Document: leaflet MAH GENERIC_PL 25174-0008 change

• leaflet MAH GENERIC_PL 04515-0392
• leaflet MAH GENERIC_PL 25174-0008
• leaflet MAH GENERIC_PL 30306-0161
• leaflet MAH GENERIC_PL 39655-0010

---

(cefuroxime sodium)

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 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 is and what it is used for

2.    Before you use Cefuroxime

3.    How to use Cefuroxime

4.    Possible side effects

5.    How to store Cefuroxime

6.    Further informaiton

The name of your medicine is Cefuroxime 750mg Powder for Injection or Cefuroxime 1.5g Powder for Injection or Infusion but will be referred to as Cefuroxime or as Cefuroxime injection throughout this leaflet.

1.    WHAT CEFUROXIME IS AND WHAT IT IS USED FOR

Cefuroxime injection is an antibiotic which helps the body fight infections by destroying certain bacteria that causes them.

Cefuroxime injection is used to treat many different types of infections including:

•    bronchitis, pneumonia and any other chest infections;

•    cystitis and kidney infections;

•    pelvic inflammatory diseases;

•    gonorrhoea;

•    ear, nose and throat infections

•    skin, soft tissue, bone and joint infections;

•    meningitis.

Your doctor may also give it to you before an operation to protect you from infection.

2.    BEFORE YOU USE CEFUROXIME

Your doctor or nurse will make sure it is safe for you to have Cefuroxime injection.

Do not take Cefuroxime if you:

•    are allergic (hypersensitive) to Cefuroxime or any of the other ingredients of Cefuroxime listed in section 6.

•    have ever had an allergic reaction to antibiotics such as penicillin or cephalosporins. An allergic reaction may include a rash, itching, swelling or breathing difficulties.

Take special care with Cefuroxime and tell your doctor if:

•    you have kidney problems or are on dialysis

•    you have jaundice (yellowing of the skin and eyes), low blood protein

•    this injection is for a premature baby

•    you are on a low sodium diet because Cefuroxime injection contains significant quantities of sodium

This medicine can alter the results of some blood tests e.g. blood cross-matching and blood sugar tests for diabetes. It is important to tell the doctor that you are taking this medicine if you have to have any of these tests.

Unlike certain cephalosporin antibiotics, Cefuroxime does not usually cause a false positive result when the urine is tested for sugar.

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.

Cefuroxime may interfere with

•    diuretics (water tablets) e.g. furosemide

•    aminoglycoside antibiotics e.g. gentamicin and neomycin

•    other antibiotics e.g. probenacid.

In some cases your doctor will arrange further monitoring, but this is routine and nothing to worry about. Using Cefuroxime with food and drink

Cefuroxime injection can be used at any time of the day without regard to food intake.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Cefuroxime is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really needed. Your doctor will decide this.

Breast-feeding is not recommended whilst taking Cefuroxime as small amounts of Cefuroxime may enter the milk. .

Driving and using machines

Cefuroxime is not known to affect the ability to drive or operate machinery.

Important Information about some of the ingredients of Cefuroxime injection

Each 750mg vial contains 36.75mg sodium; each 1.5g vial contains 73.5mg sodium. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE CEFUROXIME

Your doctor will decide which dose you need. Your doctor or nurse will inject the Cefuroxime injection into a muscle or into a vein. In some cases, it may be added to a ‘drip' intravenous infusion.

Cefuroxime Injection is made up by adding the following amount of sterile water or other recommended diluting solution:

On reconstitution, product must be mixed vigorously for at least 90 seconds prior to withdrawing into the syringe; and if not given immediately, again just prior to administration.

Usual doses

Adults: Most adults need 750mg three or four times a day but for more severe infections this may be increased to 1.5g three or four times a day. If you have kidney trouble, you may be given the lower dose just once or twice a day.

•    Your doctor may give you 1.5g of Cefuroxime injection before surgery to protect you from infection. You may get further doses of 750mg of Cefuroxime injection after the operation.

•    If you have a joint replacement operation, Cefuroxime may be mixed in the cement which is used.

Infants and children: Most need 60mg for each kilogram of their body weight each day. This will be divided into three or four doses.

Newborn babies: Most need 30 to 100mg for each kilogram of their body weight each day. This will be divided into three or four doses.

