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CEFUROXIME 750 MG POWDER FOR SOLUTION/SUSPENSION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

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 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.
What is in this leaflet:
1. What Cefuroxime is and what it is used for
2. What you need to know before you take Cefuroxime
3. How to take Cefuroxime
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

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

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

2

Pregnancy, 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 or pharmacist for advice before taking this medicine.

What you need to know before you take Cefuroxime

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.

You must not be given Cefuroxime:
• if you are allergic to cefuroxime, 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).

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

Talk to your doctor, pharmacist or nurse before using 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.

3

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

Amount of sodium per vial

1500 mg

72 mg

750 mg

How Cefuroxime is given

The recommended dose is:
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.
Continued on the next page >>

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

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.

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.

For slow intravenous injection/infusion and intramuscular injection.

• 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 a homogenous suspension. Cefuroxime 1500 mg,
powder for solution for injection, should not be administered intramuscularly.

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.
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 .

Continued on the next page >>

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36 mg

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.

Other medicines and Cefuroxime
Tell your doctor if you are taking, have recently taken or might take any other
medicine. This includes medicines you can obtain without a prescription.
Some medicines may affect how Cefuroxime works, or make it more likely that you’ll
have side effects. These include:

draft: 44006397, 971057,
44006396, 971055
laetus code: supplier to add
mat.no.: supplier to add

aminoglycoside-type antibiotics
water tablets (diuretics), such as furosemide
probenecid
oral anticoagulants

Date prepared:
12/08/2016

Colours:
Black
Dimensions: 210 x 330 mm

Font size:
7pt
Fonts:
Helvetica

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.

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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.

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.

5

Adults and adolescents
750 mg to 1.5 g of Cefuroxime two, three or four times daily.

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.

Talk to your doctor if this applies to you.

4

How to store Cefuroxime

Do not use this medicine after the expiry date which is stated on the carton/bottle
after EXP.
The expiry date refers to the last day of that month.

Possible side effects

Powder:
Keep container in the outer carton in order to protect from light.

Like all medicines, this medicine can cause side effects, although not everybody gets
them.

Do not store above 25°C.

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.

For storage conditions of the reconstituted/diluted medicinal product, see at the end
of the package leaflet ‘The following information is intended for medical or healthcare
professionals only’.
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 protect the environment.

6

Contents of the pack and other information

What Cefuroxime contains
• Active substance: the active substance is cefuroxime.

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.

750 mg, powder for solution/suspension for injection:
1 vial contains 750 mg of cefuroxime as 789 mg of cefuroxime sodium

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

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)

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

What Cefuroxime looks like and contents of the pack

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 750 mg, powder for solution/suspension for injection: white to yellowish
powder. 15 ml vials of clear glass type III (Ph. Eur.) closed with rubber stopper and
flip-off bordered caps.
Cefuroxime 1500 mg, powder for solution for injection/infusion: white to yellowish
powder. 30 ml vials of clear glass type III (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 Coomb’s test.

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

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.

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.

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

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.

This leaflet was last revised in 08/2016.

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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

draft: 44006397, 971057,
44006396, 971055
laetus code: supplier to add
mat.no.: supplier to add

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

SZ00000LT000

Artwork Proof Box
Ref: V017 - PIL update to implement outcome of EC for article 30 + RFI
Proof no.
007.1

Date prepared:
12/08/2016

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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