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CEFUROXIME 1500 MG (1.5G) POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): CEFUROXIME SODIUM

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CefUROXime 250mg Powder for Solution for Injection
CefUROXime 750mg Powder for Solution for Injection
CefUROXime 1500mg (1.5g) Powder for Solution for Injection or Infusion

Read all of this leaflet carefully before you start receiving this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor, pharmacist or nurse.
- The full name of this medicine is Cefuroxime 250mg Powder for Solution for
Injection, Cefuroxime 750mg Powder for Solution for Injection and Cefuroxime
1500mg (1.5g) Powder for Solution for Injection or Infusion but within the leaflet it
will be referred to as Cefuroxime powder.

In this leaflet:
1. What Cefuroxime powder is and what it is used for
2. Before you are given Cefuroxime powder
3. How Cefuroxime powder is given
4. Possible side effects
5. How to store
6. Further information

1. What Cefuroxime powder is and what it is used for
Cefuroxime belongs to a group of antibiotics called cephalosporins. Antibiotics are
used to kill the bacteria or ‘germs’ that cause infections.
Cefuroxime is a powder which is made into a solution to be given by injection into a
vein or into a muscle.
Cefuroxime powder is given for the treatment of infections including infections of the
chest and kidneys.
A doctor or nurse may also give it to you before an operation to protect you from
infection.

2. Before you are given Cefuroxime powder
Do not use Cefuroxime powder if you:
• are allergic (hypersensitive) to cefuroxime (see section 6 for a list of the
ingredients).
• have had an allergic reaction to antibiotics such as penicillin or cephalosporins
(an allergic reaction may include a rash, itching or breathing difficulties).
Take special care with Cefuroxime powder if you:
• have kidney disease or if you are on dialysis.
• have liver problems.
• have any blood tests, Cefuroxime powder can cause changes to the results.
Long time use of Cefuroxime powder can result in infections caused by organisms
that are not sensitive to Cefuroxime powder.

Diarrhoea may develop while you are on antibiotics, including Cefuroxime powder, or
even several weeks after you have stopped using them. If it becomes severe or
persistent or you notice that your stool contains blood or mucus tell your doctor or
nurse immediately. Cefuroxime powder treatment will have to be stopped
immediately, as this can be life-threatening. Do not take medicines that stop or slow
down bowel movements.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
The doctor, pharmacist or nurse will take special care if you are using any of the
following medicines at the same time:
- Diuretics (water tablets), e.g. furosemide
- Probenecid (used to treat gout)
- Other antibiotics (e.g. amphotericin, aminoglycosides, tetracyclines, macrolides or
chloramphenicol)
Pregnancy and breast-feeding
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
There is no evidence of harmful effects caused by Cefuroxime powder in pregnancy.
But, Cefuroxime powder should only be given during pregnancy after careful
consideration of the risks and benefits. If you are pregnant or think you may be
pregnant or you are trying to become pregnant, tell you doctor, pharmacist or nurse
before receiving this medicine.
Cefuroxime powder is excreted in breast milk and should be given with care to breastfeeding mothers. Please tell you doctor, pharmacist or nurse if you are breast-feeding.
Driving and using machines
In rare cases Cefuroxime powder may cause dizziness, nervousness or confusion. If
you feel at all unwell after being given Cefuroxime powder you should not attempt to
drive or use machines.
Important information about some of the ingredients of Cefuroxime powder
• 250mg vial
This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e.
essentially ‘sodium- free’.
• 750mg vial
This medicinal product contains 1.8mmol (42mg) sodium per vial. To be taken into
consideration by patients on a controlled sodium diet.
• 1500mg (1.5g) vial
This medicinal product contains 3.7mmol (84mg) sodium per vial. To be taken into
consideration by patients on a controlled sodium diet.

3. How Cefuroxime powder is given
Your doctor will decide on the dose and the duration of treatment. This medicine will
normally be given by an injection of a solution into a vein or a muscle. The usual dose
is:
Adolescents (aged 12 years to 17 years), adults and elderly:
750mg to 1500mg (1.5g) three times a day. For more severe infections this may be
increased to 750mg to 1500mg four times a day.
Your doctor or nurse may give you 1500mg (1.5g) Cefuroxime powder before surgery
to protect you from infection. You may get further doses of 750mg of cefuroxime

after the operation.
Infants (aged 28 days to 23 months) and children (2 years to 11 years):
The dose is based on body weight and is normally between 30mg to 100mg (usually
60mg) for each kilogram of their body weight each day. This will be divided into
doses of three or four times a day.
Patients with kidney disorders
If you have kidney problems, you may be given a lower dose just once or twice a day
depending on your kidney function.
If you miss a dose or receive too much of Cefuroxime powder
As this medicine will be given to you whilst you are in hospital, it is unlikely that you
will miss a dose or be given too much however, if you have any concerns discuss this
with your doctor, pharmacist or nurse.
While you are receiving Cefuroxime powder
If you have any further questions on the use of this product, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, Cefuroxime powder can cause side effects, although not
everybody gets them. It is important that you are aware of what these side effects
may be.
If you notice any of the following serious side effects, stop Cefuroxime powder
and contact a doctor, pharmacist or nurse immediately:
• Reddening of the skin with blisters or peeling. There may also be severe blisters and
bleeding in the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson
syndrome” or “toxic epidermal necrolysis”.
• Severe prolonged diarrhoea, which may have blood or mucus in it, accompanied
with stomach pain and fever. This could be “pseudomembranous colitis”.
These effects are rare, affecting less than 1 in 1,000 people.
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or
difficulties to swallow (severe allergic reaction).
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems
(jaundice).
These effects are very rare, affecting less than 1 in 10,000 people.
Other side effects include:
Common side effects (affects 1 to 10 users in 100):
• Diarrhoea, nausea or vomiting
• Skin rash, itchy skin
• Increase in some substances in your blood (creatinine and urea) especially in patients
with kidney problems
• Pain or swelling where the needle went into the vein or muscle.
Uncommon side effects (affects 1 to 10 users in 1,000):
• Abnormal increase in a certain type of white blood cells in your blood
(eosinophilia). Symptoms include weight loss, night sweats and fever.
• Abnormal decrease in some types of white blood cells in your blood (leucopenia and
neutropenia), which can make you more likely to get infections.