•    If you or a child is being treated for meningitis, larger doses of Cefuroxime injection may be needed.

For the treatment of gonorrhoea:

•    1.5g should be given as a single dose. This may be given as 2 x 750mg injections into different sites e.g. each buttock.

For the treatment of pneumonia:

•    A twice daily dose of 1.5g injection should be given for 48-72 hours, followed by a twice daily dose of 500mg cefuroxime axetil oral therapy for 7 days.

For the treatment of acute exacerbations of chronic bronchitis:

•    A twice daily dose of 750mg injection should be given for 48-72 hours, followed by a twice daily dose of 500mg cefuroxime axetil oral therapy for 5-7 days.

If you take more Cefuroxime than you should:

It is most unlikely that you will be given too much medicine by the nurse or doctor. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

If you forget to take Cefuroxime:

Your doctor or nurse have instructions when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor. It is important that the course of treatment your doctor has prescribed is taken. You may start to feel better but it is important not to stop taking this medicine, until the doctor advises, otherwise your condition may get worse again.

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 can cause side effects, although not everybody gets them.

Some people may be allergic to antibiotics; if any of the following rare side effects occur soon after having your injection, tell your doctor immediately:

•    Loss of consciousness

•    Sudden wheeziness and chest tightness or breathing difficulties

•    Swelling of the eyelids, face or lips

•    Severe skin rashes that can peel or blister

•    Fever

Other side effects are classified according to the following frequencies:

-    Very common (in more than 1 in 10 patients)

-    Common (in more than 1 in 100 but less than 1 in 10 patients)

-    Uncommon (in more than 1 in 1000 but in less than 1 in 100 patients)

-    Rare (in more than 1 in 10,000 but less than 1 in 1000 patients)

-    Very rare (in less than 1 in 10,000 patients including reports of isolated cases)

Common:

•    Changes in liver enzymes

•    Inflammation or pain at the site of injection

Uncommon:

•    Diarrhoea which contains blood or mucous

Laboratory tests have shown that Cefuroxime can also cause changes in the blood, such as a decrease in blood haemoglobin concentrations (may result in anaemia), decreases in white blood cell counts (with an increased risk of infection), decreases in the very tiny blood cells called platelets (resulting in bruising and prolonged bleeding) and increases in the numbers of a type of white blood cells (eosinophils).

Like other medicines used to treat meningitis, Cefuroxime may take some time in clearing up the infection. As a result of this, hearing loss caused by meningitis has occurred in a few patients after using cefuroxime.

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

Keep out of the reach and sight of children.

The un-opened dry powder should be stored below 30°C. Store in the original package.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, the reconstituted solution should be stored at 2-8°C for no longer than 24 hours.

Do not use Cefuroxime after the expiry date which is stated on the label and carton after EXP.

The expiry refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMAITON What Cefuroxime injection contains

Cefuroxime injection contains the active ingredient Cefuroxime Sodium. There are no other ingredients.

What Cefuroxime looks like and contents of the pack

Cefuroxime 750 mg powder for injection is a white or off-white powder which forms:

•    an off-white, opaque suspension for intramuscular use when reconstituted with 3ml of Water for Injections.

•    a yellowish, clear solution for intravenous use when reconstituted with 6ml of Water for Injections.

Cefuroxime 1.5 g powder for injection or infusion is a white or off-white powder which forms:

•    a yellowish, clear solution for intravenous injection when reconstituted with 15 ml of Water for Injections.

•    a yellowish, clear solution for intravenous infusion when reconstituted with 50 ml of Water for Injections.

Cefuroxime 750 mg powder for injection is available in 10 ml vials in packs of 1,5, 10 or 100 vials.

Cefuroxime 1.5 g powder for injection or infusion is available in 20 and 100 ml vials in packs of 1, 10 or 20 vials.

Not all pack sizes may be marketed.

Rare:

•    Thrush infections

•    Easy bruising (thrombocytopenia)

•    Changes in how the liver and kidneys function

Very rare:

•    Headache, joint pain, generally feeling unwell (Pseudomembranous colitis)

•    Inflammation of the kidneys

Marketing Authorisation Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitan, 10 08970 Sant Joan Despi,

Barcelona, Spain

This leaflet was last revised in October 2015.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Vials contain 750mg cefuroxime (as sodium salt).

