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CEFUROXIME SODIUM FOR INJECTION 1.5G

Active substance(s): CEFUROXIME SODIUM

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Cefuroxime Sodium for
Injection 750mg & 1.5g

The name of your medicine is Cefuroxime
Sodium for Injection 750mg & 1.5g, which
will be referred to as Cefuroxime Injection
throughout this document.
Read all of this leaflet carefully before
you start taking this medicine.
■ Keep this leaflet. You may need to
read it again.
■ If you have any further questions,
ask your doctor or pharmacist.
■ This medicine has been prescribed for
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.
In this leaflet:
1. What Cefuroxime Injection is and
what it is used for
2. Before you are given Cefuroxime
Injection
3. How you are given Cefuroxime
Injection
4. Possible side effects
5. How to store Cefuroxime Injection
6. Further information

1 What Cefuroxime Injection is
and what it is used for

Take special care with Cefuroxime
Injection if you
■ have had a severe allergic reaction to
Cefuroxime Injection contains the active
penicillin in the past
ingredient cefuroxime sodium, which is
an antibiotic.
Taking other medicines
Cefuroxime Injection is used to treat
Please tell your doctor or pharmacist if
infections caused by bacteria that can be you are taking, or have recently taken,
killed by cefuroxime, in the following
any other medicines, including medicines
infections:
obtained without a prescription. This is
■ Lungs and airways e.g. bronchitis,
especially important of the following,
pneumonia
as they may interact with your
■ Ear, nose and throat e.g. tonsillitis,
Cefuroxime Injection:
pharyingitis, sinusitis
■ probenecid (a treatment for gout)
■ Urinary tract e.g. kidney and bladder
■ strong diuretics (water tablets used to
■ Soft tissue e.g. skin, cellulitis
treat high blood pressure or fluid
■ Bone and joint
retention)
■ Pelvic inflamatory disease (e.g. infection
■ aminoglycosides (another type of
of the female reproductive system)
antibiotic e.g. tobramycin, gentamicin).
■ Gonorrhoea (a sexually transmitted
It may still be all right for you to be given
disease), particularly if penicillin is
Cefuroxime Injection and your doctor will
unsuitable
be able to decide what is suitable for you.
■ Other infections including blood
poisoning (septicaemia) and
Interference with laboratory tests
meningitis.
Tell your doctor if you are having blood or
Cefuroxime Injection can also be used to
urine tests. Cefuroxime Injection may
prevent infection during surgery where
interfere with these tests.
there is an increased risk of infection.
Pregnancy and breast-feeding
2 Before you are given
You should tell your doctor if you are
Cefuroxime Injection
pregnant or breast-feeding. Ask your
doctor or pharmacist before taking
Do not take Cefuroxime Injection if
any medicine.
■ you are allergic (hypersensitive) to
cefuroxime or any cephlosporin (other Driving and using machines
similar antibiotics). An allergic reaction Cefuroxime Injection should not affect
may include rash, itching, difficulty
your ability to drive or use machines.
breathing or swelling of the face, lips,
throat or tongue.

3 How you are given
Cefuroxime Injection

Information for the Health Care Professional

CEFUROXIME SODIUM FOR INJECTION

Cefuroxime Injection will be given to you
by a doctor or nurse.
Dosage
The dose depends on the infection to be
treated and the condition of the patient.
For adults:
The usual dose is 750mg three times
daily by injection into a muscle
(intramuscular) or into a vein
(intravenous injection).
For more severe infections this dose
should be increased to 1.5g three times
daily intravenously.
The dose may be increased by giving the
injection four times daily giving a total
daily doses of 3g to 6g.
For infants and children:
The usual total daily dose is 30 to
100mg/kg (body weight) given in three
or four doses. A total daily dose of
60mg/kg is effective for most infections.
For newborn babies:
The usual total daily dose is 30 to
100mg/kg per day given in two or
three doses.
Gonorrhoea
1.5g as a single dose.
Meningitis
For adults:
3g intravenously every eight hours.

1 Name of the Medicinal Product


Cefuroxime Sodium for Injection 750 mg and Cefuroxime Sodium for Injection 1.5 g.

2 Qualitative and Quantitative Composition
Each vial contains, as the active ingredient, cefuroxime sodium for injection equivalent to
750 mg or 1.5 g of cefuroxime.

3 Pharmaceutical Form


Vials containing an off-white to slightly yellow sterile powder for solution for injection or infusion.

4 Clinical Particulars
4.1 Therapeutic Indications
Cefuroxime Sodium for Injection is indicated for the treatment of infections caused by susceptible
strains of the designated micro-organisms, or before the infecting organism has been identified, in
the diseases listed below.

Respiratory tract infections, for example, acute and chronic bronchitis, infected bronchiectasis,
bacterial pneumonia, lung abscess and post operative chest infections.

Ear, nose and throat infections, for example, sinusitis, tonsillitis and pharyngitis.

Urinary tract infections, for example, acute and chronic pyelonephritis, cystitis and
asymptomatic bacteriuria.

Soft tissue infections, for example, cellulitis, erysipelas, peritonitis and wound infections.

Bone and joint infections, for example, osteomyelitis and septic arthritis.

Obstetric and gynaecological infections, pelvic inflammatory disease.

Gonorrhoea, particularly if penicillin is unsuitable.

Other infections, including septicaemia and meningitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal
and vascular surgery where there is increased risk from infection.
Consideration should be given to official local guidance (e.g. national recommendations) on the
appropriate use of antibacterial agents.
Susceptibility of the causative organism to the treatment should be tested (if possible), although
therapy may be initiated before the results are available.

4.2 Posology and Method of Administration
Usually cefuroxime is effective when administered alone, but when appropriate it may be used in
combination with metronidazole or an aminoglycoside.

