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CEFTAZIDIME 2.0 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime 500 mg powder for solution for injection
Ceftazidime 1 g and 2 g powder for solution for injection or infusion
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 or
nurse.
- If you get any side effects, talk to your doctor 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
1. WHAT CEFTAZIDIME INJECTION IS AND WHAT IT IS
USED FOR
Ceftazidime Injection 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 Injection 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 Injection 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 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 Injection.
→ Tell your doctor before you start on Ceftazidime
Injection 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 Injection. 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 Injection.
If you need a blood or urine test
Ceftazidime Injection 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 Injection.

You shouldn’t be given Ceftazidime Injection 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
Ask your doctor for advice before you are given Ceftazidime
Injection:
• If you are pregnant, think you might be pregnant or are
planning to become pregnant.
• If you are breast-feeding.
Your doctor will consider the benefit of treating you with
Ceftazidime Injection against the risk to your baby.
Driving and using machines
Ceftazidime Injection 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 Injection contains sodium
You need to take this into account if you are on a controlled
sodium diet.
Ceftazidime Injection Strength

Amount per vial

Ceftazidime 500 mg

26 mg

Ceftazidime 1 g

52 mg

Ceftazidime 2 g

104 mg

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 recommended dose
The correct dose of Ceftazidime Injection 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 Injection 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 Injection 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 Injection 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 Injection
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.

Other medicines and Ceftazidime Injection
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.

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INFORMATION FOR THE DOCTOR
Ceftazidime 500 mg Injection and 1 g, 2 g Injection or Infusion
INFORMATION FOR THE HEALTH CARE PROFESSIONAL
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

Amount of
diluent to be
added (ml)

Approximate
concentration
(mg/ml)

500 mg powder for solution for injection
500
mg

Intramuscular
Intravenous bolus

1.5 ml
5 ml

260
90

1 g powder for solution for injection or infusion
1g

Intramuscular
Intravenous bolus
Intravenous
infusion

3 ml
10 ml
50 ml*

260
90
20

2 g powder for solution for injection or infusion
2g

Intravenous bolus
Intravenous
Infusion

10 ml
50 ml*

* Note: Addition should be in two stages

170
40

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 concentrations between 0.05 mg/ml and
0.25 mg/ml is compatible with Intra-peritoneal Dialysis Fluid
(Lactate).
Ceftazidime may be constituted for intramuscular use with
0.5% or 1% Lidocaine Hydrochloride Injection.

If you are given more Ceftazidime Injection 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 Injection
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 use a double dose (two
injections at the same time) to make up for a missed dose.
Don’t stop using Ceftazidime Injection
Don’t stop using Ceftazidime Injection unless your doctor
tells you to. If you have any questions ask your doctor or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ceftazidime Injection 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.
• 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).
→ 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.

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.
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.
5. HOW TO STORE CEFTAZIDIME INJECTION
Keep out of the sight and reach of children.
Do not use Ceftazidime Injection after the expiry date which
is stated on the vial and carton after EXP. The expiry date
refers to the last day of that month. Store the unopened vial
below 25°C. Keep container in the outer carton.
Once the powder has been dissolved; the solution should be
used immediately or stored at 2-8°C and discarded after 24
hours. 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
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ceftazidime Injection contains
The active substance in Ceftazidime Injection is ceftazidime
pentahydrate. The other ingredients are sodium carbonate.
The total sodium (salt) content is approximately 26, 52 or
104 mg respectively.
What Ceftazidime Injection looks like and contents of
the pack
Ceftazidime is a white to almost white crystalline powder. It
is supplied in 500mg, 1g or 2g vials with 1, 5, or 10 vials in
a carton.
PL 28395/0111

PL 28395/0112

PL 28395/0113


Ceftazidime 500 mg
Powder for Solution for Injection
Ceftazidime 1 g
Powder for Solution for Injection or Infusion
Ceftazidime 2 g
Powder for Solution for Injection or Infusion

Marketing Authorisation Holder:
Pharmadreams Ltd, Old Police Station, Church Street,
Swadlincote, DE11 8LN, United Kingdom.
Manufacturer:
IPG Pharma Ltd, Atrium Court, The Ring, Bracknell,
Berkshire, RG12 1BW, UK
This leaflet was last revised in October 2016

→ Tell your doctor if you get any of these.
Uncommon side effects that may show up in blood tests:

A468/UK/B

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• 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.

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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.
500 mg powder for solution for injection, 1 g, 2 g powder for
solution for injection or infusion.:

1 g, 2 g powder for solution for injection or infusion.:

Preparation of solutions for bolus injection

1. Introduce the syringe needle through the vial
closure and inject 10 ml of diluent for the 1 g and
2 g vials.

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.

Preparation of solutions for iv infusion from ceftazidime
injection in standard vial presentation (mini-bag or burettetype set):
Prepare using a total of 50 ml (for 1 g and 2 g vials) of
compatible diluent, added in TWO stages as below.

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

+ Expand Transcript

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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