For full list of excipients, ‘List of excipients'.

PHARMACEUTICAL FORM

Powder for solution for injection

White or off-white powder.

CLINICAL PARTICULARS

Therapeutic indications

Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most beta-lactamases and is active against a wide range of Gram-positive and Gramnegative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. In addition, it is an effective prophylactic against post-operative infection in a variety of operations. Usually Cefuroxime will be effective alone, but when appropriate it may be used in combination with an aminoglycoside antibiotic, or in conjunction with metronidazole, orally or by suppository or injection, (see Pharmaceutical precautions).

In situations where mixed aerobic and anaerobic infections are encountered or suspected (e.g. peritonitis, aspiration pneumonia, abscesses in the lung, pelvis and brain), or are likely to occur (e.g. in association with colorectal or gynaecological surgery) it is appropriate to administer Cefuroxime in combination with metronidazole.

Most of these infections will respond to an i.v. regimen of Cefuroxime (750mg) plus metronidazole injection (500mg/100ml) administered eight-hourly. In more severe or well established mixed infections, an i.v. regimen of Cefuroxime (1.5g) plus metronidazole injection (500mg/100ml) eight-hourly may be indicated. For the prophylaxis of infection in surgery (e.g. colorectal and gynaecological) a single dose of 1.5g Cefuroxime plus metronidazole injection (500mg/100ml) is appropriate.

Alternatively this may be followed by two 750mg doses of Cefuroxime plus metronidazole.

Indications include:

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 diseases. Gonorrhoea particularly when penicillin is unsuitable.

Other infections such as meningitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.

This permits the use of sequential therapy with the same antibiotic, when a change from parenteral to oral therapy is clinically indicated.

Where appropriate Cefuroxime is effective when used prior to oral therapy with cefuroxime axetil in the treatment of pneumonia and acute exacerbations of chronic bronchitis.

Posology and method of administration Route and method of administration

Cefuroxime 750mg may be administered by intravenous or intramuscular injection. For instructions on dilution of the product before administration, see ‘Special precautions for disposal and other handling'.

Normal dosage

Adults:

Many infections will respond to 750mg t.i.d. by i.m. or i.v. injection. For more severe infections, this dose should be increased to 1.5g t.i.d. i.v. The frequency of i.m. or i.v. injection can be increased to six-hourly if necessary, giving total doses of 3g to 6g daily.

Where clinically indicated, adults with pneumonia and acute exacerbations of chronic bronchitis have been shown to respond to 750mg or 1.5g b.d., followed by oral therapy with cefuroxime axetil (see Sequential therapy).

Infants and Children:

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

Neonates:

Doses of 30 to 100mg/kg/day given as 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.

Elderly:

See dosage in adults.

Other Recommendations

Gonorrhoea:

1.5g should be given as a single dose. This may be given as 2 x 750mg injections into different sites (e.g. each buttock).

Meningitis:

Cefuroxime is suitable for sole therapy of bacterial meningitis due to sensitive strains. The following dosages are recommended.

Prophylaxis:

The usual dose is 1.5g i.v. with induction of anaethesia for abdominal, pelvic and orthopaedic operations, but may be supplemented with two 750mg i.m. doses eight and sixteen hours later. In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1.5g i.v. with induction of anaesthesia continuing with 750mg i.m. t.d.s. for a further 24 to 48 hours.

In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.

Sequential therapy:

Pneumonia:

1.5g b.d. (i.v. or i.m.) for 48-72 hours, followed by 500mg b.d. cefuroxime axetil oral therapy for 7 days.

Acute exacerbations of chronic bronchitis:

750mg b.d. (i.v. or i.m.) for 48-72 hours, followed by 500mg b.d. cefuroxime axetil oral therapy for 5-7 days.

Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.

Dosage in impaired renal function

Cefuroxime is 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. However, it is not necessary to reduce the dose until the creatinine clearance falls below 20ml/min. In adults with marked impairment (creatinine clearance 10-20ml/min) 750mg b.d. is recommended and with severe impairment (creatinine clearance <10ml/min) 750mg once daily is adequate.

For patients on haemodialysis a further 750mg dose should be given at the end of each dialysis. When continuous peritoneal dialysis is being used, a suitable dosage is usually 750mg twice daily.

