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CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION AND INFUSION

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime 500, 1g, Powder for solution for injection
Ceftazidime 2g, Powder for solution for injection/infusion
Ceftazidime
Read all of this leaflet carefully before you start using 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, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet:
1. What Ceftazidime Injection is and what it is used for
2. What you need to know before you are given
Ceftazidime Injection
3. How Ceftazidime Injection is given
4. Possible side effects
5. How to store Ceftazidime Injection
6. Contents of the pack and other information
The name of your medicine is “Ceftazidime powder for solution
for injection or infusion” (referred to as Ceftazidime Injection
throughout this leaflet).
1. WHAT Ceftazidime Injection 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 INJECTION
You must not be given Ceftazidime Injection:
• if you are allergic to ceftazidime or the other ingredient of this
medicine (see 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
Injection.
Take special care with Ceftazidime Injection
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.
Taking other medicines
Tell your doctor if you are taking any other medicines, if you’ve
started taking any recently or you start taking new ones. 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 and breast-feeding
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.
Important information about some of the ingredients of
Ceftazidime Injection
Ceftazidime Injection 500 mg contains 26 mg sodium per vial;
Ceftazidime Injection 1 g contains 52 mg sodium per vial;
Ceftazidime Injection 2 g contains 104 mg sodium per vial.

You need to take this into account if you are on a controlled
sodium diet.
3. HOW Ceftazidime Injection IS GIVEN
Ceftazidime Injection 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 Injection is made up by the doctor, pharmacist or
nurse using water for injections or a suitable infusion fluid.
The usual 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 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 questions ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ceftazidime 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.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or
healthcare professionals.
Please refer to the Summary of Product Characteristics for
further information.
Instructions for reconstitution
See table for addition volumes and solution concentrations,
which may be useful when fractional doses are required.
Vial
size

Route

Amount of Approximate Approximate
diluent to
available Concentration
be added
volume
(mg/ml)
(ml)
(ml)
500mg Intramuscular
1.5 ml
1.7 ml
294
500mg Intravenous
bolus
1g
Intramuscular
1g
1g
2g
2g

Intravenous
bolus
Intravenous
infusion
Intravenous
bolus
Intravenous
infusion

5 ml

5.2 ml

96

3 ml

3.5 ml

286

10 ml

10.5 ml

95

50 ml*
10 ml
50 ml*

*
11.6 ml
*

20
172
40

*Note: addition should be in two stages. See ‘Preparation of
solutions for IV infusion’
Solutions range in colour from light yellow to amber depending
on concentration, diluent 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 concentration between 0.05 mg/ml and
0.25 mg/ml is compatible with Intra-peritoneal Dialysis Fluid
(Lactate).
Ceftazidime may be reconstituted for intramuscular use with
0.5% or 1% Lidocaine Hydrochloride Injection.
The contents of a 500 mg vial of ceftazidime for injection,
reconstituted with 1.5 ml water for injections, may be added
to metronidazole injection (500 mg in 100 ml) and both retain
their activity.
Preparation of solutions for bolus injection
1. Insert the syringe needle through the vial closure and inject
the recommended volume of 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.
Preparation of solutions for iv infusion
Prepare using a total of 50 ml 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 at 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 has dissolved.

Posology
Adults and children ≥ 40 kg

Intermittent Administration
Infection
Broncho-pulmonary infections in
cystic fibrosis
Febrile neutropenia
Nosocomial pneumonia
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
Complicated urinary tract
infections
Peri-operative prophylaxis for
transuretheral resection of
prostate (TURP)
Chronic suppurative otitis media
Malignant otitis externa
Continuous infusion
Infection

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

1-2 g every 8 h

1-2 g every 8 h or 12 h
1 g at induction of
anaesthesia,
and a second dose at
catheter removal
1 g to 2 g every 8h

Dose to be
administered

Febrile neutropenia
Loading dose of
Nosocomial pneumonia
2 g followed by a
Broncho-pulmonary infections in
continuous infusion of 4
cystic fibrosis
to 6 g every 24 h1
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 of the SPC.
Children < 40 kg
Infants and toddlers > 2 months and children < 40 kg
Intermittent Administration
Infection
Usual dose
Complicated urinary tract
100-150 mg/kg/day in
infections
three divided doses,
maximum 6 g/day
Chronic suppurative otitis
media
Malignant otitis externa
Neutropenic children
150 mg/kg/day in three
Broncho-pulmonary infections in divided doses, maximum
6 g/day
cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
100-150 mg/kg/day in
Complicated skin and soft tissue three divided doses,
maximum 6 g/day
infections
Complicated intra-abdominal
infections
Peritonitis associated with
dialysis in patients on CAPD
Continuous infusion
Febrile neutropenia
Loading dose of
60-100 mg/kg followed
Nosocomial pneumonia
by a continuous infusion
Broncho-pulmonary infections in
100-200 mg/kg/day,
cystic fibrosis
maximum 6 g/day
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
* Where associated with, or suspected to be associated
with, any of the infections listed in section 4.1 of the SPC.

Any unused product or waste material should be disposed of
in accordance with local requirements.

