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CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime 250 mg powder for solution for injection
Ceftazidime 500 mg powder for solution for injection
Ceftazidime 1 g powder for solution for injection/infusion
Ceftazidime 2 g powder for solution for injection/infusion
Ceftazidime

The name of your medicine is Ceftazidime 250 mg and 500 mg powder for solution for injection and
Ceftazidime 1g and 2g 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 because it contains important
information for you.




Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Ceftazidime is and what it is used for
What you need to know before you are given Ceftazidime
How to take Ceftazidime
Possible side effects
How to store Ceftazidime
Contents of the pack and other information

1. WHAT CEFTAZIDIME IS AND WHAT IT IS USED FOR
Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing
bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftazidime is used to treat severe bacterial infections of:









the lungs or chest
the lungs and bronchi in patients suffering from cystic fibrosis
the brain (meningitis)
the ear
the urinary tract
the skin and soft tissues
the abdomen and abdominal wall (peritonitis)
the bones and joints.

Ceftazidime can also be used:




to prevent infections during prostate surgery in men
to treat patients with low white blood cell counts (neutropenia) who have a fever due to a
bacterial infection.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME
You must not be given Ceftazidime:
• If you are allergic (hypersensitive) to ceftazidime or any of the other ingredients of this medicine (listed
in section 6).
• If you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and
carbapenems) as you may also be allergic to ceftazidime.
Tell your doctor before you start on ceftazidime if you think that this applies to you. You must not be
given ceftazidime.
Warnings and precautions
You must look out for certain symptoms such as allergic reactions, nervous system disorders and
gastrointestinal disorders such as diarrhoea while you are being given ceftazidime. This will reduce the
risk of possible problems. See (‘Conditions you need to look out for’) in section 4. If you have had an
allergic reaction to other antibiotics you may also be allergic to ceftazidime.
If you need a blood or urine test
Ceftazidime can affect the results of urine tests for sugar and a blood test known as the Coombs’ test. If
you are having tests:
 Tell the person taking the sample that you have been given ceftazidime.
Other medicines and Ceftazidime
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes
medicines you can obtain without a prescription.
You shouldn’t be given ceftazidime without talking to your doctor if you are also taking:





an antibiotic called chloramphenicol
a type of antibiotic called aminoglycosides e.g. gentamicin, tobramycin
water tablets called furosemide
Tell your doctor if this applies to you.

Pregnancy, breast-feeding and fertility
Tell your doctor before you are given ceftazidime:


If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ceftazidime can cause side effects that affect your ability to drive, such as dizziness. Don’t drive or use
machines unless you are sure you’re not affected.
Ceftazidime contains sodium
You need to take this into account if you are on a controlled sodium diet.
Ceftazidime Strength
Ceftazidime 250 mg
Ceftazidime 500 mg
Ceftazidime 1 g
Ceftazidime 2 g

Amount per vial
13 mg
26 mg
51 mg
102 mg

3. HOW TO TAKE CEFTAZIDIME
Ceftazidime is usually given by a doctor or a nurse. It can be given as a drip (intravenous infusion) or
as an injection directly into a vein or into a muscle.
Ceftazidime is made up by the doctor, pharmacist or nurse using water for injections or a suitable
infusion fluid.
The recommended dose
The correct dose of ceftazidime for you will be decided by your doctor and depends on: the severity and
type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys
are working.
Newborn babies (0-2 months)
For every 1 kg the baby weighs, they’ll be given 25 to 60 mg ceftazidime per day divided in two doses.
Babies (over 2 months) and children who weigh less than 40 kg
For every 1 kg the baby or child weighs, they’ll be given 100 to 150 mg of ceftazidime per day divided
in three doses. Maximum 6 g per day.
Adults and adolescents who weigh 40 kg or more
1 to 2 g of ceftazidime three times daily. Maximum of 9 g per day.
Patients over 65
The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.
Patients with kidney problems
You may be given a different dose to the usual dose. The doctor or nurse will decide how much
ceftazidime you will need, depending on the severity of the kidney disease. Your doctor will check you
closely and you may have more regular kidney function tests.
If you are given more Ceftazidime than you should