• Unusual bleeding or bruising caused by a reduction in the number of platelets
in the blood (thrombocytopenia)
• Headache, dizziness
• Severe kidney problems (especially in elderly patients and patients with previous

kidney disorders)
• Changes to test used to measure functioning of the liver .
Rare side effects (affects 1 to 10 users in 10,000)
• Abnormal decrease in a certain type of white blood cells in your blood
(agranulocytosis) which can make you more likely to get infections
• Abnormal decrease of haemoglobin in your blood (anaemia). Symptoms include
tiredness, paleness, weakness, dizziness, shortness of breath and fast heart beat
• Various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson
syndrome or toxic epidermal necrolysis)
• Fever
• Delayed allergic reaction (serum sickness) where symptoms may include fever,
hives, skin rash, joint pains, enlarged glands, shortness of breath and generally feeling
unwell. Symptoms can take 1–2 weeks to appear after the start of treatment
• White furry, sore tongue and mouth (oral thrush)
• Sore, itchy vagina and/or discharge (vaginal thrush).
Very rare side effects (affects less than 1 user in 10,000)
• Abnormal breakdown of red blood cells (haemolytic anaemia). Symtoms include
tiredness, paleness, yellowing of skin, weakness, dizziness, shortness of breath and
fast heart beat
• Vertigo (feeling of dizziness or spinning), restlessness, nervousness, confusion.

Not known: frequency cannot be estimated from the available data:
• Some blood tests may become false positive (e.g. Coombs test)
• Severe allergic reaction (angio-oedema) with swelling of the face (e.g. lips and
eyelids), tongue, hands and feet and difficulty breathing.
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 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
Keep out of the sight and reach of children.
This medicine does not require any special storage conditions.
Reconstituted/diluted solution should be used immediately.
From the microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2°C to
8°C, unless reconstitution/dilution has taken place in controlled and validated
conditions.
Do not use Cefuroxime powder after the expiry date which is stated on the carton.
For single use only.
Discard any unused solution.
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
to protect the environment.

6. Further information

What Cefuroxime powder contains
- The active ingredient is cefuroxime 250mg, 750mg or 1500mg (1.5g) (as sodium
salt).
- Other ingredients: None.
What Cefuroxime powder looks like and contents of the pack
Cefuroxime is white to faintly yellow powder to which appropriate amounts of water
are added to prepare an off-white to pale yellow opaque suspension for intramuscular
use or a yellowish solution for intravenous administration.
250mg, 750mg powder for solution for injection:
20ml type I glass vials, sealed with grey bromo butyl rubber stopper and coloured flip
off seal.
1500mg (1.5 g) powder for solution for injection or infusion:
20ml type I glass vials (for injection) and 100ml type I glass vials (for infusion),
sealed with grey bromo butyl rubber stopper and coloured flip off seal.
Pack sizes:
250mg powder for solution for injection:
5 vials
750mg powder for solution for injection:
1 vial and 10 vials
1500mg (1.5g) powder for solution for injection or infusion
20ml vials (injection): 1 vial and 10 vials
100ml vials (infusion): 1 vial and 10 vials
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland
Manufacturer

Actavis Group PTC ehf
Reykjavikurvegi 76-78, 220
Hafnarfjordur
Iceland
This leaflet was last revised in February 2016

<-----------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:

Cefuroxime 250mg Powder for Solution for Injection
Cefuroxime 750mg Powder for Solution for Injection
Cefuroxime 1500mg (1.5g) Powder for Solution for Injection or Infusion
For single use only. Discard any unused solution.
The dilution is to be made under aseptic conditions. The solution is to be inspected
visually for particulate matter and discoloration prior to administration. The solution

should only be used if the solution is clear and free from particles.
Preparation of solution
Intramuscular
Add 1ml water for injections to 250mg Cefuroxime powder or 3ml water for
injections to 750mg Cefuroxime powder. Shake gently to produce an opaque
suspension.
Intravenous
Dissolve Cefuroxime powder in water for injections using 2ml for 250mg, 6ml for
750mg or 15ml for 1500mg (1.5g). For short intravenous infusion (e.g. up to 30
minutes), 1500mg (1.5g) may be dissolved in 50ml water for injections.
These solutions may be given directly into the vein or introduced into the tubing of
the giving set if the patient is receiving parenteral fluids. The reconstituted solution
should appear yellowish.
Cefuroxime is compatible with most commonly used intravenous fluids and
electrolyte solutions.
Water for injections is recommended for reconstitution, followed by dilution (prior to
intravenous administration) with water for injections, 5% glucose injection or 0.9%
sodium chloride injection.
Cefuroxime powder is also compatible with Hartmann's solution and 0.18% sodium
chloride + 4% glucose.
Reconstituted product:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C 8°C.

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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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