L08GBCFZ03

Neonates and infants ≤ 2 months
Intermittent Administration
Most infections
1

25-60 mg/kg/day in two
divided doses1
In neonates and infants ≤ 2 months, the serum half life of
ceftazidime can be three to four times that in adults.

Elderly: The daily dose should not normally exceed 3 g in those
over 80 years of age.
Hepatic impairment: Close clinical monitoring for safety and
efficacy is advised.
Renal impairment: Dosage should be reduced. An initial
loading dose of 1 g should be given. Maintenance doses
should be based on creatinine clearance:

Continuous veno-venous haemodialysis dose guidelines
Residual renal
function (creatinine
clearance ml/min)

Maintenance dose (mg) for a
dialysate in flow rate of 1

1.0 litre/h
2.0 litre/h
Ultrafiltration rate Ultrafiltration rate
(litres/h)
(litres/h)
0.5
1.0
2.0
0.5
1.0
2.0
0
500 500 500 500 500 750
5
500 500 750 500 500 750
10
500 500 750 500 750 1000
15
500 750 750 750 750 1000
20
750 750 1000 750 750 1000
1
Maintenance dose to be administered every 12h

Recommended maintenance doses in renal impairment –
intermittent infusion

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the
safety of this medicine.

Keep out of the sight and reach of children.
Do not use Ceftazidime Injection after the expiry date which is
printed on the label and carton.
Store the vial in the outer carton to protect from light.

Approx. serum Recommended Frequency
creatinine
unit dose of
of dosing
μmol/l (mg/dl) ceftazidime (g)
(hourly)
150-200 (1.7-2.3)
1
12
200-350 (2.3-4.0)
1
24
350-500 (4.0-5.6)
0.5
24
>500 (>5.6)
0.5
48

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ceftazidime Injection contains
Each vial contains 500mg, 1g or 2g Ceftazidime (as
pentahydrate).
The other ingredient is sodium carbonate anhydrous (E500)

Children < 40 kg
Creatinine
clearance
(ml/min)**

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.

5. HOW TO STORE CEFTAZIDIME INJECTION

Adults and children > 40 kg
Creatinine
clearance
(ml/min)
50-31
30-16
15-6
<5

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.

Approx. serum
creatinine*
μmol/l (mg/dl)

Recommended Frequency
individual dose
of
dosing
(mg/kg body
(hourly)
weight)
50-31
150-200 (1.7-2.3)
25
12
30-16
200-350 (2.3-4.0)
25
24
15-6
350-500 (4.0-5.6)
12.5
24
<5
>500 (>5.6)
12.5
48
* Guideline values
** Estimated based on body surface area, or measured.

What Ceftazidime Injection looks like and contents of the pack
Ceftazidime Injection is a white to cream-coloured powder in
a glass vial.
Each carton contains 1, 5, 10, 20 or 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Villerton Invest SA, 40 Avenue Monterey, L-2163 Luxembourg
Manufacturer
Facta Farmaceutici SpA, 64100 Teramo, Italy

Close clinical monitoring is advised.

This leaflet was last revised in September 2016.

Recommended maintenance doses in renal impairment –
continuous infusion
Adults and children ≥ 40 kg
Creatinine Approx. serum
clearance
creatinine
(ml/min)** μmol/l (mg/dl)
50 – 31
150-200 (1.7-2.3)

Frequency of dosing (hourly)

Loading dose of 2g followed
by 1g to 3g/24 hours
30 – 16
200-350 (2.3-4.0) Loading dose of 2g followed
by 1g /24 hours
≤ 15
> 350 (>4.0)
Not evaluated
** Estimated based on body surface area, or measured.
Caution is advised in dose selection. Close clinical monitoring
is advised.
Children < 40 kg
If continuous infusion is used in children with renal impairment,
the creatinine clearance should be adjusted for body surface
area or lean body mass. Close clinical monitoring is advised.
Haemodialysis
The serum half-life during haemodialysis ranges from 3 to 5 h.
Following each haemodialysis period, the maintenance dose
of ceftazidime recommended in the below table should be
repeated.
Peritoneal dialysis
Ceftazidime may be used in peritoneal dialysis and continuous
ambulatory peritoneal dialysis (CAPD).
In addition to intravenous use, ceftazidime can be incorporated
into the dialysis fluid (usually 125 to 250 mg for 2 litres of dialysis
solution).
For patients in renal failure on continuous arterio-venous
haemodialysis or high-flux haemofiltration in intensive therapy
units: 1 g daily either as a single dose or in divided doses. For
low-flux haemofiltration, follow the dose recommended under
renal impairment.
For patients on veno-venous haemofiltration and veno-venous
haemodialysis, follow the dosage recommendations in the
tables below.
Continuous veno-venous haemofiltration dose guidelines
Residual renal function
Maintenance dose (mg) for an
(creatinine clearance ml/min) ultrafiltration rate (ml/min) of 1:
5
16.7
33.3
50
0
250
250
500
500
5
250
250
500
500
10
250
500
500
750
15
250
500
500
750
20
500
500
500
750
1
Maintenance dose to be administered every 12h

L08GBCFZ03

L08GBCFZ03

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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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