Patient leaflet - Cefuroxim 1500 mg powder for solution for injection or infusion
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 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)
- have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after treatment with cefuroxi-me or any other cephalosporin antibiotics.
➔ 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.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in associ-ation with cefuroxime treatment. Seek medical attention im-mediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
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, breast-feeding and fertility
Tell your doctor before you are given Cefuroxime
- if you are pregnant, think you might be pregnant or are plan-ning 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.
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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Cefuroxime 750 mg
Powder for solution for injection
Cefuroxime 1500 mg Powder for solution for injection or infusion
Cefuroxime sodium
Cefuroxime contains sodium
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.
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.
Conditions you need to look out for
A small number of people using Cefuroxime get an allergic re-action 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 epider-mal necrolysis).
- A widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syn-drome).
- 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.
- Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).
➔ 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 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By re-porting 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.
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 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 environ-ment.
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
MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel
Germany
This leaflet was last revised in 03/2023
The following information is intended for healthcare professionals only:
Instructions for reconstitution
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 concentrati-on (mg/ml)** 750 mg intramuscular
intravenous bolus intravenous infusion
3 ml
at least 6 ml at least 6 ml
216
116
116
1500 mg intramuscular
intravenous bolus intravenous infusion
6 ml
at least 15 ml 15 ml *
216
94
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 recon-stitution 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 infu-sion 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% glu-cose solution and physiological sodium chloride solution. The reconstituted solution is yellowish to brownish. Cefuroxime solutions are basically administered separately, if the chemi-cal and physical compatibility with another infusion solution is not proven.
Important incompatibilities
Mixing of cefuroxime with sodium bicarbonate solutions sig-nificantly 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 recei-ving sodium bicarbonate solution by infusion.
Cefuroxime should not be mixed with amnioglycoside anti-biotics.
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.
MIP Pharma GmbH · Kirkeler Str. 41 · D-66440 Blieskastel