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VANCOMYCIN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MG

Active substance(s): VANCOMYCIN HYDROCHLORIDE

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Patient information leaflet.

Vancomycin
Powder for concentrate for solution for infusion
500 mg and 1000 mg
Vancomycin hydrochloride
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. Please see section 4.
What is in this leaflet:
1. What Vancomycin is and what it is used for
2. What you need to know before you use
Vancomycin
3. How to use Vancomycin
4. Possible side effects
5. How to store Vancomycin
6. Contents of the pack and other information
1. WHAT VANCOMYCIN IS AND WHAT IT IS
USED FOR
How does the medicine work?
Vancomycin is an antibiotic that belongs to a
group of antibiotics called “glycopeptides”.
Vancomycin works by eliminating certain bacteria
that cause infections.
Vancomycin powder is made into a solution for
infusion.
What is the medicine used for?
Vancomycin is used in all age groups by infusion
for the treatment of the following serious
infections:
- Infections of the skin and tissues below the
skin.
- Infections of bone and joints.
- An infection of the lungs called "pneumonia".
- Infection of the inside lining of the heart
(endocarditis) and to prevent endocarditis in
patients at risk when undergoing major
surgical procedures
- Infection in central nervous system.
- Infection in the blood linked to the infections
listed above.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE VANCOMYCIN
Do not use Vancomycin
If you are allergic to vancomycin or any of the other
ingredients of this medicine (listed in section 6).
Taking other medicines
Please tell your doctor if you are taking, have
recently taken or might take any other medicines.
Special precautions must be taken if you use
Vancomycin together with:
• other medicines, which also can cause hearing,
kidney or nervous system problems. Close
observation is necessary if you receive certain
medicines ( aminoglycosides, amphotericin B,
genatmycin, streptomycin, neomycin,
kanamycin, amikacin, tobramycin, viomycin,
bacitracin, polymyxin B, colistin and cisplatin)
• anaesthetics. This may cause reddening of the
skin, rashes or allergic reactions
• certain muscle relaxing medicines (such as
succinylcholine).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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
No effects on ability to drive and use machines
have been observed.
Warnings and precautions
Talk to your doctor or hospital pharmacist or nurse
before using Vancomycin if:
- You suffered a previous allergic reaction to
teicoplanin because this could mean you are
also allergic to vancomycin.
- You have a hearing disorder, especially if you
are elderly (you may need hearing tests during
treatment).
- You have kidney disorder (you will need to
have your blood and kidneys tested during
treatment).
- You are receiving vancomycin by infusion for
the treatment of the diarrhoea associated to
Clostridium difficile infection instead of orally.
Talk to your doctor or hospital pharmacist or nurse
during treatment with Vancomycin if:
- You are receiving vancomycin for a long time
(you may need to have your blood, hepatic and
kidneys tested during treatment).
- You develop any skin reaction during the
treatment.
- You develop severe or prolonged diarrhoea
during or after using vancomycin, consult your
doctor immediately. This may be a sign of
bowel inflammation (pseudomembranous
colitis) which can occur following treatment
with antibiotics.
Children
Vancomycin will be used with particular care in
premature infants and young infants, because
their kidneys are not fully developed and they may
accumulate vancomycin in the blood. This age
group may need blood tests for controlling
vancomycin levels in blood.
Concomitant administration of vancomycin and
anaesthetic agents has been associated with skin
redness (erythema) and allergic reactions in
children. Similarly, concomitant use with other
medicines such as aminoglycoside antibiotics,
nonsteroidal anti-inflammatory agents (NSAIDs,
e.g., ibuprofen) or amphotericin B (medicine for
fungal infection) can increase the risk of kidney
damage and therefore more frequent blood and
renal test may be necessary.
3. HOW TO USE VANCOMYCIN
You will be given Vancomycin by medical staff
while you are in hospital. Your doctor will decide
how much of this medicine you should receive
each day and how long the treatment will last.
Dosage
The dose given to you will depend on:
- your age,
- your weight,
- the infection you have,
- how well your kidneys are working,
- your hearing ability,
- any other medicines you may be taking.
Intravenous administration
Adults and adolescents
(from 12 years and older)
The dosage will be calculated according to your
body weight. The usual infusion dose is 15 to 20
mg for each kg of body weight. It is usually given
every 8 to 12 hours. In some cases, your doctor
may decide to give an initial dose of up to 30 mg
for each kg of body weight. The maximum daily
dose should not exceed 2 g.
Use in children
Children aged from one month to less than
12 years of age
The dosage will be calculated according to child’s
body weight. The usual infusion dose is 10 to 15
mg for each kg of body weight. It is usually given
every 6 hours.
Preterm and term newborn infants
(from 0 to 27 days)
The dosage will be calculated according to
post-menstrual age (time elapsed between the
first day of the last menstrual period and birth
(gestational age) plus the time elapsed after birth
(post-natal age).
The elderly, pregnant women and patients with a

1922-J
The following information is intended for
medical or healthcare professionals only
Preparation
500 mg:
Dissolve the content of the vial with 10 ml
sterile water. Dilute the reconstituted
solution with at least 100 ml sterile diluent
(to 5 mg/ml), see below.
1000 mg:
Dissolve the content of the vial with 20 ml
sterile water. Dilute the reconstituted
solution with at least 200 ml sterile diluent
(to 5 mg/ml), see below.

