4.1 Dosing Considerations
NIMENRIX should be used in accordance with available official recommendations.
4.2 Recommended Dose and Dosage Adjustment
| ||
| Age Group | Primary Immunization | Booster |
|---|---|---|
| Infants from 6 weeks to less than 6 months of age* | Two doses, each of 0.5 mL, with the first dose given from 6 weeks of age, and with an interval of 2 months between doses | At 12 months of age |
| Unvaccinated infants from 6 months to less than 12 months of age** | One dose of 0.5 mL given from 6 months of age | At 12 months of age with a minimum interval of at least 2 months after the primary dose |
| Children from 12 months of age, adolescents and adults** | One dose of 0.5 mL | Not routinely administered |
Long-term antibody persistence data following vaccination with NIMENRIX are available up to 10 years after vaccination (see 7 WARNINGS AND PRECAUTIONS – Immune: Protection Against Meningococcal Disease and 14 CLINICAL TRIALS).
NIMENRIX may be given as a booster dose to individuals who have previously received primary vaccination with NIMENRIX or other conjugated or plain polysaccharide meningococcal vaccines (see 7 WARNINGS AND PRECAUTIONS – Immune: Protection Against Meningococcal Disease: Persistence of serum bactericidal antibody titres and 14 CLINICAL TRIALS).
4.3 Reconstitution
Parenteral Products:
In the absence of compatibility studies, NIMENRIX must not be mixed with other medicinal products.
Instructions for reconstitution of the vaccine with the diluent presented in pre-filled syringe
NIMENRIX must be reconstituted by adding the entire content of the pre-filled syringe of diluent to the vial containing the powder.
To attach the needle to the syringe, refer to the below drawing.
Note: However, the syringe provided with NIMENRIX might be slightly different (without screw thread) than the syringe described in the drawing. In that case, the needle should be attached without screwing.
1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see drawing).
3. Remove the needle protector, which on occasion can be a little stiff.
4. Add the diluent to the powder. After the addition of the diluent to the powder, the mixture should be well shaken until the powder is completely dissolved in the diluent.
After reconstitution, the vaccine should be used promptly. Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution. If not used within 8 hours, do not administer the vaccine.
A new needle should be used to administer the vaccine.
4.4 Administration
NIMENRIX is for 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 deltoid muscle (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
For instructions on reconstitution of the vaccine before administration, see 4.3 Reconstitution.
The reconstituted vaccine is a clear colourless solution.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.