When a pharmaceutical company changes an SPC or PIL, 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.
Section 4.4 - Special warnings and precautions for use
Added the requirement:
‘who have previously received primary immunisation series against these diseases.’
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.
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.
Revision of side effect listings from both Clinical trials and Post-marketing surveillance
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.
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.
Section 6.1 - List of excipients Removed the excipient 2-phenoxyethanol from the formulation.
Removed the excipient 2-phenoxyethanol from the formulation.