If you accidentally use more ceftazidime than your prescribed dose, contact your doctor or nearest
hospital straight away.
If you forget to use Ceftazidime
If you miss an injection, you should have it as soon as possible. However, if it is almost time for your
next injection, skip the missed injection. Don’t take a double dose (two injections at the same time) to
make up for a missed dose.
If you stop using Ceftazidime
Don’t stop taking ceftazidime unless your doctor tells you to. If you have any further questions on the
use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to look out for
The following serious side effects have occurred in a small number of people but their exact frequency is
unknown:





severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or
mouth causing difficulty in breathing.
Skin rash, which may blister, and looks like small targets (central dark spot surrounded by a
paler area, with a dark ring around the edge).
A widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).
Nervous system disorders: tremors, fits and, in some cases coma. These have occurred in people
when the dose they are given is too high, particularly in people with kidney disease.

 Contact a doctor or nurse immediately if you get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:

diarrhoea

swelling and redness along a vein

red raised skin rash which may be itchy

pain, burning, swelling or inflammation at the injection site.
 Tell your doctor if any of these are troubling you.
Common side effects that may show up in blood tests:




an increase in a type of white blood cell (eosinophilia)
an increase in the number of cells that help the blood to clot
an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:



• inflammation of the gut which can cause pain, or diarrhoea which may contain blood
• thrush (fungal infections in the mouth or vagina)
• headache
• dizziness
• stomach ache
• feeling sick or being sick
• fever and chills.
Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:




a decrease in the number of white blood cells
a decrease in the number of blood platelets (cells that help the blood to clot)
an increase in the level of urea, urea nitrogen or serum creatinine in the blood.

Not known
Other side effects have occurred in a small number of people but their exact frequency cannot be
estimated from the available data:





inflammation or failure of the kidneys
pins and needles
unpleasant taste in the mouth
yellowing of the whites of the eyes or skin.

There have been rare reports of severe hypersensitivity reactions with severe rash, which may be
accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of
white blood cells), effects on liver, kidney or lung (a reaction called DRESS).
Other side effects that may show up in blood tests:




red blood cells destroyed too quickly
an increase in a certain type of white blood cells
severe decrease in the number of white blood cells.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517

Website: www.hpra.ie
e-mail:
medsafety@hpra.ie
Cyprus:
Κύπρος
Φαρμακευτικές Υπηρεσίες
Υπουργείο Υγείας
CY-1475 Λευκωσία
Φαξ: + 357 22608649
Ιστότοπος: www.moh.gov.cy/phs
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CEFTAZIDIME
This medicinal product does not require any special temperature storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or vial after EXP.
The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Once the powder has been dissolved: the solution should be used immediately or stored at 2-8°C and
discarded after 24 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ceftazidime contains


The active substance is ceftazidime (present as ceftazidime pentahydrate).
Ceftazidime is available in the following strengths: 2 g, 1 g, 500 mg and 250 mg.

The only other ingredient is sodium carbonate anhydrous.

See section 2 for further important information about sodium, one of the ingredients of
Ceftazidime.

What Ceftazidime looks like and contents of the pack
Ceftazidime 2 g, 1 g, 500 mg and 250 mg is supplied as sterile powder in glass vials. Each individual vial
is packed in a carton.
These are supplied to the hospital in packs of 1, 5, 10, and 25.
Not all pack sizes may be marketed.

