VANCOMYCIN 1000MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: VANCOMYCIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Vancomycin 500mg and 1000mg
Powder for Concentrate for Solution for Infusion
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
I
•  f you have any further questions, ask your doctor or
pharmacist.
•  his medicine has been prescribed for you. Do not pass it on
T
to others. It may harm them, even if their symptoms are the
same as yours.
•  f any of the side effects get serious, or if you notice any
I
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
•  he full name of this medicine is Vancomycin 500mg and
T
1000mg Powder for Concentrate for Solution for Infusion but
within the leaflet it will be referred to as Vancomycin powder.

In this leaflet:
What Vancomycin powder is and what it is used for
Read this before you are given Vancomycin powder
How to use Vancomycin powder
Possible side effects
How Vancomycin powder is stored
Further information

Injection site pain, inflammation of the vein wall and blood clotting
can occur and is occasionally severe, slow administration also
reduces these side effects.
If you are allergic to another antibiotic called teicoplanin you may
also be allergic to vancomycin. Please tell your doctor.
If you suffer from kidney failure or receive concomitant treatment
with other substances toxic to kidney the possibility of developing
toxic effects is much higher.
Your doctor may perform several tests to see if your kidneys and
liver are working properly.
If you are elderly or have kidney problems your doctor may also
perform regular tests on your hearing and measure the amount of
vancomycin in your blood.
Deafness, transitory or permanent, which may be preceded by
noises in ears, can occur in patients with prior deafness, who have
received excessive doses, or who receive treatment with another
substance toxic to hearing. To reduce this risk, blood levels should
be checked periodically and periodic testing of hearing function is
recommended.
Prolonged use of Vancomycin powder may result in the overgrowth
of resistant organisms; your doctor will monitor this.

Taking other medicines with Vancomycin powder

Tell your doctor if you are also taking:
• gentamycin (antibiotic)
• amphotericin B (antibiotic)
• streptomycin (antibiotic)
• neomycin (antibiotic)
• kanamycin (antibiotic)
• amikacin (antibiotic)
• tobramycin (antibiotic)
• bacitracin (antibiotic)
• polymixin B (antibiotic)
• colistin (antibiotic)
• viomycin (antibiotic)
• cisplatin (medicinal product used to treat some types of cancer)

What Vancomycin powder is and what it is used for
What Vancomycin powder is

Vancomycin powder is one of a group of medicines called
glycopeptide antibiotics. These are used to treat infections caused
by bacteria. Vancomycin comes in the form of a powder which is
made into a solution using sterile water (for injections).
This solution is given to you as an infusion, a slow injection, by
means of a drip. It will only be given to you through a vein. It can
also be given by mouth.

What Vancomycin powder is used for

This medicine is used for severe infections caused by bacteria which
can resist other antibiotics. It is used in patients who have not
responded to treatment with, or have had a bad reaction to, other
antibiotics.

The following can also react with vancomycin if taken at the same
time:
•  naesthetic agents (if you are going to have a general
a
anaesthetic)
• muscle relaxants (used sometimes during a general anaesthetic)

It is used to treat various severe infections of the lining or valves of
the heart, lungs, bone or soft tissue (flesh). It can also be given to
you before some surgical procedures to prevent infections.

Please tell your doctor or nurse, if you are taking or have taken
recently any other medicines, including medicines obtained
without a prescription.

Pregnancy and breast-feeding

Read this before you are given Vancomycin powder

Ask your doctor for advice before taking any medicine.
Tell your doctor if you are pregnant or think you may be pregnant.
Your doctor will then decide whether you should receive
Vancomycin powder.
Tell your doctor if you are breast-feeding, because Vancomycin
passes into breast milk. A decision will be made as to whether you
breast-feed or are treated with Vancomycin powder.

Do not have Vancomycin powder if you

•  re allergic to vancomycin hydrochloride or to any of the other
a
ingredients of Vancomycin powder (See Section 6 for a list of
these).
Tell your doctor if you have had any problems with this medicine
or any other in the past.

Driving and using machines

Take special care with Vancomycin powder if you

Vancomycin powder has very little influence on the ability to drive
or to use machinery.

• suffer from loss of hearing
• have kidney problems
• are elderly (65 years old and over)

Rapid injection of Vancomycin may cause low blood pressure, shock
and rarely cardiac arrest. Stopping the infusion usually results in a
prompt cessation of the reactions.

Important information about some of the ingredients
of Vancomycin powder
This medicinal product contains less than 1mmol sodium (23mg)
per vial, i.e. essentially ‘sodium-free’.

Continued top of next column
AAAG0244

Continued on next page

The following information is intended for medical
or healthcare professionals only:
Vancomycin powder for concentrate for infusion is for single use only
and any unused solution should be discarded.
For intravenous use the powder must be reconstituted and the
resulting concentrate must then be immediately diluted further prior
to use.
For oral use the powder must be reconstituted, the resulting
concentration may be stored in a refrigerator (2 - 8°C) for 96 hours.
Discard any unused solution.