For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units a suitable dosage is 750mg twice daily. For low-flux haemofiltration follow the dosage recommended under impaired renal function.

Cefuroxime is also available as the axetil ester for oral administration. This permits parenteral therapy with cefuroxime to be followed by oral therapy in situations where a change from parenteral to oral is clinically indicated.

Contraindications

Hypersensitivity to cefuroxime or to any of the cephalosporins. Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam drug.

Special warnings and precautions for use

Special care is indicated in patients who have experienced an allergic reaction to penicillins or beta-lactams.

There may be some variation on the results of biochemical tests of renal function, but these do not appear to be of clinical importance. As a precaution, renal function should be monitored if this is already impaired.

Delayed sterilisation of the CSF in patients with Haemophilus influenzae meningitis may result in an adverse outcome such as deafness and /or neurological sequelae. Persistence of positive CSF cultures of H. influenzae at 18-36 hours has been noted in some patients treated with cefuroxime sodium injection and, as with other therapeutic regimens used in the treatment of meningitis, hearing loss has been reported in some children.

With a sequential therapy regime the timing of change to oral therapy is determined by severity of the infection, clinical status of the patient and susceptibility of the pathogens involved. The change to oral therapy should only be made once there is a clear clinical improvement. If there has been no clinical improvement after 72 hours of parenteral treatment, then the patient's treatment should be reviewed. Please refer to the relevant prescribing information for cefuroxime axetil before initiating sequential therapy.

This medicinal product contains 36.75 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Interaction with other medicinal products and other forms of interaction

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide and aminoglycosides, as these combinations are suspected of adversely affecting renal function. Clinical experience with Cefuroxime has shown that this is not likely to be a problem at the recommended dose levels.

Cefuroxime does not interfere in enzyme-based tests for glycosuria. 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.

It is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

Pregnancy and lactation

There is no experimental evidence of embryopathic or teratogenic effects attributable to Cefuroxime but, as with all drugs, it should be administered with caution during the early months of pregnancy.

Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime is administered to a nursing mother.

Effects on ability to drive and use machines

None reported.

has been used for the classification of frequency: >1/10

>1/100 and <1/10 >1/1000 and <1/100 >1/10,000 and <1/1000 <1/10,000.

Infections and infestations

Rare: Candida overgrowth from prolonged use.

Blood and lymphatic system disorders Common: Neutropenia, eosinophilia.

Uncommon: Leukopenia, decreased haemoglobin concentration, positive Coomb's test.

Rare: Thrombocytopenia.

Very rare: Haemolytic anaemia.

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.

Immune system disorders Hypersensitivity reactions including Uncommon: Skin rash, urticaria and pruritus.

Rare: Drug fever.

Very rare: Interstitial nephritis, anaphylaxis.

See also Skin and subcutaneous tissue disorders and Renal and urinary disorders.

Gastrointestinal disorders Uncommon: Gastrointestinal disturbance.

Very rare: Pseudomembranous colitis.

Hepatobiliary disorders

Common: Transient rise in liver enzymes.

Uncommon: Transient rise in bilirubin.

Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver.

Skin and subcutaneous tissue disorders

Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome.

See also Immune system disorders.

Renal and urinary disorders

Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (See Special Warnings and Precautions for use).

See also Immune system disorders.

General disorders and administration site conditions

Common: Injection site reactions which may include pain and thrombophlebitis.

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

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: http://www.mhra.gov.uk/yellowcard.

Overdose

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: cephalosporins and related substances, ATC-Code:

Mode of action

Cefuroxime axetil owes its in vivo bactericidal activity to the parent compound cefuroxime. All cephalosporins (B-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 B-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.

Mechanism of resistance

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

•    hydrolysis by beta-lactamases. Cefuroxime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) and by the chromosomally-encoded (AmpC) enzyme that may be induced or stably derepressed 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 organisms

•    drug efflux pumps

Methicillin-resistant staphylococci (MRS) are resistant to all currently available B-lactam antibiotics including cefuroxime.

Penicillin-resistant Streptococcus pneumoniae are cross-resistant to cephalosporins such as cefuroxime through alteration of penicillin binding proteins.

