Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ceftazidime pentahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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 Venus Pharma 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 Venus Pharma 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.
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What you need to know before you take it
e Ceftazidime Venus Pharma Do not use Ceftazidime Venus Pharma: • •
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 on Ceftazidime if you think that this applies to you. You must not be given Ceftazidime. Warnings and precautions 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. Other medicines and Ceftazidime Venus Pharma 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, breast-feeding and fertility Ask your doctor for advice before you are given Ceftazidime:
- 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 against the risk to your baby.
Driving and using machines
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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 Venus Pharma contains sodium Ceftazidime Venus Pharma 1 g contains 52 mg of sodium per dose. This is equivalent to 2.6 % of the recommended maximum daily dietary intake of sodium for an adult. Ceftazidime Venus Pharma 2 g contains 104 mg of sodium per dose. This is equivalent to 5.2 % of the recommended maximum daily dietary intake of sodium for an adult.
How to take it
Ceftazidime Venus Pharma 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 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 Venus Pharma than you should If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.
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If you forget to use Ceftazidime Venus Pharma 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. Don't stop taking Ceftazidime Venus Pharma Don't stop taking Ceftazidime unless your doctor tells you to. If you have any further questions on the use of this medicine ask your doctor or nurse.
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
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•
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 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.
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How to store it
Ceftazidime Venus Pharma 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 vial and carton after EXP. The expiry date refers to the last day of that month. This medical product does not require any special storage condition. Keep vials in the outer carton to protect from light. Reconstituted and diluted solution: The doctor, pharmacist or nurse will make up your medicine in Water for Injections or compatible fluids. Once made up, this medicine should be used within 6 days if stored in refrigerator (at 2 to 8°C) or within 9 hours if stored at room temperature (below 250C). Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicine that is no longer required. This will help protect the environment.
Contents of the pack and other information
What Ceftazidime Venus Pharma contains Ceftazidime Venus Pharma is available in the following strengths: 1 g and 2 g. The active substance 1 g and 2 g of ceftazidime (present as ceftazidime pentahydrate). The only other ingredient is sodium carbonate (anhydrous sterile). See section 2 for further important information about sodium, one of the ingredients of Ceftazidime Venus Pharma. What Ceftazidime Venus Pharma looks like and contents of the pack Ceftazidime Venus Pharma 1 g powder for solution for injection/infusion is a sterile white to pale yellow powder packaged in 10 ml clear glass vials with a 20 mm grey butyl rubber plug and a 20 mm flip-off aluminium seal. Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion is a sterile white to pale yellow powder packaged in 20 ml clear glass vials with a 20 mm grey butyl rubber plug and a 20 mm flip-off aluminium seal. Available in packs of 1, 5 or 10 vials. Not all pack sizes may be marketed. Your doctor, pharmacist or nurse will make the injection or infusion up with Water for Injections or a suitable infusion fluid. Marketing Authorization Holder and Manufacturer Venus Pharma GmbH Am-Bahnhof 1-3,
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59368, Werne, Germany This leaflet was last revised in May 2021.
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The following information is intended for healthcare professionals only: Ceftazidime Venus Pharma 1 g powder for solution for injection/infusion Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion ceftazidime Please refer to the Summary of Product Characteristics for further information Shelf Life 2 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 6 days at 2 to 8°C and 9 hours at 25°C in Water for Injections or compatible fluids listed below. From a microbiological point of view, the reconstituted solution 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 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. After dilution: Chemical and physical in-use stability has been demonstrated for 6 days at 2 to 8°C and 9 hours at 25°C in Water for Injections or compatible fluids listed below. From a microbiological point of view, the reconstituted and diluted solution 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 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions Special precautions for storage This medical product does not require any special storage condition. Keep vials in the outer carton to protect from light. Special precautions for disposal and other handling. All sizes of vials of Ceftazidime Venus Pharma 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 1 and Table 2 for addition volumes and solution concentrations, which may be useful when fractional doses are required.
