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CEFUROXIME 250 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME / CEFUROXIME SODIUM / CEFUROXIME / CEFUROXIME

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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.
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.
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 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 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 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.
.../...

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
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 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
* 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.
05116/05117/05118_B00

If 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.

05116/05117/05118_B00

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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