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CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: CEFTAZIDIME PENTAHYDRATE

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Information for Health Care Professionals
Ceftazidime 1g powder for solution for Injection and Ceftazidime 2g powder for solution for Injection or Infusion
Dosage and Administration Information Only
Please refer to the Summary of Product Characteristics for further information
• Posology and method of administration
Method of administration
Ceftazidime should be administered by intravenous injection or infusion, or by deep intramuscular injection.
Recommended intramuscular injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the
thigh. Ceftazidime 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. Intramuscular administration should only be considered when the intravenous route is not possible or less
appropriate for the patient.
The dose depends on the severity, susceptibility, site and type of infection and on the age and renal function of the
patient.
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
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD
Complicated urinary tract infections
Peri-operative prophylaxis for transuretheral resection of
prostate (TURP)
Chronic suppurative otitis media
Malignant otitis externa
Continuous Infusion
Infection
Febrile neutropenia
Nosocomial pneumonia
Broncho-pulmonary infections in cystic fibrosis
Bacterial meningitis

Bacteraemia*
Bone and joint infections
Loading dose of 2 g followed by a continuous infusion of
Complicated skin and soft tissue infections
4 to 6 g every 24 h1
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.
Children < 40 kg
Infants and toddlers
>2 months and children
< 40 kg
Intermittent Administration

Complicated urinary tract infections
Chronic suppurative otitis media
Malignant otitis externa
Neutropenic children
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

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
1-2 g every 8 h or 12 h
1 g at induction of anaesthesia,
and a second dose at catheter removal
1 g to 2 g every 8h
Dose to be administered
Loading dose of 2 g followed by a continuous infusion of
4 to 6 g every 24 h1

Infection

Usual dose

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

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

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

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
Complicated intra-abdominal infections
Peritonitis associated with dialysis in patients on CAPD

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

106648/4

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Ceftazidime leaflet
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3. HOW CEFTAZIDIME FOR INJECTION IS USED
Ceftazidime for 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 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 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 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 for 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 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 for 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.
If you are given more Ceftazidime for 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 for 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 take a double dose (two injections at the same
time) to make up for a missed dose.

Clearly mark any amendments on one proof and return to MPS

Amount per vial
52 mg
104 mg

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Ceftazidime Strength
Ceftazidime 1g
Ceftazidime 2g

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceftazidime 1 g powder for solution for injection
Ceftazidime 2 g powder for solution for injection or infusion
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again while you are receiving your treatment
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed to you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of the medicine is ceftazidime 1g powder for solution for injection and ceftazidime 2g powder for solution for injection or infusion. In the rest of this leaflet it is called ceftazidime for injection.
In this leaflet:
1. What ceftazidime for injection is and what it is used for
4. Possible side effects
2. Before you are given ceftazidime for injection
5. How to store ceftazidime for injection
3. How ceftazidime for injection should be given
6. Further 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 urinary tract
• the lungs or chest
• the skin and soft tissues
• the lungs and bronchi in patients suffering from cystic fibrosis
• the abdomen and abdominal wall (peritonitis)
• the brain (meningitis)
• the bones and joints.
• the ear
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. BEFORE YOU ARE GIVEN CEFTAZIDIME FOR INJECTION
You must not be given Ceftazidime for Injection:
• if you are allergic (hypersensitive) to ceftazidime or any 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 for Injection if you think that this applies to you; you must not be given Ceftazidime for Injection.
Take special care with Ceftazidime for 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 for 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
for Injection.
If you need a blood or urine test
Ceftazidime for Injection 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 for Injection.
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.
Please check with your doctor if you are taking any of the following (or any other medication):
• An antibiotic called chloramphenicol
• Water tablets called furosemide
• A type of antibiotic called aminoglycosides e.g.gentamicin, tobramycin
➢ 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 breast-feeding.
Your doctor will consider the benefit of treating you with Ceftazidime for Injection against the risk to your baby.
Driving and using machines
Ceftazidime for 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.
Important information about some of the ingredients of Ceftazidime for Injection
Ceftazidime for Injection contains sodium
You need to take this into account if you are on a controlled sodium diet.

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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
Leaflet revised: March 2015
Usual dose

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.
* Where associated with or suspected 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 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.
For recommended maintenance doses of ceftazidime in renal impairment (including haemodialysis and peritoneal
dialysis), follow the dosage recommendations in the SPC.
• Overdose
Overdose can lead to neurological sequelae including encephalopathy, convulsion and coma.
Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment. Serum levels
of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.
• Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Ceftazidime is less stable in Sodium Bicarbonate Injection than other intravenous fluids. It is not recommended as a
diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported when vancomycin has been added to ceftazidime in solution. It is recommended that
giving sets and intravenous lines are flushed between administration of these two agents.
Ceftazidime is incompatible with aminophylline. There is a possible incompatibility with pentamide.
• Instructions for use/handling
For single use. Discard any unused contents.
Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be useful when
fractional doses are required.
PREPARATION OF SOLUTION
1

