Package leaflet: Information for the user

Cefuroxime Injection 250 mg Cefuroxime Injection 750 mg Cefuroxime Injection 1500 mg

Cefuroxime

Read all of this leaflet carefully before you start using 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.

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 Injectionis given

4.    Possible side effects

5.    How to store Cefuroxime Injection

6.    Contents of the pack and other information

1. What Cefuroxime Injectionis and what it is used for

Cefuroxime 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 is used to treat infections of:

•    the lungs or chest

•    the urinary tract

•    the skin and soft tissue

•    the abdomen

Cefuroxime 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 of the other ingredients of Cefuroxime Injection.

•    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 if you think that this applies to you. You must not be given cefuroxime.

Take special care with cefuroxime

You must look out for certain symptoms such as allergic reactions and gastrointestinal disorders such as diarrhoea while you are being given cefuroxime. This will reduce the risk of possible problems. See ('Conditions you need to look outfof ) in section 4. If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to cefuroxime.

If you need a blood or urine test

Cefuroxime 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.

Other medicines and cefuroxime

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 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.

Contraceptive pills

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with cefuroxime 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:

•    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 against the risk to your baby.

Driving and using machines

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

Cefuroxime Injection contains sodium.

This medicine contains 13 mg, 39 mg and 78 mg of sodium respectively per 250 mg dose, 750 mg dose and 1500 mg dose. You need to take this into account if you are on a controlled sodium diet.

3. How Cefuroxime Injection is given

Cefuroxime is usually be 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 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 per day divided in two or three doses.

Babies (over 3 weeks) and children

For every 1 kg the baby or child weighs, they’ll be given 30 to 100 mg of cefuroxime per day divided in three or four doses.

Adults and adolescents

750 mg to 1.5 g of cefuroxime per day divided into two, three or four doses. Maximum dose: 6 g per day. 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, cefuroxime can cause side effects, although not everybody gets them.

Conditions you need to look out for

A small number of people taking cefuroxime 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).

•    fungal infections on rare occasions, medicines like cefuroxime 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 for a long time.

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 a 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 around the edge) erythema multiformae.

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 creatinine in the blood.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Cefuroxime Injection

Keep this medicine out of the sight and reach of children.

Do not store above 25°C

Keep the container in the outer carton

The reconstituted solution for injection should not be stored for more than 24 hours at 2°C - 8°C. Immediate use after reconstitution is recommended. Any remaining solution should be discarded.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

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 The other ingredient is sodium.

What Cefuroxime Injection looks like and contents of the pack

Cefuroxime Injection is a white or slightly yellow powder. It is presented in a clear type II glass vial, stoppered with rubber closures and aluminium rings.

The 250 mg vial, the 750 mg vial and the 1500 mg vial are available in packs of 1 and 5.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL Manufacturer:

ACS Dobfar Spa, Viale Adetta, Tribiano, Italy This leaflet was last revised in 03/2013

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The following information is intended for healthcare professionals only:

Instructions for constitution

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

Addition volumes and solution concentrations, which may be useful when fractional doses are required
Vial size		Amount of water to be added (ml)*	Approximate cefuroxime concentration (mg/mL)**
250 mg powder for solution for injection
250 mg	Intramuscular	1 mL	214
	Intravenous	at least 2 mL	115
750 mg powder for solution for injection
750 mg	Intramuscular	3 mL	214
	intravenous bolus	at least 6 mL	115
1500 mg powder for solution for injection
1500 mg	intravenous bolus	at least 15mL	94
	intravenous infusion	at least 10mL	139

* See information on the preparation of suspension for intramuscular injection and solutions for intravenous injection and infusion, below

** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.

Instructions for reconstitution

PREPARATION OF A SUSPENSION FOR INTRAMUSCULAR INJECTION Shake gently to produce an opaque suspension.

PREPARATION OF A SOLUTION FOR INTRAVENOUS INJECTION 1500 mg vial: For reconstitution of the powder,

-    draw up at least 15 ml of water for injections into the suitable syringe (20 ml),

-    transfer 10 ml into the 1500 mg vial and reconstitute the content of the vial, and

-    draw up the dissolved contents of the vial into the same syringe.

PREPARATION OF A SOLUTION FOR INTRAVENOUS INFUSION

1500 mg vial: For intravenous infusions of less than 30 minutes, the contents of the 1500 mg vial may be dissolved in a 50 ml vial or bag of water for injections as following.

For reconstitution of the powder,

-    draw up at least 10 ml of water for injections from the 50 ml vial or bag using a suitable syringe (20 ml),

-    transfer the 10ml into the 1500 mg vial and reconstitute the content of the vial, and

-    draw up the dissolved contents of the vial into the 50 ml vial or bag.

The solution may be administered directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.

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