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Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
MenQuadfi should not be administered subcutaneously, intravascularly or intradermally.
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.
Hypersensitivity: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.
Intercurrent illness: Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Syncope: Syncope (fainting) and other anxiety‐related reactions can occur following or even before any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling or injury and to manage syncope.
Thrombocytopenia and coagulation disorders: MenQuadfi should be given with caution to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Protection: MenQuadfi will only protect against Neisseria meningitidis groups A, C, W, and Y. The vaccine will not protect against any other Neisseria meningitidis groups.
As with any vaccine, vaccination with MenQuadfi may not protect all vaccine recipients.
Waning of serum bactericidal antibody titres against serogroup A when using human complement in the assay (hSBA) has been reported for other quadrivalent meningococcal vaccines. The clinical relevance of this observation is unknown. No data are available for MenQuadfi.
Lower hSBA geometric mean titres (GMTs) against serogroup A have been observed after a single dose of MenQuadfi was administered to toddlers who previously received serogroup C meningococcal conjugate vaccine (MenC-CRM) during infancy. Nevertheless, seroprotection rates were comparable between treatment groups (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of this observation is unknown. This aspect might be considered for individuals at high risk for MenA infection who received MenC-CRM vaccine in their first year of life.
Immunodeficiency: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited (see Interactions). Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk of invasive disease caused by Neisseria meningitidis groups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi. No data on immunocompromised patients are available.
Tetanus immunisation: Immunisation with MenQuadfi vaccine does not substitute for routine tetanus immunisation.
Co-administration of MenQuadfi with a tetanus toxoid-containing vaccine does not impair the response to tetanus toxoid or impact the safety.
Sodium content: This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: MenQuadfi has no or negligible influence on the ability to drive and use machines.
However, some of the effects mentioned under "Adverse Reactions" may temporarily affect the ability to drive or use machines.
