Imojev

Imojev Caution For Usage

vaccine, japanese encephalitis

Manufacturer:

Kalventis Sinergi Farma
Full Prescribing Info
Caution For Usage
Incompatibilities: In the absence of compatibilities studies, this vaccine must not be mixed with any other vaccine or medicinal products.
Special precautions for disposal and other handling:
The freeze-dried vaccine should appear as a white to creamy white homogeneous cake which might be retracted from the sides of the vial.
The diluent should appear as a clear solution.
After reconstitution, IMOJEV is a colourless to amber suspension.
Contact with disinfectants is to be avoided since they may inactivate the vaccine virus.
Instructions for reconstitution and administration: Imojev single dose: Using aseptic technique, IMOJEV vaccine is reconstituted by injecting all the 0.4% sodium chloride solution into the vial of freeze-dried vaccine, using the syringe and one of the needles provided in the carton. The vial is gently swirled. After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into this same syringe. For injection, the syringe is fitted with the second needle provided in the package.
The product should be used once reconstituted.
Imojev multidose: Using aseptic technique, IMOJEV MD vaccine is reconstituted by injecting all the 0.9% sodium chloride solution into the 4-dose vial of freeze-dried vaccine, using a syringe fitted with a needle. The vial is gently swirled. After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn. For injection, the syringe should be fitted with a new sterile needle. A new sterile syringe and needle should be used when withdrawing each of the four doses.
After reconstitution, any remaining vaccine contained in the vial must be used within 6 hours. Partially used vials must be kept at the required temperature, i.e. between +2°C and +8°C (never place the product in a freezer).
Disposal: A partially used multidose vial must be discarded immediately if: Sterile dose withdrawal has not been fully observed; There is any suspicion that the partially used vial has been contaminated; There is visible evidence of contamination, such as change in appearance.
After use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures.
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