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Table 1: Powder for Solution for Injection Presentation
Amount of diluent to be added Approximate (ml) concentration (mg/ml)
1g Intramuscular Intravenous bolus
3 ml 10 ml
260 90
Intravenous bolus
10 ml
170
2g
Note: •The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table. Table 2: Powder for Solution for Infusion Presentation
Amount of diluent to be added Approximate (ml) concentration (mg/ml)
1g Intravenous infusion 50 ml*
20
Intravenous infusion 50 ml*
40
2g
Note: The resulting volume of the solution of ceftazidime in reconstitution medium is increased due to the displacement factor of the drug product resulting in the listed concentrations in mg/ml presented in the above table. Solution is clear with the defined concentration, diluents and storage conditions used. 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
- 5% dextrose injection
- 0.9% sodium chloride and 5% dextrose injection
- 10% dextrose Injection Ceftazidime at concentrations detailed in Table 1 may be constituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride Injection. 1 g and 2 g powder for solution for injection/infusion.: Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation (mini-bag or burette-type set): Prepare using a total of 50 ml (for 1 g and 2 g vials) and 75 ml (for 3 g vials) of compatible diluents (listed above), added in TWO stages as below. 1. Introduce the syringe needle through the vial closure and inject 10 ml of diluent for the 1 g and 2 g vials. 2. Withdraw the needle and shake the vial to give a clear solution.
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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 o burette-type set) making up a total volume of at least 50 ml (75 ml for the 3 g vial), 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 residual antibiotic solution should be discarded. For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. This leaflet was last revised in May 2021.
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Frequently asked questions about Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion
How do I take Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion?
Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion comes as injection containing 2g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion?
The active substance in Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion is ceftazidime pentahydrate.
Are there equivalent medicines to Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion?
Medicines with the same active substance, strength and form include: Ceftazidime 2 g powder for solution for injection/infusion, Ceftazidime 2g Powder for solution for injection or infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ceftazidime Venus Pharma 2 g powder for solution for injection/infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ceftazidime pentahydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ceftazidime Venus Pharma is indicated for the treatment of the infections listed below in adults and children including neonates (from birth).
• Nosocomial pneumonia
• Broncho-pulmonary infections in cystic fibrosis
• Bacterial meningitis
• Chronic suppurative otitis media
• Malignant otitis externa
• Complicated urinary tract infections
• Complicated skin and soft tissue infections
• Complicated intra-abdominal infections
• Bone and joint infections
• Peritonitis associated with dialysis in patient on CAPD.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing transurethral resection of the prostate (TURP).
The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1).
Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity.
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Table 1: Adults and children ≥ 40 kg
Intermittent Administration
Infection
Dose to be administered
Broncho-pulmonary infections in cystic fibrosis
100 to 150 mg/kg/day every 8 h, maximum 9 g per day1
Febrile neutropenia
2 g every 8 h
Nosocomial pneumonia
Bacterial meningitis
Bacteraemia*
Bone and joint infections
1-2 g every 8 h
Complicated skin and soft tissue infections
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
Per-operative prophylaxis for transurethral resection of prostate (TURP)
1 g at induction of anaesthesia, and a second dose at catheter removal
Chronic suppurative otitis media
1 g to 2 g every 8 h
Malignant otitis externa
Continuous infusion
Infection
Dose to be administered
Febrile neutropenia
Loading dose of 2 g followed by a continuous infusion of 4 to 6 g every 24 h1
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
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 4.1.
Table 2: Children < 40 kg
Infants and toddlers >2 months and children <40 kg
Infection
Usual dose
Intermittent Administration
Complicated urinary tract infections
100-150 mg/kg/day in three divided doses, maximum 6 g/day
Chronic suppurative otitis media
Malignant otitis externa
Neutropenic children
150 mg/kg/day in three divided doses, maximum 6 g/day
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
100 – 150 mg/kg/day in three divided doses, maximum 6 g/day
Complicated skin and soft tissue 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 by a continuous infusion 100-200 mg/kg/day, maximum 6 g/day
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue infections
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients with CAPD
Neonates and infants ≤ 2 months
Infection
Usual dose
Intermittent Administration
Most infections
25-60 mg/kg/day in two divided doses1
1 In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be three to four times that in adults.
*Where associated with, or suspects to be associated with, any of the infections listed in section 4.1.
