Patient leaflet - Vancomycin 500 mg powder for solution for infusion or for oral use
1. What Vancomycin is and what it is used for
Vancomycin contains the active ingredient vancomycin. 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 or oral solution. Vancomycin is used in all age groups by infusion for the treatment of the following serious infections:
- Infections of the s kin 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
Vancomycin can be given orally in adults and children for the treatment of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium.
2. What you need to know before you are given Vancomycin
Do not use Vancomycin:
If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Serious side effects that may lead to loss of vision have been reported following the injection of vancomycin in the eyes.
Talk to your doctor or hospital pharmacist or nurse before using Vancomycin if:
You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking vancomycin. Serious skin reactions including
Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms
(DRESS), and acute generalized
exanthematous pustulosis (AGEP) have been
reported in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.
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 a 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 with 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, liver 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 tests may be necessary.
Other medicines and Vancomycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription. This is especially important of the following, as they may interact with your
Vancomycin:
anaesthetics - these may cause redness, flushing, fainting, collapse or even heart attacks. You should, therefore, tell your doctor that you are taking
Vancomycin if you are going to have an
operation.
any drug that affects your nerves or kidneys such as amphotericin B (treats fungal infections),
aminoglycoside, bacitracin, polymixin B, colistin, viomycin (antibiotics) or cisplatin (a chemotherapy drug),
piperacillin/tazobactam.
Potent diuretics (strong medicines which are given to encourage the
production of urine) such as furosemide.
It may still be all right for you to be given Vancomycin and your doctor will be able to decide what is suitable for you.
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 or pharmacist for advice before taking this medicine.
Driving and using machines
Vancomycin should not affect your ability to drive or use machines.
3. How you are given 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 your child's body weight. The usual infusion
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.
If given for treatment of
gastric disorders (so called
Pseudo-membranous colitis),
the medicinal product must
be administrated as a
solution for oral use (you will
take the medicine by mouth).
Duration of treatment
The length of treatment
depends on the infection you
have and may last a number
of weeks.
The duration of the therapy
may be different depending
on the individual response to
treatment for every patient.
During the treatment, you
might have blood tests, be
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.
Stop using vancomycin and seek medical attention immediately if you notice
any of the following symptoms:
reddish non-elevated,
target-like or circular
patches on the trunk, often with central blisters, skin
peeling, ulcers of mouth,
throat, nose, genitals and
eyes. These serious skin
rashes can be preceded by fever and flu-like
symptoms
(Stevens-Johnson
syndrome and toxic
epidermal necrolysis).
Widespread rash, high
disorder of the digestive tract, especially if you also have a
kidney disorder, side effects
that occur when vancomycin is administered by infusion
may appear.
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
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 diarrhoea, 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,
5. How to store Vancomycin
Your doctor or pharmacist
knows how to store
Vancomycin.
Keep this medicine out of the sight and reach of children.
Keep the vial in the outer
carton in order to protect from light.
Do not use this medicine after the expiry date which is
stated on the label. The
expiry date refers to the last
day of that month.
Before it is made up it should be stored below 25°C.
After it is made up,
Vancomycin may be stored in a refrigerator (2°- 8°C) for 24
hours. Solutions intended for
oral dosing may be stored in
a refrigerator (2°- 8°C) for 96
hours. Your doctor will ensure that the solution is not
discoloured or contains
particles. Do not throw away
any medicines via
wastewater or household
waste. Ask your pharmacist
how to throw away medicines you no longer use. These
measures will help protect the over a shorter period of time or in higher
concentrations, there is the possibility of inducing marked hypotension in addition to
thrombophlebitis. Rapid administration may also produce flushing and a transient rash over the neck and shoulders.
Continuous infusion
(should be used only
when intermittent
infusion is not feasible). 1000-2000 mg can be added to a sufficiently large volume of Sodium Chloride Intravenous
Infusion or 5% Dextrose Intravenous Infusion to permit the desired daily dose to be administered slowly by
intravenous drip over a 24-hour period.
Oral Administration
The contents of vials for parenteral administration may be used for oral
administration. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.
What Vancomycin looks like and contents of the pack
500 mg presentation:
Rubber stoppered 10 ml vials each containing 500 mg of vancomycin hydrochloride as an off-white powder.
One or ten 10 ml vials packaged in a cardboard carton.
1000 mg presentation: Rubber stoppered 20 ml vials containing 1000 mg
vancomycin hydrochloride as an off-white powder.
One or ten 20 ml vials packaged in a cardboard carton.
