Cefuroxime 750 mg Powder for Injection/Infusion

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Cefuroxime sodium
Available from:
Flynn Pharma Ltd
ATC code:
J01DC; J01DC02
INN (International Name):
Cefuroxime sodium
Dosage:
750 milligram(s)
Pharmaceutical form:
Powder for suspension for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Second-generation cephalosporins; cefuroxime
Authorization status:
Marketed
Authorization number:
PA1226/009/001
Authorization date:
2000-06-23

Package leaflet: Information for the user

Cefuroxime 750 mg & 1.5 g Powder for

Injection/Infusion

Cefuroxime

The name of your medicine is Cefuroxime 750 mg & 1.5 g Powder for

Injection/Infusion, which will be referred to as Cefuroxime Injection

throughout this document.

Read all of this leaflet carefully before you start taking this medicine

because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Cefuroxime Injection is and what it is used for

2. What you need to know before you are given Cefuroxime Injection

3. How Cefuroxime Injection is given

4. Possible side effects

5. How to store Cefuroxime Injection

6. Contents of the pack and other information

1 What Cefuroxime Injection is and what it is used for

Cefuroxime injection is an antibiotic used in adults and children. It works by

killing bacteria that cause infections. It belongs to a group of medicines

called cephalosporins.

Cefuroxime Injection is used to treat infections of:

the lungs or chest

the urinary tract

the skin and soft tissue

the abdomen

Cefuroxime Injection is also used:

to prevent infections during surgery.

2 What you need to know before you are given

Cefuroxime Injection

You must not be given Cefuroxime Injection:

if you are allergic (hypersensitive) to any cephalosporin antibiotics or

any other ingredients of Cefuroxime Injection (listed in section 6).

if you have ever had a severe allergic (hypersensitive) reaction to any

other type of betalactam antibiotic (penicillins, monobactams and

carbapenems).

Tell your doctor before you start on Cefuroxime Injection if you think

that this applies to you. You must not be given Cefuroxime Injection.

Take special care with Cefuroxime Injection

You must look out for certain symptoms such as allergic reactions, skin

rashes and gastrointestinal disorders such as diarrhoea while you are being

given Cefuroxime Injection. This will reduce the risk of possible problems.

See ‘Conditions you need to look out for’ in section 4. If you have had any

allergic reaction to other antibiotics such as penicillin, you may also be

allergic to Cefuroxime Injection.

If you need a blood or urine test

Cefuroxime Injection can affect the results of urine or blood 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

Cefuroxime Injection.

Other medicines and Cefuroxime Injection

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.

Some medicines may affect how Cefuroxime Injection works, or make it

more likely that you’ll have side effects. These include:

aminoglycoside-type antibiotics

water tablets (diuretics), such as furosemide

probenecid

oral anticoagulants

Tell your doctor if this applies to you. You may need extra check-ups to

monitor your renal function while you are taking Cefuroxime Injection.

Contraceptive pills

Cefuroxime injection may reduce the effectiveness of the contraceptive pill.

If you are taking the contraceptive pill while you are being treated with

Cefuroxime Injection you also need to use a barrier method of

contraception (such as condoms). Ask your doctor for advice.

Pregnancy and breast-feeding and fertility

Tell your doctor before you are given Cefuroxime Injection:

if you are pregnant, think you might be pregnant or are planning to

become pregnant

if you are breastfeeding

Your doctor will consider the benefit of treating you with Cefuroxime

Injection against the risk to your baby.

Driving and using machines

Don’t drive or use machines if you do not feel well.

Important information about some of the ingredients of Cefuroxime Injection

Cefuroxime Injection 750 mg contains 40.6 mg sodium (main component of

cooking/table salt) in each vial. This is equivalent to 2% of the

recommended maximum daily dietary intake of sodium for an adult.

Cefuroxime Injection 1.5 g contains 81.3 mg sodium (main component of

cooking/table salt) in each vial. This is equivalent to 4% of the

recommended maximum daily dietary intake of sodium for an adult.

3 How Cefuroxime Injection is given

Cefuroxime 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.

