Document: leaflet MAH GENERIC_PL 21844-0018 change

• leaflet MAH GENERIC_PL 08828-0220
• leaflet MAH GENERIC_PL 21844-0018

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Cefuroxime 250 mg powder for solution for injection Cefuroxime 750 mg powder for solution for injection/infusion Cefuroxime 1.5 g powder for solution for injection/infusion

Cefuroxime

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

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.

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.

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, 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 renal function while you are taking Cefuroxime.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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.

Important information about some of the ingredients of Cefuroxime

•    Cefuroxime 250 mg powder for solution for injection contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium- free’.

•    Cefuroxime 750 mg powder for solution for injection/infusion contains 1.78 mmol (or 41 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

•    Cefuroxime 1.5 g powder for solution for injection/infusion contains 3.52 mmol (or 81 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

3. HOW CEFUROXIME 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 recommended 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.

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THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:

Instructions for constitution

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)1
250 mg powder for solution for injection
250 mg intramuscular	1 ml	216
intravenous	at least 2 ml	116
750 mg powder for solution for injection/infusion
750 mg intramuscular	3 ml	216
intravenous bolus	at least 6 ml	116
intravenous infusion	at least 6 ml2 3	116
1.5 g powder for solution for injection/infusion
1.5 g intramuscular	6 ml	216
intravenous bolus	at least 15 ml	94
intravenous infusion	15 ml3	94

* 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.

lf you have received more Cefuroxime than you should

Contact the doctor or healthcare professionals, if you think that you have received too much of Cefuroxime.

What is to be done if a dose has been forgotten

Ask the doctor or healthcare professional if you believe that a dose has been forgotten.

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

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 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 (may affect up to 1 in 10 people)

•    injection site pain, swelling and redness along a vein.

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 (may affect up to 1 in 100 people)

•    skin rash, itchy, bumpy rash (hives)

•    diarrhoea, nausea, stomach pain

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.

Not known side effects (frequency cannot be estimated from available data)

•    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.

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.

Reporting of side effects

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 Yellow Card Scheme.

Website: 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_

Do not store Cefuroxime above 25°C.

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

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 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 be no longer than 24 hours at 2 - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not use after the expiry date, which is stated on the carton. 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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cefuroxime contains:

The active substance: Cefuroxime (as cefuroxime sodium). There are no further excipients.

What Cefuroxime looks like and contents of the pack: Cefuroxime is a white to almost white powder.

Cefuroxime is available in cartons with vials.

Each carton contains 10 vials.

Marketing Authorisation Holder:

STRAGEN UK Limited

Castle Court 41 London Road Reigate

Surrey RH2 9RJ Manufacturer:

MITIM, S.R.L.

Via Cacciamali 34-38 I-25125 Brescia Italy

This medicinal product is authorised in the Member States of EEA under following names:

Denmark, Finland, Sweden: Cefuroxim Stragen United Kingdom:    Cefuroxime

This leaflet was last approved in November 2015

The reconstituted solution is yellowish to brownish. Differences in colour and intensity do not have any influence on the safety and efficacy.

Shake gently to produce a clear solution.

An aqueous solution of cefuroxime has a pH value of 6.0-8.5.

Compatibility

Cefuroxime sodium is compatible with the following infusion fluids:

•    Water for injection

•    Sodium chloride 9 mg/ml (0.9%) solution

•    Glucose 50 mg/ml (5%) solution

As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and practically free from particles.

For single use only. Any remaining solution should be discarded.

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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 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.

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2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME

You must not be given Cefuroxime:

•    if you are allergic to any cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6)

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   if you have ever had a severe allergic 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 then.

Take special care with Cefuroxime