AVAXIM
*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 12 January 2022
File name
Avaxim 139_uk-ie_pil_SEHxxxWS466_VarII Addition of AE Anaphylactic reaction.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 12 January 2022
File name
Avaxim 139_ie_smpc_SEHxxxWS466_VarII Addition of AE Anaphylactic reaction (1).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 April 2021
File name
139_uk-ie_pil_SEHxxxWS452 VarIB Change in CMC process, parameters+update PI excipient.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 April 2021
File name
139_ie_smpc_SEHxxxWS452 VarIB Change in CMC process, parameters+update PI excipient.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 October 2019
File name
uk-ie-avaxim-pil-distributor address change-clean.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
Marketing distributor change.
Updated on 26 September 2019
File name
uk-ie-avaxim-pil-correctionofcomposition.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Sections 2, 5 and 6 of the PIL have been amended to reflect the changes made to the SPC.
Updated on 26 September 2019
File name
ie-spc-avaxim-correctionofcomposition.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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 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
Sections 2, 4.4, 4.8. 6.1 and 6.4 & 10 of the SPC have been updated to correct the description of composition of the vaccine (making specific mention of ethanol & phenylalanine excipients) & to amend the storage recommendations (protect from light).
Updated on 19 June 2019
File name
ie-spc-avaxim-breastfeedingupdate.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
File format updated to PDF
Updated on 06 December 2018
File name
uk-ie-avaxim-pil-acfandcompactbox.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 May 2018
File name
ie-spc-avaxim-breastfeedingupdate.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- 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
Following the evaluation and approval of RMP (Risk Management Plan) for Hepatitis A vaccines
(European procedure) in December 2017, the SPC and PIL are being updated regarding the breastfeeding.
Updated on 08 May 2018
File name
uk-ie-avaxim-pil-breastfeedingupdate.docx
Reasons for updating
- 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 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 05 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 05 January 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2018
File name
PIL_10940_354.pdf
Reasons for updating
- New PIL for new product
Updated on 04 January 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 March 2017
Reasons for updating
- Change in co-marketing arrangement
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 02 March 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 4.4 addition of syncope (fainting)
Section 4.8 addition of vasovagal syncope in response to injection and inclusion of reporting of suspected adverse reactions
Section 10 revision date revised to January 2015
Updated on 02 March 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 12 February 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 6.5: The addition of alternative primary packaging components (ready-to-use primary packaging components) has an impact on sections 6.5. (chlorobromobutyl or chlorobutyl) amended to (bromochlorobutyl or chlorobutyl or bromobutyl)
Section 10: revision date changed to January 2015
Updated on 07 September 2011
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 26 November 2010
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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of information related to the long term protectin provided by Avaxim
4.1 Therapeutic indications
AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above.
The use of AVAXIM should be based on official recommendations.
In section 4.2: clarification of the section and move part of the information in section 5.1
4.2 Posology and method of administration
Posology
The recommended dosage for subjects of at least 16 years of age is 0.5 millilitre for each injection. Individuals having grown up in areas of high endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation should be considered in such situations. If not, seropositivity against hepatitis A is not a contraindication. AVAXIM is as well tolerated in seropositive as in seronegative subjects (see Section 4.8). AVAXIM is not recommended for use in children of less than or equal to 15 years of age due to insufficient data on safety and efficacy.
Initial protection is achieved with one single dose of vaccine. Protective levels of antibody may not be reached until 14 days after administration of the vaccine. There are serological data to show that there should be continuing protection against hepatitis A for up to 36 months after a first dose in subjects who responded to the initial vaccination.
In order to provide long-term protection, a second dose (booster) of an inactivated hepatitis A vaccine should be given. The second dose is preferably given between 6 and 12 months after the primary immunisation but may be administered up to 36 months after the primary immunisation first dose (see section 5.1). It is predicted that HAV antibodies persist for many years (beyond 10 years) after the booster vaccination second dose.
Current recommendations do not support the need for further booster vaccinations for immunocompetent individuals after the initial two-dose vaccination course.
In the event that the second dose (booster) has been delayed after 36 months, there may be a decreased anti-hepatitis A antibody response. If long-term protection is required, the serum anti-hepatitis A antibody titre should be determined after AVAXIM administration of the second dose.
