CEFUROXIME 1.5G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: CEFUROXIME SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefuroxime 750mg powder for solution for injection.
Cefuroxime 1.5g powder for solution for injection or infusion
(cefuroxime sodium)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
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 or pharmacist.

·
·
·
·

In this leaflet:
1.
2.
3.
4.
5.
6.

What Cefuroxime is and what it is used for
Before you use Cefuroxime
How to use Cefuroxime
Possible side effects
How to store Cefuroxime
Further informaiton

The name of your medicine is Cefuroxime 750mg Powder
for Injection or Cefuroxime 1.5g Powder for Injection or
Infusion but will be referred to as Cefuroxime or as
Cefuroxime injection throughout this leaflet.
1. WHAT CEFUROXIME IS AND WHAT IT IS USED FOR
Cefuroxime injection is an antibiotic which helps the body
fight infections by destroying certain bacteria that causes
them.
Cefuroxime injection is used to treat many different types
of infections including:
• bronchitis, pneumonia and any other chest infections;
• cystitis and kidney infections;
• pelvic inflammatory diseases;
• gonorrhoea;
• ear, nose and throat infections
• skin, soft tissue, bone and joint infections;
• meningitis.
Your doctor may also give it to you before an operation to
protect you from infection.
2. BEFORE YOU USE CEFUROXIME
Your doctor or nurse will make sure it is safe for you to
have Cefuroxime injection.
Do not take Cefuroxime if you:
• are allergic (hypersensitive) to Cefuroxime or any of
the other ingredients of Cefuroxime listed in section 6.
• have ever had an allergic reaction to antibiotics such
as penicillin or cephalosporins. An allergic reaction
may include a rash, itching, swelling or breathing
difficulties.
Take special care with Cefuroxime and tell your doctor if:
• you have kidney problems or are on dialysis
• you have jaundice (yellowing of the skin and
eyes), low blood protein
• this injection is for a premature baby
• you are on a low sodium diet because Cefuroxime
injection contains significant quantities of sodium
This medicine can alter the results of some blood tests
e.g. blood cross-matching and blood sugar tests for
diabetes. It is important to tell the doctor that you are
taking this medicine if you have to have any of these tests.
Unlike certain cephalosporin antibiotics, Cefuroxime does
not usually cause a false positive result when the urine is
tested for sugar.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Cefuroxime may interfere with
• diuretics (water tablets) e.g. furosemide
• aminoglycoside antibiotics e.g. gentamicin and
neomycin
• other antibiotics e.g. probenacid.

In some cases your doctor will arrange further
monitoring, but this is routine and nothing to worry about.
Using Cefuroxime with food and drink
Cefuroxime injection can be used at any time of the day
without regard to food intake.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Cefuroxime is not known to harm the unborn child but,
like all medicines, it will only be given to a pregnant
woman if it is really needed. Your doctor will decide this.
Breast-feeding is not recommended whilst taking
Cefuroxime as small amounts of Cefuroxime may enter
the milk. .
Driving and using machines
Cefuroxime is not known to affect the ability to drive or
operate machinery.
Important Information about some of the ingredients of
Cefuroxime injection
Each 750mg vial contains 36.75mg sodium; each 1.5g
vial contains 73.5mg sodium. To be taken into
consideration by patients on a controlled sodium diet.
3. HOW TO USE CEFUROXIME
Your doctor will decide which dose you need. Your doctor
or nurse will inject the Cefuroxime injection into a muscle
or into a vein. In some cases, it may be added to a ‘drip’
intravenous infusion.
Cefuroxime Injection is made up by adding the following
amount of sterile water or other recommended diluting
solution:
Vial size

750mg
1.5g

Intramuscular
injection
(suspension)

Intravenous
injection
(solution)

Intravenous
infusion
(solution)

3 ml

6 ml

-

-

15 ml

-

On reconstitution, product must be mixed vigorously for
at least 90 seconds prior to withdrawing into the syringe;
and if not given immediately, again just prior to
administration.
Usual doses
Adults: Most adults need 750mg three or four times a day
but for more severe infections this may be increased to
1.5g three or four times a day. If you have kidney trouble,
you may be given the lower dose just once or twice a day.
• Your doctor may give you 1.5g of Cefuroxime
injection before surgery to protect you from
infection. You may get further doses of 750mg
of Cefuroxime injection after the operation.
• If you have a joint replacement operation, Cefuroxime
may be mixed in the cement which is used.
Infants and children: Most need 60mg for each kilogram
of their body weight each day. This will be divided into
three or four doses.
Newborn babies: Most need 30 to 100mg for each
kilogram of their body weight each day. This will be
divided into three or four doses.

