Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your healthcare professional.
1. Why am I being treated with DBL Vancomycin?
DBL Vancomycin contains the active ingredient vancomycin hydrochloride. DBL Vancomycin
is used to treat severe bacterial infections. For more information, see Section
1. Why am I being treated with DBL Vancomycin? in the full CMI.
2. What should I know before being treated with DBL Vancomycin?
Do not start treatment if you/your child have ever had an allergic reaction to vancomycin,
other antibiotics that are the same type, or any of the ingredients listed at the
end of the CMI. Your doctor will know which antibiotics are the same type.
Talk to your doctor if you/your child have had any allergic reaction to any antibiotic;
have kidney or hearing problems, have inflammatory bowel disorders; take any other
medicines; or are pregnant, plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before being treated with DBL Vancomycin? in the full CMI.
3. What if I am taking other medicines?
4. How is DBL Vancomycin given?
The doctor will decide how much DBL Vancomycin is needed. It will depend on factors
such as the type of infection, age and bodyweight and if you/your child have kidney
problems.
5. What should I know while being treated with DBL Vancomycin?
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Things you should do
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Tell your doctor if you/your child have kidney or hearing problems; have suffered
from inflammatory bowel disorders; had severe diarrhoea after taking any antibiotics;
or if you are pregnant, plan to become pregnant or are breastfeeding.
Tell your healthcare professional immediately if you develop a rash or any other sign
of allergic reaction (shortness of breath, wheezing or difficulty breathing, swelling
of the lips, face, throat, tongue or other parts of the body, rash, itching or hives
on the skin)
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Things you should not do
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You/your child should not be treated with DBL Vancomycin if you/your child have had
an allergic reaction to vancomycin, the same type of antibiotics as DBL Vancomycin,
or any of the other ingredients listed in Section 7. Product details. Your doctor
will know which antibiotics are the same type as DBL Vancomycin.
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Driving or using machines
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Be careful before you drive a car or operate machinery until you know how Pfizer Vancomycin
affects you. Vancomycin may cause dizziness in some people.
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Looking after your medicine
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Store in original carton at below 25°C until ready for use.
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6. Are there any side effects?
Side effects of this medicine may include allergic reactions (chest pain, shortness
of breath, wheezing or difficulty breathing, swelling of the lips, face, throat, tongue
or other parts of the body, rash, itching or hives on the skin); rash or severe skin
reaction that may be accompanied with a fever; severe stomach or abdominal cramps;
nausea or vomiting, appetite loss, weight loss; fatigue, general aches and pains,
pale skin; severe blisters and bleeding in the lips, eyes, mouth, nose or genitals;
vertigo, dizziness, ringing in the ears or hearing loss; pain and irritation at the
injection site; extremely tender, swelling and redness along a vein; fast, slow or
irregular heartbeat, heart attack, drowsiness, loss of consciousness, sweating, restlessness;
upper body flushing, chest and backpain and muscle spasm; watery and severe diarrhoea
which may also be bloody; fever, chills, other infections; bruising more than usual;
kidney problems, little or no urine.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): vancomycin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Vancomycin. You should also speak to your healthcare professional if you would like further information
or if you have any concerns or questions about being given DBL Vancomycin.
Where to find information in this leaflet:
1. Why am I being treated with DBL Vancomycin?
DBL Vancomycin contains the active ingredient vancomycin hydrochloride. DBL Vancomycin is a glycopeptide antibiotic use to treat severe bacterial infections.
2. What should I know before being treated with DBL Vancomycin?
Warnings
You/your child should not be given DBL Vancomycin if you/your child are:
allergic to vancomycin, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
allergic to or have previously had a severe allergic reaction to similar antibiotics
as DBL Vancomycin. Your doctor will know which antibiotics are the same type as DBL
Vancomycin.
Check with your doctor if you/your child:
have kidney problems
have hearing problems
have inflammatory bowel disorders
are taking any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
3. What if I am taking other medicines?
Tell your healthcare professional if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with DBL Vancomycin and affect how it works.
These include:
some other antibiotic medicines used to treat infections, such as aminoglycoside antibiotics
(e.g. amikacin, gentamicin, neomycin and tobramycin), cephalosporin antibiotics (e.g.
cefalexin, cefalotin, cefazolin, cefoxitin, cefuroxime, cefamandole, cefaclor, cefotaxime,
ceftazidime, ceftriaxone, cefepime, ceftaroline fosamil, ceftolozane), colistin, colistimethate
sodium, capreomycin, piperacillin/tazobactam, clindamycin, ethambutol hydrochloride,
and sulfadiazine
amphotericin B, a medicine used to treat fungal infections
medicine used to control and treat viral injections e.g. elvitegravir, cobicistat,
emtricitabine and tenofovir alafenamide, tenofovir alafenamide, adefovir dipivoxil,
emtricitabine with tenofovir alafenamide, and cidofovir
ciclosporin or tacrolimus, medicine used to suppress the immune system after organ
transplants, severe rheumatoid arthritis, severe psoriasis, atopic dermatitis (skin
allergies), and dry eye disease
sulfasalazine, medicine used to treat inflammatory bowel diseases such as ulcerative
colitis and Crohn's disease, and rheumatoid arthritis.
