Patient leaflet - CEFUROXIME 750 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
Cefuroxime
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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 further questions, please ask your doctor or your nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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1. What Cefuroxime is and what it is used for
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2. What you need to know before you are given Cefuroxime
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3. How Cefuroxime is given
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4. Possible side effects
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5. How to store Cefuroxime
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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.
Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Cefuroxime during your treatment.
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)
- 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 then.
Take special care with Cefuroxime
You must look out for certain symptoms such as allergic reactions, skin rashes and gastrointestinal disorders such as diarrhoea or fungal infections 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 if you are taking, have recently taken or might take any other medicines. This includes medicines you can obtain without 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.
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:
This medicine contains less than 1 mmol sodium (23 mg) per vial that is to say essentially ‘sodium- free’.
- Cefuroxime 750 mg powder for solution for injection/infusion:
This medicine contains 41 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
- Cefuroxime 1.5 g powder for solution for injection/infusion:
This medicine contains 81 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 4% of the recommended maximum daily dietary intake of sodium for an adult.
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3. HOW CEFUROXIME IS GIVEN_________________________________
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 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. …/…
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)
250 mg powder for solution for injection
| 250 mg intramuscular intravenous | 1 ml at least 2 ml | 216 116 |
| 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 ml | 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 ml | 94 |
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist 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.
- severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuroxime can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever.
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, pharmacist 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: or search for MHRA Yellow Card in the Google Play or Apple App Store
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 leaflet was last approved in November 2020
stragen
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