Description

Product Overview

What Cefuroxime 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.

What you need to know before you are given Cefuroxime

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 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
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 (ʻConditions you need to look out forʼ) 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 youʼve 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 youʼll 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
Donʼt 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

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 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, theyʼll 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, theyʼll 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.

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 an homogenous suspension. Cefuroxime 1500 mg, powder for solution for injection, should not be administered intramuscularly

Possible side effects

Like all medicines, this medicine 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).
• 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 Coombʼs 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.

If you get any side effects tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

How to store Cefuroxime

Keep this medicine out of the sight and reach of children.
Do not use Cefuroxime after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Powder:
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.
For storage conditions of the reconstituted/diluted medicinal product, see at the end of the package leaflet ʻThe following information is intended for medical or healthcare professionals onlyʼ.

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 protect the environment.

Contents of the pack and other information

What Cefuroxime contains
• Active substance: the active substance is cefuroxime (as sodium salt).

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 medicinal product contains no other ingredients than the active substances.Cefuroxime Powder for Injection/Infusion – Taj Dearob Pharma | 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 Powder for Injection/Infusion – Taj Dearob Pharma | 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 Powder for Injection/Infusion – Taj Dearob Pharma | 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 Powder for Injection/Infusion – Taj Dearob Pharma | 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 Powder for Injection/Infusion – Taj Dearob Pharma | 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.