General Dosage



Package leaflet:
Information for the user


Adults: Many infections will respond to 750 mg three times daily by intramuscular or intravenous
injection. For more severe infections this dose should be increased to 1.5g three times daily
intravenously. The frequency of dosage may be increased to six-hourly injections intramuscular or
intravenous, giving total daily doses of 3 g to 6 g.

Infants and children: Doses of 30 to 100 mg/kg/day given in three or four divided doses.

A dose of 60 mg/kg/day will be appropriate for most infections.

Neonates: Doses of 30 to 100 mg/kg/day given in two or three divided doses. In the first weeks of
life the serum half-life of cefuroxime can be three to five times that in adults.
Gonorrhoea
1.5 g should be given as a single dose or as two 750 mg injections into different sites, e.g. each buttock.

Meningitis

Cefuroxime therapy is suitable for sole therapy of bacterial meningitis due to sensitive strains.

Infants and children: 200 to 240 mg/kg/day intravenously in three or four divided doses. This dosage
may be reduced to 100 mg/kg/day after three days or when clinical improvement occurs.

Neonates: The initial dosage should be 100 mg/kg/day intravenously.

This dosage may be reduced to 50 mg/kg/day after three days or when clinical improvement occurs.

Adults: 3 g intravenously every eight hours. No data is currently available to recommend a dose for
intrathecal administration.

Prophylaxis
The usual dose is 1.5 g intravenously with induction of anaesthesia. For orthopaedic, pelvic and
abdominal operations this may be followed with two 750 mg doses 8 and 16 hours later.
For vascular, cardiac, oesophageal and pulmonary operations this may be supplemented with
750 mg intramuscularly three times a day for a further 24 to 48 hours.
In total joint replacement, 1.5 g cefuroxime powder may be mixed dry with each pack of methyl
methacrylate cement polymer before adding the liquid monomer.

Dosage in Impaired Renal Function
As cefuroxime is excreted by the kidneys, the dosage should be reduced to allow for slower excretion
in patients with impaired renal function, once creatinine clearance falls below 20 ml/min, as follows.









Marked impairment (creatinine clearance 10 to 20 ml/min)
Severe impairment (creatinine clearance of less than 10 ml/min)*
Continuous peritoneal dialysis
Renal failure on continuous arteriovenous haemodialysis or
high-flux haemofiltration in intensive therapy units
Low-flux haemofiltration

750 mg twice daily
750 mg once daily
750 mg twice daily
750 mg twice daily
as for impaired renal function

* For patients on haemodialysis, a further 750 mg should be given at the end of each dialysis session.

4.3 Contra-indications


Contra-indicated in patients hypersensitive to the cephalosporin group of antibiotics.

4.4 Special Warnings and Special Precautions for Use
Cephalosporin antibiotics may, in general, be given safely to patients who are hypersensitive to
penicillins although cross-reactions have been reported. Special care is indicated in patien-ts who
have experienced an anaphylactic reaction to penicillin.
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent
diuretics or aminoglycosides as these combinations are suspected of adversely affecting renal
function. Clinical experience has shown that this is not likely to be a problem at the recommended
dose levels.

4.5 Interaction with other Medicinal Products and other Forms of Interaction
Concurrent administration of probenecid prolongs the excretion of cefuroxime and produces an
elevated peak serum level.
Concurrent administration of potent diuretics, aminoglycosides may adversely affect renal function.
(see section 4. 4)

Interference with Laboratory Tests
Slight interference may occur with the copper reduction methods (Fehling’s, Benedict’s) but this
should not lead to false-positive results. Cefuroxime does not interfere with the enzyme based tests
for glycosuria, or with the alkaline picrate method for creatinine. It is recommended that either the
hexokinase or glucose oxidasemethods are used for determination of blood/plasma glucose levels.

4.6 Pregnancy and Lactation
Studies in animals revealed no evidence of embryopathic or teratogenic effects due to cefuroxime,
but, as with all drugs, it should be used with caution during pregnancy. Since cefuroxime is excreted
in human milk, caution should be exercised when administering this antibiotic to a nursing mother.

4.7 Effects on the Ability to Drive and Use Machines


Cefuroxime is not known to affect the ability to drive or use machines.

4.8 Undesirable Effects

Hypersensitivity reactions: including skin rashes (maculopapular and urticarial) interstitial nephritis,
drug fever and very rarely anaphylaxis. As with any antibiotic, prolonged use may lead to overgrowth
of non-susceptible organisms, e.g. Candida.
As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson
syndrome and toxic epidermal necrolysis.

Gastrointestinal disturbance: including, very rarely, pseudomembranous colitis, which has been
reported with most broad spectrum antibiotics.

Haematological: a decrease in haemoglobin concentration, eosinophilia, leucopenia and neutropenia
have been observed. Positive Coombs’ tests have been reported. As with other cephalosporins,
thrombocytopenia has been reported rarely.

Hepatic: Transient rises in liver enzymes or serum bilirubin have been observed particularly in
patients with pre-existing liver disease, but there is no evidence of hepatic involvement.


Renal: There may be some variation in the results of biochemical tests of renal function, but these
results do not appear to be of clinical significance.

Other: Transient pain may be experienced at the site of intramuscular injection. Occasionally
thrombophlebitis may occur at the site of intravenous injection. A burning sensation may be
observed after intravenous injection. Mild to moderate hearing loss has been reported in some
children treated for meningitis.

Dizziness and headache has been reported in patients receiving cefuroxime.

