CEFTAZIDIME 3G POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance: CEFTAZIDIME PENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime 3g Powder for solution for injection/infusion
Ceftazidime
The name of your medicine is Ceftazidime 3g Powder for solution for injection/infusion, which will be
referred to as Ceftazidime throughout the rest of this document.

Read all of this leaflet carefully before you start taking this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or pharmacist.
− This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Ceftazidime is and what it is used for
2.
Before you take Ceftazidime
3.
How to take Ceftazidime
4.
Possible side effects
5.
How to store Ceftazidime
6.
Further information

1.

WHAT CEFTAZIDIME IS AND WHAT IT IS USED FOR

Ceftazidime belongs to a group of antibacterial agents called cephalosporins, which act by killing
bacteria. Ceftazidime is used to treat infections caused by one bacterium, a mixture of bacteria, and
severe infections in general.
Ceftazidime is used to treat some infections of the:
− ear, nose, throat and chest, including pneumonia
− urinary passage
− skin and layers of flesh immediately under the skin
− gut, gall bladder, and abdomen
− bones and joints
− membranes and fluid surrounding the brain and spinal cord (this infection is called meningitis)
Ceftazidime can also be used to treat infections that may occur after dialysis or to prevent infections that
may occur after some surgical operations. Your doctor may sometimes need to use Ceftazidime at the
same time as other antibiotics to help treat or prevent infection.

2. BEFORE YOU TAKE CEFTAZIDIME
Do not take Ceftazidime if
- you are allergic (hypersensitive) to ceftazidime, cephalosporins, any penicillin-like antibiotics, or
any of the other ingredients as listed in Section 6 of this leaflet.

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Take special care with Ceftazidime if you
− have ever been told that your kidneys do not work very well or if you are having any sort of
treatment for kidney failure, such as dialysis. You may still be given Ceftazidime but you may
need a lower dose.
− are taking a strong diuretic (water tablets or injections), such as furosemide, which cause
increased urination. It is often necessary to check your kidneys frequently during treatment.
This can be done with blood and urine tests.
− are taking other antibiotics
− are on a low sodium diet
Ceftazidime is not suitable for everyone. Before treatment with Ceftazidime, talk to your doctor or
pharmacist if any of the above applies to you.
If you have been on Ceftazidime treatment for a prolonged period, it may result in the overgrowth of
organisms on which Ceftazidime does not act. This may need for you to be treated by other antimicrobial
agents.
Blood and urine tests
If you are to take any blood or urine tests, inform your doctor that you are taking Ceftazidime, as
Ceftazidime can alter the results of some of these tests. The use of Ceftazidime may interfere with blood
cross-matching in some patients. Ceftazidime can also alter the results of some urine tests for sugar such
as Benedict’s, Fehling’s or Clinitest.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is especially important of the following, as they
may interact with your Ceftazidime:
− Chloramphenicol, which is also an antibiotic, weakens the effects of Ceftazidime and other
cephalosporins. They should not be used together.
− Oral contraceptives (the “pill”) that contain estrogen (female sex hormone). Taking Ceftazidime
may make oral contraceptives less effective. You should take advice from your doctor on extra
precautions needed to avoid pregnancy.
Taking Ceftazidime with food and drink
Food/meals have no influence on the effectiveness of Ceftazidime as it is given by injection or infusion.
Pregnancy and breast-feeding
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become
pregnant. Ceftazidime is not known to harm the unborn child, but has not been deemed as safe. It will
only be given to a pregnant woman if it is absolutely necessary.
Breast-feeding
Small amounts of Ceftazidime passes into the mother's milk and it may affect the child. Ask your doctor
or pharmacist for advice before taking Ceftazidime if you are breast-feeding your child. If you cannot stop
breastfeeding while you are taking Ceftazidime, you should watch your baby carefully for any signs of
diarrhoea or allergy or any other illness and tell your doctor if you notice anything wrong.
Driving and using machines
Ceftazidime can cause dizziness. If affected, you should not drive or operate machinery.

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Important information about some of the ingredients of this product:
To be taken into consideration by patients under controlled sodium diet:
This medicinal product contains 6.60 mmol (152mg) of sodium per vial.
3.

