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 doctor or pharmacist.
1. Why am I being given ZERBAXA?
ZERBAXA contains two active ingredients Ceftolozane and Tazobactam. ZERBAXA is used to treat complicated abdominal and urinary system infections and Nosocomial
pneumonia.
2. What should I know before I am given ZERBAXA?
Do not use if you have ever had an allergic reaction to ZERBAXA or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ZERBAXA and affect how it works.
4. How am I given ZERBAXA?
The recommended dose depends on the type of infection that you have, where the infection
is in your body and how serious the infection is.
Your doctor or other healthcare professional will give you this medicine through an
infusion (a drip for 1 hour) into one of your veins.
5. What should I know while being given ZERBAXA?
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Things you should do
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If you develop diarrhoea whilst being given ZERBAXA, tell your doctor immediately.
Do this even if it occurs several weeks after stopping ZERBAXA.
This may be a sign of a serious side effect that affects the bowel. You may need urgent
medical care.
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Looking after your medicine
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ZERBAXA will be stored in the pharmacy or on the ward.
ZERBAXA is stored in its original packaging in a refrigerator between 2 and 8 degrees
Celsius.
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6. Are there any side effects?
Like all medicines, ZERBAXA can cause side effects. Sometimes they are serious, most
of the time they are not. You may need medical treatment if you get some of the side
effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are being given ZERBAXA.
Active ingredients:
ceftolozane and tazobactam
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ZERBAXA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ZERBAXA.
Where to find information in this leaflet:
1. Why am I being given ZERBAXA?
ZERBAXA contains two active ingredients:
Ceftolozane, an antibiotic that belongs to the group of "cephalosporins". Ceftolozane can kill
many kinds of bacteria that can cause infection.
Tazobactam belongs to the group of medicines known as “beta-lactamase inhibitors”. Tazobactam
can help ceftolozane work against some resistant types of bacteria.
When ceftolozane and tazobactam are given together, more types of bacteria are killed.
ZERBAXA is used in adults and children (birth to less than 18 years of age) to treat:
Complicated abdominal and urinary system infections, including a condition called
pyelonephritis.
ZERBAXA is an antibiotic prescribed to treat adults aged 18 years or older with:
Nosocomial pneumonia (an infection of the lungs that can occur while in the hospital
or in recently hospitalized patients), including a condition called “ventilator-associated
pneumonia” (an infection of the lungs that can occur while on a respirator).
Your doctor may have prescribed ZERBAXA for another reason. Ask your doctor if you
have any questions about why ZERBAXA has been prescribed for you.
2. What should I know before I am given ZERBAXA?
Warnings
Do not use ZERBAXA if:
you are allergic to ceftolozane, tazobactam or any of the other ingredients of this
medicine
you are highly allergic to beta-lactam class antibiotics (such as penicillin), or
medicines known as "cephalosporins" (e.g., cephalexin)
Some symptoms of an allergic reaction may include skin rash, itching or hives on the
skin, swelling of the face, lips, tongue or other parts of the body, shortness of
breath, wheezing or trouble breathing.
Check with your doctor if you:
know you are, or have previously been hypersensitive to cephalosporins, penicillins
or other antibacterial medicines.
have recently had diarrhoea, or have had diarrhoea before taking this medicine.
know you have difficulty fighting off infections, are receiving medicines to help
fight infections, or have neutropenia (low white blood cell count).
have allergies to any other medicines, foods, preservatives or dyes.
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
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will advise if you should receive ZERBAXA during pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Your doctor will discuss the possible risks and benefits of using ZERBAXA while you
are breast-feeding.
Children
ZERBAXA can be given to children from birth and older to treat complicated bacterial
infections within the abdomen and urinary tract system, including a condition called
"pyelonephritis" (a type of urinary tract infection that affects one or both kidneys).
Addiction
ZERBAXA is not addictive.
3. What if I am taking other medicines?
Tell your doctor or pharmacist 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 and ZERBAXA may interfere with each other, including:
probenecid (a medicine for gout)
diclofenac (a medicine to treat pain and inflammation associated with arthritis)
cimetidine (a medicine used to treat heartburn and stomach ulcers)
These medicines may increase the time it takes for tazobactam to leave your body.