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

4.9 Overdose
Overdosage of cephalosporins can lead to cerebral irritation and seizures. With seizures the drug
should be discontinued and appropriate anticonvulsive and supportive therapy administered. Serum
levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

5 Pharmacological Properties
5.1 Pharmacodynamic Properties
Cefuroxime is a cephalosporin antibiotic, ATC code J01DA06 Cephalosporins and related substances.
All cephalosporins (ß-lactam antibiotics) inhibit cell wall production and are selective inhibitors
of peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell
receptors, called Penicillin-Binding Proteins. After a ß-lactam antibiotic has bound to these receptors,



Table 1: Susceptibility breakpoints


Bacterial Breakpoints

NCCLS Breakpoints

S: ≤ 8 mg/L I:16 R: ≥ 32 mg/L

S: ≤ 4 mg/L I:8 R: ≥ 16 mg/L

S: ≤ 4 mg/L I:8 R: ≥ 16 mg/L

S: ≤ 1 mg/L I:2 R: ≥ 4 mg/L

S: ≤ 0.5 mg/L I:1 R: ≥ 2 mg/L

DIN Breakpoints

S: ≤ 4 mg/L I:8 R: ≥16 mg/L

BSAC Breakpoints

S: ≤1 mg/L I:2-16 R: ≥ 32 mg/L

S: ≤1 mg/L
R: ≥ 2 mg/L


Organism
Enterobacteriaceae
Enterococcus
Haemophilus influenzae
Neisseria gonorrhoeae
Streptococcus pneumoniae
All bacterial isolates
Acinetobacter spp. and Enterobacteriaceae
Streptococcus pneumoniae, Moraxella catarrhalis,
Neisseria gonorrhoeae, Haemophilus influenzae

NCCLS: National Committee for Clinical Laboratory Standards
DIN: Deutches Institut fur Normung
BSAC: British Society for Antimicrobial Chemotherapy
S: Susceptible, I: Intermediately susceptible, R: Resistant
The prevalence of resistance may vary geographically and with time for selected species and local
information is desirable, particularly when treating several infections. This information gives only an
approximate guidance on probabilities whether organisms will be susceptible to cefuroxime or not.




Table 2: Range of bacterial resistance to cefuroxime in Europe.


CATEGORY
RANGE OF RESISTANCE IN EUROPE
SUSCEPTIBLE

GRAM + VE AEROBES

Staph. aureus (methicillin-susceptible strains)

Staph. epidermidis (methicillin-susceptible strains)
0-46%

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus viridans

GRAM - VE AEROBES

Escherichia coli 2-17%

Haemophilus influenzae 0-29%


Klebsiella spp. 6-21%

Moraxella catarrhalis

Neisseria spp.

Proteus mirabilis 0-17%

Providencia spp. including Providencia rettgeri
0-75%

Providencia rettgeri only
ANAEROBES

Clostridium perfringens
INTERMEDIATE

GRAM - VE AEROBES

Bordetella pertussis
Citrobacter 21-52%

Enterobacter spp. 36-83%
ANAEROBES

Bacteroides fragilis
INSUSCEPTIBLE

GRAM + VE AEROBES

Enterococcus faecalis

Staph. aureus (methicillin-resistant strains)

Staph. epidermidis (methicillin-resistant strains)

GRAM - VE AEROBES

Acinetobacter spp.

Campylobacter spp.

Legionella spp.

Pseudomonas spp.

Serratia spp.

Morganella morganii 70-94%

Proteus vulgaris 75-100%
ANAEROBES

Clostridium difficile

Cross-reactivity between cefuroxime and other antibiotics
Cross-resistance between cefuroxime and several other ß-lactam antibiotics including amoxicillin,
methicillin, penicillin and ampicillin and some cephalosporins has been recorded. Amoxicillin-sensitive
Haemophilus influenzae are more likely to be susceptible to cefuroxime than amoxicillin-resistant
Haemophilus influenzae. Similarly, methicillin-sensitive Staphylococcus aureus and Staphylococcus
epidermidis are usually Cefuroxime-susceptible, while methicillin-resistant Staphylococcus aureus
and Staphylococcus epidermidis are resistant to cefuroxime.
Resistance of Staphylococcus aureus and Streptococcus pneumoniae to penicillin can result in an
increase in the cefuroxime MIC50 and MIC90 values for these organisms. In addition, resistance of
Escherichia coli and Haemophilus influenzae to ampicillin may result in an increase of the cefuroxime
MIC50 values for these organisms.


Mechanisms of resistance to cefuroxime

Known mechanisms of resistance in targeted pathogens are the following:
1) Production of ß-lactamases which are able to hydrolyse cefuroxime efficiently (e.g. several of the
extended-spectrum and chromosomally-mediated ß-lactamases).

2) Reduced affinity of Penicillin- Binding Proteins for cefuroxime (e.g. Penicillin-resistant

Streptococcus pneumoniae).

3) Cell wall impermeability.

4) Efflux pumps.

5.2 Pharmacokinetic Properties
The serum half-life after either intramuscular or intravenous administration is approximately 70
minutes. After intramuscular injection the peak serum level occurs after about 45 minutes. The
antibiotic can be found in bone, synovial fluid and aqueous humour above the minimum inhibitory
levels for common pathogens. The blood-brain barrier can be passed by cefuroxime when the
meninges are inflamed.
Cefuroxime is excreted approximately 50% by glomerular filtration and 50% through the renal
tubules. Cefuroxime is almost completely recovered unchanged in the urine within 24 hours, most
being excreted within six hours.


Intramuscular injection: Add 3 ml of Water for Injections to 750 mg.

Shake gently to produce a suspension.

Intravenous administration: Dissolve cefuroxime in Water for Injections using at least 6 ml for
750 mg and at least 15 ml for 1.5 g. For short intravenous infusion 1.5 g may be dissolved in 50 ml
of Water for Injections.