The usual dose

The correct dose of Cefuroxime 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 - 3 weeks)

For every 1 kg the baby weighs, they’ll be given 30 to 100 mg Cefuroxime

Injection per day divided in two or three doses.

Babies (over 3 weeks) and children

For every 1kg the baby or child weighs, they’ll be given 30 to 100 mg of

Cefuroxime Injection per day divided in three or four doses.

Adults and adolescents

750 mg to 1.5 g of Cefuroxime Injection per day divided into two, three or

four doses. Maximum dose: 6 g per day.

The following information is intended for medical or healthcare

professionals only:

Instructions for reconstitution

Additional volumes and solution/suspension concentrations, which may be

useful when fractional doses are required.

Addition volumes and solution/suspension concentrations, which may be

useful when fractional doses are required

Vial

Route of

Amount of water

Approximate

Resulting product

size

administration

to be added

cefuroxime

(mL)

concentration

(mg/mL)**

750 mg intramuscular

3 mL

Suspension

intravenous

bolus

at least 6 mL

Solution

intravenous

infusion

at least 6 mL

Solution

1.5 g

intramuscular

6 mL

Suspension

intravenous

bolus

At least 15 mL

Solution

intravenous

infusion

15 mL*

Solution

Reconstituted solution to be added to 50 or 100 ml of compatible infusion

fluid (see information on compatibility, below)

** The resulting volume of the solution/suspension of cefuroxime in

reconstitution medium is increased due the displacement factor of the

drug substance resulting in the listed concentrations in mg/ml.

As for all parenteral medicinal products, inspect the reconstituted solution or

suspension visually for particulate matter and discoloration prior to

administration.

Intramuscular injection: After addition of the specified amount of diluent for

intramuscular injection, a suspension is formed.

Intravenous bolus injection or intravenous infusion: The solution should only

be used if the solution is clear and practically free from particles.

Solutions and suspensions range in colour from clear to yellow coloured

depending on concentration, diluent and storage conditions used.

Following reconstitution with Water for Injections, chemical and physical

in-use stability has been demonstrated for 48 hours at 2-8°C.

From a microbiological point of view, the product 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 2-8°C, unless reconstitution/dilution has taken place

in controlled and validated aseptic conditions.

Compatibility

1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be

added to metronidazole injection (500 mg/100 ml) and both retain their

activity for up to 24 hours below 25°C.

1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 ml) or 5 g

(in 50 ml) for up to 24 hours at 4°C or 6 hours below 25°C.

Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol injection may be

stored for up to 24 h at 25°C.

Cefuroxime sodium is compatible with aqueous solutions containing up to

1% lidocaine hydrochloride.

Cefuroxime sodium is compatible with the following infusion fluids. It will

retain potency for up to 24 hours at room temperature in:

0.9% w/v Sodium Chloride Injection BP

5% Dextrose Injection BP

0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Injection

5% Dextrose and 0.225% Sodium Chloride Injection

10% Dextrose Injection

Please tear here

Please tear here

continued overleaf

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

Talk to your doctor if this applies to you.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

Conditions you need to look out for

A small number of people taking Cefuroxime Injection get an allergic

reaction or potentially serious skin reaction.

Symptoms of these reactions include:

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).

Other symptoms you need to be aware of while taking Cefuroxime Injection

fungal infections on rare occasions, medicines like Cefuroxime Injection

can cause an overgrowth of yeast (Candida) in the body which can lead

to fungal infections (such as thrush). This side effect is more likely if you

take Cefuroxime Injection for a long time.

severe diarrhoea (pseudomembranous colitis). Medicines like

Cefuroxime Injection can cause inflamation of the colon (large intestine),

causing severe diarrhoea, usually with blood and mucus, stomach pain

and fever.

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:

injection site pain, swelling and redness along the vein.

Tell your doctor if any of these are troubling you.

