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CEFTAZIDIME 3 G POWDER FOR SOLUTION FOR INJECTION/INFUSION

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Package leaflet: Information for the user
Ceftazidime 250 mg, 500 mg & 1 g powder for solution for injection
Ceftazidime 2 g & 3 g powder for solution for injection / infusion

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 or pharmacist, or nurse.
- If you get any side effects talk to your doctor, or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Ceftazidime is and what it is used for
2. What you need to know before you are given Ceftazidime
3. How Ceftazidime is given
4. Possible side effects
5. How to Store Ceftazidime
6. 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 bone 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 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.

1

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 or pharmacist if you are taking, have recently taken or might take any other medicines.
You shouldn’t be given Ceftazidime without talking to 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 and, breast-feeding and fertility
Tell your doctor before you are given Ceftazidime:
If you are pregnant, think you might be pregnant or are planning to become pregnant
If you are breastfeeding
Your doctor will consider the benefit of treating you with Ceftazidime against the risk to your baby.
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
Ceftazidime 3 g
3.

Amount of sodium per vial
6.5 mg (0.28 mmol)
13 mg (0.56 mmol)
26 mg (1.13 mmol)
52 mg (2.26 mmol)
78 mg (3.39 mmol)

How Ceftazidime is given

Ceftazidime is usually given by a doctor or 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 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.

2

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 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 Ceftazdime
Don’t stop taking Ceftazdime unless your doctor tells you to.
If you have any questions 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 itchiness
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

3

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.
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is unknown:
inflammation or failure of the kidneys
pins and needles
unpleasant taste in the mouth
yellowing of the whites of the eyes or skin.
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.
If you get side effects
Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice
any side effects not listed in this leaflet.
5.

How to store Ceftazidime

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 outer carton and the vials after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light.
Reconstituted/diluted solution should be used immedialtely.
For single use only.
Discard any unused solution.
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.
<250 mg vial>
Each vial contains 291.2 mg of Ceftazidime pentahydrate corresponding to 250 mg of Ceftazidime.
<500 mg vial>
Each vial contains 582.4 mg of Ceftazidime pentahydrate corresponding to 500 mg of Ceftazidime.
<1 g vial>
Each vial contains 1.1648 g of Ceftazidime pentahydrate corresponding to 1 g of Ceftazidime.

4

<2 g vial>
Each vial contains 2.3296 g of Ceftazidime pentahydrate corresponding to 2 g of Ceftazidime.
<3 g vial>
Each vial contains 3.4945 g of Ceftazidime pentahydrate corresponding to 3 g of Ceftazidime.
-

The other ingredient is sodium carbonate, anhydrous.

What Ceftazidime looks like and contents of the pack
Ceftazidime 250 mg, 500 mg & 1 g: Powder for solution for injection
Ceftazidime 2 g & 3 g: Powder for solution for injection / infusion
Ceftazidime is white or cream coloured powder filled in moulded vials with rubber stoppers sealed with
aluminium flip off seals.
Ceftazidime is supplied in packs of 1, 5, 10, 25 & 50 vials and enclosed in a carton with a package leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
Pfizer Service Company
Hoge Wei 10, 1930, Zaventem,
Vlaams Brabant
Belgium
Pfizer PGM
Zone industrielle, 29,
route des Industries,
37530 Pocé -Sur-Cisse,
France