Vial Size
1g

Intramuscular
Intravenous

Amount of diluent to be added (ml) Approximate concentration (mg/ml)
3.0
260
10.0
95

n-a



Infection

2g

Intravenous bolus
10.0
170
Intravenous Infusion
50.0*
40‡
*Note: Addition should be in two stages.
‡Note: Use Sodium Chloride Injection 0.9%, Dextrose Injection 5% or other
approved diluent, as Water for Injections produces hypotonic solutions at this
concentration.
All sizes of vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and
a positive pressure develops. For ease of use, it is recommended that the following techniques of reconstitution are
adopted.
Preparation of a solution for bolus injection:
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.
Preparation of solutions for iv infusion:
This vial may be constituted for short intravenous infusion (e.g. up to 30 minutes) as follows:
1. Insert the syringe needle through the vial closure and inject 10ml of diluent for 2g vial. The vacuum may assist entry of
the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution obtained in about 1 to 2 minutes.
3. Insert a gas relief needle through the vial closure to relieve the internal pressure and, with the gas relief in position,
add a further 40ml of diluent for 2g vial. Remove the gas relief needle and syringe needle; shake the vial and set up for
infusion use in the normal way.
NOTE: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before
the product has dissolved.
Ceftazidime (at the given concentration) has been shown to be compatible with the following diluent solutions:
Solvents for 40mg/ml ceftazidime concentration:
• Sodium Chloride 0.9%
• Ringer Solution
• Ringer Lactate Solution
• Glucose 5%
• Glucose 10%
• Glucose 5% and Sodium Chloride 0.9%
• Glucose 5% and Sodium Chloride 0.45%
• Glucose 5% and Sodium Chloride 0.2%
• Dextran 40%/10% and Sodium Chloride 0.9%
• Dextran 70%/6% and Sodium Chloride 0.9%
• Lidocaine Hydrochloride 0.5%
• Lidocaine Hydrochloride 1%
Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used.
Leaflet last updated: March 2015
106648/4

Pharma
Code

11/03/2015

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Artwork No.

561749

2

English
Language

Date

UK
Market

Proof No.

6pt (main body) / 6pt (variables)
Min. Point Size

matt.pirie-scott

170 x 320mm
Size

106648-4
Item Code

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Ceftazidime leaflet
Description

Profile

Wockhardt UK Limited
Customer

Proof By

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Reference Number
29831/0031
29831/0032

Clearly mark any amendments on one proof and return to MPS

Product Name
Ceftazidime 1g powder for solution for injection
Ceftazidime 2g powder for solution for injection or infusion

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6. FURTHER INFORMATION
What ceftazidime for injection contains
Ceftazidime for injection contains the active ingredient 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.
What ceftazidime for injection looks like and contents of the pack
Ceftazidime for injection 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:

Neonates and infants ≤
2 months
Intermittent Administration

Keyline (non-printing)

• 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 liver enzymes.
• an increase in the number of cells that help the blood to clot
Uncommon side effects
These may affect up to 1 in 100 people:
• nflammation of the gut which can cause pain or diarrhoea which
i
• dizziness
may contain blood
• stomach ache
• thrush-fungal infections in the mouth or vagina
• feeling sick or being sick
• headache
• 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
• an increase in the level of urea, urea nitrogen or serum creatinine in the blood.
• a decrease in the number of blood platelets (cells that help the blood to clot)
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
• unpleasant taste in the mouth
• pins and needles
• 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
• severe decrease in the number of white blood cells.
• an increase in a certain type of white blood cells
If you get side effects
➢  your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.
Tell
Reporting of side effects
If you get any side effects, talk to your, 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
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie
5. HOW TO STORE CEFTAZIDIME FOR INJECTION
Keep this medicine out of the sight and reach of children
•  his medicine should not be used after the expiry date (EXP) shown on the carton and vial. The expiry date refers to the last day of that month.
T
• The vials should not be stored above 25º C.
• Keep the vial in the outer carton in order to protect from light.
•  hemical and physical in-use stability has been demonstrated for eight hours at 25º C and 24 hours at 4 º C. From a microbiological point of view, once opened, the product should be used
C
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 2-8 º 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 ceftazidime for injection if the solution contains particles or is cloudy.
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 to protect the environment.

Measure bar should be 150mm at 100% scale

• diarrhoea
• swelling and redness along a vein

Colours Used

If you stop using Ceftazidime for Injection
Don’t stop taking Ceftazidime unless your doctor tells you to. If you have any questions ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like many medicines, ceftazidime for injection may cause side effects in some patients, particularly when treatment is first started.
You should inform your doctor or nurse immediately if you feel unwell.
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).
•  ervous 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.
N
➢ Contact a doctor or nurse immediately if you get any of these symptoms.
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).
Common side effects
These may affect up to 1 in 10 people:

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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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