Reconstituted solutions may be diluted with:
5% or 10% Dextrose
5% Dextrose containing 0.2%, 0.225%, 0.45% or 0.9% Sodium Chloride Injection
5% Dextrose containing 20 mEq Potassium Chloride
0.9% Sodium Chloride Injection
Ringer’s Injection
Lactated Ringer’s Injection
Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection
10 mEq Potassium Chloride in 0.9% Sodium Chloride Injection
These solutions may be given directly into a vein or introduced into the tubing of the giving set if the
patient is receiving parenteral fluids.

5.3 Preclinical Safety Data

7 Marketing Authorisation Holder





There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime.

Flynn Pharma Limited, Alton House, 4 Herbert Street, Dublin 2, Ireland.

6 Pharmaceutical Particulars

8 Marketing Authorisation Numbers

6.1 List of Excipients

Cefuroxime Sodium for Injection 750 mg PL 13621/0018
Cefuroxime Sodium for Injection 1.5g PL 13621/0019



Each vial contains only the active ingredient cefuroxime sodium.

6.2 Incompatibilities

9 Date of First Authorisation/Renewal of Authorisation





Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.

6.3 Shelf-Life

Before reconstitution: 3 years.
In keeping with good pharmaceutical practice, freshly constituted suspensions or solutions should
be used immediately. If this is not practicable then solution may be stored at 2°C - 8°C (in a
refrigerator) for up to 24 hours.

For infants and children:
The usual total daily dose is 200 240mg/kg (body weight) given in three
or four doses. This dose may be reduced
after three days or when your child’s
health improves.
For newborn babies:
The usual total daily dose is 100mg/kg
(body weight) given in three or four doses.
This dose may be reduced after three days
or when your child’s health improves.
To prevent infections (prophylaxis)
The usual dose is 1.5g given intravenously
at the same time as you have your
anaesthetic. Your doctor may give you
more Cefuroxime Injection if they think it
appropriate.
The dose of drug you are given will be
reduced if you have severe kidney
problems e.g. you are on dialysis.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

6.6 Instructions for Use / Handling

Date of last renewal of authorisation: 19 Feb 2002

10 Date of (Partial) Revision of the Text


4 Possible side effects

July 2014

Like all medicines, Cefuroxime Injection
can cause side effects, although not
everybody gets them.
All medicines can cause allergic reactions,
although serious allergic reactions are
very rare.
Serious side effects
The following side effects are serious.
You should stop taking this medicine and
contact your doctor immediately if you
experience them:

6.4 Special Precautions for Storage
Protect from light. Before reconstitution do not store above 25°C. After reconstitution the product
may be stored at 2°C - 8°C (in a refrigerator) for up to 24 hours.

6.5 Nature and Contents of Container
Type III flint glass vial stoppered with halobutyl closures and sealed with aluminium seals that may
be combined with a polypropylene cap.
Pack sizes of 1 (all presentations), 10 (750 mg and 1.5 g) and 50 (750 mg only) vials.
Not all pack sizes may be marketed.



the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is
the end result.

Susceptibility
The following MIC breakpoints separating susceptible from intermediately susceptible organism and
intermediately susceptible from resistant organism are used.

■ serious peeling or blistering of the skin
■ severe diarrhoea with blood or mucus.

Tell your doctor immediately if you get
any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face
or lips, rash or itching (especially
affecting your whole body).
The following side effects have also
been reported
With prolonged use, there may be:
■ thrush (candida)
■ itchy red wheals (urticaria)
■ rash (alone)
■ fever
■ diarrhoea
■ changes in blood counts, which may
show up as bruising or a very tired
feeling. You will need a blood test to
confirm this.
■ damage to your liver or kidneys which
can only be detected by a blood and /
or urine test
■ jaundice (yellow skin and eyes)
■ temporary pain at the injection site
■ swelling of the vein where your drip
goes in
■ burning sensation in your arm where
the drip goes in
■ mild to moderate hearing loss in some
children treated for meningitis
■ dizziness
■ headache.
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.

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

5 How to store Cefuroxime
Injection

Your doctor or pharmacist will know how
to store Cefuroxime Injection.
It should be kept out of the sight and
reach of children.
Before it is made up, it should be stored
below 25°C and protected from light.
After it is made up Cefuroxime Injection
may be stored at 2°C-8°C (in a
refrigerator) for up to 24 hours.
Medicines should not be disposed of via
wastewater or household waste.
Ask your doctor how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

6 Further information
What Cefuroxime Injection contains
The active substance is cefuroxime sodium.
There are no other ingredients.

What Cefuroxime Injection looks like
and contents of the pack
Cefuroxime Injection is contained in glass
vials with rubber stoppers.
Pack sizes of 1 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Flynn Pharma Ltd
Alton House, 4 Herbert Street
Dublin 2, Ireland.
Manufacturer:
Facta Farmaceutici,
Nucleo Industriale S. Atto,
S. Nicolò a Tordino, 64020 Teramo, Italy
This leaflet was last revised in
June 2014.

