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.
Plunger stopper: Replacement of chlorobromobutyl by halobutyl
Tip cap: Addition of styrene - butadiene.
Section 1 - updated pharmaceutical form to include description of container
Section 6.5 – minor editorial changes to the text
Section 6.6 – minor editorial changes to the text
Section 9 – changed date of last renewal to 26th June 2007
Section 7: Changed the address of the Marketing Authorisation Holder to Sanofi Pasteur MSD Limited, Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24
Section 10: Changed the date of the revision of the text to January 2007
Section 1, 2, 3, 4, 5, 6 - Harmonisation of wording across Europe and alignment with QRD template.
Section 4.2 - Inserted details on:
▪ administration to adults and children aged > 9 months, infants aged 6-9 months and the elderly
▪ re-vaccination
▪ method of administration.
Section 4.3 - Updated and re-worded contraindications.
Section 4.4 - Updated/added information on:
▪ Association of vaccine with neurotropic and viscerotropic disease
▪ Administration to immunosuppressed and HIV infected persons, children born to HIV positive mothers, children aged 6-9 months and persons aged>60 years
▪ Administration via intramuscular injection
▪ Patients with hereditary problems of fructose intolerance should not take this vaccine.
Section 4.6 - Added information on pregnancy and lactation
Section 4.8 - Re-organised text
Section 4.4 - .
Updated/added information on:
Added effects include: nausea, diarrhoea, vomiting, neurotropic disease and viscerotropic disease.
Section 10 - Change date of revision of text to July 2006