HOW TO TAKE CEFTAZIDIME

Dosage
A doctor or nurse will usually administer the correct dose of Ceftazidime depending on the nature and
severity of your illness and your general condition, including your kidney function.
Always take Ceftazidime exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults
The adult dosage range for Ceftazidime is 1g to 6g per day, given in two or three divided doses. In the
majority of infections, 1g three times a day or 2g two times a day is given.
For infections of the urinary passage and in many less serious infections, 500mg or 1g twice a day is
usually given.
For very severe infections, especially in patients with very low immunity, including those with low counts
of the white blood cells, 2g two or three times a day, or 3g twice a day is given.
When used to prevent infections during surgery of the prostate, 1g is given just before the start of the
operation. A second dose is given at the time of catheter (tube in the bladder) removal.
In fibrocystic adults with lung infections who have normal kidney function, high doses of 100mg to
150mg per kg body weight is given per day in three divided doses. In adults with normal kidney function,
doses of up to 9g daily have been used.
Elderly
In acutely ill elderly patients, the removal of Ceftazidime from the blood is reduced and thus the daily
dosage should not normally exceed 3g, especially in those over 80 years of age.
Infants and children older than 2 months
The dose for children is based on their weight. The usual dosage range for children aged over two months
is 30mg to 100mg per kg bodyweight daily, given as two or three divided doses.
Doses up to 150mg per kg bodyweight daily (maximum 6g daily) in three divided doses may be given to
infected children with low immunity, fibrocystic children, children with meningitis.
Newborns and infants less than 2 months of age
Although the clinical experience is limited, a dose of 25mg to 60mg per kg bodyweight daily given as two
divided doses has proved to be effective.
Adults (including the elderly) with moderate to severe kidney problems
In patients with impaired kidney function the dosage of Ceftazidime is usually reduced to compensate for
its slower excretion, except in mild impairment. In patients with suspected kidney dysfunction, an initial
loading dose of 1g of Ceftazidime may be given. Your doctor will calculate the right dose for you
according to the results of blood or urine tests that measure how well your kidneys are functioning.

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Patients receiving dialysis
For patients with renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration the
dose is 1g daily in divided doses.
For patients who have haemodialysis courses, the appropriate dose is repeated after each haemodialysis
period. This is because some of the Ceftazidime may be removed from the body during this type of
dialysis and thus needs to be replaced.
Ceftazidime can be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). It
can be given intravenously or can be incorporated into the dialysis fluid (usually 125-250 mg for 2L of
dialysis fluid).
How to prepare and administer Ceftazidime
Ceftazidime is supplied as a powder, so it must be made into a solution before it can be given. Only some
types of solutions can be used to mix up the powder to make it ready for use. Your doctor or nurse will use
the proper solutions to prepare a fresh solution of Ceftazidime for administration.
If you have been instructed to give Ceftazidime to yourself, make sure that you understand how to mix the
powder with the solutions that you are given.
Ceftazidime will usually be given by a doctor or nurse either intravenously (directly into a vein) by a slow
injection over 3-5 minutes, or by a drip over a longer period of time (such as 15-30 minutes). Less often,
Ceftazidime is given intramuscularly (injected into the large muscles of the leg or buttock).
How frequently you should be given Ceftazidime
Ceftazidime is usually given two to three times a day.
Duration of treatment
Your doctor will advise you on how long your treatment should last. The duration of therapy depends on
the course of the disease. Typically this is between one and two weeks for most infections.
If you take more Ceftazidime than you should
Since a doctor or nurse will give you Ceftazidime, it is very unlikely that you will be given too much
Ceftazidime. Rarely, you may be asked by your doctor or nurse to give yourself Ceftazidime at home. If
you think you or someone you know has received too much medicine, please tell your doctor or nurse
immediately or contact the nearest hospital emergency department.
Overdose can adversely affect the nervous system leading to damage to the brain, fits and loss of
consciousness. In addition to treatment of the symptoms of overdose, the doctors may also try to reduce
the levels of Ceftazidime in the blood by dialysis.
If you forget to take Ceftazidime
Since a doctor or nurse will give you Ceftazidime, it is very unlikely that you will miss a dose. If you
think you may have missed a dose, please tell your doctor or nurse. A double dose should not be used to
make up for a forgotten dose.
If you stop taking Ceftazidime
You must use your medication exactly as directed. Do not stop your therapy on your own for any reason
because your infection could worsen and result in hospitalization.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4.

