Zavicefta®2000/500
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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
Zavicefta contains the active ingredients, ceftazidime and avibactam. It is used to
treat serious infections of the tissues and organs within the stomach, urinary tract
or kidney or certain serious lung infections.
For more information, see Section 1. Why am I being treated with Zavicefta? in the full CMI.
Do not start treatment if you/your child have ever had an allergic reaction to Zavicefta/ceftazidime/avibactam,
other antibiotics that are the same type, or any of the ingredients listed at the
end of the CMI including sodium carbonate.
Tell the doctor if you/your child have had any allergic reaction to any antibiotic,
have other medical conditions, are on a controlled sodium diet, take any other medicines
or if you are pregnant, plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before treatment with Zavicefta? in the full CMI.
Some medicines may interfere with Zavicefta and affect how it works.
More instructions can be found in in Section 3. What if I am taking other medicines? in the full CMI.
The doctor will decide how much Zavicefta is needed. It will depend on the type of
infection, age and bodyweight (for children) and if you/your child have kidney problems.
More instructions can be found in Section 4. How is Zavicefta given? in the full CMI.
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Things you should do
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Tell your doctor if you/your child have kidney problems, anaemia, are on a controlled
sodium diet, had severe diarrhoea after taking any antibiotics or if you are pregnant,
plan to become pregnant or are breastfeeding.
For more information on "Things you should do" can be found in Section 6 in the full
CMI.
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Things you should not do
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You/your child should not be treated with Zavicefta if you/your child have had a serious
allergy to penicillin or the same type of antibiotics as Zavicefta.
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Driving or using machines
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Zavicefta may affect your ability to drive a car or operate machinery.
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Looking after your medicine
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Store in original carton at below 30°C until ready for use.
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For more information, see Section 5. What should I know during treatment with Zavicefta? in the full CMI.
Side effects may include swelling of the face, lips, mouth or throat, difficulty swallowing
or breathing; shortness of breath or breathing difficulties; nausea or vomiting; changes
in taste or a metallic taste; stomach or abdominal pain; severe diarrhoea or stools
that contains blood or mucus; severe skin rash; weight gain; increased urine volume;
night urination; numbness or a tingling sensation; redness, pain or swelling at the
injection site or vein; headaches; dizziness; fever; itchy skin; hives/skin rash;
white, furry layer on the tongue; unusual vaginal discharge; yellowing of skin and
eyes (jaundice),.problems with your liver or kidneys, certain blood cells or the way
your blood clots.
For more information, including what Zavicefta to do if you have any side effects,
see Section 6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring in Australia. This will allow quick
identification of new safety information. You can help by reporting any side effects
you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problem .
ZAVICEFTA®
Active ingredient(s):
ceftazidime/avibactam
Consumer Medicine Information (CMI)
This leaflet provides important information about Zavicefta. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Zavicefta.
Where to find information in this leaflet:
Zavicefta contains the active ingredients ceftazidime and avibactam. Zavicefta is an antibiotic used in adults and children from 3 months to treat serious
infections of the tissues and organs within the stomach, urinary tract or kidney infections
and in adults to treat certain lung infections.
Do not use Zavicefta if you/your child are:
allergic to Zavicefta/ceftazidime/avibactam 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 penicillin or the
same type of antibiotic as Zavicefta. Your doctor will know which antibiotics are
the same type as Zavicefta.
Check with your doctor if you/your child:
have kidney problems
anaemia
are on a controlled sodium diet
have had severe diarrhoea after taking any antibiotics
are taking 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.
Tell your doctor or pharmacist if you/your child 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 Zavicefta may interfere with each other. These include:
probenecid, a medicine used to prevent gout and gouty arthritis
a type of antibiotic called aminoglycosides, such as gentamicin and tobramycin
a type of antibiotic called cephalosporins, such as cefazolin and ceftazidime
chloramphenicol, a medicine used to treat eye infections
medicines used to pass urine, such as frusemide
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Zavicefta.
How much will be given
The doctor will decide what dose of Zavicefta is needed depending on certain factors
such as the type of infection, age and bodyweight (for children) and if you/your child
have kidney problems.
How long will Zavicefta need to be given?
Treatment is usually given every day for 5 days to up to 14 days. The doctor will
decide how many days you will need treatment with Zavicefta.
If too much Zavicefta is given
If you think that you/your child have been given too much Zavicefta, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
If you/your child are about to have any blood tests, tell the doctor or nurse that
you/your child were recently treated with Zavicefta.
Call your doctor straight away if you/your child:
get severe diarrhoea. Do this even if it occurs several weeks after Zavicefta has
been stopped.
Remind any doctor, nurse, dentist or pharmacist you see that you are using Zavicefta.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Zavicefta
affects you.
Zavicefta may affect your ability to drive a car or operate machinery.
Looking after your medicine
Zavicefta should be stored in the original carton below 30°C.
If you are keeping this medicine at home, store it in a cool dry place away from moisture,
heat or sunlight. For example, do not store it in the bathroom, near a sink or in
the car or on windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
Discard any medicine that has passed the expiry date.
This medicine should only be used on one patient and any unused medicine should be
discarded.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
All medicines can have side effects. If you do experience any side effects, most of
them will be minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
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Side effects
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What to do
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Stomach pain
Diarrhoea
Nausea or vomiting
Changes in taste or a metallic taste in the mouth
Itchy skin
Skin rash or hives.
Dizziness
Headache
Fever
White, furry layer on the tongue
Unusual vaginal discharge
Redness, pain or swelling where injection was given into a vein
Problems with your liver or kidneys*
Problems with certain blood cells or the way your blood clots.*
*These side effects may show up when you have a blood test.
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Speak to your doctor if you have any of these side effects and they worry you.
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Side effects
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What to do
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Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing
or breathing
Shortness of breath or breathing difficulties
Abdominal pain
Diarrhoea that keeps getting worse or does not go away, or stools that contains blood
or mucus. This may occur even after treatment
Rash or hives with unusual weight gain, increased urine volume and night urination
Changes to urine volume.
Numbness or a tingling sensation
Severe skin reactions such as painful red areas, large blisters, peeling of your skin,
and bleeding in the lips, eyes, mouth, nose and genitals
Swelling of the limbs, face, lips, mouth or throat
Yellowing of the skin and eyes (jaundice).
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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 doctor or pharmacist 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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What Zavicefta contains
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Active ingredients
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Ceftazidime and avibactam
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Other ingredients
(inactive ingredients)
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Sodium bicarbonate
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Do not take this medicine if you are allergic to any of these ingredients.
What Zavicefta looks like
Zavicefta is a white to yellow powder, which will be dissolved to a clear and colourless
to yellow solution before it is given to you.
Australian Registration Number: AUST R 301205.