Artwork for:
Flynn Pharma Limited
Product name:
Cefuroxime Sodium for Injection
Size:
PL/PA no:
PL 13621/0018, 0019
Type: Leaflet
Artwork dimensions: 140mm x 700mm
Profile supplied: Yes
Date of first artwork: Reason for request:
Text edit
Version no: 1.4DL
Date of revision:
1 August 2014
Colours:
As swatch(es)
Font(s):
PIL: 9pt Zwo
Artwork software:
InDesign CS6
BAC ref:
R659 (formerly R602)

Black

Information for the Health Care Professional

4.3 Contra-indications
Contra-indicated in patients hypersensitive to the cephalosporin group
of antibiotics.
4.4 Special Warnings and Special Precautions for Use
Cephalosporin antibiotics may, in general, be given safely to patients
who are hypersensitive to penicillins although cross-reactions have been
reported. Special care is indicated in patien-ts who have experienced an
anaphylactic reaction to penicillin.
Cephalosporin antibiotics at high dosage should be given with caution to
patients receiving potent diuretics or aminoglycosides as these
combinations are suspected of adversely affecting renal function.
Clinical experience has shown that this is not likely to be a problem at the
recommended dose levels.
4.5 
Interaction with other Medicinal Products and other Forms
of Interaction

Concurrent administration of probenecid prolongs the excretion of
cefuroxime and produces an elevated peak serum level.

Concurrent administration of potent diuretics, aminoglycosides may
adversely affect renal function. (see section 4. 4)
Interference with Laboratory Tests

Slight interference may occur with the copper reduction methods
(Fehling’s, Benedict’s) but this should not lead to false-positive results.
Cefuroxime does not interfere with the enzyme based tests for glycosuria,
or with the alkaline picrate method for creatinine. It is recommended that
either the hexokinase or glucose oxidasemethods are used for
determination of blood/plasma glucose levels.
4.6 Pregnancy and Lactation
Studies in animals revealed no evidence of embryopathic or teratogenic
effects due to cefuroxime, but, as with all drugs, it should be used with
caution during pregnancy. Since cefuroxime is excreted in human milk,
caution should be exercised when administering this antibiotic to a
nursing mother.
4.7 Effects on the Ability to Drive and Use Machines
Cefuroxime is not known to affect the ability to drive or use machines.
4.8 Undesirable Effects

Hypersensitivity reactions: including skin rashes (maculopapular and
urticarial) interstitial nephritis, drug fever and very rarely anaphylaxis. As
with any antibiotic, prolonged use may lead to overgrowth of nonsusceptible organisms, e.g. Candida.
As with other cephalosporins, there have been rare reports of erythema
multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Gastrointestinal disturbance: including, very rarely, pseudomembranous
colitis, which has been reported with most broad spectrum antibiotics.

Haematological: a decrease in haemoglobin concentration, eosinophilia,
leucopenia and neutropenia have been observed. Positive Coombs’
tests have been reported. As with other cephalosporins, thrombocytopenia
has been reported rarely.

Hepatic: Transient rises in liver enzymes or serum bilirubin have been
observed particularly in patients with pre-existing liver disease, but there
is no evidence of hepatic involvement.

Renal: There may be some variation in the results of biochemical tests of
renal function, but these results do not appear to be of clinical significance.

Other: Transient pain may be experienced at the site of intramuscular
injection. Occasionally thrombophlebitis may occur at the site of
intravenous injection. A burning sensation may be observed after
intravenous injection. Mild to moderate hearing loss has been reported in
some children treated for meningitis.

Dizziness and headache has been reported in patients receiving
cefuroxime.
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
4.9 Overdose

Overdosage of cephalosporins can lead to cerebral irritation and
seizures. With seizures the drug should be discontinued and appropriate
anticonvulsive and supportive therapy administered. Serum levels of
cefuroxime can be reduced by haemodialysis or peritoneal dialysis.
5 Pharmacological Properties
5.1 Pharmacodynamic Properties

Cefuroxime is a cephalosporin antibiotic, ATC code J01DA06
Cephalosporins and related substances. All cephalosporins (β-lactam
antibiotics) inhibit cell wall production and are selective inhibitors of
peptidoglycan synthesis. The initial step in drug action consists of binding
of the drug to cell receptors, called Penicillin-Binding Proteins.
After a β-lactam antibiotic has bound to these receptors, the
transpeptidation reaction is inhibited and peptidoglycan synthesis is
blocked. Bacterial lysis is the end result.
Susceptibility
The following MIC breakpoints separating susceptible from intermediately
susceptible organism and intermediately susceptible from resistant
organism are used.



Package leaflet: Information for the user

Cefuroxime Injection can also be used to prevent infection during surgery
where there is an increased risk of infection.

The name of your medicine is Cefuroxime Sodium for Injection 750mg & 1.5g,
which will be referred to as Cefuroxime Injection throughout this document.

2 Before you are given Cefuroxime Injection
Do not take Cefuroxime Injection if
■ you are allergic (hypersensitive) to cefuroxime or any cephlosporin
(other similar antibiotics). An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue.

3 How you are given Cefuroxime Injection
Cefuroxime Injection will be given to you by a doctor or nurse.
Dosage
The dose depends on the infection to be treated and the condition of
the patient.

CEFUROXIME SODIUM FOR INJECTION
1 Name of the Medicinal Product
Cefuroxime Sodium for Injection 750 mg and Cefuroxime Sodium for
Injection 1.5 g.
2 Qualitative and Quantitative Composition

Each vial contains, as the active ingredient, cefuroxime sodium for
injection equivalent to 750 mg or 1.5 g of cefuroxime.
3 Pharmaceutical Form
Vials containing an off-white to slightly yellow sterile powder for solution
for injection or infusion.
4 Clinical Particulars
4.1 Therapeutic Indications

Cefuroxime Sodium for Injection is indicated for the treatment of
infections caused by susceptible strains of the designated microorganisms, or before the infecting organism has been identified, in the
diseases listed below.
Respiratory tract infections, for example, acute and chronic bronchitis,
infected bronchiectasis, bacterial pneumonia, lung abscess and post
operative chest infections.

