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Leo Laboratories Limited
Longwick Road, Princes Risborough, Bucks., HP27 9RR
Telephone: +44 (0)1844 347 333
Fax: +44 (0)1844 276 385
Medical Information e-mail: medical-info.uk@leo-pharma.com

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: 27/04/2012
SPC One-Alpha Injection

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 27/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • In section 3 a description of the product has been added
  • In section 10 the date of revision of the text has been updated
Updated on 15/10/2009 and displayed until 27/04/2012
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.4 'Keep the ampoule in the outer carton in order to protect it from light' has been added.
Updated on 14/04/2009 and displayed until 15/10/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2, Shake the ampoule for a minimum of  5 seconds before use has been added.
In section 6.3, the shalf life has been changed from 2 to 3 years.
In section 6.4, the special precautions have been changed to store at 2-8 degrees C.
Updated on 07/06/2007 and displayed until 14/04/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.3, 4.4 and 4.7 inclusion of statements.
Sections 4.5, 4.6, 4.8 and 4.9 additional statements.
Updated on 02/12/2005 and displayed until 07/06/2007
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/08/2001 and displayed until 02/12/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 08/02/2000 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 08/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  alfacalcidol