Common side effects that may show up in blood tests:

increases in substances (enzymes) produced by the liver

changes in your white blood cell count (neutropenia or eosinophilia)

low levels of red blood cells (anaemia)

Uncommon side effects

These may affect up to 1 in 100 people:

skin rash, itchy, bumpy rash (hives)

diarrhoea, nausea, stomach pain

Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:

low levels of white blood cells (leucopenia)

increase in bilirubin (a substance produced by the liver)

positive Coomb’s test

Other side effects

Other side effects have occurred in a very small number of people but their

exact frequency is unknown:

fungal infections

high temperature (fever)

allergic reactions

inflammation of the colon (large intestine), causing diarrhoea, usually with

blood and mucus, stomach pain

inflammation in the kidney and blood vessels

red blood cells destroyed too quickly (haemolytic anaemia).

skin rash, which may blister, and looks like small targets (central dark

spot surrounded by a paler area, with a dark ring aroung the edge)

erythema multiforme.

Tell your doctor if you get any of these.

Side effects that may show up in blood tests:

decrease in number of blood platelets (cells that help blood to clot

thrombocytopenia)

increase in levels of urea nitrogen and serum creatine in the blood.

If you get side effects

Tell your doctor or nurse. This includes any possible side effects not

listed in this leaflet.

If you get any side effects, talk to your doctor or nurse. This includes any

possible side effects not listed in this leaflet. You can also report side effects

directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; fax: +353 1 6762517. Website: www.hpra.ie; E-mail:

medsafety@hpra.ie. 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.

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 label

after ‘EXP’. The expiry date refers to the last day of that month. Before it is

made up it should be stored below 25°C. Keep the vial in the outer carton in

order to protect from light.

After it is made up Cefuroxime Injection should be used immediately but can

be stored at 2-8°C (in a refrigerator) for up to 24 hours.

Don’t throw away any medicines via wastewater or household waste. Your

doctor or nurse will dispose of any medicine that is no longer required.

These measures will help to protect the environment.

6 Contents of the pack and other information

What Cefuroxime Injection contains

The active substance is cefuroxime (as sodium salt).

Each 750 mg vial contains 750 mg cefuroxime (as sodium salt).

Each 1.5 g vial contains 1.5 g cefuroxime (as sodium salt).

There are no other ingredients.

However, see section 2 for further important information about sodium

(present as cefuroxime sodium).

What Cefuroxime Injection looks like and contents of the pack

Cefuroxime Injection is contained in glass vials with rubber stoppers.

Pack sizes of 5, 10, 50 or 100 vials for Cefuroxime 750 mg Powder for

Injection/Infusion and 1, 10 or 50 vials for Cefuroxime 1.5 g Powder for

Injection/Infusion.

Vials contain a white or almost white powder. When made up for injection

into a muscle, it becomes off-white and opaque. When made up for injection

into a vein, it may be yellowish.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Flynn Pharma Ltd

Marine House, Clanwilliam Place, Dublin 2, Ireland

Manufacturer

FACTA Farmaceutici S.P.A

Nucleo Industrial S.Atto

Frazione S.Nicolò a Tordino

64100 Teramo, Italy

This leaflet was last revised in

June 2018.

10% Invert Sugar in Water for Injection

Ringer’s Injection USP

Lactated Ringer’s Injection USP

M/6 Sodium Lactate Injection

Compound Sodium Lactate Injection BP (Hartmann’s Solution).

The stability of cefuroxime sodium in Sodium Chloride Injection BP 0.9%

w/v and in 5% Dextrose Injection is not affected by the presence of

hydrocortisone sodium phosphate.

Cefuroxime sodium has also been found compatible for 24 h at room

temperature when admixed in i.v. infusion with:

Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection;

Potassium Chloride (10 and 40 mEqL) in 0.9% Sodium Chloride Injection.

In the absence of other compatibility studies, this medicinal product must

not be mixed with other medicinal products apart from those listed as

compatible above.

Cefuroxime should not be mixed in the syringe with aminoglycoside

antibiotics.

The pH of 2.74% w/v Sodium Bicarbonate Injection BP considerably

affects the colour of the solution and therefore this solution is not

recommended for the dilution of Cefuroxime. However, if required, for

patients receiving Sodium Bicarbonate Injection by infusion Cefuroxime

1.5 g may be introduced into the tube of the giving set.

