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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: 09/11/2011
SPC Hyalase 1500 I.U. Powder for Solution for Injection/Infusion

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 09/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   04-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3, following sentence moved from Section 4.4:

Not to be used for intravenous injections.

Section 4.4; addition of following sentence:

Hyalase® should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.    

Updated on 05/09/2008 and displayed until 09/11/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - product name amended to include full pharmaceutical form:
Hyalase® 1500 I.U. Powder for Solution for Injection/Infusion (Hyaluronidase for Injection BP)     

Section 6 amended in line with current guidelines.
Section 6.1 - 

Water for Injections BP removed during the freeze drying process.

None.

Section 6.3 - 

Three years from date of manufacture.

Unopened: 3 years.

Once opened use immediately and discard any unused contents.

Section 6.5 - 

1ml neutral glass ampoule containing a plug of white freeze-dried powder.

Pack size: 10 ampoules.


Section 6.6 - 

The solution should be used immediately after preparation.  The appearance of the solution is clear and not more than faintly yellow.
For detailed instructions on preparation and administration, see section 4.2.

For single use only.  Discard any unused contents.

MA Holder amended from 'CP Pharmaceuticals Ltd' to 'Wockhardt UK Ltd'
PL number amended from PL 04543/0337 to PL 29831/0113
Updated on 01/09/2006 and displayed until 05/09/2008
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01/04/05
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3 - Amendment of description to bring in line with Ph.Eur terms
 
Section 4.8 - Addition of text "Allergic reactions have included rare reports of periorbital oedema occuring with the use of hyaluronidase in conjunction with local anaesthetics in opthalmology"
Updated on 29/09/2003 and displayed until 01/09/2006
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/08/2001 and displayed until 29/09/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  hyaluronidase