Fendrix suspension for injection
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 10 May 2023
File name
ieukni-spc-combined-fendrix-issue3draft1.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2023
File name
ieukni-pl-combined-fendrix-issue4draft1.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to dosage and administration
Updated on 31 January 2022
File name
ieukni-spc-combined-fendrix-issue2draft1-clean.pdf
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)
Updated on 31 January 2022
File name
ieukni-pl-combined-fendrix-issue3draft1-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 05 December 2018
File name
ie-pl-fendrixissue2draft1 - Medicines IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 23 November 2015
File name
PIL_13286_498.pdf
Reasons for updating
- New PIL for new product
Updated on 23 November 2015
Reasons for updating
- Change to date of revision
Updated on 24 November 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- 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 - Posology and method of administration
- Clarity on primary immunisation schedule
Section 4.3 – Contraindications
- Administration of Fendrix should be postponed in subjects suffering from Action Severe febrile illness
Section 4.5 – Interactions
- Interactions with immunosuppressive treatment
Section 4.6 – Pregnancy
- Clarity on ‘no data’ available in pregnancy
Section 4.8 – addition of reporting adverse events info
Section 4.9 – overdose
- Amendment to text that limited data is available on overdose
Section 10 - change to date of revision of text
Updated on 24 November 2014
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 11 July 2014
Reasons for updating
- 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
Updated on 08 July 2014
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 15 March 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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 - Special warnings and precautions for use
Updated on 14 March 2012
Reasons for updating
- Change to warnings or special precautions for use
Updated on 02 December 2010
Reasons for updating
- Change to side-effects
- Change due to harmonisation of PIL
- Change due to user-testing of patient information
- Change to, or new use for medicine
- Change to warnings or special precautions for use
Updated on 21 October 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - 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 6.3 - Shelf life
- 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)
Free text change information supplied by the pharmaceutical company
4.1 Therapeutic indications
Minor change to bring ‘in adolescents and adults from the age of 15 years onwards’ from then end of the paragraph to the beginning, to read:
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
4.2 Posology and method of administration
Minor changes to formatting of headings (i.e. use of underlining and italics)
Added subheading and statement regarding the use of Fendrix in the ‘Paediatric population’, i.e.:
Paediatric population
The safety and efficacy of Fendrix in children aged less than 15 years have not been established.
4.6 Fertility, pregnancy and lactation
Added ‘Fertility’ to the heading and added the subheading ‘Fertility’ with the statement that:
No fertility data are available
4.7 Effects on the ability to drive and use machines
Revised statement regarding ability to drive by removing reference to ‘minor’ influence, to read:
Fendrix has moderate influence on the ability to drive and use machine.
4.8 Undesirable effects
Added the bullet point subheading ‘Clinical trials’
Deleted the following:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Moved the statement regarding allergic reactions from the listing of side effects due to Fendrix and placed it under the subheading ‘Experience with hepatitis B vaccine’, to read:
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines.
6.3 Shelf life
Removed hyphenation from the heading to read ‘Shelf life’
6.6 Special precautions for disposal and other handling
Changed the description from ‘vaccine’ to ‘product’ in the statement regarding disposal
Updated on 18 March 2010
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 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
SPC UPDATES
Minor editorial changes are not described
Section 4.2 Posology and method of administration
Replaced word ‘dosage’ with ‘posology’
Section 4.4 Special warnings and precautions for use
The following paragraph has been moved from the end to the beginning of the section:
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Section 4.8 Undesirable effects
Deleted the statement ‘Fendrix was generally well tolerated’ and updated the terms ‘adverse events’ and ‘undesirable events’ to ‘adverse reactions’.
Updated on 27 April 2009
Reasons for updating
- Change to side-effects
- Change to warnings or special precautions for use
Updated on 25 March 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4: Removed warning regarding the risk of sensitisation due to residual thiomersal preservative as approval was granted to no longer use thiomersal in the manufacturing process.
Section 4.8: Rearrangement of side effects in line with approved QRD version 7.2: No additional side effects or changes to frequency of side effects.
Updated on 24 June 2008
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 June 2008
Reasons for updating
- New PIL for new product