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CEFUROXIME 1.5 G POWDER FOR SUSPENSION FOR INJECTION OR SOLUTION FOR INJECTION/INFUSION

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Package leaflet: Information for the user
Cefuroxime 250 mg powder for suspension for injection or solution for injection
Cefuroxime 750 mg & 1.5 g powder for suspension for injection or 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 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 other information

1.

What Cefur oxime 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 befor e you ar e given Cefur oxime

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, 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 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 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 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.
Driving and using machines
Don’t drive or use machines if you do not feel well.
Cefuroxime contains sodium
Cefuroxime contains sodium. You need to take this into account if you are on a
controlled sodium diet.

Cefuroxime strength
250 mg
750 mg
1.5 g

3.

Amount per vial
14 mg
41 mg
81 mg

How Cefur oxime 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.
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) erythema
multiformae.
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.
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 Coomb’s test.
Other side effects
Other side effects have occurred in a very small number of people but their exact
frequency is unknown:

high temperature (fever)

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).

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 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 stor e Cefur oxime

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 vial and carton after
EXP. The expiry date refers to the last day of that month.
Unopened vials: The unopened medicinal product does not require any special storage
conditions.
[250 mg]:
Intravenous injection:
After reconstitution: Chemical and physical in-use stability has been demonstrated for up
to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with
compatible diluents.
From a 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 should not, under any circumstances, exceed the
demonstrated chemical and physical stability period and conditions.
[750 mg & 1.5 g]:
Intravenous injection:
After reconstitution: Chemical and physical in-use stability has been demonstrated for up
to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with
compatible diluents.
Intravenous infusion:
After initial reconstitution: The product should be diluted immediately.
After further dilution of the reconstituted solution: Chemical and physical in-use stability
has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by
diluting the initially reconstituted solution with compatible diluents.
After further dilution of the reconstituted solution (with 10% invert sugar or 10%
Dextrose): Chemical and physical in-use stability has been demonstrated for up to 6
hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted
solution with 10 % invert sugar and 10% Dextrose (see section 6.6).
From a 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 should not, under any circumstances, exceed the
demonstrated chemical and physical stability period and conditions.
Do not use this medicine if you notice visible signs of deterioration such as particulate
matter and discoloration.
Do not 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 Infor mation

What Cefuroxime contains
The active substance is cefuroxime (present as cefuroxime sodium).
Each vial of Cefuroxime 250 mg contains 250 mg cefuroxime (as 263 mg cefuroxime
sodium).
Each vial of Cefuroxime 750 mg contains 750 mg cefuroxime (as 789 mg of cefuroxime
sodium).
Each vial of Cefuroxime 1.5 g contains 1.5 g cefuroxime (as 1.578 g of cefuroxime
sodium).
There are no other ingredients. However, see section 2 for “Cefuroxime contains
sodium”.
What Cefuroxime looks like and contents of the pack
[Cefuroxime 250 mg]: Powder for suspension for injection or solution for injection
[Cefuroxime 750 mg & 1.5 g]: Powder for suspension for injection or solution for
injection/infusion
A white to slightly yellow powder.
[250 mg]: 10 ml type I moulded glass vial stoppered with a grey bromobutyl rubber
stopper and sealed with an aluminium seal with a dark blue coloured polypropylene disc.
[750 mg]: 15 ml type I moulded glass vial stoppered with a grey bromobutyl rubber
stopper and sealed with an aluminium seal with a dark blue coloured polypropylene disc.
[1.5 g]: 20 ml type I moulded glass vial stoppered with a grey bromobutyl rubber stopper
and sealed with an aluminium seal with a dark blue coloured polypropylene disc.
Pack sizes: 1, 5, 10, 25 and 100 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland

