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Rabies Vaccine BP *
Pharmacy Only: Prescription

  • Company:

    Sanofi Pasteur

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Rabies Vaccine BP

    *Additional information is available within the SPC or upon request to the company

Updated on 22 June 2023

File name

64945e31c1cc5.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 June 2023

File name

64945deb4a76a.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 December 2020

File name

046_uk-ie_pil_Art61.3 Notification Update Med Info Contact number_2020-12-08_1608030280.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 July 2020

File name

046_uk-ie_pil_FRHxxxxWS156_VarII Update of the CCDS & Pharmacodynamics section_2020-03-31_1594042111.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 July 2020

File name

046_ie_spmc_WS156_Type II_2020-03-31_clean_1594041927.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 November 2019

File name

uk-ie-rabies-pil-distributor address change-clean_1574176457.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Distributor address change - section 6 updated.

Updated on 11 February 2019

File name

uk-ie-rabies-pil-replacementofWFI-clean_1549878143.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to further information section

Updated on 11 February 2019

File name

ie-spc-rabies-replacementofWFI-tip cap correction-clean_1549876938.pdf

Reasons for 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated due to a change of supplier of the prefilled syringe of diluent. Section 6.5 has been updated to describe the new syringe presentation and composition, and section 6.6 has been updated to give specific handling instructions for the new syringe.

Updated on 19 January 2018

File name

PIL_10960_506.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 January 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

MAH change of address from 2 avenue Pont Pasteur 69007 Lyon France to 14 Espace Henry Vallée 69007 Lyon France

Updated on 19 January 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 05 April 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IAin - SmPC update further to PSUSA_00009277_201603

Updated on 01 February 2017

Reasons for updating

  • Change of distributor details

Updated on 17 January 2017

Reasons for updating

  • Company name change or merger

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sanofi Pasteur MSD company name changed to Sanofi Pasteur

Updated on 16 January 2017

Reasons for updating

  • Company name change or merger

Updated on 16 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), advice regarding how to report side effects in Ireland has been added.

Updated on 16 March 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 10 January 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2: updated section 4.2 to bring it into line with the corresponding section of the Company Core Data Sheet (CCDS) for Rabies Vaccine.

 

  • To amend the primary vaccination series for prophylaxis to introduce Day 21 as an alternative to Day 28 for the third vaccine dose.

  • To change the recommendation for timing of booster doses: from at 2 to 3 year intervals, to one year after the primary series followed by subsequent doses every 5 years. A recommendation for regular serology testing of neutralising antibodies in individuals at an increased risk of exposure to rabies virus has also been added.
  • To change the treatment schedule for previously immunised subjects from 2 doses given on Day 0 and Day 3-7 to 2 doses given on Day 0 and Day 3.
  • To change the treatment schedule for individuals without adequate prophylaxis from a 6 dose course ending on Day 90 to a 5 dose course ending on Day 30 (or Day 28 as per WHO recommendations).

Section 4.4: Included the following sentence - If Rabies Immunoglobulin is indicated in addition to Rabies Vaccine BP, then it must be administered at a different anatomical site to the vaccination site.

Section 10: revised date to November 2012

 

Updated on 10 January 2013

Reasons for updating

  • Change to dosage and administration

Updated on 22 December 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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 July 2009

Reasons for 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

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 06 July 2009

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 March 2009

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 15 October 2008

Reasons for updating

  • Change due to user-testing of patient information
  • Change to date of revision

Updated on 18 December 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.8, addition of Guillain-Barré syndrome and paresis.

Updated on 18 December 2007

Reasons for updating

  • Change to side-effects

Updated on 09 March 2007

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 09 March 2007

Reasons for updating

  • Change to date of revision
  • Change to side-effects
  • Change of contraindications
  • Addition of marketing authorisation holder

Updated on 09 June 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 08 February 2006

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 August 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)