Ear, nose and throat infections, for example, sinusitis, tonsillitis and
pharyngitis.
Urinary tract infections, for example, acute and chronic pyelonephritis,
cystitis and asymptomatic bacteriuria.
Soft tissue infections, for example, cellulitis, erysipelas, peritonitis and
wound infections.
Bone and joint infections, for example, osteomyelitis and septic arthritis.
Obstetric and gynaecological infections, pelvic inflammatory disease.
Gonorrhoea, particularly if penicillin is unsuitable.
Other infections, including septicaemia and meningitis.
Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac,
pulmonary, oesophageal and vascular surgery where there is increased
risk from infection.
Consideration should be given to official local guidance (e.g. national
recommendations) on the appropriate use of antibacterial agents.

Susceptibility of the causative organism to the treatment should be
tested (if possible), although therapy may be initiated before the results
are available.
4.2 Posology and Method of Administration

Usually cefuroxime is effective when administered alone, but when
appropriate it may be used in combination with metronidazole or an
aminoglycoside.
General Dosage
Adults: Many infections will respond to 750 mg three times daily by
intramuscular or intravenous injection. For more severe infections this
dose should be increased to 1.5g three times daily intravenously. The
frequency of dosage may be increased to six-hourly injections
intramuscular or intravenous, giving total daily doses of 3 g to 6 g.

Infants and children: Doses of 30 to 100 mg/kg/day given in three or four
divided doses.
A dose of 60 mg/kg/day will be appropriate for most infections.

Neonates: Doses of 30 to 100 mg/kg/day given in two or three divided
doses. In the first weeks of life the serum half-life of cefuroxime can be
three to five times that in adults.
Gonorrhoea
1.5 g should be given as a single dose or as two 750 mg injections into
different sites, e.g. each buttock.
Meningitis
Cefuroxime therapy is suitable for sole therapy of bacterial meningitis
due to sensitive strains.

Infants and children: 200 to 240 mg/kg/day intravenously in three or four
divided doses. This dosage may be reduced to 100 mg/kg/day after three
days or when clinical improvement occurs.

Neonates: The initial dosage should be 100 mg/kg/day intravenously.
This dosage may be reduced to 50 mg/kg/day after three days or when
clinical improvement occurs.

Adults: 3 g intravenously every eight hours. No data is currently available
to recommend a dose for intrathecal administration.
Prophylaxis
The usual dose is 1.5 g intravenously with induction of anaesthesia. For
orthopaedic, pelvic and abdominal operations this may be followed with
two 750 mg doses 8 and 16 hours later.
For vascular, cardiac, oesophageal and pulmonary operations this may
be supplemented with 750 mg intramuscularly three times a day for a
further 24 to 48 hours.
In total joint replacement, 1.5 g cefuroxime powder may be mixed dry
with each pack of methyl methacrylate cement polymer before adding
the liquid monomer.
Dosage in Impaired Renal Function
As cefuroxime is excreted by the kidneys, the dosage should be reduced
to allow for slower excretion in patients with impaired renal function, once
creatinine clearance falls below 20 ml/min, as follows.
Marked impairment (creatinine clearance
10 to 20 ml/min)
Severe impairment (creatinine clearance
of less than 10 ml/min) *
Continuous peritoneal dialysis
Renal failure on continuous
arteriovenous haemodialysis or high-flux
haemofiltration in intensive therapy units
Low-flux haemofiltration




750 mg twice daily
750 mg once daily
750 mg twice daily
750 mg twice daily
as for impaired renal function

* For patients on haemodialysis, a further 750 mg should be given at the
end of each dialysis session.

Table 1: Susceptibility breakpoints

Bacterial Breakpoints Organism
NCCLS Breakpoints
S: ≤ 8 mg/L I:16 R: ≥ 32 mg/L
S: ≤ 4 mg/L I:8
R: ≥ 16 mg/L
S: ≤ 4 mg/L I:8
R: ≥ 16 mg/L
S: ≤ 1 mg/L I:2
R: ≥ 4 mg/L
S: ≤ 0.5 mg/L I:1
R: ≥ 2 mg/L
DIN Breakpoints
S: ≤ 4 mg/L I:8
R: ≥16 mg/L
BSAC Breakpoints
S: ≤1 mg/L I:2-16 R: ≥ 32 mg/L

S: ≤1 mg/L
R: ≥ 2 mg/L



Enterobacteriaceae
Enterococcus
Haemophilus influenzae
Neisseria gonorrhoeae
Streptococcus pneumoniae
All bacterial isolates
Acinetobacterspp. and
Enterobacteriaceae
Streptococcus pneumoniae, Moraxella
catarrhalis, Neisseria gonorrhoeae,
Haemophilus influenzae

NCCLS: National Committee for Clinical Laboratory Standards
DIN: Deutches Institut fur Normung
BSAC: British Society for Antimicrobial Chemotherapy
S: Susceptible, I: Intermediately susceptible, R: Resistant
The prevalence of resistance may vary geographically and with time for
selected species and local information is desirable, particularly when
treating several infections. This information gives only an approximate
guidance on probabilities whether organisms will be susceptible to
cefuroxime or not.
Table 2: Range of bacterial resistance to cefuroxime in Europe.
CATEGORY
RANGE OF

RESISTANCE IN

EUROPE
SUSCEPTIBLE
GRAM + VE AEROBES
Staph.aureus (methicillin-susceptible strains)
Staph.epidermidis (methicillin-susceptible strains) 0-46%
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus viridans
GRAM - VE AEROBES
Escherichia coli 2-17%
Haemophilus influenzae
0-29%
Klebsiellaspp.
6-21%
Moraxella catarrhalis
Neisseriaspp.
Proteus mirabilis 0-17%
Providenciaspp. including Providencia rettgeri 0-75%
Providencia rettgerionly
ANAEROBES
Clostridium perfringens
INTERMEDIATE
GRAM - VE AEROBES
Bordetella pertussis
Citrobacter 21-52%
Enterobacterspp.
36-83%
ANAEROBES
Bacteroides fragilis
INSUSCEPTIBLE
GRAM + VE AEROBES
Enterococcus faecalis