Patients with reduced kidney function:
The starting dose should always be at least 15 mg/kg.
The doctor will adjust the dose individually for you.

Suitable diluents are:
• Sodium Chloride 9 mg/ml (0.9%)
Injection
• Glucose 50 mg/ml (5%) Injection
• Glucose 5% and NaCl 0.9%
• Ringer-Acetate.

Patients with no kidney function:
The starting dose is 15 mg/kg followed by doses of
1.9 mg/kg body weight every 24 hours.

The concentration of vancomycin in the
prepared infusion fluid must not exceed
0.5% w/v (5 mg/ml).

Do not tamper with the bag/bottle.

The infusion should not be mixed with
other drugs.

kidney disorder, including those on dialysis, may
need a different dose.

Method of administration
Intravenous infusion means that the medicinal
product flows from an infusion bottle or bag
through a tube to one of your blood vessels and into
your body. Your doctor, or nurse, will always give
vancomycin into your blood and not in the muscle.
Vancomycin will be given into your vein for at
least 60 minutes.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Vancomycin can cause allergic reactions,
although serious allergic reactions
(anaphylactic shock) are rare. Tell your doctor
immediately if you get any sudden
wheeziness, difficulty in breathing, redness
on the upper part of the body, rash or itching.
Common side effects (may affect up to
1 in 10 people)
- Fall in blood pressure
- Breathlessness, noisy breathing (a high pitched
sound resulting from obstructed air flow in the
upper airway)
- Rash and inflammation of the lining of the
mouth, itching, itching rash, hives
- Kidney problems which may be detected
primarily by blood tests
- Redness of upper body and face, inflammation
of a vein
Uncommon side effects (may affect up to 1 in
100 people):
- Temporary or permanent loss of hearing
Rare side effects (may affect up to 1 in
1,000 people):
- Decrease in white blood cells, red blood cells
and platelets (blood cells responsible for blood
clotting)
Increase in some of the white cells in the blood.
- Loss of balance, ringing in your ears, dizziness
- Blood vessel inflammation
- Nausea (feeling sick)
- Inflammation of the kidneys and kidney failure
- Pain in the chest and back muscles
- Fever, chills

Infusion
Must be given by slow intravenous
infusion over at least 60 minutes at a
maximum rate of 10 mg/min, equal to 2
ml/min of an infusion with a concentration
of 5 mg/ml.
Dosage
The dose is adjusted individually and
according to kidney function. The usual
dose is:
Adults:

500 mg every 6 hours or
1000 mg every 12 hours given
by slow intravenous infusion.
Children: 20 mg/kg body weight every
12 hours given by slow
intravenous infusion.
Storage
Powder before opening: store below 25°C.
Reconstituted concentrate and diluted
product: store in a refrigerator (2°C - 8°C)
and use within 24 hours.
From a microbiological point of view,
unless the method of reconstitution/dilution precludes the risk of microbial
contamination, the product should be used
immediately.
If not used immediately, in-use storage
times and conditions are the responsibility
of the user and would normally not be
longer than 24 hours at 2 to 8°C.
Vancomycin powder for concentrate for
solution for infusion should not be used
after the expiry date which is stated on the
carton.

Very rare side effects (may affect up to 1 in
10,000 people):
- Sudden onset of severe allergic skin reaction
with skin flaking blistering or peeling skin. This
may be associated with a high fever and joint
pains
- Cardiac arrest
- Inflammation of the bowel which causes
abdominal pain and diarrhea, which may
contain blood
Not known (frequency cannot be estimated
from the available data):
- Being sick (throwing up), diarrhoea
- Confusion, drowsiness, lack of energy, swelling,
fluid retention, decreased urine
- Rash with swelling or pain behind the ears, in
the neck, groin, under the chin and armpits
(swollen lymph nodes), abnormal blood and
liver function tests
- Rash with blisters and fever.
Reporting of side effects
If you get any side effects, talk to you doctor,
hospital pharmacist 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 VANCOMYCIN
Your doctor will be responsible for storing the
medicine.
For healthcare professionals only, please see the
section below.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Do not throw away any medcines via wastewater.
Ask your pharmacist how to trow away medicines
you no longer use. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Vancomycin contains
The active substance is vancomycin hydrochloride.
What Vancomycin looks like and contents of
the pack
Vancomycin is available as a powder for
concentrate solution for infusion, in 2 strengths.
500 mg and 1000 mg.
The medicine is a powder that has to be dissolved
before you receive it.
Other sources of information
Advice/medical education
Antibiotics are used to cure bacterial infections.
They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need
them precisely for your current illness.
Despite antibiotics, some bacteria may survive or
grow. This phenomenon is called resistance: some
antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may
even help bacteria become resistant and therefore
delay your cure or decrease antibiotic efficacy if
you do not respect appropriate:
- dosage
- schedules
- duration of treatment
Consequently, to preserve the efficacy of this drug:
1 - Use antibiotics only when prescribed.
2 - Strictly follow the prescription.
3 - Do not re-use an antibiotic without medical
prescription, even if you want to treat a similar
illness.
Marketing Authorisation Holder and
Manufacturer:
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark
This leaflet was last revised in October 2017.

Version 02

1 Pia 1922-J Vancomcin 17-10-11, Format 150 x 420 mm, Font: Frutiger Condensed 6pt Black, Profile

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