On 24 May 2012, the European Medicines Agency completed a review of Zinacef. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinacef in the European Union (EU).
- What is Zinacef?
Zinacef 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) and infections within the abdomen, as well as to prevent infections during surgery.
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.
Zinacef is marketed in all EU Member States (except Germany and Slovakia), as well as Iceland and Norway. It is also available under other trade names: Curocef, Curoxim, Curoxim Monovial, Curoxima, Curoxime, Zinnat, Zinocep and Zinocep Vena.
The company that markets these medicines is GlaxoSmithKline.
- Why was Zinacef reviewed?
Zinacef 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.
Zinacef was identified as needing harmonisation by the Coordination 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 Zinacef in the EU.
- What are the conclusions of the CHMP?
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
The areas harmonised include:
4.1 Therapeutic indications
The CHMP agreed that Zinacef should no longer be used to treat severe ear, nose and throat infections as well as bone and joint infections and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), because not enough clinical data are available to support these indications. The CHMP concluded that Zinacef should be used in adults and children from birth for the following conditions:
- community-acquired (acquired outside the hospital) pneumonia;
- acute exacerbations (flares-up) of chronic bronchitis;
- complicated urinary tract infections, including pyelonephritis (kidney infection);
- soft-tissue infections: cellulitis, erysipelas and wound infections;
- intra-abdominal infections;
- prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including Caesarean section).
4.2 Posology and method of administration
Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinacef in adults and children and in patients with reduced kidney and liver function. Zinacef should be given by injection into a vein over a period of 3 to 5 minutes, by infusion over 30 to 60 minutes, or by deep intramuscular injection, at different doses depending on the condition it is used to treat.
The CHMP also decided that Zinacef should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).
The amended information to doctors and patients is available under the 'All documents' tab.
The European Commission issued a decision on 10 September 2012.
|International non-proprietary name (INN) or common name|
|Associated names||Curocef, Curoxim, Curoxim Monovial, Curoxima, Curoxime, Zinnat, Zinocep, Zinocep Vena|
|Type||Article 30 referrals|
This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the European Union.
|Status||European Commission final decision|
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies