Zinacef

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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.

Other changes

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.

Name Language First published Last updated
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) BG = bălgarski 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) ES = español 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) CS = čeština 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) DA = dansk 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) DE = Deutsch 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) ET = eesti keel 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) EL = elliniká 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) EN = English 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) FR = français 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) IT = italiano 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) LV = latviešu valoda 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) LT = lietuvių kalba 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) HU = magyar 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) MT = Malti 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) NL = Nederlands 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) PL = polski 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) PT = português 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) RO = română 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SK = slovenčina 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SL = slovenščina 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) FI = suomi 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SV = svenska 2012-05-25 2013-01-29

Key facts

Approved nameZinacef
International non-proprietary name (INN) or common name

cefuroxime sodium

Associated namesCurocef, Curoxim, Curoxim Monovial, Curoxima, Curoxime, Zinnat, Zinocep, Zinocep Vena
ClassAnti-infectives
Reference numberEMEA/H/A-30/1158
TypeArticle 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.

StatusEuropean Commission final decision
Opinion date24/05/2012

All documents

Name Language First published Last updated
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) BG = bălgarski 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) ES = español 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) CS = čeština 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) DA = dansk 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) DE = Deutsch 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) ET = eesti keel 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) EL = elliniká 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) EN = English 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) FR = français 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) IT = italiano 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) LV = latviešu valoda 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) LT = lietuvių kalba 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) HU = magyar 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) MT = Malti 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) NL = Nederlands 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) PL = polski 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) PT = português 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) RO = română 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SK = slovenčina 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SL = slovenščina 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) FI = suomi 2012-05-25 2013-01-29
Questions and answers on Zinacef and associated names (cefuroxime sodium, 250 mg, 500 mg, 750 mg, 1 g, 1.5 g, 2 g, powder for solution / suspension for injection or infusion) SV = svenska 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex I BG = bălgarski 2013-01-29  
Zinacef - Article-30 referral - Annex I ES = español 2013-01-29  
Zinacef - Article-30 referral - Annex I CS = čeština 2013-01-29  
Zinacef - Article-30 referral - Annex I DA = dansk 2013-01-29  
Zinacef - Article-30 referral - Annex I DE = Deutsch 2013-01-29  
Zinacef - Article-30 referral - Annex I ET = eesti keel 2013-01-29  
Zinacef - Article-30 referral - Annex I EL = elliniká 2013-01-29  
Zinacef - Article-30 referral - Annex I EN = English 2013-01-29  
Zinacef - Article-30 referral - Annex I FR = français 2013-01-29  
Zinacef - Article-30 referral - Annex I IT = italiano 2013-01-29  
Zinacef - Article-30 referral - Annex I LV = latviešu valoda 2013-01-29  
Zinacef - Article-30 referral - Annex I LT = lietuvių kalba 2013-01-29  
Zinacef - Article-30 referral - Annex I HU = magyar 2013-01-29  
Zinacef - Article-30 referral - Annex I MT = Malti 2013-01-29  
Zinacef - Article-30 referral - Annex I NL = Nederlands 2013-01-29  
Zinacef - Article-30 referral - Annex I PL = polski 2013-01-29  
Zinacef - Article-30 referral - Annex I PT = português 2013-01-29  
Zinacef - Article-30 referral - Annex I RO = română 2013-01-29  
Zinacef - Article-30 referral - Annex I SK = slovenčina 2013-01-29  
Zinacef - Article-30 referral - Annex I SL = slovenščina 2013-01-29  
Zinacef - Article-30 referral - Annex I FI = suomi 2013-01-29  
Zinacef - Article-30 referral - Annex I SV = svenska 2013-01-29  
Zinacef - Article-30 referral - Annex I IS = Islenska 2013-01-29  
Zinacef - Article-30 referral - Annex I NO = Norsk 2013-01-29  
Zinacef - Article-30 referral - Annex II BG = bălgarski 2013-01-29  
Zinacef - Article-30 referral - Annex II ES = español 2013-01-29  
Zinacef - Article-30 referral - Annex II CS = čeština 2013-01-29  
Zinacef - Article-30 referral - Annex II DA = dansk 2013-01-29  
Zinacef - Article-30 referral - Annex II DE = Deutsch 2013-01-29  
Zinacef - Article-30 referral - Annex II ET = eesti keel 2013-01-29  
Zinacef - Article-30 referral - Annex II EL = elliniká 2013-01-29  
Zinacef - Article-30 referral - Annex II EN = English 2013-01-29  
Zinacef - Article-30 referral - Annex II FR = français 2013-01-29  
Zinacef - Article-30 referral - Annex II IT = italiano 2013-01-29  
Zinacef - Article-30 referral - Annex II LV = latviešu valoda 2013-01-29  
Zinacef - Article-30 referral - Annex II LT = lietuvių kalba 2013-01-29  
Zinacef - Article-30 referral - Annex II HU = magyar 2013-01-29  
Zinacef - Article-30 referral - Annex II MT = Malti 2013-01-29  
Zinacef - Article-30 referral - Annex II NL = Nederlands 2013-01-29  
Zinacef - Article-30 referral - Annex II PL = polski 2013-01-29  
Zinacef - Article-30 referral - Annex II PT = português 2013-01-29  
Zinacef - Article-30 referral - Annex II RO = română 2013-01-29  
Zinacef - Article-30 referral - Annex II SK = slovenčina 2013-01-29  
Zinacef - Article-30 referral - Annex II SL = slovenščina 2013-01-29  
Zinacef - Article-30 referral - Annex II FI = suomi 2013-01-29  
Zinacef - Article-30 referral - Annex II SV = svenska 2013-01-29  
Zinacef - Article-30 referral - Annex III BG = bălgarski 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III ES = español 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III CS = čeština 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III DA = dansk 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III DE = Deutsch 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III ET = eesti keel 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III EL = elliniká 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III EN = English 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III FR = français 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III IT = italiano 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III LV = latviešu valoda 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III LT = lietuvių kalba 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III HU = magyar 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III MT = Malti 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III NL = Nederlands 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III PL = polski 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III PT = português 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III RO = română 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III SK = slovenčina 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III SL = slovenščina 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III FI = suomi 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III SV = svenska 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III IS = Islenska 2012-05-25 2013-01-29
Zinacef - Article-30 referral - Annex III NO = Norsk 2012-05-25 2013-01-29
Assessment report for Zinacef and associated names (English only) 2013-01-29  

Document description

  • 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

Current status:
European Commission final decision

More information on Zinacef