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CEFUROXIME 750 MG POWDER FOR SOLUTION FOR INJECTION

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Cefuroxime
250 mg
Cefuroxime 250 mg, 750 mg and 1500 mg, powder for solution for injection Cefuroxime sodium Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Cefuroxime is and what it is used for 2. Before you use Cefuroxime 3. How to use Cefuroxime 4. Possible side effects 5. How to store Cefuroxime 6. Further information 1. WHAT CEFUROXIME IS AND WHAT IT IS USED FOR Effect: Cefuroxime is an antibiotic with a bacterial-killing effect. It is used for the treatment of infections caused by bacteria that are sensitive to Cefuroxime. Cefuroxime is used in the treatment of: Infections in the lower respiratory tract (acute bronchitis, acute exacerbation of chronic bronchitis and pneumonia) Upper urinary tract infection: Pyelonephritis. Blood poisoning (Sepsis). Cefuroxime is also used as prophylactic treatment at surgeries in patients with an increased risk of infections. Always follow your doctors instructions. 2. BEFORE YOU USE CEFUROXIME You should not receive Cefuroxime if you are hypersensitive (allergic) to Cefuroxime or another type of antibiotics called cephalosporins. if you previously have experienced a serious or acute allergic reaction in connection with penicillin or a beta-lactam antibiotic. Thedoctorandthehealthcareprofessionalswilltake special care when treating you with Cefuroxime if you suffer from a severely impaired kidney function. A dose adjustment of Cefuroxime is necessary. if your doctor has prescribed a controlled sodium diet, as Cefuroxime contains sodium. if you have severe and persisting diarrhoea during or the first weeks after treatment. The risk of life threatening pseudo-membranous colitis should be taken into account.

750 mg 1500 mg
The use of Cefuroxime should be discontinued and the appropriate treatment established. Medicinal products inhibiting peristalsis is contra-indicated. You should inform your doctor or the healthcare professionals. if you have had an allergic reaction related to penicillin or beta-lactam antibiotics, as cross reactions may occur. if you suffer from impaired liver function. if you experience new infections, e.g. fungal infections, during long term treatment with Cefuroxime. It may result in overgrowth of nonsusceptible organisms (e.g. Candida, Enterococci, Clostridium difficile), which may require interruption of treatment. if you experience vomiting and diarrhoea during or following the treatment with Cefuroxime. The symptoms might affect the efficacy of other concomitant used medications, e.g. contraceptives. Other contraception (e. g. a condom) should be used. Blood test When you are having a blood test always point out that you are in treatment with Cefuroxime. It may affect the test results. Using other medicines Please tell your doctor or healthcare professionals if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The doctor will take special care if you are using any of the following medicinal products concomitantly: high doses of Cefuroxime and medicinal with potent diuretics such as furosemide, aminoglycosides and amphotericins. Cefuroxime and bacteriostatic drugs such as tetracyclines, macrolides, or chloramphenicol Cefuroxime and probenecid (medicinal product against gout). Cefuroxime and antiperistaltics (symptomatic treatments of diarrhoea). contraceptive pills (their effect may be reduced). Therefore, during the treatment with Cefuroxime a non-hormonal contraception, e.g. a condom, should be used. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy: Experience in pregnant women is limited. Cefuroxime should only be used if the advantage of using it outweights the potential risk for the child. Breast-feeding Cefuroxime is excreted in breast milk. Cefuroxime should only be used if the advantage of using it outweights the potential risk for the child. If you breast-feed your child while you are in treatment with Cefuroxime, your child may get diarrhoea and fungal infections. .../...

PACKAGE LEAFLET: INFORMATION FOR THE USER

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: Preparation When fluid is added to the vial and during dissolution of the product aseptic technique should be used.

Cefuroxime is compatible with other solutions for injection: Cefuroxime is diluted in fluid for solution immediately before use:

Water for injection 0.9% sodium chloride solution 5% glucose solution At least 2 ml for 250 mg cefuroxime At least 6 ml for 750 mg cefuroxime At least 15 ml for 1500 mg cefuroxime

Shake to the solution has become clear. The reconstituted solution is yellow to brownish-coloured. Differences in colour and intensity do not mean that the effect or the safety of the product has been affected.

