What it is and what it is used for

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.

What you need to know before you take it

CEFTAZIDIME INJECTION You must not be given Ceftazidime Injection:

• if you are allergic (hypersensitive) to ceftazidime or the other ingredients 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. 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. 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; You need to take this into account if you are on a controlled sodium diet.

How to take it

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.

Possible side effects

Like all medicines, Ceftazidime can cause side effects, although not everybody gets them. Seek medical attention if you notice any of the following symptoms:

• 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. 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. 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 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.

How to store it

CEFTAZIDIME INJECTION 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. 6. FURTHER INFORMATION What Ceftazidime Injection contains Each vial contains 500mg Ceftazidime (as pentahydrate). The other ingredient is sodium carbonate anhydrous (E500) 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

Istituto Biochimico Italiano G. Lorenzini SpA, via Fossignano 2, 04011 Aprilia (LT), Italy Manufacturer ACS DOBFAR SpA, 64100 Teramo, Italy ACS Dobfar S.p.A – via A. Fleming. 2 – 37135 Verona – Italy This leaflet was last revised in September 2024.

—————————————————————————————————————————-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. Route intramuscular intravenous bolus

Amount of diluent to be added (ml) 1.5 ml 5 ml

Approximate Approximate availabe Concentration volume (ml) (mg/ml) 1.7 ml 294 5.2 ml 96

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

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

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 transuretheral resection of prostate (TURP)

1 g at induction of anaesthesia, and a second dose at catheter removal

Chronic suppurative otitis media Malignant otitis externa

1 g to 2 g every 8h

Continuous infusion Infection

Dose to be administered

Febrile neutropenia Nosocomial pneumonia

Loading dose of 2 g followed by a

Broncho-pulmonary infections in cystic fibrosis

continuous infusion of 4 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 Complicated urinary tract infections Chronic suppurative otitis media

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

Malignant otitis externa Neutropenic children Broncho-pulmonary infections in cystic fibrosis

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

Bacterial meningitis Bacteraemia* Bone and joint infections Complicated skin and soft tissue infections

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

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

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

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. Neonates and infants ≤ 2 months

Intermittent Administration Most infections

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. 1

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: Recommended maintenance doses 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) 1 1 0.5 0.5

Frequency of dosing (hourly) 12 24 24 48

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

Approx. serum Recommende Frequency of creatinine* μmol/l d individual dosing (mg/dl) dose (mg/kg (hourly) body 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. Close clinical monitoring is advised. Recommended maintenance doses in renal impairment -continuous infusion Adults and children ≥ 40 kg Creatinine clearance (ml/min)** 50 – 31

Approx. serum Frequency of dosing (hourly) creatinine μmol/l (mg/dl) 150-200 (1.7-2.3) 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 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