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CEFUROXIME INJECTION 750MG

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER



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. See section 4.
What is in this leaflet
1.
What is and what it is used for
2.
What you need to know before you are given
3.
How is given
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information

1. What Cefuroxime Injection 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 antibiotics 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
You must not be given :
• if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of
.
• if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic
(penicillins, monobactams and carbapenems).
Warnings and precautions
Talk to your doctor or nurse before receiving Cefuroxime Mylan:
 if you are elderly
 if you have kidney problems. You may need extra blood tests to monitor how your kidneys are
working while you are taking cefuroxime.
During treatment
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Tell your doctor or nurse immediately if you get:
 allergic reactions
 gastrointestinal disorders such as diarrhoea
This will reduce the risk of possible problems (See section 4, ‘Possible side effects’).
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:
Tell the person taking the sample that you have been given cefuroxime.
Other medicines and cefuroxime
Tell your doctor if you are taking, have recently taken or might take 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.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before receiving this medicine.
During pregnancy, your doctor will consider the benefit of treating you with cefuroxime against the risk to
your baby.
Cefuroxime is present in breast milk. There is a risk of diarrhoea or fungal infection to the breast-fed child.
Your doctor will discuss with you whether it is more benficial to continue treatment or to breast-feed your
child.
Driving and using machines
Don’t drive or use machines if you do not feel well.
contains sodium.
This medicine contains 13.5 mg, 40.6 mg and 81.3 mg of sodium respectively per 250 mg dose, 750 mg dose
and 1500 mg dose. You need to take this into account if you are on a controlled sodium diet.

3. How 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.

The usual dose
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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.
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.
If you are given more than you should
If you think you have been given too much of cefuroxime injection, tell your doctor or nurse immediately.
You may have fits; hallucinations; and you may also feel drowsy; confused and unconscious. These may be
signs of problems with your brain (encephalopathy).

4. Possible side effects
Like all medicines, cefuroxime can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately or go to your nearest hospital emergency department if you
notice any of the following serious side effects:

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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).
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.
an overgrowth of bacteria in the body which can lead to stomach pain, bloating, diarrhoea or
constipation. This is more likely if you are treated with cefuroxime for a long time.
an increase in the number of infections causing fever, severe chills, sore throat and mouth ulcers.
These may be signs of low levels of white blood cells.
tiredness, headaches, shortness of breath, looking pale, yellowing of the skin or whites of the eyes.
These may be signs that you have low levels of red blood cells.
persistent or severe diarrhoea, possibly with blood and mucus and stomach pain. These may be signs
of inflammation of the intestine.
changes in the amount of urine produced, fever, dark coloured urine, exhaustion, feeling sick (nausea)
or being sick (vomiting), general swelling (water retention). These may be signs of serious problems
with your kidneys.

Other possible side effects include:
Common side effects (may affect up to 1 in 10 people)
• injection site pain, swelling and redness along a vein
• increases in substances (enzymes) produced by the liver, which can be seen in a blood test
• an increase in some white blood cells (eosinophilia)
• low levels of red blood cells (anaemia), which can
be seen in a blood test.
Uncommon side effects (may affect up to 1 in 100 people)
• skin rash, itchy, bumpy rash (hives)
• diarrhoea, nausea, stomach pain•
• increase in bilirubin (a substance produced by the liver), which can be seen in a blood test
• positive Coomb’s test.
Not known: (frequency cannot be estimated from the available data)
• high temperature (fever)
• inflammation of blood vessels in the skin which may be seen as a rash
• decrease in number of blood platelets (cells that help blood to clot)
• increase in levels of urea nitrogen and serum creatinine in the blood and decreased creatinine clearance.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store
Keep this medicine out of the sight and reach of children.
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Do not store above 25°C
Keep the vial in the outer carton
The reconstituted solution for injection should not be stored for more than 24 hours at 2C - 8C. Immediate
use after reconstitution is recommended. Any remaining solution should be discarded.
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 to protect the environment.

6. Contents of the pack and other information
What contains
The active substance is cefuroxime
The other ingredient is sodium.

What looks like and contents of the pack
is a white or slightly yellow powder. It is presented in a clear type II glass vial,
stoppered with rubber closures and aluminium rings.
The 250 mg vial, the 750 mg vial and the 1500 mg vial are available in packs of 1 and 5

Marketing Authorisation Holder and Manufacturer
[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:
250 mg powder for solution for injection
Belgium, Netherlands, Portugal, United Kingdom – Cefuroxime
750 mg powder for solution for injection
Belgium, Germany, Netherlands, Portugal, United Kingdom – Cefuroxime
1.5 g powder for solution for injection
Belgium, Germany, Netherlands, Portugal, United Kingdom – Cefuroxime
This leaflet was last revised in <{MM/YYYY}>

<------------------------------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only:
Instructions for reconstitution
Table 4. 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

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Vial size

Amount of
water to be
added (ml)*

Approximate
cefuroxime
concentration
(mg/mL)**

250 mg powder for solution for injection
250 mg
Intramuscular
1 mL
214
Intravenous
at least 2 mL
115
750 mg powder for solution for injection
750 mg
Intramuscular
3 mL
214
intravenous bolus
at least 6 mL
115
1.5 g powder for solution for injection
1.5 g
intravenous bolus
at least 15mL 94
intravenous infusion
at least 10mL 139
* See information on the preparation of suspension for intramuscular injection and solutions for intravenous
injection and infusion, 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.
Instructions for reconstitution
PREPARATION OF A SUSPENSION FOR INTRAMUSCULAR INJECTION
Shake gently to produce an opaque suspension.
PREPARATION OF A SOLUTION FOR INTRAVENOUS INJECTION
1500 mg vial: For reconstitution of the powder,
- draw up at least 15ml of water for injections into the suitable syringe (20ml),
- transfer 10ml into the 1.5g vial and reconstitute the content of the vial, and
- draw up the dissolved contents of the vial into the same syringe.
PREPARATION OF A SOLUTION FOR INTRAVENOUS INFUSION
1500 mg vial: For intravenous infusions of less than 30 minutes, the contents of the 1.5 g vial may be
dissolved in a 50 ml vial or bag of water for injections as following.
For reconstitution of the powder,
- draw up at least 10ml of water for injections from the 50ml vial or bag using a suitable syringe (20ml),
- transfer the 10ml into the 1.5g vial and reconstitute the content of the vial, and
- draw up the dissolved contents of the vial into the 50ml vial or bag.
The solution may be administered directly into the vein or introduced into the tubing of the giving set if the
patient is receiving parenteral fluids.

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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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