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CEFUROXIME 250MG POWDER FOR SOLUTION FOR INJECTION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefuroxime 250 mg and 750 mg powder for solution for injection
Cefuroxime 1.5 g powder for solution for injection or infusion
Cefuroxime
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.

if you’ve started taking any recently or you start taking new
ones. This includes medicines you can obtain without a
prescription.

- 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.

Some medicines may affect how cefuroxime works, or make
it more likely that you’ll have side effects. These include:

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 the 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.






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

è 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 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.

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).
è 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:
è Tell the person taking the sample that you have been
given Cefuroxime.
Other medicines and Cefuroxime
è Tell your doctor if you are taking any other medicines,

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 contains sodium. You need to take this into
account if you are on a controlled sodium diet.
Cefuroxime strength

Cefuroxime strength

250mg

14mg

750mg

41mg

1.5g

81mg

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.

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The following information is intended for medical or healthcare professionals only:
Instructions for reconstitution
Addition volumes and solution concentrations, which may be useful when fractional doses are required.
Addition volumes and solution concentrations, which may be useful when fractional doses are required
Vial size

Displacement (ml)

Amount of water to be
added (ml)

Approximate cefuroxime
concentration
(mg/mL)**

0.2 ml

1mL
2mL

216
116

0.6 ml

3 mL
6 mL

216
116

6 mL
15 mL
15 mL*

216
94
94

250 mg powder for solution for injection
250 mg

intramuscular
intravenous

750 mg powder for solution for injection
750 mg

intramuscular
intravenous bolus

1.5 g powder for solution for injection or infusion
1.5g

intramuscular
intravenous bolus
intravenous infusion

1.2 ml

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.

• 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.

Patients with kidney problems
If you have a kidney problem, your doctor may change your
dose.
è Talk to your doctor if this applies to you.

è Tell your doctor if you get any of these.

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 for a long time.
è 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.
è 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
è 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)

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 at: 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
Your doctor will store the unopened vial below 25°C. Once
the powder has been mixed, the solution should be stored at
2-8°C and discarded after 24 hours.
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 pack after EXP. 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 in Cefuroxime Injection is cefuroxime
as the sodium salt.
What Cefuroxime looks like and the contents of the pack
Cefuroxime is a white to faintly yellow powder.
It is supplied in 250 mg, 750 mg or 1.5 g glass vials with a rubber
stopper
The vials are boxed individually and in packs of 2, 5, 10, 20,
30, 40 and 100 vials.
Not all pack sizes may be marketed.
POM
PL 28395/0114 Cefuroxime 250mg Powder for Solution for
Injection
PL 28395/0115 Cefuroxime 750mg Powder for Solution for
Injection
PL 28395/0116 Cefuroxime 1.5g Powder for Solution for Injection
or Infusion
Marketing Authorisation Holder:
PharmadreamsLtd, Old Police Station, Church Street,
Swadlincote, DE11 8LN, UK.
Manufacturer:
IPG Pharma Ltd, Atrium Court, The Ring, Bracknell,
RG12 1BW, UK.
This leaflet was last revised in April 2017
A475/UK/C/04

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4. POSSIBLE SIDE-EFFECTS

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.

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* Reconstituted solution to be added to 35 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
Compatibility
Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol
injection may be stored for up to 24 h at 25oC.
Cefuroxime sodium is compatible with aqueous solutions
containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion
fluids. It will retain potency for up to 24 hours at room
temperature in:
Sodium Chloride Injection BP 0.9% w/v
5% Dextrose Injection BP
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
5% Dextrose and 0.9% Sodium Chloride Injection
5% Dextrose and 0.45% Sodium Chloride Injection

5% Dextrose and 0.225% Sodium Chloride Injection
10% Dextrose Injection
10% Invert Sugar in Water for Injection
Ringer’s Injection USP
Lactated Ringer’s Injection USP
M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP
(Hartmann’s Solution).
The stability of cefuroxime sodium in Sodium Chloride
Injection BP 0.9% w/v and in 5% Dextrose Injection is
not affected by the presence of hydrocortisone sodium
phosphate.
Cefuroxime sodium has also been found compatible for 24 h at
room temperature when admixed in i.v. infusion with:
Heparin (10 and 50 units/ml) in 0.9% Sodium
Chloride Injection; Potassium Chloride (10 and 40
mEqL) in 0.9% Sodium Chloride Injection.

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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