• If you or a child is being treated for meningitis,
larger doses of Cefuroxime injection may be needed.
For the treatment of gonorrhoea:
• 1.5g should be given as a single dose. This may be
given as 2 x 750mg injections into different sites e.g.
each buttock.
For the treatment of pneumonia:
• A twice daily dose of 1.5g injection should be given
for 48-72 hours, followed by a twice daily dose of
500mg cefuroxime axetil oral therapy for 7 days.
For the treatment of acute exacerbations of chronic
bronchitis:
• A twice daily dose of 750mg injection should be given
for 48-72 hours, followed by a twice daily dose of
500mg cefuroxime axetil oral therapy for 5-7 days.
If you take more Cefuroxime than you should:
It is most unlikely that you will be given too much
medicine by the nurse or doctor. Your doctor and nurse
will be monitoring your progress, and checking the
medicine that you are given. Always ask if you are not
sure why you are getting a dose of medicine.
If you forget to take Cefuroxime:
Your doctor or nurse have instructions when to give you
your medicine. It is most unlikely that you will not be
given the medicine as it has been prescribed. If you think
that you may have missed a dose then talk to your nurse
or doctor. It is important that the course of treatment your
doctor has prescribed is taken. You may start to feel
better but it is important not to stop taking this medicine,
until the doctor advises, otherwise your condition may get
worse again.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefuroxime can cause side effects,
although not everybody gets them.
Some people may be allergic to antibiotics; if any of the
following rare side effects occur soon after having your
injection, tell your doctor immediately:
• Loss of consciousness
• Sudden wheeziness and chest tightness or
breathing difficulties
• Swelling of the eyelids, face or lips
• Severe skin rashes that can peel or blister
• Fever
Other side effects are classified according to the following
frequencies:
- Very common (in more than 1 in 10 patients)
- Common (in more than 1 in 100 but less than
1 in 10 patients)
- Uncommon (in more than 1 in 1000 but in less
than 1 in 100 patients)
- Rare (in more than 1 in 10,000 but less than
1 in 1000 patients)
- Very rare (in less than 1 in 10,000 patients including
reports of isolated cases)

Laboratory tests have shown that Cefuroxime can also
cause changes in the blood, such as a decrease in blood
haemoglobin concentrations (may result in anaemia),
decreases in white blood cell counts (with an increased
risk of infection), decreases in the very tiny blood cells
called platelets (resulting in bruising and prolonged
bleeding) and increases in the numbers of a type of white
blood cells (eosinophils).
Like other medicines used to treat meningitis, Cefuroxime
may take some time in clearing up the infection. As a
result of this, hearing loss caused by meningitis has
occurred in a few patients after using cefuroxime.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE CEFUROXIME
Keep out of the reach and sight of children.
The un-opened dry powder should be stored below 30˚C.
Store in the original package.
From a microbiological point of view, the reconstituted
solution should be used immediately. If not used
immediately, the reconstituted solution should be stored
at 2-8˚C for no longer than 24 hours.
Do not use Cefuroxime after the expiry date which is
stated on the label and carton after EXP.
The expiry refers to the last day of that month.
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 INFORMAITON
What Cefuroxime injection contains
Cefuroxime injection contains the active ingredient
Cefuroxime Sodium. There are no other ingredients.
What Cefuroxime looks like and contents of the pack
Cefuroxime 750 mg powder for injection is a white or
off-white powder which forms:
• an off-white, opaque suspension for intramuscular use
when reconstituted with 3ml of Water for Injections.
• a yellowish, clear solution for intravenous use when
reconstituted with 6ml of Water for Injections.
Cefuroxime 1.5 g powder for injection or infusion is a
white or off-white powder which forms:
• a yellowish, clear solution for intravenous injection
when reconstituted with 15 ml of Water for Injections.
• a yellowish, clear solution for intravenous infusion
when reconstituted with 50 ml of Water for Injections.
Cefuroxime 750 mg powder for injection is available in
10 ml vials in packs of 1, 5 or 100 vials.
Cefuroxime 1.5 g powder for injection or infusion is
available in 20 and 100 ml vials in packs of 1, 10 or 20
vials.
Not all pack sizes may be marketed.

Common:
• Changes in liver enzymes
• Inflammation or pain at the site of injection
Uncommon:
• Diarrhoea which contains blood or mucous
Rare:
• Thrush infections
• Easy bruising (thrombocytopenia)
• Changes in how the liver and kidneys function
Very rare:
• Headache, joint pain, generally feeling unwell
(Pseudomembranous colitis)
• Inflammation of the kidneys

Marketing Authorisation Holder and Manufacturer
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí,
Barcelona, Spain
This leaflet was last revised in June 2012.

Expand view ⇕

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.

Hide
(web3)