Staph. Aureus (methicillin-resistant strains)
Staph. epidermidis (methicillin-resistant strains)
GRAM - VE AEROBES
Acinetobacterspp.
Campylobacterspp.
Legionellaspp.
Pseudomonasspp.
Serratiaspp.
Morganella morganii 70-94%
Proteus vulgaris
75-100%
ANAEROBES
Clostridium difficile
Cross-reactivity between cefuroxime and other antibiotics

Cross-resistance between cefuroxime and several other ß-lactam
antibiotics including amoxicillin, methicillin, penicillin and ampicillin and
some cephalosporins has been recorded. Amoxicillin-sensitive
Haemophilus influenzae are more likely to be susceptible to cefuroxime
than
amoxicillin-resistant
Haemophilus
influenzae.
Similarly,
methicillin-sensitive Staphylococcus aureus and Staphylococcus
epidermidis are usually Cefuroxime-susceptible, while methicillinresistant Staphylococcus aureus and Staphylococcus epidermidis are
resistant to cefuroxime.
Resistance of Staphylococcus aureus and Streptococcus pneumoniae to
penicillin can result in an increase in the cefuroxime MIC50 and MIC90
values for these organisms. In addition, resistance of Escherichia coli
and Haemophilus influenzae to ampicillin may result in an increase of the
cefuroxime MIC50 values for these organisms.
Mechanisms of resistance to cefuroxime

Known mechanisms of resistance in targeted pathogens are the
following:
1) Production of ß-lactamases which are able to hydrolyse cefuroxime
efficiently (e.g. several of the extended-spectrum and chromosomally mediated ß-lactamases).
2) Reduced affinity of Penicillin- Binding Proteins for cefuroxime (e.g.
Penicillin-resistant Streptococcus pneumoniae).
3) Cell wall impermeability.
4) Efflux pumps.

5.2 Pharmacokinetic Properties
The serum half-life after either intramuscular or intravenous administration
is approximately 70 minutes. After intramuscular injection the peak
serum level occurs after about 45 minutes.
The antibiotic can be found in bone, synovial fluid and aqueous humour
above the minimum inhibitory levels for common pathogens. The bloodbrain barrier can be passed by cefuroxime when the meninges are
inflamed.
Cefuroxime is excreted approximately 50% by glomerular filtration and
50% through the renal tubules. Cefuroxime is almost completely
recovered unchanged in the urine within 24 hours, most being excreted
within six hours.
5.3 Preclinical Safety Data
There is no experimental evidence of embryopathic or teratogenic effects
attributable to cefuroxime.
6 Pharmaceutical Particulars
6.1 List of Excipients
Each vial contains only the active ingredient cefuroxime sodium.
6.2 Incompatibilities

Cefuroxime should not be mixed in the syringe with aminoglycoside
antibiotics.
6.3 Shelf-Life
Before reconstitution: 3 years.

In keeping with good pharmaceutical practice, freshly constituted
suspensions or solutions should be used immediately. If this is not
practicable then solution may be stored at 2°C - 8°C (in a refrigerator) for
up to 24 hours.
6.4 Special Precautions for Storage
Protect from light. Before reconstitution do not store above 25°C. After
reconstitution the product may be stored at 2°C - 8°C (in a refrigerator)
for up to 24 hours.
6.5 Nature and Contents of Container
Type III flint glass vial stoppered with halobutyl closures and sealed with
aluminium seals that may be combinedwith a polypropylene cap.
Pack sizes of 1 (all presentations), 10 (750 mg and 1.5 g) and 50 (750 mg
only) vials. Not all pack sizes may be marketed.
6.6 Instructions for Use / Handling

Intramuscular injection: Add 3 ml of Water for Injections to 750 mg.
Shake gently to produce a suspension.

Intravenous administration: Dissolve cefuroxime in Water for Injections
using at least 6 ml for 750 mg and at least 15 ml for 1.5 g. For short
intravenous infusion 1.5 g may be dissolved in 50 ml of Water for
Injections.
Reconstituted solutions may be diluted with:
5% or 10% Dextrose
5% Dextrose containing 0.2%, 0.225%, 0.45% or 0.9% Sodium Chloride
Injection
5% Dextrose containing 20 mEq Potassium Chloride
0.9% Sodium Chloride Injection
Ringer’s Injection
Lactated Ringer’s Injection
Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection
10 mEq Potassium Chloride in 0.9% Sodium Chloride Injection
These solutions may be given directly into a vein or introduced into the
tubing of the giving set if the patient is receiving parenteral fluids.
7 Marketing Authorisation Holder
Flynn Pharma Limited, Alton House, 4 Herbert Street, Dublin 2, Ireland.
8 Marketing Authorisation Numbers
Cefuroxime Sodium for Injection 750 mg PL 13621/0018
Cefuroxime Sodium for Injection 1.5g PL 13621/0019
9 Date of First Authorisation/Renewal of Authorisation
Date of last renewal of authorisation: 19 Feb 2002
10 Date of (Partial) Revision of the Text
July 2014

L15GBCEFU07502


Cefuroxime Sodium for Injection 750mg & 1.5g
Read all of this leaflet carefully before you start taking this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for 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.
In this leaflet:
1. What Cefuroxime Injection is and what it is used for
2. Before you are given Cefuroxime Injection
3. How you are given Cefuroxime Injection
4. Possible side effects
5. How to store Cefuroxime Injection
6. Further information
1 What Cefuroxime Injection is and what it is used for
Cefuroxime Injection contains the active ingredient cefuroxime sodium,
which is an antibiotic.
Cefuroxime Injection is used to treat infections caused by bacteria that can
be killed by cefuroxime, in the following infections:
■ Lungs and airways e.g. bronchitis, pneumonia
■ Ear, nose and throat e.g. tonsillitis, pharyingitis, sinusitis
■ Urinary tract e.g. kidney and bladder
■ Soft tissue e.g. skin, cellulitis
■ Bone and joint
■ Pelvic inflamatory disease (e.g. infection of the female reproductive
system)
■ Gonorrhoea (a sexually transmitted disease), particularly if penicillin is
unsuitable
■ Other infections including blood poisoning (septicaemia) and meningitis.

