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Sanofi Pasteur MSD Limited
Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24,
Telephone: +353 1 468 5600
Fax: +353 1 420 3588
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Facsimile: +44 (0)1628 635 072
Summary of Product Characteristics last updated on medicines.ie: 22/12/2010
SPC Rabies Vaccine BP

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

Updated on 22/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
catalent and term strelisation
Updated on 10/07/2009 and displayed until 22/12/2010
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:   12-Jun-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

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 25/03/2009 and displayed until 10/07/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 2 qualitative and quantitative composition

Re-worded to state amount of active following reconstitution.

Change to section 3 pharmaceutical form

Visual description of the powder and solvent has been included.

Change to section 6.1 List of excipients

Ph. Eur. Title of Human Albumin Solution included.

Change to section 6.3 Shelf life

Statement regarding the in-use shelf life of the reconstituted product added.

Change to section 6.5 Nature and contents of container

The heading Lyophilised vaccine was amended to Powder

Statement re-worded to read Not all pack presentations may be marketed

Change to section 6.6 Instructions for use/handling

Update to statement regarding disposal of the product

Change to section 9 Date of renewal of authorisation

Updated following approval of the renewal

Change to section 10 Date of partial revision of the text

Date of revision updated.
Updated on 18/12/2007 and displayed until 25/03/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.8, addition of Guillain-Barré syndrome and paresis.
Updated on 09/03/2007 and displayed until 18/12/2007
Reasons for adding or updating:
  • 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 6.4 - Special precautions for storage
  • Change to marketing authorisation holder address
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2, 3, 4.6, 6.1 and 6.4:  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 beapropiolactone, 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 7: Updated the address of the Marketing Authorisation Holder
 
Section 10: Changed date of revision of the text to February 2007

 
Updated on 08/02/2006 and displayed until 09/03/2007
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 08/08/2005 and displayed until 08/02/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 23/06/2003 and displayed until 08/08/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Rabies Vaccine BP