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CEFUROXIME 1.5G POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): CEFUROXIME SODIUM

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948026233

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Cefuroxime 250 mg
Powder for Solution for Injection
Cefuroxime 750 mg
Powder for Solution for Injection
Cefuroxime 1.5 g
Powder for Solution for Injection/Infusion
Cefuroxime
The name of your medicine is Cefuroxime Powder for Solution for Injection
250 mg, 750 mg & Cefuroxime Powder for Solution for Injection/Infusion
1.5 g which will be referred to as cefuroxime throughout the rest of this
document.
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 further 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 (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)
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 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 any other medicines, if you’ve 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 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.

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, 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 breast-feeding
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:
You need to take this into account if you are on a controlled sodium diet.
Cefuroxime 250 mg Powder for Solution for Injection:
This medicinal product contains 0.59 mmol (13.56 mg) of sodium per vial
Cefuroxime 750 mg Powder for Solution for Injection:
This medicinal product contains 1.77 mmol (40.69 mg) of sodium per vial
Cefuroxime 1.5 g Powder for Solution for Injection / Infusion:
This medicinal product contains 3.54 mmol (81.38 mg) of sodium per vial

3. HOW CEFUROXIME IS GIVEN
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.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals
only.

Instructions for use and handling:
For single use only: Any unused product or waste material should be disposed
of in accordance with local requirements, immediately after use.

Intramuscular use
Add 1 ml water for injection to Cefuroxime 250 mg or at least 3 ml for
Cefuroxime 750 mg Powder for Injection.
Shake gently to produce an opaque suspension.

Intravenous use
Dissolve in water for Injection using at least 2 ml for Cefuroxime 250 mg,
6 ml for Cefuroxime 750 mg or 15 ml for Cefuroxime 1.5 g to produce a clear
solution. For short intravenous infusion (e.g. up to 30 minutes), Cefuroxime
1.5 g may be dissolved in 15 ml water for injection, add the reconstituted
solution of Cefuroxime sodium to 50 or 100 ml of any of the compatible
infusion solution mentioned below.
Reconstituted solution may be diluted with:
5% glucose injection
0.9% sodium chloride injection
0.18% sodium chloride + 4% glucose
Hartman’s solution
The contents and concentrations of cefuroxime as a suspension/solution are
shown in the table below:
Cefuroxime
Route of
Volume of
Final
per vial
administration solvent to be volume of
(mg)
added (mL) suspension/
solution
(mL)
250
IM
1
1.2
IV Bolus
2
2.2
750
IM
3
3.5
IV Bolus
6
6.7
1500
IV Bolus
15
16.2
IV Infusion
15 + 50
66.5
IV Infusion
15 + 100
116.4

Concentration
of suspension/
solution
(mg/ml)
208
114
214
112
93
23
13

These solutions may be given directly into the vein or introduced into the
tubing of the giving set of a compatible parenteral infusion.

Q74882
TN/DRUGS/763

Component Specification

Requester

Item number:

Q74882

Request number:

AS2702

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

OCI001
7
N/A

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 712 mm
Vial
Hospira India
N/A
30 x 118 mm
Yes
No

Previous Item Number: N/A

2D barcode:
2D barcode content:
Supplier Code:

Datamatrix
948026233
948026233

Version 1
Technician:
Date:

NC
20/Mar/13

Version 2
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MW
16/Apr/13

Version 3
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Date:

EM
13/Nov/14

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Version 12
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Colours
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Signed:
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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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, cefuroxime 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 sodium 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 Coombs’ 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 be 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
Tell your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5. HOW TO STORE CEFUROXIME
Keep this medicine out of the sight and reach of children.
Do not use cefuroxime after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Keep vial(s) in the outer carton.
After the solution is made, it may be stored at 2-8°C for up to 24 hours.
Medicines should not be disposed of via wastewater or household
waste. Your doctor or nurse will dispose of any medicine that is no longer
required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cefuroxime contains:
The active substance is Cefuroxime Sodium. There are no other
ingredients.
Each vial of 250 mg, 750 mg & 1.5 g contains 263 mg, 789 mg & 1.578 g
of cefuroxime sodium equivalent to 250 mg, 750 mg & 1.5 g of cefuroxime,
respectively.

What Cefuroxime looks like and contents of the pack
Cefuroxime is a white to faint yellow, amorphous sterile powder packaged
in 20 ml / 100 ml clear glass vial and sealed with grey bromo butyl rubber
stopper and coloured flip off seal.
Cefuroxime 250mg and 750mg Powder for Solution for Injection:
Packs of 1, 5, 10 or 25 vials in a carton.
Cefuroxime 1.5g Powder for Solution for Injection/Infusion:
Packs of 1 vial in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,
CV31 3RW, United Kingdom
This medicinal product is authorised in the Member States of the EEA
under the following names:

United Kingdom:
Cefuroxime 250 mg Powder for solution for injection
Cefuroxime 750 mg Powder for solution for injection
Cefuroxime 1.5 g Powder for solution for injection/infusion
Last date of revision {}

Storing Cefuroxime Injection:
This medicinal product does not require any special storage conditions.
Keep vial(s) in outer carton.
Reconstituted solution: Chemical and physical stability has been
demonstrated for 24 hours at 2-8°C. From a microbiological point of view, the
product should be used immediately. If not used immediately, in-use storage
times and conditions 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.

Incompatibilities
Solutions containing Cefuroxime should not be mixed with or added to
solutions containing other agents other than those mentioned above.
The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects
the colour of solutions and therefore this solution is not recommended for the
dilution of Cefuroxime powder for injection. However, if required, for patients
receiving sodium bicarbonate injection by infusion, the Cefuroxime powder for
injection may be introduced into the tube of the giving set.
Cefuroxime powder for injection should not be mixed in the same syringe with
aminoglycoside antibiotics.
Usually Cefuroxime is effective when administered alone, but when
appropriate it may be used in combination with metronidazole or an
aminoglycoside apart from each other.

948026233
Q74882
TN/DRUGS/763

948026233

Component Specification

Requester

Item number:

Q74882

Request number:

AS2702

Country:

United Kingdom

OI template:
Amalia version:
Mulgrave version:

OCI001
7
N/A

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

118 x 712 mm
Vial
Hospira India
N/A
30 x 118 mm
Yes
No

Previous Item Number: N/A

2D barcode:
2D barcode content:
Supplier Code:

Datamatrix
948026233
948026233

Version 1
Technician:
Date:

NC
20/Mar/13

Version 2
Technician:
Date:

MW
16/Apr/13

Version 3
Technician:
Date:

EM
13/Nov/14

Version 4
Technician:
Date:

xx
dd/mmm/yy

Version 5
Technician:
Date:

xx
dd/mmm/yy

Version 6
Technician:
Date:

xx
dd/mmm/yy

Version 7
Technician:
Date:

xx
dd/mmm/yy

Version 8
Technician:
Date:

xx
dd/mmm/yy

Version 9
Technician:
Date:

xx
dd/mmm/yy

Version 10
Technician:
Date:

xx
dd/mmm/yy

Version 11
Technician:
Date:

xx
dd/mmm/yy

Version 12
Technician:
Date:

xx
dd/mmm/yy

Colours
Black:

Signed:
Date:

Expand view ⇕

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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