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CEFUROXIME 1500MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): CEFUROXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Cefuroxime 750 mg Powder for Solution/Suspension for Injection
Cefuroxime 1500 mg 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 any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

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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• probenecid
• oral anticoagulants

What Cefuroxime is and what it is used for

Tell your doctor if this applies to you. You may need extra check-ups to monitor
your renal function while you are taking Cefuroxime.

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

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

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

2

Your doctor will consider the benefit of treating you with Cefuroxime against the risk
to your baby.

What you need to know before you are given Cefuroxime

Driving and using machines
Donʼt drive or use machines if you do not feel well.

You must not be given Cefuroxime:
• if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of
the other ingredients of Cefuroxime.
• if you have ever had a severe allergic (hypersensitive) reaction to any other type
of betalactam antibiotic (penicillins, monobactams and carbapenems).

Cefuroxime contains sodium
Cefuroxime contains 2.09 mmol (equivalent to 48 mg) of sodium per gram. This
should be taken into consideration by patients on a sodium controlled diet.

Tell your doctor before you start on Cefuroxime if you think that this applies to you.
You must not be given Cefuroxime.

Warnings and precautions

3

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 (ʻConditions you need to look out
forʼ) in section 4. If you have had any allergic reaction to other antibiotics such as
penicillin, you may also be allergic to Cefuroxime.

Amount of sodium per vial

1500 mg

72 mg

750 mg

36 mg

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.

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.

00000000

Cefuroxime strength

Other medicines and Cefuroxime
Tell your doctor if you are taking any other medicines, if youʼve started taking any
recently or you start taking new ones. This includes medicines you can obtain without
a prescription.
Some medicines may affect how Cefuroxime works, or make it more likely that youʼll
have side effects. These include:
• aminoglycoside-type antibiotics
• water tablets (diuretics), such as furosemide

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR
HEALTHCARE PROFESSIONALS ONLY:

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, theyʼll be given 30 to 100 mg Cefuroxime per day
divided in two or three doses.
Continued on the next page >>

Cefuroxime is compatible with several commonly used intravenous infusion fluids:
- water for injection
- 0.9 % sodium chloride solution
- 5 % glucose solution

Cefuroxime 750 mg/1500 mg
Powder for Solution for Injection or Infusion

The compatibility of cefuroxime in other infusion fluids should be checked before use.

Cefuroxime

When reconstituted for intramuscular or intravenous injection, the white to yellowish
powder gives a colourless to slightly yellow suspension and a colourless to brownish
solution respectively. Do not use if any particulate matter is visible. Withdraw only
one dose. Any unused solution should be discarded.

This is an extract from the Summary of Product Characteristics to assist in the
administration of Cefuroxime 750 mg/1500 mg powder for solution for injection
or infusion. When determining appropriateness of use in a particular patient,
the prescriber should be familiar with the SPC.
For slow intravenous injection/infusion and intramuscular injection.

Method of administration:
In order to prevent any risk of infection, the preparation of the infusion should be
done in close aseptic conditions. Do not delay the infusion after the preparation of
the solution.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Aseptic techniques should be used to reconstitute the solution. The reconstituted
solution is stable for 2 hours at room temperature and 24 h at 2°C - 8°C .

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INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINAL PRODUCTS
• Cefuroxime should not be added with other antibiotics, in the same syringe or
solution for infusion. This concerns especially aminoglycosides.
• Cefuroxime should not be mixed with solutions containing sodium bicarbonate.

• Intramuscular injection
Cefuroxime 750 mg powder for solution/suspension for injection:
Add 3 ml of water for injections or 1.0 % lidocain solution to Cefuroxime 750 mg.
Shake gently to produce an homogenous suspension. Cefuroxime 1500 mg,
powder for solution for injection, should not be administered intramuscularly.
Continued on the next page >>

Artwork Proof Box
Ref: V013 - SPC, PIL & Labelling update as per Art. 30 Ref., NP
Proof no.
005.1

Date prepared:
15/04/2013

Colours:
Black
Dimensions: 210 x 330 mm

Font size:
7pt
Fonts:
Helvetica

Babies (over 3 weeks) and children
For every 1 kg the baby or child weighs, theyʼll be given 30 to 100 mg of
Cefuroxime per day divided in three or four doses.

If you get any side effects tell your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.

5

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.

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

Do not use Cefuroxime after the expiry date which is stated on the carton and label
after EXP. The expiry date refers to the last day of that month.

Talk to your doctor if this applies to you.

4

How to store Cefuroxime

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

Possible side effects

For storage conditions of the reconstituted/diluted medicinal product, see at the end
of the package leaflet ʻThe following information is intended for medical or healthcare
professionals onlyʼ.

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.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.

6

Contents of the pack and other information

What Cefuroxime contains
• Active substance: the active substance is cefuroxime (as sodium salt).
750 mg, powder for solution/suspension for injection:
1 vial contains 750 mg of cefuroxime as 789 mg of cefuroxime sodium

Contact a doctor or nurse immediately if you get any of these symptoms.

1500 mg, powder for solution for injection/infusion:
1 vial contains 1500 mg of cefuroxime as 1578 mg of cefuroxime sodium

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.

• Other ingredients:
the medicinal product contains no other ingredients than the active substances.

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)

What Cefuroxime looks like and contents of the pack
Cefuroxime 750 mg, powder for solution/suspension for injection:
15 ml vials of clear glass type III (Ph. Eur.) closed with rubber stopper and flip-off
bordered caps.

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.

Cefuroxime 1500 mg, powder for solution for injection/infusion:
30 ml vials of clear glass type III (Ph. Eur.) closed with rubber stopper and flip-off
bordered caps.

100 ml infusion bottles of clear glass type II (Ph. Eur.) closed with rubber stopper and
flip-off bordered caps.

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 Coombʼs test.

Vials: 750 mg: 1, 5, 10, 25, 50, 100 vials. 1500 mg: 1, 5, 10, 25, 50, 100 vials. Bottle:
1500 mg: 1, 5, 10, 25, 50, 100 infusion bottles.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl, Austria.

This leaflet was last revised in 04/2013.

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 in the blood and serum creatinine.

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• Intravenous injection
Cefuroxime 750 mg / 1500 mg powder for solution/suspension for injection:
Dissolve Cefuroxime 750 mg in at least 6 ml of water for injections, 0.9 % sodium
chloride solution or 5 % glucose solution, Cefuroxime 1500 mg in at least 15 ml.
Shake gently to produce a clear solution.

• Short intravenous infusion (e.g. up to 30 minutes)
Cefuroxime 1500 mg powder for solution/suspension for injection:
Cefuroxime 1500 mg may be dissolved in 50 ml water for injection, 0.9 % sodium
chloride solution or 5 % glucose solution.
These solutions may be given directly into the vein or introduced into the tubing of
the giving set. Shake gently to produce a clear solution.

The contents and concentrations of cefuroxime as solution / suspension are shown
in the table below.
mg cefuroxime
per vial
250
750

1500
1500

addition of ml
solvent

volume ml of final
solution/suspension

concentration
mg/ml

6

6.8

110

2

15
50

2.2

16.5

114
91

51.5

29

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Artwork Proof Box
Ref: V013 - SPC, PIL & Labelling update as per Art. 30 Ref., NP
Proof no.
005.1

Date prepared:
15/04/2013

Colours:
Black
Dimensions: 210 x 330 mm

Font size:
7pt
Fonts:
Helvetica

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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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