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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 06/12/2010
SPC Co-amoxiclav for Injection 500/100mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 06/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   02-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 & 3 – product name amended  to  include full pharmaceutical form

Section 2 – quantity per ml reconstituted added

Section 4.2 – ‘Used within 20 minutes of reconstitution’ amended to ‘used immediately after reconstitution’.

Section 6.1 – text added – ‘This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.’

Section 6.3 – text added - Use the reconstituted solution immediately. Discard any unused solution.

Section 6.4 – text amended – Keep container the vial in the outer carton in order to protect from light.

Section 6.6 – text added - To reconstitute dissolve in 10 ml Water for Injections Ph Eur or Sodium Chloride Intravenous Injection BP (0.9% w/v)

Updated on 05/02/2010 and displayed until 06/12/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - MA Holder from CP to Wockhardt UK

Section 8 - PL Number from 04543/0472 to 29831/0044

Section 10 - Date of revision amended
Updated on 25/09/2007 and displayed until 05/02/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   05/2004
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3 - addition of -  Co-amoxiclav for Injection 500/100mg is a white or almost white powder.
 
Section 6.6 - addition of  For single use.  Discard any unused product immediately after use.
Updated on 30/01/2004 and displayed until 25/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

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