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Nimenrix® 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.1
Dosage and administration:
Nimenrix® should be used in accordance with available official recommendations.
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.1
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.1
Hypersensitivity to the active substances or to any of the excipients.1
Special Warnings and precautions for use:
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 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.1
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.1
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.1
Thrombocytopenia and coagulation disorders
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.1
Very common adverse reactions are appetite lost, irritability, drowsiness, headache, fever, redness, pain and swelling at injection site and fatigue.1
Approval Code: BF0098OA686/052023
Invalidation date: 10/05/2025
Adverse events should be reported. Adverse events can be reported to [email protected]
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