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CEFUROXIME COPHARMA 750MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): CEFUROXIME SODIUM

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CoPharma as this medicine may stop the oral contraceptives from
working properly.
PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefuroxime CoPharma 750mg and 1.5g
Powder for Solution for Injection
Cefuroxime (as sodium)
(referred to as Cefuroxime in this leaflet)
Read all this leaflet carefully before you are given Cefuroxime
CoPharma

Keep this leaflet. You may need to read it again

If you any have further questions, please ask your
doctor or nurse

If any of the side effects become serious or if you
notice any side effects not listed in this leaflet, please
tell your doctor or nurse.
In this leaflet:
1. What Cefuroxime CoPharma is and what it is used for
2. Before you are given Cefuroxime CoPharma
3. How Cefuroxime CoPharma is given
4. Possible side-effects
5. How to store Cefuroxime CoPharma
6. Further information
1.
WHAT CEFUROXIME COPHARMA IS AND WHAT IT IS
USED FOR
Cefuroxime CoPharma belongs to a group of antibiotics called
cephalosporins.
Antibiotics are used to kill the bacteria or “germs” that cause infections.
Cefuroxime CoPharma is used:

to treat infections of the lungs

to treat kidney infections

2.

BEFORE YOU ARE GIVEN CEFUROXIME COPHARMA

You should not be given Cefuroxime CoPharma if:
 you are allergic (hypersensitive) to Cefuroxime CoPharma, or to any
of the
cephalosporin type antibiotics.
 you are allergic to other antibiotics such as penicillin
Take special care with Cefuroxime CoPharma if:

you have liver or kidney problems

you are on a low sodium diet

you have severe or persistent diarrhoea that may be bloody and
that may be associated with stomach pain or cramps: these
symptoms may occur during or shortly after treatment and signal a
rare, but potentially life threatening adverse reaction. Stop taking
Cefuroxime CoPharma and contact your doctor immediately.
Medicines which may slow or stop bowel movements must not be
taken.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Tell your doctor before you are given Cefuroxime CoPharma if you are
taking any of the following medicines:

medicines that make you pass more urine (diuretics) such as
furosemide

Any other antibiotic

probenecid, a medicine used in the treatment of joint disease and
CMV infection.

oral contraceptives (birth control). You should use additional
methods of contraception during your treatment with Cefuroxime

If you have any doubts about whether Cefuroxime CoPharma is suitable
for you speak to your doctor before starting your treatment with this
medicine.

Pregnancy and breast-feeding
If you are pregnant, trying for a baby or breast-feeding you should tell
your doctor before you are given Cefuroxime CoPharma. You will only
be given Cefuroxime CoPharma if the benefits outweigh the potential
risks.
Driving and using machines
In rare cases Cefuroxime CoPharma can make you feel dizzy, nervous
or confused. If you feel at all unwell after being given Cefuroxime
CoPharma you should not attempt to drive or use machines.
Important information about some of the ingredients of Cefuroxime
CoPharma
This medicine contains 54mg of sodium per gram of Cefuroxime
CoPharma. If you are on a low sodium diet you should speak to your
doctor before being given this medicine.

3.

HOW CEFUROXIME COPHARMA IS GIVEN

Cefuroxime CoPharma will usually be given by a doctor or nurse either
directly into a vein (intravenously) or into a muscle (intramuscularly).
Cefuroxime CoPharma is supplied as a powder, so before it can be
given it must be diluted and made into a solution. This is normally done
by your doctor or nurse.
Your doctor will determine the dose you require. The usual doses are
given below, however your doctor may decide to give you less or more
Cefuroxime CoPharma than this and given more often depending on the
severity and types of infection, your weight, age and kidney function. The
duration of treatment depends on the type of infection.
Adolescents (age 12 to 17yrs), Adults and the Elderly
The usual adult dose is 750mg to 1.5g three times a day. Bigger or more
frequent doses are sometimes needed. The duration of treatment
depends on the type of infection.
Infants (age 28 days to 23 months) and Children (2 to 11 years)
The dose is based on body weight and is usually between 30mg to
100mg per kilogram of bodyweight given daily divided into three or four
separate doses.
Neonates (up to 27 days and including preterm children) and
children up to 11yrs with kidney problems
Cefuroxime CoPharma is not recommended
Adolescents (age 12 to 17yrs) and Adults with kidney problems
The dose of Cefuroxime CoPharma may be reduced if you have kidney
problems.
If you are given too much, or too little, Cefuroxime CoPharma
Your medication will usually be given to you by the health professional –
if you think you may have missed a dose or have received too much
medicine please tell your doctor or nurse.
If you stop taking Cefuroxime CoPharma
As with all antibiotics it is important that you are given Cefuroxime
CoPharma regularly and the full course is completed.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Cefuroxime CoPharma can cause side effects,
although not everybody gets them.