This medicinal product is authorised in the Member States of the EEA under the following names:
Ceftazidime 250 mg, 500 mg & 1 g powder for solution for injection:
Austria
Ceftazidim Pfizer 250 mg, 500 mg & 1 g Pulver zur Herstellung einer Injektionslösung
Belgium
Ceftazidim Pfizer 250 mg, 500 mg & 1 g, poeder voor oplossing voor injectie
Ceftazidim Pfizer 250 mg, 500 mg & 1 g, poudre pour solution injectable
Ceftazidim Pfizer 250 mg, 500 mg & 1 g Pulver zur Herstellung einer Injektionslösung
Denmark
Ceftazidim Pfizer
Germany
Ceftazidim Pfizer 250 mg, 500 mg & 1 g Pulver zur Herstellung einer Injektionslösung
Italy
Ceftazidima Pfizer
Poland
Ceftazidime Pfizer,
Spain
Ceftazidima Pfizer 250 mg, 500 mg & 1 g polvo para solución inyectable
Sweden
Ceftazidim Pfizer
United Kingdom Ceftazidime 250 mg, 500 mg & 1 g powder for solution for injection
Ceftazidime 2 g & 3 g powder for solution for injection / infusion:
Austria
Ceftazidim Pfizer 2 g & 3 g Pulver zur Herstellung einer Injektions- oder
Infusionslösung
Belgium
Ceftazidim Pfizer 2 g & 3 g, poeder voor oplossing voor injectie/infusie
Ceftazidim Pfizer 2 g & 3 g, poudre pour solution injectable/pour perfusion
Ceftazidim Pfizer 2 g & 3 g Pulver zur Herstellung einer Injektions- oder
Infusionslösung
Denmark
Ceftazidim Pfizer
Germany
Ceftazidim Pfizer 2 g & 3 g Pulver zur Herstellung einer Injektions- oder
Infusionslösung

5

Italy
Poland
Spain
Sweden
United Kingdom

Ceftazidima Pfizer
Ceftazidime Pfizer
Ceftazidima Pfizer 2 g & 3 g polvo para solución inyectable y para perfusión
Ceftazidim Pfizer
Ceftazidime 2 g & 3 g powder for solution for injection/infusion

This leaflet was last revised in 07/2013.
---------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Table 1: Adults and children

40 kg

Intermittent Administration
Infection
Broncho-pulmonary infections in cystic fibrosis

Dose to be administered
100 to 150 mg/kg/dayevery 8 h, maximum 9 g per
day1
2 g every 8 h

Febrile neutropenia
Nosocomial pneumonia
Bacterial meningitis
Bacteraemia*
Bone and joint infections
1-2 g every 8 h
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on
CAPD
Complicated urinary tract infections
1 -2 g every 8 h or 12 h
Peri-operative prophylaxis for transurethral resection 1 g at induction of anaesthesia,
of prostate (TURP)
and a second dose at catheter removal
Chronic suppurative otitis media
1 g to 2 g every 8 h
Malignant otitis externa
Continuous Infusion
Infection
Dose to be administered
Febrile neutropenia
Loading dose of 2 g followed by a continuous
Nosocomial pneumonia
infusion of 4 to 6 g every 24 h1
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on
CAPD
1
In adults with normal renal function 9 g/day has been used without adverse effects.
* When associated with, or suspected to be associated with, any of the infections listed in section 4.1.
Table 2: Children < 40 kg
Infants and toddlers> 2 months
and children < 40 kg
Intermittent Administration

Infection

Usual dose

Complicated urinary tract
infections
Chronic suppurative otitis media
Malignant otitis externa
Neutropenic children

100-150 mg/kg/day in three
divided doses, maximum 6 g/day

150 mg/kg/day in three divided

6

Broncho-pulmonary infections in
cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue
infections
Complicated intra-abdominal
infections
Peritonitis associated with dialysis
in patients on CAPD

doses, maximum 6 g/day

Febrile neutropenia
Nosocomial pneumonia
Broncho-pulmonary infections in
cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue
infections
Complicated intra-abdominal
infections
Peritonitis associated with dialysis
in patients on CAPD
Infection

Loading dose of 60-100 mg/kg
followed by a continuous
infusion 100-200 mg/kg/day,
maximum 6 g/day

100-150 mg/kg/day in three
divided doses, maximum 6 g/day

Continuous Infusion

Neonates and infants ≤ 2
months
Intermittent Administration

Usual dose

Most infections

25-60 mg/kg/day in two divided
doses1
1
In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be three to four times that in
adults.
* Where associated with, or suspected to be associated with, any of the infections listed in section 4.1.
Paediatric population
The safety and efficacy of ceftazidime administered as continuous infusion to neonates and infants ≤ 2
months has not been established.
Elderly
In view of the age related reduced clearance of ceftazidime in elderly patients, the daily dose should not
normally exceed 3 g especially in those over 80 years of age.
Hepatic impairment
Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment.
There are no study data in patients with severe hepatic impairment (see also section 5.2). Close clinical
monitoring for safety and efficacy is advised.
Renal impairment
Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the
dosage should be reduced (see also section 4.4).
An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance:

