CEFUROXIM 750 MG POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Patient leaflet - CEFUROXIM 750 MG POWDER FOR SOLUTION FOR INJECTION

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

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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 J group of medicines called cephalosporins.

a Cefuroxim 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

You must not be given Cefuroxime if you

– are allergic to any cephalosporin antibiotics or any of the other ingredients of Cefuroxime (listed in section 6).

– 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 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 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.

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.

Important information about some of the ingredients of Cefuroxime

This medicine contains 42 mg sodium (main component of cooking/table salt) per 750 mg dose and 83 mg sodium per 1.500 mg dose, respectively. This is equivalent to 2.1% and 4.2% of the recommended maximum daily dietary intake of sodium for an adult. You need to take this into account if you are on a controlled sodium diet.

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 two, three or four times daily. 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.

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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)
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 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 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefuroxime

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

B Do not use this medicine after the expiry date which is stated J on the outer carton and the label after ‘EXP‘. The expiry date refers to the last day of that month.

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

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

MIP Pharma GmbH

Kirkeler Str. 41

66440 Blieskastel

Germany

Phone 0049 (0) 6842 96 09 0

Fax 0049 (0) 6842 96 09 355

Manufacturer