Please tear here

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cefuroxime 750 mg Powder for Injection/Infusion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains 750mg cefuroxime (as sodium salt).

Excipients with known effects:

Each vial contains 40.6 mg sodium.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for suspension for injection/Powder for solution for injection or infusion

Vials containing a white or almost white powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Cefuroxime is indicated for the treatment of the infections listed below in adults and children, including neonates (from

birth) (see sections 4.4 and 5.1).

Community acquired pneumonia.

Acute exacerbations of chronic bronchitis.

Complicated urinary tract infections, including pyelonephritis.

Soft-tissue infections: cellulitis, erysipelas and wound infections.

Intra-abdominal infections (see section 4.4).

Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and

gynaecological surgery (including caesarean section).

In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered,

cefuroxime should be administered with additional appropriate antibacterial agents.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Table 1. Adults and children

40 kg

Indication

Dosage

Community acquired pneumonia and acute exacerbations

of chronic bronchitis

750 mg every 8 hours (intravenously or

intramuscularly)

Soft-tissue infections: cellulitis, erysipelas and wound

infections.

Intra-abdominal infections

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Paediatric population

Table 2. Children < 40 kg

Renal impairment

Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly

impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its

slower excretion.

Table 3. Recommended doses for cefuroxime in renal impairment

Hepatic impairment

Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the

pharmacokinetics of cefuroxime.

Complicated urinary tract infections, including

pyelonephritis

1.5 g every 8 hours

(intravenously or intramuscularly)

Severe infections

750 mg every 6 hours (intravenously)

1.5 g every 8 hours (intravenously)

Surgical prophylaxis for gastrointestinal, gynaecological

surgery (including caesarean section) and orthopaedic

operations

1.5 g with the induction of anaesthesia. This may be

supplemented with two 750 mg doses (intramuscularly)

after 8 hours and 16 hours.

Surgical prophylaxis for cardiovascular and oesophageal

operations

1.5 g with induction of anaesthesia followed by 750 mg

(intramuscularly) every 8 hours for a further 24 hours.

Infants and toddlers > 3 weeks and

children < 40 kg

Infants (birth to 3 weeks)

Community acquired pneumonia

30 to 100 mg/kg/day (intravenously)

given as 3 or 4 divided doses; a dose

of 60 mg/kg/day is appropriate for

most infections

30 to 100 mg/kg/day (intravenously)

given as 2 or 3 divided doses (see

section 5.2)

Complicated urinary tract infections,

including pyelonephritis

Soft-tissue infections: cellulitis,

erysipelas and wound infections.

Intra-abdominal infections

Creatinine clearance

T

1/2

(hrs)

Dose mg

> 20 mL/min/1.73 m

1.7-2.6

It is not necessary to reduce the standard dose (750

mg to 1.5 g three times daily).

10-20 mL/min/1.73 m

4.3-6.5

750 mg twice daily

< 10 mL/min/1.73 m

14.8-22.3

750 mg once daily

Patients on haemodialysis

3.75

A further 750 mg dose should be given

intravenously or intramuscularly at the end of each

dialysis; in addition to parenteral use, cefuroxime

sodium can be incorporated into the peritoneal

dialysis fluid (usually 250 mg for every 2 litres of

dialysis fluid).

Patients in renal failure on continuous

arteriovenous haemodialysis (CAVH)

or high-flux haemofiltration (HF) in

intensive therapy units

7.9-12.6 (CAVH) 1.6

(HF)

750 mg twice daily; for low flux haemofiltration

follow the dosage recommended under impaired

renal function.

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Method of administration

Cefuroxime should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a

drip tube over 30 to 60 minutes, or by deep intramuscular injection. Intramuscular injections should be injected well

within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater

than 1.5 g intravenous administration should be used. For instructions on reconstitution of the medicinal product before

administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Patients with known hypersensitivity to cephalosporin antibiotics.

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 reactions

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been

reported. In case of severe hypersensitivity reactions, treatment with cefuroxime 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 cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if

cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

Concurrent treatment with potent diuretics or aminoglycosides

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with

potent diuretics such as furosemide or aminoglycosides. Renal impairment has been reported during use of these

combinations. Renal function should be monitored in the elderly and those with known pre-existing renal impairment

(see section 4.2).

