Cefuroxime CoPharma 750mg and 1.5g Powder for Solution for Injection

Cefuroxime (as sodium) (referred to as Cefuroxime in this leaflet)

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 <product name> 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:

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:    May 2014

Product Licence Nos.:    PL 40386/0023

PL 40386/0024

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

Very common, affecting more than 1 in 10 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
Common, affecting up to 1 in 10 people:	•    unusual bruising or bleeding •    headache •    dizziness •    kidney problems especially in the elderly or those known to have kidney problems
Rare, affecting fewer than 1 in 1000 people:	•    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
Very rare, affecting fewer than 1 in 10000 people:	•    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

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.