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Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP
Telephone: +44 (0)1628 785 291
Fax: +44 (0)1628 671 722
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Fax: +44 (0)1628 635 072

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: 02/08/2010
SPC Rabies Vaccine BP

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 02/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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. 5 - Nature and Contents of Container
  • 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:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 - The product name has been amended to include the strength

Section 2 - Rewording to reflect the amount of active ingredient following reconstitution.

Section 3 - Addition of description of appearance of vaccine powder and solvent.

Section 4.2 – Cross-reference to section 6.6 of the SmPC added.

Section 6.1 - Changing ‘human albumin’ to ‘human albumin solution’

Section 6.3 - Addition of a statement regarding the in-use shelf life of the reconstituted product.

Section 6.5 - ‘Lyophilised vaccine’ is changed to ‘powder’.  The sentence ‘Not all presentations may be marketed’ has been updated to ‘Not all pack presentations may be marketed’

Section 6.6 - Deletion of statement ‘Discard any unused vaccine one hour after reconstitution’ in line with recommendation that reconstituted vaccine should be used immediately.

Addition of the reconstitution method and inclusion of information on the appearance of the reconstituted vaccine.

Addition of disposal statement.
Section 10 – Update of revision date
Updated on 23/07/2009 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of a warning on the risk of apnoea in very premature infants following vaccination, updates to section 4.4 and section 4.8.
Updated on 03/03/2008 and displayed until 23/07/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - addition of Guillian-Barre Syndrome and paresis
Updated on 26/02/2007 and displayed until 03/03/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1, 2, 3, 4.6, 6.1 and 6.2:  Updated in line with the QRD template.

 

Section 4.2:  Removal of ‘deep subcutaneous’ as a route of administration.

 

Section 4.3: Updated contraindications on pre and post exposure to the Rabies virus.

 

Section 4.4:  Added information on betapropiolactone, neomycin and administration to persons with bleeding disorders or receiving anticoagulants.

 

Section 4.5:  Added information on administration to patients receiving corticosteroids or immunosuppressive treatment.

 

Section 4.8: Updated in line with the QRD template and addition of further side effects including lymphadenopathy, diarrhoea, dyspnoea and wheezing.

 

Section 10: Change date of revision to December 2006

Updated on 24/03/2006 and displayed until 26/02/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 08/08/2005 and displayed until 24/03/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/09/2003 and displayed until 08/08/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/09/2002 and displayed until 25/09/2003
Reasons for adding or updating:
  • Change from datasheet to SPC
Updated on 04/09/2001 and displayed until 17/09/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  rabies vaccine bp