Update to section 4- inclusion of lymphadenopathy, as a new expected adverse reaction after vaccination in the Post marketing experience. HPRA AE reporting details updated.

the local representative of the Marketing Authorisation Holder updated for some countries

Update to section 4.8 - inclusion of lymphadenopathy, as a new expected adverse reaction after vaccination in the Post marketing experience​

Update to section 4.4 - to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

sec 4.5 - to include reference to concomitant administration with Meningococcal group B vaccine

Update to section 6.5 to the material of the container for the vial presentation

Section 7 – Change to name of marketing authorisation holder

Reasons for adding or updating:

·         Change to section 4.4 - Special warnings and precautions for use

·         Change to section 4.8 - Undesirable effects

·         Change to section 5.2 - Pharmacokinetic properties

·         Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC: 26-Mar-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update of the Section 4.8 “Undesirable effects” of the SmPC:

update of the overall exposure for children aged ≥2 years who have received the vaccine in completed clinical trials.

Update of the Section 4.4 “Special warnings and precautions for use” of the SmPC + Package Leaflet: inclusion of a warning on anxiety-related reactions as per Menveo CDS v4.3.

Addition of Renewal date into sec. 9 of the SmPC

New persistency data for children 2-10.
Existing persistency data for adolescents corrected.

4.2

Section: Posology

·         term elderly removed

·         Optimal primary dosing schedule included

Section : Booster vaccination

·         updated re Imunogenicity /Long term antibody persistence data for 5 yrs included

·         Booster dosing

4.4

Section : Special warnings and precautions

·         Consideration re booster dosing

4.5

Section : Interaction with other medicinal products and other forms of interaction

·    Concomitant vaccine advice and usage updated

·    Update advice on concomitant vaccine injection sites

4.8                           

Section: Adverse reactions from clinical trials

·         Updated on the characterisation of  safety profile of Menveo in children 2-10 years

Section: Individuals 11 to 65 years of age

·         Updated trial data and increase in trial numbers, change to results

·         In list of adverse reactions from clinical trials, removal side effects  text re: immune system disorders ,  hypersensitivity, syncope, vertigo

Section: General disorders and administration site conditions

·         Editing and inclusion of text

·         Removal of spontaneous reporting text

Section: Post marketing experience ( all age groups)

·         Updated text sections and changes to read ‘not known’

Section : Reporting of suspected adverse reactions

Inclusion of text : Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Pharmacovigilance Section at the Irish Medicines Board at www.imb.ie.

5.1

Section: Pharmacodynamic properties

Immunogenicity

·         Amended- immunogenicity in children from 2, to 2 to 10 years of age

·         Tables and data up dated re trials- tables renumbered

·         Previous Table 4-21 month post vaccination text and data removed

·         Inclusion of text re: Persistence of immune response and booster response in adolescents, before table 5

·         Text on booster dose study results included

·         After renumbered table 8, text included re the onset of the immune response after primary vaccination

6.5

Section: Nature and contents of container

·         Removal of text re contents of components( now in 6.6)

6.6

Section: Special precautions for disposal and other handling

·         Inclusion of text re mixing vials

·         Inclusion of text (metric replaces non metric) re needle length

10

Section: Date of revision of text

·         18/06/2014

·         UK/MEN/14-0012 

Paediatric population (under 2 years of age)

Available data in children 2 to 23 months of age

Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown. Currently there is limited information available on the safety of a booster dose. However, if an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.

Section 4.8 additions from post marketing spontaneous reports