Your doctor, pharmacist or nurse will make the injection or infusion up with Water for Injections or a
suitable infusion fluid. When made up, Ceftazidime varies in colour from light yellow to amber. This is
perfectly normal.
Marketing Authorisation Holder and Manufacturer
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:
Ceftazidime 500 mg Powder for Solution for Injection, Ceftazidime 1 g (or 2 g) Powder for Solution for
Injection/Infusion;
Ceftazidim Hospira 500 mg, powder for solution for injection (IV/IM), Ceftazidim Hospira 1 g (or 2 g), powder
for solution for injection/infusion (IV/IM);
Ceftazidim Hospira 500 mg Pulver zur Herstellung einer Injektionslösung, Ceftazidim Hospira 1 g (or 2
g) Pulver zur Herstellung einer Injektions-/Infusionslösung;
Ceftazidima Hospira;
Ceftazidim Hospira 500 mg poeder voor oplossing voor injectie, Ceftazidim Hospira 1 g (or 2 g) poeder
voor oplossing voor injectie/infusie.

This leaflet was last revised in August 2015
--------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:

Please refer to the Summary of Product Characteristics for full prescribing information.

Method of administration
Ceftazidime should be administered by intravenous injection or infusion, or by deep intramuscular
injection. Recommended intramuscular injection sites are the upper outer quadrant of the gluteus
maximus or lateral part of the thigh. Ceftazidime solutions may be given directly into the vein or
introduced into the tubing of a giving set if the patient is receiving parenteral fluids.
The standard recommended route of administration is by intravenous intermittent injection or intravenous
continuous infusion. Intramuscular administration should only be considered when the intravenous route
is not possible or less appropriate for the patient.
The dose depends on the severity, susceptibility, site and type of infection and on the age and renal
function of the patient.
Shelf life after reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C.

From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the
risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of user.
Instructions for constitution
See table for addition volumes and solution concentrations, which may be useful when fractional doses
are required.
Vial size
250 mg powder for solution for injection
250 mg
Intramuscular
Intravenous bolus
500 mg powder for solution for injection
500 mg
Intramuscular
Intravenous bolus
1 g powder for solution for injection/ infusion
1g
Intramuscular
Intravenous bolus
Intravenous infusion
2 g powder for solution for infusion
2g
Intravenous bolus
Intravenous infusion

Amount of diluent
to be added (ml)

Approximate
concentration (mg/ml)

1.0 ml
2.5 ml

210
90

1.5 ml
5 ml

260
90

3 ml
10 ml
50 ml*

260
90
20

10 ml
50 ml*

170
40

*Note: Addition should be in two stages.
Ceftazidime may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride
Injection only for 250mg, 500mg and 1g.
Solutions range in colour 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.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:
• sodium chloride 9 mg/ml (0.9%) solution for injection
• M/6 sodium lactate injection
• 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
Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intra-peritoneal
Dialysis Fluid (Lactate).

The contents of a 500 mg vial of ceftazidime for injection, constituted with 1.5 ml water for injections,
may be added to metronidazole injection (500 mg in 100 ml) and both retain their activity.
250 mg, 500 mg powder for solution for injection, 1 g, 2 g powder for solution for injection or infusion.
Preparation of solution for bolus injection
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.
These solutions may be given directly into the vein or introduced into the tubing of a giving set if the
patient is receiving parenteral fluids. Ceftazidime is compatible with the most commonly used
intravenous fluids.
1 g, 2 g powder for solution for injection/infusion:
Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation (mini-bag
or burette-type set):
Prepare using a total of 50 ml (for 1 g and 2 g vials) of compatible diluent, added in TWO stages as
below.
1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent.
2. Withdraw the needle and shake the vial to give a clear solution.
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.
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 50 ml and administer by intravenous infusion over 15 to 30 min.
Note: To preserve product sterility, it is important that the gas relief needle is not inserted through the vial
closure before the product is dissolved,
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Ceftazidime is less stable in Sodium bicarbonate Injection than other intravenous fluids. It is not
recommended as a diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported when vancomycin has been added to ceftazidime in solution. It is
recommended that giving sets and intravenous lines are flushed between administration of these two
agents.

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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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