Overgrowth of non-susceptible microorganisms

Use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other

non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of

treatment (see section 4.8).

Antibacterial agent-associated pseudomembranous colitis has been reported with use of cefuroxime and may range in

severity from mild to life threatening. This diagnosis should be considered in patients with diarrhoea during or

subsequent to the administration of cefuroxime (see section 4.8). Discontinuation of therapy with cefuroxime and the

administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit

peristalsis should not be given.

Intra-abdominal infections

Due to its spectrum of activity, cefuroxime is not suitable for the treatment of infections caused by Gram-negative non-

fermenting bacteria (see section 5.1).

Interference with diagnostic tests

The development of a positive Coomb’s Test associated with the use of cefuroxime may interfere with cross matching

of blood (see section 4.8).

Slight interference with copper reduction methods (Benedict’s, Fehling’s, Clinitest) may be observed. However, this

should not lead to false-positive results, as may be experienced with some other cephalosporins.

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As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or

hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime sodium.

Intracameral use and eye disorders

Cefuroxime is not formulated for intracameral use. Individual cases and clusters of serious ocular adverse reactions

have been reported following unapproved intracameral use of cefuroxime sodium compounded from vials approved for

intravenous/intramuscular administration. These reactions included macular oedema, retinal oedema, retinal

detachment, retinal toxicity, visual impairment, visual acuity reduced, vision blurred, corneal opacity and corneal

oedema.

Important information about excipients

This medicinal product contains 40.6 mg sodium per vial, equivalent to 2% of the WHO recommended maximum daily

intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral

contraceptives.

Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not

recommended. Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an

elevated peak serum level.

Potential nephrotoxic drugs and loop diuretics

High-dosage treatments with cephalosporins should be carried out with caution on patients who are taking strong-

acting diuretics (such as furosemide) or potential nephrotoxic preparations (such as aminoglycoside antibiotics), since

impairment of renal function through such combinations cannot be ruled out.

Other Interactions

Determination of blood/plasma glucose levels: Please refer to section 4.4.

Concomitant use with oral anticoagulants may give rise to increased international normalised ratio (INR).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited amounts of data from the use of cefuroxime in pregnant women. Studies in animals have shown no

reproductive toxicity (see section 5.3). Cefuroxime should be prescribed to pregnant women only if the benefit

outweighs the risk.

Cefuroxime has been shown to cross the placenta and attain therapeutic levels in amniotic fluid and cord blood after

intramuscular or intravenous dose to the mother.

Breastfeeding

Cefuroxime is excreted in human milk in small quantities. Adverse reactions at therapeutic doses are not expected,

although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. A decision must be

made whether to discontinue breast-feeding or to discontinue/abstain from cefuroxime therapy taking into account the

benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effects of cefuroxime sodium on fertility in humans. Reproductive studies in animals have

shown no effects on fertility.

4.7 Effects on ability to drive and use machines

No studies on the effects of cefuroxime on the ability to drive and use machines have been performed. However, based

on known adverse reactions, cefuroxime is unlikely to have an effect on the ability to drive and use machines.

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4.8 Undesirable effects

The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin,

particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site

reactions.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for

calculating incidence are not available. In addition the incidence of adverse reactions associated with cefuroxime

sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare adverse reactions. The

frequencies assigned to all other adverse reactions (i.e. those occurring at <1/10,000) were mainly determined using

post-marketing data, and refer to a reporting rate rather than a true frequency.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and

grade of severity. The following convention has been utilised for the classification of frequency: very common

1/10;

common

1/100 to < 1/10, uncommon

1/1,000 to < 1/100; rare

1/10,000 to < 1/1,000; very rare < 1/10,000 and not

known (cannot be estimated from the available data).

