Company: Novartis Vaccines, now a business of GlaxoSmithKline UK Limited.
Legal category: Prescription. Sport permitted.
Active ingredients: Recombinant Neisseria meningitidis group B proteins (NHBA, fHbp, NadA; 50mcg of each)/ outer membrane vesicles containing PorA P1.4 from strain NZ98/254 25mcg per 0.5ml dose.
Description: Suspension for injection in pre-filled syringe.
Presentation: 1, price available on request via Allphar Services.
Indication: Active immunisation against invasive meningococcal disease (IMD) caused by Neisseria meningitidis group B.
Pharmacology: The vaccine antigens NHBA, NadA, fHbp, and PorA P1.4 are intended to stimulate the production of bactericidal antibodies which are expected to be protective against IMD. Meningococci that express sufficient levels of these antigens are susceptible to killing by vaccine-elicited antibodies.
Dosage: Adult: Two doses of 0.5 ml by deep intramuscular injection not less than 1 month apart. Elderly: Over 50 years, no data. Children: 11 years and older, as per adults. 2-10 years, 2 doses of 0.5 ml not less than 2 months apart; 12-23 months (unvaccinated), 2 doses of 0.5 ml not less than 2 months apart followed by one booster dose 12-23 months later; 6-11 months (unvaccinated), 2 doses of 0.5ml not less than 2 months apart followed by one booster dose in the 2nd year of life at least 2 months later; 2-5 months, 1 dose of 0.5 ml given at 2 months of age followed by a further 2 doses administered not less than 1 month apart each and one booster dose 12-15 months later.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients.
Special precautions: Do not administer by intravenous, intravascular, subcutaneous, intradermal injection. Postpone if suffering from an acute severe febrile illness. Do not use in thrombocytopenia or any coagulation disorder contraindicating intramuscular injection (unless benefit outweighs risk). Administer other vaccines using separate injection sites. Post-vaccination febrile reactions may occur in children less than 2 years (administer antipyretics). Consider respiratory monitoring for 48-72 hours (apnoea risk) in premature infants (born ≤ 28 weeks of gestation); especially with history of respiratory immaturity; do not withhold or delay vaccination. May not protect all recipients. Immunocompromised patients, chronic medical conditions; no data. May contain kanamycin. Syringe cap contains latex. Driving/using machines. Pregnancy (no data). Lactation (assess risk/benefit).
Drug interactions: None studied.
Adverse drug reactions: Injection site reactions, gastrointestinal upset. ≥11 years: Headache, malaise, myalgia, arthralgia. ≤10 years: Eating disorders, sleepiness, unusual crying, rash, fever (≥38°C), irritability.
Full prescribing information and references available from Novartis Vaccines. Telephone: +44 (0) 1748 828816.
E-mail: novartisvaccines@professionalinformation.co.uk