Rabies Vaccine BP * Pharmacy Only: Prescription
Company:
Sanofi PasteurStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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
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
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.
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To amend the primary vaccination series for prophylaxis to introduce Day 21 as an alternative to Day 28 for the third vaccine dose.
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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.
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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.
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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
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
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 4.2: Removal of ‘deep subcutaneous’ as a route of administration.
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)