Manufacturer:
Pfizer Service Company BVBA
Hoge Wei 10, B-1930, Zaventem
Belgium

This leaflet was last revised in 07/2013.
----------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
This leaflet contains practical information on the preparation and/or handling of
medicinal product. Read this leaflet carefully before administering this medicine to the
patient.
Please note: This leaflet does not contain all the necessary information for this medicine.
When determining appropriateness of use in a particular patient, the prescriber should be
familiar with the Summary of Product Characteristics (SmPC).
1.Instructions for reconstitution
For single use only.
The dilution is to be made under aseptic conditions.
Shake the vials gently to reconstitute fully.
Instructions for reconstitution
See table for addition volumes and solution/suspension concentrations, which may be
useful when fractional doses are required. Water for Injections is recommended as the
diluent for reconstitution of cefuroxime powder.
Preparation of suspension for injection or solution for injection/infusion
Addition volumes and solution/suspension concentrations, which may be useful when
fractional doses are required.
Addition volumes and solution/suspension concentrations, which may be useful
when fractional doses are required
Vial size
Amount
of Approximate
Resulting
water to be cefuroxime
Product
added (ml)
concentration
(mg/mL)**
250 mg powder for suspension for injection or solution for injection
250 mg
Intramuscular
1 mL
208
Suspension
Intravenous
at least 2 mL
114
Solution
750 mg powder for suspension for injection or solution for injection/infusion
750 mg
Intramuscular
3 mL
208
Suspension
intravenous bolus
at least 6 mL
114
Solution
intravenous infusion 6 mL*
114
Solution
1.5 g powder for suspension for injection or solution for injection/infusion
1.5 g
Intramuscular
6 mL
208
Suspension
intravenous bolus
at least 15 mL 93
Solution
intravenous infusion 15 mL*
93
Solution
*: Reconstituted solution to be added to 50 ml or 100 ml of compatible infusion fluid
(see information on compatibility, below)

**: Resulting volume of the solution/suspension of cefuroxime in reconstitution medium
is increased due to the displacement factor of the drug substance resulting in listed
concentrations in mg/ml.
As for all parenteral medicinal products, inspect the reconstituted solution or suspension
visually for particulate matter and discoloration prior to administration.
[Intramuscular injection]: After addition of the specified amount of diluent for
intramuscular injection, a suspension is formed.
[Intravenous bolus injection or intravenous infusion]: The solution should only be used if
the solution is clear and practically free from particles.
Solutions and suspensions range in colour from clear to yellow coloured depending on
concentration, diluent and storage conditions used.
[750 mg & 1.5 g]
Preparation of solution for intravenous infusion
Compatibility
Cefuroxime 750 mg & 1.5 g should be reconstituted following the instructions for
reconstitution of intravenous injection with water for injection (see table 4 above).
Further dilution should take place in 50 - 100 ml of one of the following compatible
infusion fluids prior to intravenous infusion administration:
Cefuroxime 750 mg & 1.5 g is compatible for up to 12 hours at 2-8oC in following
diluents:
• Sterile water for Injection
• Sodium chloride intravenous infusion (0.9% w/v)
• Potassium chloride (10 and 40 meq) in 0.9% sodium chloride intravenous infusion
• Ringer’s injection
• Lactated Ringer’s injection
• Sodium lactate intravenous infusion (M/6).
Cefuroxime 750 mg & 1.5 g is compatible for up to 6 hours at 2-8oC in following
diluents:
• 10% invert sugar in intravenous infusion
• 10% Dextrose.
2.Method of administration
[250 mg]: Cefuroxime should be administered by intravenous injection over a period of 3
to 5 minutes directly into a vein or by deep intramuscular injection.

[750 mg & 1.5 g]: Cefuroxime should be administered by intravenous injection over a
period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60
minutes, or by deep intramuscular injection.
3.Stability and Storage Conditions
[250 mg]:
Unopened vials: 2 years.
Intravenous injection:
After reconstitution: Chemical and physical in-use stability has been demonstrated for up
to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with
compatible diluents (see section 6.6 of the SmPC).
From a 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 should not, under any circumstances, exceed the
demonstrated chemical and physical stability period and conditions.
[750 mg & 1.5 g]:
Unopened vials: 2 years.
Intravenous injection:
After reconstitution: Chemical and physical in-use stability has been demonstrated for up
to 12 hours when stored at 2-8 ºC for solutions prepared by reconstitution with
compatible diluents (see section 6.6 of the SmPC).
Intravenous infusion:
After initial reconstitution: The product should be diluted immediately.
After further dilution of the reconstituted solution: Chemical and physical in-use stability
has been demonstrated for up to 12 hours when stored at 2-8 ºC for solutions prepared by
diluting the initially reconstituted solution with compatible diluents (see section 6.6 of
the SmPC).
After further dilution of the reconstituted solution (with 10% invert sugar or 10%
Dextrose): Chemical and physical in-use stability has been demonstrated for up to 6
hours when stored at 2-8 ºC for solutions prepared by diluting the initially reconstituted
solution with 10 % invert sugar and 10% Dextrose (see section 6.6 of the SmPC).
From a 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 should not, under any circumstances, exceed the
demonstrated chemical and physical stability period and conditions.
4.Incompatibilities
This medicinal product must not be mixed with other medicinal products except those
mentioned in the section containing reconstitution instructions.

5.Disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

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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