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CEFUROXIM 750 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

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

1. What Cefuroxime is and what it is used for

Important information about some of the ingredients of Cefuroxime

This medicine contains sodium. You need to take this into account if you are on a controlled sodium diet.
Cefuroxime 750 mg: 42 mg sodium per vial.
Cefuroxime 1500 mg: 83 mg sodium per vial.

3. How Cefuroxime is given
Administration:

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 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.

Cefuroxim is used to tread infections of:
• the lungs or chest
• the urinary tract
• the skin and soft tissue
• the abdomen

The usual dose:

Cefuroxime is also used:
• to prevent infections during surgery.

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.

2. What you need to know before you are
given Cefuroxime

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.

You must not be given Cefuroxime if you

- are allergic (hypersensitive) to any cephalosporin antibiotics
or any of the other ingredients of Cefuroxime.
- 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.

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.
Contraceptive pills
Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are
being treated with Cefuroxime you also need to use a barrier
method of contraception (such as condoms). Ask your doctor
for advice.

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.


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.

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.
 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 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
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 multiformae
 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.

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any side effects not listed in this leaflet.

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

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 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

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

750 mg

Amount of
water to be
added (ml)
intramuscular
3 ml
intravenous bolus
at least 6 ml
intravenous infusion at least 6 ml

Approximate
cefuroxime
concentration (mg/ml)**
216
116
116

1500 mg intramuscular
6 ml
216
intravenous bolus
at least 15ml 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.
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 infusion 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% glucose solution and physiological sodium chloride solution. The
reconstituted solution is yellowish to brownish. Cefuroxime
solutions are basically administered separately, if the chemical and physical compatibility with another infusion solution is
not proven.
Important incompatibilities
Mixing of cefuroxime with sodium bicarbonate solutions significantly 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 receiving sodium bicarbonate solution by infusion.
Cefuroxime should not be mixed with amnioglycoside antibiotics.
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.

Manufacturer
MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel
Germany

This leaflet was last revised in 03/2013.

2013/03 GBR



MIP Pharma GmbH

·

Cefuroxim MIP 750/1500 mg UK - 210 x 400 mm - Pantone 288C / Pantone 288 C - 15%

Kirkeler Str. 41

·

D-66440 Blieskastel

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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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