Paediatric population
The safety and efficacy of Ceftazidime administered as continuous infusion to neonates and infants ≤ 2 months has not been established.
Elderly
In view of the age related reduced clearance of ceftazidime in elderly patients, the daily dose should not normally exceed 3 g in those over 80 years of age.
Hepatic impairment
Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment. There are no study data in patients with severe hepatic impairment (see also section 5.2). Close clinical monitoring for safety and efficacy is advised.
Renal impairment
Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the dosage should be reduced (see also section 4.4).
An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance:
Table 3: Recommended maintenance doses of Ceftazidime in renal impairment – intermittent infusion
Adults and children ≥ 40 kg
Creatinine clearance Ml/min
Approx. serum creatinine µmol/l(mg/dl)
Recommended unit dose of Ceftazidime (g)
Frequency of dosing (hourly)
50-31
150-200 (1.7-2.3)
1
12
30-16
200-350 (2.3-4.0)
1
24
15-6
350-500 (4.0-5.6)
0.5
24
<5
>500 (>5.6)
0.5
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In patients with severe infections the unit dose should be increased by 50% or the dosing frequency increased. In children the creatinine clearance should be adjusted for body surface area or lean body mass.
Children < 40 kg
Creatinine clearance (ml/min)**
Approx. serum creatinine* µmol/l (mg/dl)
Recommended individual dose mg/kg body weight
Frequency of dosing (hourly)
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
* The serum creatinine values are guideline values that may not indicate exactly the same degree of reduction for all patients with reduced renal function.
** Estimated based on body surface area, or measured.
Close clinical monitoring for safety and efficacy is advised.
Table 4: Recommended maintenance doses of Ceftazidime in renal impairment – continuous infusion
Adults and children ≥ 40 kg
Creatinine clearance (ml/min)
Approx. Serum creatinine µmol/l (mg/dl)
Frequency of dosing (hourly)
50-31
150-200 (1.7-2.3)
Loading dose of 2 g followed by 1 g to 3 g /24 hours
30-16
200-350 (2.3-4.0)
Loading dose of 2 g followed by 1 g /24 hours
≤ 15
> 350
(>4.0)
Not evaluated
Caution is advised in dose selection. Close clinical monitoring for safety and efficacy is advised.
Children < 40 kg
The safety and effectiveness of Ceftazidime administered as continuous infusion in renally impaired children < 40 kg has not been established, Close clinical monitoring for safety and efficacy is advised.
If continuous infusion is used in children with renal impairment, the creatinine clearance should be adjusted for body surface area or lean body mass.
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 tables 5 & 6 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 250mg 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 tables 5 & 6 below.
Table 5: Continuous veno-venous haemofiltration dose guidelines
Residual renal function (creatinine clearance ml/min)
Maintenance dose (mg) for an ultrafiltration rate (ml/min) of1:
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 12 h.
Table 6: Continuous veno-venous haemodialysis dose guidelines
Residual renal function (creatinine clearance in ml/min)
Maintenance dose (mg) for a dialysate in flow rate of 1:
1.0 litre/h
2.0 litre/h
Ultrafiltration rate (litre/h)
Ultrafiltration rate (litre/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 12 h.
Method of administration
The dose depends on the severity, susceptibility, site and type of infection and on the age and renal function of the patient.
Ceftazidime Venus Pharma 2 g should be administered by intravenous injection or infusion. Ceftazidime Venus Pharma solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids. The standard recommended route of administration is by intravenous intermittent injection or intravenous continuous infusion.
4.3. Contraindications
Hypersensitivity to ceftazidime, to any other cephalosporin or to any of the excipients listed in section 6.1.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
4.4. Special warnings and precautions for use
Hypersensitivity
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with ceftazidime must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftazidime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Spectrum of activity
Ceftazidime has a limited spectrum of antibacterial activity. It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment with ceftazidime. This particularly applies when considering the treatment of patients with bacteraemia and when treating bacterial meningitis, skin and soft tissue infections and bone and joint infections. In addition, ceftazidime is susceptible to hydrolysis by several of the extended spectrum beta lactamases (ESBLs). Therefore information on the prevalence of ESBL producing organisms should be taken into account when selecting ceftazidime for treatment.
