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Nycomed UK Ltd
Nycomed UK Ltd, 3 Globeside Business Park, Fieldhouse Lane, MARLOW, Buckinghamshire, SL7 1HZ, UK
Telephone: +44 (0)1628 646 400
Fax: +44 (0)1628 646 401
WWW: http://www.nycomed.com
Medical Information Direct Line: +44 (0) 800 633 5797
Medical Information e-mail: medinfo@nycomed.com
Medical Information Fax: +44 (0)1628 646 534

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: 20/06/2011
SPC TachoSil medicated sponge

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 20/06/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 22/07/2010 and displayed until 20/06/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5

Each sponge is packed in a polystyrene blister sealed with a peel lacquer laminate paper. The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.

Section 6.5

Each sponge is packed in a PET-GAG blister sealed with a coated PE foil. The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.

 
Updated on 12/03/2009 and displayed until 22/07/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The indication for TachoSil (section 4.1) has been updated to include promotion of tissue sealing and suture support in vascular surgery.  Sections 4.4, 4.8 and 5.1 has been updated as a consequence of this new indication.
Updated on 17/10/2008 and displayed until 12/03/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   16-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of the Black Triangle following letter from confirming that it can be removed.  Date of revision of text changed to reflect the date that MHRA letter was received.
Updated on 13/12/2006 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
  • Section 2: 'a full list of' added in last sentence to read 'For a full list of excipients, see section 6.1'
  • Section 4.4: heading amended in line with updated EMEA guidance (on original document)
  • Section 5.1: ATC code updated to B02BC30
  • Section 6.6: heading amended in line with updated EMEA guidance (on original document)
  • Section 10: Date of revision of the Text 8 November 2006
Updated on 26/04/2006 and displayed until 13/12/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   26/01/06
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1 Removal of 'Efficacy has only been demonstrated in liver surgery'
 
Section 4.8 Addition of (under Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.)
                       General disorders and administration site condition:
                        Pyrexia may occur commonly.
 
Section 5.1 (3rd paragraph) Clinical studies demonstrating haemostasis were conducted in a total of 240 patients undergoing partial liver resection surgery and 185 patients undergoing surgical resection of superficial renal tumour.  A further controlled clinical trial (n = 189) investigating tissue sealing in lung surgery failed to document superiority over standard treatment measured by air leakage.
 
Section 10 DATE OF REVISION OF THE TEXT
26 January 2006
Updated on 21/09/2005 and displayed until 26/04/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  human fibrinogen
  human thrombin