some medicines used to treat pain and inflammation such as naproxen, ketorolac trometamol,
flurbiprofen, and methoxyflurane
etoricoxib, a medicine used to treat osteoarthritis, gout attacks, and relieve short-term
pain
medicines used to treat certain cancers, including cisplatin, carmustine, cyclophosphamide
mitomycin, Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain, and teicoplanin
antithyroid medicines (e.g. propylthiouracil and carbimazole)
clozapine, medicine used mainly in the treatment of schizophrenia
fluid tablets (diuretics), such as furosemide (frusemide) and bumetanide
anaesthetic agents, e.g. halothane, isoflurane, desflurane, sevoflurane, thiopental,
fentanyl, alfentanil, ketamine, propofol, nitrous oxide, and esketamine
colestyramine, a powder taken to lower cholesterol levels
medicines used to relax muscles, such as suxamethonium, vecuronium, pancuronium, atracurium,
cisatracurium, rocuronium bromide, mivacurium chloride, and botulinum toxin.
Check with your healthcare professional if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect DBL Vancomycin.
4. How is DBL Vancomycin given?
How much will be given
The doctor will decide what dose of DBL Vancomycin is needed depending on certain
factors such as the type of infection, age, bodyweight, and if you/your child have
kidney problems.
How long will DBL Vancomycin need to be given?
A course of treatment depends on the type, severity of the infection and how you/your
child responds. The doctor will decide how many days you will need treatment with
DBL Vancomycin.
How is DBL Vancomycin given?
DBL Vancomycin is given as either an injection into a vein or my mouth, depending
on the infection. Vancomycin has an offensive taste.
If too much DBL Vancomycin is given
As DBL Vancomycin is generally given to you in hospital under the supervision of your
healthcare professional, it is very unlikely that you will receive an overdose. Symptoms
of a vancomycin overdose include the effects listed below in Section
6. Are there any side effects?, but are usually of a more severe nature.
If you think that you/your child have been given too much DBL Vancomycin, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being treated with DBL Vancomycin?
Things you should do
Remind any doctors, nurses, dentists and pharmacists you see that you/your child are
being given DBL Vancomycin.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine. It may affect other medicines used during surgery.
If you become pregnant soon after being given vancomycin, tell your doctor.
Tell your healthcare professional straight away if you/your child:
get severe diarrhoea, severe abdominal or stomach cramps
get a fever, in combination with one of all of the above.
Do this even if it occurs several weeks after DBL Vancomycin has been stopped.
Diarrhoea may be caused by a serious condition affecting the bowel. You or your child
may need urgent medical care.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Pfizer
Vancomycin affects you.
Pfizer Vancomycin may cause dizziness in some people.
Looking after your medicine
DBL Vancomycin will be stored in the pharmacy or on the ward. The injection is kept
in a cool, dry place away from moisture, heat or sunlight, where the temperature stays
below 25°C. The expiry date will be checked that it has not passed.
6. Are there any side effects?
All medicines can have side effects. If you/your child do experience any side effects,
most of them are minor and temporary. However, some side effects may need medical
attention.
See the information below and, if you need to, ask your healthcare professional if
you have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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severe pain, warmth, itching, redness of the skin at the injection site
severe blisters and bleeding in the lips, eyes, mouth, nose or genitals
severe flaking or peeling of the skin
fluid-filled blisters that are located along creases in the skin which may be itchy
severe skin reaction starting with painful red areas, then large blisters and end
with peeling layers of skin, accompanied by fever and chills, aching muscles and generally
feeling unwell
rash with small puss-filled blisters that may be accompanied by a fever
pain, swelling and redness along a vein which is extremely tender when touched
itchy spots accompanied by fever and feeling unwell
signs of an allergic reaction, such as chest pain,shortness of breath, wheezing, coughing
or difficulty breathing, swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin
bleeding or bruising more easily than normal
flushing of the upper body or pain and muscle spasm of the chest and back
chills or fever, which may be accompanied by shivering
fever, loss of appetite, weight loss, fatigue, general aches and pains
severe and constant abdominal pain, fever, inability to break wind or pass stools,
nausea and vomiting, shock
fast, slow or irregular heart beat, heart palpitations
dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness,
loss of consciousness; heart attack
ringing in the ears (tinnitus) or hearing loss, deafness, dizziness or problems with
your balance
diarrhoea, usually with blood and mucus, stomach pain, fever
frequent infections such as fever, severe chills, sore throat or mouth ulcers; tiredness,
being short of breath and looking pale
little or no urine, drowsiness, nausea, vomiting, breathlessness, kidney disease
other infections.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your healthcare professional if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Vancomycin contains
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Active ingredient
(main ingredient)
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Vancomycin hydrochloride
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Other ingredients
(inactive ingredients)
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• disodium edetate
• hydrochloric acid
• sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What DBL Vancomycin looks like
DBL Vancomycin is a white to off-white powder, which will be dissolved to a clear
solution before it is given to you.
DBL Vancomycin is available in the following strengths and pack sizes:
Vials containing 500 mg (500,000 IU) of vancomycin activity; packs of 1 and 10 vials
(AUST R 62603)
Vials containing 1000 mg (1,000,000 IU) of vancomycin activity, packs of 1 vial, (AUST
R 62595).
Who distributes DBL Vancomycin
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
® Registered trademark.
© Pfizer Australia Pty Ltd 2023.
This leaflet was prepared in February 2023.