IPV-Infanrix
- Name:
IPV-Infanrix
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
Diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated) vaccine
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/03/18
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GlaxoSmithKline (Ireland) Ltd
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When a pharmaceutical company changes any document, 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 2 July 2019 SmPC
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 from word to PDF. Approval date of SPC 26 January 2017.
Updated on 1 June 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 April 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 2 March 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 30 March 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2017 SmPC
Reasons for updating
- 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
Updated on 29 March 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 8 March 2016 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
· Update section 4.5 to include ‘varicella’ in the sentence ‘IPV Infanrix has been administered concomitantly with measles-mumps-rubella vaccine, varicella vaccine or Hib vaccine in clinical trials.’
· Admininistration changes to sections 2, 4.3, 4.8, 5, 5.1, 5.2, 6.6 and 9.
Updated on 7 March 2016 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 17 July 2015 SmPC
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 10 - change to date of revision of text.
Updated on 16 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 16 March 2012 SmPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 13 August 2010 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
4.1 Therapeutic indications
Added the requirement:
‘who have previously received primary immunisation series against these diseases.’
4.3 Contraindications
Deleted the following statement:
IPV Infanrix should not be administered to subjects who experienced neurological complications (for convulsions or hypotonic-hyporesponsive episodes, see section 4.4) following previous immunisation with any of the antigens in the vaccine.
Updated contraindication warning regarding administration in children who have experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine, adding that:
In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus and polio vaccines.
4.4 Special warnings and precautions for use
Removed the requirement for a clinical examination prior to administration of the vaccine
Added the following statement regarding the risk-benefit of immunising in children with new onset or progression of a severe neurological disorder:
As for any vaccination, the risk-benefit of immunising with IPV Infanrix or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
4.8 Undesirable effects
Revision of side effect listings from both Clinical trials and Post-marketing surveillance
4.9 Overdose
Previously no cases of over dose had been reported. This was updated with the addition of the following statement:
Cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.
6.5 Nature and contents of container
Added the optional 10 pack and statement that all packs may be presented with or without needles and a statement that not all pack sizes may be marketed.
Updated on 13 August 2010 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 13 April 2010 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 22 February 2010 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.1 - List of excipients
Removed the excipient 2-phenoxyethanol from the formulation.
Updated on 20 March 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 17 November 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 15 August 2005 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2005 PIL
Reasons for updating
- New PIL for new product