POSSIBLE SIDE EFFECTS

Like all medicines, Ceftazidime can cause side effects, although not everybody gets them.
Serious side effects
Serious allergic reactions to Ceftazidime are very rare (affect fewer than one in ten thousand people).
These can include:
− Sudden wheezing and tightness of chest
− Swelling of eyelids, face or lips
− Severe skin rashes that can blister and may involve the eyes, mouth, throat and genitals
− Loss of consciousness (fainting)
All of these allergic reactions need urgent medical attention. If you think you are having any of
these types of reactions, you must tell your doctor or nurse immediately. If you are giving yourself
Ceftazidime at home, stop taking Ceftazidime and contact your doctor or your nearest hospital
emergency department.
Common side effects (affect fewer than one in ten people)
− Eosinophilia (an abnormal increase in the number of a type of white blood cells called
eosinophil)
− Abnormal increase in the number of blood platelets
− Altered results of some blood tests (such as Coomb’s test). If you are having a blood test for any
reason, tell the person who is taking your blood sample that you are taking this medicine, as it
may affect your result
− Pain and/or inflammation of vein at the site of intravenous injection
− Diarrhoea
− Liver and bile problems: blood tests which show changes in the way the liver is working
− Skin rashes that are less severe allergic reactions than mentioned above
− Lumpy rash (hives)
− Pain and/or inflammation at the site of intramuscular injection
Uncommon side effects (affect fewer than one in a hundred people)
− Infections: having a course of Ceftazidime can temporarily increase the risk of getting infections
caused by other types of germs. For example, thrush (an infection caused by yeast called Candida)
in the mouth or vagina.
− Reduction in the number of some types of white blood cells, which makes infections more likely
− Reduction in blood platelets, which increases risk of bleeding or bruising
− Headache
− Dizziness
− Nausea (feeling sick)
− Vomiting
− Abdominal (tummy) pain
− Colitis (inflammation of the colon (lower end of the bowel))
− Itching
− Changes in blood tests that check how your kidney is working
− Fever
Very rare side effects (affect fewer than one in ten thousand people)
− Increase in the number of white blood cells called lymphocytes

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Reduction in red blood cells which can make the skin pale or yellow and cause weakness or
breathlessness
Severe reduction in the number of white blood cells which makes infections more likely
Serious allergic reaction which causes difficulty in breathing, dizziness or swelling of face or
throat
A pins and needles feeling
Bad taste in the mouth
Yellowing of the skin or whites of the eyes caused by liver or blood problems
Serious illness with blistering of the skin, mouth, eyes and genitals

[

There have been some reports of certain nervous and digestive system side effects experienced since the
product has been in the market. However the exact incidence of such side effects is not known. When too
much of Ceftazidime is given, especially in people whose kidneys are not working properly, it can cause
trembling, fits and in a few cases, coma. In certain cases, an infection of the large bowel (called
pseudomembranous colitis) that needs special treatment may occur. If you have severe diarrhoea or if you
see blood and/or mucus in your diarrhoea, you should stop taking this medicine and contact your doctor
immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
[

5.

HOW TO STORE CEFTAZIDIME

Keep out of the reach and sight of children.
Do not use Ceftazidime after the expiry date, which is stated on the label or carton.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Keep vial(s) in the outer carton to protect from light.
The reconstituted solution should be used immediately. After reconstitution, the solution may be stored
between 2-8°C for up to 24 hours if the reconstitution has taken place in controlled aseptic conditions.
Single use only.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Ceftazidime contains
The Active substance is Ceftazidime pentahydrate equivalent to 3 g of Ceftazidime. The other ingredient
is sodium carbonate, anhydrous.
What Ceftazidime looks like and contents of the pack
Ceftazidime is a white to cream coloured crystalline powder, packaged in 100 ml clear glass vial.
Pack of 1 vial in a carton.

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Marketing Authorisation Holder

Hospira UK LIMITED,
Queensway,
Royal Leamington Spa,
Warwickshire, CV313RW, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Finland – Ceftazidim Hospira 3 g injektio-/infuusiokuiva-aine, liuosta varten
United Kingdom – Ceftazidime 3g Powder for solution for injection/infusion
This leaflet was last revised in May 2012.

