Nimenrix IM Injection

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.

After reconstitution, 1 dose (0.5 ml) contains:

• Neisseria meningitidis group A polysaccharide 1 5 micrograms
• Neisseria meningitidis group C polysaccharide 1 5 micrograms
• Neisseria meningitidis group W-135 polysaccharide 1 5 micrograms
• Neisseria meningitidis group Y polysaccharide 1 5 micrograms

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

• 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 doseshould be administered.
• An additional primary dose of Meningococcal Conjugate Vaccine may be considered appropriate for some individuals.

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. For instructions on reconstitution of the medicinal product before administration.

• In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and with 10-valent pneumococcal conjugate vaccine.
• From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles- mumps-rubella (MMR) vaccine, measles- mumps- rubella- varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
• In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria- tetanus- acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine.
• In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2).
• Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, should be co-administered or Nimenrix should be administered at least one month before the TT containing vaccine.
• One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein). The clinical relevance of this observation is unknown.
• There was no impact of co-administration on immune responses to the other nine pneumococcal serotypes.
• One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens included in Tdap.
• If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
• It may be expected that in patients receiving immunosuppressive treatment, an adequate response may not be elicited.

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

Adverse reactions are Appetite lost, Irritability, Insomnia, Crying, Drowsiness, Headache, Hypoaesthesia, Dizziness, Diarrhoea, Vomiting, Nausea, Pruritus, Rash, Myalgia, Pain in extremity, Fever, Swelling at injection site, Pain at injection site, Redness at injection site, Fatigue, Injection site haematoma, Malaise, Injection site induration, Injection site pruritus, Injection site warmth, Injection site anaesthesia

Pregnancy: There is limited experience with use of Meningococcal Conjugate Vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Meningococcal Conjugate Vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.

Breast-feeding: It is unknown whether Meningococcal Conjugate Vaccine is excreted in human milk. Meningococcal Conjugate Vaccine should only be used during breast-feeding when the possible advantages outweigh the potential risks.

No case of overdose has been reported.

Vaccines, Anti-sera & Immunoglobulin

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