PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SZ00000LT000

Cefuroxime 750 mg Powder for Solution/Suspension for Injection Cefuroxime 1500 mg Powder for 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 pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Cefuroxime is and what it is used for

What you need to know before you take Cefuroxime

How to take Cefuroxime

Possible side effects

How to store Cefuroxime

Contents of the pack and other information

1 What Cefuroxime is and what it is used for

aminoglycoside-type antibiotics

water tablets (diuretics), such as furosemide

probenecid

oral anticoagulants

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 before you take Cefuroxime

You must not be given Cefuroxime:

•    if you are allergic to cefuroxime, to any cephalosporin antibiotics or any of

the other ingredients of this medicine listed in section 6.

•    if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

Tell your doctor before you start on Cefuroxime if you think that this applies to you. You must not be given Cefuroxime.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using 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.

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 Sandoz may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with Cefuroxime Sandoz you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 2.09 mmol (equivalent to 48 mg) of sodium per gram. This should be taken into consideration by patients on a sodium controlled diet.

How Cefuroxime is given

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 medicine. 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:

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 recommended dose is:

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.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:

Cefuroxime 750 mg/1500 mg

Powder for Solution for Injection or Infusion

Cefuroxime

““ This is an extract from the Summary of Product Characteristics to assist in the administration of Cefuroxime 750 mg / 1500 mg powder for solution for injection or infusion. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SPC.

For slow intravenous injection/infusion and intramuscular injection.

INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINAL PRODUCTS

•    Cefuroxime should not be added with other antibiotics, in the same syringe or solution for infusion. This concerns especially aminoglycosides.

•    Cefuroxime should not be mixed with solutions containing sodium bicarbonate.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

Aseptic techniques should be used to reconstitute the solution. The reconstituted solution is stable for 2 hours at room temperature and 24 h at 2°C - 8°C .

Continued on the next page >>

Cefuroxime is compatible with several commonly used intravenous infusion fluids:

-    water for injection

-    0.9 % sodium chloride solution

-    5 % glucose solution

The compatibility of cefuroxime in other infusion fluids should be checked before use.

When reconstituted for intramuscular or intravenous injection, the white to yellowish powder gives a colourless to slightly yellow suspension and a colourless to brownish solution respectively. Do not use if any particulate matter is visible. Withdraw only one dose. Any unused solution should be discarded.

Method of administration:

In order to prevent any risk of infection, the preparation of the infusion should be done in close aseptic conditions. Do not delay the infusion after the preparation of the solution.

• Intramuscular injection

Cefuroxime 750 mg powder for solution/suspension for injection:

Add 3 ml of water for injections or 1.0 % lidocain solution to Cefuroxime 750 mg. Shake gently to produce a homogenous suspension. Cefuroxime 1500 mg, powder for solution for injection, should not be administered intramuscularly.

SZ00000LT000    Continued on the next page >>

h-

lo

o

h-

LO

~o

~o

CO

§\9

o

o

"d-

"d-

■o

o

o

"d-

i?

is

"S TO

iH £

N

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 two, three or four times daily.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store Cefuroxime

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 carton/bottle after EXP.

The expiry date refers to the last day of that month.

Powder:

Keep container in the outer carton in order to protect from light.

Do not store above 25°C.

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).

•    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:

•    fungal infections

•    high temperature (fever)

•    allergic reactions

•    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).

•    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.

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 to clot - thrombocytopenia)

•    increase in levels of urea nitrogen in the blood and serum creatinine.

For storage conditions of the reconstituted/diluted medicinal product, see at the end of the package leaflet ‘The following information is intended for medical or healthcare professionals only’.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Cefuroxime contains

•    Active substance: the active substance is cefuroxime.

750 mg, powder for solution/suspension for injection:

1 vial contains 750 mg of cefuroxime as 789 mg of cefuroxime sodium

1500 mg, powder for solution for injection/infusion:

1 vial contains 1500 mg of cefuroxime as 1578 mg of cefuroxime sodium

•    Other ingredients:

the medicine contains no other ingredients than the active substances.

What Cefuroxime looks like and contents of the pack

Cefuroxime 750 mg, powder for solution/suspension for injection: white to yellowish powder. 15 ml vials of clear glass type III (Ph. Eur.) closed with rubber stopper and flip-off bordered caps.

Cefuroxime 1500 mg, powder for solution for injection/infusion: white to yellowish powder. 30 ml vials of clear glass type III (Ph. Eur.) closed with rubber stopper and flip-off bordered caps.

100 ml infusion bottles of clear glass type II (Ph. Eur.) closed with rubber stopper and flip-off bordered caps.

Vials: 750 mg: 1, 5, 10, 25, 50, 100 vials. 1500 mg: 1, 5, 10, 25, 50, 100 vials.

Bottle: 1500 mg: 1,5, 10, 25, 50, 100 infusion bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd.

Frimley Business Park, Frimley, Camberley, Surrey,

GU16 7SR. UK.

Manufacturer:

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria This leaflet was last revised in 08/2016.

SZ00000LT000

•    Intravenous injection

Cefuroxime 750 mg / 1500 mg powder for solution/suspension for injection: Dissolve Cefuroxime 750 mg in at least 6 ml of water for injections, 0.9 % sodium chloride solution or 5 % glucose solution, Cefuroxime 1500 mg in at least 15 ml. Shake gently to produce a clear solution.

•    Short intravenous infusion (e.g. up to 30 minutes)

Cefuroxime 1500 mg powder for solution/suspension for injection:

Cefuroxime 1500 mg may be dissolved in 50 ml water for injection, 0.9 % sodium chloride solution or 5 % glucose solution.

These solutions may be given directly into the vein or introduced into the tubing of the giving set. Shake gently to produce a clear solution.

The contents and concentrations of cefuroxime as solution / suspension are shown in the table below.

h-

LO

o

h-

LO

~o

~o

CO

§\9

o

o

■O

o

o

"3

-3-

1?

is

"S TO

iH £

N