Preparation of the reconstituted concentrate

Dissolve the content of each 500mg vial in 10ml of sterile water for
injections.
Dissolve the content of each 1000mg vial in 20ml of sterile water for
injections. 
One ml of reconstituted solution contains 50mg of vancomycin. pH
of the reconstituted solution is 2.5 to 4.5. The solution should be clear
colourless to pale yellow and free from fibre and visible particulate
matters.

be further diluted depending on the method of administration.
Suitable diluents are: 5% Glucose Injection or 0.9% Sodium Chloride
Injection.

Intermittent infusion:

Reconstituted concentrate containing 500mg of vancomycin
(50mg/ml) must be diluted further with at least 100ml diluent.
Reconstituted concentrate containing 1000mg vancomycin (50mg/ml)
must be diluted further with at least 200ml diluent.
The concentration of vancomycin in Solution for infusion should not
exceed 5mg/ml.
The desired dose should be administered slowly by intravenous
infusion at a rate of no more than 10mg/minute, for at least 60 minutes
or even longer.
Before administration, the reconstituted and diluted solutions should
be inspected visually for particulate matter and discoloration. Only
clear and colourless to pale yellow solution free from particles should
be used.

Preparation of final diluted Solution for infusion

Reconstituted concentrate containing 50mg/ml of vancomycin should
AAAG0244

Vancomycin Powder for solution for infusion 500mg & 1000g PIL - UK
item no: AAAG0244

dimensions: 170x328

print proof no: 2

pharmacode:

origination date: 15.10.13

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 05.11.13

Technical Approval

revised by: DR

date sent: 15.10.13

supplier: Strides Poland

technically app. date: 28.10.13

Non Printing Colours
1. Pharmacode position
2.
3.

Vancomycin powder is given to you by hospital staff, using an
infusion, (a slow injection by means of a drip). Each infusion will
be given slowly, usually lasting for at least one hour. It may also be
given to you to drink or via a tube in your nose.

How much you will receive

The dose of Vancomycin powder your doctor gives you will depend
on your age, weight, general health condition, the severity of the
infection, whether you need certain other medicines and how well
you respond to the treatment.

For patients whose kidneys are working normally

Adults and children above 12 years of age: the usual dose is 2000mg
daily in two or four doses (or 30mg per kilogram of bodyweight, per
day either 500mg every 6 hours or 1g every 12 hours).
Children (from one month to 12 years of age): the usual intravenous
dosage is 10mg/kg per dose given every 6 hours (total daily dosage
40mg/kg of body weight).
New-born babies (born full term):
•  - 7 days old: a starting dose of 15mg for each kilogram of the child’s
0
weight, followed by 10mg per kilogram, every 12 hours.
•  - 30 days old: a starting dose of 15mg for each kilogram of the child’s
7
weight, followed by 10mg per kilogram, every 8 hours.

For patients whose kidneys are not working normally

The doctor will reduce the dose or extend the interval between two
doses.
Special tests will be carried out and the dose will be adjusted to meet the
results of the tests.
If you are elderly, (65 years of age and over), your doctor will also consider
how well your kidneys are likely to be working.

For patients whose liver is not working normally

If you have severe liver damage, special tests will be carried out and the
dose will be adjusted to meet the results obtained from the tests.

For patients whose kidneys do not work at all

The starting dose is 15mg for each kilogram of bodyweight, followed
by a maintenance dose of approximately 1.9mg for each kilogram of
bodyweight, over each 24 hours.

Oral doses

Adults and elderly: 500mg a day in divided doses for 7-10 days
Children: 40mg for each kilogram of bodyweight, in 3-4 doses for
7-10 days
Maximum daily dose of 2000mg
Your doctor will decide when your treatment should end.

If you receive too much Vancomycin

Your doctor monitors the amount of Vancomycin you receive. If the regular
blood tests and other tests show that you have too much in your body, the
amount of Vancomycin will be reduced or infusion will be stopped. The
level remaining in your blood will be lowered.
If you have any further questions about receiving this medicine, please ask
your doctor.

Possible side effects

Like all medicines, Vancomycin powder can cause side effects, although
not everybody gets them.
•  ontact your doctor at once if the following effects happen:swelling of
C
the face or throat, difficulty in breathing, feeling faint, itchy skin or hives.
The consequences could become very serious so, tell your doctor or
nurse immediately. Infusion will be halted.
•  ancomycin may cause a serious or life-threatening allergic reaction
V
that may affect your skin or other parts of your body such as your liver
or blood cells (DRESS syndrome). Symptoms include skin rash, fever,
swollen glands that do not go away, swelling of your lip and tongue,
yellowing of your skin or of the whites of the eyes, unusual bruising
or bleeding, severe fatigue or weakness, unexpected muscle pain or
frequent infections
•  uring or shortly after rapid infusion low blood pressure, difficulty
D
breathing, itchy skin rash, redness of the skin of the upper body, pain
and cramp in chest or back muscle can occur. Vancomycin is given
slowly (for more than 60 minutes) to avoid these reactions.