Beta-lactamase negative, ampicillin resistant (BLNAR) strains of H. influenzae should be considered resistant to cefuroxime despite apparent in vitro susceptibility.

Strains of Enterobacteriaceae, in particular Klebsiella spp. and Escherichia coli that produce ESBLs (extended spectrum B-lactamase) may be clinically resistant to therapy with cephalosporins despite apparent in vitro susceptibility and should be considered as resistant.

Breakpoints:

According to the NCCLS (National Committee on Clinical Laboratory Standards) in 2001 the following breakpoints have been defined for cefuroxime: Enterobacteriaceae: < 4 pg/ml susceptible, > 32 pg/ml resistant Staphylococcus spp.: < 4 pg/ml susceptible, > 32 pg/ml resistant Haemophilus spp.: < 4 pg/ml susceptible; > 16 pg/ml resistant Streptococcus pneumoniae: < 1 pg/ml susceptible, > 4 pg/ml resistant Streptococcus spp. other than S.pneumoniae: Streptococcal isolates susceptible to penicillin (MIC90 < 0.12 pg/ml) may be considered susceptible to cefuroxime.

Susceptibility:

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Aerobes, Gram positive:

Staphylococcus aureus (methicillin-susceptible)

Coagulase-negative staphylococci (methicillin-susceptible)

Streptococcus agalactiae Streptococcus pneumoniae

Streptococcus pyogenes_

Aerobes, Gram negative:

Escherichia coli Haemophilus influenzae Klebsiella species Moraxella catarrhalis Proteus mirabilis

Proteus rettgeri_

Anaerobes,

Peptococcus species

Peptostreptococcus species_

Other organisms:

Borrelia burgdorferi._

Species for which resistance may be a problem_

Acinetobacter species Citrobacter species Enterobacter species

Morganella morganii_

Resistant

Bacteroides fragilis Clostridium difficile Enterococci

Listeria monocytogenes Proteus vulgaris Pseudomonas species Serratia species

Pharmacokinetic properties

Peak levels of cefuroxime are achieved within 30 to 45 minutes after intramuscular administration. The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes. Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level. There is almost complete recovery of unchanged cefuroxime in the urine within 24 hours of administration, the major part being eliminated in the first six hours. Approximately 50% is excreted through the renal tubules and approximately 50% by glomerular filtration. Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in bone, synovial fluid and aqueous humor. Cefuroxime passes the blood-brain barrier when the meninges are inflamed.

Preclinical safety data

No additional data of relevance.

PHARMACEUTICAL PARTICULARS List of excipients: None.

Incompatibilities

Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions.

The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Cefuroxime. However, if required, for patients receiving sodium bicarbonate injection by infusion the Cefuroxime may be introduced into the tube of the giving set.

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

Shelf life

Un-opened dry powder: 3 years

Reconstituted solution: 24 hours stored in the conditions recommended in ‘Special precautions for storage'.

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

Special precautions for use

Up-opened dry powder: Store below 30°C. Store in the original package.

Reconstituted solution:The reconstituted solution should be stored at 2-8°C for no longer than 24 hours.

Refer to ‘Shelf life' for the storage of sterile products that have been opened, diluted or reconstituted.

Nature and contents of container

A type II transparent, colourless glass vial, with a bromobutyl stopper and a blue aluminum and polypropylene flip off cap with adhesive labels.

Cefuroxime 750mg Powder for Injection is available in 10ml vials in packs of 1, 5, 10 or 100 vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Cefuroxime 750mg when dissolved in Water for Injections forms an off-white, opaque suspension for intramuscular use or a yellowish, clear solution for intravenous administration.

Intramuscular injection

750mg of Cefuroxime should be dissolved in 3ml of Water for Injections.

Shake gently to produce an opaque suspension.

Intravenous injection

750mg of Cefuroxime should be dissolved in 6ml of Water for Injections.

Shake gently to produce a clear solution. This solution may be given directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.

On reconstitution, product must be mixed vigorously for at least 90 seconds prior to withdrawing into the syringe; and if not given immediately, again just prior to administration.

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

MARKETING AUTHORISATION HOLDER

Laboratorios Reig Jofre, S.A.

Gran Capitan, 10

08970 Sant Joan Despt, Barcelona (Spain)

MARKETING AUTHORISATION NUMBER

PL 25174/0008