In this case the breast-feeding might have to be discontinued. Driving and using machines Cefuroxime may cause side effects (e. g. dizziness, confusion, headache), which may affect the ability to work safely and to drive a vehicle. It is your responsibility to decide whether you are able to drive a car or to perform risk-bearing work. 3. HOW TO USE CEFUROXIME Prior to the use Cefuroxime is mixed with solution for injection. It is administered as an injection into a blood vessel by the healthcare professionals. The usual dose for the treatment of infections: Adults and adolescents (over 12 years): 1.5 6 g/24h. In most infections a sufficient dose is 750 mg every 8 hours. Children (above 1 month): 30-100 mg/kg/day, divided into 3-4 doses. In the majority of the infections 60 mg/kg/daily is sufficient. Children below 1 month: 30-100 mg/kg/daily, divided into 2 doses. The usual dose as prophylaxis in surgeries: Adults and adolescents (above 12 years): 1.5 g into a blood vessel 30-60 minutes before an operation. Reduced kidney function: You may need a lower dose. Ask your doctor. Dose depends on the infection type and the severity degree. Your doctor will adjust your dose. If you have the impression that the effect of Cefuroxime is too strong or too weak, you should contact your doctor or healthcare professionals. The duration of the treatment with Cefuroxime will depend on how severe your infection is and how well you are responding to the treatment. In general antibiotic treatment should be continued for at least three days above decline of fever. If you have received too much of Cefuroxime, powder for solution for injection Contact the doctor or healthcare professionals, if you think that you have received too much of Cefuroxime. What is done if a dose has been forgotten Ask the doctor or healthcare professional if you believe that a dose has been forgotten. If you have any further questions on the use of this product, ask your doctor or healthcare professional. 4. POSSIBLE SIDE EFFECTS Like all medicines, Cefuroxime can cause side effects, although not everybody gets them. Common side effects (occur in between 1 and 10 out of 100 treated): rash, itching, nettle rash (may be an allergic reaction). gastrointestinal discomfort, diarrhoea, nausea, vomiting. acute pain or inflammation at the injection site heat sensation or nausea after rapid injection. changes in blood levels: decreased number of white blood cells, increased number of the eosinophil subtype of white blood cells. Uncommon side effects (occur in between 1 and 10 out of 1,000 treated): headache. dizziness. inflammation of the kidneys and other kidney diseases, especially by large doses and in elderly.

changes in blood levels: affected liver and kidney levels. Rare side effects (occur in between 1 and 10 out of 10,000 treated): severe skin reactions with blistering and peeling. fever. allergic reaction causing swelling and joint pain (serum sickness). fungal infection of the mucous in the mouth, vagina and intestine. diarrhoea caused by infected large intestine. loss of hearing, especially in children suffering from meningitis. changes in blood levels: decreased number of blood platelets Very rare side effects (occur in less than 1 out of 10,000 treated): jaundice. anaemia. restlessness, nervousness, confusion. severe allergic reaction.e.g. followed by fainting and difficulty in breathing. Contact a doctor immediately if you experience an infection with symptoms like fever followed by strong aggravated general condition or fever including locale symptoms of infection such as pain in neck/throat/mouth or difficulty with urination. By blood tests it is possible to exclude shortage of white blood cells. In this connection it is important to inform about your treatment. Also contact your doctor if you suspect loss of hearing or have strong and persistent diarrhoea during or after treatment with 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 healthcare professional. 5. HOW TO STORE CEFUROXIME Keep out of the reach and sight of children. Do not store Cefuroxime above 25C. Keep vial in the outer carton in order to protect from light. Reconstituted solutions should be used at once, but can be stored for 24 hours in refrigerator (2 8 C) protected from light. Do not use after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month. 6. FURTHER INFORMATION What Cefuroxime contains: The active substance: Cefuroxime (as cefuroxime sodium). There are no further excipients. What Cefuroxime looks like and contents of the pack: Cefuroxime is a white to cream-coloured powder. Cefuroxime is available in cartons with vials. Each carton contains 10 vials. Marketing Authorisation Holder: STRAGEN UK Limited Castle Court, 41 London Road, Reigate, Surrey RH2 9RJ Manufacturer: MITIM, S.R.L. Via Cacciamali 34-38, I-23125 Brescia, Italy This leaflet was last approved in May 2010

The reconstituted solution has to be inspected for visible particles before use. The solution should only be used if clear and free of particles. Administration: The reconstituted solution should be administered immediately. The solution should be administered as a slow 3-5 minute injection. Cefuroxime should not be mixed with solutions containing sodium hydrogen carbonate or aminoglycosides. If required, the Cefuroxime solution in water for injections can be introduced into the tubing of the giving set in patients receiving sodium bicarbonate solution by infusion. The compatibility of Cefuroxime with other solutions for injection should be checked before use. Cefuroxime should neither be mixed with other medicinal products in a syringe nor in a solution for infusion. For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

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