Cefuroxime sodium in the EU

On 24 May 2012, the European Medicines Agency completed a review of Cefuroxime sodium. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cefuroxime sodium in the European Union (EU). 

So what is Cefuroxime sodium? Cefuroxime sodium is an antibiotic used to treat certain bacterial infections,including pneumonia (infection of the lungs), urinary tract infections (infections of the structures that carry urine), soft-tissue infections (infections of tissues just below the skin), infections within the abdomen, as well as to prevent infections during surgery. 

Cefuroxime sodium is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. The CAS NO. is 56238-63-2, Molecular Weight is446.4, Molecular Formula is C16H15N4O8S.

The active substance, cefuroxime sodium, belongs to the group ‘cephalosporins’. It works by attaching to proteins on the surface of bacteria. This prevents the bacteria from building their cell walls, and eventually kills them. It is marketed in all EU Member States (except Germany, Latvia, Slovakia and Spain), as well as Iceland and Norway. It is also available under other trade names: Curocef, Curoxim, Curoxime, Zinnat.

Cefuroxime sodium is given by injection into a muscle or vein as directed by your doctor. The dosage is based on your medical condition and response to therapy.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If you are using the frozen pre-mixed solution, thaw the container at room temperature or in the refrigerator. If the bag is thawed in the refrigerator, let it sit at room temperature at least 1 hour before using. Do not thaw by putting in a water bath or microwaving. After thawing, shake well and squeeze the container to check for leaks. Discard solution if the container leaks. Do not re-freeze the solution after thawing.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, use this drug at evenly spaced intervals.Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Cefuroxime sodium is authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.

Cefuroxime sodium was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Cefuroxime sodium in the EU.