• redness, a burning sensation, swelling of a vein and the area around it
r
•  edness and soreness at the point where the infusion goes into your
body
• redness of the upper body and the face
• pain and spasm of the chest and back muscles
Uncommon side effects (affect 1 to 10 users in 1000):
• temporary or permanent loss of hearing
Rare side effects (affect 1 to 10 users in 10,000):
• anaphylactic reactions, allergic reactions
• a ringing or buzzing in your ears
• dizziness
• feeling sick
• diarrhoea
• raised temperature or shivering
•  hanges to the number of various types of white blood cells in
c
the blood - an increase or decrease
•  decrease in the number of platelets (a type of blood cell important
a
in blood clotting) in the blood
• inflammation of the kidneys
• acute kidney failure
Very rare side effects (affect less than 1 user in 10,000):
• cardiac arrest
• nflammation of the bowel which causes abdominal pain or bloody
i
diarrhoea
•  evere skin reactions such as red and scaly or blistering skin, lesions and
s
flu-like symptoms
• inflammation of the blood vessels

How Vancomycin powder is stored

Keep out of the reach and sight of children.
Do not use Vancomycin powder after the expiry date which is
stated on the carton and vial after EXP. The expiry date refers to the
last day of that month.
Keep the vial in the outer carton in order to protect from light. Store
below 25°C.
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.

Further information

What Vancomycin powder contains

•  he active substance is vancomycin . Each vial contains either 500mg
T
vancomycin (equivalent to 525,000 IU) (as vancomycin hydrochloride)
or 1000mg vancomycin (equivalent to 1,050,000 IU) (as vancomycin
hydrochloride).
• The other ingredients are sodium hydroxide, hydrochloric acid.

What Vancomycin powder looks like and the contents of
the pack
Vancomycin powder is a freeze-dried, off-white powder. It is vacuumpacked in a glass vial with a rubber stopper and an aluminium seal with
flip-off cap.
Pack sizes: 1 vial in a carton
Marketing Authorisation Holder:
Actavis Group PTC ehf., Reykjavikurvegur 76-78,
220 Hafnarfjörður, Iceland           
Manufacturers:
Agila Specialties Polska Sp. z o.o.
10, Daniszewska Str.
03-230 Warsaw
Poland
Actavis Group PTC ehf,
Reykjavíkurvegur 76-78,
IS-220 Hafnarfjörður,
Iceland
This leaflet was last revised in October 2013.


If you would like a
leaflet with larger
text, please contact
01271 311257.

Tell your doctor or pharmacist if the following side effects occur or get
worse:
Common side effects (affect 1 to 10 users in 100):
• shortness of breath; noisy breathing (stridor)
• low blood pressure
• vein wall inflammation including blood clotting (thrombophlebitis)
• kidney problems
• skin reactions such as rashes, swelling, itching or hives

Actavis, Barnstaple, EX32 8NS, UK
101xxxx

Shelf-life of diluted product:

Chemical and physical in-use stability of the diluted product has been
demonstrated for 48 hours at both 2-8 °C and 25°C when diluted with
either 0.9% sodium chloride or 5% glucose.
From a microbiological point of view, the medicinal product should be
used immediately unless reconstitution and dilution has taken place in
controlled and validated aseptic conditions. If not used immediately,
in-use storage times and conditions prior to use are the responsibility
of the user and the product should be protected from light during
storage.
In patients with impaired renal function the dose must be adjusted.
Serum levels of vancomycin should be monitored regularly. For most
patients with impaired renal function the following nomogramm
can be used to determine the dose needed. The total daily dose of
vancomycin (in mg) should be about 15 times the glomerular filtration
rate (in ml/min). The starting dose should always be at least 15mg/kg.
The nomogram is not valid for functionally anephric patients on
dialysis.

VANCOMYCIN DOSIS (mg/kg/24h)

Shelf-life of reconstituted concentrate:

The reconstituted concentrate should be diluted immediately after
preparation.

VANCOMYCIN CLEARANCE (ml/min/kg)

Continued top of next column
AAAG0244

CREATININE CLEARANCE (ml/min/kg)

If the creatine clearance is not available, the following formula may be
applied to calculate the creatinine clearance from the patient’s age, sex
and serum creatinine:

Men:
Weight (kg) x 140 - age (years)


72 x serum creatinine (mg/100ml)

Women:
0.85 x value calculated by the above formula.

AAAG0244

Actavis, Barnstaple, EX32 8NS, UK

Vancomycin Powder for solution for infusion 500mg & 1000g PIL - UK
item no: AAAG0244

dimensions: 170x328

print proof no: 2

pharmacode:

origination date: 15.10.13

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: DR
approved for print/date

colours/plates:

revision date: 05.11.13

Technical Approval

revised by: DR

date sent: 15.10.13

supplier: Strides Poland

technically app. date: 28.10.13

Non Printing Colours
1. Pharmacode position
2.
3.

Please note: 101xxxx is a supplier code that
will be updated by the supplier when printed.

How to use Vancomycin powder

Expand view ⇕

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.

Hide
(web3)