IMVAMUNE Suspension for injection Ref.[50013] Active ingredients: Smallpox, live attenuated

To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date.

Dosage Form

Suspension for injection.

Composition

Each single-dose vial of liquid-frozen IMVAMUNE is formulated to have a titer of at least 0.5 × 10⁸ infectious units (Inf.U) per 0.5 mL (1 dose) of MVA-BN (see Section 13).

Each dose contains 0.61 mg trometamol and 4.1 mg sodium chloride. The vaccine contains trace amounts of host cell DNA and protein, benzonase, gentamicin and ciprofloxacin. The product contains no preservatives and no adjuvants.

Packaging

IMVAMUNE is supplied as a single dose in a 2-mL type I borosilicate glass vial closed with a sterile bromobutyl rubber stopper, crimped with an aluminum cap and covered with a polypropylene closure.

IMVAMUNE is supplied in a package of twenty 2-mL single dose vials.

Table 1 Dosage Forms, Strengths, Composition and Packaging:

^* The vaccine contains trace amounts of host cell DNA and protein, benzonase, gentamicin and ciprofloxacin.