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Ceftazidime 1g Powder for Solution for Injection or Infusion

Active Ingredient:
ceftazidime pentahydrate
Company:  
Wockhardt UK Ltd See contact details
ATC code: 
J01DD02
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 16 Aug 2021

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0031.

Ceftazidime 1g, 2g, Powder for Solution for Injection or Infusion

Package leaflet: Information for the user

Ceftazidime 1g powder for solution for injection or infusion

Ceftazidime 2g 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.
  • This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of the medicine is ceftazidime 1g powder for solution for injection or infusion and ceftazidime 2g powder for solution for injection or infusion. In the rest of this leaflet it is called ceftazidime.

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 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 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 ceftazidime if you think that this applies to you; you must not be given ceftazidime.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start on ceftazidime

Take special care with ceftazidime

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 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.

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

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

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

Ceftazidime contains sodium

This medicine contains 52mg sodium (main component of cooking/table salt) in each 1g vial. This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 104mg sodium (main component of cooking/table salt) in each 2g vial. This is equivalent to 5.2% of the recommended maximum daily dietary intake of sodium for an adult.

3. 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 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 1kg the baby weighs, they’ll be given 25 to 60mg ceftazidime per day divided in two doses.

Babies (over 2 months) and children who weigh less than 40kg

For every 1kg the baby or child weighs, they’ll be given 100 to 150mg of ceftazidime per day divided in three doses. Maximum 6g per day.

Adults and adolescents who weigh 40kg or more

1 to 2g of ceftazidime three times daily. Maximum of 9g per day.

Patients over 65

The daily dose should not normally exceed 3g 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. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop taking ceftazidime

Don’t stop taking ceftazidime unless your doctor tells you to. If you have any 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.

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 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
  • 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.

Very rare side effects

These may affect up to 1 in 10,000 people:

  • inflammation or failure of the kidneys

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 national reporting systems listed below.

United Kingdom:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and vial. The expiry date refers to the last day of that month.
  • The vials should not be stored above 25º C.
  • Keep the vial in the outer carton in order to protect from light.
  • Chemical and physical in-use stability has been demonstrated for eight hours at 25º C and 24 hours at 4º 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 2-8º C, unless reconstitution has taken place in controlled and validated aseptic conditions. For single use only. Once reconstituted, any unused portion of solution should be discarded.
  • Do not use this medicine if you notice that the solution contains particles or is cloudy.

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 as ceftazidime pentahydrate.

Each vial contains the equivalent of 1g or 2g of ceftazidime. It also contains the ingredient, sodium carbonate.

The sodium content per vial is approximately 52mg (2.26 mmol) for the 1g vial and 104mg (4.52 mmol) for the 2g vial.

What ceftazidime looks like and contents of the pack

Ceftazidime is a white to cream coloured powder, which must be made into a solution before injection or infusion. It is available in packs of 1, 5 or 10 vials. Not all pack sizes are marketed.

X-PIL Information

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name Reference Number

Ceftazidime 1g powder for solution for injection or infusion 29831/0031

Ceftazidime 2g powder for solution for injection or infusion 29831/0032

This is a service provided by the Royal National Institute of Blind People.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

This leaflet was last revised in 07/2021

106648/6

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]