Ceftazidime 2g Powder for solution for injection or infusion

• 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.

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

• 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.

• 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.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ceftazidime treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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.

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.

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

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.

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

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.

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 accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

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.

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.

Seek medical attention immediately if you notice any of the following symptoms. 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).
• Reddish patches on the trunk, the patches are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis)
• 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
• 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 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 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 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.

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 (2.26mmol) for the 1g vial and 104mg (4.52mmol) for the 2g vial.

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.

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

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

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