The vaccine may be used as a to provide the second dose (booster) in subjects from 16 years of age who received another inactivated hepatitis A vaccine (monovalent or with purified Vi polysaccharide typhoid) 6 months to up to 36 months previously.
AVAXIM is not recommended for use in children of less than or equal to 15 years of age due to insufficient data on safety and efficacy.
Addition of a precaution in section 4.4
4.4 Special warnings and precautions for use
Individuals having grown up in areas of high endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation should be considered in such situations. If not, seropositivity against hepatitis A is not a contraindication. AVAXIM is as well tolerated in seropositive as in seronegative subjects (see Section 4.8).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Viral vaccine, ATC Code: J07BC02
AVAXIM confers immunity against hepatitis A virus by inducing antibody titres greater than those obtained after passive immunisation with immunoglobulin. Antibody appears shortly after the first injection and 14 days after vaccination more than 90% of immunocompetent subjects are seroprotected (titre above 20 mIU/millilitre).
One month after the first injection, almost 100% of subjects have antibody titres above 20mIU/millilitre. Serological data show continuing protection against hepatitis A for up to 36 months in subjects who responded to the first dose. In a study of 103 healthy adults who were followed serologically for three years after the first injection of AVAXIM, 99% still had at least 20 mIU/ml anti-HAV antibody at month 36.
The long-term persistence of protective antibody levels to hepatitis A virus after a second dose (booster) dose of AVAXIM is not currently available has not been fully evaluated. Nevertheless, available data (antibody titres obtained two years after the second dose) suggests that anti-HAV antibodies persist beyond 10 years after the booster vaccination second dose in healthy individuals.
Updated on 26 November 2010
Reasons for updating
- Change to dosage and administration
Updated on 08 July 2009
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 11 December 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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
Change to section 2 - qualitative and quantitative composition
Changed mL to millilitre in line with current guidelines. Added Excipient(s) as per QRD template.
Change to section 4.1 - therapeutic indications
Wording at end of 1st paragraph changed to improve clarity.
Change to section 4.2 - Posology and method of administration
Added heading Posology to aid navigation, information moved into more appropriate sections, cross-reference to other sections to meet QRD template.
Change to section 4.3 - Contra-indications
Re-worded contraindication on hypersensitivity as per QRD template.
Change to section 4.4 - Special warnings & precautions for use
Information moved into more appropriate sections and re-ordered as per SPC guideline.
Change to section 4.5 - Interactions with other medicaments
Re-worded to improve clarity.
Change to section 4.6 - Pregnancy and lactation
Headings added to aid navigation and text on pregnancy re-worded in line with QRD template.
Change to section 4.7 - Effects on ability to drive and use machines
Re-worded in line with QRD template.
Change to section 4.8 - Undesirable effects
Section re-organised in line with QRD template.
Change to section 4.9 - Overdose
Amended to state whether any cases of overdose have been reported.
Change to section 5.1 - Pharmacodynamic properties
Pharmacotherapeutic group has been added, as per SPC guidelines.
Change to section 5.2 - Pharmacokinetic properties
Re-worded to improve clarity.
Change to section 5.3 - Preclinical safety data
Re-worded as per QRD template.
Change to section 6.1 - List of excipients
Re-formatted to improve clarity. Mention of phenylalanine, as per guideline on excipients.
Change to section 6.4 Special precautions for storage
Re-worded according to QRD template.
Change to section 6.6. Instructions for use/handling
Added sentences as per the guideline Pharmaceutical aspects of the product information for human vaccines and as per QRD template.
Change to section 10 Date of partial revision of the text.
Updated on 24 May 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2007
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
Section 7 - updated the address of the Marketing Authorisation Holder
Updated on 21 March 2007
Reasons for updating
- Change to marketing authorisation holder address
Updated on 13 September 2006
Reasons for updating
- Change to date of revision
Updated on 04 September 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION - Addition of the word “section” before “6.1”.
6.1 List of Excipients - The wording “the formulation contains:” has been deleted
6.2 Incompatibilities - Rewording of sentence to bring it in line with the Guideline on Pharmaceutical aspects of the product information for human vaccines.
Section 6.5 - updated to include the addition of a prefilled syringe presentation with 1 or 2 separate needles.
Section 6.6 - sentence added to describe needle attachment.
Section 10 - update to date of revision of the text.
Updated on 09 June 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 09 May 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 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 10 March 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)