7

Table 3: Recommended maintenance doses of ceftazidime in renal impairment – intermittent infusion
Adults and children ≥40 kg
Creatinine clearance
(ml/min)
50-31
30-16
15-6
<5

Approx. serum
creatinine
µmol/l (mg/dl)
150-200
(1.7-2.3)
200-350
(2.3-4.0)
350-500
(4.0-5.6)
>500
(>5.6)

Recommended unit
dose of ceftazidime
(g)

Frequency of dosing
(hourly)

1

12

1

24

0.5

24

0.5

48

In patients with severe infections the unit dose should be increased by 50% or the dosing frequency
increased.
In children the creatinine clearance should be adjusted for body surface area or lean body mass.
Children < 40 kg
Approx. serum
Recommended
Frequency of dosing
creatinine*
individual dose mg/kg
(hourly)
µmol/l (mg/dl)
body weight
150-200
50-31
25
12
(1.7-2.3)
200-350
30-16
25
24
(2.3-4.0)
350-500
15-6
12.5
24
(4.0-5.6)
>500
<5
12.5
48
(>5.6)
* The serum creatinine values are guideline values that may not indicate exactly the same degree of
reduction for all patients with reduced renal function.
** Estimated based on body surface area, or measured.
Creatinine clearance
(ml/min)**

Close clinical monitoring for safety and efficacy is advised.
Table 4: Recommended maintenance doses of ceftazidime in renal impairment – continuous infusion
Adults and children ≥ 40 kg
Approx. serum
creatinine
Frequency of dosing (hourly)
µmol/l (mg/dl)
150-200
Loading dose of 2 g followed
50-31
(1.7-2.3)
by 1 g to 3 g /24 hours
200-350
Loading dose of 2 g followed
30-16
(2.3-4.0)
by 1 g/24 hours
>350
≤15
Not evaluated
(>4.0)
Caution is advised in dose selection. Close clinical monitoring for safety and efficacy is advised.
Creatinine clearance
(ml/min)

8

Children < 40 kg
The safety and effectiveness of ceftazidime administered as continuous infusion in renally impaired
children < 40 kg has not been established. Close clinical monitoring for safety and efficacy is advised.
If continuous infusion is used in children with renal impairment, the creatinine clearance should be
adjusted for body surface area or lean body mass.
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.
All sizes of vials of Ceftazidime are supplied under reduced pressure. As the product dissolves, carbon
dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted
solution may be ignored.
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
1g
Intramuscular
Intravenous bolus
2 g powder for solution for injection or infusion
2g
Intravenous bolus
Intravenous infusion
3 g powder for solution for injection or infusion
3g
Intravenous bolus
Intravenous infusion
*Note: Addition should be in two stages.

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

260
90

10 ml
50 ml*

170
40

15 ml
75 ml*

170
40

Solutions range in colour from light yellow to amber depending on concentration, diluent and storage
conditions used. Within the stated recommendations, the product potency is not adversely affected by such
colour variations.
Ceftazidime may be constituted for administration by intravenous injection and intramuscular injection
with Water for injection.
Ceftazidime may be constituted for administration by intramuscular injection with 1% Lidocaine
Hydrochloride Injection.
Ceftazidime for administration by intravenous infusion with one of the following compatible diluents:
- sodium chloride 9 mg/ml (0.9%) solution for injection
- compound sodium lactate injection
0.9% sodium chloride and 5% dextrose injection
- 10% dextrose Injection
- Dextran 40 Injection 10% in sodium chloride 0.9% Injection
Dextran 40 Injection 10% in dextrose 5% Injection

9

250 mg, 500 mg, 1 g powder for solution for injection, 2 g, 3 g powder for solution for injection or
infusion.:
Preparation of solutions 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.
2 g, 3 g powder for solution for injection or infusion.:
Preparation of solutions for iv infusion
Prepare using a total of 50 ml (for 2 g vials) and 75 ml (for 3 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 for the 2 g vials, and
15 ml for the 3 g vial.
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 at least 50 ml (75 ml for the 3 g vial), 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 has dissolved.

10

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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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