System organ class

Common

Uncommon

Not known

Infections and infestations

Candida overgrowth,

overgrowth of Clostridium

difficile

Blood and lymphatic

system disorders

neutropenia, eosinophilia,

decreased haemoglobin

concentration

leukopenia, positive

Coomb’s test

thrombocytopenia,

haemolytic anaemia

Immune system disorders

drug fever, interstitial

nephritis, anaphylaxis,

cutaneous vasculitis

Gastrointestinal disorders

gastrointestinal

disturbance

pseudomembranous colitis

(see section 4.4)

Hepatobiliary disorders

transient rise in liver

enzymes

transient rise in bilirubin

Skin and subcutaneous

tissue disorders

skin rash, urticaria and

pruritus

erythema multiforme, toxic

epidermal necrolysis and

Stevens-Johnson syndrome,

angioneurotic oedema

Renal and urinary

disorders

elevations in serum

creatinine, elevations in

blood urea nitrogen and

decreased creatinine

clearance (see section 4.4)

General disorders and

administration site

conditions

injection site reactions

which may include pain

and thrombophlebitis

Description of selected adverse reactions

Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies

directed against the drug to produce a positive Coomb’s test (which can interfere with cross matching of blood) and

very rarely haemolytic anaemia.

Transient rises in serum liver enzymes or bilirubin have been observed which are usually reversible.

Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for

discontinuation of treatment.

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Paediatric population

The safety profile for cefuroxime sodium in children is consistent with the profile in adults.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; Email: medsafety@hpra.ie.

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 cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, Second-generation cephalosporins, ATC code J01DC02

Mechanism of Action:

Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This

results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Mechanisms of resistance

Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:

Hydrolysis by beta-lactamases including (but not limited to) extended-spectrum beta- lactamases (ESBLs), and

Amp-C enzymes, that may be induced or stably de-repressed in certain aerobic Gram-negative bacterial species;

Reduced affinity of penicillin-binding proteins for cefuroxime;

Outer membrane impermeability, which restricts access of cefuroxime to penicillin binding proteins in Gram-

negative bacteria;

Bacterial efflux pumps.

Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime.

Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced

susceptibility or resistance to cefuroxime.

Cefuroxime sodium breakpoints

The Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial

Susceptibility Testing (EUCAST) are as follows:

Microorganism

Breakpoints (mg/L)

Enterobacteriaceae

>8

Staphylococcus spp.

Note

Note

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S=susceptible, R=resistant.

Microbiological susceptibility

The prevalence of acquired resistance may vary geographically and with time for selected species and local information

on resistance is therefore desirable, particularly when treating severe infections. As necessary, expert advice should be

sought when the local prevalence of resistance is known and the utility of the agent in at least some types of infections

is questionable.

Cefuroxime is usually active against the following microorganisms in vitro.

Streptococcus A, B, C and G

Note

Note

Streptococcus pneumoniae

>1

Streptococcus (other)

>0.5

Haemophilus influenzae

>2

Moraxella catarrhalis

>8

Kingella kingae

>0.5

Non-species related breakpoints

>8

The cephalosporin breakpoints for Enterobacteriaceae will detect all clinically important resistance mechanisms (including

ESBL and plasmid mediated AmpC). Some isolates that produce beta-lactamases are susceptible or intermediate to 3rd or 4th

generation cephalosporins with these breakpoints and should be reported as tested, i.e. the presence or absence of an ESBL

does not in itself influence the categorisation of susceptibility. In many areas, ESBL detection and characterisation is

recommended or mandatory for infection control purposes.

Breakpoint relates to a dosage of 1.5 g × 3 and to E. coli, P. mirabilis and Klebsiella spp. only.

Susceptibility of staphylococci to cephalosporins is inferred from the cefoxitin susceptibility except for cefixime, ceftazidime,

ceftazidime avibactam, ceftibuten and ceftolozane-tazobactam, which do not have breakpoints and should not be used for

staphylococcal infections.

The susceptibility of streptococcus groups A, B, C and G is inferred from the benzylpenicillin susceptibility.

Breakpoints apply to daily intravenous dose of 750 mg × 3 and a high dose of at least 1.5 g × 3.