Some medicines may be affected by ZERBAXA or may affect how well it works. You may
need different amounts of these medicines, or you may need to be given different medicines.
Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZERBAXA.
4. How am I given ZERBAXA?
How much is given
Adults
The recommended dose depends on the type of infection that you have, where the infection
is in your body and how serious the infection is. Your doctor will decide on the dose
that you need. The recommended dose is one or two vials of ZERBAXA (containing 1000
mg of ceftolozane and 500 mg of tazobactam) every 8 hours, which is given into one
of your veins (directly into the bloodstream).
Children
The dose for children will be calculated by the doctor based on the weight of the
child.
Patients with kidney problems
Your doctor may need to reduce the dose of ZERBAXA or how often you are given it.
Your doctor may also want to test your blood to make sure that your treatment is at
the right dose, especially if you have to take this medicine for a long time. ZERBAXA
should not be given to children with kidney problems.
How is ZERBAXA given
Your doctor or other healthcare professional will give you this medicine through an
infusion (a drip for 1 hour) into one of your veins.
How long is ZERBAXA given for
Treatment with ZERBAXA normally lasts between 4 and 14 days, depending on the severity
and location of the infection and how your body responds to treatment.
Your doctor will determine when your treatment should be stopped.
If you are given too much ZERBAXA
As this product is administered by a doctor or healthcare professional, it is very
unlikely that you will be given too much ZERBAXA. However, if you have any concerns,
talk to your doctor or other health care professional.
If you think you have used too much ZERBAXA, 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 given ZERBAXA?
Call your doctor straight away if you:
develop diarrhoea whilst being given ZERBAXA. Do this even if it occurs several weeks
after stopping ZERBAXA.
This may be a sign of a serious side effect that affects the bowel. You may need
urgent medical care.
Remind any doctor, dentist or pharmacist you visit that you are using ZERBAXA.
Looking after your medicine
ZERBAXA will be stored in the pharmacy or on the ward.
ZERBAXA is stored in its original packaging in a refrigerator between 2 and 8 degrees
Celsius.
Heat and light can destroy some medicines.
Getting rid of any unwanted medicine
Hospital staff will dispose of this medicine safely.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are being given ZERBAXA.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects for patients treated for complicated bacterial infections
within the abdomen and urinary tract system
Serious side effects for patients treated for complicated bacterial infections within
the abdomen and urinary tract system
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Serious side effects
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What to do
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Cardiac disorders:
Decrease in blood pressure
Gastrointestinal disorders:
Abdominal pain (stomach ache)
General disorders and administration site conditions:
Fever (high temperature)
Headache
Nausea
Infections and infestations:
Inflammation of the large intestine due to C. difficile bacteria
Investigations:
Increase in liver enzymes (from blood tests)
Increase in number of certain types of blood cells known as platelets
Metabolism and nutrition disorders:
Low red blood cell counts
Nervous system disorders:
Ischemic stroke (stroke caused by reduced blood flow in brain)
Vascular disorders:
Blood clot in a vein (venous thrombosis)
Renal and urinary system:
Kidney problems
Kidney disease
Obstruction of the intestine
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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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Less serious side effects for patients treated for nosocomial pneumonia
Serious side effects for patients treated for nosocomial pneumonia
Additional nervous system side effects include:
Seizures
Twitching or jerking of muscles
Feeling confused or agitated
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
This is not a complete list of all possible side effects. Your doctor or pharmacist
has a more complete list. Others may occur in some people and there may be some side
effects not yet known.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ZERBAXA contains
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Active ingredients
(main ingredients)
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Ceftolozane sulfate
Tazobactam
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Other ingredients
(inactive ingredients)
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Citric acid
Sodium Chloride
Arginine
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Do not take this medicine if you are allergic to any of these ingredients.
What ZERBAXA looks like
ZERBAXA is a white to slightly yellow powder supplied in glass containers (vials).
The powder is mixed with sterile liquid to give a clear, colourless to yellow solution
for infusion by your doctor (AUST R 229608).
Who distributes ZERBAXA
Merck Sharp and Dohme (Australia) Pty Ltd
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113 Australia
This leaflet was prepared in June 2024.
CCPPI-MK7625A-IV-092022
RCN: B000000887
Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.