Take special care with Cefuroxime Injection if you
■ have had a severe allergic reaction to penicillin in the past
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription. This is especially important of the following, as they may
interact with your Cefuroxime Injection:
■ probenecid (a treatment for gout)
■ strong diuretics (water tablets used to treat high blood pressure or
fluid retention)
■ aminoglycosides (another type of antibiotic e.g. tobramycin,
gentamicin).
It may still be all right for you to be given Cefuroxime Injection and your
doctor will be able to decide what is suitable for you.
Interference with laboratory tests
Tell your doctor if you are having blood or urine tests. Cefuroxime Injection
may interfere with these tests.
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant or breast-feeding. Ask your
doctor or pharmacist before taking any medicine.
Driving and using machines
Cefuroxime Injection should not affect your ability to drive or use machines.

For adults:
The usual dose is 750mg three times daily by injection into a muscle
(intramuscular) or into a vein (intravenous injection). For more severe
infections this dose should be increased to 1.5g three times daily
intravenously. The dose may be increased by giving the injection four times
daily giving a total daily doses of 3g to 6g.
For infants and children:
The usual total daily dose is 30 to 100mg/kg (body weight) given in three or
four doses. A total daily dose of 60mg/kg is effective for most infections.
For newborn babies:
The usual total daily dose is 30 to 100mg/kg per day given in two or
three doses.
Gonorrhoea
1.5g as a single dose.
Meningitis

For adults:
3g intravenously every eight hours.
For infants and children:
The usual total daily dose is 200 - 240mg/kg (body weight) given in three or
four doses. This dose may be reduced after three days or when your child’s
health improves.
For newborn babies:
The usual total daily dose is 100mg/kg (body weight) given in three or four
doses. This dose may be reduced after three days or when your child’s
health improves.

To prevent infections (prophylaxis)
The usual dose is 1.5g given intravenously at the same time as you have
your anaesthetic. Your doctor may give you more Cefuroxime Injection if
they think it appropriate. The dose of drug you are given will be reduced if
you have severe kidney problems e.g. you are on dialysis.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4 Possible side effects
Like all medicines, Cefuroxime Injection can cause side effects, although
not everybody gets them.
All medicines can cause allergic reactions, although serious allergic
reactions are very rare.
Serious side effects
The following side effects are serious. You should stop taking this medicine
and contact your doctor immediately if you experience them:
■ serious peeling or blistering of the skin
■ severe diarrhoea with blood or mucus.
Tell your doctor immediately if you get any sudden wheeziness,
difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body).
The following side effects have also been reported
With prolonged use, there may be:
■ thrush (candida)
■ itchy red wheals (urticaria)
■ rash (alone)
■ fever
■ diarrhoea
■ changes in blood counts, which may show up as bruising or a very tired
feeling. You will need a blood test to confirm this.
■ damage to your liver or kidneys which can only be detected by a blood
and / or urine test
■ jaundice (yellow skin and eyes)
■ temporary pain at the injection site


■ swelling of the vein where your drip goes in
■ burning sensation in your arm where the drip goes in
■ mild to moderate hearing loss in some children treated
■ dizziness
■ headache.

Marketing Authorisation Holder and Manufacturer
for meningitis

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.
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 By reporting side effects you can help provide
more information on the safety of this medicine.
5 How to store Cefuroxime Injection
Your doctor or pharmacist will know how to store Cefuroxime Injection.
It should be kept out of the sight and reach of children.
Before it is made up, it should be stored below 25°C and protected from
light. After it is made up Cefuroxime Injection may be stored at 2°C-8°C
(in a refrigerator) for up to 24 hours.
Medicines should not be disposed of via wastewater or household waste.
Ask your doctor how to dispose of medicines no longer required. These
measures will help to protect the environment.

Marketing Authorisation Holder:
Flynn Pharma Ltd
Alton House, 4 Herbert Street
Dublin 2, Ireland.
Manufacturer:
Facta Farmaceutici,
Nucleo Industriale S. Atto,
S. Nicolò a Tordino
64020 Teramo, Italy
This leaflet was last revised in
June 2014.

6 Further information
What Cefuroxime Injection contains
The active substance is cefuroxime sodium.
There are no other ingredients.
What Cefuroxime Injection looks like and contents of the pack
Cefuroxime Injection is contained in glass vials with rubber stoppers.
Pack sizes of 1 and 10 vials.
Not all pack sizes may be marketed.
CEFPL/0606/UK

Artwork for:
Flynn Pharma Limited
Product name:
CefUROXime Sodium for Injection
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 420mm x 420mm
Profile supplied:
Dimensions supplied
Date of first artwork: Reason for request:
Revisions to Facta version
Version no: 1.3DL
Date of revision:
1 August 2014
Colours:
As swatch(es)
Font(s):
Text 8pt Helvetica
Artwork software:
InDesign CS6
BAC ref: R659

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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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