Menveo Powder and Solution for Solution for Injection

4.1 Therapeutic indications

Menveo is indicated for active immunization of children (from 2 months of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease.

The use of this vaccine should be in accordance with official recommendations.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

• Vaccine schedule for children from 2 to 23 months of age

  Infants initiating vaccination from 2 to 6 months of age

  First three doses of Menveo, each of 0.5 ml, should be given with an interval of at least 2 months; the fourth dose should be administered during the second year of life (at 12 to 16 months).

  Alternatively, when Menveo is given as part of a routine infant immunisation programme or according to a national recommendation, a series consisting of three doses, each of 0.5ml, may be given. The first dose should be administered from the age of 2 months, with a second dose 2 months later. The third dose should be administered as early as possible during the second year of life (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  If optimal protection against serogroup A is required (for example, travellers to areas where serogroup A is endemic), a 4-dose schedule should be used (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  Infants with medical conditions associated with increased risk of invasive meningococcal disease should receive a 4-dose schedule (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

  Unvaccinated children from 7 to 23 months of age,

  Menveo should be administered as two doses, each as a single dose (0.5 ml), with the second dose administered in the second year of life and at least two months after the first dose.

• Vaccine schedule for children 2 to 10 years of age

  Menveo is to be administered as single dose (0.5 ml).

• Vaccine schedule for adolescents and adults (from 11 years of age)

  Menveo is to be administered as single dose (0.5 ml).

Booster

Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine. The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.

Elderly

There are limited data in individuals aged 56 to 65 and there are no data in individuals aged >65 years.

Method of administration

Each Menveo dose is to be administered as a single 0.5 ml intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in children, adolescents and adults.

It must not be administered intravascularly, subcutaneously or intradermally.

Separate injection sites must be used if more than one vaccine is being administered at the same time.

For instructions on preparation and reconstitution of the product, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.