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Technical Information Leaflet
The following information is intended for medical or healthcare professionals only:
Ceftazidime 3g Powder for solution for injection/infusion
This is an extract from the Summary of Product Characteristics to assist in the administration of
Ceftazidime 3g Powder for solution for injection/infusion. When determining appropriateness of use in a
particular patient, the prescriber should be familiar with the SmPC.
Method and route of administration:Ceftazidime may be given intravenously or by deep intramuscular injection into a large muscle mass such
as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.
Incompatibilities:
Ceftazidime should not be mixed with solutions with a pH above 7.5 for example sodium bicarbonate
solution for injection. Ceftazidime and aminoglycosides should not be mixed in the solution for injection
because of the risk for precipitation.
Cannulae and catheters for intravenous use should be flushed with physiological salt-solution between
administrations of ceftazidime and vancomycin to avoid precipitation.
Reconstitution Directions:
For single use only. Discard any unused solution.
The dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate
matter and discoloration prior to administration. The solution should only be used if the solution is clear
and free from particles.
Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be
useful when fractional doses are required.
Vial
size

Route of
Administration

Amount of Diluent
to be added (ml)

Approximate
Concentration (mg/ml)

3g

Intravenous bolus

15.0

170

*

40‡

3g

Intravenous Infusion

75.0

*Note: Addition should be in two stages.
‡Note: Use Sodium Chloride Injection 0.9%, Dextrose Injection 5% or other approved diluent, as
Water for Injections produces hypotonic solutions at this concentration.
Ceftazidime (at the given concentration) has been shown to be compatible with the following diluent
solutions:At Ceftazidime concentrations between 1mg/ml and 40mg/ml in:0.9% Sodium Chloride Injection
M/6 Sodium Lactate Injection

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Compound Sodium Lactate Injection (Hartmann's Solution)
5% Dextrose Injection
0.225% Sodium Chloride and 5% Dextrose Injection
0.45% Sodium Chloride and 5% Dextrose Injection
0.9% Sodium Chloride and 5% Dextrose Injection
0.18% Sodium Chloride and 4% Dextrose Injection
10% Dextrose Injection
Dextran 40 Injection 10% in 0.9% Sodium Chloride Injection
Dextran 40 Injection 10% in 5% Dextrose Injection
Dextran 70 Injection 6% in 0.9% Sodium Chloride Injection
Dextran 70 Injection 6% in 5% Dextrose Injection
At concentrations of between 0.05mg/ml and 0.25mg/ml in Intraperitoneal Dialysis Fluid (Lactate).
When admixed at 4mg/ml with (both components retain satisfactory potency):
Potassium Chloride 10mEq/L or 40 mEq/L in 0.9% Sodium Chloride Injection
Vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a
positive pressure develops. For ease of use, it is recommended that the following techniques of
reconstitution are adopted.
3g i.v. bolus vial:
1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The
vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in about 1 to 2
minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the vial closure and
withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal).
Ensure that the needle remains within the solution and does not enter the head space. The withdrawn
solution may contain small bubbles of carbon dioxide; they may be disregarded.
3g i.v. infusion vial:
Prepare using a total 75ml (for 3g vials) of compatible diluent, added in TWO stages as below:1. Insert the syringe needle through the vial closure and inject 15ml for 3g vial. The vacuum may assist
entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution obtained in about 1 to 2 minutes.
3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the
vial closure to relieve the internal pressure.

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4. Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag or burette-type set) making
up a total volume of a least 75ml and administer by intravenous infusion over 15-30 minutes.
NOTE: To preserve product sterility, it is important that a vent needle is not inserted through the vial
closure before the product has dissolved.
Solutions range from light yellow to amber depending on concentration, diluents and storage conditions
used. Within the stated recommendations, product potency is not adversely affected by such colour
variations.
Any unused product or waste material should be disposed of in accordance with local requirements.
Special Precautions for Storage:
This medicinal product does not require any special storage conditions.
Keep vial(s) in the outer carton to protect from light.
After reconstitution:- Reconstituted product has demonstrated chemical and physical stability for 24 hrs
when stored in a refrigerator 2-8°C.
From a microbiological point of view, once opened, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and
validated aseptic conditions.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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