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.
Reference to 'subjects' has been amended to read 'individuals' throughout the SmPC. Change to section 4.2 - Posology and method of administration
Paediatric population: Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy (see section 5.1).
Has been amended to read:
Paediatric population: There is no experience with the use of Gardasil in children below 9 years of age (see section 5.1).
Change to section 4.4 - Special warnings & precautions for use
Addition of the following information:
Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Gardasil does not prevent lesions due to a vaccine HPV type in women already infected with that HPV type at the time of vaccination (see section 5.1).
The use of Gardasil in adult women should take into consideration the variability of HPV type prevalence in different geographical areas. In the clinical study of adult women (24 to 45 years of age), no statistically significant vaccine efficacy was observed after 2.2 years of follow-up in the full analysis set that includes women regardless of baseline HPV status (see section 5.1). The decision to vaccinate an individual woman 27 to 45 years old should take into account her risk for previous HPV exposure and her potential benefit from vaccination.
Change to section 4.5 - Interactions with other medicaments
Update to the numbers of mid-adult women using hormonal contraceptives.
Change to section 4.6 - Pregnancy and lactation
Update to the numbers of women in the clinical development program that reported pregnancy.
Change to section 4.8 - Undesirable effects
Update to the numbers in the safety population.
The inclusion of the adverse reaction pain in the extremity as common
Change to section 5.1 - Pharmacodynamic properties
Update of efficacy in women 16 through 26 years and addition of data regarding efficacy in women 24 through 45 years. Update to immunogenicity. Change to section 10 - Date of revision to 09/2009
Update to immunogenicity.
Change to section 10 - Date of revision to 09/2009
4.5 - Addition on concomitant use with Repevax/other vaccines
4.8 - updates to undesirable efects
4.6 - Update of clinical data and rewording of section.
4.8 Updates to the number of cases in clinical trails section
Change to section 4.4
Addition of warning, fainting (syncope) may follow any vaccination. Vaccinees should be observed for approximately 15 minutes after administration.
Change to section 4.8
Addition of side effects from post marketing experience, nausea, vomiting, arthralgia, myalgia, asthenia, fatigue and malaise.
Section 4.4 – Special warnings and precautions for use – Update to protection offered by Gardasil
Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types.
Gardasil will not provide protection against every HPV type.
Section 5.1 Update to data
Inclusion of data relating to cross protection efficacy.
Update to
Section 4.1 – Indication – expansion of the indication,
Gardasil is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).
Section 4.2 – Rewording of the route of administration paragraph.
Subcutaneous and intradermal routes of administration have not been studied and are therefore not recommended.
Section 4.4 – Addition of statement regarding interchangeability of vaccine
The interchangeability of the vaccine with other HPV vaccines, has not been studied and is therefore not recommended.
Section 4.6 – Update to data
Update to the numbers involved in the clinical development program and the outcomes.
Section 4.8 – Update to data
Rewording of the side effect ; ‘bleeding’ changed to ‘bruising’
Addition of side effects; Lymphadenopathy, Gullain Barre syndrome and headache.
Section 5.1 – Update to data
Following analysis of 3 year clinical data, the data has been updated and added to reflect the results.
Section 6.4 – Grammatical correction
Change to section 4.8: Addition of post marketing safety data.
Change to section 10: date changed to July 2007
Section 6.6 has been modified to improve clarity of the instructions for use of the needle guard (safety device).