MA Holder
SGS Pharma Magyarorszag Kft.
Honved Utca 8. 1.em. 2 1054 Budapest
Hungary
Manufacturer
Dr. Friedrich Eberth
Arzneimittel GmbH
Am Bahnhof-2
92289, Ursensollen
Germany
This leaflet was last revised
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 any antibiotic without medical prescription, even if you want to treat a similar illness.
418 mm
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Vancomycin Packinsert for UK 30100018326
FINAL
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shaji
12/03/2022
30100018326
69751
35/11/21
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TO BE CONFIRM
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arial
1 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.
If given for treatment of gastric disorders (so called Pseudo-membranous colitis), the medicinal product must be administrated as a
solution for oral use (you will take the medicine by mouth).
Duration of treatment
The length of treatment depends on the infection you have and may last a number of weeks.
The duration of the therapy may be different depending on the individual response to treatment for every patient.
During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.
If you are given more
Vancomycin than you should receive
As Vancomycin will be given to you whilst you are in hospital is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. If you have any further questions on the use of this medicine, ask your doctor or nurse.
- 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.
Stop using vancomycin and seek medical attention immediately if you notice any of the following
symptoms:
reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like
symptoms
(Stevens-Johnson
syndrome and toxic epidermal necrolysis). • Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). • red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute
generalised
exanthematous
pustulosis).
The absorption of
vancomycin from the
gastrointestinal tract is negligible. However, if you have an inflammatory
disorder of the digestive tract, especially if you also have a kidney disorder, side effects that occur when vancomycin is administered by infusion may appear.
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
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 diarrhoea, 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 your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information
- 5. How to store Vancomycin
Your doctor or pharmacist knows how to store
Vancomycin.
Keep this medicine out of the sight and reach of children.
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Before it is made up it should be stored below 25°C.
After it is made up,
Vancomycin may be stored in a refrigerator (2°- 8°C) for 24 hours. Solutions intended for oral dosing may be stored in a refrigerator (2°- 8°C) for 96 hours. Your doctor will ensure that the solution is not
discoloured or contains particles. Do not throw away any medicines via
wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Vancomycin contains:
Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin, or 1 g
vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin. There are no other ingredients.
over a shorter period of time or in higher
concentrations, there is the possibility of inducing marked hypotension in addition to
thrombophlebitis. Rapid administration may also produce flushing and a transient rash over the neck and shoulders.
Continuous infusion
(should be used only when intermittent
infusion is not feasible). 1000-2000 mg can be added to a sufficiently large volume of Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion to permit the desired daily dose to be administered slowly by
intravenous drip over a 24-hour period.
Oral Administration
The contents of vials for parenteral administration may be used for oral administration. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
What Vancomycin looks like and contents of the pack
500 mg presentation:
Rubber stoppered 10 ml vials each containing 500 mg of vancomycin hydrochloride as an off-white powder.
One or ten 10 ml vials packaged in a cardboard carton.
1000 mg presentation: Rubber stoppered 20 ml vials containing 1000 mg vancomycin hydrochloride as an off-white powder.
One or ten 20 ml vials packaged in a cardboard carton.
MA Holder
SGS Pharma Magyarorszag Kft.
Honved Utca 8. 1.em. 2 1054 Budapest
Hungary
Manufacturer
SGS Pharma Magyarorszag Kft.
Derkovits Gyula utca 53 1193 Budapest,
Hungary
This leaflet was last revised in Feb 2023.
_______________________ _______________________
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 any antibiotic without medical prescription, even if you want to treat a similar illness.
418 mm
SAP Code: 30100018326 30100018326 Vancomycin Packinsert for UK_v7
TEMPLE
SAP Code :-
File No. :-
Old File No. :-
Old Product Code :-
Barcode :-
Perforation :-Gluing :-
:-
Issued For Final Production :-
Issued For Re-Approval :-
Issued For Approval :-
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:- info@templepackaging.co.in
Customer :-
Location :-
Product Name :-
Product Code :-
Version No. :-
Date :-
Folding Size :-
Substrate :-
Cover Page (PAD) :-
Cover Pg Substrate :-
No.of Pages / PAD :-
Remark :-
Printing Colours
:-
Font Name
GUFIC BIOSCIENCES LTD.
07
9pt
Mumbai
Vancomycin Packinsert for UK 30100018326
FINAL
418X210 MM
NA
60 GSM MAPLITHO PAPER
NA
NA
shaji
12/03/2022
30100018326
69751
35/11/21
NA
NA
NA
NA
NA
TO BE CONFIRM
NA
arial
1