Important Safety Information²

Therapeutic indications:
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.

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.¹  

Booster doses:
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

Contraindications:
Hypersensitivity to the active substances or to any of the excipients.¹

Special Warnings and precautions for use:
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. 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

Intercurrent illness
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
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

Adverse reactions:
Very common adverse reactions are appetite lost, irritability, drowsiness, headache, fever, redness, pain and swelling at injection site and fatigue.¹