Commonly susceptible species

Gram-positive aerobes:

Staphylococcus aureus (methicillin-susceptible) *

Streptococcus pyogenes

Streptococcus agalactiae

Gram-negative aerobes:

Haemophilus parainfluenzae

Moraxella catarrhalis

Microorganisms for which acquired resistance may be a problem

Gram-positive aerobes:

Streptococcus pneumoniae

Streptococcus mitis (viridans group)

Gram-negative aerobes:

Citrobacter spp. not including C.freundii

Enterobacter spp. not including E. aerogenes and E. cloacae

Escherichia coli

Haemophilus influenzae

Klebsiella pneumoniae

Proteus mirabilis

Proteus spp. (other than P. penneri and P. vulgaris)

Providencia spp.

Salmonella spp.

Gram-positive anaerobes:

Peptostreptococcus spp.

Propionibacterium spp.

Gram-negative anaerobes:

Fusobacterium spp.

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* All methicillin-resistant S. aureus are resistant to cefuroxime.

In vitro the activities of cefuroxime sodium and aminoglycoside antibiotics in combination have been shown to be at

least additive with occasional evidence of synergy.

5.2 Pharmacokinetic properties

Absorption

After intramuscular (IM) injection of cefuroxime to normal volunteers, the mean peak serum concentrations ranged

from 27 to 35 µg/mL for a 750 mg dose and from 33 to 40 µg/mL for a 1000 mg dose, and were achieved within 30 to

60 minutes after administration.

Following intravenous (IV) doses of 750 and 1500 mg, serum concentrations were

approximately 50 and 100 µg/mL, respectively, at 15 minutes.

AUC and C

appear to increase linearly with increase in dose over the single dose range of 250 to 1000 mg

following IM and IV administration. There was no evidence of accumulation of cefuroxime in the serum from normal

volunteers following repeat intravenous administration of 1500 mg doses every 8 hours.

Distribution

Protein binding has been stated as 33 to 50%, depending on the methodology used. The average volume of distribution

ranges from 9.3 to 15.8 L/1.73 m

following IM or IV administration over the dosage range of 250 to 1000 mg.

Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in the

tonsilla, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum

and aqueous humour. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.

Biotransformation

Cefuroxime is not metabolised.

Bacteroides spp.

Inherently resistant microorganisms

Gram-positive aerobes:

Enterococcus faecalis

Enterococcus faecium

Gram-negative aerobes:

Acinetobacter spp.

Burkholderia cepacia

Campylobacter spp.

Citerobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Morganella morganii

Proteus penneri

Proteus vulgaris

Pseudomonas aeruginosa

Serratia marcescens

Stenotrophomonas maltophilia

Gram-positive anaerobes:

Clostridium difficile

Gram-negative anaerobes:

Bacteroides fragilis

Others:

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

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Elimination

Cefuroxime is excreted by glomerular filtration and renal tubular secretion. The serum half-life after either

intramuscular or intravenous injection is approximately 70 minutes. There is an almost complete recovery (85 to 90%)

of unchanged cefuroxime in urine within 24 hours of administration. The majority of the cefuroxime is excreted within

the first 6 hours. The average renal clearance ranges from 114 to 170 mL/min/1.73 m

following IM or IV

administration over the dosage range of 250 to 1000 mg.

Special patient populations

Gender

No differences in the pharmacokinetics of cefuroxime were observed between males and females following a single IV

bolus injection of 1000 mg of cefuroxime as the sodium salt.

Elderly

Following IM or IV administration, the absorption, distribution and excretion of cefuroxime in elderly patients are

similar to younger patients with equivalent renal function. Because elderly patients are more likely to have decreased

renal function, care should be taken in cefuroxime dose selection, and it may be useful to monitor renal function (see

section 4.2).

Paediatrics

The serum half-life of cefuroxime has been shown to be substantially prolonged in neonates according to gestational

age. However, in older infants (aged >3 weeks) and in children, the serum half-life of 60 to 90 minutes is similar to that

observed in adults.

Renal impairment

Cefuroxime is primarily excreted by the kidneys. As with all such antibiotics, in patients with markedly impaired renal

function (i.e. C1

<20 mL/minute) it is recommended that the dosage of cefuroxime should be reduced to compensate

for its slower excretion (see section 4.2). Cefuroxime is effectively removed by haemodialysis and peritoneal dialysis.

