Document: document 2 change

• document 0
• document 1
• document 2

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefuroxime 750 mg

Powder for solution for injection

Cefuroxime 1500 mg

Powder for solution for injection or infusion

Cefuroxime sodium

What is in this leaflet:

1.    What Cefuroxime is and what it is used for

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

3.    How Cefuroxime is given

4.    Possible side effects

5.    How to store Cefuroxime

6.    Contents of the pack and other information

IPP

Important information about some of the ingredients of Cefuroxime

This medicine contains sodium. You need to take this into account if you are on a controlled sodium diet.

Cefuroxime 750 mg: 42 mg sodium per vial.

Cefuroxime 1500 mg: 83 mg sodium per vial.

1.    What Cefuroxime is 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.

Cefuroxim is used to tread 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

You must not be given Cefuroxime if you

-    are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of Cefuroxime.

-    have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobac-tams 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 out for') in section 4. If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to Ce-furoxime.

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 or pharmacist if you are taking, have recently taken or might take any other medicines.

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 kidney 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

Cefuroxime has no or negligible influence on the ability to drive and use machines. Don't drive or use machines if you do not feel well.

3. How Cefuroxime is given Administration:

Cefuroxime 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 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 using 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 Cefuro-xime 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 side effects not listed in this leaflet.

5.    How to store Cefuroxime

Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.

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 outer carton and the label after ‘EXP‘. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Cefuroxime contains

•    The active substance is cefuroxime. Each vial contains 750 mg or 1500 mg cefuroxime (as cefuroxime sodium), respectively.

•    There are no other ingredients.

What Cefuroxime looks like and contents of the pack

Fine white or almost white powder.

Cefuroxime 750 mg is available in 15 ml glass vials with a rubber stopper and a flip-off cap.

Cefuroxime 1500 mg is available in 50 ml and 100 ml glass vials with a rubber stopper and a flip-off cap.

Pack sizes: Packages with 1, 5 or 10 glass vials. Not all pack sizes may be marketed.

Marketing authorisation holder

IPP International Pharma Partners GmbH Marienplatz 10-12 94081 Furstenzell Germany

Phone 0049 (0) 8502 9184 410 Fax 0049 (0) 8502 9184 492

Manufacturer

MIP Pharma GmbH Kirkeler Str. 41 66440 Blieskastel Germany

The following information is intended for healthcare professionals only:

Instructions for reconstitution

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

Preparation of the solution for injection

For the preparation of the solution, Cefuroxime 750 mg is dissolved in at least 6 ml water for injections, Cefuroxime 1500 mg is dissolved in at least 15 ml water for injections.

The intravenous injection should be carried out slowly over a time of 3-5 minutes.

Preparation of the solution for infusion

For short-term infusion, Cefuroxime 1500 mg is dissolved in 50 ml water for injections, isotonic sodium chloride solution or 5% glucose solution and infused over a time of about 20 minutes.

Cefuroxime 1500 mg can also be dissolved in 100 ml isotonic sodium chloride solution or 5% glucose solution for slow infusion over a time of about 60 minutes.

Intramuscular injection

Add 3 ml water for injections to Cefuroxime 750 mg or 6 ml water for injections to Cefuroxime 1500 mg.

In order to avoid pain caused by the volume of the injected solution, not more than 5 ml should be injected per site.

Compatibility with intravenous solutions

Cefuroxime is compatible with water for injections, 5% glucose solution and physiological sodium chloride solution. The reconstituted solution is yellowish to brownish. Cefuroxime solutions are basically administered separately, if the chemical and physical compatibility with another infusion solution is not proven.

Important incompatibilities

Mixing of cefuroxime with sodium bicarbonate solutions significantly affects the colour of the solution. Therefore, this solution is not recommended for the dilution of cefuroxime. If required, the cefuroxime solution in water for injections can be introduced into the tubing of the giving set in patients receiving sodium bicarbonate solution by infusion.

Cefuroxime should not be mixed with amnioglycoside antibiotics.

Storage after reconstitution

Shelf-life of the prepared solution

The chemical and physical stability of the prepared solution has been demonstrated for 3 hours at 25°C and for 12 hours at 5°C. From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

This leaflet was last revised in 12/2012