Date:

KN
25/Jun/15

Version 4
Technician:
Date:

KN
26/Jun/15

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

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dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

Colours
Black:

Signed:
Date:

If you are given too much or too little
Vancomycin Hydrochloride Powder for
Concentrate for Infusion
This medicine will be given to you by a
doctor or nurse. It is unlikely that you will
be given too much or too little, however,
tell your doctor or nurse if you have any
concerns.

4. Possible side effects
Like all medicines, vancomycin can cause
side effects, although not everybody gets
them.

If any of the following happen, tell your
doctor immediately:
• 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
• chest pain
• hearing loss or ringing in your ears
• blistery rash or scaling of the skin
• fast heart beat, palpitations or
breathlessness
• dizziness or feeling faint
These are serious side effects. You may
need urgent medical attention.

If any of the following happen, tell your
doctor as soon as possible:









widespread skin rash which may be itchy
fever, chills, shivering
muscle spasms
a change in the amount or colour of
urine
fluid retention
pain, swelling, redness or itching at the
injection site
feeling sick or vomiting
diarrhoea

Vancomycin may lead to changes in your
blood cells and kidney function.
Your doctor may take blood samples to
check for these.

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 via

5. How to store Vancomycin
Hydrochloride Powder for
Concentrate for Infusion
Keep this medicine out of the sight and
reach of children

Expiry
This medicine must not be used after the
expiry date which is stated on the vial label
and carton after ‘EXP’. Where only a month
and year is stated, the expiry date refers to
the last day of that month.

Storage
Keep the vial in the outer carton, in order
to protect from light, and store at or below
25°C.
The reconstituted solution should be
used immediately, however, if this is not
possible it can be stored for up to 4 days
in a refrigerator, provided it has been
prepared in a way to exclude microbial
contamination.

6. Contents of the pack and other
information
What Vancomycin Hydrochloride
Powder for Concentrate for Infusion
contains
The active substance is vancomycin. After
reconstitution each millilitre (ml) of solution
contains 50 milligrams (mg) of vancomycin.
There are no other ingredients.

What Vancomycin Hydrochloride
Powder for Concentrate for Infusion
looks like and contents of the pack
Vancomycin Hydrochloride Powder for
Concentrate for Infusion is a white or
almost white solid which comes in glass
containers called vials.
It may be supplied in packs containing:
• 1 x 500 mg vial
• 1 x 1 g vial
Not all packs may be marketed.

Marketing Authorisation Holder and
Manufacturer
Hospira UK Limited, Queensway,
Royal Leamington Spa, Warwickshire,
CV31 3RW, UK
This leaflet was last approved in 06/2015

UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.

Q79237

W xx-xxxx
Code xxx

Component Specification

Requester

Item number:

Q79237

Request number:

AS5296

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

WB003
4
N/A

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

480 x 160 mm
Vial
Recipharm
N/A
30 x 160 mm
Yes
No

Previous Item Number: Q73120

Pharma code:
Pharma code length:
Supplier Code:

Decimal (Binary)
XX mm
Wxx-xxxx

Version 1
Technician:
Date:

NR
18/Jun/15

Version 2
Technician:
Date:

NR
23/Jun/15

Version 3
Technician:
Date:

KN
25/Jun/15

Version 4
Technician:
Date:

KN
26/Jun/15

Version 5
Technician:
Date:

XX
dd/mmm/yy

Version 6
Technician:
Date:

XX
dd/mmm/yy

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

Colours
Black:

Signed:
Date:

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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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