Pseudomembranous colitis
Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including ceftazidime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftazidime (see section 4.8). Discontinuation of therapy with ceftazidime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Renal function
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function.
Ceftazidime is eliminated via the kidneys, therefore the dose should be reduced according to the degree of renal impairment. Patients with renal impairment should be closely monitored for both safety and efficacy. Neurological sequelae have occasionally been reported when the dose has not been reduced in patients with renal impairment (see section 4.2 and 4.8).
Overgrowth of non-susceptible organisms
Prolonged use may result in the overgrowth of non-susceptible organisms (e.g. Enterococci, fungi) which may require interruption of treatment or other appropriate measures. Repeated evaluation of the patient's condition is essential.
Test and assay interactions
Ceftazidime does not interfere with enzyme-based tests for glycosuria, but slight interference (false-positive) may occur with copper reduction methods (Benedict's, Fehling's, Clinitest).
Ceftazidime does not interfere in the alkaline picrate assay for creatinine.
The development of a positive Coombs' test associated with the use of ceftazidime in about 5% of patients may interfere with the cross-matching of blood.
Sodium content
Important information about one of the ingredients of Ceftazidime Venus Pharma:
Ceftazidime Venus Pharma 2 g contains 104 mg sodium per gram, equivalent to 5.2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This should be considered for patients who are on a controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been conducted with a probenecid and furosemide.
Concurrent use of high doses with nephrotoxic medicinal products may adversely affect renal function (see section 4.4).
Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime with chloramphenicol is proposed, the possibility of antagonism should be considered.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amounts of data from the use of ceftazidime in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Ceftazidime should be prescribed to pregnant women only if the benefit outweighs the risk.
Breast-feeding
Ceftazidime is excreted in human milk in small quantities but at therapeutic doses of ceftazidime no effects on the breast-fed infant are anticipated. Ceftazidime can be used during breast-feeding.
Fertility
No data are available.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8).
4.8. Undesirable effects
The most common adverse reactions are eosinphilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or uticarcial rash, pain and/or inflammation following intramuscular injection and positive Coomb's test.
Data from sponsored and unsponsored clinical trials have been used to determine the frequency of common and uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following convention has been used for the classification of frequency:
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1000
Very rare <1/10,000
Unknown (cannot be estimated from the available data)
System Organ Class
Common
Uncommon
Very rare
Unknown
Infections and infestations
Candidiasis (including vaginitis and oral thrush)
Blood and lymphatic system disorders
Eosinophilia
Thrombocytosis
Neutropenia
Leucopenia
Thrombocytopenia
Agranulocytosis
Haemolytic anaemia
Lymphocytosis
Immune system disorders
Anaphylaxis (including bronchospasm and/or hypotension) (see section 4.4)
Nervous system disorders
Headache
Dizziness
Neurological sequelae1
Paraesthesia
Vascular disorders
Phlebitis or thrombophlebitis with intravenous administration
Gastrointestinal disorders
Diarrhoea
Antibacterial agent-associated diarrhoea and colitis2 (see section 4.4)
Abdominal pain
Nausea
Vomiting
Bad taste
Heptobiliary disorders
Transient elevations in one or more hepatic enzymes3
Jaundice
Skin and subcutaneous tissue disorders
Maculopapular or urticarial rash
Pruritus
Toxic epidermal necrolysis
StevensJohnson syndrome
Erythema multiforme
Angioedema
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)4
Renal and urinary disorders
Transient elevations of blood urea, blood urea nitrogen and/or serum creatinine
Interstitial nephritis
Acute renal failure
General disorders and administration site conditions
Pain and/or inflammation after intramuscular injection
Fever
Investigations
Positive Coombs' test5
1 There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy and coma in patients with renal impairment in whom the dose of Ceftazidime has not been appropriately reduced.
2 Diarrhoea and colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
3 ALT (SGPT), AST (SOGT), LHD, GGT, alkaline phosphatase.
4 There have been rare reports where DRESS has been associated with ceftazidime.
5 A positive Coombs test develops in about 5% of patients and may interfere with blood cross matching.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma.
Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4)
Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.
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