Meningococcal Polysaccharide Vaccine

Meningococcal Polysaccharide Vaccine is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y.

After reconstitution, 1 dose (0.5 ml) contains:

• Neisseria meningitidis group A polysaccharide: 5 micrograms
• Neisseria meningitidis group C polysaccharide: 5 micrograms
• Neisseria meningitidis group W-135 polysaccharide: 5 micrograms
• Neisseria meningitidis group Y polysaccharide: 5 micrograms
• Conjugated to tetanus toxoid carrier protein: 44 micrograms

Anti-capsular meningococcal antibodies protect against meningococcal disease via complement mediated bactericidal activity. Nimenrix induces the production of bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis groups A, C, W-135 and Y when measured by assays using either rSBA or hSBA.

Nimenrix should be used in accordance with available official recommendations.

Primary immunisation: Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.

Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered. An additional primary dose of Nimenrix may be considered appropriate for some individuals.

Booster doses: Long-term antibody persistence data following vaccination with Nimenrix are available up to 10 years after vaccination. After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Nimenrix vaccination.

In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine.

Method of administration: Immunisation should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.

Hypersensitivity to the active substances or to any of the excipients.

Meningococcal polysaccharide vaccine is generally well tolerated. Adverse reactions usually occur within 48 hours following vaccination.

• Metabolism and nutrition disorders- Common: appetite lost Psychiatric disorders; Very common: irritability
• Nervous system disorders- Very common: drowsiness, headache; Uncommon: dizziness
• Gastrointestinal disorders- Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhea
• Musculoskeletal and connective tissue disorders- Common: myalgia
• General disorders and administration site conditions- Very common: pain and redness at the injection site, fatigue; Common: swelling at the injection site, fever

Pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. This vaccine should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus.

Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.

As with other vaccines, the administration of Meningococcal polysaccharide vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunization. This vaccine gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response.As with all injectable vaccines, appropriate medication (e.g. adrenaline) should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.

Vaccines, Anti-sera & Immunoglobulin

Store in a refrigerator (2-8°C). Do not freeze. Store in the original package in order to protect from light.