VAXNEUVANCE Suspension for injection Ref.[28342] Active ingredients: Pneumococcus, purified polysaccharides antigen

Posology

Individuals 18 years of age and older

1 dose (0.5 mL).

The need for revaccination with a subsequent dose of Vaxneuvance has not been established.

Paediatric population

The safety and efficacy of Vaxneuvance in children and adolescents less than 18 years of age have not been established.

Special populations

One dose of Vaxneuvance may be given to individuals who have one or more underlying conditions predisposing them to an increased risk of pneumococcal disease (e.g., adults living with human immunodeficiency virus (HIV) or immunocompetent adults 18 to 49 years of age with risk factors for pneumococcal disease; see section 5.1).

Method of administration

The vaccine should be administered by intramuscular injection. The preferred site is the deltoid muscle of the upper arm.

No data are available for administration via the subcutaneous or intradermal routes.

For instructions on the handling of the vaccine before administration, see section 6.6.

There are no data with regard to overdose.

2 years.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Vaxneuvance should be administered as soon as possible after being removed from the refrigerator.

In the event of temporary temperature excursions, stability data indicate that Vaxneuvance is stable at temperatures up to 25°C for 48 hours.

0.5 mL suspension in pre-filled syringe (Type I glass) with a plunger stopper (latex-free bromobutyl rubber) and a tip cap (latex-free styrene-butadiene rubber).

Pack sizes of 1 or 10 pre-filled syringes, either without needles, with 1 separate needle, or with 2 separate needles.

Multipacks containing 50 (5 packs of 10) pre-filled syringes without needles.

Not all pack sizes may be marketed.

• The vaccine should be used as supplied.
• Immediately prior to use, hold the pre-filled syringe horizontally and shake vigorously to obtain an opalescent suspension. Do not use the vaccine if it cannot be resuspended.
• Inspect the suspension visually for particulate matter and discolouration prior to administration. Discard the vaccine if particulates are present and/or if it appears discoloured.
• Attach a needle with Luer lock connection by twisting in a clockwise direction until the needle fits securely on the syringe.
• Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm.
• Exercise care to avoid harm from an accidental needle stick.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.