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 treated with Zinforo?
Zinforo contains the active ingredient, ceftaroline fosamil. Zinforo is used to treat
you or your child for serious infections of the skin, tissues under the skin and infection
of the lungs (pneumonia).
2. What should I know before treatment with Zinforo?
Do not start treatment if you/your child have ever had an allergic reaction to Zinforo/ceftaroline,
other antibiotics that are the same type, or any of the ingredients listed at the
end of the CMI including L-arginine.
Tell the doctor if you/your child have had any allergic reaction to any antibiotic;
have other medical conditions; take any other medicines; or if you are pregnant, plan
to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Zinforo and affect how it works.
4. How is Zinforo given?
The doctor will decide how much Zinforo is needed. It will depend on factors such
as the type of infection, age and bodyweight (for children) and if you have kidney
problems.
5. What should I know during treatment with Zinforo?
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Things you should do
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Tell your doctor if you/your child have kidney problems; have suffered from fits (seizures/convulsions);
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 should not be treated with Zinforo if you/your child have had a serious allergy
to penicillin or the same type of antibiotics as Zinforo. Your doctor will know which
antibiotics are the same type as Zinforo.
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Driving or using machines
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Zinforo 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 25°C until ready for use.
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6. Are there any side effects?
Side effects of this medicine may include sudden swelling of the lips, face, throat
or tongue (allergic reactions); stomach pain; nausea or vomiting; constipation; itching:
skin rash; painful red areas, large blisters, peeling of your skin and bleeding in
the lips, eyes, mouth, nose or genitals; dizziness; trouble sleeping; pain and irritation
at the injection site and vein; problems with muscles; severe diarrhoea or stools
that contain blood or mucus; fever, headache, chills, weakness in your limbs, sore
throat, mouth or problems with your gums; bleeding or bruising more than usual; confusion
and personality changes; pneumonia; problems with your liver or kidneys, certain blood
cells or the way your blood clots.
ceftaroline fosamil
Full Consumer Medicine Information (CMI)
This leaflet provides important information about Zinforo. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Zinforo.
Where to find information in this leaflet:
1. Why am I being treated with Zinforo?
Zinforo contains the active ingredient ceftaroline fosamil. Zinforo is an antibiotic used to treat serious infections of the skin, tissues below
the skin and infection of the lungs (pneumonia).
2. What should I know before treatment with Zinforo?
Warnings
Do not use Zinforo if you/your child are:
allergic to Zinforo/ceftaroline 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 Zinforo. Your doctor will know which antibiotics are the
same type as Zinforo.
Check with your doctor if you/your child:
have kidney problems
have ever suffered from fits (seizures/convulsions)
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.
3. What if I am taking other medicines?
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Zinforo.
4. How is Zinforo given?
How much will be given
The doctor will decide what dose of Zinforo is needed depending on certain factors
such as the type of infection, age and bodyweight (for children) and if you have kidney
problems.
How long will Zinforo need to be given?
A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to
7 days for pneumonia. The doctor will decide how many days you will need treatment
with Zinforo.
If too much Zinforo is given
If you think that you/your child have been given too much Zinforo, 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 during treatment with Zinforo?
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 Zinforo.
Call your doctor straight away if you/your child:
get severe diarrhoea. Do this even if it occurs several weeks after Zinforo has been
stopped.
Remind any doctor, nurse, dentist or pharmacist you see that you are using Zinforo.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Zinforo
affects you.
Zinforo may affect your ability to drive a car or operate machinery.
Drinking alcohol
No information available.
Looking after your medicine
Zinforo should be stored in the original carton below 25°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.
6. Are there any side effects?
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
Nausea or vomiting
Constipation
Itching
Skin rash
Dizziness
Trouble sleeping
Fever
Headache
Redness, pain or swelling where the injection was given and pain and irritation of
the vein
Muscle cramps, weakness, tenderness or pain
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 or nurse 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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Sudden swelling of the lips, face, throat or tongue, severe rash, swallowing or breathing
problems. These are signs of severe allergic reaction (anaphylaxis)
Diarrhoea that does not go away or stools that contain blood or mucus
Do not take any diarrhoea medicine without checking with the doctor.
Severe skin reaction, e.g., painful red areas, large blisters, peeling of your skin,
and bleeding in the lips, eyes, mouth, nose or genital
Sudden fever with chills, weakness in your limbs, sore throat, mouth or gum ulcers
or bleeding gums
Bleeding or bruising more than usual
Confusion, memory loss or changes in personality
Fever with cough, chest pain, body aches with difficulty breathing
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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, nurse 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.
7. Product details
This medicine is only available with a doctor's prescription.
What Zinforo contains
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Active ingredient
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Ceftaroline fosamil
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Other ingredients
(inactive ingredients)
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L-arginine
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Do not take this medicine if you are allergic to any of these ingredients.
What Zinforo looks like
Zinforo is a pale yellowish-white to light yellow powder, which will be dissolved
to a pale yellow solution before it is given to you.
Australian Registration Number: AUST R 192260.
Who distributes Zinforo
Pfizer Australia Pty Ltd
Sydney NSW.
Toll Free Number: 1800 675 229.
This leaflet was prepared in January 2021.