[NIMENRIX] ® ABBREVIATED PRESCRIBING INFORMATION
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine. Each dose (0.5ml) contains 5 micrograms 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 conjugated to 44 micrograms tetanus toxoid carrier protein.
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.
DOSAGE AND ADMINISTRATION: Primary immunization:
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.
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. Immunisation should be carried out by intramuscular injection only.
Hypersensitivity to the active substances or to any of the excipients: Sucrose, Trometamol, Sodium chloride and Water for injections.
WARNING AND PRECAUTIONS:
Nimenrix should under no circumstances be administered intravascularly, intradermally or subcutaneously. It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. Persons with familial complement deficiencies and persons receiving treatments that inhibit terminal complement activation are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even if they develop antibodies following vaccination with Nimenrix. Nimenrix will only confer protection against Neisseria meningitidis group A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups. A protective immune response may not be elicited in all vaccinees. Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with rabbit complement serum bactericidal assay (rSBA) than subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years. Clinical relevance of this observation is unknown. The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib) in the second year of life. The administration of Nimenrix one month after the DTaP-HBV-IPV/Hib vaccine resulted in lower rSBA GMTs against groups A, C and W-135 compared with co-administration. The clinical relevance of this observation is unknown. A single dose administered at 6 months was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 4, and 6 months. The clinical relevance of this finding is unknown. If an infant aged 6 months to less than 12 months of age is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second primary dose of Nimenrix after an interval of 2 months. Toddlers aged 12-14 months had similar rSBA responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart. A single dose was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with two doses given two months apart. Similar responses to groups A and C were observed after one or two doses. The clinical relevance of the findings is unknown. If a toddler is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second dose of Nimenrix after an interval of 2 months. Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against group A when using human complement in the assay (hSBA) (see section 5.1). The clinical relevance of the waning of hSBA antibody titres against group A is unknown. However, if an individual is expected to be at particular risk of exposure to group A and received a dose of Nimenrix more than approximately one year previously, consideration may be given to administering a booster dose. A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical relevance of the waning antibody titres is unknown. A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 or Y. Although an increase of the anti-tetanus toxoid (TT) antibody concentrations was observed following vaccination with Nimenrix, Nimenrix does not substitute for tetanus immunisation. Giving Nimenrix with or one month before a TT-containing vaccine in the second year of life does not impair the response to TT or significantly affect safety. No data are available beyond the age of 2 years. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
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-HBVIPV/ Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 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. Pregnancy and lactation: There is limited experience with use of Nimenrix in pregnant women. Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus. It is unknown whether Nimenrix is excreted in human milk. Nimenrix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
No case of overdose has been reported.
Very common (≥ 1/10): Appetite lost, Irritability, Drowsiness, headache, Fever, swelling, pain and redness at injection site and fatigue. Common (≥1/100 to <1/10): Gastrointestinal symptoms (including diarrhoea, vomiting and nausea) and Injection site haematoma. Uncommon (≥1/1,000 to<1/100): Insomnia, crying, Hypoaesthesia, dizziness, Pruritus,Urticaria, rash, Myalgia, pain in extremity, Malaise and injection site reaction (including induration, pruritus, warmth, anaesthesia). Rare: (≥1/10,000 to <1/1,000): Febrile convulsion.
PHARMACEUTICAL PARTICULARS: Special precautions for storage:
Store in a refrigerator, (2°C – 8°C). Do not freeze, Store in the original package in order to protect from light.
4 years. After reconstitution, the vaccine should be used promptly.
LPD (SmPC), Revision Date May 2022. Date of revision of the abbreviated prescribing information November 2022.
FULL PRESCRIBING INFORMATION IS AVAILABLE UPON REQUEST.
-Nimenrix Egyptian drug authority leaflet approval date 19/10/2022 Revision date: May 2022
-Always read the full prescribing information
-Healthcare professionals are asked to report any suspected adverse reactions to the Egyptian pharmacovigilance center (EPVC number:15301) & for reporting adverse events please contact:[email protected]
-Approved by Egyptian Drug Authority: BF0098OA686/052023; Invalidation date: 10/05/2025.
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