Hepatic impairment

Since cefuroxime is primarily eliminated by the kidney, hepatic dysfunction is not expected to have an effect on the

pharmacokinetics of cefuroxime.

PK/PD relationship

For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has

been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the

minimum inhibitory concentration (MIC) of cefuroxime for individual target species (i.e. %T>MIC).

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated

dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies have been

performed; however, there is no evidence to suggest carcinogenic potential.

Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins, however the level of

inhibition is less with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

In the absence of other compatibility studies, this medicinal product must not be mixed with other medicinal products

apart from those listed as compatible in section 6.6.

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

The pH of 2.74% w/v Sodium Bicarbonate Injection BP considerably affects the colour of the solution and therefore

this solution is not recommended for the dilution of Cefuroxime.

6.3 Shelf life

As packaged for sale: 30 months

In use: Following reconstitution with Water for Injections, chemical and physical in-use stability has been

demonstrated for 48 hours at 2-8°C.

From a microbiological point of view, the product 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-

8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

As packaged for sale: Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

In use: see 6.3.

6.5 Nature and contents of container

750 mg (for intramuscular/intravenous injection) - Type III uncoloured glass vials with rubber stoppers in packs of 5,

10, 50 or 100.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Instruction for constitution

Table 4. Addition volumes and solution/suspension concentrations, which may be useful when fractional doses are

required.

Addition volumes and solution/suspension concentrations, which may be useful when fractional doses are

required

Vial

size

Routes of

Administration

Amount of water to

be added (mL)

Approximate

cefuroxime

concentration

(mg/mL)**

Resulting product

750mg

intramuscular

intravenous bolus

intravenous infusion

3 mL

at least 6 mL

at least 6 mL *

Suspension

Solution

Solution

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* Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see information on compatibility,

below)

** The resulting volume of the solution/suspension of cefuroxime in reconstitution medium is increased due the

displacement factor of the drug substance resulting in the listed concentrations in mg/ml.

As for all parenteral medicinal products, inspect the reconstituted solution or suspension visually for particulate matter

and discolouration prior to administration.

Intramuscular injection: After addition of the specified amount of diluent for intramuscular injection, a suspension is

formed.

Intravenous bolus injection or intravenous infusion: After addition of the specified amount of diluent for intravenous

bolus or infusion, a clear solution is formed. The solution should only be used if the solution is clear and practically

free from particles.

Solutions and suspensions range in colour from clear to yellow coloured depending on concentration, diluent and

storage conditions used. When made up for intramuscular use, it becomes off-white and opaque. When made up for

intravenous administration, it may be yellowish.

Compatibility

Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 h at 25 °C.

Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 24 hours at room

temperature in:

0.9% w/v Sodium Chloride Injection BP

5% Dextrose Injection BP

0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP

5% Dextrose and 0.9% Sodium Chloride Injection

5% Dextrose and 0.45% Sodium Chloride Injection

5% Dextrose and 0.225% Sodium Chloride Injection

10% Dextrose Injection

10% Invert Sugar in Water for Injection

Ringer’s Injection USP

Lactated Ringer’s Injection USP

M/6 Sodium Lactate Injection

Compound Sodium Lactate Injection BP (Hartmann’s Solution).

The stability of cefuroxime sodium in Sodium Chloride Injection BP 0.9% w/v and in 5% Dextrose Injection is not

affected by the presence of hydrocortisone sodium phosphate.

Cefuroxime sodium has also been found compatible for 24 h at room temperature when admixed in i.v. infusion with:

Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection; Potassium Chloride (10 and 40 mEqL) in 0.9%

Sodium Chloride Injection.

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

For single use. Discard any unused contents.

Contains no preservative.

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7 MARKETING AUTHORISATION HOLDER

Flynn Pharma Limited

Marine House

Clanwilliam Place

Dublin 2

Ireland

8 MARKETING AUTHORISATION NUMBER

PA1226/009/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 June 2000

Date of last renewal: 22 June 2015

10 DATE OF REVISION OF THE TEXT

July 2018

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