CEFUROXIME INJECTION 1.5G - patient leaflet, side effects, dosage

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 nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Cefuroxime Injection is and what it is used for

• 2. What you need to know before you are given Cefuroxime Injection

• 3. How Cefuroxime Injection is given

• 4. Possible side effects

• 5. How to store Cefuroxime Injection

• 6. Contents of the pack and other information

1. what cefuroxime injection 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 antibiotics 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 are given cefuroxime injection if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of cefuroxime injection.

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

Warnings and precautions

Talk to your doctor or nurse before receiving Cefuroxime Mylan:

• if you are elderly
• if you have kidney problems. You may need extra blood tests to monitor how your kidneys are working while you are taking cefuroxime.

During treatment

Tell your doctor or nurse immediately if you get:

• allergic reactions
• gastrointestinal disorders such as diarrhoea

This will reduce the risk of possible problems(See section 4, ‘Possible side effects’).

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, have recently taken or might take any other medicines. 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:

• 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.

Pregnancy and breast-feeding

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

During pregnancy, your doctor will consider the benefit of treating you with cefuroxime against the risk to your baby.

Cefuroxime is present in breast milk. There is a risk of diarrhoea or fungal infection to the breast-fed child. Your doctor will discuss with you whether it is more benficial to continue treatment or to breast-feed your child.

Driving and using machines

Don’t drive or use machines if you do not feel well.

Cefuroxime Injection contains sodium.

This medicine contains 13.5 mg, 40.6 mg and 81.3 mg of sodium respectively per 250 mg dose, 750 mg dose and 1500 mg dose. You need to take this into account if you are on a controlled sodium diet.

3. How Cefuroxime Injection 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, 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 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.

If you are given more Cefuroxime Injection than you should

If you think you have been given too much of cefuroxime injection, tell your doctor or nurse immediately. You may have fits; hallucinations; and you may also feel drowsy; confused and unconscious. These may be signs of problems with your brain (encephalopathy).

4. possible side effects

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

Contact your doctor or nurse immediately or go to your nearest hospital emergency department if you notice any of the following serious side effects:

• 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).
• 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.
• an overgrowth of bacteria in the body which can lead to stomach pain, bloating, diarrhoea or constipation. This is more likely if you are treated with cefuroxime for a long time.
• an increase in the number of infections causing fever, severe chills, sore throat and mouth ulcers. These may be signs of low levels of white blood cells.
• tiredness, headaches, shortness of breath, looking pale, yellowing of the skin or whites of the eyes. These may be signs that you have low levels of red blood cells.
• persistent or severe diarrhoea, possibly with blood and mucus and stomach pain. These may be signs of inflammation of the intestine.
• changes in the amount of urine produced, fever, dark coloured urine, exhaustion, feeling sick (nausea) or being sick (vomiting), general swelling (water retention). These may be signs of serious problems with your kidneys.

Other possible side effects include:

Common side effects

(may affect up to 1 in 10 people)

• injection site pain, swelling and redness along a vein.
• increases in substances (enzymes) produced by the liver, which can be seen in a blood test
• an increase in some white blood cells (eosinophilia)
• low levels of red blood cells (anaemia), which can be seen in a blood test.

Uncommon side effects

• diarrhoea, nausea, stomach pain
• increase in bilirubin (a substance produced by the liver), which can be seen in a blood test
• positive Coomb’s test.

Not known: (frequency cannot be estimated from the available data)

• high temperature (fever)
• inflammation of blood vessels in the skin which may be seen as a rash
• decrease in number of blood platelets (cells that help blood to clot)
• increase in levels of urea nitrogen and serum creatinine in the blood and decreased creatinine clearance.

Reporting of side effects

If you get any side effects, talk to your doctor 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 at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefuroxime injection

Keep this medicine out of the sight and reach of children.

Do not store above 25°C

Keep the vial in the outer carton

The reconstituted solution for injection should not be stored for more than 24 hours at 2°C – 8°C. Immediate use after reconstitution is recommended. Any remaining solution should be discarded.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

Don’t throw away any medicines via wastewater or household waste. Your doctor or nurse will dispose of any medicine that is no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationthe active substance is cefuroxime

The other ingredient is sodium.

What Cefuroxime Injection looks like and contents of the pack

Cefuroxime Injection is a white or slightly yellow powder. It is presented in a clear type II glass vial, stoppered with rubber closures and aluminium rings.

The 250 mg vial, the 750 mg vial and the 1500 mg vial are available in packs of 1 and 5.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL

Manufacturer:

ACS Dobfar Spa, Viale Adetta, Tribiano, Italy

This leaflet was last revised in 05/2018

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The following information is intended for healthcare professionals only:

Instructions for reconstitution

Table 4. Addition volumes and solution concentrations, which may be useful when fractional doses are required.

• See information on the preparation of suspension for intramuscular injection and solutions for intravenous injection and infusion, below

• * * The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.

Instructions for reconstitution

PREPARATION OF A SUSPENSION FOR INTRAMUSCULAR INJECTION

Shake gently to produce an opaque suspension.

PREPARATION OF A SOLUTION FOR INTRAVENOUS INJECTION

1500 mg vial : For reconstitution of the powder,

• – draw up at least 15 ml of water for injections into the suitable syringe (20 ml),

• – transfer 10 ml into the 1500 mg vial and reconstitute the content of the vial, and

• – draw up the dissolved contents of the vial into the same syringe.

PREPARATION OF A SOLUTION FOR INTRAVENOUS INFUSION

1500 mg vial : For intravenous infusions of less than 30 minutes, the contents of the 1500 mg vial may be dissolved in a 50 ml vial or bag of water for injections as following.

For reconstitution of the powder,

• – draw up at least 10 ml of water for injections from the 50 ml vial or bag using a suitable syringe (20 ml),

• – transfer the 10ml into the 1500 mg vial and reconstitute the content of the vial, and

• – draw up the dissolved contents of the vial into the 50 ml vial or bag.