The following side effects are important and will require immediate action
if you experience them. You should stop taking and see
your doctor immediately if the following symptoms occur:
Rare side effects affecting fewer than 1 in 1,000 patients

severe, extensive, blistering skin rash

watery and severe diarrhoea that may also be bloody
Very rare side effects affecting fewer than 1 in 10,000 patients

a sudden allergic reaction with shortness of breath, rash,
wheezing and drop of blood pressure
Frequency not known:

swelling of the face, tongue and windpipe which can cause
great difficulty in breathing
The following side-effects have also been reported:

Very common, affecting
more than 1 in 10
people







Common, affecting up to
1 in 10 people:

Rare, affecting fewer
than 1 in 1000 people:

Very rare, affecting
fewer than 1 in 10000
people:














diarrhoea
feeling sick or being sick
changes in blood test results
pain, swelling or redness at the
site of injection
skin rash, itch and hives
unusual bruising or bleeding
headache
dizziness
kidney problems especially in the
elderly or those known to have
kidney problems
thrush in the mouth or vagina
a type of allergic reaction known
as serum sickness, the symptoms
of which include a rash, fever and
pain in the joints.
fever
symptoms of anaemia such as
pale skin and feelings of tiredness
feeling dizzy, restless, nervous or
confused
yellowing of the skin (jaundice)

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or nurse.

5.

HOW TO STORE CEFUROXIME COPHARMA

Store unopened vials below 25°C. Store in the outer carton in order to
protect from light.
Keep out of the reach and sight of children.
This product has an expiry date on the vial and carton label. The doctor
or nurse will check that the product has not passed this date.
Reconstituted solutions for injection should be used immediately.

6.

FURTHER INFORMATION

What Cefuroxime CoPharma contains
The active ingredient is Cefuroxime CoPharma sodium, equivalent to
750mg or 1500mg of cefuroxime. The sodium content is 40.65mg per
750mg and 81.3mg per 1500mg of Cefuroxime.
There are no other ingredients.
What Cefuroxime CoPharma looks like and contents of the pack
Cefuroxime CoPharma is a white or off-white powder supplied in 15ml
and 20ml vials.
Each 15ml vial contains 750mg of Cefuroxime

Each 25ml vial contains 1500mg of Cefuroxime
Marketing Authorisation Holder and Manufacturer:
MA holder: COPHARMA ApS, Kanalholmen 14-18, DK-2650 Hvidovre
Denmark
Manufacturer: Cardinal Health UK 434 Limited, Bampton Road,
Romford, RM3 8UG, United Kingdom

Date of Revision:
Product Licence Nos.:

May 2014
PL 40386/0023
PL 40386/0024

If this leaflet is difficult to see or read, please contact the marketing
authorisation holder for help.

TECHNICAL PRESCRIBING INFORMATION

Cefuroxime Copharma 750mg and 1.5g
Powder for Solution for Injection
The following information is intended for medical or healthcare
professionals only.
Incompatibilities:
Cefuroxime CoPharma is compatible with most commonly used
intravenous fluids and electrolyte solutions.
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 Sodium. However, if
required, for patients receiving sodium bicarbonate injection by infusion
the Cefuroxime Sodium may be introduced into the tube of the giving
set.
Cefuroxime CoPharma should not be mixed in the syringe with
aminoglycoside antibiotics.
In use storage
From a microbiological point of view, the product should be used
immediately after reconstitution. If not used immediately, in-use storage
times and conditions prior to use are responsibility of the user.
Instruction for use, handling and disposal
Intravenous injection:
Add water for injection immediately before use:
Dissolve using at least 6ml to 750mg and 15 ml to 1500 mg.
Shake until a clear solution is obtained.
Intramuscular Injection (for 750mg only)
Add 3ml water for injections to Cefuroxime Sodium 750mg. Shake gently
to produce an opaque suspension.
Appropriate amounts of water are added to prepare a solution for
intravenous injection. The reconstituted solution is yellowish to brownish.
Differences in colour and intensity do not have any influence on the
safety and efficacy.
Shake gently to produce a clear solution.
An aqueous solution of Cefuroxime CoPharma has a pH value of 6.08.5.
Cefuroxime can be mixed with the following solutions for injection:
- Water for injection
- sodium chloride 9 mg/ml (0,9%)solution
- glucose 50mg/ml (5%) solution
As for all parenteral medicinal products, inspect the reconstituted
solution visually for particulate matter and discoloration prior to
administration. The solution should only be used if the solution is clear
and practically free from particles.
For single use only. Any remaining solution should be discarded.
Empty vials and any unused medical products should be returned to
pharmacy/supplier or to the local waste disposal site.

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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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