SKYVaricella Injection Special Precautions

As with other vaccines, vaccination with SKYVaricella Inj. does not result in protection of all vaccine recipients.
As with other vaccines, anaphylactic/anaphylactoid reaction might occur with SKYVaricella Inj. Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use.
Deferral of vaccination should be considered in acute illness (e.g., fever >38.0°C).
After blood or plasma transfusion, or administration of immune globulin or varicella-zoster immune globulin, SKYVaricella Inj. should be vaccinated with the minimum interval (3 to 11 months), depending on the type and dose of blood or immunoglobulin.
SKYVaricella Inj. should not be given concomitantly with immune globulin including varicella-zoster immune globulin. Also, any immune globulin including varicella-zoster immune globulin should not be given for 2 months thereafter unless its use outweighs the benefit of vaccination.
Since Reye syndrome has been reported after the use of salicylates in the case of wild-type varicella infection, the vaccine recipients avoid the use of salicylates for 6 weeks post-vaccination.
Transmission of the vaccine virus has not been reported from SKYVaricella Inj. clinical studies. However, it has been confirmed at post-marketing of other varicella virus vaccine that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts and transmission of vaccine virus from vaccinees who do not develop a varicella-like rash has also been reported. Therefore, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to 6 weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus. Susceptible high-risk individuals are as follows: Immunocompromised individuals; Pregnant women without documented history of chickenpox or laboratory evidence of prior infection; Newborn infants of mothers without documented history of chickenpox or laboratory evidence or prior infection.
Use in Children: Since the safety and efficacy of the vaccine for infants less than 12 months of age has not been established, SKYVaricella Inj. is not administered to infants less than 12 months of age.
Use in the Elderly: SKYVaricella Inj. is not used in adults including elderly for the prevention of varicella.